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Response and Resilience: Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic

Authors:
  • TEConomy Partners, LLC.
  • TEConomy Partners, LLC

Abstract and Figures

The central goal of this study is to generate enhanced understanding of the favorable characteristics of global life sciences ecosystems that were able to energize their intellectual and infrastructural resources to respond to the COVID-19 challenge. It seeks to communicate the characteristics of best-practice ecosystems, so that the world and individual nations can be better prepared in the future.
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Response and Resilience:
Lessons Learned from Global Life Sciences
Ecosystems in the COVID-19 Pandemic
Prepared by TEConomy Partners, LLC for Pfizer, Inc.
Report Authors: Simon Tripp, David Hochman, and Mitch Horowitz
TEConomy Partners, LLC is a global leader in research, analysis, and strategy for
innovation-based economic development. Today, we’re helping nations, states, regions,
universities, and industries blueprint their future and translate knowledge into prosperity.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 3
Table of Contents
Executive Summary ................................................................................................ 1
Introduction ...............................................................................................................9
Lessons Learned Across Life Sciences Ecosystems ................................. 13
Framework Element 1: The Central Value Chain ...................................13
1a: Life Sciences R&D .............................................................................16
1b: Clinical Trials ..................................................................................... 24
1c: Production .......................................................................................... 28
1d: Distribution ........................................................................................ 32
Framework Element 2: Talent (Human Capital) ................................... 35
Framework Element 3: Capital ...................................................................38
Framework Element 4: Policies and Regulation...................................44
Framework Element 5: Customers and Markets .................................. 51
Conclusions ............................................................................................................ 55
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 1
“ Vision” has been the title of many plans,
strategies, and projections over the past decade.
It is doubtful that any of these forward-looking
documents accurately foresaw the reality of .
While the year started out much like any other,
the emergence of the coronavirus disease 
(COVID-) quickly re-shaped daily life for much
of the world’s population and drove the global
economy into recession.
What is now clear is that, without a vaccine or a
group of effective treatments, COVID-19 will likely
continue to impact humanity and commerce for a
considerable amount of time. A race is on to find
therapeutics and vaccines, and everyone has a
stake in the race. Because of this, COVID-19 has
shone an extremely bright spotlight on the critical
importance of life sciences research, and the
commercialization of life sciences innovations,
as mechanisms for effective pandemic response.
The ability of industrial life sciences ecosystems to
develop diagnostic tests, vaccine candidates, and
antiviral agents (and to rapidly scale-up their clinical
trials, manufacturing, and distribution) will ultimate-
ly make the difference in resolving the pandemic.
Executive Summary
The central goal of this study is to generate enhanced understanding
of the favorable characteristics of global life sciences ecosystems that
were able to energize their intellectual and infrastructural resources
to respond to the COVID-19 challenge. It seeks to communicate the
characteristics of best-practice ecosystems, so that the world and
individual nations can be beer prepared in the future.
There is, however, observable geographic vari-
ability in “capacity to respond,” and there has
been inconsistency in speed and effectiveness of
actual national responses, suggesting that there
are valuable lessons to be learned. From those
locations that have responded effectively, we
may learn “what to do” in terms of best practices
in life sciences ecosystem development and the
deployment of ecosystem assets in responding
to a fast-moving pandemic event. Equally, those
places that have struggled in their response may
offer lessons regarding the gaps or barriers that
constrained these ecosystems as they endeavored
to mount a response.
This study identifies key lessons learned in na-
tional responses to COVID- and seeks to help
policymakers across the globe focus on advancing
favorable characteristics and emerging best
practices that contribute to success. It does this
through examining the approaches of  nations
drawn from across the globe that have active
biomedical life sciences ecosystems, producing a
series of summary vignees of approaches taken
and lessons learned (see Figure ES-).
2Response and Resilience
A Viral “Perfect Storm”
Severe acute respiratory syndrome coro-
navirus 2, or SARS-CoV-2, is a particularly
challenging virus to control. Its incubation
period is quite variable, at between 1and
14 days, and symptoms may present
between 2 and 14 days aer infection.
These symptoms range from being so
mild that they go unnoticed through to
quite rapid onset of acute life-threatening
respiratory challenges and organ failure.
The virus is transmied human-to-human
via respiratory droplets or via contact
with contaminated surfaces, but there is
also evidence of aerosolization of virus
particles at a level that might be resulting
in transmissions. Patients recovering from
COVID-19 demonstrate far from a uniform
immune serology, and it is unclear the
level of protection accorded through prior
infection. In some respects, it is a “perfect
storm” of a virus—slow enough in causing
symptoms to allow asymptomatic individ-
uals to continue daily interactions that
unknowingly spread the virus, just deadly
enough to overwhelm healthcare systems
in major hot spots, but apparently not
deadly enough for some people to change
their behaviors and take it seriously (thus
perpetuating transmission).
Key Findings and
Recommendations
for Policymakers
Life sciences advancements result from the
presence and operations of a complex ecosystem,
comprising intellectual assets, specialized infra-
structure, a skilled workforce, complex production
technologies, and sophisticated supply chains.
These ecosystems comprise private-industry, aca-
demic, nonprofit, and government actors and are
supported by a range of public- and private-sector
capital resources. The life sciences ecosystem is
presented in a simplified structure on Figure ES-,
comprising the key value chain from research and
development (R&D) to market, and the cross-cut-
ting support domains of talent, capital, and public
policy that facilitate ecosystem operations.
Examination herein of pandemic-related activities,
experiences, and challenges across global life sci-
ences ecosystems has provided multiple lessons
learned regarding the conditions that enabled life
sciences ecosystems to effectively respond to the
pandemic. It has also highlighted gaps and weak-
nesses in pandemic response for multiple nations.
Figure ES-1: Nations Reviewed for COVID-19
Life Sciences Ecosystem Lessons
Source: TEConomy Partners, LLC.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 3
The report details 34 lessons learned (see Table ES-1 for a summary of many) across all key elements
of the value chain from R&D to market and supporting domains of talent, capital, and public policy.
Ultimately, the individual lessons can be summarized under five key themes with associated recommen-
dations for consideration by policymakers:
. Prior investments and advancements toward a robust life sciences ecosystem matter greatly in
responding to a pandemic. The fact that, in the face of the COVID- pandemic, so many vaccine
candidates and drugs have been brought forward into testing, trials, and emergency use is a heart-
ening achievement and is a testimony to the foresight of those who have developed, work in, and
support the complex life sciences R&D and industry ecosystems around the world. The complexity
of the ecosystems that must be in-place to advance R&D, product development, and production and
distribution of biopharmaceuticals, vaccines, and diagnostics is such that they cannot be stood up
from scratch in a real-time situation. They must already be in place, fully operational, well proven, and
well funded in advance of an emergent need.
Recommendation – Policymakers must prioritize and sustain investments in life sciences research
infrastructure, workforce development, and advanced production systems. Enacted policies and
regulations must support life sciences ecosystem development at scale and sustain favorable
ecosystem operating conditions.
. Promotion of collaborations is key to quickly mobilizing and pursuing new medical innovations.
Public- and private-sector collaborations, and inter-industry collaborations, have played a key role
in rapidly advancing innovations for pandemic response. These collaborations often build upon
the complementary and robust roles of public-supported academic basic research together with
industry expertise in applied discovery, development, and clinical testing that routinely take place in
high-functioning life sciences ecosystems. What the response to the COVID- pandemic has vividly
demonstrated is the benefit of collaboration, even between peer companies, whereby different, but
complementary, R&D and industrial strengths and capacities can be brought together for advancing
medical innovations.
Recommendation – Policymakers should develop and align incentives to encourage collaborations
that will advance and speed the development and commercialization of medical innovations and take
advantage of the full capacities found across life sciences research institutions and industry.
MarketDistribution
Talent Support: Education, training, and a positive labor-market conditions
Capital Support: Private and public capital to fund ecosystem development and ongoing operations
Public Policy Support: Enabling legislation, regulations, and government programs
ProductionTrialsR&D
Figure ES-2:
Simplified
Life Sciences
Ecosystem
Source: TEConomy
Partners, LLC.
4Response and Resilience
. The convergence of digital technology with life sciences helps accelerate innovations and supports
ecosystem resiliency. One broad benefit of the COVID- pandemic has been the acceleration in the
use of digital technologies across all stages of life sciences development and the industrial val-
ue-chain. Digital technologies are proving effective in speeding up research insight and innovation,
sustaining trials and regulatory oversight, building supply chain transparency, facilitating trade, and
supporting safer (remote) clinical healthcare interactions.
Recommendation – For the future, policymakers should continue to promote the use of digital
technologies in R&D, clinical testing, supply chain management, and healthcare delivery and seek
ways to further the integration across distinct activities to improve the effectiveness of life sciences
ecosystems.
. Flexibility in government regulatory approaches is making a difference. Given the typical drug and
vaccine development timelines of a decade or more, the speed of the overall response mounted
by the global life sciences community to COVID- is nothing short of astonishing. This has been
accomplished, in part, because of flexibility shown in regulatory processes by government. Perhaps
the most-publicized area of flexibility is in
the clinical testing of potential vaccines
and therapies through mechanisms such as
emergency use authorizations, compassionate
use, conditional market authorizations, and
short timeframe approvals, while still allowing
for thorough scientific evaluation of a medi-
cine’s benefits and risks. Other less publicized
forms of flexibility have also been advanced in
the use of digital technologies in clinical trials
A Powerful Collective Scientific Response
The complete SARS-CoV-2 genome was decoded by Chinese scientists extremely quickly in the early
stage of the emergence of the disease. The sharing of the coronavirus genome worldwide activated
existing international life sciences ecosystems that investigated the pharmacopoeia of drugs for
potential candidate therapies against the virus, accelerated investigation of new molecules for
potential effectiveness against the disease, and supported rapid R&D in existing and novel vaccine
development and delivery platforms. Researchers from academia, government, and industry have
shared data and rapidly stood-up domestic and international collaborations to access and share
supercomputing resources, chemical libraries, analytical instrumentation, and other research tools.
Governments, nonprofits, and private industry funders have stepped-up to provide large-scale
capital resources; and private industry has taken substantial financial risk in accelerating product
development and even building additional manufacturing capacity “at risk,” in the humanitarian quest
(both for human health and the economy) to get therapeutics and vaccines into clinical application
against the virus as soon as physically possible. It has represented an unprecedented globally
collaborative mobilization of research, production, and capital (both financial and intellectual).
The rapid acceleration of research,
innovation, product development,
commercialization, and production
scale-up (all performed in the midst of an
ongoing global pandemic affecting those
doing the work) represents a collective
effort deserving worldwide appreciation.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 5
monitoring, remote manufacturing inspections, ability to make changes in suppliers, and allowance for
joint ventures and other collaborations.
Recommendation – Policymakers should consider how increased flexibility with accountability can be
achieved on a more regular basis as a means for ensuring that unmet medical needs are addressed to
improve patient lives.
. The existing business environment for innovation in life sciences ecosystems has proven to be highly
agile and able to be effectively leveraged through the COVID-19 pandemic. In challenging times
there is a strong impetus for government to be seen to be “doing something.” COVID- has certainly
required critical government interventions and actions, but it is important to recognize that care must
always be taken to avoid actions that may undermine the favorable ecosystem characteristics needed
to maintain life sciences advancements and innovation. There are multiple “fundamentals” that are
influenced by governments that must be sustained in order for life sciences ecosystems to flourish,
requiring for example:
Substantial commitment of government funds to supporting R&D through well-funded research
grant funding agencies, together with favorable tax treatment of private sector R&D investments.
Sustaining effective rules against trade barriers, and facilitating international trade, to enable
resilient and flexible supply chains to operate that reliably meet demand for medical products.
Maintaining predictable and sustainable payer pricing systems that balance the need to manage
health care payer costs with the need for return-on-investment for innovative life sciences companies.
Operation of a flexible, science-based regulatory system.
Robust intellectual property protections and enforcement.
Jerry Stewart, et al. “COVID-: A Catalyst to Accelerate Global Regulatory Transformation.” Clinical Pharmacology & Therapeutics. 
September, . hps://ascpt.onlinelibrary.wiley.com/doi/./cpt.
6Response and Resilience
The last bulleted fundamental is particularly critical. One of the core elements for life sciences innova-
tion is having in place robust protection and enforcement of intellectual property rights, which provide
the necessary incentives to advance novel medicines — especially when it may cost billions of dollars
in private investment to bring a novel medicine to market. Beyond ensuring private investment funding,
IP protections are proving to be effective in enabling collaborations to take place between organi-
zations with solutions to different pieces of the puzzle (even among traditionally competing firms).
With robust IP protections, innovators can collaborate and work together to advance such solutions,
knowing that their R&D efforts, inventions, and creativity are secure. The first bulleted fundamental on
government funding support for research is similarly important, and the life sciences ecosystem has
responded well to government incentives aimed at furthering R&D into novel antivirals and vaccines
and increasing production capacities within their nation.
Recommendation – Policymakers need to ensure that the core elements of high-functioning life sciences
business environments are in place to facilitate innovation advancement. Some of the key elements to be
advanced include strong IP protections and provision of secure market access for innovative medicines.
The above recommendations are rooted in multiple lessons learned during the COVID- pandemic.
Table ES- summarizes many of the lessons covered in the full report.
Table ES-1: Summary of Main Themes and Related Lessons Learned
Prior investments and advancements towards a robust life sciences
ecosystem maer greatly in responding to a pandemic.
Innovations derive from a diversity of university, government labs, non-profit research institutions and
industry research seings with no single group of actors dominating.
Research grants and development support set a key foundation for rapid innovation.
Large-scale signature R&D and scientific infrastructure
(e.g. supercomputers, synchrotrons, etc.) pay dividends.
Scaling a life sciences workforce requires foresight and a long-time horizon.
Venture capital and angel investment activity helps to prime the pump of innovation.
Multiple sources of critical supplies are beneficial.
Promotion of collaborations is key to quickly mobilizing and pursuing new medical innovations.
Collaborations appear to have accelerated the research and development
of candidate vaccines and therapeutics.
Inter-industry partnerships and collaborations make a difference.
Big and small players will be contributing solutions and collaborating.
The convergence of digital technology with life sciences helps accelerate
innovations and supports ecosystem resiliency.
Advancement of life sciences, digital and advanced analytics convergence skills is required.
Adoption of virtual and contactless solutions sustains clinical trials.
Regulatory oversight of GMP production can be accomplished remotely.
Digital supply chain monitoring is desirable and feasible.
Virtualization or digitalization of healthcare has accelerated.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 7
Flexibility in government regulatory approaches is making a difference.
Emergency regulatory flexibility in use of new medicines is required.
Regulatory oversight of GMP production can be flexible in its approach.
Universal, patient centric, access to care, diagnostics, therapeutics, and vaccines must be facilitated.
Existing business environment for innovation has proven to be agile and able
to be effectively leveraged through incentives and co-investment.
Public co-investment can be significant as a catalyst for commercial innovation advancement.
Commitment to building strategic stockpiles and government purchasing is required.
Government can facilitate the implementation of new biopharma production technologies.
The COVID- crisis has vividly illustrated the critical importance of life sciences research and innovation
systems and the ecosystems that support the advancement of innovations through commercial deployment
to address health needs. The pandemic has equally provided multiple lessons learned regarding what worked
well in addressing the crisis and has highlighted gaps and weaknesses in pandemic response for multiple
nations. These have been hard-earned lessons learned, with less-than-optimal responses to COVID-
contributing to large-scale morbidity and mortality loads globally and extracting a heavy economic and
social cost for humanity.
The coronavirus caught humanity’s leadership off guard in many
places across the globe. When the next high-threat infectious disease
emerges (and such an emergence is likely), all need to be beer
prepared. Funding, building, reinforcing, and sustaining robust life
sciences ecosystems is a key component of that preparation. The
lessons learned and recommendations herein are proffered as core
elements for consideration in building resiliency and responsiveness
into critically important life sciences ecosystems worldwide.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 9
Were it not for the intellectual and scientific
horsepower of industrial, academic, and
governmental R&D communities, and their
ability to characterize the virus and develop
diagnostic tests, the pandemic would be
orders of magnitude worse. The capacity of
nations and the global life sciences commu-
nity to develop and produce diagnostic tests,
vaccine candidates, and therapeutic agents
(and to then scale up their clinical trials,
manufacturing, and distribution) is the direct
result of prior investments in developing the
science, technologies, and skilled people that
power R&D, innovation commercialization,
and advanced biopharmaceutical and medical
product manufacturing.
The geographic variability in “capacity to
respond,” and the inconsistency in speed and
effectiveness of actual national responses,
suggests that there are valuable lessons
to be learned. From those locations that
have responded effectively, “what to do”
may be learned in terms of best practices
Introduction
The coronavirus disease 2019 (COVID-19) pandemic has shone a
spotlight on the importance of national and international research
and development (R&D), innovation, and manufacturing ecosystems
in life sciences. As a novel virus, severe acute respiratory syndrome
coronavirus 2, or SARS-CoV-2, has illustrated the critical importance
of having robust life sciences innovation ecosystems in place that can
pivot to address a new and urgent challenge.
A Highly Complex Sector
Even before the COVID-19 pandemic, it was
well understood that the bar to advance life sci-
ences development is higher than many other
advanced industries and is rising with the fast
pace and complexity of scientific advances.
The life sciences industry is more connected to,
and dependent upon, basic science discoveries
and their translation for driving innovations
than other advanced industries. The industry
not only has to advance product discovery, but
also has to innovate and advance cuing-edge
manufacturing processes to bring forward
novel products (in complex areas, e.g., such as
genomic-based medicines, immunotherapies,
cell therapies, diagnostics, and vaccines).
Advancing products from discovery through
clinical trials and onward into production and
distribution is complex, costly, time consuming,
and highly regulated.
It is no easy feat to rapidly accelerate innova-
tion in a pandemic—yet it seems some nations
have done just that.
10 Response and Resilience
supported by a range of public- and private-sector
capital resources. Those ecosystems that innovate
and produce products for human clinical applica-
tion operate, by necessity, under strict regulations
regarding efficacy and safety, and public policy
plays a significant role in governing the operation
of the ecosystems and their markets.
Understanding the structure of these ecosystems,
or their operational “framework,” is a foundational
requirement for considering the context of lessons
to be learned. To that end, the first step taken in
the study approach was to develop an overview
structure of a biomedical life sciences ecosystem
framework. The framework (Figure ) serves as the
contextual canvas upon which lessons learned may
be placed and understood.
As shown in Figure , the framework comprises a
central “value chain,” which contains the continuum
of core activity from basic scientific inquiry, through
applied research, preclinical and clinical testing, on-
in life sciences ecosystem development and the
deployment of ecosystem assets in responding to a
fast-moving pandemic event. Equally, those places
that have struggled in their response no doubt
offer lessons regarding the gaps or barriers that
constrained these ecosystems as they endeavored
to mount a response. This study examined 
nations from across the globe that have active
biomedical life sciences ecosystems (see Figure ).
This report seeks to identify and summarize many
of the main lessons learned.
Study Approach
The work herein recognizes that life sciences
advancements result from the presence and
operations of a complex ecosystem, comprising
intellectual assets, specialized infrastructure, a
skilled workforce, complex production technol-
ogies, and sophisticated supply chains. These
ecosystems comprise private industrial, academic,
nonprofit, and governmental actors and are
Figure 1: Nations Reviewed for COVID-19 Life Sciences Ecosystem Lessons
Source: TEConomy Partners, LLC.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 11
ward into commercial development, manufacturing,
distribution, and market application. In support of
the operations of the value chain are three principal
domains: talent (the human intellectual and skills
resources required to operate the value chain), the
capital required to build and fund activities across
the value chain, and the public policies and regula-
tions that support and impact the operation of the
ecosystem. This framework is used as an organizing
element in understanding and contextualizing
the lessons learned from the varied life sciences
ecosystems that deployed in response to COVID-
across the globe.
The study has focused on identifying lessons
learned from two perspectives. First, it considers the
general lessons learned that may not be geograph-
ically specific and are observable across multiple
life sciences ecosystems. Second, it reports on the
research teams series of nation-specific examina-
tions, producing summary vignees of approaches
taken and lessons learned in the countries shown
in Figure . These nations were selected for exam-
ination because they have active biomedical life
sciences ecosystems, yet the variation in response
to COVID- and the effectiveness of their respons-
es have differed quite widely (providing a basis for
investigating what has worked and what has not
worked in these locations).
The central goal of this study is to generate
enhanced understanding of the favorable charac-
teristics of national life sciences ecosystems able
to energize their intellectual and infrastructural
resources to respond to the challenge. It seeks to
communicate the characteristics of best-practice
ecosystems, so that the world and individual
nations can be beer prepared in the future.
12 Response and Resilience
Patient
Government
Stockpiles
Clinicians &
Health Systems
Market
Basic
R&D
Applied
R&D
Pre-
clinical
Testing
Clinical
Trials
Ph. 2/3
Clinical
Trials
Ph.1.
Small-Scale/Pilot Manufacturing
Specialized Research
Infrastructure
Production Inputs (Supplies, Equipment)
Value
Chain
Intellectual Property Protection
Sales &
Mktg.
Distrib-
ution
Warehousing &
Transportation
Manufacturing
Skilled Workforce & Management
R&D Personnel Trials Management Production Business Operations
External Professional & Contracted Services
Talent
Capital
Investment in R&D
(Public & Private)
Early-Stage Capital
(Governmental, Private Equity
or Industrial)
Production and Operations Capital
(Industrial, Private Equity and Commercial Markets)
Policies & Regulation
Crosscuing Supports Core Activities
Market
Access
Public Health
System Price
Policies
Predictability
& Stability
Contingency
Planning
Trade Policy
Market Rules
& Regulation
Workforce
Safety &
Health Regs
Environmental
Regulations
Quality
Controls
Liability
Regulations
Production
Process
Regulations
Taxation
Policies
Trials
Regulation
Government
Co-investment
Government
Grants &
Incentives
Government
Research
Funding
Workforce
Development
Intellectual
Property
Protections
Collaboration
Supports
Education
Regulatory Review and Approval
Figure 2: Biomedical Life Sciences Ecosystem “Framework
Source: TEConomy Partners, LLC.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 13
The research findings and lessons learned from this
review are organized by macro framework element,
as illustrated in Figure . The key focus is on life sci-
ences ecosystems in relation to the development,
production, and distribution of biopharmaceuticals
and related products, including diagnostics,
vaccines, and therapeutics (both small and large
molecule). Much of what is found also holds
relevance to the development and production of
other critical products required in the pandemic
response, including medical devices and supplies
(such as personal protective equipment [PPE]).
Lessons Learned Across
Life Sciences Ecosystems
The complexity of the ecosystem required to advance R&D, product
development, and production of biopharmaceuticals, vaccines, and
diagnostics is such that it cannot be stood up from scratch in a real-
time situation. It must already be in place, fully operational, and proven
well in advance of an emergent need.
Framework Element 1:
The Central Value Chain
When a new biopharmaceutical product is deployed
for clinical application, it will have followed a
complex, time-consuming, and monetarily expensive
path that originated in the initial scientific research
insights upon which it is based and progressed
through a rigorous process of preclinical testing,
human trials, regulated Good Manufacturing Prac-
tice (GMP) development, packaging development,
and supply-chain and distribution structuring. The
Market
Value Chain
Distribution
1d
Talent
2
Capital
3
Policies & Regulation
4
5
Production
1c
Trials
1b
R&D
1a
1
Figure 3: Simplified
Framework
Source: TEConomy
Partners, LLC.
14 Response and Resilience
degree of scientific, technical, and regulatory rigor
deployed across this process is uncommon in other
manufactured products.
PhRMA notes that:
On average, it takes at least ten years for a new
medicine to complete the journey from initial
discovery to the marketplace, with clinical trials
alone taking six to seven years on average. The
average cost to research and develop each
successful drug is estimated to be $2.6 billion.
This number incorporates the cost of failures
– of the thousands and sometimes millions of
compounds that may be screened and assessed
early in the R&D process, only a few of which
will ultimately receive approval. The overall
probability of clinical success (the likelihood that
a drug entering clinical testing will eventually be
approved) is estimated to be less than 12%.1
The process to advance from first scientific insight
just through the full R&D process comprises the
steps shown in Figure . This is the process for
biopharmaceuticals regulated by the U.S. Food
and Drug Administration (FDA), and it is typical of
that required in other nations. The development
PhRMA. Biopharmaceutical Research & Development: The Process Behind New Medicines. Accessed online at: hp://phrma-docs.
phrma.org/sites/default/files/pdf/rd_brochure_.pdf.
pathway for vaccines is similarly complex and reg-
ulated—understandably so given that vaccines are
preventative agents provided to healthy patients.
Vaccines carry their own unique challenges that
complicate development, including for example,
the ability of targeted pathogens to mutate and
develop subtypes, challenges in activating a robust
immune response in diverse patient populations,
and the fact that vaccines oen target infant
populations who are still developing. As noted by
the International Federation of Pharmaceutical
Manufacturers & Associations (IFPMA):
The intention of a vaccine is to prevent
an infection and/or a disease in a healthy
population. Since vaccines are given to healthy
people throughout life, from childhood to older
age, it is necessary to establish a very large
safety database, by carrying out many studies
involving thousands of participants, before a
vaccine can be licensed. Ultimately, the benefit
of the vaccine must significantly outweigh any
risks. Before a vaccine is licensed and brought
to the market, it undergoes a long and rigorous
process of research, followed by many years
of clinical testing. The overall development
Discovery Clinical Development Post-Approval
BASIC
RESEARCH
Scientists in
a range of
private and
public research
seings seek
to understand
disease mech-
anisms and
identify poten-
tial therapeutic
targets
DRUG
DISCOVERY
Existing or
new molecules
are tested for
effectiveness
against
the target.
Candidates are
advanced for
further testing
PRECLINICAL
TESTING
In silico, lab
and animal
model testing
is performed
to examine
effects and
safety of
the drug for
advancing
to human
testing.
CLINICAL
TRIALS
Three phases
of trials, with
successively
larger popula-
tions, used to
further test
efficacy,
safety and
dosages.
NDA/BLA
SUBMISSION
A New Drug
Application
or a Biologics
License
Application is
provided to the
FDA to request
permission
to market the
drug. Includes
full test results,
manufacturing
and labeling
plan.
FDA REVIEW &
DECISION
A detailed
review of the
application
and supporting
materials is
performed by
the FDA. FDA
may approve
the application
or request
additional study
or information
to render a
decision.
PRODUCTION
& ONGOING
STUDY
Once FDA
approval is re-
ceived, the drug
can proceed to
manufacturing
and marketing
the drug. The
company con-
tinues to study
and report on
efficacy and
safety.
IND
SUBMISSION
The drug develop-
er submits
an Investigational
New Drug
application
to the FDA, show-
ing preclinical
data and trials
planning. FDA
reviews and
advises if OK
to proceed to
human trials.
Process requires an average of 10 years and $2.6 billion to complete
Figure 4: Primary Steps in the Biopharmaceutical R&D Process
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 15
Key Finding
Given typical drug and vaccine develop-
ment timelines, the speed of the overall
response mounted by the global life sci-
ences community to COVID- is nothing
short of astonishing. The rapid acceleration
of research, innovation, product develop-
ment, commercialization, and production
scale-up (all performed in the midst of an
ongoing global pandemic affecting those
doing the work) represents a collective
effort deserving worldwide appreciation.
of a vaccine consists generally of a discovery
phase, a pre-clinical phase, the clinical
development phase (phases I to III) and the
post licensure phase (phase IV), and it takes on
an average about 10 to 15 years.
Diagnostic tests are an order of magnitude less
costly and time consuming to develop. They are
able to be developed, tested, and reviewed more
rapidly than therapeutics and vaccines because
they do not themselves represent a product admin-
istered into a patient. Certainly, a diagnostic has to
be proven to have efficacy in clinical use, because
false positives or false negatives can have serious
implications for patient health and the ongoing
transmission of a disease. A false positive may
result in a patient being prescribed unnecessary
treatments or therapeutics that may have a risk of
adverse side effects, while a false negative leads
to a misdiagnosis of a patient, missed opportunity
for timely and effective treatment of the patient,
and (in the case of an infectious disease) enhanced
A Multidisciplinary International Response
The fact that, in the face of the COVID- pandemic, so many vaccine candidates and drugs have
been brought forward into testing, trials, and emergency use is on the one side an astonishing
achievement; but, it is also a testimony to the foresight of those who developed, work in, and
support complex life sciences ecosystems around the world.
The full SARS-CoV- genome was decoded extremely quickly by Chinese scientists in the early
stage of the emergence of the disease—an achievement possible only because of previous
investment in genomics technologies built upon original U.S. and UK investment in the Human
Genome Project and subsequent rapid advancement of genomics tools and techniques. The
sharing of the coronavirus genome worldwide activated international life sciences ecosystems
that investigated the existing pharmacopoeia of drugs for potential candidate therapies against
the virus, accelerated investigation of new molecules for potential effectiveness, and supported
rapid R&D in existing and novel vaccine development and delivery platforms. Researchers
from academia, government, and industry have shared data and rapidly stood up domestic and
international collaborations to access and share supercomputing resources, chemical libraries,
analytical instrumentation, and other research tools.
Government, nonprofit, and private industry funders have stepped-up to provide unprecedented
capital resources, and private industry has taken substantial financial risk in accelerating
product development and even building additional manufacturing capacity “at risk,” in the
humanitarian quest (both for human health and the economy) to get therapeutics and
vaccines into clinical application against the virus as soon as physically possible. It has been a
mobilization of research, production, and capital (both financial and intellectual) akin to that
deployed in previous world wars, only this time the war is against a microscopic insentient entity
and the whole world is fighting the threat together.
16 Response and Resilience
potential for the patient to infect others (e.g.,
through not being quarantined or encouraged
to social distance). The development of novel
diagnostic platforms can be a lengthier process
(more akin to medical device or biopharmaceutical
development); but, for the most part, diagnostics
are developed to use existing platform technolo-
gies at clinical diagnostic laboratories or point of
care (POC) locations.
The complexity of the ecosystem that must be
in-place to advance R&D, product development,
production, and distribution of biopharmaceu-
ticals, vaccines, and diagnostics is such that it
cannot be stood up from scratch in a real-time situ-
ation. It has to be already in-place, fully operational,
and well proven in advance of an emergent need.
Similarly, the complexity of the process to advance
a novel drug, vaccine candidate, or diagnostic
platform to market, and the timeline for doing so,
places further urgency on ensuring life sciences
ecosystems are constantly innovating, advancing,
and equipped to respond to urgent needs.
Framework Element 1a:
Life Sciences R&D
The story of the global life sciences ecosystem
response begins with R&D. R&D forms the basis
of discovery that then underpins innovation.
There are certainly locations that serve only to
host routine manufacturing or a distribution
center without being engaged in innovation. Such
locations would not be characterized as having a
complete life sciences ecosystem, because they
are limited in innovation and advancement of novel
solutions to challenges—rather, they primarily
work with the innovations that were generated
elsewhere. Such non-innovative locations are
generally at risk of losing their sectoral position if
other locations are able to offer more inexpensive
labor, taxation advantages, or other incentives for
relocation. R&D, on the other hand, which is rooted
in scientific infrastructure and, most notably, the
tacit knowledge of skilled and highly educated
people, is a key anchoring force in a life sciences
ecosystem. Advanced manufacturing locations can
The Importance of
Fundamental Research
Basic (fundamental) life sciences research
is typically conducted in academic or
government labs and seeks understanding
of the processes that govern life. Basic
research advances the stock of knowledge
upon which later applied discoveries may
build. Applied research focuses on devel-
oping technologies, solutions, or processes
with practical application to observed life
sciences opportunities, challenges, and
needs. It is important to note that a healthy
basic research environment is the platform
upon which later applied research advance-
ments are built.
Applied R&D in medicine is built upon a
vast library of fundamental research ad-
vancements—advancements that elucidat-
ed the role of microbes in disease, immune
system function, processes of evolution
and mutation, the structure of DNA, and
discovery of chemical elements, to name
just a handful. The advanced tools used
in drug discovery similarly are built upon
fundamental advancements in chemistry
and physics. Advancements in mathemat-
ics and computational theory are similarly
fundamental in enabling the advanced data
analysis, artificial intelligence, visualization,
and modeling algorithms used by life
sciences companies and research teams.
The advancement of basic science is very
much dependent on public funding. Basic
research is inherently nonmarket in nature
(focused on phenomena or subject maer
without an immediate line-of-sight to a
market application). Because of the specu-
lative nature of early fundamental research,
because of the long time horizons involved
in the performance of much basic inquiry,
because of the risk of experiment failures,
but most importantly, because of the lack
of immediate line-of-sight to a market,
private-sector investment in basic science
is relatively scarce.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 17
also be innovation hubs if they perform proactive
work to innovate more efficient systems, advance
continuous manufacturing processes, etc.
The COVID- pandemic has illustrated the central
contribution that R&D and associated innovation
plays within the life sciences framework and
an ability to mount a scientific and technologi-
cal-based response. Several global ecosystems
have proven particularly effective, and there are
significant lessons to be learned from them.
Summary of Lessons Learned
for Life Sciences R&D:
Innovations derive from a diversity of
research settings in universities, government
labs, nonprofit research institutions, and
industry, no single typology dominates.
Collaborations appear to have accelerated
candidate vaccines and therapeutics.
R&D-performing entities themselves will be
negatively impacted in a pandemic.
Prior investment in large-scale signature R&D
and scientific infrastructure (e.g., supercom-
puters, synchrotrons, etc.) pays dividends.
The economic cost of a pandemic dwarfs
the investment in the R&D resources needed
to address it.
Lesson 1a.1: Innovations derive from a diversity
of research settings in universities, government
labs, nonprofit research institutions, and indus-
try, no single typology dominates.
As ecosystems have responded to the R&D
challenges of the pandemic, it is evident that inno-
vations addressing the challenges of COVID- are
being derived from a broad range of organizational
types and sizes. Diagnostics, vaccine candidates,
and therapeutics have been rapidly researched
and advanced into trials by many organizations
including private industry (ranging from small
entrepreneurial firms through major multinational
biopharmaceutical companies), research universi-
ties and academic medical centers, independent
nonprofit research institutes, and government labs.
No single organizational type dominates the
innovation sphere, and it is notable that many of
the faster-advancing approaches have been driven
forward by collaborations between organizational
types. Private industry is the most cross-cuing of
all organizational types, demonstrating a contribu-
tory presence in the case of almost all innovations
advancing toward commercialization to address
the pandemic.
Lesson 1a.2: Collaborations appear to have accel-
erated candidate vaccines and therapeutics.
In normal situations, it is logical for an inventing
entity to keep its invention closely held and seek to
singularly advance its innovation with a clear goal
of maximizing return on investment. Certainly, clin-
ical trials will engage multiple parties, but usually a
single entity is in control and structured to receive
the core returns. The urgency of need for products
to address COVID- has evidently opened up a
more dynamic marketplace for joint ventures in
commercialization and intensive collaboration.
Collaborations have occurred between previous
competitors, between nonprofit and for-profit
entities, and internationally. Figure  summarizes
information reported by the Regulatory Affairs
Professional Society on many advancing COVID-
vaccine candidates, and it is apparent that the
vaccines more rapidly advancing into trials have a
propensity to demonstrate significant collabora-
tions in their development and advancement.
Collaborations include partnerships between
companies and close collaboration between
universities and other R&D organizations and
companies. In several cases, the collaborations are
international, crossing national boundaries. Some
examples of collaborations include the following:
The University of Oxford (UK) and Astra-
Zeneca (HQ: UK) collaboration to advance
development and production of the ChAdOx
nCoV- vaccine innovated by the Jenner
18 Response and Resilience
Institute and Oxford Vaccine Group, at the
University of Oxford.
Roche Holding AG (HQ: Switzerland) and Gil-
ead Sciences (HQ: USA) teaming-up for trials
for a drug combination to treat COVID-.
BioNTech SE (HQ: Germany) and Pfizer Inc.
(HQ: USA) collaborating to advance candi-
dates from BioNTech’s messenger ribonucleic
acid (mRNA) vaccine program.
Merck (HQ: USA) and the nonprofit scientific
research organization IAVI (HQ: USA) collab-
orating to develop a vaccine candidate using
the recombinant vesicular stomatitis virus
(rVSV) technology that is the basis for Merck’s
Ebola Zaire virus vaccine.
Sanofi (HQ: France) and GSK (HQ: UK) co-de-
veloping an adjuvanted vaccine for COVID-,
using innovative technology from both
companies. Sanofi has contributed its S-protein
COVID- antigen, which is based on recombi-
nant DNA technology, while GSK contributed
its proven pandemic adjuvant technology.
Heat Biologics, Inc. (HQ: USA) collaborating
with Waisman Biomanufacturing, a subsidiary of
the University of Wisconsin (USA), to manufac-
ture Heat’s experimental COVID- vaccine.
National Findings:
Nonprofit Research
Institutes Contribute as
Ecosystem Actors
Independent nonprofit research
institutions have played an important
innovator role during the pandemic.
Brazil—Initiatives to develop a domestic
vaccine candidate are being coordinated
on the government’s behalf by the Oswaldo
Cruz Foundation, a long-standing public-
health research institution.
France—One of the strongest directed
efforts at vaccine development is
coming from the Pasteur Institute,
a nongovernment, private nonprofit
laboratory with a long history in
microbiology and, more recently,
molecular biology.
South Africa—Recognizing that the
fight against COVID- leverages some
of the same contact-tracing and public-
education skills needed to fight the HIV
and tuberculosis epidemics in-country,
the nation mobilized entities including
(but not limited to) the Aurum Institute
that have long experience in these other
infectious diseases.
UK—The Oxford vaccine candidate
reflects a collaboration with the Jenner
Institute, now loosely affiliated with the
university, but with a long history as an
institute for farm animal health supported
by both government and private
contributions.
USAThe nonprofit Battelle Memorial
Institute rapidly innovated and produced
a novel container-based system using
vaporized hydrogen peroxide for on-site
decontamination and sanitation of PPE.
Lessons Learned from Global Life Sciences Ecosystems in the Covid-19 Pandemic 19
Figure 5: Engagement of Various Organizational Types in Advancing COVID-19 Vaccines into Clinical Trials. Evidence of Positive Effect of
Collaborations in Information Reported by the Regulatory Affairs Professionals Society1
Leader/Sponsor Corporate
Leader/Sponsor University or Non-Profit
Engaged Institutions: Corporate
Engaged Institutions: University or AHC
Engaged Institutions: Hospital/Health System
Engaged Institutions: Non-Profit
Engaged Institutions: Government Lab
Funder: Corporate
Funder: University or AHC
Funder: Hospital/Health System
Funder: Non-Profit
Funder: Government
Phase
2/3
Phase
1/2 Pre-Clinical
Classification: Single Country Solo
Classification: Single Country Collaboration
Classification: International Collaboration
Phase
1
Phase
2
BCG
mRNA-1273
BNT162
AZD1222
PiCoVacc
Ad5-nCoV
Inactivated Vaccine
bacTRL-Spike
INO-4800
Recombinant vaccine
PiCoVacc
Li-Key Peptide
mRNA-based vaccine
NVX-CoV2373
Self Amplifying RNA
LUNAR-COV19
Protein subunit
AdCOVID
Janssen AdVac-based
DNA-based vaccine
Plant-based vaccine
rVSV vaccine
Adenovirus-based
Demonstrates diversity of engaged
parties and collaborations. Those most
advanced tend towards collaboration.
Measles vecotor
TEConomy analysis of data reported by the Regulatory Affairs Professionals Society (RAPS). hps://www.raps.org/news-and-articles/news-articles///Covid--vaccine-tracker. It should be
noted that this is not a complete listing of vaccine candidates.
20 Response and Resilience
Lesson 1a.3: R&D-performing entities themselves
will be negatively impacted in a pandemic.
Insights and innovations stemming from the life
sciences R&D community represent a key tool in
addressing the challenge of COVID-, yet at the
same time, the R&D environment itself has been
negatively impacted by the pandemic. R&D is an es-
sentially human activity, advanced by a highly skilled
scientific and technical workforce—typically working
in relatively close confines in research laboratories.
Universities closed or deeply restricted campus
activities, and for those labs remaining open, the
requirements of social distancing substantially
reduced operational capacity, and thus productivi-
ty, in labs and specialized research spaces.
McKinsey & Company. “The Next Normal.” hps://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/
Covid--implications-for-life-sciences-r-and-d-recovery-and-the-next-normal.
Similar space and occupancy restrictions led to
a decline in corporate research productivity also.
McKinsey & Company (McKinsey) reports, based
on a survey of life sciences R&D leaders, that at life
sciences companies “R&D labs are operating at
below  percent of normal capacity” and “across
all R&D related groups, companies estimate pro-
ductivity has fallen by between  and  percent
due to remote working.”
Architects and space planners specializing in life
sciences research environments at Flad Architects
note that: “the recent and ongoing COVID-
Pandemic is requiring new paradigms and a
fundamental shi in how we think about research
design and space use at all levels of interaction.
With the goal of lessening density and creating
A Diversity of Collaborations
In Brazil, the Ministry of Science, Technology, Innovation and Communication (MCTIC) and the
University of Sao Paulo formed and funded a new Virus Network bringing together specialists,
government representatives, funding agencies, researchers, and universities to integrate
initiatives. Also, the Instituto Butantan is collaborating on vaccine development with the Bill &
Melinda Gates Foundation and pharmaceutical companies.
In China, the Global Health Drug Discovery Institute—a nonprofit comprising a partnership among
the School of Pharmaceutical Sciences at Tsinghua University, the Bill & Melinda Gates Foundation,
and Beijing municipal government—was an early mover in sharing its compound libraries and
opening its high-throughput screening capacity to researchers. Much of the institutes capability and
findings are shared through a portal hosted via an open GitHub repository.
In Singapore, the cPass rapid test was developed through a collaboration between the Duke-
National University of Singapore Medical School, the A*STAR Diagnostics Development Hub,
and GenScript (a Chinese-headquartered biotech firm). Singapore’s Immunology Network is also
collaborating with Chugai Pharmabody of Japan on antibody optimization, and Duke-NUS received a
national grant to work with US-based company Arcturus on mRNA vaccine development.
The largest-scale international collaboration is being coordinated by the World Health
Organization (WHO). “Solidarity” is an international clinical trial for COVID- solutions. The
Solidarity Trial compares options against standard of care, to assess relative effectiveness. As
of July , , nearly , patients had been recruited in  countries (among  countries
that have approvals to begin recruiting). WHO reports that more than  countries in all  WHO
regions have joined or expressed an interest in joining the trial.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 21
safer environments, many perspectives will be
needed to plan for safe and effective solutions”
(see Figure ).
It is anticipated that there will be long-term impli-
cations for life sciences R&D space planning as a
result of lessons learned from the pandemic. Most
notable is likely to be a need for more lab space as
the density of personnel allocated to existing lab
space will need to reduce in the “new normal.” The
boom line is likely to be that the capital cost of
space for performing research will increase.
Flad Architects. Scientific Workplace Strategy. Expert planning to reoccupy safely and economically. hps://www.flad.com/stories/
scientific-workplace-strategy.php.
Lesson 1a.4: Prior investment in
large-scale signature R&D and scientific
infrastructure pays dividends.
SARS-CoV-, as a novel coronavirus, has markedly
illustrated the importance of prior investment
in major shared scientific assets. As the threat
of COVID- became evident, signature national
scientific assets—the “big iron” of science—
were brought to bear on immediate study and
characterization of the virus. Ranging from
supercomputers to synchrotron X-ray light sources
(particle accelerators), national research assets
have been made available for use in coronavirus
research on a prioritized basis.
Figure 6: Researcher Density Greatly Reduced Through Lab Social-Distancing
Requirements.
Source: Flad Architects
22 Response and Resilience
Many of these world-class international scientific
facilities were established and funded by govern-
ments because of the very high level of capital
expenditure involved; and they typically operate
as “user facilities” available for use by academic,
industry, and other scientists based on submission
of research proposals. These powerful research
assets have been pivoted to prioritize COVID-
research, and scientists at the facilities are proac-
tively networking to share results. For example, the
international network of X-ray Science Facilities,
composed of X-ray Synchrotron Radiation and
X-ray Free Electron Laser Facilities, came together
in April  to share experiences and les-
sons-learned and to develop a cooperative strategy
to maximize the usefulness of their resources in
the fight against the pandemic. The collaboration is
facilitating sharing of results and data and facili-
Examples of Signature Research Assets Leveraged
for SARS-CoV-2 and COVID-19 R&D
The U.S. National Synchrotron Light Source II at Brookhaven National Laboratory (which cost
US million and opened in ) has provided expedited rapid access for groups requiring
beam time for projects directly related to COVID-.
Diamond Light Source, the UK’s national synchrotron (a UK million facility), is being used on
a wide range of Covid- projects ranging from examining fundamental interactions of the virus
to drug repurposing.
European high-performance computing (HPC) centers are coordinating access to
supercomputers and other HPC assets across Europe through the EU PRACE COVID-
Initiative. Supercomputing centers in Germany, France, Finland, Italy, Ireland, Czech Republic,
Slovakia, and Switzerland, for example, are providing prioritized access to computer resources
and specialized support services for computationally intensive studies.
Japan operates a national network of seven non-university research institutes with specialized
scientific infrastructure. Several key assets were made available to COVID- researchers,
including the Fugaku supercomputer, the SPring- synchrotron, and the Mendeley Data
Repository.
In South Africa, the science and technology agency’s Centre for High Performance Computing
has made computing time available for COVID-related work including using huge amounts of
telephone network data for contact tracing.
In Australia, the National Biologics Facility of the Commonwealth Scientific and Industrial
Research Organisation (CSIRO) is being leveraged to produce vaccine candidates at pilot scale,
while preclinical work has leveraged investment in biosecurity facilities at the Australian Centre
for Disease Preparedness.
In Canada, Genome Canada’s national resource base for high-throughput sequencing and
analysis (with nodes in Montreal, Toronto, and Vancouver) received C million to apply to
leveraging its resources to address COVID-.
In Sweden, the RISE institutes (a network of industry-facing applied research institutes) were
mobilized to provide testing certification of protective devices.
Four of China’s National Supercomputer Centers provided free usage of resources to COVID-
researchers.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 23
tating access to light-source beamlines around the
world when local beamlines are at capacity.
Processing and analyzing the massive amounts
of data being generated worldwide through
research tools applied to COVID- could have
been a boleneck for advancing solutions to the
pandemic. However, the international COVID-
High Performance Computing (HPC) Consortium
was quickly established to manage and provide
access to a “range of computing capabilities that
span from small clusters to some of the largest
supercomputers in the world.” Comprising HPC
centers of industry, academia, and government,
the consortium leverages the expertise of global
leaders like Microso, Intel, and Amazon Web
Services, together with university-based supercom-
puting centers in the U.S., UK, and Switzerland, and
the scientific computing resources of U.S. National
Laboratories and federal agencies. The U.S.-based
consortium is collaborating with other similar ini-
tiatives, such as the EU PRACE COVID- Initiative.
The EU has highlighted “on-demand, large-scale
virtual screening” of potential drugs and antibodies
at the HPC Centre of Excellence for Computational
Biomolecular Research, as well as “prioritized and
immediate access” to supercomputers operated by
the EuroHPC Joint Undertaking.
It is important to note that such specialized, capi-
tal-intensive scientific infrastructure projects (such
as synchrotron light sources and supercomputing
facilities) would not have been available to address
the virus were it not for billions of dollars in prior
investment and the foresight of multiple govern-
ments and supporting organizations in commiing
to the development and ongoing operations of
infrastructure focused on advancing fundamental
and applied scientific discovery.
 hps://covid-hpc-consortium.org/who-we-are.
Oliver Peckham. “Global Supercomputing Is Mobilizing Against COVID-.” HPC Wire. March , . hps://www.hpcwire.
com////global-supercomputing-is-mobilizing-against-Covid-/.
Congressional Research Service. Global Economic Effects of COVID-. Updated September , . Accessed online at: hps://
crsreports.congress.gov/product/pdf/R/R.
Lesson 1a.5: The economic cost of a pandemic
dwarfs the investment in the R&D resources
needed to address it.
It is certainly the case that the development and
ongoing operation of a comprehensive life sciences
research ecosystem runs into the tens of billions,
if not hundreds of billions, of dollars (depending on
the geographic scale of the ecosystem considered).
Scientific research staff and specialist supporting
personnel, life sciences laboratories, and special-
ized research instrumentation do not come cheap.
Research ecosystems will typically comprise Tier
 research universities, clusters of R&D-oriented
life sciences companies (including large and
mid-size companies and emerging entrepreneurial
ventures), and a host of specialized support
services and infrastructure required to support
the collective research effort. In some locations,
major government laboratories are also part of the
research ecosystem. It is a substantial investment.
What the COVID-19 pandemic makes clear, howev-
er, is that the economic cost of a major pandemic
that causes business shutdowns and wide-ranging
social-distancing requirements will be orders of
magnitude higher than the cost of the research
infrastructure required to address the crisis.
As noted by the U.S. Congressional Research Ser-
vice in its updated September  report on impacts
of the COVID- pandemic:
Since the COVID-19 outbreak was first
diagnosed, it has spread to over 200 countries
and all U.S. states. The pandemic is negatively
affecting global economic growth beyond
anything experienced in nearly a century.6
The financial cost of the pandemic is of an unprec-
edented scale. The International Monetary Fund
(IMF) estimates that:
24 Response and Resilience
Government spending and revenue measures
to sustain economic activity adopted
through mid-June 2020 amounted to $5.4
trillion and that loans, equity injections
and guarantees totaled an additional $5.4
trillion, or a total of $11 trillion.7
To fund investment in pandemic response and
associated economic supports, governments are
increasingly borrowing funds. The IMF estimates
that increase in global borrowing by governments
will rise dramatically from a pre-pandemic estimate
of .% of global gross domestic product (GDP) in
 to .% in .
The World Bank notes the following:
Over the longer horizon, the deep recessions
triggered by the pandemic are expected to
leave lasting scars through lower investment,
an erosion of human capital through lost work
and schooling, and fragmentation of global
trade and supply linkages.9
Against this background of severe economic
damage wrought by COVID-19, it is clear that the
investment of funds in the life sciences ecosystems
combaing the crisis pales in comparison. Put
another way, the return on government investment
in life sciences research is high when considering
the alternative (an inability to bring forth diagnos-
tics, vaccines, and therapeutics to combat it).
It should be noted that, while it takes considerable
funding to build up a life sciences ecosystem over
time, the net real economic returns to that invest-
ment will likely be high—with revenues generated
via innovation commercialization, ongoing sales of
life sciences products and services, and positive
returns realized through improved health associat-
ed with life sciences innovations. The argument for
investment in life sciences R&D holds strong even
 Ibid.
International Monetary Fund. World Economic Outlook Update. June , .
The World Bank. “The Global Economic Outlook During the COVID- Pandemic: A Changed World.” June , .
 McKinsey & Company. “The Next Normal.” hps://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/
Covid--implications-for-life-sciences-r-and-d-recovery-and-the-next-normal.
without a major public health crisis, but a global
pandemic adds a whole new level of argument for
the positive returns achieved.
Framework Element 1b:
Clinical Trials
No maer how urgent the need, nor dire an infec-
tious disease, promising biopharmaceuticals and
vaccines cannot be introduced for use until they
have been tested, with rigor, in clinical populations.
The formal process of clinical trials, outlined in Fig-
ure , has evolved out of necessity, and comprises
best practices to ensure that therapeutic products
for human use have been tested for efficacy and,
most important of all, for safety.
The clinical trials ecosystem has been heavily
impacted by the COVID- pandemic. At the most
macro level, three distinct pathways have occurred
in terms of the performance of clinical trials:
Pathway 1—Clinical trials for COVID-
therapeutics and vaccines. Given expedited
clearance and prioritized activity.
Pathway 2—Clinical trials in high-priority
disease areas and serving high-risk patients
with life-threatening conditions (e.g., cancers
or neurodegenerative diseases) that were
important to continue during the pandemic.
Pathway 3—Clinical trials in lesser-priority
diseases or conditions that could be suspend-
ed during the pandemic, together with new
trial starts delayed and enrollments stopped.
Overall, outside of specific COVID- trials, McKinsey
notes that clinical trials have been “affected with
disruptions in both new enrollment and in keeping
existing patients on therapies.” Because clinical
trials typically require trial participants to have
physical interactions with clinicians at medical
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 25
practices and at hospitals, any location experiencing
significant COVID- caseloads became problematic
for trial participation; and, even if still allowed to
visit clinical sites, some participants have chosen to
miss hospital visits as a result of concern over virus
exposure (especially if they are immunocompromised
or otherwise concerned with pre-existing conditions).
Trials specific to COVID- have experienced the
reverse situation—accelerating at a dramatic pace.
Chicago-based life sciences start-up accelerator,
MATTER, has conducted discussion panels with
life sciences companies in relation to pandemic
response experiences and clinical trials. The chief ex-
ecutive officer (CEO) of MATTER notes the following:
According to participants, in the face of this
pandemic, regulatory groups have become
exceptionally collaborative, which has allowed
 Steven Collens. “Four ways life sciences companies are adapting to a COVID- world.” May , .
 Rod MacKenzie, Peter Honig, Judy Sewards, Robert Goodwin and Marie-Pierre Hellio. “COVID- must catalyze changes to clinical
development.” Nature Reviews Drug Discovery. September , . hps://www.nature.com/articles/d---
projects to move through much more quickly.
One participant shared that they’ve been able
to stand up studies in two weeks versus a
normal timeline of several months.11
This finding is echoed in an article in Nature Review
Drug Discovery which notes that “the response to
the COVID- pandemic has shown that exceptional
efforts can dramatically accelerate the clinical
development of vaccines.” The authors find that
“the overnight review of COVID- protocols, the
waiver of the -day investigational new drug (IND)
application waiting period and analogous clinical
trial application (CTA) provisions, the delivery of
scientific advice almost in real time and virtual
meetings between sponsors and regulators have
all enabled rapid decision-making in response to
COVID-.”
It appears that for clinical trials, while COVID- has
created challenges for trials in some non-pandemic
related products, the crisis has revealed pathways
towards streamlined and digitally enabled regula-
tory processes likely to prove beneficial for future
biopharmaceutical and vaccine development.
Summary of Lessons Learned
for Clinical Trials:
Adoption of virtual and contactless
solutions sustains trials.
Proactive and responsive regulatory
guidance is highly important.
Speed in trials for vaccine and therapeutic
advancement is critical.
Moving at the Speed
of Crisis
At Genentech, and our parent company
Roche, we’ve launched trials to study one
of our medicines in COVID-19 pneumonia
in a maer of weeks rather than the more
typical months, expanded production
capacity from hundreds of thousands to
millions of doses to ensure sucient sup-
ply, and developed two diagnostic tests,
ramping up manufacturing exponentially
in record time to help meet unprecedented
demand. These actions have been made
possible by the exceptional eorts of
government and regulatory institutions,
as well as partnerships across the health
care ecosystem with distributors, insurers,
patient organizations and providers.
Alexander Hardy, CEO Genentech. Guest post on the
PhRMA website. “What will we learn from COVID-?”
26 Response and Resilience
Lesson 1b.1: Adoption of virtual and contactless
solutions sustains trials.
Several emerging approaches to patient interac-
tions and supply of drugs for trials—approaches
that remove the need to physically visit a provid-
er—have been expanded during the pandemic.
As alternatives to participants visiting a clinical site
to receive their trial drugs, direct home shipment
has been deployed and virtual/telemedicine
consultations operationalized between clinical
staff and participants. Trial sponsors and managers
have found it increasingly feasible to transition to
decentralized trials with remote monitoring and
source document verification (SDV) to ensure that
participants may continue to participate. Video con-
sultations, access to telemedicine platforms, home/
wearable monitoring devices, eConsent forms, etc.,
have come together to enable a “physically contact-
less” approach.
The shi that has occurred has been quite dra-
matic, with McKinsey noting that “among major
pharma companies,  percent are already using
 McKinsey & Company. “Winning against COVID-: The implications for biopharma.” hps://www.mckinsey.com/industries/
pharmaceuticals-and-medical-products/our-insights/winning-against-Covid--the-implications-for-biopharma.
telemedicine for trial visits in response to the
COVID- crisis and more seem likely to follow.”
It should be anticipated that, should this approach
be found to have been effective and safe, policies
and regulations will be permanently modified to
allow this approach to be used long term.
Lesson 1b.2: Proactive and responsive
regulatory guidance is highly important.
The penalties for stepping outside of national regu-
latory requirements can be severe for life sciences
companies, and firms are understandably cautious
in making modifications to trials performance
norms. The unprecedented global challenges posed
by COVID- have, however, necessitated change
in order to keep trials running and rapidly advance
new trials to address the disease.
The back-and-forth between companies seeking
guidance, and regulatory agencies providing it, has
been accomplished quite rapidly. A good example
of this is the U.S. Coronavirus Treatment Acceler-
ation Program (CTAP), at the FDA, representing a
proactive response by the FDA to advance clinical
The U.S. Coronavirus Treatment Acceleration Program (CTAP).
A novel process to rapidly advance innovations and trials for
COVID-19.
The process is designed to bring the strongest proposals to the front of the line:
As soon as received, proposals for new drug and biologic therapy development and
evaluation are triaged, directed to the right FDA team members, and generally
responded to within one day.
Applicants are provided with rapid interactive input on most development plans.
Interactions are prioritized based on a product’s scientific merits, stage of development,
and identification as a possible priority product in consensus documents.
Ultra-rapid protocol review is performed. Some have been performed
within  hours of submission.
Close coordination is maintained with applicants and other regulatory agencies
to expedite quality assessments for COVID- products.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 27
trials for COVID- as fast as possible while sus-
taining efficacy and safety protocols. Under CTAP,
FDA medical and regulatory staff were repurposed
to specific COVID- review teams, and emergency
streamlined processes and operations enabled for
responding to developers’ and scientists’ questions
and requests. CTAP also enables clinicians and
researchers to submit emergency requests for
the use of investigational products for patients
with COVID- infections. CTAP’s implementation
process (see sidebar) has been well received.
What is clear is that the trials world is shiing, and
that companies will need to closely monitor regula-
tory decisions and be proactive in seeking guidance
from relevant regulatory agencies. As nations move
into the post-pandemic recovery phase, companies
with active trials during the pandemic will need to
seek advice regarding missing data procedures and
the ongoing use of telemedicine, remote monitoring
technologies, home nurse visits, and contactless
drug delivery systems. McKinsey notes the following:
The gradual and staggered path to recovery
could lead to a greater emphasis on creative
ways to generate evidence. For example,
supplementing controlled data with real-world
evidence, using master protocols or adding
arms to in-flight trials are all top of mind for
R&D leaders and likely to figure prominently
in discussions with regulators and in health-
technology assessments. None of these
approaches are unheard of but could gain
further momentum in the next normal.14
Lesson 1b.3: Speed in trials for vaccine and
therapeutic advancement is critical.
As noted earlier in this report, vaccine development
is a complex science; and it is typical for the research,
development, and clinical trials process to require
upward of a decade to complete. For diseases that
are endemic and long-standing, for example, malaria
or HIV-AIDS, the ever-present nature of the disease
 McKinsey & Company. “The Next Normal.” hps://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/
Covid--implications-for-life-sciences-r-and-d-recovery-and-the-next-normal.
 As of the date of writing this report section (June , ).
provides long-term access to impacted or potentially
exposed patient populations to enable research and
trials activity. In the case of COVID-, however, the
rapid transmissibility and spread of the disease, its
incubation period, and other factors place an extraor-
dinary urgency in advancing a vaccine (while ensuring
safety and efficacy). In Europe, where COVID-
appears to be currently quite well contained, it is a
challenge for vaccine developers to gain sufficient ex-
posure of vaccine trial participants to the coronavirus
in order to evaluate immune response and efficacy.
It is generally considered unethical to deliberately
expose a vaccine trial participant to the virus;
instead, protocols require a significant population to
be tested and impacted by natural exposure to the
virus in daily activity—thus, if the development takes
too long, and mitigation efforts are successful, the
prevalence of the disease becomes too low for study.
The likelihood of a resurgence of COVID- in the
fall and winter of / will provide a further
vaccine trial window, but the obvious preference is
for a vaccine to have been developed and distrib-
uted to prevent this resurgence. It is a paradox
not easily resolved, and a similar situation exists
for the development of novel therapeutics for the
coronavirus also.
The key lesson to be learned from this is that
well-funded fundamental research programs in
vaccine platform technologies must be encour-
aged, especially in regard to the development of
flexible and fast development platforms, to ensure
that when the next novel virus presents, candidate
vaccines can be produced and advanced into trials
as rapidly as possible.
It should be noted that moving fast in product
development and the conduct of clinical research
carries significant risk that will likely require
government intervention to address. It presents is-
sues in regard to legal liability, high risk of product
development failures and lost capital resources,
28 Response and Resilience
and potential for process errors to occur that may
have negative regulatory implications for product
developers. These issues are discussed further in
the Policies and Regulations section of this report.
Framework Element 1c: Production
By necessity, diagnostic test kits, vaccines, and
biopharmaceuticals are manufactured under
especially high standards, with strict requirements
and rigorous approvals to ensure the safety, quality,
and reliability of production to protect patients and
deliver the intended therapeutic benefits.
To a significant degree, the manufacturing of bio-
pharmaceuticals is an international undertaking.
Companies specialize in the production of active
pharmaceutical ingredients (APIs), excipients,
organic and inorganic fine chemicals, encapsula-
tion materials, etc., that are raw materials for the
production process undertaken by biopharma orig-
inal equipment manufacturers (OEMs) or contract
manufacturers; and some of these raw material
producers are clustered in a few nations around
the globe. China is one of the largest suppliers of
APIs into the global pharmaceutical manufacturing
network (although in the U.S. the majority of APIs
are produced domestically), and much of the
production of generic drugs and vaccines
for global use occurs in India.
The worldwide COVID- pandemic raised ques-
tions about the ability of these national clusters to
meet existing and new demand at OEM and con-
tract generic pharma production sites in Europe,
North America, Asia, and other markets, due largely
to restrictions on export from these countries.
The pandemic has highlighted the importance of
sustaining a resilient supply-chain framework that
may have implications for biopharmaceutical and
vaccine production in the future.
 Chris Sloan, Massey Whorley, Mitchell Cole, and Alessandra Fix. “Majority of API in US-consumed Medicines is Produced in the US.”
Avalere. July ,. hps://avalere.com/insights/majority-of-api-in-us-consumed-medicines-is-produced-in-the-us
 Abhishek Dadhich. “The COVID- pandemic and the Indian pharmaceutical industry.” European Pharmaceutical Review. April , .
hps://www.europeanpharmaceuticalreview.com/article//the-covid--pandemic-and-the-indian-pharmaceutical-industry/
 Ivan Gandayuwana. The Science Advisory Board. “COVID-: A double-edged sword for the pharma industry.” hps://www.scienceboard.
net/index.aspx?sec=prtf&sub=def&pag=dis&itemId=&printpage=true&fsec=sup&fsub=bioproc).
There is talk of new supply-chain networks needing
to be designed that would balance total cost
versus supply-chain interruption risk. But care
needs to be taken not to overreact, since it appears
that biopharmaceutical supply chains have proven
quite resilient. If the balance swings more toward
risk mitigation, then there may be shis in the
geography of the industry.
Some actions are already being observed in the
market. The government of India, for example, has
allocated an equivalent of US. billion for its
pharmaceutical industry to adopt alternatives to
Chinese-sourced APIs. It is imperative, however,
that any potential changes in the supply chain be
carefully assessed in terms of their impact on mar-
kets, costs, and resiliency. The “commoditization”
of products has led to global supply chains that
have been structured to promote desirable cost
efficiencies and standardized quality and care must
Resiliency may be enhanced through the
development and adoption of harmonized
international standards for diagnostics,
biopharmaceutical, and vaccine manu-
facturing. Harmonized standards need to
be pursued both for existing production
platforms, and for emerging continuous
manufacturing, single-use systems, and
modular manufacturing facilities.
The International Council for Harmonisation
of Technical Requirements for Pharmaceu-
ticals for Human Use is developing stan-
dards and aempting to incorporate new
manufacturing techniques into the existing
regulatory structures. Reaching agreement
and achieving universal international
adoption of standards should be a priority.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 29
be taken to not offset these characteristics. Rules
against trade barriers and agreements allowing fair
competition between medical products regardless
of origin also play a critical role in maintaining
resilient supply chains.
The other factor evident in discussions related
to COVID- relates to manufacturing processes
themselves. Biopharmaceutical products are
produced under two quite different production re-
gimes—with small-molecule drugs being produced
using chemical processes, and biologics produced
using biological processes. In both cases, manu-
facturing operations are typically built to produce
an individual product on a large or relatively large
scale, and the production processes themselves
are not very amenable to changes in process
technologies or production scale. It may take many
months to design, build, and commission a new
biopharmaceutical facility; and large-scale pro-
duction equipment comes from a select few global
manufacturers. COVID- appears to be accelerat-
ing interest in alternative production systems, such
as the use of continuous manufacturing systems
and smaller batch processing and disposable
systems in biologics manufacturing. Increased
levels of automation may also be considered given
challenges with the workforce and social-distanc-
ing and PPE requirements.
Summary of Lessons Learned for Production:
Big and small players will be contributing
solutions and collaborating.
Supply-chain resiliency must be built.
Advanced production methods need
to be accelerated.
Regulatory oversight of GMP production
can be accomplished remotely.
Lesson 1c.1: Big and small players will be contrib-
uting solutions and collaborating.
Products moving through trials for application to
COVID- are coming from large multinational bio-
pharmaceutical firms such as Pfizer, GSK, Merck,
Regeneron, and Sanofi, but are also being generat-
ed by smaller up-and-coming and midsize ventures
such as Moderna, CanSino Biologics, and Translate
Bio. A key takeaway is that innovation may emanate
across the company size spectrum. However,
when it comes to manufacturing, it is evident that
the robust experience base of large multinational
biopharmaceutical companies, and the expertise in
major biopharma contract manufacturing firms, is
likely to be leveraged by smaller innovators who do
not have manufacturing expertise, or only limited
manufacturing resources themselves. Collabora-
tive partnerships focused around manufacturing
and bringing a product quickly to market are
evident in collaborations between:
Pfizer and Gilead, with Pfizer providing
contract manufacturing services
for Gilead’s Remdesivir.
Moderna working with Lonza for
manufacturing its mRNA vaccine
Eli Lilly and Co. partnering with
Vancouver-based biotech AbCellera
on a COVID- antibody treatment
BioNTech partnering with Pfizer (PFE)
Ridgeback Bio working with Merck on a
potential COVID- antiviral
Vir Biotechnology teaming with Biogen
Novavax and Vaxart both collaborating with
Emergent BioSolutions for manufacturing.
As companies have come together to facilitate
rapid advancement of products, they have had to
work rapidly on developing agreements on patents,
trade secrets, proprietary manufacturing systems,
etc., while navigating potential challenges such as
anti-trust regulations.
30 Response and Resilience
Lesson 1c.2: Supply-chain
resiliency must be built.
It is likely that intense aention will now be paid to
ensuring that assets and supply chains are orga-
nized for risk mitigation and resiliency. Achieving
this goal does not, however, automatically mean
geographic redistribution of the production of
manufacturing inputs or OEM production plants.
Elements of resiliency can be built through requiring
more information transparency up and down the
supply chain, so that producers know in real-time
the situation of their suppliers, and also those who
supply their suppliers. Digital tracking tools for
inventory management across the supply chain may
be leveraged to accomplish this. Resiliency can also
be enhanced in life sciences production systems
through increasing inventory levels of critical
supplies and medicines. While cost efficiencies have
been built around efficient delivery of supplies in
manufacturing, the post-pandemic production envi-
ronment may require more “just-in-case” stockpiling
of critical inputs and resources to enhance resilien-
cy. Building relationships with multiple suppliers of
the same inputs, particularly suppliers not located in
the same region as each other, may also be pursued.
The pandemic interrupted some of the modes of
transportation for products. One of the lessons
learned is that shipment by dedicated air trans-
portation service providers (such as FedEx) were
comparatively less impacted than shippers that
relied more on transportation in the cargo holds
of passenger air carriers. In terms of international
sea–based shipping (which carries  percent of
global trade), interruptions were created by national
measures and local restrictions in response to the
pandemic. Challenges were further exacerbated by
ports experiencing reduced workforce capacity and
also by antiquated administrative processes, pro-
cedures, and systems (many of which are still paper
based rather than digital). Logistics challenges not
only impacted raw materials and finished product
shipments, but also hampered the distribution of
important R&D materials being moved between
international research locations.
Another key lesson learned for all across the supply
chain has been the critical importance of having
on-hand, and sustaining, a significant inventory of
PPE so that critical workers could be maintained on
the job and protected from disease transmission.
While some governments have expressed a goal of localizing biomanufacturing supply
chains (especially for APIs whose lack might inhibit timely or full production of a vaccine or
therapeutic), the reality is that even new manufacturing efforts have required international
cooperation and interchange to work. Examples are as follows:
Brazil—The Instituto Butantan, long a leader in antivenom serums and other aspects of
tropical medicine, is collaborating with China’s Sinovac Biotech on producing quantities of
the company’s vaccine candidate for clinical trials in Brazil, and with the Bill & Melinda Gates
Foundation of the United States.
Germany—Merck KGaA has become the manufacturing partner to the UK vaccine candidate
being developed by the University of Oxford and the Jenner Institute, reducing the process
development phase from  months to  months.
Singapore—The Prime Minister has commied to building up biomanufacturing capacity
to serve vaccine developers, not only to meet domestic needs which are relatively small but
also to serve as a base for export. This will inevitably involve global connections. For example,
Switzerland-based Lonza–the company selected as manufacturing partner by U.S.-based
Moderna–has the option to use its existing Singapore plant.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 31
Lesson 1c.3: Advanced production
methods need to be accelerated.
Because of the opportunities related to an
emerging personalized medicine market, multiple
biopharmaceutical companies have been studying
alternative and flexible production technologies.
This has been an ongoing trend for several years,
but COVID- and its need for rapidly installed,
scalable, and distributed production systems has
increased the potential urgency for development
and deployment of alternative production systems.
Some of the alternative production systems
being considered also lend themselves to smaller
production operations, providing a potential fit
with a distributed local production ecosystem that
some are raising as an option to build post-pan-
demic ecosystem resiliency. The technologies
and production systems anticipated to see more
widespread use include the following:
Wider adoption of continuous manufacturing
technologies, which requires less space
and less upfront investment and generates
flexibility. According to the Director of the
FDAs Center for Drug Evaluation and Research
(CDER), the FDA has approved “several continu-
ous manufacturing applications.”
More single-use systems (SUS) process
lines and facilities (as opposed to traditional
large stainless-steel systems). Respondents
to BioPlan’s Survey of Biopharmaceutical
Manufacturing expect that “pandemic-related
new facilities will largely engage SUS due to its
flexibility which will be needed, combined with
SUS speed and much lower capital investment.
Long-term, this flexibility will imprint on the
responses to future pandemics and health
crises. Due to the speed, cost and flexibility
 McKinsey & Company. “The Next Normal.” hps://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/
pharma-operations-the-path-to-recovery-and-the-next-normal.
 National Academies of Sciences, Engineering, and Medicine . Innovations in Pharmaceutical Manufacturing: Proceedings of a
Workshop—in Brief. Washington, DC: The National Academies Press. hps://doi.org/./.
 Ronald A. Rader and Eric S. Langer. “Covid-: Impact on Bioprocessing and Outsourcing.” Contract Pharma. May , .
 Ibid.
 National Academies of Sciences, Engineering, and Medicine . Innovations in Pharmaceutical Manufacturing: Proceedings of a
Workshop—in Brief. Washington, DC: The National Academies Press. hps://doi.org/./.
benefits of SUS, most pandemic-related new
facilities and process lines are expected to be
SUS-based.”
Increased adoption of modular facilities,
which facilitate rapid development and
cloning of formats in multiple locations.
It should be noted that the anticipated significant
increase in the use of SUS systems will mean that
aention will need to be paid to the supply-chain
resiliency of the companies that make these
systems and supply the materials used in them
(such as polymer membranes and affinity media).
Daniel Blackwood at Pfizer notes the following:
Continuous manufacturing initiates a cascade
of transformational advances in technology. It
allows process intensification, which enables
miniaturization of systems that have small
footprints and reduced energy consumption.
Miniaturization makes modularity and
ultimately portability possible. … Focusing on
portable, continuous, miniature, and modular
technology will allow Pfizer to transform how
it develops, manufactures, and distributes its
drug products. Such technology might make
it possible for pharmaceutical companies to
share space and possibly some operations
if precompetitive agreements are in place.23
Lesson 1c.4: Regulatory oversight of GMP
production can be accomplished remotely.
Restrictions on travel have impacted the usual
regulatory practices of manufacturing plant inspec-
tions and have complicated access to experts and
contractors for manufacturers seeking to change
or improve their processes. It is anticipated that
32 Response and Resilience
experience during the pandemic will accelerate
moves for more remote auditing and inspections
using remote video and virtual reality platforms.
The net effect may be more efficiency in the
system, with regulators, consultants, contractors,
etc., being able to limit time spent in travel and
serve more customers with the time gained.
International auditing guidelines allow for remote
auditing; regulatory authorities are issuing guid-
ance to beer facilitate them during the pandemic;
and experts are starting to direct and monitor
remediation efforts remotely, using video, virtual
reality, and other advanced tools.
Framework Element 1d: Distribution
The movement of raw materials and inputs within
the supply chain, and the distribution of finished
products, have been challenged by the COVID-
pandemic. Observable issues have included the
following:
Government-based redirection or interception
of materials and products, such as PPE, for
which there were previous contracts.
Large-scale purchases of existing medicines
thought to be potentially effective against
COVID- causing shortages for patients
needing those medicines for their traditional
indications. Most notable in the case of
hydroxychloroquine.
Shutdown of ports and slowdown of port
operations related to staffing challenges.
Major cutbacks in ability to transport prod-
ucts in the cargo holds of commercial passen-
ger flights due to reduction in flights.
Closures of land borders and increased delays
and inspections at borders.
Some distribution challenges were experienced
across manufacturing industries in general (not
specific to life sciences) as the pandemic took hold.
 See discussion at: hps://www.contractpharma.com/contents/view_experts-opinion/--/Covid-s-long-term-impact-on-drug-
development-the-new-pragmatism/.
 Institute for Supply Management. “Covid- Survey: Impacts on Global Supply Chains.” March , . hps://www.ismworld.org/
supply-management-news-and-reports/news-publications/releases//covid--impacts-on-global-supply-chains/.
 Ibid.
Between February  and March , the Institute
for Supply Management received  responses
to a survey of U.S. manufacturing ( percent) and
nonmanufacturing ( percent) organizations.
Seventy-five percent of respondents reported
supply-chain disruption in some capacity due to
coronavirus-related transportation restrictions;
and by the end of March, when resurveyed, this
increased to  percent. Reduced Chinese man-
ufacturing capacity was felt first, with Chinese
manufacturing operating at only  percent of
capacity by late February. Other Asian nations,
European and North American manufacturing
disruptions quickly followed.
Summary of Lessons Learned for Distribution:
Multiple sources of critical supplies are
beneficial.
Well-planned supply chains and distribution
agreements may be interrupted.
Digital supply-chain monitoring is desirable
and feasible.
Lesson 1d.1: Multiple sources of critical
supplies are beneficial.
While multiple governments are discussing
potential regulations that would require critical
biomedical products to be manufactured in their
respective countries, the challenge is that a
domestic outbreak can still be disruptive. Sustain-
ing participation in international supply networks
makes sense from a “hedging against risk” stand-
point, and indeed the Institute for Supply Manage-
ment reports that organizations that diversified
their supplier base aer experiencing tariff impacts
could be beer positioned to address the effects of
COVID- on their supply chains.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 33
Life sciences products are complex and special-
ized, and it would be both expensive and technical-
ly difficult to re-shore industries that have devel-
oped sophisticated supply relationships based
on national and regional core competencies and
specializations rooted in both infrastructure and
workforce know-how. Rather, the more reasonable
option being discussed is to ensure that no single
location has a monopoly on critical products.
Modern digital supply-chain tools (discussed fur-
ther below) provide an ability to manage multiple
suppliers and more complex supply chains more
efficiently, significantly improving the technical
feasibility of inputs supply diversification.
Lesson 1d.2: Well-planned supply chains and
distribution agreements may be interrupted.
The global spread of COVID- led to some ag-
gressive actions by governments. As the pandemic
spread, nations banned the international shipment
of certain medical products, meaning companies
could not honor existing contracts and orders from
their international customers. As nations scram-
bled to secure PPE for frontline healthcare person-
nel and other essential workers, some government
actions in terms of intercepting products ordered
by others reached a level whereby nations accused
each other of international piracy.
The pandemic generated a surge in demand for
medical goods, exacerbated by panic buying,
causing significant stress on supply chains. Fearing
critical shortages and under immense public
pressure, more than  jurisdictions implemented
export restrictions to keep critical products within
their borders. Though restrictions largely focused on
PPE, biopharmaceuticals and diagnostic tests were
also targeted, hindering the life sciences sector’s
ability to respond to the COVID- crisis. Export
restrictions also made it difficult for some countries,
especially those reliant on imported medical goods,
 The Washington Post, “White House asks Congress for . billion to bolster coronavirus response.” February , . hps://www.
washingtonpost.com/business////white-house-preparing-ask-congress-more-moneyfinance-coronavirus-response/).
 World Trade Organization. April , . hps://www.wto.org/english/news_e/news_e/igo_apr_e.htm.
 World Trade Organization. March , . hps://www.wto.org/english/news_e/news_e/dgra_mar_e.htm.
 Philip Stevens and Nilanjan Banik. “Abolishing Pharmaceutical and Vaccine Tariffs to Promote Access.” Geneva Network. July .
hps://geneva-network.com/article/-pharmaceutical-tariffs/.
to secure critical products. Peter Navarro, White
House director of trade and manufacturing policy,
suggested that “if we have learned anything from
the coronavirus … it is that we cannot necessarily
depend on other countries, even close allies, to sup-
ply us with needed items.” In response, the World
Trade Organization (WTO) called export restrictions
“dangerously counterproductive and G leaders
earlier stated that “emergency measures ... must be
targeted, proportionate, transparent, and tempo-
rary.”
While many restrictions have now lapsed, to avoid
future challenges, the EU and other economies
have called to remove trade barriers that needlessly
delay the distribution of medical goods and drive up
their price. Notably, these steps would include the
elimination of tariffs on certain biopharmaceuticals.
Similar proposals have been seen in other regional
forums, including the Asia-Pacific Economic
Cooperation (APEC). Although tariffs have been
declining over the last  years on biopharmaceuti-
cals (. percent in  to . percent ), many
jurisdictions continue to apply large duties and are
expanding the number of treatments covered. It is
likely that, for PPE and certain other critical prod-
ucts, two mitigation pathways will be pursued to
prevent reoccurrence of this challenge in the future:
Nations, state governments, and large health
systems will seek to build significant emer-
gency preparedness stockpiles—stockpiles
far larger than previously sustained. In the
near- to mid-term, this will be a challenge as
many of the products are still in short supply
as the pandemic expands and a second wave
is predicted for late in the year.
Nations will collaborate with PPE man-
ufacturers, and manufacturers of other
34 Response and Resilience
critical products, to build new manufacturing
capacity dedicated to domestic supply.
It is also likely that companies will collaborate
more in ensuring that supplies of critical products
are available. During the pandemic, for example,
the European Medicines Agency notes that
pharmaceutical companies, which have been
competitors, came together to secure critical,
high-demand medicines for hospital intensive-care
units by seing up the industry-single-point-of-con-
tact (i-SPOC ) system, which enables close moni-
toring of possible disruptions in supply. Because
collaborations have been effective in addressing
pandemic needs, the changes in competition laws
(or flexibility in their application) used to facilitate
such collaborations should be evaluated as effec-
tive crisis response mechanisms for future use.
Lesson 1d.3: Digital supply-chain
monitoring is desirable and feasible.
Digitally enabled, resilient distribution and supply
chains will expand in the biopharmaceuticals and
other medical product spaces as a result of the
pandemic. Advanced supply-chain analytics and
artificial intelligence (AI) systems, implementation
of Internet of Things sensing and tracking systems,
automated warehouses, and other technologies
are already being deployed by many major biophar-
maceutical and medical products manufacturers
and distributors; and this trend will likely be accel-
erated post-pandemic as companies strive to build
more resilient and transparent distribution and
supply operations. Improved transparency across
the supply chain will allow predictive analytics
systems to identify pending supply bolenecks and
adjust inventories and order paerns to suit.
 European Medicines Agency. “Update on EU actions to support availability of medicines during Covid- pandemic.” April , . ema.
europa.eu.
Telemedicine models for clinical care, combined
with home monitoring and wearable systems, will
provide mechanisms that further facilitate effi-
cient distribution of digitally enabled biomedical
products to patients.
Amazon shows what can be accomplished
through the use of digital supply-chain
management and distribution tools.
Delivering over . billion packages a year,
Amazon carries over  million products
and deals with thousands of individual
suppliers. Amazon operates a digitally
managed supply ecosystem that is able to
be predictive, resilient, and transparent to
their customers (who can track orders and
make changes even when products are
already shipped). Using AI and advanced
analytics and robotics automation in
warehouses and fulfillment centers,
Amazon is on the leading edge of supply-
chain technologies, and has a highly
scalable and resilient business model—
one that could expand, not contract, in
the pandemic. Amazon’s success is well
recognized, and other industries are
seeking to build similar capabilities.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 35
Framework Element 2:
Talent (Human Capital)
The biomedical products ecosystem is powered by
people. From the front-end of scientific discovery
through to the back-end of highly skilled physicians
and pharmacists providing products to patients,
the biomedical sector is heavily dependent on
highly skilled human capital. Highly skilled and
intensively trained staff perform R&D, supervise
clinical trials, manage the commercialization of
innovations, operate and supervise manufacturing
operations, sustain quality control and reporting
to regulators, manage sophisticated supply chains
(oen requiring cold storage and distribution
of perishable and time-sensitive products), and
deploy the products in clinical seings.
It takes time to build the human capital needed to
power a life sciences ecosystem. The amount of
education and specific skills training required for
these jobs is such that life sciences ecosystems
cannot be rapidly scaled from scratch, and edu-
cators and workforce development professionals
need to be proactive in building workforce supply
systems that are predictive of need and responsive
to input from life sciences companies.
The life sciences ecosystem evolves, and the
education and skills of the workforce have to
evolve with it. The rise of biotechnology, for
example, required a new set of R&D and, especially,
production skills that differed significantly from
traditional chemistry-based small molecule drugs.
Advancements in genomics and related fields are
advancing opportunities for personalized medicine
and custom compounding, and manufacturing
is expanding in alternative production platforms
that will require education in new technologies. In
addition, the ongoing convergence of advanced
analytics and digitalization with life sciences is
placing a premium on highly educated personnel
skilled in new (to life science) areas such as
machine learning and AI, informatics, advanced
statistical analysis, soware engineering, and
robotics process automation. Competition for
much of this talent is very high; and biomedical
industries have to compete with other sectors for
the talent, particularly in digital, computational,
and analytics fields.
The pandemic has changed the way that many
people conduct their work. Remote work, enabled
by efficient telecommunications and digital
systems, has proven itself to be quite feasible and
productive for many jobs. It seems likely that a
significant component of work will remain remote
and distributed for companies, and this may
require changes in the way work is managed and
personnel are trained.
Summary of Lessons Learned for Talent:
Scaling a life sciences workforce requires
foresight and a long time horizon.
Protection of workforce and contingency
planning should be emphasized.
Advancement of life sciences, digital,
and advanced analytics convergence
skills is required.
Lesson 2.1: Scaling a life sciences workforce
requires foresight and a long time horizon.
The single largest challenge for scalability in
life sciences ecosystems, especially scalability
during pandemic conditions, is the workforce. As
noted above, a large proportion of life sciences
ecosystem workers are highly-educated and
technically-skilled workers—workers with capabil-
ities that took considerable time to acquire. Thus,
ramping-up a supply of workers for the sector is
not something than can be accomplished quickly.
This especially holds true during a pandemic when
movement of people, especially internationally,
becomes challenging.
One of the best practices observed in workforce
development for the sector is investment in
specialized training facilities for bioprocessing
that duplicate the facilities used in industry (and
36 Response and Resilience
typically engage industry in their design and curric-
ulum). An example of this is in North Carolina in the
United States where the Biomanufacturing Training
and Education Center (BTEC) has been developed
on the campus of North Carolina State University.
BTEC is a cross-disciplinary instructional center
providing education and training for skilled profes-
sionals needed in the biomanufacturing industry.
It is equipped with industry standard equipment,
helping to build industry-transferable skills in those
trained at the facility. One of the benefits of BTEC is
that potential workers can be trained in the facility
in parallel with a new biomanufacturing facility
being constructed in North Carolina, thereby
ensuring that a workforce is ready to go once a
new production facility is commissioned. Another
example of such a training facility is the Jefferson
Institute for Bioprocessing (JIB) at Thomas
Jefferson University in Pennsylvania. JIB conducts
education and training for biopharmaceutical
processing, combining commercial single-use
processing equipment with the internationally
recognized National Institute for Bioprocessing
Research and Training curriculum.
While these, and other, specialized training centers
represent a solution for workforce scaling in normal
times, they are less viable as an option during a
pandemic. BTEC, for example, has not been opera-
tional during the pandemic and its on-site training
programs were suspended. The solution in the
future will likely require implementation of remote
education and training resources, supported by
advancements in education technology (EdTech).
Advancements in virtual and augmented reality,
digital models of equipment, and gamification of
learning can enable students and trainees to interact
with their training content in simulated environ-
ments when aendance at physical training facilities
is limited by social-distancing requirements.
Training in bioprocessing, and new technologies
in bioprocessing, will be particularly important
for pandemic preparedness. Industry responses
 Ronald A. Rader and Eric S. Langer. “Covid-: Impact on Bioprocessing and Outsourcing.” Contract Pharma. May , .
to a survey by BioPlan indicate that “R&D and
manufacturing will compete for limited staff
with the cellular and gene therapies sectors, as
new facilities come online. Expect bioprocessing
expertise and even technicians to be increasingly
in short supply, with recruiting more difficult and
salaries increasing.”
Lesson 2.2: Protection of workforce and contin-
gency planning should be emphasized.
While many of us have had the ability to work from
home during the pandemic, countless “essential
workers” have continued to go into their places of
work. While the frontline clinical healthcare work-
force has been rightly recognized and celebrated
for their selfless commitment to working during
the crisis, and the bravery they have shown in the
face of potential virus exposure, many other critical
infrastructure workers who have remained on the
job may not be as well recognized. Among these
pandemic heroes are thousands of workers within
the life sciences ecosystems—workers who have
continued to perform R&D and new product innova-
tion for the pandemic response; clinical personnel
who have continued to operate critically important
trials; pharmaceutical and biologics manufacturing
workers keeping the production of medicines,
vaccines, and diagnostics flowing; and distribution
and transportation workers ensuring that critical
biomedical products get to where they are needed.
One of the key lessons from the pandemic is the
importance of having in place plans to provide
for the protection of these workers and an ability
for sustaining access to critically important PPE
to protect workers on the job. Organizations and
companies have been creative in shi development
and work scheduling to promote social distancing
on the job and have called on their information
technology departments for supporting remote
working for personnel with positions that could be
handled remotely. Given the scarce and critically
important skills of life sciences workers, and the
importance of the products they produce, a high
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 37
priority should be placed on securing protective
equipment supplies for their health and safety
during infectious disease events.
Lesson 2.3: Advancement of life sciences,
digital, and advanced analytics convergence
skills is required.
Longer term, it is likely that the challenges posed
by the scalability of workforce (as well as the issues
of protecting workers during an infectious disease
pandemic) will be a driver of interest in automating
manufacturing and warehousing systems. Futurists
envision “lights out” automated facilities able
to operate /, with maintenance performed
using robotics, and human monitoring of systems
performed remotely. At a minimum, it is likely that
the trend toward digitalization of manufacturing
processes and the monitoring of these processes
will continue apace, and that work will continue to
shi from requiring manual skills to more techni-
cal/digital skills. McKinsey notes as follows:
As the adoption of digital and analytics tools
and automation increases, pharmaceutical-
operations organizations may have a greater
need for talent that can program, operate, and
interpret data from these new technologies.
This will require significant up-skilling and
capability-building efforts alongside ongoing
strategic planning.33
Jun Huang, director of the Process Monitoring,
Automation, and Control Group at Pfizer Global
Technology & Engineering, recently noted that
Pfizer is “recruiting data architects who can build
data infrastructure or central repositories, data
engineers who can transform or aggregate data
into a suitable format, and data scientists who can
build models and analyze data.”
 McKinsey & Company. “Pharma operations: the path to recovery and the next normal.” hps://www.mckinsey.com/industries/
pharmaceuticals-and-medical-products/our-insights/pharma-operations-the-path-to-recovery-and-the-next-normal.
 National Academies of Sciences, Engineering, and Medicine . Innovations in Pharmaceutical Manufacturing: Proceedings of a
Workshop—in Brief. Washington, DC: The National Academies Press. hps://doi.org/./.
 Simon Tripp, Ryan Helwig, and Joseph Simkins. “Artificial Intelligence and Advanced Analytics in Indiana: An Initial Discussion of
Industry Needs and University Capabilities.” TEConomy Partners, LLC. January .
For those concerned with the future performance
of their life sciences economic clusters, there
should be lile doubt that core competencies in
advanced data analytics, including AI, will have
a critical impact on ecosystem performance.
Core competencies in advanced data analytics
represent an increasingly essential driver of
regional competitiveness and will only become
more so in the future. Because it takes time to
impart education and skills in analytics and data
science, national and regional leaders need to pay
special aention to digital literacy. A recent report
for BioCrossroads in Indiana in the United States
notes as follows:
Mathematics and English have long been
foundational in our education – rightly seen
as essential cross-cuing core competencies
that provide the ability to comprehend content
in other disciplines and successfully navigate
the worlds of work and society. The changing
landscape may also require adding Digital
literacy to the existing foundation. Digital
technology and data pervade modern economic
and societal activity and are at the core of most
expanding job markets. A key sub-component of
this skill set involves Data Analytics – providing
capacity to understand, process, manage and
use sets of digital information.35
It is also notable that the pace of digitization means
that pure reliance on public education systems to
build a responsive workforce may be too slow. The
report for BioCrossroads notes as follows:
The pace of digitally enabled change and the
breadth of advanced analytics adoption across
industries will be such that skills required cannot
be accommodated solely by new entrants to
the workforce (those currently coming through
the K-12 and traditional higher education
38 Response and Resilience
pathways). It will also be necessary to train and
re-skill many in the incumbent workforce, and
indeed, the rate of technological change will
likely require personnel to re-skill or upgrade
skills with increasing regularity, multiple times
over their career-span. This requirement will
place a premium on having the educational
fundamentals that facilitate a life-long learning
mindset and access to multiple modalities of
affordable and timely education delivery.36
Karen Balss at Janssen Pharmaceuticals echoes
this in comments to the National Academies,
emphasizing “the importance of taking advantage
of internal talents and providing training oppor-
tunities for current staff rather than searching for
talents outside.”
Framework Element 3:
Capital
Life sciences ecosystems are funded by a diversity
of funding sources, and the makeup of these
funding sources varies across the value chain.
Government (especially) and philanthropic funding
dominate at the very earliest precompetitive stages
of research, while private-sector funding takes the
lead in advancing drug discovery and development
and advancing potential therapeutics, vaccines,
etc., into trials and commercialization. If the
commercialization pathway takes the form of new
company development to advance a product or
technology, private risk-capital markets (and to
a lesser degree government small and emerging
business supports) come into play. If the com-
mercialization pathway is via an existing biophar-
maceutical or medical product corporation, then
companies have access to funding from equity
markets, loan sources, or internal funding from
ongoing operations.
 Ibid
 National Academies of Sciences, Engineering, and Medicine . “Innovations in Pharmaceutical Manufacturing: Proceedings of a
Workshop— in Brief.” Washington, DC: The National Academies Press. hps://doi.org/./.
While the above pathways for funding generally
work well in supporting a highly active life sciences
commercialization market, the COVID- pan-
demic has highlighted some weaknesses when it
comes to funding and capital access in infectious
diseases. Developed nations have tended to be
more concerned with chronic illness in the re-
search they fund, largely because chronic disease
presents the greatest burden to the populations
of developed nations and the health systems that
serve them (whether public or private). COVID-
has highlighted vulnerabilities in an R&D system
heavily focused on chronic disease and has greatly
increased awareness of the health and economic
threat that emergent and novel infectious diseases
still pose for both developed and developing
nations when they are caught unprepared.
Summary of Lessons Learned for Capital:
Research grants and development support
set a key foundation for rapid innovation.
Public co-investment can be a significant
catalyst.
Inter-industry partnerships and collabora-
tions make a difference.
Public markets may infuse capital.
Venture capital (VC) and angel investor
activity prime the pump of innovation.
Lesson 3.1: Research grants and development
support set a key foundation for rapid innovation.
The earliest phases of research, especially (but not
limited to) fundamental research, are supported
by governments and, to a lesser degree, by phil-
anthropic organizations worldwide. In the United
States, funding by federal funding agencies, such
as the National Institutes of Health (NIH) and the
National Science Foundation (NSF) is a critically
important element in the funding equation. In
research in infectious diseases, the importance of
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 39
Examples of Actions by National R&D Funding Organizations
In Australia, the National Health and Medical Research Council (NHMRC) issued an A
million call for proposals for COVID- R&D.
In Brazil, the National Council for Scientific and Technological Development (CNPq) mobilized a
paid call for R&D proposals resulting in support for  research projects funded by R million.
The Canadian government allocated C million for the pre-existing Vaccine and Infectious
Disease Organization–International Vaccine Centre at the University of Saskatchewan to
accelerate development of a vaccine based on plant-produced antigens. The government
also allocated C. million to the Canadian Institutes of Health Research to support
rapid development grants for COVID- solutions.
The Chinese government supported  emergency R&D programs. Support to businesses,
universities, and research institutes was directed to supporting work in five core areas:
clinical treatment, new medicines and vaccines, testing techniques and products, viral
etiology and epidemiology, and animal model construction.
In France, the ANR (National Agency for Research) issued a “flash” call for R&D proposals
to address COVID-. The call resulted in  submissions, with  million going to 
projects, supplemented by further funding from the private nonprofit Foundation for
Medical Research for a total of  million.
Germany advanced multiple funding streams to support basic, clinical, and applied
COVID- research. These included:  million to the Coalition for Epidemic
Preparedness Innovations (CEPI) and . million to the WHO Solidarity Trial of alternative
therapeutics;  million to strengthen and accelerate vaccine development;  million
for developing therapeutics and improving understanding of the virus; and  million for
establishment of a new research network to pool the research strengths of German medical
schools, and establish a central infrastructure including a patient database to identify and
reinforce best practices.
Japan allocated an unspecified amount of R&D funds under its COVID- supplemental budget
of  trillion (. trillion). Funds are to be directed to R&D for therapeutic medicines and
vaccines and an increase of production and stockpiling of  million doses of Avigan.
A COVID- Africa Rapid Grant Fund of . million has been established with 
participating African countries. South Africa’s National Research Foundation is a major
funding supporter.
The government of Sweden allocated approximately  million krona to the Swedish
Research Council to expand initiatives in virus and pandemic research. The government
also provided recipients of existing grants an option to repurpose their supported work to
address COVID- .
UK Research and Innovation, together with the National Institute for Health Research, and
the Medical Authority, issued a joint call for R&D proposals for COVID-. Fourteen million
pounds was allocated to  accelerated research projects. Innovate UK also stood up a
. billion package for innovative commercialization projects for COVID- by UK firms.
40 Response and Resilience
government and philanthropic funding has been
particularly important, whereas major industry
research activity has been more focused on the
large-scale challenges associated with chronic
diseases. Writing in Contract Pharma, Paul Bridges
and Sheela Hegde note the following:
For many years now, funding for R&D in
infectious disease treatments or vaccines
has come mainly from government entities,
such as the U.S. National Institute of Allergy
and Infectious Diseases, and philanthropic
organizations, including the Bill & Melinda
Gates Foundation. The biopharma industry
has invested its development dollars in other
areas, and infectious disease programs
currently represent less than 2 percent of the
overall development pipeline.38
It is likely that the COVID- pandemic will prove
to be a wake-up call for research funders and
will result in governments allocating a greater
portion of their life sciences research funds toward
addressing infectious diseases. Industry has,
for logical business reasons, primarily focused
on chronic diseases. In infectious diseases,
products have generally not been reimbursed at
levels conducive to intensive innovation. Generic
antibiotics dominate, and vaccines are a more
challenging market because a vaccine is typically
administered only once or twice to a patient across
their life span.
Bridges and Hegde note the following:
To spur greater investment in infectious
disease, policymakers will need to address
both “push” and “pull” incentives. While funding
grants (push) and regulatory incentives can
help companies de-risk the early stages of
development, they do not address the low
 Paul Bridges and Sheela Hegde. “COVID-’s Long-Term Impact on Drug Development: The New Pragmatism.” Contract Pharma.
May , . hps://www.contractpharma.com/contents/view_experts-opinion/--/covid-s-long-term-impact-on-drug-
development-the-new-pragmatism/.
 Ibid.
return on investment… Pull incentives would
create more certain and aractive returns
for successful antibiotic development. These
could include market-entry rewards, such as
payments over multiple years to companies
aer approval or transferable vouchers that
would extend the exclusivity period on other
drugs in a company’s portfolio.39
Lesson 3.2: Public co-investment can be a
significant catalyst.
A specific trend observable in the response to
COVID- has been the quick engagement of
government in developing funding mechanisms to
boost capital flows to industry that can help more
rapidly advance relevant products in development
and de-risk industry exposure for potential devel-
opment challenges.
In the EU, for example, the European Commission
has been funding projects to develop vaccines,
treatments, and diagnostics via grants from
Horizon  and the Innovative Medicines
Initiative (IMI). Through these mechanisms, the EU
announced up to  million (US. million) in
public funding. The IMI expects pharma companies
to pitch in more money to make a total investment
of  million (US. million).
In the United States, the federal government’s
Biomedical Advanced Research and Development
Authority (BARDA) is providing substantial finan-
cial support to help companies dramatically accel-
erate the development of promising vaccines and
therapeutics against COVID-, even to the extent
of helping to support manufacturing investments
in advance of a proven product (an unprecedented,
but necessary, forward-looking step to take, given
the health and economic damage being wrought by
the coronavirus). The following are examples of the
significant funding being provided by BARDA:
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 41
. billion in support to help Moderna
develop manufacturing capacity for its
mRNA-based Covid- vaccine.
. billion in investment alongside Astra-
Zeneca for accelerating clinical testing and
advancing manufacturing for its ChAdOx
COVID- vaccine candidate.
 billion in investment with Sanofi Pasteur
and GSK to advance recombinant SARS-
CoV- Protein Antigen + AS Adjuvant-based
vaccine candidate.
As of September , , the BARDA website
reporting on its co-investment support for
advancing COVID- countermeasures lists 
investments including work to advance solutions
at universities, device companies, diagnostics
companies, biopharmaceutical firms, and vaccine
manufacturers.
 Moderna Base Award Amount ,, (April , ); Mod/Option  Amount ,, (May , ); Mod/Option  Amount
,, (July , ); Mod/Option  Amount ,,,. (August , ). Source: hps://medicalcountermeasures.
gov/app/barda/coronavirus/COVID.aspx?filter=vaccine.
 Ibid.
 Base Award Amount ,,. (April , ); and Mod/Option  Amount ,,,. (July , ). Ibid.
 Ibid.
 Olivia Goldhill. “The US is spending hundreds of millions to make experimental coronavirus vaccines.” Quartz. April , . Accessed
online at: hps://qz.com//us-invests-hundreds-of-millions-to-produce-Covid--vaccines/.
It should be noted that these government
investments represent a co-investment. Industry
itself is making large-scale at-risk investments,
and self-funding major capital undertakings in
advance of having fully proven products. This is
unprecedented in terms of the risk being taken
and the willingness of the life sciences industry
to extend itself, given the urgency of the situation
for humanity. Phyllis Arthur, vice president for
infectious diseases and diagnostic policy at
Biotechnology Innovation Organization (BIO),
notes as follows:
This is unique. Normally, companies would not
invest in their manufacturing scale-up until
they were deep into phase 2 and starting phase
3. They’d have more clarity that a product was
going to work.44
Without the luxury of time to achieve such clarity,
the industry has stepped out on a financial limb in
efforts to advance a cure.
International Funding for Scale-up and Manufacturing
In Brazil, the government issued a credit line of R million to support companies in
scaling-up products and devices. Among the results is a -minute diagnostic launched by
Hi Technologies.
The National Research Council of Canada agreed to upgrade its Human Health Therapeutics
facility in Montreal to facilitate manufacturing of a CanSino vaccine candidate.
In the UK, the government accelerated the development of a Vaccine Manufacturing and
Innovation Centre (VMIC), allocating an incremental  million so that the facility can
open in , a year ahead of schedule. The government also allocated an additional 
million for distributed or virtual support of vaccine manufacturing competencies in the
country, in advance of the VMIC opening. The UK also invested in the National Biologics
Manufacturing Centre in Darlington, which is slated as a manufacturing site for Imperial
College’s mRNA candidate vaccine.
42 Response and Resilience
The European Unions
Central Response
As a formal component of the overall  billion
EU-level response to the crisis, the European
Commission’s strategy for vaccine development
released in June included the following:*
A pledge of  billion from the current Horizon
 research program, of which 
million was dedicated to projects on vaccine
development through a series of emergency calls
and enhanced flexibility in existing projects.
An Accelerator Pilot managed by the European
Innovation Council (EIC), the agency for investing
in company-based innovation, resulting in
 million being placed in projects run by 
companies with relevant projects. (The EIC is
set to become part of the succeeding research
framework program, Horizon Europe, which will
run from  through ). *
Commitment of  million in lending capacity
through the European Investment Bank to
buy down the risks of high-stakes vaccine
development in exchange for secured supplies,
resulting in loans of  million to BioNTech
and  million to CureVac.
Building on previously funded programs such
as the European Virus Archive, TRANSVAC,
the European Infrastructure for Translational
Medicine, and the European Clinical Research
Network.*
Funding of  million toward large-scale,
multicenter trials through CEPI.
Development of a COVID- data portal* for
sharing of research results.
* European Commission. EU research and innovation supporting
vaccine development for COVID-19. June 17, 2020. Online at: https://
ec.europa.eu/info/sites/info/files/research_and_innovation/research_
by_area/documents/ec_rtd_cc-vaccine-development_factsheet.pdf.
Lesson 3.3: Inter-industry partner-
ships and collaborations make a
difference.
In addition to government-sourced
funding supports, industry has entered
into inter-firm business collaborations
and formal partnerships to more
rapidly advance coronavirus vaccine
and therapeutic candidates. Large
biopharmaceutical companies have
partnered to leverage their respective
intellectual property (IP) and propri-
etary technology platforms, a level of
collaboration and potential financial
exposure that likely would not have
been pursued were it not for the
urgency of the pandemic.
Similarly, smaller and emerging bio-
tech and pharmaceutical early-stage
ventures are teaming with large
biopharmaceutical companies to gain
access to their development, produc-
tion, and distribution expertise and
networks. Again, these earlier-stage
companies would have been more
likely to have cautiously advanced
their products and more closely held
their IP were it not for the urgency of
the pandemic. Some of these part-
nerships and collaboration decisions
may well not be optimized from a
financial return perspective for the
participating companies, but they are
being advanced anyway because not
to do so puts lives at risk in delaying
potential solutions to the COVID-
pandemic.
Lesson 3.4: Public markets
may infuse capital.
Equity markets have proven to be a
source of rapidly injected cash into
companies announcing promising
candidate vaccines and therapeutics
for COVID-. Multiple publicly traded companies with candidate products (especially those that
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 43
are able to report robust preclinical results or,
especially, success in early-stage clinical trials)
have seen their stock prices increase substantially
upon public announcements of results. Increases
in company share prices provide a capital cushion
to companies, providing cash for capital invest-
ments and acquisitions (if the company owns
substantial shares in its own stock) and enhanced
retention of talent (for those employees who have
stock options). Enhanced company value also
provides assurance to commercial lenders who
may be approached to fund capital investments for
scaling-up a company’s products and operations.
Lesson 3.5: VC and angel investor activity
prime the pump of innovation.
One of the reasons why the United States has been
a leader in advancing candidate biopharmaceutical
products (see Figure ) is its access to a robust
domestic network of early-stage capital providers.
TEConomy and BIO note the following in their
 TEConomy Partners and BIO. The Bioscience Economy: Propelling Life-Saving Treatments, Supporting State & Local Communities. .
hps://www.bio.org/sites/default/files/-/BIO-report.pdf.
recently released  joint report on the U.S. life
sciences ecosystem:
The availability of investment capital is
critical for advancing and sustaining industry
development; and for an innovation-intensive
and science-driven industry such as the
biosciences, it is especially important for
companies navigating lengthy time horizons
to achieve commercial viability. Access to
seed- and early-stage capital is especially
important to sustain product development and
where relevant, to conduct and meet rigorous
pre-clinical and clinical testing requirements.45
Having access to a rich resource of early-stage
capital primes the pump in terms of building en-
trepreneurial companies that may address health
challenges. In  alone, analysis of Pitchbook
data by TEConomy shows that U.S.-based compa-
nies in drug discovery and development, pharma-
ceuticals, medical biotechnology, and diagnostics
Figure 7: COVID-19 Therapies in Development by Originating Company Headquarters
Source: Analysis by BIO
44 Response and Resilience
received . billion in risk capital investments. A
total of , companies were funded with ,
investment deals made by VC firms, angel inves-
tors, and seed-stage funders.
The key lesson to be learned is that there are
pandemic countermeasure advantages, as well as
economic development advantages, in building
entrepreneurial life sciences ecosystems that are
supported by a substantial pool of active risk-capital
providers. It should also be noted that the devel-
opment of VC and angel capital providers is further
enabled in nations by having access to strong
publicly traded stock markets, which provide key
liquidity (or “exit”) events for early-stage investors
when companies undertake initial public offerings
(IPOs). The United States accounted for circa 
percent of global VC investments in , with other
highly active nations including Israel, Sweden, the
United Kingdom, Germany, France, and China.
It must also be recognized that investment capital
is extremely hard to aract without robust protec-
tions for IP. Patent protection, and a well-struc-
tured legal system for defense of patents, is very
much a requirement for sustaining investment
momentum in life sciences markets.
Framework Element 4:
Policies and Regulation
Policies and regulations enacted by governments
represent a cross-cuing series of factors that
have an impact across the value chain of the life
sciences industry. Perhaps no other industry is as
heavily regulated and influenced by public policies
globally, and at the individual nation level, as is the
human life sciences sector. Products for clinical
application have profound implications for human
health, and thus carefully constructed regulatory
systems have evolved to govern and ensure the effi-
cacy and safety of biomedical products (especially
those that enter or touch the patient).
The COVID- pandemic has highlighted elements
of the policies and regulations framework that have
worked well and has generally shown regulators to
be quite responsive and flexible in the face of the
unprecedented real-time threat of the coronavirus.
At the same time, however, the pandemic has
also highlighted areas in need of improvement
or revision based on barriers generated to more
effective and timelier pandemic response.
Overall, as shown in this report, life sciences eco-
systems across the globe have been extraordinarily
responsive to the pandemic, activating and advanc-
ing production in diagnostics and therapeutics
and accelerating R&D for vaccines and therapeutic
products. Manufacturers of biopharmaceuticals,
medical devices (such as ventilators), PPE and oth-
er critically needed products have worked round
the clock to boost production—working even while
the pandemic impacted their own communities.
Regulatory bodies have been working equally hard
in accelerating reviews of critical R&D projects and
innovations and developing programs designed to
provide rapid response to questions and inquiries
from researchers and manufacturers.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 45
The life sciences ecosystem has evolved in
response to scientific advancements, market
needs, business realities, and public policies. It
is generally a well-refined ecosystem, and care
must be taken with decisions that may disrupt
ecosystem operations. The pandemic has certainly
generated a rude awakening as to the damage that
can be wrought to health and the economy by a
fast-spreading novel virus, and it may be tempting
for governments or other actors to seek to quickly
make changes in the system that they believe
will fix problems they observed in their individual
nations. However, turning the dials on a refined
and balanced system without understanding the
ramifications of a change in one area on other
areas, or the system overall, carries risk. A topline
caution to policymakers and regulators is to be
cautious and considered in the development
of policies and procedures that will impact the
ecosystem’s equilibrium unless there is certainty in
positive outcomes to be achieved.
There is already discussion in some markets of
quite significant actions that governments and
other parties are considering, and the following are
some cases in which such actions have been taken:
Requiring domestic production of medicines
or other medical products that are currently
imported.
Requiring the transfer/licensing of IP from
an originating firm to an in-country domestic
manufacturer in order for the product to be
sold in the nation.
Banning or severely restricting the export of
critical medical products and technologies, or
government interception of contracted goods.
Actively attempting to “poach” companies
with promising technologies from their
originating countries in order to relocate
them and capture their innovations.
For the most part, such actions have been in the
minority, and public bodies have generally been
thoughtful and professional in the policies being
adopted or considered as the pandemic progress-
es. Actions taken have been diverse, and it is
beyond the scope of this document to cover them
all, but a number of the most important lessons
learned are highlighted below.
Summary of Lessons Learned
for Policies and Regulation:
It is important to sustain the existing
ecosystems characteristics that are favor-
able to life sciences ecosystem operations.
Centralized, preplanned, and well executed
rapid national response strategies are
critically important.
Regulatory flexibility is required
in emergency situations.
Liability and other risk mitigation
should be addressed.
Commitment to building strategic stockpiles
and government purchasing is required.
Disinformation and misinformation must be
proactively addressed and managed.
Government can facilitate the implementation
of new biopharma production technologies.
Lesson 4-1: It is important to sustain the existing
ecosystem characteristics that are favorable to
life sciences ecosystem operation.
In responding to a crisis, care must be taken to
avoid actions that may undermine existing favor-
able ecosystem characteristics. Many of the “fun-
damentals” that underpin successful life sciences
ecosystems are influenced by government policies
and regulations, including, for example:
Government funding for research
Favorable tax treatment of private sector
R&D investments.
Nationally funded “big science” infrastructure
assets operated as user facilities to advance
basic and applied research.
Robust intellectual property protections
and enforcement.
46 Response and Resilience
Funding for K- and higher education
systems, and training programs for a life
sciences workforce.
Operation of predictable and scientifically-
based regulatory systems
Maintenance of free and fair international trade.
While each of the above is important, intellectual
property protections (IP) are particularly critical for
life sciences innovation commercialization. Robust
IP protections and enforcement are essential for
companies that may spend billions of dollars to
conduct the R&D, trials, and establish manufactur-
ing to bring novel biopharmaceuticals, vaccines,
and other therapeutic products to market. IP
protections have also shown themselves, during
the pandemic, to be effective protections that
enable companies and organizations to collabo-
rate. Innovators can work together on coronavirus
solutions, secure in the knowledge that IP protec-
tion allows their individual R&D investments and
rights to be preserved.
The cost of responding to a pandemic, and fiscal
challenges generated through economic slow-
downs, place substantial pressures on government
budgets. However, government plays a central role
in supporting basic and investigative research that
“primes the pump” for applied innovations. Sus-
taining funding for ongoing government sponsored
research is critically important.
Lesson 4.2: Centralized, preplanned, and well
executed rapid national response is required.
With a fast-spreading virus, it is imperative that
mitigation actions stay ahead of the spread. Nations
in Southeast Asia that were impacted by the SARS
outbreak in  learned this lesson, and both
Taiwan and Korea, for example, captured their
lessons-learned and developed a formal response
strategy and action plan for when the next major
pandemic would emerge. The actions laid out in
the Taiwanese and Korean response plans swung
into action very early as the coronavirus started
to spread in China. Under these strategies, travel
restrictions were quickly implemented; and recent
passengers from originating destinations were
traced, contacted, and quarantined—and those
with whom they had contact were notified and
quarantined also. Taiwan, for example, established
a central National Health Command Center
aer SARS and activated it as soon as reports of
COVID- surfaced. Executing its plan, Taiwanese
health officials quickly boarded aircra arriving from
Wuhan China to assess passengers for symptoms
before allowing them to deplane; and by January
, Taiwan was tracing people who had traveled
to Wuhan within the previous  days and then
quarantining any contacts with signs of a respiratory
infection. Taiwan’s plan also prioritized personal
protective shipments to frontline health providers
and, in parallel, ramped up production or supplies
purchasing to enable distribution to the general
population. Korea acted similarly quickly, and its
plan called for quickly developing diagnostic tests
for the coronavirus, scaling them quickly and puing
in place drive-through testing centers. Singapore
was likewise effective in its early response.
Countries that did not have a predeveloped plan
that they could rapidly execute found themselves
on the back foot, trying to play catch-up to viral
spread. Some adopted the playbook of those with a
plan and had relative success with this copy-based
approach—including quickly approving, adopting,
and rolling out diagnostics proven in the forerunner
fast-moving nations. Others were slow in response,
for whatever reason, either not having a central
plan for a pandemic, not executing previously
developed response plans (perhaps because they
were developed by a previous out-of-favor adminis-
tration), or deciding to cede control over response
to subnational regional or state authorities. The key
lesson to be learned from COVID- is that speed is
of the essence and, to move fast enough, a formal
national plan must be in place and executed. Trying
to pull together a novel plan in real time as a highly
infectious disease takes hold has largely been
shown to be ineffective by the current pandemic.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 47
Lesson 4.3: Regulatory flexibility is required
in emergency situations.
It can take months to advance research proposals,
clinical trial plans, or product approvals through
established regulatory approval processes. In
non-emergency conditions, that timing can be
absorbed; but, in a fast-moving pandemic, a slow
moving regulatory system that is inflexible in its
processes or protocols will be an impediment to
advancing innovations and potential solutions.
Actions taken by agencies in the United States
to COVID- and diagnostics, for example, have
illustrated both good and less-than-ideal actions:
The FDA has been highly responsive and
taken unprecedented actions to help re-
searchers and companies advance products
and technologies to address COVID-.
The agency issued multiple Emergency Use
Authorizations (EUAs) that expedited review
of diagnostic test kits and authorized their
use for cases involving COVID-. Also, as
noted in the Clinical Trials section of this
report, the CTAP program at FDA provided a
novel process to rapidly advance innovations
and trials for COVID-.
The Centers for Disease Control (CDC)
decided not to use diagnostic tests already
developed and in use in other nations, or the
WHO’s promoted test, and instead followed
its preferred course to develop its own test.
Unfortunately, the CDC-developed test had
problems when implemented, resulting in a
significant delay in rolling out an approved
U.S. test for labs across the nation to use.
A report by FTI Consulting captures many of the
FDAs actions during the pandemic, serving to
illustrate the fact that the agency has been both
responsive and flexible to the real challenges
posed by the pandemic. It is noted that FDA
actions included the following:
 FTI Consulting. Covid-: Impact on Global Pharmaceutical and Medical Product Supply Chain Constrains U.S. Production. hps://www.
iconsulting.com/~/media/Files/us-files/insights/articles//mar/Covid--impact-global-pharmaceutical-medical-product-supply-
chain.pdf.
Working with manufacturers to expedite the
initiation of clinical trials of COVID- vaccines
as well as subsequent review and approval.
Evaluating approved, currently available drugs,
such as Actemra (approved for rheumatoid
arthritis), for repurposing to treat COVID-.
Actively reaching out to pharmaceutical manu-
facturers to identify potential drug shortages.
Exercising enforcement discretion to allow
multiple laboratories to develop COVID- tests.
Working through disruption of inspections of
drug and medical supply firms in China that
followed the U.S. State Department’s travel
advisory for that country. Approximately 
scheduled inspections in February and March
were placed on hold. Consequently, FDA has
stated that it will use, where appropriate, the
agency’s authority to request records from
firms “in advance or in lieu of” drug surveil-
lance inspections in China.
Active monitoring of marketing materials to
protect the public from false and misleading in-
formation. The FDA has issued multiple Warning
Leers to companies promoting unproven or
fraudulent products for combaing COVID-.
Relaxing compounding oversight for some
of the drugs in high demand for the most
severe COVID- patients. The drugs include
sedatives (e.g., fentanyl and ketamine) used
during intubation, as well as antibiotics such
as vancomycin.
The U.S. government has also been proactive in
easing some of its anti-trust limitations for com-
panies working together to advance products to
combat COVID-.
48 Response and Resilience
Lesson 4.4: Liability and other risk
mitigation should be addressed.
Even with many years of R&D and trials devel-
opment, there are times when a pharmaceutical
approved for sale is found to produce exception-
ally rare side effects not encountered in trials.
Human biology is complex; and factors, such as
genetic diversity, rare allergies, and differences
in environmental factors people encounter, can
produce unforeseen adverse drug events. The
extreme humanitarian need for therapeutics to
treat COVID- infection, and vaccines to prevent
infections, is justifiably requiring R&D and trials
management teams to advance products as rapidly
as possible within the bounds of established
protocols. Candidate vaccines and therapeutics
have been advanced to human trials at an unprec-
edented pace upon regulatory consultation and
with regulatory permission, and selfless volunteers
have come forward to participate in trials. There
is a possibility that the accelerated pace of
development and production of COVID- medical
countermeasures may result in some adverse
events in the future. Governments should consider
special legislation for COVID- treatment and
vaccine manufacturers to mitigate legal liability for
companies or establish ways to transfer potential
liability to government to mitigate corporate risk
based on companies accelerating development for
the public good.
There are other risk factors for companies in this
fast-moving environment that governments should
also consider and address. Companies are making
unprecedented financial decisions to invest in
production facilities, for example, prior to having
a fully proven and approved product. Companies
risk having stranded assets if their product is
ultimately unsuccessful against the virus, and
negative financial ramifications of this may lead
to later shareholder suits or other issues. Again,
legislation should be considered to cover this risk.
Rapid construction of new plants may also lead to
other liabilities (such as environmental issues or
other factors) that may also need to be addressed
to reduce or remove company liability.
Examples of Government
Approaches to Regulatory
Flexibility and Speed of
Response in the Covid-19
Pandemic
The Brazilian Registry of Clinical
Trials announced intent to fast-track
approval of COVID- trials, with a
target of  hours for turnaround.
Health Canada approved 
COVID-–related clinical trials,
in the process allowing a wider
range of health professional and
investigator classifications to be
involved, rather than only drug
manufacturers. It has also approved,
on an expedited basis, importation
of drugs and devices.
In Korea, the Ministry of Science
and ICT announced its intention to
reduce from one or two months to
less than one week the time that
would be required, under existing
procedures, for institutional IRB
approval of COVID-–related
clinical trials. The Ministry of Food
and Drug Safety developed its “Go
Expedited Review Program (GERP)”
to support rapid commercialization
of innovations for COVID-.
Multiple trials were launched in the
UK in record time as a consequence
of fast-track review by the Health
Research Authority.
Regulatory agencies in multiple
countries have enabled virtualization
of clinical trials through digital health
technologies, and extended the use
of digital technologies for virtual
regulatory inspections (in areas
such as Good Clinical Practice and
pharmacovigilance inspections),
and electronic files submission
of Certificates of Pharmaceutical
Products and Good Manufacturing
Practices.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 49
Lesson 4.5: Commitment to building
strategic stockpiles and government
purchasing is required.
Multiple nations found that they had insufficient
inventory of PPE, ventilators, and other medical
supplies needed to address the scale of the
COVID- pandemic. The current pandemic
was created by a virus with an R (its effective
reproduction number or its effective capacity to
spread) that is higher than seasonal flu but much
lower than many other infectious diseases, such as
measles, for example. Still, the R of the coronavirus
stretched the healthcare systems and intensive
care units in hospitals in hot spot locations to the
breaking point. Existing stockpiles and supply
chains for PPE, especially, were found to be
insufficient, and frontline healthcare workers in
many locations were reduced to reusing PPE that
was designed only for one-time use.
As best practice moving forward, each nation will
need to assess the appropriate level of stockpiling
(of PPE, medical devices, critical medicines, etc.)
that will be necessary to develop based on the
experience of COVID- and take into consideration
the possibility that a future pandemic may have
an even higher R than COVID-. Having portable
decontamination systems (see sidebar) that may be
shipped to hot spots may also be a consideration.
Lesson 4.6: Disinformation and misinformation
must be proactively addressed and managed.
Making rational, scientifically based decisions
in a fast-moving dynamic health event is difficult
enough—but, it is rendered even more difficult if
misinformation, or deliberate disinformation, is
spread to impacted populations. The risk of mis/
disinformation impacting decision making is one of
the reasons why having a predeveloped strategic
action plan, rooted in scientific evidence and best
practices, that is mandated for use when an event
presents, is so important—it helps remove political
pressures, fast-moving opinions, and distractions
from the equation.
Combaing mis/disinformation is a challenge that
is expanding under proliferation of social-media and
other communications platforms that can quickly
disseminate non-refereed or inadequately reviewed
content. It is a challenge that extends far beyond
pandemic response and is a thorny issue to address
with the inherent paradox of balancing freedom of
speech issues, personal freedoms and responsibil-
ities, and collective public health needs. The reality
is that each country is different in its social norms,
response of citizens to authorities, and the powers
invested in its government; and individual nations
will likely need to engage not only epidemiologists
and public health experts in their pandemic action
plan development but also sociologists, anthropolo-
gists, psychologists, and political scientists.
Innovation in the Pandemic. Nonprofit Baelle Memorial
Institute Invents Containerized Decontamination Units
for N95 Masks
One of the notable innovation success stories during the pandemic was the creativity
and engineering skills at Ohio-based Battelle, which rapidly designed, engineered, and
manufactured unique systems based on shipping containers, using vaporized hydrogen
peroxide, to decontaminate the protective equipment (such as N masks) being used by
frontline healthcare workers in COVID- hot spots. As of June , Battelle had CCDS Critical
Care Decontamination Systems operating at  sites across the United States and the systems
had decontaminated over . million masks.
50 Response and Resilience
Everyone lives with restrictions on their personal
behavior. In the United States, one needs a driver’s
license to operate a car and must follow rules of the
road for the safety of themselves and the public.
Rules have been adopted on where smoking is
allowed and where it is not. One also may not shout
fire in a crowded movie theater when there is no fire.
Other countries have more restrictions on acceptable
behaviors based on their own cultures, social norms,
and experiences. Developing a universal lesson
learned for mis/disinformation under the COVID-
pandemic is, for the above reasons, difficult to do.
But, perhaps most could agree as follows:
Deliberately spreading false information that
would be harmful to public health should have
consequences for the individual or organiza-
tion that knowingly originates a claim that will
cause increased exposure to infections.
Deliberate noncompliance with lawfully enact-
ed restrictions or public policies designed to
foster public safety in a pandemic should have
consequences. If deliberate noncompliance
results in a proven contagion spike event, then
consequences should be elevated.
What the “consequence” should be is a maer for
individual national legislative and judicial systems to
address; and they should be deliberated in advance
of a pandemic event, incorporated into a pandemic
event strategic action plan, and communicated to
the public. As part of a global community, nations
themselves have a responsibility to act appropri-
ately also. National borders are porous, and viruses
do not respect them. COVID- shows that poor
containment in one location can spill over to affect
neighbors, and again, international agreement may
need to be reached on future consequences.
 National Academies of Sciences, Engineering, and Medicine . Innovations in Pharmaceutical Manufacturing: Proceedings of a
Workshop—in Brief. Washington, DC: The National Academies Press. hps://doi.org/./.
 Ibid.
Lesson 4-7: Government can facilitate
the implementation of new biopharma
production technologies.
As noted earlier in this report, biopharmaceutical
production technologies are evolving, and the
COVID- pandemic may accelerate the evaluation
and adoption of emerging production technologies
such as single-use systems and continuous
manufacturing. Best practice will be for regulatory
agencies to monitor emerging technologies and to
prepare scientifically and technically for innovative
technologies as they are being developed and
piloted. Janet Woodcock, director of the U.S. FDA’s
Center for Drug Evaluation and Research (CDER),
has noted that “industry’s reluctance to embrace
new technologies … is probably related to expected
regulatory obstacles with FDA and other regula-
tors, and promotion of broad adoption of advanced
manufacturing will likely require incentives.” Dr.
Woodcock noted that there is a “need for advances
in regulatory policy given that the agency is unsure
how some of the innovative ideas will fit into the
regulatory framework.”
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 51
Framework Element 5:
Customers and Markets
The long-term effects of the pandemic on the
delivery of healthcare and the market for medical
products remain to be seen. At this point in time,
there are, however, four lessons learned that are
important to consider.
Summary of Lessons Learned
for Customers and Markets:
Virtualization or digitalization of healthcare
has accelerated.
Universal, patient-centric access to care,
diagnostics, therapeutics, and vaccines must
be facilitated.
There will be growth in product and service
market niches rooted in pandemic prepared-
ness and response.
Long-term health implications for patients re-
covering from COVID-19 are, as yet, unknown.
Lesson 5.1: Virtualization or digitalization
of healthcare has accelerated.
It does appear that “virtualization” of per-
son-to-person interactions (e.g., physician tele-
medicine consults with patients) has accelerated
during the pandemic, and this is likely to be a
continuing trend within the healthcare delivery
environment. This assumes that post-pandemic
study of the effectiveness of such virtual consult
systems proves that they were of benefit and did
not negatively impact health outcomes.
In general, it seems that accelerated advancement
in the digital transformation of healthcare more
broadly has been stimulated by the pandemic. This
likely has implications for the following:
More efficient use of clinician time.
Reduced exposure of patients and clinicians
to pathogens in clinical settings via reduced
physical interactions.
Enhanced development of, and acceptance of,
home health solutions and wearable health
monitoring devices.
Increased use of online pharmacy ordering
and home delivery of prescribed and over-the-
counter pharmacy products.
More virtual, and less face-to-face, interactions
between medical product sales representa-
tives and clinicians.
A key advantage of the virtual and digitalized deliv-
ery of healthcare is that this mode of interaction is
inherently efficient for the capture of data—data
that can then be used for analysis and systematic
improvement of healthcare and health outcomes.
Lesson 5.2: Universal, patient-centric
access to care, diagnostics, therapeutics,
and vaccines must be facilitated.
When it comes to human transmissible diseases,
there is substantial imperative to ensure that all
potentially impacted members of a population
have access to healthcare services and resources.
If the public or private market is unable to deliver
diagnostics, therapeutics, or vaccines to specific
subpopulations, these subpopulations are likely to
become reservoirs for the ongoing spread of the
subject disease. Barriers to universal access to
necessary healthcare resources have been high-
lighted by COVID-, most notably in terms
of the following:
Variation in the ability, or willingness, of
populations to pay for tests, therapeutics, or
other interventions.
Substantial geographic and socioeconomic
disparities in access to healthcare.
Long term, the resolution of health disparities—
working to smooth the landscape of patient
access—will be beneficial to overall public health.
In the near term, public health has been served
by governments quickly moving to assure their
populations that the government or third-party
payers would fully cover costs of testing, diag-
nostics, and treatments. Most governments are
52 Response and Resilience
Collaborating to Advance
Vaccine Access for All
Nations
An output of the June  Global Vaccine
Summit hosted (virtually) by the UK, COVAX
is a multinational collaborative designed
to support rapid vaccine advancement
and avert counterproductive competition
between countries. The overall financing
arrangement—under which higher-income
countries will buy in advance for their own
needs and contribute a cross-subsidy that
supports the needs of low- and lower-
middle income countries—is known as the
COVAX Facility. COVAX is co-led by Gavi,
CEPI, and WHO, working in partnership with
developed and developing country vaccine
manufacturers.
CEPI notes that “the overall aim of COVAX
is to accelerate the development and
manufacture of Covid- vaccines, and to
guarantee fair and equitable access for
every country in the world. It will achieve
this by sharing the risks associated with
vaccine development, and where necessary
investing in manufacturing upfront so
vaccines can be deployed at scale as soon
as they are proven to be safe and effective,
and pooling procurement and purchasing
power to achieve sufficient volumes to end
the acute phase of the pandemic by .”
As of July ,  million toward
the targeted  billion urgently
needed minimum for Advance Market
Commitments had been raised through
the COVAX Facility. The COVAX Facility
is pitched as a global insurance policy.
Participation gives all interested
governments—regardless of income level
and ability to pay full freight—a guaranteed
share of any future successful vaccine
production that will be allocated by Gavi
in a fair and equitable way across nations.
The goal is to cover the most vulnerable
 percent of the participating countries’
population (and also healthcare workers).
similarly planning to cover the cost of vaccines
for patients, while nonprofits and transnational
organizations are stepping forward to help
fund patient access for developing nations that
lack the financial resources to fully implement
required access programs.
Some commercial enterprises and partnerships
have stated that they will be supplying vaccines
on a cost recovery basis only—not seeking to
receive profits from their R&D and commercial-
ization efforts. While this is admirable, it may not
be in the long-term interest of building respon-
sive infectious disease and associated product
development ecosystems. A profit incentive will
be required to sustain long-term commitment to
expensive life sciences R&D needed to address
infectious diseases and associated public health
events. It may be that COVID- is a one-time
event—but the likelihood is that this will not
be the last fast-moving pandemic to be seen.
Infectious disease has tended to be an area of
life sciences commerce that has received lower
levels of commercial R&D aention than chronic
disease (for the basic reason that ongoing chron-
ic diseases sustain long-term patient demand
for therapeutics and thus a sustained market,
whereas infectious disease outbreaks are sin-
gular events and vaccines may be administered
only periodically, with long time spans between
original vaccination and a required booster
shot). Given the more challenging commercial
market characteristics of infectious diseases,
increased funding support and engagement by
government funding sources will be important to
help pull through a greater volume of research
and commercial products. A mechanism being
deployed to accomplish this by governments
is the structuring of advanced purchase agree-
ments with biopharmaceutical companies. This
is extremely helpful in mitigating some of the
significant risk that companies are taking in
greatly accelerating product development and, in
some cases, developing manufacturing capacity
in advance of having a fully proven product.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 53
Lesson 5.3: There will be growth in product
and service market niches rooted in pandemic
preparedness and response.
It is probably safe to predict that the market for
products used in the decontamination or sanita-
tion of surfaces will see a sustained increase in
demand. Similarly, the use of certain PPE, especial-
ly face masks, will become more accepted in daily
life worldwide (akin to the cultural acceptance of
their use in Southeast Asian nations).
There will also be an increase in demand for multi-
ple medical and healthcare products to replenish
and maintain national strategic stockpiles of
medications (diagnostics, critical therapeutics, and
vaccines) and supplies found to be relevant to spe-
cific or general pandemic response. Individuals and
families are also likely to create moderate home
stockpiles based on experiences with hard-to-find
products during the pandemic.
There is also a potential for seasonality to infec-
tions and for reemergence of COVID- cases in
places where it has been previously suppressed.
Potential waves, or smaller ripples of resurgence,
need to be considered in mid- and long-term
planning of production and purchasing strategies
for all products needed in pandemic response.
Policymakers will need to consider implications
of seasonality or future infection events for their
health budgets.
 DeeDee Stiepan. “Long-term symptoms, complications of COVID-.” Mayo Clinic News Network. August , . hps://newsnetwork.
mayoclinic.org/discussion/long-term-symptoms-complications-of-Covid-/.
Lesson 5.4: Long-term health implications
for patients recovering from COVID-19 are,
as yet, unknown.
An unknown factor is what will be the long-term
health implications for patients in their recovery
from acute cases of COVID-. Many patients may
experience chronic illness as a result of lasting
damage to their lungs and other organ systems as
a result of severe forms of the illness. There is also
an expanding base of patients experiencing what
has come to be called “Long COVID” or “Long-Haul
COVID,” a sustained experience of a diversity of
negative health effects, noted by Mayo Clinic to
include long-term fatigue, headaches, vertigo,
difficulties with cognition, hair loss, and cardiac
issues, in addition to diminished cardiorespiratory
fitness. There may also be unknown health
impacts associated with even milder forms of the
disease that did not require hospitalization.
The reality is that “we don’t know what we don’t
know” at this stage. The ongoing pressures of
COVID- on patients, on healthcare systems, and
on healthcare costs remain to be seen, and new
lessons learned will no doubt appear. Long-term
monitoring of survivors and subpopulations should
be conducted to inform public health.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 55
Review, herein, of lessons learned across the pandemic used a structured approach to examination of
issues and observations across each main element of life sciences ecosystems. This approach enables
readers to home in on those issues of most relevance to their specific interests or roles across the ecosys-
tem. Figure  provides a quick-reference summary of lessons learned placed in the context of each core
element of the ecosystem.
In reviewing these lessons learned across life sciences ecosystems, TEConomy finds that five key themes
emerge as particularly important takeaways from this project. Associated with these themes are five recom-
mendations for policymakers:
. Prior investments and advancements toward a robust life sciences ecosystem maer greatly in
responding to a pandemic. The fact that, in the face of the COVID- pandemic, so many vaccine
candidates and drugs have been brought forward into testing, trials, and emergency use is a heartening
achievement, and is a testimony to the foresight of those who have developed, work in, and support the
complex life sciences R&D and industry ecosystems around the world. The complexity of the ecosys-
tems that must be in place to advance R&D, product development, and production and distribution of
biopharmaceuticals, vaccines, and diagnostics is such that they cannot be stood up from scratch in
a real-time situation. They must already be in place, fully operational, well proven, and well funded, in
advance of an emergent need.
Recommendation—Policymakers must prioritize and sustain investments in life sciences research
infrastructure, workforce development, and advanced production systems. Enacted policies and
regulations must support life sciences ecosystem development at scale and sustain favorable
ecosystem operating conditions.
Conclusions
The COVID-19 pandemic has had a worldwide impact, creating
societal and economic challenges of a scale not seen in a very long
time. Typically, a crisis will bring forth lessons learned in terms of what
was handled well and where gaps or flaws in response mechanisms
were observed. Such is certainly the case in global, national, and
regional responses to COVID-19.
56 Response and Resilience
Figure 8: Lessons Learned During the COVID-19 Pandemic Across Life Sciences Ecosystems
MarketDistribution
Talent Support: Education, training, and a positive labor-market conditions
Capital Support: Private and public capital to fund ecosystem development and ongoing operations
Public Policy Support: Enabling legislation, regulations, and government programs
ProductionTrialsR&D
Innovations derive from a diversity of
university, government labs, non-profit
research institutions and industry research
seings, no single typology dominates.
Collaborations appear to have accelerated
candidate vaccines and therapeutics.
R&D performing entities themselves will be
negatively impacted in a pandemic.
Prior investment in signature R&D and
scientific infrastructure (e.g. supercomputers,
synchrotrons, etc.) pays dividends.
Scaling a life science
workforce requires foresight
and a long time horizon.
Protection of workforce and
contingency planning should
be emphasized.
Advancement of life science,
digital, and advanced
analytics convergence skills
is required.
Adoption of virtual and
contactless solutions
sustains trials.
Proactive and responsive
regulatory guidance is
highly important.
Speed in trials for vaccine
and therapeutic
advancement is critical.
Multiple sources of critical
supplies are beneficial.
Well-planned supply
chains and distribution
agreements may be
interrupted.
Digital supply chain
monitoring is desirable
and feasible.
Big and small players will
be contributing solutions
and collaborating.
Supply chain resiliency
must be built.
Advanced production
methods need to be
accelerated.
Regulatory oversight of
GMP production can be
accomplished remotely.
Research grants and development
support set a key foundation for rapid
innovation.
Public co-investment can be a
significant catalyst.
Inter-industry partnerships and
collaborations make a difference.
Public markets may infuse capital.
VC and Angel investor activity primes
the pump of innovation.
Virtualization or digitalization
of healthcare has accelerated
Universal, patient centric, access
to care, diagnostics, therapeutics,
and vaccines must be facilitated.
There will be growth in product and
service market niches rooted in
pandemic preparedness and response.
Long-term health implications for
patients recovering from COVID-19
are, as yet, unknown.
Centralized, preplanned, and well executed rapid national
response strategies are critically important.
Regulatory flexibility is required in emergency situations.
Liability and other risk mitigation should be addressed.
Commitment to building strategic stockpiles and
government purchasing is required.
Disinformation and misinformation must be proactively
addressed and managed.
Government can facilitate the implementation
of new biopharma production technologies.
Source: TEConomy Partners, LLC.
Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic 57
. Promotion of collaborations is key to quickly mobilizing and pursuing new medical innovations.
Public- and private-sector collaborations, and inter-industry collaborations, have played a key role
in rapidly advancing innovations for pandemic response. These collaborations oen build upon the
complementary and robust roles of public-supported academic research in basic research together
with industry expertise in applied discovery, development, and clinical testing that routinely take place
in high-functioning life sciences ecosystems. What the response to the COVID- pandemic has vividly
demonstrated is the benefit of collaboration, even between previous competitors, whereby different,
but complementary, R&D and industrial strengths and capacities can be brought together for advancing
medical innovations.
Recommendation—Policymakers should develop and align incentives to encourage collaborations
that will advance and speed the development and commercialization of medical innovations and take
advantage of the full capacities found across life sciences research institutions and industry.
. The convergence of digital technology with life sciences helps accelerate innovations and supports
ecosystem resiliency. One broad benefit of the COVID- pandemic has been the acceleration in the
use of digital technologies across all stages of life sciences development. Digital technologies are prov-
ing effective in speeding up research insight and innovation, sustaining trials and regulatory oversight,
building supply-chain transparency, and facilitating safer (remote) clinical healthcare interactions.
Recommendation—For the future, policymakers should continue to promote the use of digital
technologies in R&D, clinical testing, supply-chain management, and healthcare delivery and seek
ways to further the integration across distinct activities to improve the effectiveness of life sciences
ecosystems.
. Flexibility in government regulatory approaches is making a difference. Given the typical drug and
vaccine development timelines of at least  years, the speed of the overall response mounted by
the global life sciences community to COVID- is nothing short of astonishing. This has been, in
part, accomplished because of flexibility shown in regulatory processes by government. Perhaps the
most-publicized area of flexibility is in the clinical testing of potential vaccines and therapies through
mechanisms such as emergency use authorizations, compassionate use, conditional market autho-
rizations, and short timeframe approvals, while still allowing for thorough scientific evaluation of a
medicine’s benefits and risks. Other less publicized forms of flexibility have also been advanced in the
use of digital technologies in clinical trials monitoring, remote manufacturing inspections, ability to
make changes in suppliers, and allowance for joint ventures and other collaborations.
Recommendation—Policymakers should consider how increased flexibility with accountability can
be achieved on a more regular basis as a means for ensuring unmet medical needs are addressed to
improve patient lives.
. The existing business environment for innovation in life sciences ecosystems has proven to be highly
agile and able to be effectively leveraged through the COVID-19 pandemic. In challenging times there
is a strong impetus for government to be seen to be “doing something.” COVID- has certainly required
critical government interventions and actions, but it is important to recognize that care must always be
taken to avoid actions that may undermine the favorable ecosystem characteristics needed to maintain
58 Response and Resilience
life sciences advancements and innovation. There are multiple “fundamentals” that are influenced by
governments that must be sustained in order for life sciences ecosystems to flourish, for example:
Substantial commitment of government funds to supporting R&D through well-funded research
grant funding agencies, together with favorable tax treatment of private sector R&D investments.
Sustaining effective rules against trade barriers, and facilitating international trade, to enable
resilient and flexible supply chains to operate that reliably meet demand for medical products.
Operation of a flexible, science-based regulatory system.
Maintaining predictable and sustainable payer pricing systems that balance the need to manage
health care payer costs with the need for return-on-investment for innovative life sciences companies.
Robust intellectual property protections.
The last bulleted fundamental is particularly critical. One of the core elements for life sciences
innovation is having in place robust intellectual property (IP) protections for knowledge, ideas and
data required for advancing novel medicines that are consistent with international treaty obligations
and align with best practices. These IP protections are essential when it may cost billions of dollars in
private investment to bring a novel medicine to market. Beyond ensuring private investment funding, IP
protections are proving to be effective in enabling collaborations to take place between organizations
with solutions to different pieces of the puzzle (even among traditionally competing firms). With robust
IP protections, innovators can collaborate and work together to advance such solutions, knowing that
their R&D efforts, inventions, and creativity are secure. Government funding support for research is
similarly important, and global life sciences ecosystems have responded well to government incentives
aimed at furthering R&D into novel antivirals and vaccines and increasing production capacities.
Recommendation—Policymakers need to ensure that the core elements of high-functioning life
sciences business environments are in place to facilitate innovation advancement. Some of the key
elements to be advanced include strong IP protections, operation of a flexible science-based regulatory
system, and provision of secure market access for innovative medicines.
The coronavirus caught humanity’s leadership off-guard in many
places across the globe this time. When the next high-threat
infectious disease emerges (and such an emergence is all but a
certainty and just a maer of time) all need to be beer prepared.
Funding, building, reinforcing, and sustaining robust life sciences
ecosystems is a key component of that preparation, and the above
themes and recommendations are proffered as important elements
for consideration in building resiliency and responsiveness into
critically important life sciences systems.
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