A disruptor to Precision Medicine & Nutrition through
biomarkers’ discovery
Labros Digonis, Co-Founder & CEO
Dr. Konstantinos Theofilatos, Co-Founder and CTO
If severely ill, what are the chances he survives if his life
depends on drug under trial?
52%
of clinical trials fail due
to drug efficacy and
wrong targeting of
patients!
Source: IMS
6.7%
of hospitalized patients
have adverse drug
reaction (ADR) and
0.32% die
Source: FDA
2
Drug development is a long, expensive process
Source: The Tribune
Average $2.9B and 8 years to get drug to market
The History of Waiting and its deadly track record
4
Drug Indicated disease Clinical Delay Result
Eloxatin Colorectal cancer 3 years 40,000 Americans died
waiting
Erbitux Colorectal and head and
neck cancer
2 years 179,000 people died
waiting
Revlimid MDS, Multiple Myeloma,
MCL
2.5 years 74,000 patients died
without getting drug
Tarceva Lung cancer, Pancreatic
cancer
3 years 633,000 patients died
waiting
Tykerb Breast cancer 3 years 28,000 women died
waiting
Velcade Multiple Myeloma 1 year 2,600 patients died
waiting
Drug efficacy results are negatively affected because
people respond to treatments differently
+
+
=
=
BiDil approved for use only in
patients of African descent
• Two medications combined.
Indicated for cardiovascular
disease, heart failure diabetes
• Only a subgroup of people
received a benefit during trials
Example:
Molecular biomarkers can be used to predict
responses to drugs or food
Molecular Biomarker
Something that can be measured which
points to the presence of a disease or
differentiation in response to a treatment
or drug
Specific to: different -omics technologies
Molecular Biomarker Example
A combination of overexpressed
genes, or mutations to diagnose
tumors
Molecular biomarkers can be used to predict
responses to drugs or food
Molecular Biomarker
Something that can be measured which
points to the presence of a disease or
differentiation in response to a treatment
or drug
Specific to: different -omics technologies
Benefits of Finding Biomarkers
• Minimizes the risks for failed trials
• Patient Stratification: Enables the optimal
selection of participants to clinical trials
• Interpretation of the cause of diseases
• Allows precision medicine: provide the
more suitable drug to each patient in a
personalized manner.
Molecular Biomarker Example
A combination of overexpressed
genes, or mutations to diagnose
tumors
Biomarker discovery is a fragmented Data-driven process
Biological
Experiments Data
Preprocessing &
Visualization
Meta-Analysis
Biomarker
extraction
Diagnostic &
Clinical Trials
Applications
• DNA & RNA sequences
• Microarrays
• NGS
• Mass Spectrometry.
• Proteins
• Biological networks
• Associated sequences,
mRNA, non-coding
RNA, SNPs)
• Holistic/Systemic
approach to Research
& Clinical deduction
• Integrated biomarkers
of high confidence
• Biological
interpretation with
affected pathways &
side-effects prediction.
• Diagnosis, prognosis
• Drug Response/Toxicity
prediction
• Disease progression
• Therapeutic response.
Biomarker ID takes time, money and expertise
Biomarker discovery is a fragmented Data-driven process
Biological
Experiments Data
Preprocessing &
Visualization
Meta-Analysis
Biomarker
extraction
Diagnostic &
Clinical Trials
Applications
• DNA & RNA sequences
• Microarrays
• NGS
• Mass Spectrometry.
• Proteins
• Biological networks
• Associated sequences,
mRNA, non-coding
RNA, SNPs)
• Holistic/Systemic
approach to Research
& Clinical deduction
• Integrated biomarkers
of high confidence
• Biological
interpretation with
affected pathways &
side-effects prediction.
• Diagnosis, prognosis
• Drug Response/Toxicity
prediction
• Disease progression
• Therapeutic response.
Existing platforms are performing only part of the analysis
Biomarker discovery is a fragmented Data-driven process
Biological
Experiments Data
Preprocessing &
Visualization
Meta-Analysis
Biomarker
extraction
Diagnostic &
Clinical Trials
Applications
• DNA & RNA sequences
• Microarrays
• NGS
• Mass Spectrometry.
• Proteins
• Biological networks
• Associated sequences,
mRNA, non-coding
RNA, SNPs)
• Holistic/Systemic
approach to Research
& Clinical deduction
• Integrated biomarkers
of high confidence
• Biological
interpretation with
affected pathways &
side-effects prediction.
• Diagnosis, prognosis
• Drug Response/Toxicity
prediction
• Disease progression
• Therapeutic response.
InSyBio is first to
integrate the
process and
extract prioritized
and relevant
biomarkers from
raw data
Public
databases &
knowledge
InSyBio Suite is a proprietary, cloud platform for big biological data analysis
Biomarkers
Disease
Interpretation
Cause of
Disease
Mechanism
Genetic Mutations
Diagnostic tests
Prognosis/Predispositions
Novel Therapies
Improved efficiency
Personalized Medicine
AI-
Machine
Learning
Biological Experiments
Clinical Trials Hospital EHR Research Institutes Pharma
Disrupting Clinical trials
and Drug discovery
process
A model approach to Precision Medicine
& Nutrition through biomarkers’
discovery at a glance
Accurate, targeted, and highly reproducible
biomarkers with small sample size requirements
10
Case Studies Method
Number of
biomarkers
Accuracy
Early Stage
Parkinson’s
Diagnosis
State-of-the-art Method 834 ~96%
InSyBio solution 5 100%
Ischemic Stroke
Diagnosis
State-of-the-art Method ~3000 <70%
InSyBio solution 4 88%
Glioblastoma
Diagnosis
State-of-the-art Method 24 90.01%
InSyBio solution 13 94.45%
…extracted Fast and at a Low-cost thru a single user
friendly platform decreasing thus the need for many
validation experiments and outsourced bioinformatics
analysis
~ 6 months
~ 1/6 of time
$100,000 - $millions
Time to
extract
biomarkers
Relative Cost
to extract
biomarkers
1/8 cost
Fast
Cost
Effective
Our innovation lies in 4 main areas
One, end-to-end, integrated
process for biomarker discovery
Data (Vertical) Integration from many
sources with
patent-protected network-based
approach
Technology to locate
30%
more common proteins in
proteomics data
Rifle Approach
Fewer, relevant and accurate
biomarkers
Our technology has already demonstrated ability to
accelerate pharma & nutrition R&D tasks
Nutrition
Diet Selection/Effects of nutrition
products in health and patients
Pharma: Clinical Trials
Discovery of candidate-biomarkers for
effective patient recruitment
R&D resources efficiency
Shorten time-to-market
Pharma: Pre-clinical Drug
Design
Faster and more reliable detection of
drug targets
Minimization of risk for side effects
Diagnostic Companies and Labs
Diagnostic, prognostic and therapeutic
biomarker discovery
Less candidate biomarkers, higher
predictive accuracy
More than 400 active
users with applications
in:
• Parkinson’s
• Alzheimer’s
• Major Depression
• Melanoma
• Cancer radiotherapy
The incorporation of InSyBio’s Technology in Clinical
Trials can save thousands!
• ~25,000 new clinical trials per year
• Average success rate is being
increased by 16% with the use of
predictive biomarkers
• 40% of those trials already try to use
predictive biomarkers
• InSyBio technology can allow the
use of predictive biomarkers in the
remaining 60% ending up with on
average ~2400 more successful
clinical trials and drugs to market
annually
15
Sources: Clarivate Analytics Cortellis, Feb 2017; Quintiles IMS Institute, April 2017,
BiomedTracker for Pharma Intelligence, Informa, Clinical Development Success Rates 2006-2015
The InSyBio team
Efficient & forward-looking with strong business and scientific background
Dr. Christos Alexakos
COO
Computer Engineer, MSc,
PhD in Computer Science
Labros Digonis
CEO
Entrepreneurial Manager,
Naval Architect & Marine Engineer, MBA
Dr. Konstantinos Theofilatos
CTO, Technical Sales Mgr.
Computer Engineer, MSc,
PhD in Bioinformatics
Christos Dimitrakopoulos
R&D Mgr.
Computer Engineer, MSc,
PhD Candidate in Computational Biology
Aigli Korfiati
Product Development Mgr.
Computer Engineer, MSc,
PhD Candidate
Dr. Seferina Mavroudi
CSO
Computer Engineer, MSc,
PhD in Bioinformatics
Prof. Georgios Georgiou
University of Texas
Prof. Nicholas Peppas
University of Texas,
Member of Chinese Academy
Prof. Konstantinos
Stathopoulos
University of Patras
Dr. Alexandros Georgakilas
National Technical University of
Athens
Co – Founders Team
Scientific Advisory
Committee
13
Recent Publications and patents
• Theofilatos, K., Alexakos, C., Korfiati, A., Dimitrakopoulos, C. and Mavroudi, S., Theofilatos and Konstantinos, 2018. Generalized Computational
Framework And System For Integrative Prediction Of Biomarkers. U.S. Patent Application 15/837,407.
• Theofilatos, K., Dimitrakopoulos, C., Mavroudi, S., Korfiati, A. and Alexakos, C., InSyBio Ltd, 2017. Protein functional and sub-cellular
annotation in a proteome. U.S. Patent Application 15/361,461.
• J. Corthésy and K. Theofilatos, et al., An Adaptive Pipeline To Maximize Isobaric Tagging Data in Large-Scale MS-Based Proteomics,
Journal of Proteome Research 2018 17 (6), 2165-2173, DOI: 10.1021/acs.jproteome.8b00110
• A. Korfiati, K. Theofilatos, C. Alexakos and S. Mavroudi, InSyBio ncRNASeq: An efficient tool for analyzing non-coding RNAs, EMBnet.journal,
[S.l.], v. 23, p. e882, oct. 2017, DOI :https://doi.org/10.14806/ej.23.0.882.
• C. Dimitrakopoulos, K. Theofilatos, et al. (2016) InSyBio BioNets: A new tool for analyzing biological networks and its application to
biomarker discovery, EmbNet Journal, vol. 22, pp. e871, 2016, DOI: http://dx.doi.org/10.14806/ej.22.0.871.
• C. Dimitrakopoulos, K. Theofilatos, A. Pegkas, S. Likothanassis, S. Mavroudi, Predicting overlapping protein complexes from weighted
protein interaction graphs by gradually expanding dense neighborhoods, Artificial Intelligence in Medicine Journal, 2016, DOI:
http://dx.doi.org/10.1016/j.artmed.2016.05.006
• Nikitaki, Zacharenia, et al. "Systemic mechanisms and effects of ionizing radiation: A new ‘old’ paradigm of how the bystanders and
distant can become the players." Seminars in cancer biology. Academic Press, 2016, DOI: https://dx.doi.org/10.1016/j.semcancer.2016.02.002.
• K. Theofilatos, S. Likothanassis, S. Mavroudi (2015) Quo vadis* Computational Analysis of PPI data Or Why the Future isn’t Here
Yet, Frontiers in Genetics, vol. 6, pp. 289, DOI= https://dx.doi.org/10.3389/fgene.2015.00289
• Kleftogiannis, D., Theofilatos, K., Likothanassis, S., & Mavroudi, S. (2015). YamiPred: A novel evolutionary method for predicting pre-miRNAs
and selecting relevant features. IEEE/ACM Transactions on Computational Biology and Bioinformatics (TCBB), 12(5), 1183-1192.
• Rapakoulia, T., Theofilatos, K., Kleftogiannis, D., Likothanasis, S., Tsakalidis, A., & Mavroudi, S. (2014). EnsembleGASVR: a novel ensemble
method for classifying missense single nucleotide polymorphisms. Bioinformatics, 30(16), 2324-2333.
• Theofilatos, K., Dimitrakopoulos, C., Likothanassis, S., Kleftogiannis, D., Moschopoulos, C., Alexakos, C., ... & Mavroudi, S. (2014). The Human
Interactome Knowledge Base (HINT-KB): an integrative human protein interaction database enriched with predicted protein–protein
interaction scores using a novel hybrid technique. Artificial Intelligence Review, 42(3), 427-443.
16
Insybio Biomarkers
22
Insybio Bionets
23
Insybio Interact
24
Find Us
url: http://www.insybio.com
demo: http://demo.insybio.com
evaluation: http://evaluation.insybio.com
Contact Us
info@insybio.com
Open Jobs
careers@insybio.com

InSyBio at Open Coffee Athens CI

  • 1.
    A disruptor toPrecision Medicine & Nutrition through biomarkers’ discovery Labros Digonis, Co-Founder & CEO Dr. Konstantinos Theofilatos, Co-Founder and CTO
  • 2.
    If severely ill,what are the chances he survives if his life depends on drug under trial? 52% of clinical trials fail due to drug efficacy and wrong targeting of patients! Source: IMS 6.7% of hospitalized patients have adverse drug reaction (ADR) and 0.32% die Source: FDA 2
  • 3.
    Drug development isa long, expensive process Source: The Tribune Average $2.9B and 8 years to get drug to market
  • 4.
    The History ofWaiting and its deadly track record 4 Drug Indicated disease Clinical Delay Result Eloxatin Colorectal cancer 3 years 40,000 Americans died waiting Erbitux Colorectal and head and neck cancer 2 years 179,000 people died waiting Revlimid MDS, Multiple Myeloma, MCL 2.5 years 74,000 patients died without getting drug Tarceva Lung cancer, Pancreatic cancer 3 years 633,000 patients died waiting Tykerb Breast cancer 3 years 28,000 women died waiting Velcade Multiple Myeloma 1 year 2,600 patients died waiting
  • 5.
    Drug efficacy resultsare negatively affected because people respond to treatments differently + + = = BiDil approved for use only in patients of African descent • Two medications combined. Indicated for cardiovascular disease, heart failure diabetes • Only a subgroup of people received a benefit during trials Example:
  • 6.
    Molecular biomarkers canbe used to predict responses to drugs or food Molecular Biomarker Something that can be measured which points to the presence of a disease or differentiation in response to a treatment or drug Specific to: different -omics technologies Molecular Biomarker Example A combination of overexpressed genes, or mutations to diagnose tumors
  • 7.
    Molecular biomarkers canbe used to predict responses to drugs or food Molecular Biomarker Something that can be measured which points to the presence of a disease or differentiation in response to a treatment or drug Specific to: different -omics technologies Benefits of Finding Biomarkers • Minimizes the risks for failed trials • Patient Stratification: Enables the optimal selection of participants to clinical trials • Interpretation of the cause of diseases • Allows precision medicine: provide the more suitable drug to each patient in a personalized manner. Molecular Biomarker Example A combination of overexpressed genes, or mutations to diagnose tumors
  • 8.
    Biomarker discovery isa fragmented Data-driven process Biological Experiments Data Preprocessing & Visualization Meta-Analysis Biomarker extraction Diagnostic & Clinical Trials Applications • DNA & RNA sequences • Microarrays • NGS • Mass Spectrometry. • Proteins • Biological networks • Associated sequences, mRNA, non-coding RNA, SNPs) • Holistic/Systemic approach to Research & Clinical deduction • Integrated biomarkers of high confidence • Biological interpretation with affected pathways & side-effects prediction. • Diagnosis, prognosis • Drug Response/Toxicity prediction • Disease progression • Therapeutic response. Biomarker ID takes time, money and expertise
  • 9.
    Biomarker discovery isa fragmented Data-driven process Biological Experiments Data Preprocessing & Visualization Meta-Analysis Biomarker extraction Diagnostic & Clinical Trials Applications • DNA & RNA sequences • Microarrays • NGS • Mass Spectrometry. • Proteins • Biological networks • Associated sequences, mRNA, non-coding RNA, SNPs) • Holistic/Systemic approach to Research & Clinical deduction • Integrated biomarkers of high confidence • Biological interpretation with affected pathways & side-effects prediction. • Diagnosis, prognosis • Drug Response/Toxicity prediction • Disease progression • Therapeutic response. Existing platforms are performing only part of the analysis
  • 10.
    Biomarker discovery isa fragmented Data-driven process Biological Experiments Data Preprocessing & Visualization Meta-Analysis Biomarker extraction Diagnostic & Clinical Trials Applications • DNA & RNA sequences • Microarrays • NGS • Mass Spectrometry. • Proteins • Biological networks • Associated sequences, mRNA, non-coding RNA, SNPs) • Holistic/Systemic approach to Research & Clinical deduction • Integrated biomarkers of high confidence • Biological interpretation with affected pathways & side-effects prediction. • Diagnosis, prognosis • Drug Response/Toxicity prediction • Disease progression • Therapeutic response. InSyBio is first to integrate the process and extract prioritized and relevant biomarkers from raw data Public databases & knowledge InSyBio Suite is a proprietary, cloud platform for big biological data analysis
  • 11.
    Biomarkers Disease Interpretation Cause of Disease Mechanism Genetic Mutations Diagnostictests Prognosis/Predispositions Novel Therapies Improved efficiency Personalized Medicine AI- Machine Learning Biological Experiments Clinical Trials Hospital EHR Research Institutes Pharma Disrupting Clinical trials and Drug discovery process A model approach to Precision Medicine & Nutrition through biomarkers’ discovery at a glance
  • 12.
    Accurate, targeted, andhighly reproducible biomarkers with small sample size requirements 10 Case Studies Method Number of biomarkers Accuracy Early Stage Parkinson’s Diagnosis State-of-the-art Method 834 ~96% InSyBio solution 5 100% Ischemic Stroke Diagnosis State-of-the-art Method ~3000 <70% InSyBio solution 4 88% Glioblastoma Diagnosis State-of-the-art Method 24 90.01% InSyBio solution 13 94.45%
  • 13.
    …extracted Fast andat a Low-cost thru a single user friendly platform decreasing thus the need for many validation experiments and outsourced bioinformatics analysis ~ 6 months ~ 1/6 of time $100,000 - $millions Time to extract biomarkers Relative Cost to extract biomarkers 1/8 cost Fast Cost Effective
  • 14.
    Our innovation liesin 4 main areas One, end-to-end, integrated process for biomarker discovery Data (Vertical) Integration from many sources with patent-protected network-based approach Technology to locate 30% more common proteins in proteomics data Rifle Approach Fewer, relevant and accurate biomarkers
  • 15.
    Our technology hasalready demonstrated ability to accelerate pharma & nutrition R&D tasks Nutrition Diet Selection/Effects of nutrition products in health and patients Pharma: Clinical Trials Discovery of candidate-biomarkers for effective patient recruitment R&D resources efficiency Shorten time-to-market Pharma: Pre-clinical Drug Design Faster and more reliable detection of drug targets Minimization of risk for side effects Diagnostic Companies and Labs Diagnostic, prognostic and therapeutic biomarker discovery Less candidate biomarkers, higher predictive accuracy More than 400 active users with applications in: • Parkinson’s • Alzheimer’s • Major Depression • Melanoma • Cancer radiotherapy
  • 16.
    The incorporation ofInSyBio’s Technology in Clinical Trials can save thousands! • ~25,000 new clinical trials per year • Average success rate is being increased by 16% with the use of predictive biomarkers • 40% of those trials already try to use predictive biomarkers • InSyBio technology can allow the use of predictive biomarkers in the remaining 60% ending up with on average ~2400 more successful clinical trials and drugs to market annually 15 Sources: Clarivate Analytics Cortellis, Feb 2017; Quintiles IMS Institute, April 2017, BiomedTracker for Pharma Intelligence, Informa, Clinical Development Success Rates 2006-2015
  • 17.
    The InSyBio team Efficient& forward-looking with strong business and scientific background Dr. Christos Alexakos COO Computer Engineer, MSc, PhD in Computer Science Labros Digonis CEO Entrepreneurial Manager, Naval Architect & Marine Engineer, MBA Dr. Konstantinos Theofilatos CTO, Technical Sales Mgr. Computer Engineer, MSc, PhD in Bioinformatics Christos Dimitrakopoulos R&D Mgr. Computer Engineer, MSc, PhD Candidate in Computational Biology Aigli Korfiati Product Development Mgr. Computer Engineer, MSc, PhD Candidate Dr. Seferina Mavroudi CSO Computer Engineer, MSc, PhD in Bioinformatics Prof. Georgios Georgiou University of Texas Prof. Nicholas Peppas University of Texas, Member of Chinese Academy Prof. Konstantinos Stathopoulos University of Patras Dr. Alexandros Georgakilas National Technical University of Athens Co – Founders Team Scientific Advisory Committee 13
  • 18.
    Recent Publications andpatents • Theofilatos, K., Alexakos, C., Korfiati, A., Dimitrakopoulos, C. and Mavroudi, S., Theofilatos and Konstantinos, 2018. Generalized Computational Framework And System For Integrative Prediction Of Biomarkers. U.S. Patent Application 15/837,407. • Theofilatos, K., Dimitrakopoulos, C., Mavroudi, S., Korfiati, A. and Alexakos, C., InSyBio Ltd, 2017. Protein functional and sub-cellular annotation in a proteome. U.S. Patent Application 15/361,461. • J. Corthésy and K. Theofilatos, et al., An Adaptive Pipeline To Maximize Isobaric Tagging Data in Large-Scale MS-Based Proteomics, Journal of Proteome Research 2018 17 (6), 2165-2173, DOI: 10.1021/acs.jproteome.8b00110 • A. Korfiati, K. Theofilatos, C. Alexakos and S. Mavroudi, InSyBio ncRNASeq: An efficient tool for analyzing non-coding RNAs, EMBnet.journal, [S.l.], v. 23, p. e882, oct. 2017, DOI :https://doi.org/10.14806/ej.23.0.882. • C. Dimitrakopoulos, K. Theofilatos, et al. (2016) InSyBio BioNets: A new tool for analyzing biological networks and its application to biomarker discovery, EmbNet Journal, vol. 22, pp. e871, 2016, DOI: http://dx.doi.org/10.14806/ej.22.0.871. • C. Dimitrakopoulos, K. Theofilatos, A. Pegkas, S. Likothanassis, S. Mavroudi, Predicting overlapping protein complexes from weighted protein interaction graphs by gradually expanding dense neighborhoods, Artificial Intelligence in Medicine Journal, 2016, DOI: http://dx.doi.org/10.1016/j.artmed.2016.05.006 • Nikitaki, Zacharenia, et al. "Systemic mechanisms and effects of ionizing radiation: A new ‘old’ paradigm of how the bystanders and distant can become the players." Seminars in cancer biology. Academic Press, 2016, DOI: https://dx.doi.org/10.1016/j.semcancer.2016.02.002. • K. Theofilatos, S. Likothanassis, S. Mavroudi (2015) Quo vadis* Computational Analysis of PPI data Or Why the Future isn’t Here Yet, Frontiers in Genetics, vol. 6, pp. 289, DOI= https://dx.doi.org/10.3389/fgene.2015.00289 • Kleftogiannis, D., Theofilatos, K., Likothanassis, S., & Mavroudi, S. (2015). YamiPred: A novel evolutionary method for predicting pre-miRNAs and selecting relevant features. IEEE/ACM Transactions on Computational Biology and Bioinformatics (TCBB), 12(5), 1183-1192. • Rapakoulia, T., Theofilatos, K., Kleftogiannis, D., Likothanasis, S., Tsakalidis, A., & Mavroudi, S. (2014). EnsembleGASVR: a novel ensemble method for classifying missense single nucleotide polymorphisms. Bioinformatics, 30(16), 2324-2333. • Theofilatos, K., Dimitrakopoulos, C., Likothanassis, S., Kleftogiannis, D., Moschopoulos, C., Alexakos, C., ... & Mavroudi, S. (2014). The Human Interactome Knowledge Base (HINT-KB): an integrative human protein interaction database enriched with predicted protein–protein interaction scores using a novel hybrid technique. Artificial Intelligence Review, 42(3), 427-443. 16
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    Find Us url: http://www.insybio.com demo:http://demo.insybio.com evaluation: http://evaluation.insybio.com Contact Us [email protected] Open Jobs [email protected]