The document summarizes a webinar on COVID-19 therapies and vaccines. It discusses the state of development for different therapeutic modalities, including antivirals, antibodies, and immunomodulators. It also discusses vaccine platforms under investigation, including nucleic acid, protein subunit, virus, and viral vector vaccines. Timelines for clinical trials and availability of leading candidates are provided. The need to prepare for large-scale production and delivery to meet target population goals is discussed. Partnerships across different organizations are highlighted as critical for success.

1. JUNE 3, 2020
Worldwide Health Care Alumni Webinar
COVID-19 Therapies
and Vaccines

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1
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By remaining connected to this call, you agree with the above

3. 2
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COVID-19 therapy and vaccine 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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3
Agenda
State of the science
Preparing to scale and deliver
Q&A

5. 4
State of the science

6. 5
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Critical to have a
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

7. 6
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Therapies: three main modalities 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)

8. 7
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Vaccines: four main platforms 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)

9. 8
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Q1 2020 Q2 2020 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

10. 9
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Vaccines: Traditional development takes 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

11. 10
Preparing to scale and deliver

12. 11
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Potential target populations and 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.

13. 12
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Scaling production for high-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

14. 13
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Partnerships critical for success
Private-private partnerships Public-private partnerships
Various parties
Examples / not-exhaustive
Other
manufacturers

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14
Take-homes
Myriad of therapies and 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

16. 15
Q&A session

17. 16
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Thank you!

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