COVID-19 Therapies and Vaccines

COVID-19 Therapies and Vaccines

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  JUNE 3, 2020 WorldwideHealth Care Alumni Webinar COVID-19 Therapies and Vaccines
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  Copyright©2020byBostonConsultingGroup.Allrightsreserved. 1 Antitrust Compliance Statement 1. Chatham HouseRules apply: Participants are free to use the information received, but may not reveal the identity or the affiliation of the other participants 2. Participants shall only discuss the topics listed on the agenda 3. Participants shall neither exchange nor discuss competitively sensitive information. Competitively sensitive information includes but is not limited to information: i. regarding recent, current or future pricing strategies; ii. that affects price such as specific discounts, costs or profit margins; iii. regarding capacity or output. iv. regarding allocating customers or geographic areas. v. regarding boycotting third parties or discriminating against or excluding other competitors, suppliers or customers. vi. regarding their market positions or individual plans, including client or supplier relationships, costs, production levels, R&D etc. By remaining connected to this call, you agree with the above
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  2 Copyright©2020byBostonConsultingGroup.Allrightsreserved. COVID-19 therapy andvaccine team on today's webinar Managing Director & Senior Partner Barry Rosenberg, MD Managing Director & Partner Josh Kellar, PhD Managing Director & Partner Emily Serazin Principal Ciarán Lawlor, PhD Chicago ChicagoWashington D.C. Boston
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  Copyright©2020byBostonConsultingGroup.Allrightsreserved. 3 Agenda State of thescience Preparing to scale and deliver Q&A
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  4 State of thescience
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  5 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Critical to havea variety of therapeutic modalities and vaccine approaches in development for several reasons: Only a small % of assets will gain regulatory approval Different therapies / vaccines will be suitable for different populations Supply chain limitations mean that no single asset can be produced quantities to meet demand For therapies: potential that combination treatment becomes standard-of-care
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  6 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Therapies: three mainmodalities under development Antivirals Antibodies Immunomodulators Description • Prevent viral entry into cells or inhibit viral replication • Create passive immunity by neutralizing viral particles • Ameliorate damage caused by hyperimmune response to infection Current status • Modest efficacy shown for Remdesivir • Lopinavir-ritonavir in WHO Solidarity trial • Numerous trials in progress • Initial lead-candidate data expected in Q3 • Preliminary results show mortality reduction • Potential wide availability in Q3, pending Ph 3 results Example companies (not-exhaustive)
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  7 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Vaccines: four mainplatforms under development Nucleic acid Protein subunit Virus Viral vector Description • Genetic info. for cells to make "safe" viral proteins • Immune-stimulating component of the virus • Inactivated or weakened form of the virus • Replicating and non- replicating approaches Current status • Moderna in Ph 2 • Other companies in Ph 1/2 & preclinical phases • Novavax in Ph 1/2 • Other companies in preclinical phases • Sinopharm & Sinovac inactivated candidates in Ph 1/2 • Other companies in preclinical phases • Oxford/AstraZeneca candidate in Ph 2b/3 • CanSino candidate in Ph2 • Numerous other companies in preclinical phases Example companies (not-exhaustive)
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  8 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Q1 2020 Q22020 Q2 2020 Q3 2020 Q3 2020 Q4 2020 Q4 2020 2021+ Remdesivir Gilead and NIH launch multi-center Ph 3 trials Gilead provides compassionate use access Prelim results from China site indicates no clinical benefit Gilead and NIH Ph 3 studies achieve primary endpoint Modest benefit of 5- day course shown in moderate patients Chloroquine/ Hydroxy- chloroquine French study shows reduction in viral loads Retrospective study shows no clinical benefit NIH ORCHID and Oxford trials launch in April 2020 Inc. mortality per Lancet study – drugs pulled from WHO trial Preliminary ORCHID results expected in Fall 2020 Wide availability Interim Oxford study results are expected in 2021 Ritonavir- lopinavir RCT in China failed to show clinical benefit Drug combo included WHO SOLIDARITY Trial Neutralizing antibodies Trials launched; multiple companies pushing development Eli Lily launches Ph 1 trial of first-ever COVID-19-specific tx Initial lead-candidate data expected from multiple trials Convalescent plasma FDA allows emergency use authorization FDA greenlights Ph 2 in April 2020 Ph 3 RCTs expected to launch in May 2020 CP therapy to expand nationwide, pending Ph 3 results Hyperimmune globulin H-Ig clinical trials anticipated to begin in June 2020 Phase 2/3 readouts in Aug - Sep 2020 and early access Tocilizumab Observation study in China shows improved survival Roche Ph 3 trial launched in March 2020 Preliminary results reveal significant mortality reduction Wide availability, pending Ph 3 trial results Sarilumab Ph 2/3 trial launched in March 2020 Interim results show lower mortality in MV patients Wide availability, pending Ph 3 trial results Therapy Therapies: Many assets in development, broad availability as soon as Q3 2020 Q2 2020 2021+Q3 2020 Q4 2020 Key: Prelim. data Early accessTrial start Q1 2020 Broad availability
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  9 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Vaccines: Traditional developmenttakes at least 5-10 years; companies are moving aggressively towards a 12-18 month COVID-19 vaccine Traditional paradigm takes > 5 years Small-scale clinical trial material Commercial scale-up Potential accelerated pathway for Covid-19 vaccine Phase 3 Commercial launch Phase 2 Phase 1 Disc . Discovery / screening Phase 3 Commercial launchPhase 2Phase 1 Small-scale clinical trial material Commercial scale-up Limited pre- clinical testing Start Ph 2 with interim Ph1 data Emergency use authorization for a small volume release (millions scale) Scale-up at risk Potential surrogate of efficacy study Scale to support global demand (billions scale) 0 101 2 3 4Time-frame (yrs) 5
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  10 Preparing to scaleand deliver
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  11 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Potential target populationsand requisite capacity vary by public health or economic objective Health care workers (10s of millions) 65+ y/o population (100s of millions) Underlying conditions (~1 Billion) Essential workers (100s of millions) Remaining workforce (2-3 Billion) 60-70% of total pop. (5-6 Billion) "Super spreaders" (TBD) High density areas/outbreak response (TBD) 60-70% of total pop. (5-6 Billion) Lower volume Higher volume Objective Protect those most vulnerable Minimum economic disruption Prevent transmission Low demand scenarios target highest-priority population Relevant population (estimated number of people) Key considerations include: supply availability, regulatory confidence, epidemiology, delivery feasibility, etc.
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  12 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Scaling production forhigh-volume scenarios is a complex task Multiple elements to end-to-end design for large-scale COVID-19 vaccines Need to anticipate requirements, bottlenecks, and interventions for each element (e.g. finish / fill) Materials & components Bulk antigen mfg. Formula- tion Filling Packaging Lot release / QA Testing / QC Logistics, Storage, and Distribution Information and Analytics Six potential interventions to optimize finish / fill capacity Collaborate across industry to identify capacity opportunities Pull forward production and stockpile existing vaccines Standardize how vaccine will be filled / distributed Suppliers to make stoppers, vials, other critical materials available Build additional new capacity rapidly if / as needed Potentially reconfigure existing lines and de-bottleneck
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  13 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Partnerships critical forsuccess Private-private partnerships Public-private partnerships Various parties Examples / not-exhaustive Other manufacturers
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  Copyright©2020byBostonConsultingGroup.Allrightsreserved. 14 Take-homes Myriad of therapiesand vaccines in development today • Crucial to have multiple assets in development, to account for regulatory approval rates, different patient populations, supply chain limitations, and potential need for combination therapies Must proactively prepare to scale and deliver • Potential target populations and requisite capacity vary by public health or economic objective (i.e., protect vulnerable populations vs. prevent disease transmission) • There are multiple elements to end-to-end design for large-scale COVID-19 vaccines - need to anticipate requirements, bottlenecks, and interventions for each element Partnerships are critical for success • These involve a wide variety of parties, including: pharma / biotech companies, pharma / biotech trade organizations, academic medical centers, government agencies, and NGOs / philanthropic organizations
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  15 Q&A session
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  16 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Thank you!
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