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12 | December 2020

Pharma Times
ISSN 0031-6849 Total Pages : 60

Indexed by Scopus & Embase Official Monthly Newsmagazine of Indian Pharmaceutical Association

Listed in journals approved by UGC for CAS & Appointment of University Teachers

Digitization in Pharmaceutical Industry

Special Issue

U nlocking the Potential of Artificial

Intelligence for Pharma Inspection ... 32
Digitization in Pharma and Digital Therapeutics:
A Migratory Birds Eye View for Charting a Path Forward...............11
Digital Reimagination of R&D In the Biopharma Industry................16
Pharma Times
Official Publication of: Digitization in Pharma Industry – Trends and Outlook.....................23
The Indian Pharmaceutical Association, Digitization in Pharmaceutical Quality .................................................27
Kalina, Santacruz (E), Mumbai 400098.
Digitization in the Pharmaceutical Industry .......................................37
Pharma Times - Vol. 52 - No. 12, December 2020 2
Pharma Times - Vol. 52 - No. 12, December 2020 3
out of lockdown passport' and collect social credits for compliance?
we comply with, and we call these 'best' and 'good' practices. Our
Are we witnessing a new order emerging out of chaos? If so, will
ability to understand and execute SOPs relate to education and
this new order preserve or erode our inalienable rights?
training needed to realize operating cause and effect relationships
The process by which we can understand chaos is intricately in an environment such as in a pharmaceutical factory. In simple
related to what is familiar to professionals in the pharmaceutical sytems cause and effect, relationships are self-evident in a

Contents
sector – current good (manufacturing) practices and quality general population ('best' practices). In contrast, in a complicated
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and we have anarchy - freedom to be creative for good and evil.
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References
1.
Digitization in Pharma Industryerode the assurance of quality and the predictability needed in a
– Trends and Outlook
Should a small business invest in AI and machine learning software? Rishi Mehra. Economic Times

2.
Dr. Anil Kane, Ph.D., MBA
[Internet] [updated on May 25, 2019; cited on Sept 11, 2019]. Available from: https://bit.ly/2YUNwN9
Pharma Times - Vol. 52 - No. 06 - June 2020 15
Why Every Company Needs An Artificial Intelligence (AI) Strategy For 2019. Bernard Marr. Forbes

Global Technical Scientific Affairs, Patheon by Thermo Fisher Scientific .......................................................................................23

[Internet] [updated on Mar 21, 2019; cited on Sept 11, 2019]. Available from: https://bit.ly/2lKdeFE

3. A beginner’s guide to AI: Computer vision and image recognition. Tristan Greene. TNW [Internet]
[updated on Jul 18, 2018; cited on Sept 11, 2019]. Available from: https://bit.ly/2uviIpr

4. Artificial Intelligence — Future of Business. [Internet] Available from: https://medium.com/

5.
Digitization in Pharmaceutical Quality
datadriveninvestor/artificial-intelligence-future-of-business-d5107108dcfd

COMPUTER VISION: THE FUTURE OF ARTIFICIAL INTELLIGENCE. Priya Dialani. Analytics Insight.

Dr. Parizad Elchidana

[Internet] [updated on Jan 1, 2019; cited on Sept 11, 2019]. Available from: https://www.analyticsinsight.
net/computer-vision-the-future-of-artificial-intelligence/

Principal Technical Consultant – Pharma, ACG .............................................................................................................................27

AUTHOR DETAILS
Unlocking the Potential of Artificial Intelligence for Pharma Inspection
Ronak Dave
Product Manager
Ronak Dave
Ronak is a post graduate in marketing with an engineering

Product Manager, ACG Inspection ................................................................................................................................................32

degree in Electronics & Telecommunication. He is associated
with ACG Inspection for past 5 years and handles Inspection
product portfolio which includes vision systems (camera-

Digital Marketing and its Impact on the Pharma Industry

based applications) and non-vision systems (IR/NIR based
applications).

Priti R.Mohile
ACG INSPECTION
Co-Founder and Managing Director, MediaMedic Communications Pvt.Ltd. ...................................................................................34
Plot 62 CD, Kandivali Industrial Estate,

Maharashtra, India.
Tel: +91 22 3919 4725/34
Digitization in the Pharmaceutical Industry
Charkop, Kandivali (West), Mumbai - 400067,

J. Jayaseelan
E-mail: [email protected]

Vice President & Chairperson, Industrial Pharmacy Division-IPA ....................................................................................................37

Digitalisation and the Changing Healthcare Landscape
Lars-Åke Söderlund
President, Community Pharmacy Section, The International Pharmaceutical Federation ................................................................38
Blockchain: The Next Big Thing for the Pharmaceutical Supply Chain
Tariq Ahmed
Co-Founder & Editor, Logistics Insider............................................................................................................................................42
Cyber Check for Pharma - Need of the hour
Samir Aksekar
Director, Cyberwis Private ............................................................................................................................................................44
How Covid-19 has Accelerated the Need for Digitization in the Pharma Industry
Anoop Madhusudanan
Vice President, Digital Marketing, West Pharmaceutical Services...................................................................................................46

Regular Features Pharma Times

From The Editor’s Desk...........................................................................................5 Official Publication of The Indian Pharmaceutical Association
President Speak......................................................................................................7 Indexed by Scopus & Embase
Guest Editor............................................................................................................9 Editor Dr. C. Gopalakrishna Murty Dr. N. Shivaprasad
Announcements....................................................................6, 8,10, 15, 45, 49, 56 Dr. Alka Mukne Dr. J. A. S. Giri Dr. P. Khadgapathi
Editorial Assistants Kaushik Desai Dr. Premnath Shenoy
Advertisement Tariff.............................................................................................15 Dr. Mukund Yelvigi Puneet Gupta
Arjun Jeswani
Pharmaxcil Updates..............................................................................................20 Neha Dabholkar Prafull Sheth Dr. P.N. Murthy
Pooja Kulthe Dr. Rao V.S.V. Vadlamudi Raj Vaidya
Leadership Bytes..................................................................................................21 Shashikant Joag Rajesh Bhandari
Rasika R. Dharap
IPA Building Progress Report................................................................................26 Saee H. Misal Subodh Priolkar Dr. R.N. Gupta
Sakshi Y. Kasat Sanjay Jain
Association News.................................................................................................49 Shweta S.Shinde
Editorial Board
Dr. Shailendra Saraf
Dr B.N. Sinha
Advocacy Corner..................................................................................................49 Tamanna Gidwani Dr. Divakar Goli Shyamal Kalani
Vibhusha Dube Sripati Singh
Pharmascence......................................................................................................50 Hemanta Kr. Sharma
Dr. Subhash Mandal
Advisory Board Dr. Jayant Dave
Letter to Editor.....................................................................................................56 Dr. A. I. Mehta Kalhan Bazaz Dr. S.P. Manek
Prof. T.V. Narayana
Campus News.......................................................................................................57 Dr. B. Suresh M.P. George
Advertisement Index.............................................................................................59 Copyright of Indian Pharmaceutical Association. All rights reserved throughout the world.
Reproduction in any manner is prohibited.
For Pharma Times Advertisements please contact Please send your communications to:
Tel. 022-26671072 / 26670744, [email protected] / [email protected] The Editor, Pharma Times, The Indian Pharmaceutical Association, Kalina,
Website: www.ipapharma.org Santacruz (E), Mumbai 400098. Tel: 91-22-2667 1072 E-mail: [email protected]
Designed, Typeset & Printed at Ebenezer Printing House Printed by Dr. Alka Mukne, Published by Dr. Alka Mukne on behalf of
Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg, Dadar (West), Mumbai The Indian Pharmaceutical Association and published
28. Tel.: 2446 2632 / 3872 Fax: 2444 9765. E-mail: [email protected] at The Indian Pharmaceutical Association, Kalina, Santacruz (E), Mumbai 400 098.

Pharma Times - Vol. 52 - No. 12, December 2020 4

From the Editor’s Desk...
end of a year, as they do now! The annus sector being no exception. Irrespective of
horribilis that it has been, 2020 has seen the scale of operations, pharmaceutical
the world literally grinding to a halt, with manufacturers and so also regulators,
never-before-seen damage to human life academia and practice professionals were
and health and global economies taking left with no choice but to adopt measures
a hit of a magnitude that will take them that would at least initiate the ‘digitization’
years to recover from. Even as nations of procedures and systems. This special on
begin limping back to normalcy, resurging “Digitization in Pharmaceutical Industry”
‘waves’ of infection have seen reimposition though scheduled much earlier, when
of lockdowns in some of the regions. The the pandemic was nowhere in sight, has
only silver lining has been development turned out to be a very timely issue. We
of multiple vaccine candidates, with some have write-ups from the senior most experts
of them recently approved or in ver y from across the globe, covering impact of
advanced stages of regulatory approval, digitization in every single segment of the
for use in humans. There have been pharmaceutical operations’ value chain. &
misgivings in certain sections, about a then a special feature Leadership Bytes¸
hurriedly developed vaccine, especially that presents views and opinions of the top
with respect to its safety and efficacy. So national and international pharmaceutical
also, the requirement of ultra-cold supply regulatory, academia, industry and practice.
The sheer logistics of
chain for some of the vaccines, that may be Truly a collector’s issue! The issue is
vaccinating the billions a challenge in many of the countries. The supported by Associated Capsules Group
sheer logistics of vaccinating the billions (ACG) and I place on record, our sincere
of peoples makes it any of peoples makes it any government’s gratitude to Mr. Karan Singh, Managing
government’s nightmare! nightmare! Indian Pharmaceutical Director, ACG, for this generous gesture.
Association (IPA), in a joint communication
Through its well-entrenched Based on your inputs and after detailed
along with International Pharmaceutical
discussions with the editorial team, we have
network of 22 state and 63 Federation (FIP), to the Ministry of Health finalized the Editorial Calendar of theme-
& Family Welfare, Government of India has based special issues. Needless to say, the
local branches in the country, offered its services for training registered issues apart from the specials listed below,
IPA, along with FIP and pharmacists as vaccinators for the proposed would feature articles on general interest to
mass vaccination program. Through its the profession and industry at large. You can
WHO plans to train 10 lakh well-entrenched network of 22 state and write in to me at alkamukne@ipapharma.
pharmacists for administering 63 local branches in the country, IPA, along org, with your suggestions, inputs and
with FIP and WHO plans to train 10 lakh critiques. As always, we look forward to
the vaccine to the public. pharmacists for administering the vaccine hearing from you!
to the public.
A significant fallout of the lockdown
Dear Readers,
has also been the undoubted and decided
Never before have people from all shifting of all operations and businesses into
around the world so eagerly awaited the the digital realm, with the pharmaceutical Alka Mukne

Editorial Calendar for 2021 - 22

Theme Based Special Issues Month & Year Theme Based Special Issues Month & Year
Nutraceuticals February 2021 Excipients November 2021
Ethnopharmacology July 2021 Health Economics & Outcomes Research February 2022

Our Mission
The Indian Pharmaceutical Association (IPA) is the national professional body of pharmacists engaged in various facets of the profession of Pharmacy. The IPA
is committed to promote the highest professional and ethical standards of pharmacy, focus the image of pharmacists as competent healthcare professionals,
sensitize the community, government and other on vital professional issues and support pharmaceuticals education and sciences in all aspects.

The information and opinions presented in the issue reflect the views of the authors and not of the Indian Pharmaceutical Association or the Editor Board. Publication
does not constitute endorsement by IPA or Pharma Times. IPA, Pharma Times and/or its publisher cannot be held responsible for errors of for any consequences
arising from the use of the information contained in this journal. The appearance of advertising or product information in the various section in the journal does not
consitute an endorsement or approval by the Journal and/or its publisher of the quality or value of the said product or of claims made for it by its manufacturer.

Pharma Times - Vol. 52 - No. 12, December 2020 5

 IPA BUILDING SPONSORSHIP OPPORTUNITIES

Pharma Times
Pharma Times -- Vol.
Vol. 52
52 -- No.
No. 12,
05 -December
May 20202020
34 6
President Speak...
thousands of logistics professionals including that pharmacists would be needed more
corporate shippers, freight forwarders, cargo than ever to prevent ill health and ensure
terminal operators, airlines, customs house patient safety. The burden of diseases that
agents, industry consultants, warehouse existed before COVID-19 remains and some
constructors, automation providers. Logistics are likely to worsen because of the socio-
Insider  is coming up with a detailed and economic problems brought by this pandemic
well researched  Knowledge Report on the and Pharmacists have a major role to play
Indian Cold Chain Market in order to provide in future.
logistics industry insights on  Indian Cold
The National Pharmacy Week celebrations
Chain Market in terms of growth prospects,
2020 have been successfully organized
challenges before the industry in the post-
throughout India during 16th to 23rd November,
COVID era and how Government is taking
2020 with the theme of “Pharmacist: Frontline
initiative to bolster growth and much more.
Health Professional”. I congratulate all the
Logistic Insider partnered only with IPA in the
stakeholders (Students, teachers, community
Pharmaceutical segment and IPA will be on
Pharmacist and educators) involved in
their board in this knowledge dissemination
organizing the NPW activities and their by
endeavor. My thanks to Mr. Gaurav Dubey, Co-
creating awareness amongst the public
founder & Lead - Business Development for the
about Pharmacist role in making healthy
I am of the opinion that collaborative initiative and my compliments to
India. My compliments to Mrs. Manjiri Gharat,
Mrs. Alka Mukne, Editor, Pharma Times for
Chairperson of Community Pharmacy Division
the profession must now think bringing the proposal.
and IPA Student’s Forum for the NPW material
I am of the opinion that the profession must prepared. There was a good response to the
ahead and complement the now think ahead and complement the positive NPW competitions throughout India towards;
recognition it has received with evidence that Leaflet making competition, Comic poster
positive recognition it has can be used for discussions with governments making competition, Patient counselling video
after the crisis to enhance pharmacy practice. making competition. The completion results
received with evidence that can “Disease prevention is imperative to achieve were announced and displayed on IPA website
universal health coverage, development and my congratulations to all the winners of
be used for discussions with and prosperity. It is imperative for countries the competitions.
to expand their infrastructure and diversify
governments after the crisis to I am happy to share that all the divisions
their pathways for vaccination and for
of IPA are contributing to maximum extent with
pharmacies to commit to playing a central
enhance pharmacy practice. various collaborative projects, fund raising
role in vaccination strategies. The first series
activities throughout India and contributing
of FIP’s “Transforming vaccination globally
immensely to build the brand image of IPA and
and regionally” programme  involves a three-
also contributing towards the dream project of
Dear Members, part series of 8 online events, culminating
IPA building. I request the members to support
in the signing of a historical commitment by
I am happy to share with our members the activities of IPA and its divisions and make
FIP and member organisations to transform
that our official Magazine, Pharma Times, IPA more visible in their respective state and
vaccinations globally and regionally through
nowadays e-version has received several local branches.
workforce enablement, addressing anti-science
applauds and recognition from all walks of
and misinformation, addressing vaccine The construction of long awaited IPA
Pharma Profession. My special appreciation
hesitancy, and incorporating vaccination building has been completed and plastering
to Mrs. Alka Mukne, Editor, Pharma Times
qualifications into pharmacist workforce work is going on. If everything goes well, the
and the entire team for their commendable
education, from undergraduate to continuing inauguration of the IPA Building will be done
contribution and hard work during this
development, in order to ensure all in February 2021. I extend my deep sense
pandemic time. I am also happy to share
pharmacists in all settings are capable of of gratitude to Pharma institutions, Pharma
with our members that IPA is more visible
delivering vaccinations as a standard part of industries for their voluntary contribution and
and vibrant during the recent past and
pharmacist practice.  “People are now seeing sponsorship. My sincere appeal to all the
attracting several companies who are
the importance of pharmaceutical science IPA members, IPA state and local branches,
coming forward with proposals to organise
and the hope it carries. What this crisis has donors to come forward and contribute
various collaborative activities. Recently
shown is that investing in science is a prudent towards the fixtures and furniture of the IPA
IPA has signed several MOU’s with different
decision. We need new medicines that are office and building.
organisations and one such important one is
effective, affordable and accessible, as well
with Logistics Insider as Associate Partner.
as new vaccines. Research also helps us
Logistics Insider is an agency established to
to be prepared for pandemics. It is evident
bring fresh approach to the news, updates and
that Post-pandemic period is going to prove Dr. T. V. Narayana
happenings in the logistics industry. They have

Pharma Times - Vol. 52 - No. 12, December 2020 7

 Pharma Times is leading Vol.
Vol.5251 08 |05
No.No. | May2020
August 2019

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• The one of the few journals being referred by the
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Well-Being: Opportunity for Pharmacists in India to
Kalina, Santacruz (E), Mumbai 400098.

Pharmaceutical Industry.
Pharma Times - Vol. 51 - No. 08 - August 2019 PB Elevate Public Health Out-comes...................................... 28
Pharma Times - Vol. 52 - No. 10 - 11, October - November 2020 PB

Editorial Calendar
Calendarfor
for2021
2018- -22
19

Theme Based Special Issues Month & Year

Theme Based Special Issues Month
Nutraceuticals February 2021
Project Management November 2019
Ethnopharmacology July 2021

Excipients November 2021

For Opportunities, Contact us at
Health Economics & Outcomes Research February 2022 [email protected] / [email protected]
[email protected]
Tel. 022-26671072 / 26670744 Mob.: 9594745412
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Website: www.ipapharma.org
Website: www.ipapharma.org

Pharma Times - Vol. 52 - No. 12, December 2020 8 Pharma Times - Vol. 51 - No. 09 - September 2019 55
 Guest Editorial
Karan Singh
Managing Director, ACG

The COVID-19 pandemic has brought to forefront the strengths and weaknesses of pharmaceutical ecosystem
not only in India but across the globe. During these unprecedented times, pharmaceutical companies responded to
the rapid challenges arising from disruption in supply chains and the need to change business processes. Where
there was once cut-throat competition to discover, develop and market medicines, now there is collaboration.
Alongside, we have witnessed, perhaps inevitably, a rapid uptake of digital technologies in the healthcare sector,
which has been one of the slowest adopters of digital trends. Companies are now more focused on operational
resilience and accelerating initiatives that enable agility and transparency through greater deployment of digital
and analytics tools and automation.
As the recovery begins to take shape, the regulators have set the ball rolling to leverage technology to govern
and oversee better. Recently, the US FDA has formulated a Process Analytical Technology (PAT) framework. With
the goal of ensuring final product quality this unique system is deployed for designing, analyzing, and controlling
manufacturing through timely measurements of critical quality and performance attributes of raw and in-process
materials and processes. Over and above this, the US FDA has launched a pilot project to study the feasibility
of applying Artificial Intelligence (AI), Big Data, Machine Learning, in various stages of production, approval and
transportation of drugs and medicines.
The way I see it, this migration will make the USFDA ‘visits’ a thing of the past. Sitting in any part of the
world, the regulators can now ask manufacturing companies to share production data in real-time. At any given
moment, they can monitor multiple factories across the world, from just their screens.  Add a layer of AI to this,
the systems will give a pop-up anytime the manufacturing control systems even deviate by a point percentage.
In principle, the batches will be approved even before shipping, thus reducing inefficiencies and controlling the
inflow and outflow of medicines.
The second advantage of tapping into technology that regulators are looking at is trend forecasting. Ahead
of the seasonal flus, or preparing for any health-emergency, big-data will give a realistic view of how much stock
is available within the country and how much more will be required.   
These developments point to one thing – that the regulators are watching the industry with hawk eyes and
are serious about the smart application of technology to maximize potential. The Indian pharma industry is at
an inflection point, either we adapt and grow, or we perish on the sidelines. It is prudent to mention that we
had to recall 40,000 batches of drugs exported to the US in 2019 alone. Such actions could potentially impact
the position of being the second-highest exporter of pharmaceuticals to the United States and destabilize the
trust earned by Indian drug manufacturers. To avoid such last-mile failures and speed up the approval of drugs,
regulators are increasingly relying on new-age tech innovations mentioned above. Their application albeit at a
nascent stage will only rise in the future as stakeholders explore ways to bring in more efficiency and agility.
Moreover, an ecosystem as big as the pharma industry does not operate in isolation, therefore, the practices
of the USFDA will percolate to other regulators worldwide and the industry should be ready to embrace the
change.      

Pharma Times - Vol. 52 - No. 12, December 2020 9

Pharma Times - Vol. 52 - No. 12, December 2020 10
PHARMACEUTICALS BEYOND 2020: PROFESSIONALS AND
Article
ARTIFICIAL INTELLIGENCE
Dr. Ajaz S. Hussain
Digitization in Pharma and Digital Therapeutics: A Mi-
President, National Institute for Pharmaceutical Technology & Education, USA
gratory Birds Eye View for Charting a Path Forward
Summary
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(except humans) is accelerating to detect, identify, and contact trace COVID-19. Are 'Smart' technologies now a necessity to curtail this
Introduction
and prevent the next, pandemic? Smart pharmaceutical factories, From analog
with few or noto analogy-
humans a- their
cognitive process
errors of transferring
and deviant behaviors are now
moreAnalog
satisfying
and to the (US)
digital regulators,
are two ways ofand therefore
storing information
at an advantage.
and processing to another
Learning from theandrange
making ofmeaning
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the lockdown, and
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emergency use authorizations,
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such as paper in which continuously variable physical quantities the order of the four
we learn something
representing usefulDigitization
information. from knowing how AI develops
is converting aminohumans?
to emulate
analog into acids - Thymine (T), Adenine
The premise here(A), Cytosine
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attention placed on
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our DNA encodes (genetic) information.
to learnSo, areimprove
we humans
digital or numerical form,how we (adults)
typically and
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necessary for professionals,
the information particularly
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compassionate to provide
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speed accurately without a loss (or degradation) compared to view for charting a path forward to ride the metaphorical tsunami of
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analog information processing. digital transformations sweeping across the analog world, creating
a digital matrix for us to live and work.
Introduction
Several decades ago, some may remember that the process of to introspect how we individually and collectively can preven
analog to digital conversion, for example, in electronics, ushered Increasing
mistakes profitability,
and provide business process of
assurance efficiency,
quality reducing
in pharmaceuticals
We are in an epoch of unprecedented changes in the ways human errors, eliminating
beyond 2020. human intervention, improved control
in the ‘Information Age.’ The advancement of analog technology
we work and live. In this global public health emergency, the rules and compliance, integrating information, enhancing knowledge
for recording and playback from vinyl records to cassette tapes is
and regulations intended to protect patients and the public from Background
now a fading memory. Perhaps some readers may still remember and decisions and reducing environmental footprint and impact are
negligence and preventable mistakes are either suspended or not the main drivers of theCOVID-19
Industry 4.0 revolution. inNow
digital formats such as compact discs or CDs that encode digital Before the pandemic, thejuxtaposing
context of recurring
enforceable. Paradoxically, the COVID-19 pandemic is showing us the with COVID-19 pandemic to ushering what the World Economic
signals on a disk and read by lasers. challenges in the US Pharmaceutical Chain Supply 'chaos' was on
best and worst of human nature. We are amazed at the team-work and Forumsmyrefersmindtoinas twothe ‘Great
2019 Reset’[3]. This
publications (1,2) rate of change is
. In these papers, I elaborated
collaborations that
Digitalization emerged
efforts have to takeadvancing
been care of patients and toand
exponentially, develop
unprecedented
on why itinisour lifetime.
useful to recognize that a new order often emerges
WKHUDSHXWLFVDQGYDFFLQHV:HDUHKRUULÀHGLQWKHVWDUNGLVUHJDUGIRU
digital technologies influence almost all aspects of the economy
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and society. For example, a vision to transform India into a digitally Emphasizing topics pertinentcan
in chaos, and how we think of chaos
to pharmaceutical as a system and move
manufacturing,
in this IURPFKDRVWRFRQWLQXDOLPSURYHPHQW%ULHÁ\WKHNQRZKRZRUODFN
paper, we seek answers to: (a) Why has the pharma sector
empowered society and knowledge economy, an umbrella program
Along with the spreading of SARS-COV-2 in the real world, digital been thereof of
relatively understanding
slow to digitization, cause
(b) and
how it effect
is now relationships
accelerating is a usefu
‘Digital India,’ has been advancing since 2015. It has nine pillars
viruses are spreading in the virtual world. A virus is but a packet the way (c)
pace, to characterize
what changes, systems
amidst as
and simple,
beyond complicated,
the COVID-19 complex, and
ofofinformation.
growth areas: Broadband Highways, Universal Access to Mobile
No wonder contact-tracing of both RNA and digital pandemic,chaotic.we Wecanroutinely
expect inmove in and out ofoperations
pharmaceuticals these systems,
and but often
information isPublic
Connectivity, on the Internet
minds Access Programme,
of different e-Governance:
authorities. Might this without
regulatory appreciating that we can learn from feeling the emotions
oversight.
Reforming Government through Technology, e-Kranti - Electronic
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Delivery of Services,
Intelligence Information
or AI-enabled appsforand
All, bots?
Electronics Manufacturing,
Are we to acquire a 'get The paper aims to help the Pharma Times readers introspect on
IT for
out Jobs and Early
of lockdown Harvest
passport' andProgrammes.
collect social Under thefor
credits pillar Early importantSimple
compliance? lessonsand and complicated
know why we must systemslearnutilize routines (SOPs), which
to be self-assured
Harvest Programmes, the government plans to set up Wi-Fi facilities before we comply
credibly with, and
assuring we call
patients on these
the 'best' of
quality and 'good' practices. Ou
medicines,
Are we witnessing a new order emerging out of chaos? If so, will
in all universities and public spaces and provide eBooks to schools. ability to understand and execute SOPs
herbal, chemical, biological and digital, we make. The emergence relate to education and
this new order preserve or erode our inalienable rights?
Email and social media posts such as Tweets are becoming of ‘digital training
pharmaceuticals’ or ‘digital therapeutics’ reminds usrelationships
needed to realize operating cause and effect
theThe process
primary by which wemode
communication can and
understand
a ‘Biometricchaos is intricately
Attendance that weinmustan environment
pay attention to such as health
digital in a pharmaceutical
and digital regulation. factory. In simple
related to what is familiar to professionals in the pharmaceutical sytems cause and effect,
System,’ linked to Adhar, to control central government offices . Security and compliance risks need mitigation. Effective digital risk
[1] relationships are self-evident in a
sector
The notion – current
of ‘digitalgood (manufacturing)
citizenship’ is now becoming practices
a reality,and
and it quality general population ('best' practices).
management, which among other things, should also account for In contrast, in a complicated
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example,
loosening as social inrestrictions
the US and Current Good
Manufacturing Practice (CGMP) regulations
inhibitions normally present in face-to-face interactions. at 21 CFR 211.25.
Dr.Ajaz
AjazS.S. Hussain In complex systems, research and experimentation are necessary
Dr. Hussain Digitization in ‘Highly
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Office of Pharmaceutical Science, US FDA, VP and Global Head
6DQGR]&KLHI6FLHQWLÀF2IÀFHUDW3KLOLS0RUULV,QWHUQDWLRQDODQG its manufacturing techniques lag far behind those of potato-chip
Biopharmaceutical Development at Sandoz, Chief Scientific
&KLHI6FLHQWLÀF2IÀFHUDQG3UHVLGHQW%LRWHFKQRORJ\DW:RFNKDUGW Recurring errors[6] become mistakes, and product recalls to
Officer at Philip Morris International and Chief Scientific Officer and laundry-soap makers” . of
erode the assurance There are and
quality valuable lessons in this needed in a
the predictability
and President Biotechnology at Wockhardt. pharmaceutical experience amidst and beyond the COVID-19
pandemic. What might these be, how to navigate beyond 2020
Pharma Times - Vol. 52 - No. 06 - June 2020 15
Pharma Times - Vol. 52 - No. 12, December 2020 11
across an uncharted territory- are questions many should be asking. meets its specifications. Although stipulated in CGMP regulations
In this paper, we take a migratory birds-eye view, scan across the (e.g., 21 CFR 211.25), human resources qualification is often not as
familiar and uncharted territory. rigorous as it should be. Focusing on the organizational/procedural
controls is an appropriate place for gap assessment and audit of
CFR Part 11, Electronic Records; Electronic Signatures nonconformance to develop the strategy for going paperless. Starting
Modernization of pharmaceutical manufacturing and taking with software qualification and pharmaceutical process validation[7]
a risk-based approach to Current Good Manufacturing Practice provides an opportunity to improve and redefine monitoring and
Regulations necessitated a review of rules on the acceptability reporting responsibility across organizational hierarchy– from senior
of electronic records, electronic signatures and handwritten management to operational users.
signatures executed to electronic records equivalent to paper
records and handwritten signatures executed on paper, CFR Part Digitization in Pharma Juxtaposing with Politics
11. Since part 11 came into effect in August 1997, interpretation The pharma sector’s profitability, aversion to regulatory
and implementation of these regulations posed many challenges uncertainty and fear of non-compliance are often why the industry
and were often cited as an impediment to the broad adoption is reluctant to change its operations despite its low efficiency
of electronic records and electronic signatures[4, 7]. In part, this and other challenges such as drug shortages and regulatory
regulatory uncertainty is often suggested as a key contributing enforcement actions. Before the COVID-19 pandemic, the FDA
factor to a lag in progress towards digitization in the pharma sector. push towards PAT-based continuous manufacturing[9] and increased
Perhaps, the lag was necessary– as we will discuss later. scrutiny of data integrity[8] juxtaposed with digitization trends
supported by the Internet of Things (IoT) and Industry 4.0[10].
Paperless
Within the context of the US Current Good Manufacturing Industry 4.0 and Pharma 4.0
Practice (CGMP) regulations, electronic copies can be used as true The industry is part of the economy that produces material goods
copies of paper or electronic records and electronic signatures can using machines and automation. From handicraft to mechanization
be used instead of handwritten signatures for master production using steam power occurred over two centuries ago– the First Industrial
and control records. Of course, only when the copies preserve the Revolution. The Second Industrial Revolution is a Technological
original data, content and meaning include associated metadata and Revolution that ushered in standardization and industrialization and
the original records’ static or dynamic nature. Part 11 establishes began opening the gates to globalization into the early 20th Century. With
criteria for when electronic signatures are legally binding equivalent the adoption and proliferation of digital computers and digital record-
of handwritten signatures. Controls to identify the specific person keeping came the Digital Revolution, the Third Industrial Revolution. In
who signed the records electronically are essential[7]. the Fourth Industrial Revolution, which, in 2013, was named Industry
4.0 in the German High-Tech Strategy 2020 Action Plan[10].
Note that scanning a paper document to an electronic form can
generate semi-structured data from unstructured data. However, Before the COVID-19 pandemic declaration, Industry 4.0 was
electronically capturing data at its point of origination generates already a major force with significant organizational implications.
structured data. Digitization integrates structured data with At the core of several ‘Make in My Country’ efforts to secure
unstructured data, providing an organization a holistic view of its a competitive advantage in the geopolitical chaos weakening
data. It offers a means to give employees, suppliers, contractors, interrelationships that hold together the global supply chains. Now
and customers information regardless of format. it is like a hurricane. Enabling intelligent manufacturing is the goal
of Industry 4.0 via technologies such as cloud computing, cyber-
Part 11 is an important set of public health regulations; adherence
physical systems, big data analytics and artificial intelligence, and
offers (a) protection and retrieval of electronic records, (b) provides a
the Internet of Things (IoT).
means to go 'paperless,' © gain operational efficiency, improve data
integration and collaboration across organizational units that may Given the ‘market failure’ and other pharma peculiarities,
be dispersed across the globe to be able to take a ‘product lifecycle several Pharma 4.0 efforts are underway in the sector. For
approach’ to quality management, (d) it enables electronic submission example, the Pharma 4.0 initiative at the International Society of
to the regulators and (e) its requirements seek to curtailing, detecting Pharmaceutical Engineering or ISPE has progressed discussion on
and correct breaches in assuring data integrity (BAD-I). an ‘operating model’ Pharma 4.0 in the context of Digital Maturity
and Data Integrity by Design. It focuses on– (a) Resources -
BAD-I for digitization and workforce qualification and availability, (b)
Data integrity refers to the completeness, consistency, and Information Systems – holistic value network, integration, and
accuracy of data. Complete, consistent, and accurate data should traceability, (c) Organization & Processes – holistic control strategy
be attributable, legible, contemporaneously recorded, original or and lifecycle management and (d) Culture – communication and
decision-making[11]. The ISPE’s Special Interest Group Pharma
a true copy, and accurate (ALCOA). BAD-I violations have led to
4.0 aims to provide industry-wide, accepted implementation
numerous regulatory actions, including warning letters, import
methodologies, approaches, and case studies on evolving life
alerts, and consent decrees[8].
science organizations to Pharma 4.0. The ISPE framework suggests
Going paperless in a sector in which documentation of data and two additional key enablers of the ICH Q10 model, digital maturity
evidence is a core function demands companies understand the and data integrity by design.
current state of documentation control in the context of BAD-I risk. In
companies wherein BAD-I risk is high, going “paperless” can offer an Warp Speed the Great Rest
opportunity to reset the current management system and introduce A recent FDA Voice blog and tweets sought to remind the
more efficient and reliable solutions to mitigate BAD-I risk. Note community that, “the COVID-19 pandemic has shown how
that in computer science, validation refers to ensuring that software conventional manufacturing practices and predominantly

Pharma Times - Vol. 52 - No. 12, December 2020 12

international supply chains may be a liability for America’s philosophy based on the idea of progress in which advancements in
emergency response efforts.” It goes on to promote ‘Advanced science, technology, economic development, and social organization
Manufacturing,’ which encompasses process intensification are vital to improving the human condition. Progressives attempt to
methods such as continuous manufacturing and technologies progress their agenda via ‘Never Let a Serious Crisis Go to Waste,’
such as 3D printing, digital and smart design and manufacturing the origin of this quote, like the SARS-COV-2, is controversial. ‘Don’t
processes - “Because pandemics by nature are unpredictable, Waste a Crisis— Your Patient’s or Your Own,’ by M.F. Weiner, Medical
our approach to manufacturing must be adaptable. Advanced Economics 53, no. 5, 8 March 1976, is perhaps a more logical place
manufacturing provides an approach for protecting our supply for this notion in this paper. A crisis (Webster’s Dictionary) is ‘a crucial
chain and improving our response capacity during crisis situations. or decisive point or situation; a turning point’’[18]. The question now
By establishing the regulatory foundation, the FDA has created a is where are we going, to a world that provides a digital matrix to
pathway for industry to continue adopting the needed improvements empower us to pursue our life-purpose or a police state.
in manufacturing technology for the benefit of public health”[12].
From ‘Predictably Irrational’ to a Rational Path Forward
‘Operation Warp Speed’ or OWS is a public-private partnership
conducted as a military operation (aka war on virus analog to the Dr. Deming reminds us that, “A Bad System Will Beat a Good
war on terror) to produce and deliver 300 million doses of COVID- Person Every Time,” emphasizing the importance of the system
19 vaccines within twenty-four hours of FDA authorization. It is and the futility of trying to focus on blaming people for failures[19].
a strategy to accelerate the development, manufacturing, and Our healthcare system and system for education, politics, finance,
distribution of COVID-19 vaccines, therapeutics and diagnostics economics, corporate management and regulatory oversight are
(collectively known as countermeasures)[13]. socio-technical systems. The maturity of these systems depends
on society’s maturity (that is, us) and our technologies. The only
Politics playing medicine is a dangerous game. Wide-ranging way to improve these systems is to improve self, individual and
perceptions of pandemic, lockdowns, mask mandates and FDA collectively as communities of knowledge and practice.
review of medications and vaccines for COVID-19 entangled in the
increasingly divided, ‘bi-polar,’ politics. Censorship by private social In 2008, the economic crisis was the end of ‘rational economics.’
media platforms, fake-news broadly and biased mainstream news Since then, “we’re painfully blinking awake to the falsity of standard
has bewildered clinicians and the public’s significant proposition economic theory—that human beings are capable of always
about what is happening and raised concern about vaccine safety making rational decisions and that markets and institutions, in the
and effectiveness. Attempting to ‘clear the air’ and to reassure aggregate, are healthily self-regulating”[20]. Prof. Ariely wrote the
the public FDA Voice, more recently, again responded – “We are book ‘Predictably Irrational: The Hidden Forces That Shape Our
committed to expediting the development of COVID-19 vaccines, but Decisions’ in 2008 to help the communities fundamentally rethink
not at the expense of sound science and decision making. We will what makes us ‘tick’[21].
not jeopardize the public’s trust in our science-based, independent Towards the end of the 20thcentury, some had started to sense
review of these or any vaccines. There’s too much at stake”[14]. that we were rapidly moving into an ‘experience economy,’ we value
A major magazine– Time, in partnership, with the World memorable experience more, perhaps more than a product we
Economic Forum to ask leading thinkers to share ideas for how purchase[22]. So is it just a coincidence that placebo and nocebo
to transform the way we live and work. It dedicated its entire effects have been exploded in the 21st Century - a topic that has
October, 2020 issue to the Great Reset. Reset the whole economic been elaborated on in several previous reports[23,24]?
governance system by reimagining to introduce ‘stakeholder Many of us are addicted to our smartphones – checking in,
capitalism’[15]. communicating and searching. We were constantly searching for
what is missing that we need to feel satisfied and in our inbuild
Chaos to Continual Improvement: Digitization Friend or Foe? dopamine prediction error – we want more and more[24]. We may
The pharma journey – Chaos to Continual Improvement, not verbalize these words, but our actions speak loudly - please give
anticipated in 2019, before the pandemic, called the pharma me the answer to my search question. Please give me a platform to
community to recognize that chaos is a system- an unpredictable reach out to those around me. Please give me a way to share and
system exhibiting extreme sensitivity to ‘initial’ or starting explore. Oh, and do all those things immediately, if you don’t mind.
conditions– self, raw materials and regulatory submissions[16]. Our personal and professional lives are weaved together digitally
Now we must expand our efforts to think rationally about the role and through blended experiences[25]. Some can sense that we are
digitization will play in this journey. ‘in over our head’[26], but most don’t realize that we have acquired
an ‘immunity to change’[27].
The bi-polar politics of digitization is likely to yield two choices–
digitization a friend and a foe. Why so? The levels of fear, anxiety and We are in an epoch of unprecedented changes in the ways we
mistrust among a large portion of the public induced by the novelty of work and live. Paradoxically, the COVID-19 pandemic is showing
SARS-COVE-2 have expanded with juxtaposing of Industry 4.0, Warp us the best and worst of human nature. We are amazed at the
Speed, and the Great Reset to win the war against the SARS-COV-2 team-work and collaboration to take care of patients and develop
virus, whose origins remain controversial. Pinpointing the sources therapeutics and vaccines. We are also horrified by the disregard
of COVID-19, for example, as being attempted by the Lancet Task for human life and profiteering from human vulnerabilities. In this
Force[17] is necessary; they are unlikely to be sufficient. global public health emergency, the rules and regulations intended
to protect patients and the public from negligence and preventable
As a registered ‘independent,’ observing the bi-polar political mistakes are either suspended or not enforceable. The regulators
parties invoking ‘science’ to play medicine has been a valuable have no choice but to find new ways to review and inspect– and
learning experience. The next administration’s agenda is apparently they have begun exploring how to measure the maturity of systems.
shaping up to be more progressive. Progressivism is a political The COVID-19 pandemic, the first world lockdown and recurring

Pharma Times - Vol. 52 - No. 12, December 2020 13

lockdowns have fundamentally changed the economy, politics, and validation, quality by design and systems approach to quality
how we think about organizing our activities and societies. How management within the pharma sector holds valuable lessons
to rebuild the economy and re-organize a nation’s governance, a within and without, i.e., for the world. We have debated and
corporation, and the public is a burning question[28]. sometimes struggled to comply; this struggle has contributed to
the pharma’s suitability and capability to advance emergency use
Where to Start: “I feel; therefore, I am,” then... therapeutics and vaccines at warp speed.
Learning in real-time to notice emotions we feel (i.e., Nothing is perfect, and, in due course, we will reflect and learn
experience), be mindful of expanding the space between stimuli from our mistakes. The lessons we have learned and are learning
and response can be the way forward to make sense of our in pharma are obviously valuable within the sector; perhaps there
knowledge, to move from being predictably irrational to a rational is a need to appreciate that these lessons may be more useful
being. With all due respect to Descartes, “I feel; therefore, I am,” outside the industry. Pharma professionals need to be aware and
then “I am; therefore, I think” is a preferred ‘Rx’ for how to interact be engaged to ensure the unfolding of Industry 4.0 and the Great
with digital tools. With this attention, we begin to ensure digitization Reset plan adheres to the first principle, ‘first do no harm,’ and
is a friendly tool aiding our development[28]. Note that many social is evidence-based. Finally, on the intriguing question posed at the
media Apps we download for free, do not bother to read the terms beginning- are we humans analog or digital? Perhaps, from the
and conditions, are designed to addict users- and industry insiders bird-eye view perspective, we are analog and digitally quantum!
have noted that , “If you don’t give your brain time to catch up with In this recognition is our true enlightenment to chart forward from
your impulses, you just keep scrolling”[29]. chaos to continual improvement.
Evidence-based Digital Therapeutics References
In line with this ‘Rx is the 15th June, 2020 approval by the US FDA 1. Ministry of Electronics & IT (Government of India). How Digital India will be
of the first prescription-only digital therapeutics device (interesting realized: Pillars of Digital India. https://digitalindia.gov.in/content/programme-
pillars (Accessed 2 December 2020).
to consider how Rx becomes Dx), a non-drug option for improving
symptoms associated with ADHD in children[30]. To a large extent, 2. Is The Human Brain Analog or Digital? Forbes. 27 September 2016.
https://www.forbes.com/sites/quora/2016/09/27/is-the-human-brain-analog-
the digital industry has had the freedom of minimal regulatory or-digital/?sh=37928a127106 (Accessed 2 December 2020).
oversight and similar to the tobacco sector, we are now confronting 3. Now is the time for a ‘great reset’ boldly claims the World Economic Forum
consequences of social disruptions in part induced by our digital - HTTPS://WWW.WEFORUM.ORG/AGENDA/2020/06/NOW-IS-THE-TIME-
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ep-20160531pages (Accessed 3 December 2020) 571.

Ashish Pal elected President of SAPI

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Pharma Times - Vol. 52 - No. 12, December 2020 15

Article

Digital Reimagination of R&D in the Biopharma Industry

Vikram Karakoti
Vice President & Business Unit Head, Life Sciences, TCS
From vaccines to X-rays to antibiotics, innovations from the of required number of patients across geographies, ethnicities, age,
Biopharma industry have always had a life-changing impact on gender, etc. All these factors lead to delays in the timely completion
society. The industry thrives on discovery and every successful of trials, increasing costs and hindering the successful progression
innovation potentially changes the lives of millions. While the of ‘Conventional Trials’ to ‘Site-less or Remote Trials’.
industry’s focus has been on meeting
unmet medical needs, be it preventive,
diagnostic, treatment or post-care
wellness, never more has the patient
been at its center. Digital technologies
are playing a game-changing role in
enabling Biopharma’s evolving R&D
needs, be it through personalized
medicines, use of genomics and
improving clinical trial efficiency and
productivity.
The pharmaceuticals and
biotechnology (Biopharma) industry
is a highly competitive playing ground
marked by heightened regulatory
scrutiny and high-risk investments and
therefore, balancing between existing
for the greater good and maintaining
profitable bottom-lines has been akin Figure 1: Select Challenges and Opportunities for Improvement
to a tight rope walk.
Existing systems lack a compatible interface with new data
● Current Business Challenges across the Value Chain
sources such as the Internet of Things (IoT), mobile devices, patient
The industry’s traditional ways of tackling its problems have diaries, and electronic clinical outcome assessments (eCOA). Sub-
not proven to be very efficient thus far (it takes a billion dollars optimal harmonization of trial data can hinder effective mid-course
and 10 years to develop a blockbuster drug). Various challenges correction during actual studies, complicating the entire process
and improvement opportunities that can be enabled by digital and running up costs.
technologies across the value chain are depicted in Figure 1.
Drugmakers across the globe are aware that R&D is a critical
● Digital Enablers and their Role in R&D
area, involving significant time and cost. As depicted in the above Digital adoption so far has been slow in R&D when compared
diagram, Biopharma faces several challenges on this front, including to other parts of the value chain, but we believe that the biggest
inconsistent trial data, low visibility into treatment adherence, high impact to Pharma will come by accelerating digital adoption in
level of manual intervention at every stage and timely recruitment R&D. The current pandemic situation and the race to find vaccines
and cures has brought about the best of ‘collaboration’ among
Vikram Karakoti all institutions and also laid the foundation for accelerated digital
Vice President & Business Unit Head, Life adoption. This we believe will be the game changer for all future
Sciences, TCS research in Pharma.
Vikram heads the North America arm of the Genomics and Translational research, driven by digital forces
TCS Life Sciences business unit. An out and can provide breakthrough solutions in terms of relevant target
out pharma person, he followed through his identification and interventions for specific disease areas in early
Bachelor’s degree in Pharmaceutical Sciences with an MBA in drug discovery. This represents a great opportunity to accelerate
Operations. His initial experience was in R&D, product trans- drug discovery provided Biopharma companies and researchers
fers and manufacturing at an Indian pharma major, followed are able to adapt and utilize it to the maximum.
by a mid-sized pharma firm where he led the supply side of
business for India and China. His first stint at TCS was a lead- Our analysis of the current penetration of digital forces across
ership role in its SAP Practice, managing the CoE across all various stages in pharma R&D is pictorially depicted below (See
applications and industry verticals. He then moved to the US Figure 2).
to head TCS’ SAP Practice, anchoring several global, complex
multi-year transformation engagements. He has extensively ● Social Media
worked in Digital, Data and Analytics and is a key member of
Social media is increasingly gaining acceptance within R&D.
TCS strategic initiatives and investments in new technologies.
It can potentially aid in communication, allowing researchers to
Vikram is based in New Jersey, US. increase their outreach capacity by having direct contact with
potentially eligible patients for patient recruitment. It can also

Pharma Times - Vol. 52 - No. 12, December 2020 16

help in creating awareness amongst patients and the public to operations across continents. Consider clinical development –
help individuals and researchers advocate and educate others from making clinical trials adaptive to allowing global integration
regarding disease-specific clinical trials[1]. of clinical studies, cloud solutions are simplifying processes. These
cloud-based solutions enable Biopharma companies/Sponsors/
Real-world evidence and adverse event details can be collected
CROs in execution of data management strategy, real time access
through social media channels, enabling better decisions in the
to data and more importantly analysis of data to draw insights.
interest of patients. It can also help in creating a supportive
However, security and compliance are still critical to achieving in
environment (e.g. online communities) for individuals who want to
this highly regulated industry, hindering holistic adoption.
participate in trials and may help sponsors in overcoming barriers
like recruitment, participation and faster progression of clinical ● Artificial Intelligence and Robotics
trials.
The traditional process of clinical
trial has a success rate of only 13.8%[4]
AI algorithms, combined with an
effective digital infrastructure, would
help in cleaning, aggregation, coding,
storing and managing clinical trial
data. In addition, improved electronic
data capture (EDC) would also reduce
the impact of human error in data
collection and facilitate seamless
integration with other databases. AI
automation would also help in trial
design with RWD, a trial start-up by
using NLP/ML and analyzing digital
biomarkers.
Figure 2: Penetration of Digital Forces across various stages in R&D
Within R&D, natural language
processing is being leveraged to
● Mobility & Pervasive Computing
speedily analyze a plethora of scientific publications to extract
Mobility per se doesn’t need an introduction. Anyone with meaningful inferences and separately, identify candidate patients
a smartphone or a smartwatch can explain the advantages of for clinical trials.
anytime anywhere access to information. With the evolution of
technology, the definition of mobility has been broadened to Although robots are available to perform mundane tasks to
include a multitude of devices which can be connected via WiFi, reduce human errors on the benchtop in research labs, their costs
cellular networks or other forms of communication like sensors, are currently prohibitive for widespread adoption.
RFID tags and video cameras, giving a true sense of the pervasive
While taking into consideration AI/ML we need to be aware
nature of computing
of conforming to all the regulatory needs of ICH/GCP, CFR21 part
A multitude of dedicated apps in R&D can serve as laboratory 11 validation, etc. We also need to appreciate that for AI/ML
calculators and recipe management interfaces for MES. Pervasive solutions to be effective, diverse teams of individuals with expertise
computing in the form of sensors and other technologies is being in multiple areas such as medicine (as per disease), research,
seriously evaluated for applications in remote patient monitoring biostatistics, modelling and AI algorithm design specialists are
in clinical trials and remote equipment diagnosis, repair and needed. Also, continuous supervision of machine outputs and
servicing. For instance, increasing usage of mobile phones, necessary recalibration is important.
automated speech recognizing personal assistants, and internet
access among the geriatric patients have been providing new ● IoT and Connected Smart Devices
opportunities to incorporate such technologies into clinical research Internet of Things (IoT) and connected smart devices expected
and personalized medical care for Alzheimer’s disease[2]. to improve efficiency of overall clinical trials through better patient
retention and reduced trial duration. Such devices streamline the
● Big Data & Analytics data collection process and make the entire clinical development
It has been estimated that Big Data can add US$100 billion in workflow smarter and intuitive. IoT enabled trials to help in patient
value to the pharmaceutical industry by improving research and engagement and empowerment, remote patient monitoring, faster
development[3]. Indeed, analytics run on big data can generate patient enrollment and lesser dropouts and thereby leading to
some unique insights that are either descriptive (past trends), reduced operational expenses, higher efficiency, data quality and
predictive (future trends) or prescriptive (actions necessary to alter integrity. Application of digital health on IoT platforms can create
the course of future trends). Combined with high performance unlimited opportunities for wearable devices and smart technology
computing, these digital forces are enabling faster and efficacious sensors to change and simplify the process of clinical trials to be
drug discovery and development. more cost effective[5].

● Cloud Computing ● Augmented Reality/Virtual Reality

The Biopharma industry has commenced cloud adoption, with Augmented and Virtual reality devices present new possibilities
multiple teams collaborating in R&D and sales and marketing in clinical trials. From helping patients to manage anxiety and pain

Pharma Times - Vol. 52 - No. 12, December 2020 17

to providing key training for researchers, VR has big potential. For example, an AI-driven drug discovery company, Exscientia
Cedars-Sinai has the largest clinical VR program in the world collaborated with Sumitomo Dainippon Pharma company to
which has been treating more than 3,000 patients through AR/ invent a new drug candidate using AI technology for the treatment
VR. Johnson & Johnson Institute’s global VR training program for of obsessive-compulsive disorder as an initial indication. This
surgeons and nurses is also gaining significant traction. While innovation took less than 12 months to complete the exploratory
current adoption is limited to drug discovery area mainly due to research phase, just a fraction of the typical average of 4.5 years
operational challenges, AR/VR is still an exciting addition to the using conventional research techniques and have got approval from
use of digital technologies in clinical research[6]. regulatory authorities to enter in phase 1 human clinical trials[8].

● Research & development – Reducing Costs and ● Personalizing Medicine

Improving Throughput Personalized medicine is a form of medicine that uses
While innovation may seem like a buzzword, for a business that information about a person’s own genes or proteins to prevent,
depends significantly on research and development for its revenue diagnose, or treat diseases. Examples include using targeted
and earnings sustenance, the life sciences industry is grappling therapies to treat specific types of cancer cells, such as HER2-
with issues that, if left unaddressed, threaten to undermine its positive breast cancer cells, or using tumor marker testing to help
existence. In 2019, R&D expenditure of the global top 10 pharma diagnose cancer. At times, this is also referred to as precision
companies was more than 20% of their revenue. J&J, Merck, Eli medicine.
Lilly, BMS, and Roche were amongst the top spenders[7]. Digital
Digital technologies are also enabling personalized medicine.
technologies present several opportunities to reimagine R&D.
Physicians and researchers are using high-performance computing
to correlate biomarkers, genetics and genomic data to an individual
● Drug Discovery and Pre-development
patient to a similar population and subsequently to the most
Target identification and validation is the earliest phase of R&D efficacious treatment. Clinical trials are incorporating genomics to
and making the right choice of targets at the outset is a critical understand variability in drug response. The genetic differences
first step in the protracted and expensive R&D process. As depicted in participants enable scientists to identify biomarkers associated
in Figure 3, traditional R&D processes are evolving into models with the clinical patient outcome, which plays a key role in drug
bolstered by digital technologies, greatly improving productivity development. Additionally, genomics helps in distinguishing
and shortening drug discovery times.
patients into sub-groups, identifying best candidates for a trial and
● In vitro to in silico eliminating ineffective therapies at an earlier stage[9].

High-throughput screening (HTS) is a drug discovery technique Devices and sensors allow physicians to continuously monitor
widely used in the pharmaceutical industry which leverages patients remotely and tailor treatments on the go. In the near
future, 3D bioprinting will come to
medicine and nothing will become
more personal than the ability to print
an organ from one’s own cells.

● Driving Collaboration and

Researcher Productivity
Since the R&D process is long,
cumbersome, multi-locational
and partnered, collaboration and
knowledge management among
researchers is an important enabler.
Using cloud solutions, portals and
Figure 3: Evolving R&D Models for Drug Discovery and Development social media networks, data is being
made available in near real-time
across departments, functions and
automation to quickly assay the biological or biochemical activity geographically diverse locations, ultimately resulting in better
of a large number (upwards of 1012) of drug-like compounds collaboration among researchers and increased researcher
against disease targets to identify ‘hits’. Compared to traditional productivity. These digital solutions allow for analyzed R&D data
drug screening methods, HTS is characterized by its rapidity, low to be made available in rapid time, facilitating quicker go-no-go
cost and high efficiency. Using digital technology, Virtual Screening decisions, saving precious time and dollars.
automatically evaluates very large libraries of compounds, allowing
HTS to be extended to filter a large universe of over 1060 conceivable ● Pre-clinical and Clinical Trials - Managing Trial Tribulations
compounds to a manageable number (~102 - 103) that can be Managing clinical trials is fraught with multiple challenges -
synthesized and tested. Virtual Screening has now become an patient recruitment and retention, medication adherence, data
integral part of the drug discovery process. In addition, published capture and protocol compliance, being the significant few. With
scientific literature can be scoured using cognitive computing by increased regulation driving larger and longer trials, clinical trial
applying Artificial Intelligence (AI) to gather information on identified recruitment is becoming increasingly difficult, complex and time
targets and to prioritize them. Ultimately, the approach results in consuming. Companies are adopting eRecruiting, eCommunication,
non-trivial cost and time savings. digital consent management, eClinical trials etc. with combination

Pharma Times - Vol. 52 - No. 12, December 2020 18

of the digital forces to transform multiple aspects of clinical trials, from people who live in areas where access is restricted. Combining
from patient recruitment and retention to data collection to supply this Real-World Evidence (RWE) with lab-generated data can mitigate
chain, as depicted in Figure 4. failed clinical trials. RWE has the advantage over clinical trial data
in that it often provides information
on comparators and outcomes
representing a broader population
over a longer timeframe, which are
not part of the clinical trial protocol.
By harnessing the power of predictive
analytics, researchers are able to
optimize Risk Based Monitoring (RBM)
to pre-emptively identify potential patient
safety and operational performance
issues, mitigating risks for the subject
and trial.

● Trial Data Management

Traditional trial data collection and
management is a cumbersome process
required to support the volume and
Figure 4: The Past and Current State of Clinical Trials with Enabling Digital Technologies
velocity of data generated during the
● Patient Retention product development life cycle. Hence, pharmaceutical companies
have been transforming Clinical Data Management through:
Keeping patients involved and compliant from the start of a trial to
the end is a challenge. Gamification simplified and digitized consent 1. Driving holistic programs focused on process reengineering and
forms, text message/smartphone notifications can be implemented IT rationalization.
to address the high dropout rates (average around 30%) which 2. Investing in building capabilities in advanced analytics and
jeopardizes trial results, extending time (by as much as 80%), failing adopting next-generation technologies.
to retain enough patients (~85%) and increasing costs[10]. 3. Augmenting data standardization using technologies such as
Utilizing digital technologies like social networks and gamification robotic process automation, artificial intelligence, machine
to collect study data and cloud systems to collect data remotely learning, and natural language processing.
without an in-person visit, can drastically improve patient retention 4. Data repository creation.
rates and save precious time. To help the patient understand the 5. Creating synergies between technology vendors, CROs, others
clinical trial better and allow for improved data collection, better for better trial outcomes.
training using gamification and interactive material can be employed.
For example, a simulation of the clinical trial can be presented in ● Regulatory Compliance
the form of a game which investigates molecular compounds at a Innovation opportunities in regulatory affairs span across
research desk, tests it in the laboratory, then conducts clinical trials everything from global labelling management, creation and proof-
and if successful, advances the drug to the market. reading of documents, to automated artwork generation[11].
● Medication Adherence Automation led platforms and solutions integrated with digital
Multiple digital initiatives can be used to address and improve technologies can play a key role in quality and compliance and
medication adherence and protocol compliance. Connected overall efficiency of regulatory submissions. Digital automation
Clinical Trials (CCT) solution (developed via collaboration between will also transform the way to manage health authority queries and
Janssen Pharmaceuticals and TCS) is a noteworthy example auto-filling regulatory forms for the EMA or FDA.
tackling this issue. Trial participants receive all communications
● Pharmacovigilance
through smartphones (with multi-lingual support) - trial instructions,
dosage regimens, changes in drug labeling and timely reminders Pharmacovigilance and Post-marketing safety analysis use
to take their medicine. Logging of treatment adherence occurs informative systems to suspect adverse reactions spontaneous
through microelectronics embedded in the blister packaging of reporting[12]. Today, major technologies that are influencing these
medicines which notes the time and geographic location every critical processes are:
time patients remove a pill, allowing immediate interventions ● Big Data- Signal detection, substantiation and validation
whenever necessary. Automated logging eliminates cumbersome of drug or vaccine safety signals and online channels and
paperwork, manual drug count and verification of patients’ drug social media[13].
log and use of paper-based booklets, ultimately reducing human ● Natural Language Processing - Incorporation of NLP into
error and improving efficiency. pharmacovigilance still needs refining and development,
with respect to detect adverse events on social media.
● Trial Data Collection ● Cloud - Moving into cloud allows companies to play with large
Investments should be made in mobile and cloud technologies for amounts of data. With a growing number of adverse events,
remote patient monitoring and to allow for communication between there is a need for technology that would accommodate the
patients and investigators. Devices can collect information from growing volume of data to take the most informed decisions
patients, presenting an opportunity to gain insights for the trial even about the benefit-risk profiles of drugs.

Pharma Times - Vol. 52 - No. 12, December 2020 19

● Clinical Operations trials-and-errors-the-use-of-social-media-in-clinical-trials/)
There are multiple limitations that clinical trial sponsors 2. Mobile and pervasive computing technologies and the future of
Alzheimer’s clinical trials (https://www.ncbi.nlm.nih.gov/pmc/
should overcome to make the overall process more efficient and
articles/PMC6550135/)
to increase overall trial productivity. Areas like faster study start-
3. The Growing Importance of Big Data in the Pharmaceutical Industry
up, study build and execution, adaptive monitoring, site feasibility,
(https://www.smartdatacollective.com/growing-importance-big-data-
and targeted study interventions, digitization supply activities for pharmaceutical-industry)
clinical trials, etc. does hold a huge scope for adoption of digital
4. Clinical Trial Success Rates By Phase And Therapeutic Area (https://
technology led platforms and solutions. www.acsh.org/news/2020/06/11/clinical-trial-success-rates-phase-
and-therapeutic-area-14845)
In 2019, Microsoft rolled out a new Clinical Trials Bot, which
is part of their larger health care bot initiative designed to create 5. Internet of Things in Clinical Trials (https://www.jli.edu.in/blog/
iot-clinical-trials/#:~:text=Adoption%20of%20digital%20health%20
automatic chat programs for triaging patients. The trials bot aims
on,that%20collect%20data%20more%20efficiently.)
to make it easier for patients and their doctors to find clinical trials
6. Virtual Reality in Clinical Research: Potential, Implementation
related to a specific illness.
and Challenges https://www.anjusoftware.com/about/all-news/
insights/virtual-reality#:~:text=VR%20has%20already%20been%20
● Reimagining tomorrow successful,can%20heal%2C%20Spiegel%20tells%20Holland.)
The regulated nature of the Biopharma industry has led 7. Pharmamanufacturing.com (https://www.pharmamanufacturing.
its executives to perceive compliance as the major barrier for com/articles/2020/top-10-pharma-companies-by-r-and-d-spend/),
digital adoption. However, there are other important issues EvaluatePharma_World_Preview_2019 Report
at play - management resistance, data security concerns, 8. Sumitomo Dainippon Pharma and Exscientia Joint Development New
infrastructure and trained manpower requirements. To address Drug Candidate Created Using Artificial Intelligence (AI) Begins Clinical
these effectively, the fundamental prerequisites are – a clear Trial (https://www.exscientia.ai/news-insights/sumitomo-dainippon-
vision, correct evaluation parameters for assessing benefits, pharma-and-exscientia-joint-development)
cultural change, increased employee adoption and enhanced 9. The benefits of using genomics in clinical trials (https://
frontlinegenomics.com/the-benefits-of-using-genomics-in-clinical-
security measures.
trials/)
The industry needs to actively examine the applications and 10. Considerations For Improving Patient Recruitment Into Clinical Trials
implications of digital forces. To fully realize benefits, companies (https://www.clinicalleader.com/doc/considerations-for-improving-
need to set up the base of platforms, policies, organization patient-0001#:~:text=85%25%20of%20clinical%20trials%20
structures and governance. Creating an enabling environment fail,no%20patients%20in%20their%20studies)
for the digital forces will empower the business to reimagine 11. How Digital Innovation Is Helping To Drive Transformation In
itself. Adoption should be explored not only within specific value Regulatory Affairs (https://pharma.nridigital.com/pharma_nov18/
how_digital_innovation_is_helping_to_drive_transformation_in_
chain segments like R&D but also pan-enterprise by leveraging
regulatory_affairs)
a combination of the digital forces to solve critical business
12. Pharmacovigilance and Digital Transformation: Growing Role of
issues. Technology (http://sequrelifesciences.com/pharmacovigilance-
digital-transformation/)
References
1. Trials and Errors: The Use of Social Media in Clinical Trials, August 13. The role of “big data” in pharmacovigilance (https://www.pharmaco-
19, 2019, by Christina Ditlof (https://www.immpressmagazine.com/ vigilance.eu/content/role-big-data-pharmacovigilance)

(Setup by Ministry of Commerce & Industry, Govt. of India)

Business Collaboration with Japanese companies

We are pleased to inform our members that the Council has Indian companies who may be interested in collaboration
received a communication from the Embassy of India, Japan with Japanese companies in the area of pharmaceuticals with
with regard to business cooperation with Japanese companies. their specific area of interest/ business sector/ technology may
About 17 Japanese companies are willing to work with Indian please share  the  short self-introduction about the company
companies and are open for business collaboration/ technical along with contact  details directly to the Sri. Gaurav Gupta,
collaboration/ JV, etc. in the pharmaceutical sector (related Second Secretary, Embassy of India, Tokyo (email: gaurav.
to API/ COVID-19, etc.)  and medical device sector.  List of [email protected]). The Indian embassy is kind enough to
Japan  https://drive.google.com/file/d/1pNM4uYgTjtLTK5hQ share the details with the Japanese side to explore any possible
wDLoEnZRlNY4gvDI/view business opportunities and to connect both parties directly.

Pharma Times - Vol. 52 - No. 12, December 2020 20

 Leadership Bytes

Dr. Eswara Reddy

Joint Drugs Controller (India)
Future Impact of Digitization in the Pharmaceutical Industry

T
he process of digitization is transforming the whole world in to a new digital world and has made
human life very easy and interesting. It’s impact can be seen everywhere in almost all the sectors
of life and society. As pharmaceutical industry is a highly science and knowledge driven industry,
the impact of digitization has profound effect in improved data sharing, creation of system integrations,
improvement in supply chain efficiency, implementing unified quality management systems through unique
servers, improvement in various analytical and manufacturing technologies and capabilities, implementing
quality by design strategy in product and processes development, enhancing drug development process
by utilizing real-time information of drug effect to the patient, providing 24 X 7 virtual care/ assistance
to the patients, collating post marketing data such as pharmacovigilance of any drug across the world
through single web-based software, enhancing regulatory compliances, drug designing processes by maintaining a huge database
of protein data banks, aids in advancement of newer therapies, diagnostic tools and techniques such as robotics surgery,
wireless brain sensors, 3-D printing prosthetics, wireless brain sensors, artificial organs, health wearables etc with the help of
artificial intelligence, machine learning and other advanced techniques. Thus in overall, this digitization process will facilitate
the healthcare transformation and enable pharma companies to improve drug development and patient care.

Dr. B. Suresh
President, Pharmacy Council of India

D
igitization of all facets of life, industry, and education is an inevitable direction in which we are
all set to progress. The education sector which does readily accept disruptive changes saw
itself transforming almost overnight into a digitally supported initiative and continued to provide
education to the students. A three dimensional (3D) change is all set to happen. The digitisation of
education is going to be ‘Perpetual’ and not vanish after the pandemic ; it will be ‘Pervasive’ and influence
education at all levels and it will be ‘Exponential’, accelerating at a rapid rate. Digitisation will be our
own PPE for ensuring that the education quality is visible from out of the class room to a global view
room. Pharmacy Council of India is all set to embrace this technology advantage and equip students
respond to the digital needs of the industry and other stakeholders. Many consider the year 2020 as
an anamoly but it may not be, as these are conditions for accelerating the change that has been building for years. This will of
course necessitate unlearning, learning and relearning but we have to be prepared for the same.

Dominique Jordan
President, International Pharmaceutical Federation

J
ust as industrialisation did in the 20th century, a new tsunami ― technology and artificial intelligence
― is hitting pharmacy. We must quickly consolidate our role and, just as our profession integrated
industries into its environment, it will be necessary to take ownership of new trends, new technologies,
new logistic models and integrate them into our everyday work. As we have seen this year, technology
has allowed us to continue to provide high quality pharmaceutical care during the COVID-19 pandemic
and to ensure safe access to medicines and their optimal use, and it will create more opportunities for
our profession. FIP has recently published a position statement on emerging technologies and pharmacy
practice: www.fip.org/file/4874. By being part of technological advances, pharmacy can deliver universal,
safer, more accessible, timely and better value healthcare through a more compassionate, personalised
and rewarding model of care for the communities we serve, now and into the future.

Pharma Times - Vol. 52 - No. 12, December 2020 21

 Dr. Dinesh Dua
Chairman, Pharmexcil

R
ight from the onset of Covid-19 in India since Lockdown towards the end of March, 2020, digitization
has taken a centre stage in the industry & more so in the Pharmaceutical industry. All of us are
aware Pharma industry post the first 10 days of lockdown has been working 24x7 as per the
clarion call by Hon’ble Prime Minister, Shri Narendra Modi Ji & has more than fulfilled its performance as
“PHARMACY TO THE WORLD” by supplying highly cost effective, affordable & excellent quality Medicines,
Vaccines, APIs & Biologics to 206 out of 211 countries.
On account of severe pandemic constraints, digitization came to the rescue of pharma industry & helped
in all functional areas particularly Communication by way of Webinars & Videoconferencing, Manufacturing
through virtual mapping of parameters of performance as also enhancing productivity through virtual
tracking, Quality Management System both Quality Control & Quality Assurance in terms of digital mapping & capture of the quality
parameters, its interpretation & course correcting many issue, Regulatory compliances through virtual audits, sharing of all
aspects of virtual tour of the facilities. All SOPs, CAPAs & other related documents were not only digitized but very quick analysis
& discussions on the same was done through Video Conference which helped in clearing of almost all the Q & A discussions.
In Sales & Marketing, there has been a paradigm shift because of digitization since there has been no physical travel & only
digital platforms that brought about a dynamic change in the conduct & marketing efforts in the pharma industry, more so in
case of exports where Intercontinental discussions were held very frequently & helped to understand, interpret various issues
comprehensively not only through discussions but also through extensive & comprehensive analytical tools.
In the pharma industry a new wave of dynamic change is happening slowly but surely, in terms of considered automation through
digital interface. Although India has an advantage of lower labour costs when compared to the West, China, South East Asia &
MENA in particular, a combination of the same with digital practices & interventions will not only bring about precision management
in all functional areas but will help save Indian Pharma companies significant amounts through Operational Excellence.
Current wave of digitization in Pharma industry is not only to be maintained & sustained but should be taken complete advantage
to the benefit of all stakeholders of Pharma industry i.e. Manufacturers, Customers, Supply Chain protocols, Institutions as well
as achieve the ultimate objective of the expeditious alleviation of the suffering of patients.

Dr. Rao Vadlamudi

President, Commonwealth Pharmacists Association
Impact of Digitization on Pharmacy Practice

D
igitization is the process of converting information into a digital format, which has a huge impact
on the way work is managed at the workplace. To move into digital ways of working, one not only needs
new technologies but also a shift in mindset, leading to digital transformation. Digitization and digital
transformation profoundly impacted business in various domains including pharmaceutical manufacturing, supply-
chain and pharmacy practice. Digitization is capable of transforming your local pharmacy to a wellness centre.
The impact of digitisation on pharmacy practice is particularly pertinent in our current pandemic times. Digitisation
provides many opportunities to consider new and innovative ways of delivering pharmacy care - including
enabling routine repetitive tasks to be automated and standardised to improve care efficiency. Digitisation
enables connectivity between health systems, facilitates communication between providers and sharing of health
information, which streamlines care and improves patient safety. Technologies such as barcode medicines identification, automation of
medicine supply, and technologies to check for substandard and falsified medicines have significant impacts on safety. Digitisation also
supports better quality care to enable patients self-managing their conditions, for example, via adherence monitoring, and telehealth,
though considerations regarding privacy, data governance and impact on health inequities need to be made.

Mahesh Doshi
National President, Indian Drug Manufacturers' Association
Digitization in the Pharmaceutical Industry

T
he COVID-19 pandemic altered the directions of growth in pharma market in India. For marketers a
lot of challenges rose with no physical Sales Conferences, most Doctors not ready to meet MRs etc.
The only way now to reach a doctor is digitally. Every business will now see the need to build a robust
digital-driven delivery capability. The gradual emergence of a ‘new normal’ as we exit the emergency phase
of COVID-19 pandemic comes with some important considerations for all companies, mainly the need to
accelerate digital transformation. Initiatives like ERP or mobile applications are increasingly being adapted
to provide real-time information for making strategic decisions. Automation of production processes and
Digitization will be key factors for enabling robust regulatory compliance infrastructure in future. Many
companies are investing enormous resources in building corporate brands and strong patient-friendly
online presence and also effectively using social media to create awareness about their initiatives. Digitization, however, will
also come with its own protocols, risks, resourcing challenges apart from investment and maintenance considerations.

Pharma Times - Vol. 52 - No. 12, December 2020 22

 Article

Digitization in Pharma Industry – Trends and Outlook

Dr. Anil Kane, Ph.D., MBA
Global Technical Scientific Affairs, Patheon by Thermo Fisher Scientific

Digitization is the use of information

shared through systems integration, connected
devices, and more to understand and predict
consumer demand, connect businesses and
improve supply chain efficiency. Digitization
can provide enormous benefits for small and
large businesses within the pharmaceutical
industry[1]. Pharmaceutical companies need
to be acutely aware of changes in global
healthcare and focused on how to best utilize
digitization.
For example, the use of digitization can help
create counterfeit-proof medications with serial
numbers that are trackable across the supply
chain, ensuring quality while meeting upcoming
serialization requirements[2]. Pharmaceutical create opportunities for new entrants outside of pharma business
companies can also use digitization to meet the expected increased whose innovation and business clock speed are on a completely
demands from markets across the globe. Digitization can help different level[4].
them meet regulations, find manufacturing efficiencies to address
cost pressures and use cloud-based information sharing to quickly The Pharma industry is facing the biggest transformation
connect with suppliers and distributors. In addition, automation, since the rise of modern medicines in the nineteenth century and
smart sensors, social media, and health apps can help measure the introduction of manufacturing automation in the 1980s. The
drug compliance and predict demand across regions to support transformation is already driven by the increasing global regulation,
real-time manufacturing[3]. intensifying competition, demanding payer requirements and
increasingly complicated product supply ecosystems.
Key Drivers to Digitial transformation in Pharma Industry:
At the same, completely new business opportunities are
Pharma business is undergoing a transformation in multiple, opening with new novel technologies and partnerships with high-
unrelated areas changing the whole product lifecycle from early tech companies. The future defining challenge will be how the
drug development to manufacturing and patient care. This inevitable very diverse and complex business requirements can
transformation will not only challenge the incumbents but also be implemented with the current manufacturing, product supply
networks and– most significantly – business models and products.
This means that pharma companies already clearly perceive that
Anil Kane, Ph.D., MBA their future competitiveness is at stake due to external and internal
Global Head of Technical & Scientific Af- drivers.
fairs, Patheon Inc. part of Thermo Fisher
Scientific The pharma manufacturing infrastructure implementations are
already highly complex with an increasing number of connected
Dr. Kane has more than 25 years of experi-
equipment and internal and external system integrations. The pharma
ence in the science and business of taking
molecules through the entire drug development process. His ecosystem is highly networked with the pharma industry-specific
extensive knowledge spans early stage development to scale- requirements eg, for collaborative R&D data management and
up and commercial manufacturing, and includes technical supply chain regulatory compliance reporting. These fundamental
transfers between global sites and drug life cycle manage- pharma ecosystem, business model and technology changes are the
ment. factors leading to a new manufacturing and product supply industry
Dr. Kane received his Bachelors, Masters and Ph.D. degrees
transformation called the New Pharma Reality.
from the Bombay College of Pharmacy, University of Bombay, It is obvious that these market challenges and requirements
India, and served as a post-doctoral fellow at the School of can’t be met with the current products, business models and
Pharmacy, University of Cincinnati, Ohio. He has also earned
operations. Therefore, the pharma business transformation is
an executive MBA from Richard Ivey School of Business, Uni-
inevitable which will lead to the digitization of the pharma products,
versity of Western Ontario, Canada. Dr. Kane is a member of
various international pharmaceutical professional organiza- business models, operations and ultimately– the patient care. For
tions, and is often invited to speak about scientific topics on example, pharma giants like Novartis, GSK and Novo Nordisk are
formulation, technology, other technical aspects, QbD, etc at already investing in partnerships and new business models with
major industry events. He has also published many articles in technology companies such as Google, IBM and Qualcomm. Not to
International journals and delivered many talks at meetings mention traditional device manufacturers like Apple, Samsung and
and conferences cross the globe. Nokia who are already researching beyond the wellness products
and looking to the patient care market.

Pharma Times - Vol. 52 - No. 12, December 2020 23

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Fig.2: Digitization– shaping the future of Pharma Industry from Discovery to Supply Chain
and Patient Care  Patient Recruitment:
Drug Discovery: Digital brings with it predictive algorithms
that can help find the most efficient, appropriate trial sites, and
Pharmaceutical research is highly complex and has a relatively
tools to accelerate and broaden eligibility assessment and patient
low probability of success. Less than one percent of the projects
recruitment. More than 70% of trials are currently delayed because
make it from early research to market approval. Many Big Pharma
companies leverage advances in analytics and digitization to of patient recruitment. Companies are now using digital to recruit
accelerate drug discovery and to improve the drug development more efficiently, using multiple channels and data categories,
productivity in terms of quality, cost and cycle time. such as electronic health records, to identify eligible patients.
They are also engaging partners with their virtual trial platform,
Combinatorial Chemistry in Drug design and discovery: or ‘meta-site,’ which allows patients to participate in trials from
Combinatorial chemistry has turned traditional chemistry their living rooms.
upside down when introducing automated substance synthesis to
the drug discovery process. By accelerating the process of chemical Data Capture:
synthesis, it allows rapid synthesis of large, organized collections Wearable devices are allowing faster, more reliable, and more
of compounds. convenient data capture from both on-site and remote patients,
Approaches adopted to increase productivity/
success rates in Drug Design include Big Data,
Artificial Intelligence (AI), Machine Learning (ML),
Neural Networks (NN), QSAR modeling and many
other computation and experimental approaches
have been adopted by researchers, medicinal
chemists and pharmaceutical experts like:
-Molecular docking
-Genetic association
-Phenotype screening
-Signature mapping
-Retrospective clinical analysis

Many Pharma companies are investing

in artificial intelligence and machine learning
in drug design and discovery. AI serves as a Fig. 3: Approaches adopted to increase productivity / success rates in Drug Design
promising avenue to aid R&D by designing better
drugs and reducing time and cost. While hurdles helping minimize geographical distances and widening catchment
exist in its integration, the coming decade will see greater use of areas. Several pharmaceutical companies including Novartis are
AI in R&D, with various approaches seeing success or failure. The doing research studies using mobile phone-based apps to track
analysis suggests AI could reduce R&D costs between 5%-47% certain movement and symptom data remotely.
and save up to 2-3 years in approval time for pharma and biotech
companies and should gain traction given it may optimize different Other Digital applications in Clinical Data Management also
phases of drug development. include:

Pharma Times - Vol. 52 - No. 12, December 2020 24

 o Clinical Trial Informatics Pharmaceutical companies often adopt Continuous Process
o Cloud Storage Verification (CPV), through which all data generated during product
manufacturing can be continuously assessed and validated
o Electronic Health Records
against regulatory guidelines, to ensure they stay within the
o e-Consenting parameters documented when those processes were validated.
o Bioinformatics Hundreds, sometimes thousands of variables must be monitored
to verify that they remain within the specifications established
Digital Pharmaceuticals: for this process. This is an ideal application for Pharma 4.0
Digital is providing entirely new diagnostic and treatment technology[9].
modalities. And the first digital-only solutions have been winning
There are four key ways in which digitization can contribute
approval– from the same authorities that regulate conventional
to CPV.
new drugs and devices. In September, 2017 Pear Therapeutics
made waves by gaining FDA approval for its application to treat 1. Analytics: Statistical process control (SPC) techniques
opioid use disorder. This marked the first FDA clearance of a develop the data collection plan and statistical methods and
software application with a safety and efficacy label[6]. The reSET-O procedures used in measuring and evaluating process stability
device supports addicts in using techniques such as community and process capability.
reinforcement, fluency training (in the language of recovery), 2. Risk-based real-time approach: To verify a process that
and contingency management (incentives for not using drugs). produces material which meets all critical quality attributes
It is designed as a ‘digital monotherapy’– software intended for and control strategy requirements.
use without medicines, in combination with other behavioral 3. In-line, on-line, or at-line controls: To monitor process
counseling[7]. performance and product quality.
Digital Transformation in Pharma Manufacturing: 4. Quality attributes: Of incoming materials, in-process materials,
and finished products
The ‘digital plant’ and the use of various modern manufacturing
technologies that go along with digital transformation promise Introduction and implementation of Digitization and
greater efficiency and quality. The basic principle is that by Pharma 4.0 within our Pharma Services Group (PSG) at
connecting machines and systems, we can create intelligent
Patheon– Thermo Fisher:
networks along the value chain that control each other. For
example, machines would be able to predict failures and trigger Pharma 4.0 is the use of flexible, modular continuous
maintenance processes autonomously or self-organize logistics manufacturing systems globally connected and integrated into
that react to changes in production. Industry 4.0 technologies a digital shop floor where connected operators equipped with
include many of today’s buzzwords like Big Data, advanced augmented reality technology, real-time data analytics, artificial
analytics, virtual reality, the cloud, Internet of Things (IoT), and intelligence (AI), advanced robotics and in-line quality sensors
machine-to-machine communication (M2M). In simple terms, would manufacture and directly release high-quality, low-cost
Pharma 4.0 refers to the smart factory  in pharmaceutical precision medications to patients in need.
manufacturing, where everything is connected through digitization
and automation. Pharma 4.0 is related to the development, manufacture
and release of drug substances and drug products but many
A primary goal of Pharma 4.0 is making pharmaceutical of the concepts and technologies apply across Thermo Fisher.
production safer and more efficient along the whole value chain. Digitization of our operations, use of augmented and virtual
The idea is a transformation from today’s current submission- reality, artificial intelligence and machine learning, increased
based control strategy, in which a strategy for commercial use of robotics and using connected data systems to drive better
manufacturing is transferred or scaled up from the development quality and business decisions are all being actively pursued in
phase to a holistic strategy that includes equipment, facility, GMP, many parts of our business. Basically, it allows us to run better,
and business controls, which includes adaptation throughout the
grow faster and create differentiating capabilities that meet the
product lifecycle as learning is captured[8]. This holistic strategy
future needs and requirements of our customers. The bottom line
is the basis for the automation and digitization program and for
is we want to use new technologies to increase our competitive
lifecycle management as outlined by the upcoming International
advantage and strengthen our role as an industry leader. ​
Council for Harmonization Q12 Technical and Regulatory
Considerations for Pharmaceutical Product Lifecycle Management At Patheon– Thermo Fisher, we are exploring a number of
guideline. To obtain the efficient, robust and flexible manufacturing cutting-edge technologies and processes: augmented execution
operations envisioned in Pharma 4.0, the manufacturing control systems, continuous manufacturing, data engineering and
strategy must be integrated with all parts of the manufacturing advanced process analytics, artificial intelligence and machine
process as well as with quality and business functions. learning, process models, integrated manufacturing execution
Pharmaceuticals represent one of the most regulated systems, manufacturing data and reference architectures,
industries, and thus, provide a good opportunity to demonstrate integrated process analytical technologies, digital twins– and
an optimal approach for digitization. Every aspect of a much more.
pharmaceutical product’s development, testing, manufacturing,
The use of flexible, modular, connected manufacturing
packaging, marketing, storage, distribution and use is subject
to scrutiny— at every stage, data is captured, analyzed and systems will allow us to produce more with a smaller footprint.
reported. One continuous manufacturing suite at peak volume will produce

Pharma Times - Vol. 52 - No. 12, December 2020 25

as much product as a single facility. Connected operators, real- References:
time data analytics and real-time release quality will lead to 1. Barbara Jonischkeit, “Industry 4.0: Pfizer opens continuous
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news/industry-40-pfizer-opens-continuous-manufacturing-Jplant-in-
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Pharma-Management-Radar.pdf, accessed November 2017.
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revolution of technology that in the next 10 to 15 years will change 4. https://www.europeanpharmaceuticalreview.com/article/51733/
everything, in the pharma business. Pharmaceutical firms are pharma-digitalisation-challenges/
engaging in digitization at different speeds and in different ways. 5. Jefferies Report, Equity Research Report, March 2020
There are already early signs of the benefits of digital– in terms 6. FDA (2017) FDA permits marketing of mobile medical application for
of R&D efficiency and speed, as well as in data transparency substance use disorder. https://www.fda.gov/NewsEvents/Newsroom/
and accessibility. But ‘going digital’ is difficult. It is changing PressAnnouncements/ucm576087.htm [Accessed 18 May 2018].
how pharmaceutical firms operate. It means introducing and 7. CNBC (2017) The FDA just approved the first app for treating substance
investing in new systems, skill sets, and approaches to a sector abuse. Available from: https://www.cnbc.com/2017/09/14/the-fda-
whose processes have remained largely unchanged for decades approved-the-first-mobile-app-to-treat-substance-use-disorders.html
[Accessed 18 May 2018].
We will see more and more global pharma companies enter the
new world of ‘Digitization.’ 8. J. Markarian, “Pharma 4.0,” Pharmaceutical Technology 42 (4)
2018.
Until recently, Digital was a ‘competitive advantage’– soon 9. Pharma 4.0: Industry 4.0 Applied to Pharmaceutical Manufacturing,
Digital will be a ‘competitive requirement.’ Peter Guilfoyle, Northwest Analytics, October 23, 2018

IPA Building Progress Report

WORK STATUS AS ON DECMBER, 2020 & PROPOSED ACTIONS FOR THE IPA BUILDING PROJECT
1. The External Plumbing work will start from 15th December 2020 onwards
2. The Internal Plumbing work is going on
3. The Fire Fighting work will begin from end of December 2020
4. The terrace waterproofing work will get over by end of December 2020
5. The storm water drainage work will start from 15th December 2020 onwards
Donations received in November – December 2020
1. Mr. P.D. Sheth – 21,00,000/-

Pharma Times - Vol. 52 - No. 12, December 2020 26

 Article

Digitization In Pharmaceutical Quality

Dr. Parizad Elchidana
Principal Technical Consultant – Pharma, ACG already been made by using technology platforms and data a
Abstract : markets, the patients and product consumption patterns. How
targeted
Digitization in Pharmaceutical Quality is an important component of Pharma 4.0towards
… an impactdigital transformation
of Industry covering
on pharma sector. entire opera
This is an
absolutely essential link in the horizontal value chain in pharma industry. Looking at the current state of pharmaceutical manufacturing, a
to fully integrate the entire supply chain starting from order r
paradigm shift in technical operations needs to be looked into as the environment for manufacturing and quality has become challenging
for various reasons since the past decade. The application of digital procurement, planning, manufacturing,
technology in pharmaceutical packaging,
quality control, assurance and testing, re
systems is key critical at this juncture of IIOT and its complete integration into the supply chain to increase productivity and
enable accuracy in planning and executing thus overall impr improve
operational efficiencies and product quality and safety is the need of the hour.
the horizontal value chain.
As per simple definitions, digitisation  is the process of reported that CEOs across all industries are looking at executing
converting information from a physical format into a digital one. digital transformations as part of their corporate strategies.
When this process is leveraged to improve business processes, it
For the pharma industry, digitization and industry 4.0 have
is called digitalisation and the results of this process are called
the potential to significantly transform supply chain operations
digital transformation.
by fundamentally improving the processes, boosting productivity,
Under the current industrial evolution, Industry 4.0 (I 4.0) enhancing quality and thereby bringing about a direct saving. The
represents the fourth industrial revolution which includes ‘Internet beginning has already been made by using technology platforms and
of Things and Services’ (IoT) and ‘Industry Internet of Things’already
(IIoT). been made by using technology platforms and data analytics to better unde
data analytics to better understand the markets, the patients and
markets, the patients and product consumption patterns. However, the next stage sh
The first three industrial revolutions were mechanized production, product consumption patterns. However, the next stage should be
mass production and automated production, respectively, whereastargeted targeted
towards towards
digital transformation covering entireentire
operations. This will allow
digital transformation covering operations.
the I 4.0 represents to fully integrate the entire supply chain starting from order receipts, inventory con
This will allow industries to fully integrate the entire supply chain
⮚ Cognitive Computing procurement,
starting from order receipts, inventory control, procurement, planning, distribution
planning, manufacturing, packaging, testing, release and
⮚ The digital revolution enable accuracy in planning
manufacturing, and executing
packaging, thus overall
testing, release improving
and distribution. Thisthe
willservice level
⮚ Cyber based systems enablevalue
the horizontal accuracy in planning and executing
chain.
⮚ Internet of things & Robotics
⮚ Big data
⮚ Artificial Intelligence (AI)
⮚ Cloud Computing
I 4.0 when applied to the pharmaceutical industry P 4.0 does
bring out the fact that we are lagging behind on quite a few fronts. !,)

To a certain extent, AI and cloud computing has been embraced in
healthcare, big data, IoT, robotics, cyber-based systems and cognitive
computing are not adopted industry-wide. However, it has been
thus overall
However, itimproving the service
can be noted thatlevels across
in each the of
link horizontal
the value
chain
value chain.
Dr. Parizad A Elchidana role in the form of lab testing and release, as all the activities
Principal Technical Consultant, ACG Control (QC) for testing or Quality Assurance (QA) for relea
Dr. Parizad Elchidana is a PhD in Pharma- Quality Management Systems (QMS). In Pharma, IoT has th
ceutical Technology with around 35 yrs of
industrial experience in close collaboration
change pharmaceutical quality control, quality assurance, an
with academia. She is Ex Managing Director!,)

of IVAX (currently TEVA) followed by Apotex Research Pvt. Ltd. Figure 1.
which is the Indian arm of number one generic pharmaceuti- However, it can be noted
cal company in Canada. Her recent past assignment was in that in each link of the value
Dubai where she was invited to support a start up company However, it can be noted that in each link of chain
the value chain1),
(Figure (Figure 1), quality pla
quality
Pharmax Pharmaceuticals FZ LLC, as Chief Technical Officer. role in the form of lab testing and release, as plays
all the activities
a major role inare
thecovered
form either un
She moved back to India post completion of the commitments Control (QC) for testing or Quality Assurance of (QA) for release
lab testing or ultimately under
and release,
in Dubai and joined ACG as Principal Technical Consultant –
Quality Management Systems (QMS). In Pharma, as allIoT thehas the potential
activities are to significa
Pharma from May 2019. She has delivered numerous global
FTF, 505(b)(2) and NCE-1 submissions along with successful change pharmaceutical quality control, quality assurance,
covered either and
under quality management
Quality
launches in the regulated and semi regulated markets. She Control (QC) for testing or
also has experience of digitization in quality along with total Quality Assurance (QA) for
remediation for the USFDA, OAI and followed by successful release or ultimately under
facility clearance. the Quality Management
Systems (QMS). In Pharma,
She is an invited speaker at various national and international !,)

IoT has the
potential to
seminars and symposia and currently President of Controlled Figure 2
Release Society Indian Chapter and co-chair of AAPS Western significantly change
India Chapter, Mumbai Discussion Group.
When all three
pharmaceutical layers
quality of quality
control, come together
quality assurance, (figure2) and
and quality
management systems.
networking systems are formed. This should allow all the res
instrumentation, system interphase and data acquisition syste
Pharma Times - Vol. 52 - No. 12, December 2020 27
together in a network to digitise the entire quality operations
!,)

 When all three layers of quality come together (figure2) and Thus, it can be seen that QM activities are not limited to just
work in a synchronized manner, networking systems are formed. one specific function in an organisation but spread across the
This should allow all the resources like humans, instrumentation, whole organisation and its document creation and maintenance
system interphase and data acquisition systems and software to processes.
come together in a network to digitise the entire quality operations
The disciplines of quality management and documentation
in the horizontal value chain.
are intrinsically connected. A company is quickly faced with
Quality Control : thousands of documents in which, for instance, Standard Operating
Procedures (SOPs), work instructions and policies are defined and
When digitisation is planned in quality control with an aim to outcomes and test results are recorded. Documenting audits and
achieve paperless labs, all instruments are linked to a Laboratory ‘Corrective And Preventive Actions’ (CAPAs) means the stream of
Instrument Management System (LIMS) which is a software- documents only further increases.
based solution with features that support a modern laboratory’s
operations. It can also perform a range of core functions like These documents are necessary to demonstrate the quality of
Quality Control :
● Workflow management products, processes and services and compliance with laws and
When digitisation is planned in quality control with an aim to achieve paperless labs, all
legislations. But, a lot more is possible with the data from quality
● Record
instruments keeping
are linked to a Laboratory Instrument Management System (LIMS) which is a
software-based solution with features that support a modern laboratory's operations. It can systems. Just think of the advantage of being able analyse quality
● perform
also Inventory
a range ofmanagement
core functions like
data, so that trends become visible and threatening issues can be
● 2 Workflow
Samplemanagement
life management including chain of custody, storage quickly identified. A company can then intervene before matters are
conditions
2 Record keeping etc.
noticed by customers and the cause of the threatening problem
2 Inventory management
● 2 Sample
Reportinglife management including chain of custody, storage conditions etc. can also be retrieved from the data. If the data is reliable enough,
2 Reporting
● 2 Interphase
Interphase with
with third partythird
systemsparty systems enterprises can even leverage this for true knowledge-based
ThisThis
decision-making
will the
will support support the
IoT devices IoT devices
to communicate, to communicate,
share data share
and identify testing issues
any which can impact the quality of the product and effectively communicate to the
if data
and identify
analyst testing
in time to help issues
make certain if anyregarding
key decisions whichthecan impact the quality of
product. Documentation is a Process which comprises of:
the product and effectively communicate to the analyst in time to ⮚ Recording of data
help make certain key decisions regarding the product. ⮚ Approval of documents
⮚ Issuance and disposal of documents
⮚ Managing change control
⮚ Retrievability of documents
⮚ Presentation of documents

⮚ Review of documents
⮚ Retention of documents
⮚ Creating backup in case of electronic document
⮚ Having a process for disaster recovery

Figure 3 Digitisation of QMS Documentation Systems and Data

Figure 3
Management:
The best solutions implemented should be one which can be easily configured, adapt to the
The best solutions implemented should be one which can be
constantly evolving requirements of specifications, can be easily subjected to validation, For this purpose, a number of solutions based on Quality
easily
captures the configured,
complete audit trail,adapt to thetraceability
has high-quality constantly evolvinganrequirements
and can demonstrate
Management System Fundamentals are available
automated and a bullet proof process that can withstand the rigors of regulatory audits.
of specifications, can be easily subjected to validation, captures
the
The LIMScomplete audit
solutions can then trail,
be further has with
integrated high-quality
and can traceability
the Enterprise Resource Planning • A state-of-the-art quality management software solution allows
(ERP) system which totally manages the end to end supply chain quality management
demonstrate an automated and a bullet proof process that can a regulated company to enhance the efficiency of its quality
withstand the rigors of regulatory audits. systems while ensuring that those systems are also compliant,
connected, and cost-effective.
The LIMS solutions can then be further integrated with the • A proven QMS management software solution is a vital
Enterprise Resource Planning (ERP) system which totally manages component of maintaining quality management system
the end to end supply chain quality management systems along fundamentals and achieving regulatory compliance. Plus, QMS
with the Vertical Value Chain comprising of support functions software can be invaluable in helping companies keep pace
like finance, legal, IT, HR, etc. The data generated would be in a with industry trends.
digitised form. (Figure 3)
• Companies may vary in scope and size, but if they’re doing
Quality Management Systems (QMS) business in environments where regulatory bodies are pushing
General philosophy of any Quality System is : toward the usage of electronic systems, they all need effective
quality management software solutions.
● Document what you do;
• An automated QMS management system also connects all
● do what you have documented;
departments, product lifecycles, and quality processes. An
● prove that you have done as per what you have documented electronic system’s ability to automatically route tasks and
through records.
escalate them when necessary ensures that task completion,
It is assumed that what is not documented, has not been done approval cycles, and inter-departmental input occur in a timely
and this certainly applies to the discipline of regulatory compliance manner. Plus, when quality is built directly into the QMS system,
in the pharma industry. every department— from engineering to quality assurance and

Pharma Times - Vol. 52 - No. 12, December 2020 28

 quality management system fundamentals and achieving regulatory compliance. Plus,
QMS software can be invaluable in helping companies keep pace with industry
trends.
• Companies may vary in scope and size, but if they’re doing business in environments
where regulatory bodies are pushing toward the usage of electronic systems, they all
need effective quality management software solutions.
• An automated QMS management system also connects all departments, product
manufacturing to regulatory—
lifecycles, and quality system’s ability to automatically route lab and the shop floor
stays connected.
processes. An electronic
tasks and escalate them when necessary ensures that task completion, approval cycles,
• A QMS software solution helps companies overcome the ⮚ Better use of resources
and inter-departmental input occur in a timely manner. Plus, when quality is built
common challenges
directly into discussed
the QMS system, abovefrom
every department— and also establish
engineering to quality ⮚ Reduce manual and repeated efforts
solid quality
assurance management
and manufacturing systemsstays
to regulatory— fundamentals,
connected. enhance ⮚ Fewer quality issues with products and helps to enhance
• A QMS software solution helps companies overcome the common challenges
and harmonize
discussed above andtheir overallsolid
also establish quality
quality processes and achieve
management systems fundamentals, quality
digitization.
enhance and harmonize their overall quality processes and achieve digitization. ⮚ Less wastage of resources
Expectations of the Areas of Control from a Typical QMS 
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 ⮚ Increases knowledge sharing and collaborative working
approach are given below (Figure 4)
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The biggest concern regarding any digitized operations is
cybersecurity and disaster recovery management.
To add to that organizations need to improve the efficiencies
The Process
The Process : : in the quality department whilst adhering to regulations and
RoadRoad
map tomap to a pharma
a digitized digitized pharma
Quality Quality
Management Management
System System
implementation is simultaneously driving innovation.
implementation is enumerated
enumerated below (Figure 5) below (Figure 5)
Considering the volume of data being generated, practically
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,%
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However, to take this initiative forward, organizations need to get the human resources totally technology, pharma companies need to make digitization of their
However,
aligned through : to take this initiative forward, organizations need to operations and supply chain a priority, starting today.
getCreating

the human
awarenessresources totallyabout
within the organization aligned through
the current : smart systems
trends and Digitization has the potential to fundamentally transform
associated with P4.0
⮚ Creating awareness within the organization about the current

Provide an understanding of the core elements and technologies required pharma operations, opening the door to step-change improvements
trends

Creating and plan
a project smart systems
to move associated
towards digitization– fromwith P4.0to e documentation
hard copies in performance. Pharma companies should get started on this
⮚ andProvide
data management
an understanding of the core elements and technologies journey, taking immediate steps to digitize their operations and

Explanation of the benefits that will accrue due to adoption of latest technologies
required

Collaborative prediction of the challenges that are likely to be faced during the complete supply chains and develop a strategy and road map for the next
⮚ digital
Creating a project plan to move towards digitization– from hard
transformation three to five years. Those companies that seize the initiative can
copies to
Advantages : e documentation and data management give themselves a sustainable competitive advantage; operate with
⮚ Explanation of the benefits that will accrue due to adoption of greater agility, cost-efficiency, and control; and ultimately provide
There are multiple benefits that are accrued company wide with implementation of
latest technologies
digitization: better care for patients.
⮚ Collaborative prediction of the challenges that are likely to be Through digitisation, downtime in pharma plants can be

Improves productivity and efficiency as more testing can be done through IoT
faced during the complete digital transformation

Provides accuracy of data due to reduction in manual errors and hence better compliance reduced by 30 to 40 percent.

Helps maintain data integrity
Advantages : costs due to faster decision making

Reduces operating Digitisation will ultimately help to improve upon the compliance

Cloud applications encourage greater collaboration between the lab and the shop floor
There

Better are
use of multiple benefits that are accrued company wide
resources and help raise the bar for overall Quality Management Systems.
with implementation

Reduce manual and repeatedofefforts
digitization:

Fewer quality issues with products and helps to enhance quality
⮚ Improves productivity and efficiency as more testing can be done
References :

Less wastage of resources 1. Digitization in Pharma & gaining an edge in Operations. PWC; Peter
through

Increases IoT sharing and collaborative working
knowledge
Behner & Dr. Marcus Ehrhardt 2016.

Increases flexibility and agility in analytical labs
⮚ Provides accuracy of data due to reduction in manual errors and 2. How to digitize the quality process and gain new insights : Daniela

Makes compliance easier
henceinnovation

Creates better opportunities
compliance Jansen of Dassault Systèmes, Pharma IQ, 11/05/2019
⮚ Helps maintain

Facilitate data integrity
continual improvement
3. ICH Q 10 Pharmaceutical Quality System
⮚ Reduces operating costs due to faster decision making 4. 3 Ways Digitization Is Changing Pharmaceutical Quality Assurance and
⮚ Cloud applications encourage greater collaboration between the Quality Control. May 7, 2019, AAPS.ca/blog

Pharma Times - Vol. 52 - No. 12, December 2020 29

Pharma
Pharma Times
Times -- Vol.
Vol. 52
52 -- No.
No. 12,
03 -December 2020 24 30
March 2020
Pharma Times
Pharma - Vol.
Times 52 -52
- Vol. No. 12, 03
- No. December 2020 25
- March 2020 31
Article

Unlocking the Potential of Artificial Intelligence

for Pharma Inspection
Ronak Dave
Product Manager, ACG Inspection

In today’s world, artificial intelligence (AI) is transforming Harnessing the Power of AI Technology
several industries, and many of us interact with AI on regular AI has created an impact on several industries, including those
basis in some form or another. From banking and manufacturing based on machine vision inspection systems. Being a pioneer in
to e-commerce and personalized advertisements, AI is becoming machine vision systems and with a decade of rich experience,
imperative in almost every business. Business experts believe that ACGI has tapped into some of the essential in-trend business
it is an essential tool for data analytics, predictive suggestions, drivers of the market, which require vision systems to be adaptive,
chatbots, and so on. self-learning, and able to make decisions. Also, keeping the future
AI can be defined as any software algorithm which possesses roadmap in mind, ACGI is in the process of developing products
human-like features, such as an ability to learn, plan, and solve based on the Internet of Things (IoT) and process analytical
problems. These attributes can be groomed, and the system made technology (PAT), which will be capable of generating huge amounts
ACG
more INSPECTION
intelligent depending upon - OUR
the typeAI ADVANTAGE
of industry where it is of data accumulated over long periods, using interconnected
going to be used. equipment. However, to analyze data at such a colossal scale
is humanly impossible, and that is where AI can intervene. ACGI
AsMachine
AI pervades learningalmost (ML) is presently
every aspect ofthe most life
modern common and has
and industry, its applications are only integrating it into existing as well as
adopted AI technology,
goingused
widely to proliferate.
type of AI in ACGI has always
businesses. It isembraced
predominantly new trends
used toin the industry to provide its
new products. Using AI, our machines can analyze data to foresee
customers
process with up-to-date
and analyze large amountssolutions.
of data Byswiftly
leveraging AI technology
and rapidly. ML theand integrating it with
expectedinto load through a discrete type of DL neural network.
algorithms tend to “learn” over time and enhance themselves to This dataAI
our inspection systems, we have become the first company to introduce machine
vision systems for the pharmaceutical industry. Our AI-based machine vision algorithmsinto insight, the insight into a result, and
is then turned
produce better outcomes
can automate various for the tasks
complex thatencountered
tasks they perform repeatedly.
during pharma thepackaging.
result into an Our action.
visionThis approach is known as “informative-
Ininspection
a typical systems
manufacturing integrate unit where process
seamlessly with variousequipmentblister packaging machines and
based manufacturing” and is widely discussed on platforms such
continuously
other pharma collects production
equipment datacomprehensive
to offer via connected devices, it is as Industry
defect detection. Finally, these
4.0. systems
achieve
difficult forenhanced
humans to overall
processefficiency
and interpret by thereducing
massive downtime,
amounts false-rejects, reworks, and
ofcostly
data beingproduct recalls.
collected. InThus, with the use
such situations, of AI, we
ML-based AI aim to revolutionize inspection systems
is extremely Current Challenges in Pharma Vision Inspection
used in the pharmaceutical industry and ensure that our customers always receive
effective as it can analyze the data by recognizing patterns and
products and services of the highest quality. In the pharmaceutical industry, once tablets or capsules are
abnormalities. For example, if due to some unforeseen activities,
manufactured, they are sent to be packed in a blister using a blister
the production capacity of a pharmaceutical manufacturing plant
packaging machine. In most cases, the tablets or capsules are
is reduced, ML will inform the stakeholders, who can then take
manually fed into the hopper of the packaging machine. Hence,
appropriate corrective actions. With the evolution of interconnected
there are chances of errors occurring during this process.
artificial neural networks, there has been a rise in the use of deep
learning
References (DL), which is another form of AI. Essentially, DL is a Below are some of the commonly observed problems that occur
subset of ML and operates with different capabilities. With a DL during this process:
1. Should a small business invest in AI and machine learning software? Rishi Mehra. Economic Times
model, an algorithm
[Internet] [updated canondetermine
May 25, 2019; oncited
its own whether
on Sept a prediction
11, 2019]. Available from:1. Foreign particles
https://bit.ly/2YUNwN9
is accurate or not, through its neural network. An excellent example
2. Why Every Company Needs An Artificial Intelligence (AI) Strategy For 2019.2. Crushed/broken
Bernard Marr. Forbes product
of DL [Internet]
are chatbots used on websites, which interact with humans
[updated on Mar 21, 2019; cited on Sept 11, 2019]. Available from: https://bit.ly/2lKdeFE
to solve their queries and enrich the customer experience. Another 3. Only body/cap in capsule
3. A beginner’s guide to AI: Computer vision and image recognition. Tristan Greene. TNW [Internet]
example of DL-based AI are autonomous or semi-autonomous 4. Changes in shape, size, and form
[updated on Jul 18, 2018; cited on Sept 11, 2019]. Available from: https://bit.ly/2uviIpr
vehicles, which receive information through millions of individual DL 5. Spots or discolorations
models that allow
4. Artificial the vehicle
Intelligence — Futureto of
avoid accidents
Business. through
[Internet] thefrom:
Available usehttps://medium.com/
of
various datadriveninvestor/artificial-intelligence-future-of-business-d5107108dcfd
safety features. In this era of smart technologies, there are Besides these, there are other challenges that traditional
opportunities
5. COMPUTER forVISION:
businesses to transcend
THE FUTURE OF ARTIFICIAL to new levels. Utilizing
INTELLIGENCE. vision systems
Priya Dialani. Analytics may not be capable of addressing effectively, such
Insight.
the correct technology
[Internet] [updated according to business
on Jan 1, 2019; cited on Sept needs, companies
11, 2019]. Available can as learning a new model for a new product from an operator or
from: https://www.analyticsinsight.

ML- or DL-based AI to develop intelligent infrastructure, detecting defects in products having similarly colored packaging
net/computer-vision-the-future-of-artificial-intelligence/
implement
potentially revolutionizing the way they compete, grow, and engage (e.g., grey tablet in grey foil). The learning time for a new product
with customers. is almost 15–30 minutes for traditional vision systems, and these
systems may sometimes fail to detect the aforementioned color-
related defects, resulting in high rejection ratios and lowered
Ronak AUTHOR
Dave DETAILS
productivity.
Product Ronak
Manager,Dave ACG Inspection
To overcome these challenges and to further improve the
Product Manager
Ronak is a post graduate in marketing with machine efficiency, ACGI has developed an intelligent camera-
an engineering degree in Electronics & Tele- based inspection system for blister packaging machines, which
Ronak is a
communication. Hepost graduate
is associated within ACG
marketing with andefect-less
ensures engineering product packaging, with minimal human
degree
Inspection for inpastElectronics
5 years and & Telecommunication.
handles interventionHe is and associated
no requirement for rework.
Inspection product portfolio with which includes vision
ACG Inspection for systems
past 5 years and handles Inspection
(camera-based applications) and non-vision systems
product portfolio which includes (IR/NIR vision How Ai-Based
systems Inspection Systems Can Help
(camera-
based applications).
based applications) and non-vision systems (IR/NIR
AI-based based
applications involve opinion-based (a software
applications).

Pharma Times - Vol. 52 - No. 12, December 2020 32

 CTION

ON algorithm that possesses human-like abilities, such as learning, Minimal setup time
pinion-based (a and problem-solving) inspection and therefore, are more
planning,
It can auto-teach new models for new products
ses human-like than manual inspection or traditional machine vision
efficient
with a single click on HMI.
systems. Several manufacturers are now opting for AI to find
g, and problem-
solutions for their most complex inspection requirements.
ore, are (amore Reduced production time
n-based AI-based image analysis is a combination of learning and
n or traditional It can quickly transfer the data of the trained
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fed into the system
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Figure 2: References
a new
he cavitiesmodel
c o n tis
i n u o u s l y
1. Should a small business invest in AI and machine learning software?
White them
captures images and compares
hich minimizes product onreference
with the white foilimage. Rishi Mehra. Economic Times [Internet] [updated on May 25, 2019;
of a good With ACGI’s AI-enabled inspection system, the teaching or setup cited on Sept 11, 2019]. Available from: https://bit.ly/2YUNwN9
f there are any for a new model is achieved via a single click, which
process
after that, 2. Why Every Company Needs An Artificial Intelligence (AI) Strategy For
amera provides
minimizes the product changeover time. If there are any defects 2019. Bernard Marr. Forbes [Internet] [updated on Mar 21, 2019; cited
sed image
tive blisteror gets
rogue products, the camera provides a rejection signal, and the on Sept 11, 2019]. Available from: https://bit.ly/2lKdeFE
s. Allimages
the defective
faulty blister gets rejected at the end of the line. All the faulty 3. A beginner s guide to AI: Computer vision and image recognition. Tristan
blisters are automatically collected in a separate rejection bin Greene. TNW [Internet] [updated on Jul 18, 2018; cited on Sept 11,
ceinimage.
ed a separate
without any manual intervention. 2019]. Available from: https://bit.ly/2uviIpr
l intervention.
ystem, the 4. Artificial Intelligence — Future of Business. [Internet] Available from:
SALIENT FEATURES OF ACGI’S INTELLIGENT BLISTER
w model INSPECTION
is Figure 2: https://medium.com/ datadriveninvestor/artificial-intelligence-future-
SYSTEM of-business-d5107108dcfd
minimizes White product on white foil 5. COMPUTER VISION: THE FUTURE OF ARTIFICIAL INTELLIGENCE. Priya
An intelligent solution
re are any The inspection system is a complete solution,
Dialani. Analytics Insight. [Internet] [updated on Jan 1, 2019; cited
on Sept 11, 2019]. Available from: https://www.analyticsinsight. net/
a provides integrating hardware, software, and DL models. computer-vision-the-future-of-artificial-intelligence/

lister gets
Pharma Times - Vol. 52 - No. 12, December 2020 33
the faulty
a separate
Article

Digital Marketing and its impact on the Pharma Industry

Priti R.Mohile
Co-Founder and Managing Director, MediaMedic Communications Pvt.Ltd.

Pharmaceutical marketing has been based on the one-to-one In the meantime, a digital revolution gradually crept into the
promotion of products to its customer base (the doctor) who are not pharma marketing world. This digital revolution changed every
the direct consumers of the products. Convincing the doctor using aspect of the doctor and patient’s life, the direct and indirect TG
science and creative methods has been the path taken by most of the industry, respectively. The doctor, as well as the patient, now
senior managers of the industry for almost their entire career. The have access to information around the world at their fingertips,
doctors depended on the latest information provided by the pharma can compare products and prices online, and reach company and
industry through their medical representatives, while the patients medical websites easily. Google search and social media reach
relied entirely on their doctor’s prescription of medicines. In the has given the power of knowledge to patients and their caregivers,
20th century, control of infectious diseases through medication along with its positive and negative repercussions. They are now
made patients in India equate doctors to God! able to access information that may not be accurate and can get
misled easily, opening up avenues for the pharma industry to
What is changing in the pharmaceutical marketing provide accurate information to them through the digital media
ecosystem? and therefore undertake digital marketing.
A lot has changed and continues to change in the pharmaceutical
marketing ecosystem over the last few decades. What is Digital Marketing?
When the buzz of digital began in pharma marketing, it was
From the 1990s, a barrage of launches of branded generics misunderstood as just the use of technology using the traditional
changed the direction of pharmaceutical marketing to a CRM based channel. So, the pharma marketing community in India focussed
system with its good and evil aspects emerging over the following their attention on building websites, mobile apps or using
two decades. The perception of the general public towards doctors augmented reality to awe their doctor community. These were
began to change, and the blind faith on doctors started dropping. created with the traditional mindset of print media and were used
The government stepped in with UCPMP guidelines and expected for pushing of product messages, without consideration of the
the industry to self-regulate itself. user behaviour towards the new medium. While this got some
attention for the short term, it did not build any long-term value for
In the same period, the numbers of medical representatives the ‘Brand’, leaving the marketer with immense doubts about the
employed by companies in India rose, while their quality declined use of digital; to the extent of even blaming that ‘digital is not for
significantly. In such a situation, the doctors put limits to the number pharma.’ Moreover, the absence of guidelines on the use of social
of representatives they will see every day, as well as reduce the media by pharma companies deterred pharma from venturing
time given to each representative, causing immense challenges anywhere close to it.
for the pharmaceutical marketing professional. Additionally, the
COVID pandemic further limited the time available at the doctor’s Back to the basics:
end for medical representatives; and social distancing norms
The basis of marketing is to understand the environment
virtually abolished how medical representatives would crowd
and the target audiences, on which one builds plans for creating
doctor’s reception areas.
the right perception of the product in the mind of the customer.
Using the right marketing mix along with the proper channels of
Priti R.Mohile communication where your TG is present and serving the right
Co-Founder & MD, MEDIAMedic Communi- message where they wish to access it, is the need of the hour.
cations That is what digital marketing is all about. It is not about merely
using technology or gimmicks, but using various digital media and
Priti Mohile has 35 years experience in the
technology platforms that allow reaching the TG, give data about
pharma industry. She has moved from her
your customer to help serve their needs better, or even personalise
previous role as Marketing Head of a phar-
the communication to their needs.
ma organization and co-founded ‘MediaMedic Communica-
tions Pvt.Ltd’ – a specialised agency offering integrated com- When the environment has changed, and how the target
munications to the pharma, diagnostics, devices, healthcare audiences form their opinions has changed, the pharma marketers
and nutraceutical companies. MediaMedic is the exclusive must rethink their strategies. For this, understanding this new
partner in India for ‘Global Health PR’ network of independent media is the beginning.
health & science communication agencies in the world. Priti
Mohile has a unique background of pharmacology, marketing Understanding the medium:
management & Digital marketing, which she has successfully
put in practice to provide path-breaking solutions for various The changing ecosystem described above has disrupted both
HealthBrands using integrated communication solutions. She the reliance of the industry on the singular channel of personal
has been invited at various forums to speak about pharmaceu- selling through the medical representatives, as well as the
tical marketing and use of digital & social media for pharma manner in which interactions are carried out between the medical
and healthcare ; and her organization, MediaMedic Commu- representative and the doctor. Moreover, technological advances
nications, conducts an event called ‘DigiSights’ on the use of now offer opportunities to analyse customer preferences. This
digital marketing in pharma and healthcare. is where multichannel, data specific marketing channels and
solutions come into the picture.

Pharma Times - Vol. 52 - No. 12, December 2020 34

Understanding regulations: levels of success. Success has been dependent on deploying the
A seasoned pharma marketer is well aware of the regulations right resources, methodology, training and commitment of the top
that govern the promotion of a prescription product versus an management. Many companies have relied on internal IT teams
OTC product. While in India, a ‘prescription only’ product can be to deploy these, but IT teams don’t understand marketing and the
promoted only to a doctor, and not to a lay consumer, an OTC end objective; hence a multifunctional team will help achieve the
product can be. Even for those products promoted to doctors, desired results.
only approved indications are allowed. Patient data collection is
Multichannel marketing for the end consumer (patients
not allowed too. Additionally, social media platforms have their
own set of regulations for advertising health-related products. and caregivers):
Understanding these regulations is key to setting up any strategies There is much to be done within the pharma-healthcare
in digital marketing for pharma. ecosystem that will help achieve better health outcomes for
patients. Patient adherence to medication, reaching audiences
Different aspects of Digital marketing: where the field force is not deployed, improving disease awareness
Closed Loop Marketing (CLM) for product promotion to and testing, are some areas that if improved, can expand markets
doctors: and the sales for pharma companies.
CLM is the process by which one can build two-way The evolved consumer:
communication with the target audience. It consists of planning
activities, engaging customers into a dialogue, getting real-time Today, the patient is a consumer who has access to information
feedback and analysing it. The loop closes after analysis, where you through search engines and social media. From researching
see what your customers need, modify the strategy and update all symptoms to reading about medicines, looking for the right doctors
with good reviews to expressing themselves on social media, the
the marketing materials according to customer preferences.
new-age consumer is an evolved one. A significant number of them
By employing iPads/tablets integrated with a back-end platform, are digital natives, to whom the use of websites, apps, online buying,
the field force can easily track their interactions with individual etc. are second nature. Other industries have pampered them no
doctors, including understanding their preferences and objections. end, such that their expectation from every sector is the same.
This data can be compiled and fed back to marketing to enable
Moreover, the attitude towards health and disease has also
customisation and personalisation of future promotional activities.
changed significantly. Consumers are now more open; they do not
CLM can also work in the opposite direction as well. The hide their illness like they did a few decades ago. Such a change
learnings from the non-personal promotion such as which content in attitude opens a whole lot of new opportunities.
is the most popular, top sources preferred, downloads etc. can 1. It allows the industry to study what the consumers search for,
provide valuable information for the field force when trying to get read what they express on social media and draw meaningful
‘in the door’ or keep a physician engaged in a conversation. insights to help marketing strategies.
2. It opens avenues to engage them on social media for disease
Such a CLM also enables multichannel marketing within
awareness with specific messaging, without crossing any
the regulatory framework of the pharmaceutical world. While regulatory limitations.
e-Detailing remains central to CLM, it is made more useful with the
3. By mapping patient journeys for specific disorders and by
integration of other digital channels that provide more significant
identifying gaps, one can build assets like websites, mobile apps
opportunities for customer engagement. This includes ‘approved that help achieve the patient-centricity, change behaviours and
emails’, messages, microsites and even remote detailing. improve outcomes.
Some medical information websites have also successfully 4. Use channels that can connect doctors and patients for better
used multichannel marketing to doctors. They provide personalised dialogue and impactful outcomes.
information to them based on their interests, using Search Engine 5. Use interactive formats that draw attention and engage the
Optimisation (SEO) and Search Engine Marketing (SEM) and creating consumer.
compelling user journeys for key message communication. 6. Use multiple languages with a proper understanding of the
cultural nuances to engage the diverse audiences in a country
When content and interactions are fine-tuned across various like India.
channels according to the customer journey, it gives an omnichannel
experience to the customer leading to customer satisfaction. However, just building assets does not complete the process.
If continued efforts are not taken to reach the right audiences,
For success in CLM, there is a need to upgrade the skills of the draw them to the assets with systematic digital marketing efforts
field force and the brand management team to understand and and guide them through a well-designed user experience to take
use this to the best possible advantage. The field force must be necessary actions for desired outcomes, it is all wasted.
trained to use it effectively. On the other hand, brand teams must
be trained to build interactivity in the presentations, or else they Many companies are still making mistakes here. A website or
remain a mere replica of the print version that does not utilise the app is built, a social media channel is opened, but the content
key features of the technology. It also requires the right selection populated is the same as that has been used for personal selling
of the platform technology that will achieve the objectives of the through the field force. Moreover, no commitment is made towards
company for a long-term. Some of these platforms are expensive, the media spends on the digital medium that is required to reach
but they reduce the print material load and cost, help gain cutting- the target audiences.
edge insights into the customer preferences and thus achieve It is essential to understand that there is science behind digital
marketing objectives and build brands. Over the past 3 to 5 years, media strategy, planning and communication strategy; and that
some organisations have moved to these systems with varying a different copy and messaging is required for consumers that is

Pharma Times - Vol. 52 - No. 12, December 2020 35

entirely different from that for doctors. While doing this, all regulations that can produce impactful business results.
that govern the pharma industry, the social media platforms, as well
as legalities, need to be taken into consideration. OTC and nutraceutical products:
This is where a change of mindset is required urgently. Senior While these products can be directly marketed to consumers,
managers must accept the fact that this is a new way that needs gone are the days when push messages would serve the purpose. In
to be understood and integrated into the marketing mix. Junior today’s digital world, consumers want the brand to be on the platforms
managers must not undertake activities for the sake of doing which they frequent, be involved in their wellness journey and develop
something but should tie their efforts to the marketing objectives a relationship with them. This is possible through engagement on the
by setting the right KPIs. The field force should be involved in the website, social media platforms, in-app promotions, influencers, etc.
entire project by creating the right touchpoints for the involvement
E-pharmacies:
of their doctors. Without all of this, digital marketing will remain
as the ‘new shiny object’ that everyone desires, but the failure to E-pharmacy businesses are here to stay. With close interaction
produce results will quickly make many abandon it entirely. with patients, the data that is generated by these e-pharmacies
has tremendous potential for the pharma industry. While patient
Before starting on this journey, it is worth studying how some data related regulations bring certain restrictions, there are still
early adopters have been able to improve their market shares by various possibilities for deep engagement for better outcomes. This
careful planning and commitment. aspect is still in its infancy but will evolve as regulations become
more explicit.
Artificial Intelligence (AI):
By creating automated algorithms, Artificial Intelligence can Corporate Reputation:
perform tasks that would typically have been carried out by humans . With the potential for ‘information amplification’ and the era
Today, AI is being used for facial recognition and self-driving cars, of ‘fake news’, close monitoring of all online media is an essential
while for pharma, it has changed the way drugs are being developed aspect of corporate reputation management. Moreover, the use of
and diseases managed. Through such technological advances, social media to present the narrative in a manner suitable to each
various marketing processes can also be optimised. For example, channel makes it an altogether new avenue in the armamentarium
in multichannel marketing, AI can optimise promotional spends and of the communications manager.
segment audiences as per channels, timing, location or interest and
many more such tasks. Such use of AI has various implications: With disease awareness, growth of markets and patient and
caregiver engagement through social media, the paths of marketing
For patients and caregivers: managers and communication managers are now crossing; hence
1. Messages can be tailored based on the patient’s historical data an integrated approach towards these is highly desirable.
or predicted behaviour.
2. In the case of search marketing, personalised advertisement’s Connected Health:
targeting can be achieved through programmatic media Wearable technologies, sensors, mobile apps and social
bidding. communities, all of this connectivity ensure that the patient is the
3. Chatbot interfaces can be created to answer queries or access centre of attention. It creates opportunities for better wellness
usage guidelines. management and to improve health in the patient journey, with
4. Reminders for medicine doses can be set. implications for the pharmaceutical industry. Going ‘beyond the
5. Critical appointments can be scheduled on priority. pill’, to a service model may emerge soon.
For companies: Conclusion:
1. Optimise multichannel activities
As new products and devices created by the pharma industry
2. Improve channel effectiveness by recommending the timing, get more complex, there will be an increased need to communicate
frequency and content of messages.
these to the target customers. Changing dynamics of the digital
3. Enhance HCP profiling, segmentation and targeting. media are creating new opportunities, albeit complex, to use them
4. Map influencers (KOLs) for brands or therapeutic areas. effectively in the marketing mix to achieve marketing and business
5. Undertake social media listening to map shortages and objectives. For this, the senior management should keep an open
reorganise or prioritise deliveries. mind to understand this media and its complexities, train the
juniors and build an integrated strategy that will take the company
These are just a few examples. Some companies have already
to success. In this process, it will be imperative to partner with the
created chatbots that give disease-related information to the
right technology and agency partners who understand the pharma
consumer. AI, thus, has tremendous potential for applications in
marketing landscape, customers and its regulatory framework;
pharma marketing.
as well as the digital media and creative formats to deliver key
Using Augmented Reality (AR) and Virtual Reality (VR) in messages through his media.
pharma marketing: Armed with this, pharmaceutical companies can grow markets,
Better visualisation of complicated mechanisms, explanation increase patient adherence, change behaviours and achieve any
of the technology, product usage, experience of disease, etc. are such objectives by setting appropriate goals, mapping customer
some examples companies have used to grab the attention of journeys, using data analytics for personalisation and technology
their customers. for optimisation.

Well thought out use of AR and VR in the customer journey with The future of pharmaceutical marketing and communication is clear.
an in-built call to action can create immersive customer experiences Those who embrace it with enough preparedness can be winners.

Pharma Times - Vol. 52 - No. 12, December 2020 36

 Article

Digitization in the pharmaceutical industry

J. Jayaseelan
Vice President & Chairperson, Industrial Pharmacy Division - IPA

Pharmaceutical  Industry is now moving from knowledge based So this way digitalization ensures complete Track and Trace
to learning based industry. The evolution of computer programs and of medicines in the current distribution channel.
Information technology is having a direct impact on the pharma
Documentation: Digitalization made documentation more
industry. Most of the manual based documentations are getting shifted
easier and tracible.
in to digital mode. For example, the pharmaceutical industry were
using manual intervention earlier during Warehousing, Dispensing, i) Laboratory Information Management system software used in
Processing, Packing, Labeling, Distribution and Documentations. Now assessing the information acquired by quality control unit
most of this activities are digitalized as briefed below.  ii) Data processing software are used for storing the raw data and
also analyzing the data for audit trial purposes
Warehousing: . Track and trace software’s are used in pharma industry
iii) Documentation Management system software is used in the
for reducing the activity of storing and finding the material easily at one
document review and approval process
go. In future the same will be automated by robotic machine integrating
the storage and transportation merged with the system itself. iv) Enterprise Resource Planning software is used in conjunction with
supply, receipt and payment of raw materials and/or products
Dispensing: Previously the dispensing process was by manual
v) Design of experiments software is used as simulator for
intervention only. Currently  the dispensing was carried out using development of robust product during development stage thereby
automated machines connected to the printer thereby reducing reducing time and wastage during development stage
the time of manual transcription in the batch records. The entire
dispensing to labeling will be performed in closed environment vi) eCTD software is used for submission of dossiers to various
regulatory agency, which reduces the time, resource and courier
using automated technology in future.
charges previous incurred during paper submissions
Processing:  In the pharmaceutical processing machines old vii) Sharing/receiving of documents with clients/vendors through
analogues circuits and meters were replaced with the Programmable FTP links
Logic Controller (PLC) devices which can be connected to the printer
or system for processing. In future all electronic batch records are Digitalization revolutionized regulatory mechanism in pharma
connected to the system driven by software, whereby reducing the industries. Due to Covid emergency audits by regulatory agency are
time consumed by the operator on writing batch records.   taking place in remote manner. Distinct possibilities of audits might
be carried out remotely using software where all documents are
Packing: The packaging  operation was so complicated shared with the regulatory agencies and the entire process carried
earlier which involved multiple manual documentations . in the facility will be made available to the regulatory agencies
This was simplified by  digitalization  by using automated line through online and/or by recordings.
packaging systems where cleaning, filling, weighing, insertion,
sealing, capping,  carton, labeling and shipping are performed  Some daily used software’s are listed below which is used by
simultaneously. Software systems are developed to detect  faults all the departments in pharmaceutical industries.
in the packing line and automatically  reject the components not • Operating system
matching with the required specification. • Word processing software
Labeling and distribution: labeling of products using 2D and • Excel spread sheets
3D barcoding technology was the new norm. The software’s used • PowerPoint presentation software
in this technology paves the way in finding the distribution from • Portable document format (PDF) software for viewing and
manufacturer to customer level and  also provides the information editing PDF files
needed by the consumer in  their hands  using bar code reader. • Xml software for preparation of submission packages
• SPL software for package insert viewing
J. Jayaseelan • Publishing software for creation of package insert
Vice President & Chairperson, Industrial
• Drawing software for viewing and editing plans
Pharmacy Division - IPA
• Designing software for creation of labels (container and carton
J. Jayaseelan is currently the Director of Nuray label of products)
Chemicals Pvt. Ltd, Saimirra Innopharm Pvt.
• Human resource management system
Ltd, Delvin Formulations Pvt. Ltd and Hibrow
Health Care Pvt. Ltd. He completed his B. Pharm. from the pres- • Mailing software for processing emails
tigious Madras Medical College & later completed post graduate • Digital certificates used for secured dossier submission and
diploma in Marketing Management and MBA in Marketing. Jaya- mails to regulatory agency
seelan began his career in Sales and marketing in Torrent Phar- • Electronic entry and exit management software
maceuticals Ltd in 1989 and had successfully grown as Area Sales
Manager in Eli Lilly, as Regional Sales Manager in RPG (Searle) • Video processing software for monitoring the premises from
with a stellar track record of 10 years. He has held various positions inside and outside
in pharma affiliations in PCI, IPA, IACC and IDMA and has been Apart from this company website, WhatsApp, Twitter, LinkedIn
awarded IPA Fellowship and Best Pharmacist award. and etc. are some software’s used in receiving and sharing
information within and with outside people.

Pharma Times - Vol. 52 - No. 12, December 2020 37

Article

Digitalisation and the changing healthcare land-

scape
Lars-Åke Söderlund
President, Community Pharmacy Section, The International Pharmaceutical Federation

Technology is revolutionizing the healthcare industry. And we Of course, budgetary pressure and changes in both demographic
are only at the beginning of a transformation which will lead to and consumer behaviour, as well as the evolution of the healthcare
improved access to health services, greater patient empowerment, system itself, drive this development.
and continuity of care.
Digital care also fits well into the transition to ‘close and
Digital transformation in healthcare is the positive impact of accessible primary healthcare’. However, digital healthcare can’t
technology in healthcare. solve everything. A risk probably lies in the fact that many have a
conviction that digital care will solve everything, because after all,
The reason for this is that telemedicine, artificial intelligence (AI)
the physical meeting is perhaps the most important thing in the end.
enabled medical devices and electronic health records are just a
It is probably never possible to make care completely digital, but it
few concrete examples of digital transformation in healthcare which
can help both the patient and healthcare in both communication
are completely reshaping how we interact with health professionals
and for healthcare to prioritize.
and our patients. This also has an impact on how our data is shared
among providers and how decisions are made about treatment Healthcare and pharmacy are both facing this technological
plans and health outcomes. Today’s citizens/patients have more revolution. No matter where we live, the conversation is the
access than ever to health information and they’re getting used to same. The ongoing need to reduce the cost of care, higher service
the benefits that come from technology. expectations from consumers/patients, and advances with big
data in being able to predict diseases faster and more accurately.
The keyword for everything is ‘Innovation’, where the main
All these factors contribute to the growth of digital health and the
objective is streamlining physicians’ work, optimizing healthcare
use of technology. The technological revolution brings with it the
systems, improving patient outcomes, reducing human errors and
ability to deliver true ‘beyond-the-pill’ value, with new services from
lowering costs through digital experiences. Digital technologies
the pharmacy. For the community pharmacy to remain competitive
provide healthcare organizations the tools to support greater
and to be best positioned for the future integration of our health
standardization of work, which can improve efficiency. At the same
systems, investing in some of the emerging digital technologies
time, ‘big data’ also holds the promise of personalized medicine,
will be a prerequisite.
which is about individualized care.
Impact of digitalisation
Lars-Åke Söderlund
Globally, digitalisation has radically changed the care landscape
President, Community Pharmacy Section - in many ways. Digital solutions have enabled integration for example
FIP between healthcare information systems, remote contacts with
Lars-Åke Söderlund is a Doctor in pharmacy healthcare and pharmacy staff and home monitoring solutions.
and has extensive experience of working to-
gether with health systems in Sweden and
The impact of technology within healthcare can be described
other countries, improving health and creating a sustainable in many perspectives, like reducing healthcare costs, avoiding
healthcare system/primary healthcare model. He has been preventable deaths, improving outcomes and quality of life,
a health advisor in China for many years. He has been the reducing healthcare wastage, improving efficiency and quality of
Vice President of the Swedish Pharmaceutical Society, and care and developing new medicines and treatments. Linked to
has had a number of executive positions within Apoteket AB advances in analytic software, mobile technologies, sensors and
(Sweden), recently as Head for National Customers and New genomic sequencing, it is now becoming possible to capture and
Business. He has also been the President for the national analyze huge amounts of information about individual patients and
Swedish project "Check My Medicines" (www.kollpalakemedel. populations, and to use this information to develop healthcare in
se) which significantly has improved medical treatment for el- a way that couldn’t have been imagined in the past.
derly in Sweden. He holds various national and international
appointments - currently he works as an Executive Advisor Digitalisation will thus be one of the most important tools to
to Apoteket, and he holds several Board positions within the make healthcare more efficient and more effective. Smart systems
healthcare sector internationally. Lars-Åke is the President of capable of understanding health issues and complicated diseases
the Community Pharmacy Section FIP (the International Phar- will lead to innovations that will affect pharmacy from diverse
maceutical Federation). Lars-Åke Söderlund is also member perspectives. On one hand, it will improve screenings and therapy,
of the FIP Covid-19 Global Expert Advisory Group, and mem- improve the decision-making processes, facilitate electronic
ber of the Board of Pharmaceutical Practice., He is a frequent prescriptions, automate handling of medicines in the supply chain,
speaker in Sweden and internationally, regarding the future of
provide tools for medicines management and inventory control-
healthcare and pharmacy, with over 130 presentations during
ultimately enabling pharmacists to contribute to the provision of
the last 7 years.
high-quality care and ensuring that patients make the most of
Lars-Åke Söderlund is an FIP Fellow, and he has received sev- their medicines. On the other hand, it will impact the business
eral international awards for his work. He was recently award- side of the industry and pharmacy, providing the opportunity for
ed the "Pharmacist of the Year Award 2020" in Sweden. companies and organizations to more accurately and efficiently
deliver optimized healthcare to patients and customers. The truth

Pharma Times - Vol. 52 - No. 12, December 2020 38

is that consumers and patients will expect changes in healthcare spatially separated like video meetings, written digital care contact,
and pharmacy through their experiences with other industries that telephone contact or by different applications (apps).
have embraced these developments.
There are currently many apps on the market– used by
Digital technologies will then be strategic for pharmacy when patients– and directed for disease management and an
defining what’s the path or patient journey of this new consumer increasingly developed market of smart devices for chronic
(better informed, curious and proactive), and offer them new tools disease assessment. For example, many apps exist to help with
to interact with pharmacy. the management of diabetes, with key features such as a blood
glucose log, medication ‘pillbox,’ weight chart and diet log. These
Disruptive technologies features can be very helpful, as this information can be exported
The industrial world is at the beginning of the fourth industrial and given to the healthcare provider or pharmacist responsible
revolution. This era, often called the digital era, will radically change for the patient’s treatment. As such, technological empowerment
our use of technology, with major implications for the way people is key to patients becoming more health literate and actively
live and work. The COVID-19 pandemic has already been a disruptor engaging in and managing health. The future of healthcare is
for community pharmacy services, and is serving as a catalyst for based on ‘e-patients’ as active and autonomous contributors to
more pharmacies than ever delivering medicines and providing their own health.
advice and other services remotely due to patients having to The overall goal of recommending these apps is to put the
reduce contact with others. Unlike other healthcare professionals, patient in control of their own health, while also allowing patients
pharmacists have continued providing face-to-face services, which to share their data in real-time with their providers and caregivers.
have been enhanced by technology in many cases, and the access
to a pharmacist has proved invaluable to our communities.
Technological advances are disrupting the status quo.
Pharmacists should be involved in the development of digital
health technologies. By being part of the R&D side, pharmacists
can help develop better digital health tools and AI applications that
are more tailored to the clinical needs of patients. Technology also
brings new opportunities through combining care with supply, rather
than seeing them operate in silos. These technological advances
should be utilized as an enabler of seamless care, combining
diagnostic management by doctors with medicines optimisation
and pharmaceutical care by pharmacists.

Utilising digital technologies The provider can then better assess the
It is time to evaluate the services that pharmacists are patient’s condition, medication adherence and
providing through digital health tools that enhance pharmacy therapeutic efficacy. Changes to medication
services by improving access for patients who choose to receive therapy can then be made depending on
care digitally. the patient’s results. Pharmacists have for
years been actively involved in telehealth
Pharmacists must be able to respond to people’s needs and management for patients with for example
expectations, optimising care based on each person’s preferences diabetes and hypertension. Some other
and circumstances, while also leveraging their own expertise to examples are (disclaimer: the following
identify all patient needs requiring to be addressed. Pharmacists examples are just a few examples for
must understand that these needs can only be met if there are enhancing the reader’s understanding of
opportunities for the establishment of meaningful interactions. how apps can be used. There are many similar
New roles will include educating patients and the public on
consumer health technologies and how to interpret data from such
technologies in monitoring their health and health care.
While welcoming and embracing new technologies, pharmacists
will remain a strong advocate and supporter for patient safety,
patient data privacy and personalised care.

Improved patient-doctor-pharmacist relationship

In the past, healthcare has always been based on physical
meeting and the relationship between doctor and/or pharmacists
and patient, but with the development of digital care, these
conditions have changed. Digitalization makes it easier for patients
to maintain a history accessible for all healthcare providers with
the patient’s consent.
Digital healthcare services are healthcare that takes place
through digital distance contact, i.e. through some form of digital
communication where an identified patient and healthcare staff are

Pharma Times - Vol. 52 - No. 12, December 2020 39

apps, with a similar/equivalent functionality to be found in many our lives. With every advance comes a new challenge to the status
countries): quo— a factor that might cause anxiety for some, but what creates
opportunities for those who want to thrive, and to work in close
The app 'My pharmacy', developed by Apoteket in Sweden,
co-operation with the evolving health care sector.
has been downloaded more than 1 million times. With the app
the patient can chat with a clinical pharmacist 24x7, view his/ Now it’s possible to integrate data into processes that optimize
her medicine profile, order prescription- OTC-medicines and other patient care at the bedside or in our communities. And when
products, have a contact with a GP present on-line, get a renewal data is used at the point-of-care, it is when it makes the biggest
of current prescriptions or get a new prescription for a symptom impact. This goes for pharmacy as well, the evolution of pharmacy
presented to the doctor online, as well as chose where to the technology is best seen in the light of real-world benefits at every
medicine should be delivered (home, workplace) or to be picked touchpoint with the patient.
up at the local pharmacy. The new prescription will immediately
Today’s pharmacists continuously use innovations to improve
be stored in the patient’s profile.
pharmaceutical care and provide access to safe and effective
Aspen RxHealth is an American company using a gig economy medicines for patients. In the past 20 years, the pharmacy has
model to connect patients with pharmacists. The company plans developed and implemented a range of people-centered clinical
to connect licensed, vetted pharmacists with health plan members services which incorporate technological advancements that
in need of pharmacological consultations. The pharmacists will improve the care provided and further assist our profession to fully
be able to set their own hours and work from different locations, embrace the digital revolution.
connecting to patients to help them optimize their medications, in
So how can this development affect pharmacy and create new
consultation with the patient’s doctor.
opportunities? Some examples are:
Aspen RxHealth, deploys inventive technology to foster ● Identifying drug-related problems or drug interactions,
longitudinal relationships between health plan members and their maximizing the value of medication adherence: Evidence
community of pharmacists. This creates a new approach to match shows that patients with life-long diseases don’t take their
clinical pharmacists looking to practice at the top of their license medications as prescribed. With the help from the new
with members deserving the best care experiences, making it technology, pharmacists can target patients at risk of falling
easier for health plans and providers to achieve greater results, out of compliance with their medications. This can result in
while reducing costs without ever forsaking quality. fewer unplanned hospitalizations and reduced chances of
The platform’s matching algorithm connects pharmacists with complications. Drug-related problems can easier be identified,
patients in their area, with whom they match across a variety of and medication reconciliation services can be performed.
criteria– including their clinical area of interest or expertise– to ● Personalized access to healthcare resources: One advantage
increase the likelihood of building a trusted, longitudinal relationship. of the emerging technology is that patients can be monitored
Upon completion of each successful consult, payment is directly in their homes thanks to medical devices measuring health
rendered for clinical services delivered. After each consult, the health data. They can access their health record online, order their
plan member gives their pharmacist a quality rating from 1 to 5 stars medicines. They can also be monitored how they take their
medicines, and should a medication not be taken as directed,
and has the ability to favourite them for future engagements.
automated text alerts can subsequently be sent as timely
LudaFarma is a small and successful start-up from Spain. It reminders to patients.
was developed in co-creation with a team of pharmacists, who ● Developing more perfect pictures of health: Various
were upset, worried and tired to see patients trying to find the augmented reality devices that allow pharmacists to see
medicines they needed, too many times were in short supply. A patient records and prescription information are already being
software was developed and is now in use in pharmacies. When used in many settings. Many new technologies have emerged
a specific medicine is needed, the software indicates the closest and matured over the past decade. We are now using mobile
pharmacy with it in stock. This way patients can be referred directly devices in almost all aspects of our life, including healthcare
to that pharmacy saving time, costs and problems for pharmacists, and pharmacy. The upside brings the pharmacist to the patient,
patients, physicians and health systems. It is simple and convenient rather than the other way around, through telehealth video and
to use, since pharmacists can reserve the product without further other online support systems in real-time.
waiting, no phone calls or human interaction.
● Automation that sets free time for the pharmacist: As the use
Independent pharmacies form for the first time an electronic- of robotic technology for time-consuming duties, becomes more
virtual network, so patients know where to find their medicine from commonplace, pharmacists are increasingly finding more time
the convenience of their mobile phones, too. As in the analogic to interact with their patients. Many are using social media to
world, patients can define their favourite pharmacy, so they get to actively engage with patients on their health-empowering data-
know first if their regular pharmacy has the product in stock. driven decision-making- offering new services and contributing
to greater cost savings as well as a more accessible and
The evolving role of community pharmacy sustainable health care system.
Patients are embracing different ways of accessing healthcare, ● Community pharmacy is ideally positioned to use new
as well as pharmacy services. Community pharmacy has a long technologies and to dedicate more time to providing patient
history of changing and adapting, always evolving the way that we care, use patient data to provide a more personalized
work, the products we sell and the services we provide. healthcare service and utilize mobile health tools to identify
Nowadays technology is evolving every day. And we as patients at risk.
consumers and/or patients are eager to use the new technology in ● By embracing advances in IT, automation, technology,

Pharma Times - Vol. 52 - No. 12, December 2020 40

 genomics and biologicals, pharmacists and pharmaceutical aimed at improving medication adherence is emerging, with the aim
scientists and educators can embrace new opportunities and to provide user-friendly devices and applications centered around
grow their practice and science accordingly. the patient. The development of new technology will definitely play
● Pharmacists will become medication managers by embracing a bigger role in how pharmacy is practiced.
new roles in primary care or filling other gaps in the healthcare The best may be yet to come. From the perspective of today,
system while developing new practice and interdisciplinary much of what the new and emerging technology promises is
models to enhance patient access to pharmaceutical care. already here- ready and waiting. The proof will be in our pharmacy
practice. Understanding the changing healthcare landscape and
The changing role of the pharmacist patient evolving needs and expectations will be crucial for the
The importance of patient-centered–and digitally-enabled - profession of pharmacy as we develop new services, incorporate
pharmaceutical care is growing. Pharmacists are often the last new evidence-based digital tools and advance our possibilities
healthcare professional that patients interact with. This means that in the scope of patient-centered care. It is time to evaluate the
pharmacists are in an ideal situation to offer and provide certain services that pharmacists are providing through digital health tools
digital health services. that enhance pharmacy services by improving access for patients
There is also a global trend that pharmacy will cover a strategic who choose to receive care digitally.
importance in health services, evolving from its traditional role of However, digitalization will not replace the pharmacist nor the
dispensing medicines to become an actual center for well-being, human face of pharmacy- it is a tool for empowering pharmacists to
and by this changing the pharmacist’s role. The pharmacist will take an active role in patient care, as well as becoming an integrated
become a specialized advisor that guides the patient throughout and connected actor within primary healthcare. Digitalization is
the treatment and search of welfare; an advisor during the patient’s definitely also about people– the power of the patient/consumer
journey within the healthcare system. to engage and participate, to become an active, autonomous
Digitally empowered consumers will take a greater control of contributor to their own health. After all, digital health and digital
their health and expect a personalised, transparent and convenient pharmacy, in the end, is about health– digitally enabled.
care in all aspects, including services from pharmacy.
Executive Summary
If the pharmacy’s future is its evolution into a well-being center, Healthcare and pharmacy are facing a digital revolution,
digital technologies offer tools to get to know and track the most bringing the latest technology to healthcare, empowering patients
conscious and demanding consumers, keeping them company and potentially giving healthcare professionals the tools and
during the entire treatment period as well as in the search for information they need to work more effectively and improve
a healthier lifestyle. The challenge for pharmacy will be to have outcomes.
an available integrated database with a much deeper customer
profile that includes details about their general condition, visit Pharmacists will need the time and willingness to explore the
history, consultations and transactions, always while protecting new technology, to learn how to use it, and have education and
the patient’s right to privacy. As such, the pharmacy should training in place to develop new services. The greatest challenge is
digitally position itself as an advisor and true source of information the shift in learning and innovation, with a willingness to embrace
that helps the patient resolve their doubts and understand the technology.
indications in their therapy. Understanding the changing healthcare landscape and patient
It is also important to remember that society keeps expecting evolving needs and expectations will be crucial for the profession of
professionalism and closeness from the pharmacy. One of the key pharmacy as we develop new services, incorporate new evidence-
factors in supporting patients is recognizing that every person-and based digital tools, and advance our possibilities in the scope
therefore, every therapy- is different, so communication and care of patient-centered care. It is time to evaluate the services that
should be adapted to everyone. pharmacists are providing through digital health tools that enhance
pharmacy services by improving access for patients who choose to
What is of importance for pharmacists during 2021? receive care digitally. After all, digital health, in the end, is about
It is important to empower pharmacists to embrace the ongoing health– digitally enabled. While automation and digitalization will
disruption and bring technologies to their practices, upgrading what improve efficiency, it will not replace the patient’s interaction with
they have been doing. Good examples can be found in India, and other the pharmacist.
countries, to demonstrate how these can decrease costs and increase How pharmacists and pharmacy organizations can rise to the
the quality and range of the services pharmacies provide today– and challenge of new technologies is set out in a new position statement
at the same time showing how pharmacy contributes to a sustainable released by the International Pharmaceutical Federation, FIP. The
healthcare model with improved outcomes and efficiency. statement highlights technological advances, some considered
Digital technologies will make medicine use safer for patients, disruptive, that are affecting the pharmacy profession, including
where pharmacists use digital technology regardless of their successfully providing remote services during the COVID-19
practice setting. This digital transformation will enable pharmacists pandemic; 24/7 online access to pharmacists; harvesting of patient
to make better clinical decisions with their patients, thus improving health and online purchasing data by profit-seeking entities; the
patient care. The predominant enabler of these changes will use of artificial intelligence; and the use of marketing tools to
be technology. While integrating technology into pharmacy, it encourage patients to buy medical products they may not need
is important to remember that patients come from different and which may be detrimental.
technology literacy levels. As technology is such a key component of The statement can be downloaded here: https://www.fip.org/
our lives, it is clear to see that many would benefit. More technology file/4874

Pharma Times - Vol. 52 - No. 12, December 2020 41

Article

Blockchain: the next BIG thing for the Pharmaceuti-

cal Supply Chain
Tariq Ahmed
Co-Founder & Editor, Logistics Insider

Blockchain in itself is one of the most revolutionary programmes in order to study Blockchain’s ability to securely
technologies that mankind has stumbled upon. For a lot of us, exchange serialized data from manufacturers all the way to
Blockchain can seem to be complicated. And it truly can be. But pharmacies.
once someone looks past that layer of complexity, one would
The pharmaceutical supply chain is a complex process, with
understand that its core concept is quite simple. Key benefits
drugs changing ownership from manufacturers to distributors,
of the Blockchain technology include trust, transparency,
wholesalers, stockists and pharmacies before reaching the end-
disintermediation, immutability and consensus.
customer. There is often little to no visibility for manufacturers
There’s a lot of buzz around Blockchain in general, about the to track the authenticity of their product throughout the supply
world of possibilities this technology holds. A lot of industries chain. Consequences include the counterfeit drug problem
have already started to harness the power of this amazing and inefficient processes for conducting recalls and returns
technology, such as banking, cybersecurity, food, healthcare and processing. These not only result in financial losses but also the
manufacturing. And, slowly but certainly, even governments are loss of trust with consumers.
eyeing this technology to help them better manage administrative
Counterfeit drugs are drugs that do not contain the active
works.
ingredients they are supposed to and consequently can harm
Among all these industries, one industry that hopes to patients. According to a 2010 study by the World Health
find multiple applications of Blockchain technology is the Organization, the estimated worldwide sales of counterfeit
pharmaceutical industry. With the right use of this technology in medicines had witnessed a 90% increase in terms of value than
the pharmaceutical industry, the possibilities are limitless. in 2005. According to another estimate from BIS Research, global
pharma companies lose around $200 billion to counterfeit drugs
annually.
Counterfeit drugs are motivated by the potentially huge
profits and especially developing countries are targets because
the cost of legitimate drugs is often beyond the reach of much
of the population (WHO, 2010). Countries like India and China
specifically are very vulnerable to counterfeit drugs, as are
several other Southeast Asian countries. The overall death
toll attributable to counterfeit medicines, like the scale of the
business, is unknown, but the costs to public health are huge
since apart from death counterfeits can cause resistance to
medicines (WHO, 2010).
In the U.S., pharmaceutical manufacturers, wholesale
distributors and dispensers, in collaboration with the U.S. Food Blockchain technology is hailed as the answer to this problem
and Drug Administration (FDA), have conducted several pilot as it could be an opportunity platform to increase trust and
transparency. By giving each strip, bottle or vial of medicine a
unique number, it can be closely tracked all along the supply
Tariq Ahmed chain. The packaging of a drug could be scanned by a barcode
Co-Founder & Editor, Logistics Insider anytime, the drug changes ownership. Only trusted parties
Tariq Ahmed is the editor, publisher and co- are granted access to write on the Blockchain. The record is
founder of Logistics Insider – India’s most delivered on the Blockchain in real-time. Manufacturers and end
comprehensive logistics media network. He customer can scan the barcode and see the history. Optimally,
is a media professional who has seen the the platform ensures drug identification, tracing, verification
logistics and supply chain industry from a close purview and and notification in case an illegitimate drug is found. The
wishes to bring about a radical change in the mindset of peo-
intelligent Blockchain-based control system ensures end-to-
ple regarding this industry. With Logistics Insider’s one-of-its-
kind digital magazine and website, he aims to leverage on the end tracking. It will eliminate the opportunity for illegible drug
growth potential of the logistics industry, and provide the read- modification, in particular at interfaces and wherever there is
ers with data-driven insights, industry updates, interviews and manual intervention.
news articles. Logistics Insider has recently won the award for
the “Best Digital Magazine 2020 in the Logistics Industry” at 40% of health execs see Blockchain as among their top
the Asia Logistics & Supply Chain Congress & Awards. 5 priorities, with spending on this technology expected to hit
$5.61 billion by 2025, according to a report by BIS Research.

Pharma Times - Vol. 52 - No. 12, December 2020 42

This technology could save the healthcare industry billions of plus adoption are the keys to that endgame. Because data
dollars per year in data breach-related costs, IT costs, operations and products move among trading partners in a complex and
costs, support function costs and personnel costs, and through interconnected web, it may be unrealistic to expect trading
a reduction in frauds and counterfeit products, the agency partners to participate in multiple Blockchain solutions.
reports.
Another major challenge for establishing a supply chain
The Pistoia Alliance1, a global not-for-profit group, surveyed Blockchain is funding. The industry has not yet developed the
120 life science leaders in June 2016 and found that 83 percent model for sharing the cost even though all stakeholders are
anticipated adopting Blockchain by 2021, with nearly one quarter likely to benefit. Some stakeholders stand to benefit more
(22%) responding that they were already using or experimenting than others, but to what degree depends on the Blockchain
with Blockchain. design. This leaves a question mark regarding which stakeholder,
introduced jointly with Ghatkopar Medical Association, Indian Medical or stakeholders, will assume responsibility for paying for the
In India, Nitiand
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project. The motive of project was to rationalise the hospitalisationthe
trustworthy … the risk of entry of fake drugs arises when as supply chain. The most important of them all is the need for more
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treatment by providing Oxygen to suffering patients by offering 24x7 significant need for awareness and education at a baseline level
facility which is being supported by the MCGM. chemist’s association and that has helped a lot to many such
However, there are still a few stumbling blocks that will on thepatients.
ailing benefits and outcomes of the technology. Second, for
Community Pharmacy Division of IPAMSB helped in bridging the those who are more familiar with the technology, they must be
pose challenges to widespread Blockchain adoption. First and Ms. Savita Garje, 2016-passed out alumnus of the IPAMSB’s
gap 'between' 'and' 'uninterrupted' supply of Tocilizumab and
foremost, standardisation or, more accurately, the absence

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breakthrough to renowned Ayurvedic doctor dispensing AYUSH by Ms.Manjiri Gharat, Chairperson, IPA-CPD. This was the
medicines in Corona care Centres at Navi Mumbai, Panvel best example of teachers’ contribution that was also equally
Municipal Corporations and provided smart phone applications for acknowledged and highly appreciated by her about the support,
real time monitoring and compilation of data. timely help and proper guidance by mentor Dr.Alka Mukne.

Pharma Times - Vol. 52 - No. 06 - June 2020 36

Pharma Times - Vol. 52 - No. 12, December 2020 43
Article

Cyber Check for Pharma - Need of the hour

Samir Aksekar
Director, Cyberwis Private

Introduction Above is a small snippet of what has been happening globally

Coronavirus or Covid-19 has changed the entire security across the overall healthcare and pharma ecosystem.
matrix in India and rest of the world in an unprecedented manner.
A unique sector
It has consequently exposed the fault-lines that existed in our
security management infrastructure. We currently have two major The Pharmaceutical sector has been facing an increased
challenges. The first challenge is that our institutions of governance, threat from cyberattacks long before the outbreak of this
both domestic and global are based on sector-specific knowledge pandemic. For years malicious actors have had an increased
and management systems. These are unable to collaborate in interest in this unique sector - and there are good reasons for it.
delivering multi-disciplinary and multi-sectoral response, which Given the importance and prevalence of the intellectual property
an interconnected and globalised economy requires. The second (IP) they create and manage, biopharmaceutical companies are
challenge is creating increasing salience across the national a prime target.
landscape for obtaining maximum. India has to break out of the
“Silo” system, both in government and the corporate sector to Vulnerabilities
achieve better and faster national development. Pharmaceutical companies are all geared up both nationally
and globally to rake in significant mileage from the Covid-19
Covid-19 has blurred the lines separating the Traditional and vaccine. This makes the research and development (R&D) data, the
Non-Traditional National Security Interests. In an exponentially lifeblood and fundamental basis for everything a biotech or pharma
globalised world heavily dependent on rapid digitalisation. The company does. This IP becomes increasingly valuable as a drug
need for enhancing security across the spectrum cannot be candidate progresses throughout the R&D process and in clinical
overemphasized, failure to address this will come at a heavy trials. As companies increase digitization to take advantage of cost
cost.
efficiencies, efficient & effective supply chain, and more online data
Cybersecurity is now a household topic as it relates to credit storage, the attack surface continues to increase.
card data breaches, phishing scams and ransomware attacks.
Companies that manufacture drugs face another vulnerability:
2020 has set a new benchmark for all - including cybersecurity. The
COVID-19 pandemic has triggered a spike in attacks on WHO and while the drug formulations might be held in a secure
the healthcare sector across the globe[1]. As drug manufacturers environment, at some point the formula translates into amounts
started research on the vaccine, the attacks have pivoted into the of liquids, powders, water, and other chemicals. The formula is
pharmaceutical sector. revealed through that process, and if an unauthorized individual
understands the process, then they can easily re-engineer the
Q1’2020: Large scale attacks on WHO & Healthcare Sector formulation[2].
globally[1].
Consequences
Q2’2020: ExecuPharm suffered a ransomware attack and
The potential consequences of a cybersecurity attack depend
subsequent data breach in which hackers had access personally
on the size and scale of the organization but can range from stolen
identifiable information (PII) of ExecuPharm’s employees[2]. IP, compromised clinical trials, litigation, and lost revenue through
Q3’2020: Significant uptick in phishing attacks on Pharma halted manufacturing. A data breach incurs serious consequences
executives[3]. no matter whether a company is big or small. Staff gets fired,
Q4’2020: Dr. Reddy’s Laboratories & Lupin hit by executives issue apologies, and entire systems are overhauled to
ensure that it doesn’t happen again. It instils doubt in consumers,
cyberattacks[4].
damages the company’s reputation, and the impact can last
for years. A data breach can harm both public sentiment and a
company’s competitive edge in the market[3].
Samir Aksekar
Director, Cyberwis Private What drives the cyber criminals?
A cybersecurity expert, business leader and The two main drivers are financial profits (i.e. ransomware)
entrepreneur working to secure business op- and geopolitical. Many of the research firms headquartered in
erations. Samir co-founded Cyberwis with a the United States or Europe are targeted purely for this reason.
singular aim of simplifying cybersecurity for In some cases, expensive drugs draw attention from “hacktivists”
businesses. With over two decades of leadership experience who do not have traditional profit motives but attempt to access
at the front line of cybersecurity for IBM & JPMorgan Chase, proprietary information and disclose data.
Samir was responsible for developing and executing a simple,
effective, & prioritised approach to Cybersecurity for Asia Pa- Lagging Behind
cific businesses. An effective decision maker and communi-
cator; Samir regularly brings his interdisciplinary background, The pharmaceutical industry is lagging behind other
mental models, systems thinking to drive innovation, effective industries when it comes to cybersecurity practices. The industry
decision, tackle complex problems and support his team. has had enough wake-up calls in recent years, and larger
organizations started to take cybersecurity more seriously and

Pharma Times - Vol. 52 - No. 12, December 2020 44

make improvements. However, cybersecurity practices are not actors attack & at the same time, there is considerable inside
consistent across the sector and the large ecosystem of third threat, as IP theft is often linked to inside actors. The string of
parties/ vendors supporting pharma & its crucial supply chain. successful attacks since the last couple of years serve a wake-up
call to the industry. A top-down pro-active cybersecurity strategy
Approach Going Forth that includes mitigating the human factor, insider threat, third
Cybersecurity is not an IT problem and the accountability of party risk and covers sector specific aspects such as custom
it needs to rest with the senior leadership of the organization technologies, industrial control systems and mergers and
or the board. In fact, this point is so important that it is the acquisitions security assessments will fortify the information
first requirement of the international cyber and information security posture of organizations in this sector. All of this starts
security standard ISO 27001. Perform a gap analysis to input with a check-up. Leverage external help to get an unbiased view
into the development of a proactive roadmap for governance of your organizational security posture.
program, third party assessments internal threat management
and IoT amongst others. Execution of the cybersecurity strategy References
needs to be handled by a dedicated security team to ensure it 1. https://www.who.int/news-room/feature-stories/detail/attacks-on-
health-care-in-the-context-of-covid-19
gets the required focus, funding and expertise to support the
business objectives. Additionally, cybersecurity is the job of 2. https://www.theguardian.com/society/2020/oct/28/us-healthcare-
every employee, and embedding cybersecurity in the corporate system-cyber-attacks-fbi
culture is essential. As with any organizational change, this has 3. https://ago.vermont.gov/blog/2020/04/17/execupharm-inc-notice-
to be communicated properly throughout the organization. This of-data-breach-to-consumers/?=april-17-2020
allows employees to see adherence to policies and procedures 4. https://threatpost.com/threatlist-pharma-mobile-phishing-attacks-
not as an annoyance, but rather, as a protection for themselves turn-to-malware/161318/
as well as their company. 5. https://www.businesstoday.in/sectors/pharma/lupin-hit-by-
cyberattack-threat-increases-for-pharma-firms-amid-covid-19/
Conclusion story/421348.html
The pharmaceutical industry is a very vital sector that 6. https://www.pharmamanufacturing.com/articles/2017/industrial-
produces and thrives on its IP and R&D data. Consequently, the cybersecurity-defenses-essential-for-pharma-companies/
entire sector is a prime target for attackers from all sides. From 7. https://www.comparitech.com/blog/information-security/data-breach-
the outside, well-funded and highly sophisticated nation state share-price-analysis/

Last date of submission Thursday 31st December 2020

Pharma Times - Vol. 52 - No. 12, December 2020 45

Article

How COVID-19 Has Accelerated The Need For Digitiza-

tion In The Pharma Industry
Anoop Madhusudanan
Vice President, Digital Marketing, West Pharmaceutical Services
The COVID-19 global pandemic has rewritten the history of 6.0%  between 2020-2027. Some of the major factors leading to
mankind within a short span of time, adversely impacting world the packaging market growth: rising concerns related to the safety
markets, with businesses shutting down, and jobs and the health of of medicines from physical damage or external influences that can
millions of people at risk. With more than 35.5 million[1] people being contaminate the medicines before their consumption; the rising
infected globally since the outbreak, and the numbers increasing need to curb the growth of counterfeit drugs and medicines; and
daily at an alarming rate, COVID-19 is more than a global health crisis, the increasing adoption of generic drugs in developing countries
it is affecting countries and economies at their very foundation. due to their low costs.
In fact, the World Bank[1] has forecasted that the global economy Thus, the significant role played by this industry makes it
will shrink by 5.2% this year, leading to a recession more severe imperative for the various players involved in different aspects
than the one post the Second World War. With domestic demand of business operations – discovering, testing, developing,
and supply, trade, and finance badly disrupted, developed nations manufacturing, and distributing – to continue, despite numerous
are expected to witness a massive 7% shrinkage in their economic hurdles slowing down the processes.
activities.
The crisis has exposed the need for more agility, resilience
Pharmaceuticals – one of the most valuable industries, especially and efficiency, and Industry 4.0 is being embodied by emerging
in times of major health crises such as the current pandemic — is not technologies such as automation, artificial intelligence and
an exception. Even as the overburdened healthcare industry is, at machine learning. Due to this, there are various prospects through
the frontline, trying to save lives and control the spread of infection, which pharmaceuticals can adopt digitization, leading to improved
the pharma industry, while maintaining continuous business productivity in factories and laboratories and making the pharma
operations and providing a constant supply of essential drugs at products better in terms of costs and quality. McKinsey[1] reports that
affordable prices, has been making strenuous efforts in developing the use of digital technology can mitigate human error and improve
a “silver bullet” vaccine and attempting to repurpose existing drugs quality by up to 40%.
to neutralise the effect of the virus.
Challenges Faced in the Pharma Sector During the Pandemic
Across the world, the beginning of the outbreak saw people
fearing shortages, hoarding medicines as much as they were The negative impact of the COVID-19 crisis, of potentially both
stockpiling food items. Adobe Analytics[1] reported the U.S. market a medium- and long-term nature, is already at the forefront across
saw e-commerce sales for disinfectant gels, protective face masks, the pharma value chain from manufacturing to sales and marketing.
and antibacterial sprays increase by 187% while sales for cold and Disrupted supply chains and the urgent need to revamp the existing
cough medicines rose by 198%. business processes have created hurdles in sustainability and growth
within the pharma segment, for both big pharma companies as well
An IQVIA report[1] stated that the global pharmaceutical market as start-ups. The ripple effect of the pandemic is beginning to reflect
is expected to surpass $1.5 trillion by 2023. Furthermore, until the across various processes and factors as follows.
beginning of October 2020, globally, there are 628 drugs[1] and
vaccines in development targeting the coronavirus disease. An Research & Development activities: Export bans, trade
important segment within this industry –packaging – can be seen restrictions, and other safety measures have resulted in supply
adopting innovative and technological solutions to meet the changing shortages of vital medicines that are hampering clinical trials of
business requirements. Case in point, a Fortune Business Insights[1] various life-threatening diseases. This is further emphasized by the
study shows that the global pharmaceutical packaging market is fact that patients, who are part of the clinical trials, are unable to
projected to reach $142.59 billion by 2027, reflecting a CAGR of reach their trial sites for requisite monitoring and medication.
Likewise, some pharma companies have had to postpone candidate
recruitment for clinical trials to reduce the risk to patients getting infected
Anoop Madhusudanan by the virus, while others are delaying trials and opting not to start new
Vice President, Digital Marketing, West ones to avoid overloading the health care systems[1].
Pharmaceutical Services
Most importantly, there has been a drastic shift within R&D with
Anoop Madhusudanan currently serves as the primary focus on finding a plausible treatment or cure for the
the Vice President of Digital Marketing & coronavirus. What this translates into is a trade-off of the ongoing
Platforms for West Pharmaceutical Servic- and planned clinical trials for other diseases, which in turn, would
es. Anoop has served in various senior leadership positions in delay the development of new drugs.
multi-national healthcare & life science corporations including
Sigma Aldrich, Merck KGaA and Avantor/VWR, driving digital Delayed production activities: The manufacturing and
business initiatives. He is passionate about transforming busi- distribution of key medicines is being adversely affected due to
ness through data & engineering driven innovations – empow- varying availability of Active Pharmaceutical Ingredients (APIs). Two
ering customers to meet complex challenges. He received his major players, India and China—who together have about 31%[2]
engineering degree in Computer Science from Mahatma Gan- of the world’s API manufacturing plants—have had nation-wide
dhi University, and Post Graduate Diploma in Hardware Engi- lockdowns and halted production, along with export bans. This
neering from IHRD. led to a significant fall in production of medicines in developed
countries. Also, inadequate ancillary supplies such as bottles, caps

Pharma Times - Vol. 52 - No. 12, December 2020 46

and packaging material for medicines will affect the output, and the machine learning models to design new small molecules that might
impact is expected to be felt over the next 6-12 months[3]. inhibit COVID-19’s functioning. As another example[12], a leading
Indian IT firm, Saama Technologies, partnered with iNDX.Ai to launch
The nature of the pharma manufacturing segment has always
a COVID-19 Command Center analytics platform that offers data
been considered high-risk due to the high probability of any infections
analytics capabilities specific to the research and development of
spreading quickly across production units due to working in close
therapies targeted at coronavirus.
contact with one another, and thus worker health and safety
policies ranked high on employers’ lists in the pre-pandemic times. Virtual R&D: Recently, Medidata[13], a SaaS firm, commenced
Additionally, the pre-existing shortage of skilled labour to work a three-year long virtual study with 14,600 patients, wherein the
in this industry added to the woes of the pharma producers. The observations were self-reported and securely stored in a database,
ongoing crisis has exacerbated this issue, creating further delays in and easily accessible by the researchers. This is just one of the many
production with limited manpower on the floor due to the COVID-19 instances where the researcher community is embracing technology
safety measures and the unwillingness of workers to come back due for conducting digital trials and improving capacity. The process for
to the risk of getting infected[4]. recruitment and retention of candidates for the trials may not have
changed much over the past 30 years, but many components of a
Changing demand for medical products: The demand[5] for
clinical trial can now be done remotely through the use of connected
branded drugs and biologics is also impacted with consumers and
digital devices and the internet[14].
patients refraining from starting new treatment or opting for elective
medications. Also, some next-generation therapies might not be II. Digitization of Supply Chain Networks
available to patients if hospitals do not have the requisite resources
to prepare and treat those patients. The pandemic has highlighted one of the harsh realities within
the pharma sector – the existence of a highly complex, under-utilised
Constraints in organizational growth strategies: With and inflexible supply chain ecosystem. With the industry rapidly
organizations facing business continuity challenges, various growth evolving, the products have shorter life cycles, the environmental
and diversification strategies including planned mergers and safety and protection policies are becoming more stringent, patient
acquisitions, new projects and ventures have also been shelved. data is garnering more value, and there is a greater emphasis on
Case in point, the “megamerger”[6] between Upjohn, Pfizer’s off- outcomes. Add to this, pharmaceutical enterprises need to stay front
patent branded and generic established medicines business, and and ahead in catering to domestic and international demand for
Mylan has been delayed indefinitely. drugs, medical equipment and devices, and other supplies.

Digitization - An Imperative in the New Normal All these factors indicate one important strategy – reorganizing
the existing supply chain infrastructure. With the nature of supply
Even before the outbreak, digital transformation had begun
chains becoming more patient-centric due to increased adoption
reshaping the pharma sector. In the new normal, technological
of digital tools, telehealth, telemedicine and app-based systems,
adoption has accelerated this change with the role of technology
digitalization within various touchpoints of the supply chain network
evolving from being a mere support system to becoming the key
has become imperative.
enabler in this highly vital, human-intensive industry. Big data analytics,
predictive analytics, process automation, Artificial Intelligence (AI), A recently conducted Pharma Manufacturing Smart Pharma
Machine Learning (ML), and other advanced technologies are Survey[15] found that 93% of drug manufacturers and 87% of
playing a pivotal role in creating new and improved processes, thus equipment and services vendors believed that automation is highly
enabling pharma companies to continue to operate to the best of their advantageous for this sector.
capabilities and provide much needed assistance to both healthcare
providers and patients during the unprecedented times of crisis. III. Digitization within Packaging
Recent studies[7] show that global AI spending in the healthcare and In the growing list of essential materials—ranging from personal
protective equipment, ventilators, ICU capacity, to even home quarantine-
pharmaceutical industries is expected to increase from $463 million in
related healthcare services—that need to be easily accessible is another
2019 to more than $2 billion by 2025. In India, according to a survey
item recently added: pharmaceutical packaging. While efforts are being
conducted by C Com Digital marketing agency[8], almost 35% of the made to develop a vaccine, it is equally important to take a hard look
domestic pharma companies’ operations need to be shifted to digital. at packaging materials like vials and syringes that will act as vehicles
for bringing the vaccine to those who need it.
I. Digitization within Research & Development (R&D)
Packaging may come at a fraction of the cost of medicines;
Augmentation of AI and other technologies: The drug discovery however, it forms an integral part of a drug product, even in pre-
and development process forms the core of the pharma segment. pandemic times. What makes it even more crucial for pharma
The impact of COVID-19 can be seen in the fact that it has brought companies to have fail-proof, proper packaging materials is the rising
forward digitisation within this sphere from years to mere months. threat of counterfeit pharmaceutical drugs entering the supply
Enterprises[9] such as Alibaba, NVIDIA, Graphen, and Google chain and causing damage to public health or a company’s brand
DeepMind are working towards developing AI tools that would aid image. The pandemic is pushing hard at the need for technologically
in understanding the evolution and spread of coronavirus, track its advanced packaging solutions to improve patient convenience and
geographical footprint, and even predict its potential protein structure provide safety such as packaging with antiviral and antibacterial
to find an antiviral vaccine for it. The 3D models of proteins generated properties, self-administered drug delivery devices, and COVID-19
by Google DeepMind’s Alpha Fold, are far more accurate than any “intelligent” test kits.
that have come before – and they recently published predictions of While QR codes, holograms, and Radio Frequency Identification
five understudied SARS-CoV-2 targets[10]. Thus, AI and other advanced Technology (RFID) are some of the technologies already in play, innovative
technologies can help speed up drug discovery by analysing the technologies like blockchain, IoT, and Near-Field Communications (NFC)
existing pharma research data more effectively, screening chemical technology for smart packaging techniques are some of the game-
libraries, drug repurposing, binding target predictions and pre-clinical changing solutions that can provide traceability of pharma products
testing. Case in point [11] - Insilico Medicine is using 28 different across their product lifecycles and down the supply chain [16].

Pharma Times - Vol. 52 - No. 12, December 2020 47

 Further, with the emergence of e-pharmacies or online pharmacies Virtual collaborations between universities and start-ups are giving
in the new normal, packaging companies are looking at new and rise to ‘open health platform’ initiatives, leading to innovation across
innovative ways of providing pharma products that can sustain in this boundaries. Case in point[16]– IndVentr, a not for profit consortium
fast-expanding distribution channel. Connected drug delivery models of three start-ups – Sinergia Media Labs and Ionics 3DP based in
are evolving to support some of the remote care use cases. Kerala, India and Aruvii based in Singapore – and Prana Foundation,
a not-for-profit foundation which grew out of biomedical engineering
IV. Digitization in Sales and Marketing efforts at MIT and the Brigham and Women’s Hospital have been
With clinics and hospitals turning into triage centres and COVID- working on low-cost, connected emergency ventilators to cater to the
19 treatment facilities, and safety norms being enforced in terms of rapidly escalating challenges presented by the pandemic.
stay-home or work-from-home orders, pharmaceutical marketing and The compliance & regulatory world is also changing. FDA
salesforce are at a loss to connect with the healthcare providers to pitch approved a few artificial intelligence models to help clinicians
their products. The face-to-face interactions are no longer happening in diagnose and treat COVID-19, the latest being COViage – an
today’s environment. Further, this accessibility issue would have a huge algorithm developed by a California based digital health company,
impact in reaching out to potential patients for research and clinical trials, Dascena [17]. COViage, a HIPAA-compliant cloud-based software uses
leading to further disruptions in drug development stages. AI models to calculate the risk levels for both hemodynamic instability
These issues have thus given rise to the growing trend of and respiratory decompensation.
companies employing ‘marketing as a service’[16], a shift that is largely Digitization has led to a greater emphasis on reskilling and
based on accelerated adoption of digital channels. Virtualisation of upskilling the workforce for the next normal, reinvention of the
engagement through websites, webinars, virtual events, and remote organizational culture as agility, scalability, and efficiency become
detailing is set to replace personal interactions in the post-COVID-19 key elements of working, cross-sector/-industry recruitments to fill in
era. Case in point [16], even as the pandemic restricted the salesforce the digital-driven job roles, and new collaborations and partnerships
across various industries within their homes, global pharmaceuticals within this industry. The new normal has brought the entire vaccine
giant Novartis ensured that its 30,000 sales representatives ease development life cycle to the forefront, turning it into an open book
smoothly into the remote working model with the aid of its ACTayla sales process, providing consumers a better understanding of the tireless
platform. The salesforce has been able to stay at the top of their game efforts behind the price tag.
by applying digital capabilities to gather relevant insights, as well as be
more approachable to a “pull” of demand from their target customers The use of path-breaking technologies such as AI, data analytics, big
– the healthcare providers and patients – rather than a sales “push.” data, IoT, and blockchain, amongst others, promise to present not only a
Few companies are also launching 360 immersive experiences and solution to the COVID-19 crisis, but bring forth a new age in pharma.
‘Virtual Expos’, supplementing traditional exhibition booths and trade
shows, pushing the boundaries of customer experience [16]. References:
1. https://www.statnews.com/2020/03/23/as-covid-19-spreads-
disruptions-to-clinical-trial-and-drug-development-accelerate/
V. Digitization of Knowledge
2. http://timesofindia.indiatimes.com/articleshow/75861526.cms?utm_
It is often said that knowledge is power. This has never been source=contentofinterest&utm_medium=text&utm_campaign=cppst
more true for the infinite volume of information and data that exists 3. http://www.peah.it/2020/04/covid-19-impact-on-the-pharmaceutical-
in this complex and critical pharmaceutical industry. Every process, industry/
big or small—from drug development to medical equipment to value 4. https://www.outsourcing-pharma.com/Article/2020/07/06/Pharma-
chains to marketing products and services—generates information industry-needs-tech-in-the-face-of-COVID-19
that can be utilized across the closely interconnected segments, in 5. https://www2.deloitte.com/us/en/blog/health-care-blog/2020/covid-
some form or the other. 19-pandemic-could-forever-change-biopharma.html
6. https://www.dcatvci.org/pharma-news/6418-covid-delays-closing-of-
This has given rise to ensuring vital information resources merger-of-pfizer-s-generics-biz-and-mylan
are easily accessible to the different players in the sector and the 7. https://www.statista.com/statistics/309471/randd-spending-share-of-
digitization of knowledge centres is making it possible. Increasingly, top-pharmaceutical-companies/
companies are offering all-encompassing integrated solutions services 8. https://healthtekpak.com/health-industr y -update/digital-
that provide strong support across all processes including drug transformation-of-pharma-industry-amid-covid-19-crisis/
products commercialisation and contract manufacturing services. 9. https://www.prnewswire.com/news-releases/covid-19-pandemic-
Other services such as know-how and guidance on industry regulations impact--global-rd-spend-for-ai-in-healthcare-and-pharmaceuticals-will-
increase-us1-5-billion-by-2025--301041073.html
and policies, analytical testing requirements, risk mitigation strategies
relating to packaging and delivery from development to sales are also 10. https://deepmind.com/research/open-source/computational-
predictions-of-protein-structures-associated-with-COVID-19
becoming a vital part within the pharma knowledge-sharing space.
11. https://syncedreview.com/2020/03/05/ai-based-drug-discovery-
pipeline-generates-novel-drug-compounds-against-coronavirus/
The Way Forward
12. https://www.outsourcing-pharma.com/Article/2020/05/12/
Every cloud has a silver lining and as we cope with this Artificial-intelligence-technology-improves-clinical-trials?utm_
unprecedented global health crisis, it has never been more true. On source=copyright&utm_medium=OnSite&utm_campaign=copyright
one hand, both people and businesses are dealing with the impact 13. https://timesofindia.indiatimes.com/business/international-business/
of the pandemic, on the flip side it has accelerated the adoption of how-covid-19-holds-the-potential-to-change-the-pharmaceutical-supply-
chain/articleshow/75861526.cms
digital in all spheres of life.
14. https://www2.deloitte.com/us/en/blog/health-care-blog/2020/patient-
Within the pharmaceuticals sector, decades turned into recruitment-holy-grail.html
mere days for a large number of organizations in adopting digital 15. https://www.pharmamanufacturing.com/articles/2020/pharma-finds-
transformation during this pandemic. Companies, from global its-digital-groove/
conglomerates to start-ups, began making digital investments and 16. https://www.thehindu.com/news/cities/Kochi/start-ups-develop-
undergoing a massive change in various aspects of their businesses. prototype-of-cost-effective-ventilator/article32644964.ece

Pharma Times - Vol. 52 - No. 12, December 2020 48

 Dr. Suresh Sarvedekar felicitated
by Governor of Maharashtra

IPA-RAD & IPA-ED

Webinar on “Drug Regulatory Affairs-Indian and the US
scenarios”
A webinar on “Drug Regulatory Affairs-Indian and the US
scenarios” was jointly organized by IPA-RAD & IPA-ED on 27th
August, 2020. Dr. S.
Vidyadhara, Chairman,
Education Division
extended a warm
welcome to the Chief
Guest, Speakers and Dr. Suresh Saravdekar, Vice Chairman, IPA - Hospital Pharmacy
the participants. The Division was felicitated by Honourable Shri Bhagat Singh
programme began with Koshyari, Governor of Maharashtra in a function held at Raj
the speech of Dr. T. V. Bhavan on 1st November, 2020 at 11.00 a.m.
Narayana, Chief Guest He was felicitated for rendering excellent health care services
of the programme. Dr. during his government jobs with the Ministry of Health and during
Subhash C. Mandal Covid-19 pandemic.
s p o ke o n t h e to p i c
Around 45 persons mainly from health care and from film industry
“Drug Regulator y
like Mr. Subhash Ghai from Hindi and Mr. Prashant Damle, Miss.
Mechanism of India”.
Velankar from Marathi film industry were felicitated.
During his speech, he
elaborately explained The felicitation program was followed by a high tea and a short
the structure and meeting with the Governor.
function of the
Drug Regulatory
authorities of India.
He also mentioned
that opportunities are The team of IPA Office Bearers led by President Dr. T.
growing in this area for V. Narayana has been proactively engaged in taking up
the young pharmacists. advocacy initiatives with the government & regulatory
Mrs. Madhuri Gupta bodies to safeguard and promote professional interests.
spoke on “Regulatory Pharma Times begins a new feature - Advocacy Corner
Affairs in the USA and FDA’s Regulations for ANDA/NDAs”. presenting an abridged version of the initiatives taken
She explained the procedure of filling out applications for by the Association. Readers can go to the IPA website
ANDAs & NDAs. At the end both the speakers joined in a live Q on www.ipapharma.org for checking details of the
same.
• Letter sent to Dr. Harsh Vardhan, Union Minister for
Health and Family Welfare requesting for engaging
the Indian Pharmaceutical Association as a partner
in training pharmacists for immunization against
COVID – 19 along with the letter from FIP President
(04.12.2020)
• Letter sent to Dr. V.K. Paul, Member – NITI Ayog,
Government of India, requesting for engaging the Indian
Pharmaceutical Association as a partner in training
& A session. Dr. S. Vidyadhara, Chairman, Education Division
pharmacists for immunization against COVID – 19 along
Indian Pharmaceutical Association moderated the session.
with the letter from FIP President (04.12.2020)
Pharmaceutical personnel from around the globe attended
the webinar.

Pharma Times - Vol. 52 - No. 12, December 2020 49

 Treatment for: Bowel Preparation
Sutab (sodium sulfate, magnesium sulfate, and potassium chloride)
is an osmotic laxative in a tablet formulation indicated for cleansing
the colon in preparation for colonoscopy in adults.

NEW DRUG APPROVALS VACCINES AND DRUGS APPROVED AGAINST

www.drugs.com NOVEL CORONAVIRUS
Orladeyo (berotralstat) Capsules To enhance immunity, UK to combine Pfizer, Astra shots in
Company: BioCryst Pharmaceuticals, Inc. vaccine trials
Date of Approval: December 3, 2020 www.business-standard.com; 08th December, 2020
Treatment for: Hereditary Angioedema
Even as it begins the first Covid immunizations with a shot
Orladeyo (berotralstat) is a is a plasma kallikrein inhibitor indicated from Pfizer Inc., the U.K. plans to test it in combination with another
for prophylaxis to prevent attacks of hereditary angioedema (HAE) vaccine from AstraZeneca Plc. Studies aimed at determining
in adults and pediatric patients 12 years and older. whether using the two jabs together can enhance immunity are
Ga 68 PSMA-11 Injection planned for next year, according to the U.K. Vaccine Taskforce.
Company: University of California, San Francisco The group disclosed the plans as it published a report on its
Date of Approval: December 1, 2020 work so far, including deals for 357 million doses from seven
Treatment for: Diagnostic makers and investments in three sites to expand the nation’s
manufacturing capacity. The U.K. is set to begin administering
Ga 68 PSMA-11 Injection is a radioactive diagnostic agent
doses from Pfizer and German partner BioNTech SE, making it the
indicated for positron emission tomography (PET) of prostate-
first Western country to receive a vaccine. The massive logistical
specific membrane antigen (PSMA) positive lesions in men with
challenge of inoculating as many as 67 million people is getting
prostate cancer.
underway at about 50 hospitals. Approval for the shot from Astra
Danyelza (naxitamab-gqgk) Injection and its partner, the University of Oxford, could come by the end of
Company: Y-mAbs Therapeutics, Inc. the year. That would set the stage for the combination trials, which
Date of Approval: November 25, 2020 will involve initial shots from either of the two vaccines, followed
Treatment for: Neuroblastoma by a booster jab with the other.
Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody Japan’s AnGes begins Phase 2 trials of DNA vaccine against
indicated, in combination with granulocyte-macrophage colony- Covid-19
stimulating factor (GMCSF), for the treatment of patients with www.business-standard.com; 08th December, 2020
relapsed or refractory high-risk neuroblastoma.
Japan’s AnGes, a biopharmaceutical company has started phase
Imcivree (setmelanotide) Injection 2 clinical trials of its DNA vaccine against the coronavirus. The trial
Company: Rhythm Pharmaceuticals, Inc. involves 500 people. A group of 250 people will be vaccinated twice
Date of Approval: November 25, 2020 with an interval of two weeks; the second group of 250 people -
Treatment for: Obesity twice with an interval of four weeks. In both groups, 50 people will
Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor be vaccinated with a placebo. Vaccination will take place before
agonist for chronic weight management of obesity due to March 2021 at eight medical facilities. According to the company,
proopiomelanocortin (POMC), proprotein convertase subtilisin/ the main advantage of the DNA vaccine is its safety, as it does not
kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency. use pathogens. Instead, the body creates antibodies in response
Oxlumo (lumasiran) Injection to DNA information about the virus.The ability to produce a
Company: Alnylam Pharmaceuticals, Inc. vaccine quickly and practically in unlimited quantities is an added
Date of Approval: November 23, 2020 advantage. Another important feature of the new vaccine is the
Treatment for: Primary Hyperoxaluria Type 1 (PH1) flexibility of the creation process, as even if the virus mutates, a
new vaccine can be developed in two weeks.
Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic
acid (siRNA) indicated for the treatment of primary hyperoxaluria Covid-19: India pins hopes on 4 vaccines to inoculate 30 crore
type 1 (PH1) to lower urinary oxalate levels in pediatric and adult by July
patients. www.economictimes.indiatimes.com; 07th December, 2020
Zokinvy (lonafarnib) Capsules The government is expecting two vaccines against Covid-19,
Company: Eiger BioPharmaceuticals, Inc. Oxford-AstraZeneca’s Covishield and Bharat Biotech’s Covaxin to be
Date of Approval: November 20, 2020 available by January and around four vaccines by the end of April,
Treatment for: Progeria and Progeroid Laminopathies increasing the prospects of adequate supplies to inoculate some 30
crore priority population by July. While Covishield, according to a PTI
Zokinvy (lonafarnib) is an oral farnesyltransferase inhibitor (FTI) for
report late on Sunday evening, sought emergency approval, Covaxin
the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or
is expected to be approved for emergency use by the end of January
Progeria) and processing-deficient Progeroid Laminopathies (PL).
or early February, if the shots clear scrutiny. The drugs regulator
Sutab  (sodium sulfate, magnesium sulfate, and potassium and the government are also examining Pfizer’s application for
chloride) Tablets emergency authorisation and may give the go-ahead but are keen
Company: Sebela Pharmaceuticals, Inc. to understand how many shots can be supplied to boost India’s
Date of Approval: November 10, 2020 priority vaccination programme. Apart from these three, Russia’s

Pharma Times - Vol. 52 - No. 12, December 2020 50

Sputnik V is also likely to be rolled out by April. There will be at Industry Research Assistance Council (BIRAC), Department of
least four vaccines in India. So, there should be enough vaccines Biotechnology (DBT) for advisory support and to use BIRAC’s clinical
available to cover the priority group by June-July. trial centres for the vaccine. Recently, RDIF announced the second
After Haryana’s Anil Vij tests positive, Bharat Biotech says interim analysis of clinical trial data, which showed 91.4 per cent
COVAXIN efficacious, safe. efficacy for the vaccine on day 28 after the first dose; vaccine
efficacy over 95 per cent 42 days after the first dose. Currently,
www.economictimes.indiatimes.com; 05th December, 2020
40,000 volunteers are taking part in Phase III of Sputnik V clinical
Bharat Biotech defended its COVID-19 vaccine, Covaxin, terming it safe trials, out of which over 22,000 have been vaccinated with the first
and efficacious after Haryana Home Minister Anil Vij tested positive for dose of the vaccine and more than 19,000 – with both the first
the viral disease despite taking the first shot of the medication. Vij had and second doses of the vaccine.
offered to be the first volunteer in the phase three trials for Covaxin,
an indigenous potential vaccine against COVID-19 being developed
by Bharat Biotech in collaboration with the Indian Council of Medical
TESTING KITS
Research (ICMR). The drug firm said its vaccine Covaxin is based on US FDA authorizes Quest Diagnostics RC COVID-19 +Flu RT-PCR
two dose schedule and its efficacy is determined 14 days post the Test for prescription use with home-collected samples
second dosage. The phase 3 trials of the vaccine are double blinded www.pharmabiz.com; 07th December, 2020
and randomised, where 50% of subjects will receive the vaccine and
The US Food and Drug Administration (FDA) authorized the first
50 per cent of subjects will receive placebo.
diagnostic test for at home collection of patient samples to detect
COVID-19: Zydus Cadila gets DGCI nod for phase 3 clinical trials both COVID-19 and influenza A and B (flu). The FDA authorized
with biological therapy. Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription
www.economictimes.indiatimes.com; 04th December, 2020 use with the Quest Diagnostics Self-Collection Kit for COVID-19
Drug firm Zydus Cadila has received the approval from the Drugs +Flu by individuals who are suspected of respiratory viral infection
Controller General of India (DCGI) to start phase 3 clinical trials consistent with COVID-19 when home collection is determined to be
with its biological therapy PegiHep in COVID-19 patients. The results appropriate by an individual’s healthcare provider. Under a health
of phase 2 study of Pegylated Interferon alpha 2-b has shown the care provider’s order, patients can collect a sample at home and
potential to reduce virus titres when given earlier in the disease. ship it to a Quest Diagnostics laboratory for analysis following the
The trials, which will commence in December, will be conducted instructions included with the self-collection kit.
on 250 patients across 20-25 centres in India. New CRISPR-based test for COVID-19 uses a smartphone camera
Rhizen Pharmaceuticals gets USFDA approval for phase one www.sciencedaily.com; 04th December, 2020
clinical trials for Covid-19 drug In a new study published in the scientific journal Cell, the team from
www.economictimes.indiatimes.com; 02nd December, 2020 Gladstone, UC Berkeley, and UCSF has outlined the technology for
Rhizen Pharmaceuticals, an associate company of Alembic a CRISPR-based test for COVID-19 that uses a smartphone camera
Pharmaceuticals has received approval from the US health to provide accurate results in under 30 minutes. The technique
regulator to commence phase one clinical trials on retroviral oral was designed in collaboration with UC Berkeley bioengineer Daniel
drug for the treatment of COVID-19. The Switzerland-based firm, Fletcher, PhD, as well as Jennifer Doudna, PhD, who is a senior
which is a clinical-stage oncology-focussed biopharmaceutical investigator at Gladstone, a professor at UC Berkeley, president
company, has received approval for its investigational new drug of the Innovative Genomics Institute, and an investigator of the
(IND) application from the US Food and Drug Administration (FDA) Howard Hughes Medical Institute. Doudna recently won the 2020
to study its oral Dihydroorotate dehydrogenase (DHOHD) inhibitor Nobel Prize in Chemistry for co-discovering CRISPR-Cas genome
for SARS-CoV-2 infection. The initial study would evaluate single editing, the technology that underlies this work. Not only can their
ascending doses of the RP7214 in healthy volunteers and that new diagnostic test generate a positive or negative result, it also
dosing is expected to commence in early December. DHOHD is a measures the viral load (or the concentration of SARS-CoV-2, the
key enzyme involved in pyrimidine biosynthesis in the cell. RP7214 virus that causes COVID-19) in a given sample. When coupled
is potentially a best-in-class selective DHODH inhibitor that has with repeated testing, measuring viral load could help determine
shown potent inhibition of COVID-19 viral replication. RP7214 has whether an infection is increasing or decreasing. Monitoring the
a unique preclinical profile, high oral bioavailability, robust antiviral course of a patient’s infection could help health care professionals
potency and broad anti-inflammatory role, that the company expects estimate the stage of infection and predict, in real time, how long
will translate in the clinic and support its eventual development as is likely needed for recovery.
a potential treatment for Covid-19. Roche’s Elecsys Anti-SARS-CoV-2 S antibody test receives US
Dr Reddy’s and RDIF begin clinical trials for Sputnik V vaccine FDA Emergency Use Authorization
in India www.pharmabiz.com; 03rd December, 2020
www.expresspharma.com; 02nd December,2020 Roche announced that its Elecsys Anti-SARS-CoV-2 S antibody test
Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) has received Emergency Use Authorization (EUA) from the US Food
announced that they have commenced adaptive phase 2/3 clinical and Drug Administration (US FDA). The serology (blood) test can be
trials for Sputnik V vaccine in India after receiving the necessary used to measure the level of antibodies in people who have been
clearance from the Central Drugs Laboratory, Kasauli, India. This exposed to the SARS-CoV-2 virus. The EUA in the United States
will be a multicentre and randomised controlled study, which will follows the launch of the Elecsys Anti-SARS-CoV-2 S antibody test
include safety and immunogenicity study. The clinical trials are for markets accepting the CE Mark announced on 18 September.
being conducted by JSS Medical Research as the clinical research The new test targets antibodies that are directed against the region
partner. Further, Dr Reddy’s has partnered with the Biotechnology of the novel coronavirus known as the spike protein, specifically the

Pharma Times - Vol. 52 - No. 12, December 2020 51

area that enables the virus to bind to a host cell receptor, which is most effective COVID-19 testing technique using dry swabs which
required for the virus to enter the host cell. Many current candidate will help in scaling up samples as well as reduce cost and time.
vaccines aim to induce an antibody response against the SARS- With this, the CCMB scientists’ claim that the testing of samples
CoV-2 spike protein. Tests that quantify antibodies to the spike collected from the suspected coronavirus infected can be speeded
protein could be used to measure the level of that response and up 2-3 times compared to the present method and at the same time
track that measurement over time. The test provides a numerical the new technique is more safe and involves less complexities with
result describing the concentration of antibodies from 0.40-250 U/ regard to transportation of samples from one place to the other
mL as well as a qualitative result. In addition to its role in helping to during testing. The new COVID-19 testing technique does not even
measure a patient’s immune response, the test may help guide the require transportation of the collected samples in viral transport
allocation of plasma donations from recovered COVID-19 patients medium (VTM) and also eliminates the RNA extraction step in the
to current patients by identifying donors that have antibodies to RT-PCR tests, which will save time and money. The new technique
SARS-CoV-2 virus. Convalescent plasma therapy is an investigational of dry swab testing developed by the scientists, there is no need for
procedure that separates and removes the plasma from a patient’s the samples to be placed in the VTM and there does not involves
blood. This plasma is then replaced with plasma from a donor to give the complex process of packing heavily to make sure there is no
the ill patient antibodies to help fight the virus. The laboratory-based leakage. And also the testing staff at the testing laboratories can
Elecsys Anti-SARS-CoV-2 S test runs on Roche’s widely available handle a large number of samples and go straight to RT-PCR,
cobas e analyzers and is the latest addition to Roche’s growing without wasting hours of time for extracting RNA.
diagnostic portfolio to help healthcare systems combat COVID-19
through testing in the laboratory and at the point of care. Currently, REGULATORY AFFAIRS
this portfolio includes molecular, serology and digital solutions
that help healthcare professionals diagnose COVID-19 and provide Bharat Biotech applies for emergency use authorisation for
optimal patient care during the initial stages of infection and the Covaxin
recovery phase, as well as following the resolution of infection. www.business-standard.com; 08th December, 2020
Divoc and Canary Health collaborate to conduct clinical trials After Pfizer and Serum Institute of India, Hyderabad-based Bharat
for new breath test to detect COVID-19 Biotech  has applied for an emergency use authorisation for
www.pharmabiz.com; 03rd December, 2020 its investigational vaccine candidate, Covaxin, to the Indian
regulator. The firm is conducting its Phase 3 trial, involving 26,000
India-based Divoc Labs and US-based Canary Health technologies
participants. This is one of the largest efficacy trials held in the
have collaborated to conduct clinical trials for developing new
country. The firm has Phase 1 and Phase 2 data ready and will
breath test to detect COVID-19 infection among the public. As
submit the interim data from the large-scale efficacy trials to
part of their efforts to make COVID-19 testing simpler and to get
the Drug Controller General of India. Officials from the Central Drugs
results rapidly, Canary Health has already developed a diagnostic
Standard Control Organization and the Indian Council of Medical
medical device which enables breath testing of people to identify
Research have been in touch with the firm.
COVID-19 infection among them. The breath testing machine to
detect COVID-19 infection is highly accurate and can be hand Serum Institute likely to supply Covid vaccine at Rs 250 a dose
held. It requires minimum training to conduct tests and can be to the government: Media reports
offered at any point of care without the need of a laboratory. It is www.economictimes.indiatimes.com; 08th December, 2020
learnt that the new breath testing process is developed based on Serum Institute of India, the world’s largest vaccine producer by volume,
the technology that employs exhaled volatile organic compounds is close to signing a supply contract with the country’s Central government
(VOCs) found in human breath as bio makers of the coronavirus. and likely to fix prices at Rs 250 ($3.39) per dose of the vaccine. The
The screening is designed to detect the virus in people with and government is pinning its hopes for mass supply on Serum Institute,
without symptoms. More or less, the new breath testing machine which lodged the first formal application for emergency-use approval
is expected to work similar to alcohol detection machines which of AstraZeneca’s shot. Chief Executive Officer Adar Poonawalla had
are used to detect persons during drunk and drive using breath earlier said the vaccine would be priced at Rs 1,000 ($13.55) per dose
analyzers. Divoc Labs and Canary Health have come together to in India’s private market, but governments signing large supply deals
integrate their technology and research data to successfully develop would likely buy it at lower prices.
a breath analyzing device to detect the COVID-19 infection just using
DCGI may await UK nod for AstraZeneca’s Covid shot before
the breath of the infected person. In continuation to this, it is learnt
approving SII vaccine.
that initially as many as 750 people including COVID-19 positive
patients and those who do not have the virus infection are expected www.economictimes.indiatimes.com; 08th December, 2020
to participate in the clinical trials. The breath samples of all these India’s drug regulatory body has started reviewing the application of
people will be collected using breath analyzer machines and later Serum Institute of India (SII) seeking emergency use authorisation
they will analyze the results to identify if the machine is functioning for its Covid jab but officials say it could wait for the UK regulator’s
effectively or not to detect the COVID-19 infections. The preliminary nod for the AstraZeneca vaccine before giving approval Officials said
results are expected by end of December. It is also claimed that both the Pfizer and the SII emergency use applications are being
the breath analyzer device is incorporated with such a powerful reviewed on an accelerated basis. But as the trials for Serum’s
technology that it can detect COVID within three minutes. Covishield are still ongoing in India, the absence of approval from
CCMB scientists develop new COVID-19 testing technique that the UK regulator for the AstraZeneca shot might prove a hurdle.
helps in scaling up samples and reduce cost & time. as approval from them would be of utmost importance.
www.pharmabiz.com; 01st December, 2020 Price of Remdesivir injection fixed at Rs 2,360 in Maharashtra.
A team of scientists from Centre for Cellular and Molecular www.economictimes.indiatimes.com; 04th December, 2020
Biology (CCMB) in Hyderabad has developed an innovative and The Maharashtra government fixed the price of Remdesivir injection,

Pharma Times - Vol. 52 - No. 12, December 2020 52

used for treating critical COVID-19 cases, at Rs 2,360 a piece. The bioprinted constructs), will be available for purchase from Cellink,
government has also put together a list of 59 pharmaceutical so that the research community may procure all their bioprinting
outlets where it can be purchased, covering all the major cities, requirements in one place. Cellink is the leading bio-convergence
towns and districts. company and a global provider of technologies, products and
services to create, understand and master biology. Founded in
MERGERS, ACQUISTIONS AND COLLABORATION 2017, Atelerix is a biotech company based in the UK with a novel
technology that enables the shipment of cells at room temperature,
Amgen, McKesson ink strategic agreement to help improve thus avoiding the problems with cryo-logistics and particularly
cancer care in community damage caused to cells by freeze-thaw processes.
www.pharmabiz.com; 07th December, 2020 Singapore-based Everstone buys controlling stake in Calibre
McKesson and Amgen, one of the world’s leading biotechnology for Rs 1,000 cr
companies, have signed a strategic agreement to help improve www.business-standard.com; 06th December, 2020
cancer care in community oncology settings. Today, 1 in 5 cancer
Singapore-headquartered, India-focused private equity firm Everstone
patients receives an Amgen medicine, while McKesson reaches
Capital has acquired a controlling stake in Calibre, a specialty
20% of US cancer patients.This multi-year agreement bridges the
ingredients player focused on pharma, nutrition and personal care
power and reach of the two companies and will focus on reducing
segments, in a reported Rs 1,000-crore deal. Mumbai-headquartered
gaps in care by optimizing access to innovative precision medicine
Calibre, founded in 1984 by Ranjit Bhavnani in Gujarat, is a leading
and immuno-oncology in the community setting. Access to the latest
specialty ingredients player in the iodine derivatives, persulfates
innovations in cancer care is still very dependent on demographics,
and perchlorates segments. Though the companies did not disclose
socioeconomic status, and where in the US patients receive their care.
the deal value, the transaction is valued at around Rs 1,000 crore.
This partnership will be led by Ontada, McKesson’s new oncology
Calibre boasts of a customer base across 75 countries including the
technology and insights business. Ontada is focused on helping life
US, and those in Europe, Asia and exports contribute around two-
sciences companies like Amgen improve patient outcomes for cancer
thirds of its revenue. While JM Financial advised Calibre, Everstone
care, from early clinical development to drug commercialization and
was advised by Alantra. Everstone is one of the largest India and
post-launch activation of insights, as well as empowering oncology
Southeast Asia-focused investors and its portfolio of companies
providers at the point of need to deliver more-informed, more-
include one of the largest nutraceutical ingredients businesses
effective, more-efficient care to their patients. Through real-world
OmniActive, generic and specialty pharma maker Slayback Pharma
data gathered with Ontada’s proprietary technology for community
and domestic pharma distribution platform Ascent Health amongst
oncology practices, such as those that are part of The US Oncology
others. Last year, Everstone exited from Rubicon Research generating
Network, Ontada has the real-world knowledge to help push cancer
returns of 4.5 times its investment. The Everstone Group has assets
care forward. Amgen and Ontada will launch various programs over
of over USD 5 billion across private equity, real estate, infrastructure,
the course of the partnership and build on projects that have already
and venture capital and its resource base spans New York, India,
begun, such as those focusing on reducing gaps in molecular testing
Singapore, London, and Mauritius.
and understanding treatment patterns in the community setting.
Through the partnership, McKesson and Amgen hope to: Elevate PharmaEngine, Sentinel Oncology ink collaboration and licensing
awareness on molecular testing; uncover insights on unmet need pact to advance development of Chk1 inhibitor, SOL-578
and treatment outcomes by enriching data and insight capabilities; www.pharmabiz.com; 05th December, 2020
leverage real-world evidence to better understand and optimize the PharmaEngine Inc, a commercial stage oncology company,
deployment of biosimilars to offer providers and their patients greater announced that it has entered into a collaboration and license
choice of therapies relative to value; co-develop new approaches to agreement with UK-based Sentinel Oncology Limited for advancing
deliver immuno-oncology therapies in the community setting and the new drug development of SOL-578, a Checkpoint Kinase 1 (Chk1)
Optimize therapy sequencing to improve patient outcomes including inhibitor, under which PharmaEngine will fund the IND enabling
supportive care. studies for SOL-578. Sentinel Oncology Limited is a drug discovery
SCellink, Atelerix partner to enable shipping at room temperature company developing novel therapeutics to treat cancer patients. The
of fragile 3D bioprinted constructs company’s mission is to increase survival and improve outcomes
for cancer patients with CNS tumors. SOL-578 is a best-in-class
www.pharmabiz.com; 07th December, 2020
checkpoint kinase 1 (Chk1) inhibitor featuring high kinase selectivity
Cellink and Atelerix announced a partnership to bring to market and oral bioavailability which targets the DNA Damage Response
Atelerix’s portfolio of innova­tive hydrogel biological encapsulation (DDR) network. Under the terms of the agreement, Sentinel Oncology
products, which preserve fragile biological samples for shipping will receive an exclusivity payment and PharmaEngine will obtain an
at room temperature. Conven­tional shipping methods often option to receive the exclusive rights to develop and commercialize
involve storing cells and tissues in liquid nitrogen or dry ice, which SOL-578 worldwide. In the event that PharmaEngine completes the
requires a freeze-thaw process notorious for damaging biological IND enabling studies and exercise its option, Sentinel Oncology will
material. Therefore, the global bioprinting community will greatly be eligible to receive an upfront payment and development milestone
benefit from Atelerix products that allow for room-temperature payments in addition to tiered royalties based on future worldwide
storage and shipping of sensitive primary cells, iPSC-derived net sales of SOL-578. SOL-578 is a best-in-class checkpoint kinase 1
cells, multicellular models and especially cell-laden bioprinted (Chk1) inhibitor featuring high kinase selective and oral bioavailability
constructs, such as those manufactured with Cellink’s range of which targets the DNA Damage Response (DDR) network. Checkpoint
innovative 3D bioprinters. Atelerix’s range of innovative products, kinases play a crucial role in the cellular response to DNA damage.
including BeadReady (used for cells in suspension), WellReady Chk1 inhibitors potentiate the DNA-damaging effects of cytotoxic
(used for plated cells and cell-laden bioprinted constructs) and therapies and/or promote elevated levels of replication stress,
TissueReady (used for tissue samples and larger cell-laden leading to tumor cell death. SOL-578 has demonstrated single-agent

Pharma Times - Vol. 52 - No. 12, December 2020 53

activity in preclinical cancer models with high levels of replication Drug firm AstraZeneca India has signed a memorandum of
stress. understanding with the Research Society for Study of Diabetes in India
Tevard Biosciences, Zogenix collaborate to identify and develop (RSSDI) for driving awareness of diabetes among people to prevent
novel tRNA-based gene therapies for Dravet syndrome and other complications arising from its uncontrolled incidence. As a key facet
genetic epilepsies of this association, the company has unveiled a three-year patient
awareness programme, ‘Beyond Sugar’, developed to benefit over 1
www.pharmabiz.com; 05th December, 2020
crore people living with diabetes across the country. The partnership
Tevard Biosciences, a privately-held biotechnology company pioneering between AstraZeneca and RSSDI will go a long way in supporting
tRNA-based gene therapies, and Zogenix, a global biopharmaceutical patient-centric digital awareness campaign and programmes to raise
company developing and commercializing rare disease therapies, awareness about diabetes and its complications.
announced that the companies have entered into a collaboration
Laurus Labs acquires biotech company Richcore Lifesciences
to identify and develop novel tRNA-based gene therapies for Dravet
syndrome and other genetic epilepsies. Under the collaboration, Tevard www.businesstoday.in; 25th November, 2020
will utilize its two unique tRNA-based discovery platforms focused on Hyderabad-based pharmaceutical company Laurus Labs has
mRNA Stabilization and Nonsense Codon Suppression to discover acquired Bangalore-based biotech company Richcore Lifesciences,
and advance novel drug candidates for the treatment of Dravet to diversify into manufacturing of biotech drugs. Laurus Labs has
syndrome and other genetic epilepsies. Zogenix will further develop signed a definitive agreement to acquire 72.55% of Richcore’s
the candidates through advanced preclinical studies and clinical shares from its private equity investors Eight Roads Ventures and
development, and be responsible for worldwide commercialization. VenturEast and other promoters for a value of Rs 246.7 crore.
Tevard’s unique tRNA technology platforms are designed to address Richcore has advanced R&D and manufacturing facilities, develops
underlying genetic mutations in a precise and regulated manner and manufactures biotech products critical for manufacturing
through the correction of nonsense mutations and the enhanced biological drugs and offers support to develop and scale up
production of functional proteins. Together, these approaches bioprocesses by providing contract research, development, and
hold promise to treat genetic disorders that are not well-suited to manufacturing services (CDMO). Richcore is currently setting
conventional gene replacement approaches. Dravet syndrome is a up its second manufacturing plant near Bengaluru and this is
rare childhood-onset epilepsy marked by frequent debilitating seizures, expected to be completed by March 31, 2021. Laurus is focused on
lifelong developmental and motor impairments, and an increased pharmaceutical active ingredients (API), formulations and synthesis.
risk of death (SUDEP). In addition to the catastrophic impact on the It is one of India’s leading manufacturers of API for Anti-Retroviral
patient, the severity and unpredictability of the seizures, coupled with (ARV), Oncology, Cardiovascular, Anti-Diabetics, Anti-Asthma and
around-the-clock concern for the diagnosed child’s safety and well- Gastroenterology medicines, besides pharmaceutical contract
being, can present significant emotional and logistical challenges for manufacturing services. Following the successful closure of the
parents and all members of the family. transaction, Richcore will be renamed to Laurus Bio Pvt Ltd.
Aurobindo Pharma completes sale of Natrol LLC to New Mountain
Capital RESEARCH
www.economictimes.indiatimes.com; 01st December, 2020 High-dose influenza vaccine shows no additional benefit for heart
Drug firm Aurobindo Pharma has completed the sale of Natrol LLC, disease patients: Study
a wholly-owned unit of its US-based subsidiary, to private equity www.pharmabiz.com; 07th December, 2020
firm New Mountain Capital. In October this year, the company had High-dose influenza (commonly known as flu) vaccines are no
announced that it had inked a pact to divest Natrol LLC to private better than regular-dose influenza vaccines in reducing deaths
equity firm New Mountain Capital for USD 550 million. The aforesaid and hospitalizations among patients with underlying heart
transaction has been completed on November 30, 2020. disease, according to a large study publishing in JAMA. The
Dr Reddy’s to acquire select brands from Glenmark in Russia, results do not change well-established findings about the value of
Ukraine an annual influenza vaccine for persons with heart disease and
www.economictimes.indiatimes.com; 28th Novevmber, 2020 other chronic illnesses, and do not change the recommendation
for an annual influenza vaccine for most people. The study was
Dr Reddy’s Laboratories has inked a pact with Glenmark funded by the National Heart, Lung, and Blood Institute (NHLBI),
Pharmaceuticals to acquire its select anti-allergy brands in part of the National Institutes of Health, and appeared online on
Russia, Ukraine, Kazakhstan and Uzbekistan. The Hyderabad- December 4. Researchers have known for some time that people
based company has entered into a definitive agreement with with cardiovascular disease are at higher risk for developing
Glenmark to acquire brands Momat Rino (for Russia, Kazakhstan serious complications from influenza, including heart attacks,
and Uzbekistan), Momat Rino Advance (for Russia), Momat A (for hospitalizations for heart failure, and death. As a result, experts
Kazakhstan and Uzbekistan), Glenspray and Glenspray Active (for have strongly recommended that this group get an influenza
Ukraine), along-with rights to the trademarks, dossiers and patents
vaccine, and at least one study has suggested that a high-dose
for the territories mentioned. The acquired brands represent two
version might help reduce these complications more than the
types of products -- mometasone mono product and combination of
regular-dose vaccine. To determine if there is benefit in the higher
mometasone with azelastine, which are indicated for the treatment
dose, the NHLBI funded the Influenza Vaccine to Effectively
of seasonal and perennial allergic rhinitis. The company however
Stop Cardio Thoracic Events and Decompensated heart failure
did not disclose financial details.
(INVESTED) trial, a randomized, double-blind trial conducted at
AstraZeneca inks pact with Research Society for Study of 157 medical centers in the United States and Canada over three
Diabetes in India influenza seasons. This study is supported by grants from the NHLBI
www.economictimes.indiatimes.com; 26th Novevmber, 2020 (U01HL130163 and U01HL130204).

Pharma Times - Vol. 52 - No. 12, December 2020 54

Novartis announces positive data from REACH3 trial of Jakavi in cocaine-seeking behavior. Investigators have also discovered that
patients with steroid-resistant/dependent chronic GvHD GLP-1Rs are expressed primarily on GABAergic neurons in the
www.pharmabiz.com; 07th December, 2020 hindbrain and that the efficacy of the GLP-1R agonist exendin-4
to reduce cocaine seeking depends, in part, on activation of these
Detailed results from the pivotal phase III REACH3 study
GABA circuits. Moreover, activating these endogenous anti-craving
demonstrate Jakavi (ruxolitinib) significantly improved outcomes
circuits in the brain using viral-mediated gene delivery methods
across a range of efficacy measures in patients with steroid-
was sufficient to reduce cocaine-seeking behavior. These findings
refractory/dependent chronic graft-versus-host disease (GvHD)
highlight GLP-1R-expressing anti-craving circuits in the brain that
compared to best available therapy (BAT). The results of REACH3,
could serve as potential targets to reduce cocaine craving-induced
the first successful, randomized phase III trial in chronic GvHD,
relapse. The findings are published in the journal  Molecular
were presented during the 62nd American Society of Hematology
Psychiatry.
Annual Meeting & Exposition (ASH). REACH3 is jointly sponsored
by Novartis and Incyte. Patients receiving Jakavi had a significant Clover Biopharma announces positive results from phase 1 trial
improvement of failure-free survival (FFS; defined as time to the of adjuvanted S-Trimer COVID-19 vaccine candidates
earliest recurrence of the underlying disease, the start of new www.pharmabiz.com; 05th December, 2020
systemic treatment for chronic GvHD, or death) than patients Clover Biopharmaceuticals, a global clinical-stage biotechnology
receiving BAT (median FFS not yet reached vs. 5.7 months; company, announced positive clinical data from its phase 1 trial
hazard ratio, 0.370, 95% CI, 0.268 to 0.510; p<0.0001). demonstrating that its protein-based COVID-19 S-Trimer vaccine
Patients treated with Jakavi also had greater improvements in candidates in combination with adjuvants from either GSK or
patient-reported symptoms than those treated with BAT (24.2% Dynavax induces strong immune responses, including neutralizing
vs. 11.0%; p=0.0011), as measured by the rate of responders antibodies and cell-mediated immunity, as well as favorable safety
who achieved a reduction of = 7 points of total symptom score and tolerability profiles in 150 adult and elderly participants. The
(TSS) from baseline of the modified Lee Symptom Score (mLSS). manuscript describing the detailed results will be accessible on an
Additionally, best overall response (BOR) rate was achieved in online preprint server shortly. Based on the positive phase 1 results
76.4% of patients in the Jakavi arm compared to 60.4% in the reported and the unprecedented need for COVID-19 vaccines,
BAT arm (odds ratio [OR], 2.17; 95% CI, 1.34-3.52). The median Clover and its partners are confident to enter late-stage clinical
duration of response was 6.24 months in the BAT arm, but was not development for both adjuvanted vaccines. A global phase 2/3
reached in the Jakavi arm. Jakavi (ruxolitinib) is an oral inhibitor efficacy study of the S-Trimer vaccine candidate in combination with
of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is a registered GSK’s pandemic adjuvant system is expected to begin in December
trademark of Novartis AG in countries outside the United States. 2020. Clover intends to initiate a separate pivotal clinical trial of
Jakafi is a registered trademark of Incyte Corporation. The safety the S-Trimer vaccine candidate in combination with Dynavax’s
and efficacy profile of Jakavi has not yet been established outside advanced CpG 1018 adjuvant plus alum in the first half of 2021.
of its approved indications.
CAR T-cell therapy found highly effective in patients with high-
Novel form of Alzheimer’s protein found in spinal fluid indicates risk non-Hodgkin lymphoma
stage of the disease
www.sciencedaily.com; 05th December, 2020
www.sciencedaily.com; 07th December, 2020
While NHL tends to be a slow-growing disease, patients frequently
The discovery of so-called microtubule binding region tau (MTBR relapse after standard treatment, underscoring the need for new
tau) in the cerebrospinal fluid could lead to a way to diagnose
therapies. Axi-cel’s effectiveness in trial participants who had
people in the earliest stages of Alzheimer’s disease, before they
either relapsed or become resistant to other drugs is especially
have symptoms or when their symptoms are still mild and easily
encouraging, according to investigators. Axi-cel is made by collecting
misdiagnosed. It also could accelerate efforts to find treatments
for the devastating disease, by providing a relatively simple way some of a patient’s disease-fighting T cells and genetically altering
to gauge whether an experimental treatment slows or stops the them to deploy a specialized receptor on their surface. The receptor
spread of toxic tangles. The study is published Dec. 7 in the enables the modified T cells called chimeric antigen receptor, or
journal  Brain. Alzheimer’s begins when a brain protein called CAR T cells -- to latch onto cancer cells and destroy them. The
amyloid starts forming plaques in the brain. During this amyloid CAR T cells are then infused into the patient. In previous trials in
stage, which can last two decades or more, people show no signs of patients with large B cell lymphoma, the therapy reduced cancer
cognitive decline. However, soon after tangles of tau begin to spread cells below detectable levels, achieving a “complete response,” in
in the neurons, people start exhibiting confusion and memory many patients. All the participants had active lymphoma despite
loss, and brain scans show increasing atrophy of brain tissue. Tau undergoing multiple previous treatments. A median of 17.5
tangles can be detected by positron emission tomography (PET) months after treatment with axi-cel, 92% of the trial participants
brain scans, but brain scans are time-consuming, expensive and had an objective response a detectable reduction in their cancer
not available everywhere. Bateman and colleagues are developing
and 76% had a complete response. At the cutoff date for data
diagnostic blood tests for Alzheimer’s disease based on amyloid or
collection, responses continued in 62% of all treated patients.
a different form of tau, but neither test can pin down the amount
Almost all patients experienced adverse side effects, with 86%
of tau tangles across the stages of disease.
experiencing adverse events of grade 3 or higher. Seven percent
Novel anti-craving mechanism discovered to treat cocaine relapse
experienced grade 3 or higher cytokine release syndrome and 19%
www.sciencedaily.com; 07th December, 2020 experienced grade 3 or higher neurologic events. Response rates
New research from the University Of Pennsylvania School Of were slightly higher and adverse effect rates were slightly lower
Nursing (Penn Nursing) has discovered that GLP-1Rs are expressed for patients with follicular lymphoma than for those with marginal
on specific cell types and neural circuits in the brain that reduce zone lymphoma.

Pharma Times - Vol. 52 - No. 12, December 2020 55

Letter to Editor
Effective Awareness about Pharmacy Education Otherwise, M. Pharm in pharmacology is stated under M.Sc in
covering Specialization Science in one post of Scientist. Whereas there were several
posts where M. Pharm of different specialisation was most suited
The 59th National Pharmacy Week was celebrated and completed
in both AIIMS and ICMR. This is all mainly due to the inadvertent
successfully throughout the country via online webinars. In the
unawareness about our Pharmaceutical Education specialization
year 1961, during IPC at Puri the Central Executive Council of
by the recruitment authorities.
IPA decided to arrange a week-long programme by all branches
of IPA to make proper awareness about the role of pharmacists Similarly, 'community pharmacy' could still not be converted
being played at Hospitals, Drug stores, Drug industry in research, as a profession as it is in the hands of traders and manned by
Manufacturing and Quality Control, Regulatory as Drugs Inspector, non-pharmacists. Whereas today more than 2 lakh Diploma and
etc. At that time, there were only 10 institutes providing the Degree holder pharmacists are graduating each year.
graduate programme in pharmacy. Though pharmacy education In view of the information mentioned above, it is desired that
had started in 1932 in BHU, pharmacy graduates were rarely our pharmacists should take lead and open their own drug
appointed as Drug Controllers in any state and only a few Drug stores and run it as a professional. Further to make proper
Inspectors were pharmacy graduates. Similarly in hospitals, only awareness about Pharmaceutical Education there are 12 PG
a few diploma pharmacists were working in dispensing and drug specializations as per PCI- Pharmaceutics, Industrial Pharmacy,
dispensing and these personnel were called as Compounders. Pharmaceutical Technology, Pharmaceutical Chemistry,
Also, non-pharmacists were working in retail drug stores when Pharmaceutical Analysis, Pharmaceutical Quality Assurance,
drug license was in the name of a registered pharmacist to Regulatory Affairs, Pharmaceutical Biotechnology, Pharmacy
comply with the Drugs Rules. Practice, Pharmacology, Pharmacognosy and Phytopharmacy
On retrospection of 59 years of celebrating NPW and 88 years of & Phytomedicine. Also, there are 10 PG specialisations
pharmacy education, we observed that we have achieved a lot as per National Institute of Pharmaceutical Education and
but still there is improper awareness of pharmacy education and Research (NIPER)- Natural Products, Pharmaceutical Analysis,
specialisation amongst many of govt authorities and institutions. Pharmacology & Toxicology, Pharmaceutics, Biotechnology,
Some of the remarkable achievements are as stated below. Pharm. Technology (Process Chemistry), Pharm. Technology
(Formulations), Clinical Research, Traditional Medicine and
Today much more advancements have been made in
Pharmacoinformatics.
pharmaceutical education and pharmaceutical technology.
Resulting in the setting up of many pharmaceutical institutions In conclusion, NPW should be organised to make effective
and world-class premium institutes like NIPER with specialization awareness of pharmacy education and PG specialization among
in PG level in 12 advanced pharmacy subjects and also the Govt authorities, Policymakers and Directors of all drug-related
introduction of 6 years Pharm. D course that is clinically institutions then only the objective of NPW would be achieved.
oriented. Accordingly, GMP was introduced in 1988 in Drugs In addition to it, all the pharmacy professionals have to be alert
Rules and then cGMP and various amendments in Drugs Rules and submit convincing representation to the authorities on
for qualifications of Controlling and Licensing authority (1989) seeing discrepancy in their recruitment advertisements or any
and Drugs Inspector (1983), new drugs and many more for notifications from time to time.
manufacturing of quality drugs and medical devices, setting up Dr. R. N. Gupta,
of Indian Pharmacopeia Commission, Pharmexcil, PVPI Centres, Fellow IPA, Eminent Pharmacist
implementation of Section 42 of Pharmacy Act from September Vice President & Chairperson, Hospital Pharmacy Division - IPA
1984, implementation of Hathi Committee (1975) and NHRC
(1999) in Hospital Pharmacy, upgradation of Hospital Pharmacy
and posts of pharmacists are upgraded with better pay scale Attention Subscribers
as officer and promotion upto Dy. Director rank in some states
has been done. RENEWAL OF SUBSCRIPTION
But many of Govt. authorities /National level Govt. institutions are FOR THE YEARS AHEAD
ignoring or under-evaluating pharmacy education and denying /
not utilizing qualified postgraduate and Doctorate degree holder Your Pharma Times subscription has expired on 31st
pharmacists. Recently the advertisements of ICMR and AIIMS December, 2020. We request you to kindly renew your
Delhi clearly showed their unawareness /underestimation subscription for the year 2021.
of specialisation of Postgraduate and Ph.D. programmes. In
Pharmacy, it is very much unfortunate that they are still ignorant Type of Subscription Subscription Amount (Rs.)
and unable to utilise properly qualified advanced categories of Annual 3000
pharmacists.
For 3 years 7250
ICMR has issued an Advt. for 141 posts of medical and non-
medical scientists of different specialisation but not a single For 5 years 12000
post is for Ph.D. /M. Pharm in pharmacy. Whereas M. Pharm Agency Discount 10%
specialization was best suitable for various posts.
Cheque / D.D. should be drawn in favour of “Pharma
Similarly AIIMS, Delhi has advertised for various Scientist / Times” payable at Mumbai and send to Indian
Chemist /Stores Officer /Stores Keeper and many more posts,
but out of several posts, only one post of Store Keeper is for
Pharmaceutical Association, Kalina, Santacruz (E),
B. Pharm/D. Pharm which was due to legal requirements. Mumbai – 400 098.

Pharma Times - Vol. 52 - No. 12, December 2020 56

 for Innovation And Entrepreneurship. The objectives of the centre
are to provide guidance and to motivate healthcare-related
Startups, to commercialize them and achieve social welfare
through it. This SKiiLD PCP center was inaugurated by Dr. Umesh
Banakar, President, Banakar Consulting
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Faculty in ‘Top 2 % Global Scientist Dataset 2019’

Bharati Vidyapeeth’s Poona College of Pharmacy, Pune in

association with Sinhgad College of Pharmacy, Pune arranged an
International E-Symposium on ‘Understanding IP for Scientists and
Scholars’ on 30th November, 2020. As a part of National Pharmacy The research culture and potential of Bharati Vidyapeeth’s Poona
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India. He motivated students and faculties about the importance of 2019’ published in the prestigious Mendeley Global Database
Incubation Center, start-up policies, innovative ideas and business by a team of researchers at Stanford University led by Professor
plans in his inaugural address. Guest of Honor was Prof. Umesh Ioannidis. Dr. Varsha Pokharkar, Vice Principal & Head, Dept
Banakar, Chairman, Banakar Consulting Services, USA and Prof. of Pharmaceutics and Prof. Subhash Bodhankar, Department
Anant Paradkar, Bradford University, USA; Dr B K Sahu, Regional of Pharmacology has been ranked in the ‘Top 2% of Global
Manager, NRDC, Govt. of India; Dr Hemant Dande, President Pharmacology & Pharmacy Scientists’.  Prof. Anant Paradkar,
& Chief Operating Officer, Raptakos, Brett & Co Ltd, Mumbai; former faculty and Dr. Amit Kandhare, alumni of Poona College
Dr K N Gujar, Principal, Sinhgad College of Pharmacy, Pune; Dr of Pharmacy have also been ranked in this global top-scientists
Manohar Patil, Principal, Mitramandal College of Pharmacy; Dr list. The aim of this study was to avoid misuse of citation metrics.
Atmaram Pawar, Incharge Principal, Poona College of Pharmacy This database illustrates the contributions of the top scientists
attended the ceremony. The participants received guidance on of the world based on research citations, authorships & their
Intellectual Property (IP) from the experts in the field of education, research impact. This phenomenal achievement by the faculty and
entrepreneurship and governing authorities. Professors and alumni of Bharati Vidyapeeth's Poona College of Pharmacy at the
students from different national and international universities international level has been highly appreciated by Hon. Chancellor
participated in the workshop. The event was hosted by Dr. Sharvil Prof. Dr. Shivajirao S. Kadam; Pro-Vice-Chancellor and Secretary
Patil and Prof. Nisha Ranpise. Dr. Vishwajeet Kadam; Vice-Chancellor, Dr. Manikrao Salunkhe;
Dr. Kakasaheb R. Mahadik and Dr. Atmaram Pawar (I/C Principal),
Poona College of Pharmacy along with all faculty members of Poona
Poona College of Pharmacy College of Pharmacy.
Establishment of “SKiiLD PCP” Centre
KLE College of Pharmacy, Belagavi
Quality Improvement Programme
KLE College of Pharmacy, Belagavi organized two weeks Quality
Improvement Programme in Virtual Mode on “Drug Discovery &
Development: Natural and Synthetic Prospective” from 18th August
to 1st September, 2020 sponsored by All India Council for Technical
Education (AICTE). Prof. Dr. Vivek A. Saoji, Hon. Vice-Chancellor,
KAHER, Belagavi presided the inaugural ceremony. Prof. Dr. V.A.
Kothiwale, Registrar, KAHER, Belagavi, was Guest of Honour. Dr.
Poona College of Pharmacy established “SKiiLD (Skill Knowledge Sunil S. Jalalpure Principal KLE College of Pharmacy, Belagavi
Incubate Innovate Learning & Development Centre) PCP” Centre welcomed the dignitaries. Dr. Shivaraj Katagari, Chief Scientific

Pharma Times - Vol. 52 - No. 12, December 2020 57

Officer, Accord Life Spec Pvt. Ltd. Chennai was the Chief Guest. Dr. Mohan Kale, Principal and 16 faculty members attended the
Dr. Rajshekar Karpoormath, Dept. of Pharmaceutical Chemistry, program whereas from AIT, Ireland Karl Turley, Deputy Director
Discipline of Pharmaceutical Sciences, College of Health Sciences, of International relations (Non-EU market), Dr. Don Faller, Dean
University of KwaZula-Natal, Durba, South Africa, delivered a of Faculty of Science and Health, Mary Simpson, Director of
presentation on “Exploring New Horizons in Chemical Sciences: International Relations attended the ceremony. Victoria Sukhiya,
working as Partner with AIT introduced both the colleges and
felicitated this collaboration. The ceremony started with the
introduction of both institutes delivered by Dr. Vaishali Jadhav from
KGRDCP & RI and Karl Turley from AIT followed by the virtual signing
of MOU. Dr. Mohan Kale and Dr. Vaishali Jadhav interacted with the
AIT Institute team on various points like interdisciplinary research,
exchange of students, exchange of faculty, cooperative research
and development activities, joint research activities, etc. The entire
program was hosted by Karl Turley and Dr. Vaishali Jadhav and
ended with a Vote of Thanks given by them. The management,
Karjat people, students, academicians appreciated the efforts
and teamwork of Principal, Dr. Mohan Kale, D.r Vaishali Jadhav,
HOD, and all faculties.

Methodology and Biosensors”. Ms. Leena Kaveriappa, Team

Leader, Mylan Lab Ltd. Bengaluru, spoke on “Product Life Cycle University Institute of Pharmaceutical Sciences (UIPS),
Management”. Mr. Vinod, Schrodinger, Bengaluru highlighted Panjab University
the utility and scopes of Schrodinger software; Dr. Prakash NS., Webinars under UIPS Expert Talk Series
Himalaya Drug Principal Scientist R & D, The Himalaya Drug MHRD Institutions Innovation Council and Placement Cell of the
Company, Bangalore threw light on “Phytopharmaceuticals: University Institute of Pharmaceutical Sciences (UIPS), Panjab
Challenges and opportunities”. Rajendra B., Himalaya Drug Sr. University, Chandigarh successfully organized three Webinars, under
Research Scientist R & D, The Himalaya Drug Company, Bangalore UIPS Expert Talk Series for upskilling and reskilling the students
delivered his talk on “Advancement in Phyto-Aanlysis”. Dr. Syeed in different sectors. On 17th October, Mr. Kapil Jhawar, Associate
Ahmad, In Charge: Bioactive Natural Product Laboratory Associate CPM Director, Renowned CRO, Ahmedabad, Gujarat delivered an
Professor, Jamia Hamdard, New Delhi, delivered his lecture on informative talk on the topic “Overview of Clinical Research Industry
“Need of Metabolomics and stability studies for ensuring quality & Tips and Tricks for Career Development”. On 24th October, another
of herbal drugs”. Dr. Banappa Unger, Scientist-E ICMR, Belagavi virtual session was organised on “Innovations in NDDS: Challenges
gave an in-depth talk on ‘Translational of Traditional Medicine’. and Opportunities” by Dr Rakesh Kumar Bhasin, Vice President
Delegates from various states like Karnataka, Maharashtra and & Head R & D, Biocon Pharma Ltd, Bengaluru, Karnataka. Dr.
Goa participated in the program. The program concluded with Rakesh gave his expert views on applications of new drug delivery
valedictory session and Vote of Thanks. systems and opportunities for existing drug molecules to improve
their bioavailability and safety. On 30th October, Dr Amit Bansal,
Scientist, Perrigo Company, Michigan, USA shared novel findings
Konkan Gyanpeeth Rahul Dharkar College of Pharmacy of his research works “Comparative evaluation of Nanoparticulate
and Research Institute, Karjat immuno-contraceptive rabies vaccination administered via ID and
Konkan Gyanpeeth IM route”; “Biofabrication of microencapsulated pancreatic β TC-6
Rahul Dharkar College cells for type1 diabetes mellitus using a spraying nozzle” and “Taste
of Pharmacy and masking of granulated test drug by layering of pH-independent
Research Institute, polymer for pediatric oral delivery”. The webinars proved to be an
Karjat is planning enlightening experience witnessing more than 200 participants.
to sign an MoU with
Athlone Institute
o f Te c h n o l o g y, Sinhgad College of Pharmacy, Pune
Ireland. The virtual Inauguration of “SCOP: Center for Innovation and IP
s i g n i n g c e r e m o ny Management” and one-day international e-symposium on
was organised on “Understanding IP for Scientists and Scholars”
29 th October, 2020. Pharmacy Colleges under the aegis of Sinhgad Technical Education
It was a historic Society drafted the IP Policy in order to strengthen the IIC and
and proud moment CIIE activities to be conducted as part of MHRD, GOI initiatives for
for KGRDCP & RI to STES Pharmacy Colleges. Sinhgad College of Pharmacy (SCOP)
collaborate with AIT, inaugurated “SCOP: Center for Innovation and IP Management”
Ireland, which would on 29th November, 2020. The IP Policy draft was released for the
enable it to function review by IP experts. The “SCOP: Center for Innovation and IP
as an “Institution of Management” was inaugurated at the auspicious hands of Prof.
Eminence” in the Umesh Banakar, a renowned academician and an independent
region of Konkan. consultant to Pharmaceutical Industry and IP expert in the USA.
From KGRDCP & RI, A one-day international e-symposium on “Understanding IP for

Pharma Times - Vol. 52 - No. 12, December 2020 58

 Scientists and Scholars” Few Posters submitted by Students
was also conducted on
30 th November, 2020.
The e-symposium was
organized as part of NPW
2020 and was jointly
organized by BVDU Poona
College of Pharmacy,
STES Sinhgad College of
Pharmacy on IPA Platform
Pune branch. Dr. Abhay World Pharmacists Day was celebrated on 25th September, 2020 at
Jere, Chief Innovation Delhi Pharmaceutical Sciences and Research University (DPSRU),
Officer, MHRD, Govt. of New Delhi. Prof R K Goyal, Honorable Vice-Chancellor, DPSRU
India, gave the opening presided the function. Dr. V. Kalaiselvan Principal Scientific Officer
remarks as Chief Guest at Indian Pharmacopoeia Commission and Prof. S. S. Sharma,
a n d D r. B . K . S a h u , Professor, NIPER graced the occasion. The event started with a
Regional Manager (IPR welcome address by Dr. Rajani Mathur, Assistant Professor, DIPSAR.
and TOT), NRDC, Govt. Prof. Geeta Aggarwal, Dean Academics highlighted the contribution
of India, was one of the of DPSRU faculty in the fight against COVID-19.  Prof. Harvinder
Eminent Speakers. A Popli, Director, School of Pharmaceutical Sciences explained the
theme for this year of Pharmacist day ‘Transforming Global Health’.
Panel discussion was held on the occasion which was chaired by
Prof D. P Pathak, Director, DIPSAR acknowledged the  gathering
Dr. Hemant Dande, President and Chief Operating Officer, Raptakos,
by introducing himself as a proud pharmacist. Dr. S. S. Sharma,
Brett and Co., Mumbai. Dr. Umesh Banakar, an internationally
Professor, NIPER highlighted the contribution of Pharmacists to
renowned IP expert was the Guest of Honour. Dr. Anant Paradkar, a world where everyone benefits from access to safe, effective,
Director, Center of Pharmaceutical Engineering, Bradford University, quality and affordable medicines.
UK delivered a talk on “Managing Innovation In Academic Set Up.”
Prof R K Goyal, Vice-Chancellor highlighted the role of Pharmacists
Dr. K.N. Gujar, Principal SCOP and member – secretary of the IP
in the present COVID pandemic. The program proceeded further
Policy welcomed all the guests for the inauguration. Dr. Rajshree
with the “Oath Ceremony” by Prof. Rajiv Tonk, Dean Students’
Gude, Professor of Pharmaceutics, Goa College of Pharmacy, Goa,
Affairs, wherein all the dignitaries along with the students took the
Dr K G Bothara, Principal, Sinhgad Institute of Pharmacy, Dr S D
oath.  This event was concluded by Vote of Thanks by Dr. Rajani
Sawant, Principal, Smt. Kashibai Navale College of Pharmacy and Mathur. In the evening, Dr. Sushama Talegaonkar, Associate
Dr. M.P. Mahajan, Principal, Sinhgad Institute of Pharmaceutical Professor, DPSRU organized different on-line activities including
Sciences, Lonawala were present for the inauguration along with poster and slogan making competition under the theme. A huge
faculty members and research scholars. Dr A P Pawar, Principal diversified response from students of various Pharmacy institutions
I/C BVDU Poona College of Pharmacy and Dr K N Gujar, Principal, from Delhi NCR and other states including Andhra Pradesh,
STES Sinhgad College of Pharmacy were Conveners and Dr N Karnataka and Maharashtra was received. Another interesting
S Ranpise, Professor, SCOP along with Dr. Sharvil Patil, Asst. activity, “Placard Wish Collage” was also conducted by the students
Professors, BVDU PCP were the co-coordinators for the one-day under the guidance of Dr. Sushama Talegaonker.
international e-symposium.
Awards and Honors
Delhi Pharmaceutical Sciences and Research University Ph.D. Award
(DPSRU) Name: Dr. Rajesh Suresh Parab
World Pharmacists Day - 2020 Title: Study of Polymers and Advances in Coating
Chemistry
University: Goa University
Guide: Dr. Gopal Krishna Rao, Principal, Goa College
of Pharmacy, Panaji Goa

Advertisement Index
Sr. No. Company Name Pg. No.

1. ACG.......................................................................2, 3
2. Elmach Packages (India) Pvt. Ltd............30, 31, 60
3. Ami Polymer Pvt. Ltd.. ...........................................43
Placard wish Collage by Students of DPSRU and DIPSAR wishing
World Pharmacists Day

Pharma Times - Vol. 52 - No. 12, December 2020 59

RNI No. 18943/69 Date of Publication on 17th December, 2020
Regd. No. MCN/206/2018-2020 at Mumbai Patrika Channel Sorting Office
Mumbai - 400 001 on 21st of every month.
Licence to post without prepayment No. MR/Tech/WPP-151/North/2018-20

Printed at Ebenezer Printing House, Dadar (W), Mumbai

on behalf of the Indian Pharmaceutical Association

Pharma Times - Vol. 52 - No. 12, December 2020 60