GAO-23-106562, PANDEMIC ORIGINS: Technologies, Challenges, and Policy Options to Support Investigations
- Issuer
- Government Accountability Office
- Document type
- Report
- Date
- 2023-02-01
Summary
GAO testimony GAO-23-106562, Pandemic Origins: Technologies, Challenges, and Policy Options to Support Investigations, delivered Wednesday, February 1, 2023 before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce by Dr. Karen L. Howard, Acting Chief Scientist. The statement summarizes GAO's January 2023 technology assessment, GAO-23-105406, which drew on a 3-day meeting of 27 experts in March 2022. It describes genetic sequence analysis, pathogen exposure monitoring and disease tracking, and laboratory-based pathogen studies as key technologies. It identifies three cross-cutting challenges: access to samples and genetic sequence data, lack of standardized database processes and lack of a skilled interdisciplinary workforce. GAO presents five policy options, including multilateral data-sharing agreements.
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United States Government Accountability Office
Testimony
Before the Subcommittee on
Oversight and Investigations,
Committee on Energy and Commerce,
House of Representatives
PANDEMIC ORIGINS
For Release on Delivery
Expected at 2:00 p.m. ET
Wednesday, February 1, 2023
Technologies, Challenges,
and Policy Options to
Support Investigations
Statement of Dr. Karen L. Howard,
Acting Chief Scientist and Director,
Science, Technology Assessment, and Analytics
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Appendix I: Expert Meeting Participants
Chair Griffith, Ranking Member Castor, and Members of the
Subcommittee
Thank you for the opportunity to discuss our work on pandemic origins.
My testimony today summarizes our January 2023 technology
assessment entitled Pandemic Origins: Technologies and Challenges for
Biological Investigations. 1 GAO’s technology assessments focus on
examining technologies and identifying their challenges and benefits. The
report I am discussing today examines technologies—including tools and
methods—used to investigate the origin of infectious diseases that lead to
pandemics. 2
Given the magnitude of the health and economic costs of pandemics,
there is a need to better understand how and where they originate. 3
According to scientific literature, most pandemics where the origin is
known were caused by the natural transmission of a pathogen through
animal-to-human contact, also known as zoonotic transmission. A
pandemic could also potentially be initiated through the accidental
infection of an individual or individuals by a pathogen in a laboratory
setting, or infections outside the laboratory caused by an accidental or
intentional release of the pathogen from a laboratory. For example,
research suggests the 1977-1978 H1N1 influenza pandemic may have
been the result of a laboratory accident or other cause. 4 Determining the
likely origin of pandemics is challenging and requires information
1GAO, Pandemic Origins: Technologies and Challenges for Biological Investigations,
GAO-23-105406 (Washington, D.C.: January 27, 2023).
2Determination of a pandemic’s origin has some level of inherent scientific uncertainty. For
our January 2023 report and this testimony statement, we use the term “origin” to mean
“likely origin,” acknowledging this uncertainty.
3As of the week ending January 7, 2023, the U.S. had about 1,090,000 reported deaths
attributed to COVID-19. A recent assessment estimated the human and economic cost of
the COVID-19 pandemic to the U.S. totaled more than $10 trillion. The 2009 H1N1
influenza pandemic resulted in approximately 61 million cases and 12,500 deaths in the
U.S. Prior to a successful vaccination campaign that eradicated smallpox in 1980, the
disease killed approximately 300 million people globally between 1900 and 1980.
4Other causes suggested for the 1977-1978 H1N1 influenza pandemic include deliberate
release of the virus or a vaccine trial mishap. See M. Rozo and G.K. Gronvall, “The
Reemergent 1977 H1N1 Strain and the Gain-of-Function Debate,” mBio, vol. 6
(2015):e01013-15.
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Appendix I: Expert Meeting Participants
gathered from established methods for disease outbreak investigations
that may, in some cases, take a decade or longer of research to acquire. 5
Our January 2023 report and my statement today address key
technologies available for pandemic origin investigations; strengths and
limitations of these technologies; and cross-cutting challenges
researchers face in trying to determine a pandemic’s origin. 6
To understand the available technologies and challenges in determining
the origins of pandemics, we convened a 3-day meeting of 27 experts in
March 2022 with assistance from the National Academies of Sciences,
Engineering, and Medicine. 7 We also examined peer-reviewed scientific
literature and other documents, including the 2022 National Biodefense
Strategy and reports from the World Health Organization, Department of
Health and Human Services’ (HHS) Centers for Disease Control and
Prevention (CDC), Office of the Director of National Intelligence, the
Johns Hopkins Center for Health Security, and select national
laboratories. Further, we interviewed officials and researchers from 11
relevant federal agencies as well as nonfederal experts with a diverse set
of perspectives on the science and application of these technologies.
Additional information about our scope and methodology can be found in
our January 2023 report. We performed the work on which this testimony
is based in accordance with all sections of GAO’s Quality Assurance
Framework that are relevant to technology assessments.
Several key technologies and approaches can help inform investigations
Technologies Are of a pandemic’s origin, including: genetic sequence analysis; pathogen
Mature and Can Help exposure monitoring and disease tracking; and laboratory-based
pathogen studies. However, to effectively apply these technologies,
Inform Pandemic researchers require samples and data obtained from infected people,
Origin Investigations animals, and the environment in or around outbreak areas from as early
in an outbreak as possible.
5For example, it took approximately 13 years to determine the origin of the SARS-
associated coronavirus (SARS-CoV) pathogen that caused the 2002-2003 SARS
pandemic. While the first human outbreak of H1N1 occurred in Mexico in early 2009, it
wasn’t until 2016 that it was established that the virus jumped from pigs to humans in
central Mexico. The origin of the Ebola virus remains inconclusive.
6For the purposes of our report, the term “technologies” includes the instruments,
techniques, skills, methods, and processes used in pathogen characterization.
7Meeting participants were from academia, business, and nonprofit organizations. For a
complete list of participants, see Appendix I of this statement.
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Appendix I: Expert Meeting Participants
Genetic sequence analysis. Experts told us that they consider genomic
sequencing one of the key technologies for pandemic origin investigations
due to its speed, accuracy, and cost. Genomic sequencing allows
researchers to generate a pathogen’s genetic sequence. This genetic
sequence is then analyzed using bioinformatics tools and compared to
reference genetic sequences stored in databases to identify matches with
other known pathogens, mutations in the sequences, potential
genetically-engineered sequences, and likely relationships to the nearest
relatives. For example, researchers used genetic sequence analysis to
help establish the likely natural origins of the 2002-2003 SARS pandemic,
the 2009 H1N1 influenza pandemic, and the initial MERS outbreak in
2012. However, some laboratory-based genetic modifications may be
indistinguishable from natural variations. For example, some traditional
genetic engineering techniques and newer genome editing tools—such
as CRISPR—may not leave readily detectable traces of genetic
modification. Further, repeated growth of the pathogen in laboratory
animals or cell cultures may result in changes (i.e., mutations) in the
pathogen that closely mimic the natural processes of evolution.
Pathogen exposure monitoring and disease tracking. Technologies
such as serology (i.e., blood analysis) and epidemiological surveillance—
tracking a disease as it moves through a population—are also key
technologies for pandemic origin investigations. These technologies allow
researchers to monitor pathogen infection and disease occurrence in
human and animal populations. For example, serology surveillance in
people and camels provided two key pieces of information that
contributed to the determination that camels were direct sources of
human infection with MERS-CoV.
Laboratory-based pathogen studies. The exact processes by which
some pathogens adapt to infect and transmit between humans are not
well-understood, which may limit investigators’ abilities to establish the
origin of a pandemic. Therefore, laboratory-based pathogen studies using
cell cultures or animals may provide evidence supporting known natural
or unusual patterns of spread. The latter may indicate a possible
laboratory-related origin. For example, researchers studying pandemic
H1N1 influenza virus in ferrets identified the viral genes, proteins of
transmission, and host receptor sites that drive different routes of
transmission. The results of these studies supported the conclusion that
this virus likely originated from animal-to-human transmission. However,
results from controlled laboratory studies may not accurately represent
the natural environment, making it difficult for researchers to clearly
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Appendix I: Expert Meeting Participants
distinguish between natural versus laboratory-controlled patterns of
spread.
Investigators need access to samples and data, particularly from infected
or exposed individuals, from as early in an outbreak and as
geographically close to the first reported human disease cases as
possible, for these technologies to be effective in determining a
pandemic’s origin. However, certain countries may refuse or limit
researchers’ access to field sites, facilities, data, or people. For example,
researchers and agency analysts reported that uncertainty still exists
about where the first SARS-CoV-2 infections occurred because of a lack
of clinical samples available for serological and genetic analyses as well
as a lack of epidemiological data from the earliest cases.
According to experts, technologies are not the limiting factor for
Cross-Cutting determining the likely origin of a pandemic. Experts identified three cross-
Challenges that cutting key challenges that hinder researchers trying to investigate the
origin of a pandemic:
Hinder Pandemic
Origin Investigations • Lack of sufficient access to samples and genetic sequence data;
and Policy Options • Lack of standardized processes for submitting, accessing, and using
genetic sequence data stored in databases around the world; and
that May Help
• Lack of a sufficient and skilled interdisciplinary workforce.
Address Them
We identified five policy options that may help address these challenges
and help improve the ability of researchers to respond more quickly and
effectively to future pandemics.
Challenge: Lack of sufficient access to samples and genetic
sequence data. Privacy concerns, general mistrust, perceived
infringements on a country’s sovereignty, or fear of negative
consequences may limit access to samples and data. Further, even if
researchers have access to samples and data, their ability to extract
suitable information may be limited by a lack of standardized processes.
For example, health officials may collect samples for a purpose other than
pathogen surveillance, or store and process the data obtained from the
samples in a way incompatible with what is needed for effective
investigations. Additionally, no one entity is responsible for determining
and enforcing standardized processes.
Policy Option: Experts and some agency officials told us that federal
policymakers, such as the Department of State, and others could help
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Appendix I: Expert Meeting Participants
address this challenge in advance of future outbreaks by establishing
comprehensive multilateral, international agreements for accessing and
sharing genetic sequence samples and data. These proactive
agreements could include definitions of the roles and responsibilities of
international investigation teams and incentives for adherence, helping
ensure more timely access to critical information. Negotiating or modifying
agreements each time a pandemic occurs is not effective because of the
speed with which pandemics spread. That is, agencies do not have
months to negotiate a series of bilateral agreements with every country
every time an outbreak occurs. Instead, policymakers and others could
proactively:
• Develop multilateral sample and data-sharing agreements—for
example, agreements which include expectations of timely access to
samples and detailed standards for sample collection;
• Work with international health organizations, such as the World Health
Organization, to identify and address barriers to establishing
multilateral, international agreements for ensuring access to genetic
sequence samples and data, and support the development of such
agreements; and
• Seek agreement with stakeholders on incentives for participation,
such as equitable access to vaccines and therapeutics. These
incentives could also include economic assistance and assurances to
mitigate stigmatization when promptly sharing samples and genetic
sequence data.
A key benefit of establishing these proactive agreements is ensuring
timely access to genetic information and samples in the critical beginning
stages of a pandemic and throughout an origin investigation. Such access
may help in the determination of a pandemic’s origin. However, some
countries may be unwilling to participate in these agreements because of
concerns related to national sovereignty, among other reasons. Further,
identifying an appropriate responsible entity to determine and monitor
whether countries are following agreed-upon standard processes may be
challenging.
Challenge: Lack of standardized processes for genetic sequence
databases prevents researchers from analyzing data effectively. To
investigate the origin of a pandemic, researchers need access to genetic
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Appendix I: Expert Meeting Participants
sequence data, which may be stored in multiple databases. 8 Experts cited
three main issues with working across multiple databases:
• Each genetic sequence database may have different processes for
submitting, accessing, and using the data. As a result, gathering all of
the data necessary to investigate the origin of a pandemic can be
challenging.
• Genetic sequence databases generally lack standardized user
interfaces for data submission and access, and some existing user
interfaces can be cumbersome. The need for different procedures to
submit and retrieve data from relevant databases can be time-
consuming and inefficient for researchers.
• Metadata such as the date and location of sample collection are
crucial for investigating the origin of a pathogen, but their availability
and quality may vary. For example, although GenBank® allows users
to report specific locations where samples were collected, a 2017
study estimated that 99 percent of records do not include that
information. If the information does exist, researchers may still have to
perform additional steps of integrating this information from other
fields in the sample’s record, which is challenging and may affect the
reliability of the location data.
Rapid growth of big data These issues may be exacerbated by the immense scale and continued
A 2015 study predicted that, by 2025, growth of genetic sequence data. (See text box for a prediction on the
genomics research worldwide will generate future growth of genomic data.)
between 2 and 40 exabytes of data annually.
(For reference, 1 exabyte equals 1 billion
gigabytes.) This would make genomics one of As the amount of data in each database grows, and as more databases
the most challenging domains of Big Data in are added, standardized processes are crucial to ensure that researchers
terms of data acquisition, storage,
distribution, and analysis. can compile, analyze, and share all the genetic sequence data necessary
Accommodating the expected growth of to investigate the origin of a pandemic. However, it is unclear whether the
genomic data will require advancements in existing infrastructure of the independent databases worldwide can
computational speed and power, as well as
algorithms optimized for Big Data. support the growth of genomic data.
Source: GAO review of literature. | GAO-23-106562
Policy Options: Experts identified two possible options policymakers
could consider to address this challenge of a lack of standardized
processes for genetic sequence databases. First, federal policymakers
and others—such as HHS, current database providers, developers, and
users—could collaborate to identify and develop standardized processes
8These databases include GenBank®, Global Initiative on Sharing All Influenza Data
(GISAID), and European Molecular Biology Laboratory-European Bioinformatics Institute
(EMBL-EBI).
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Appendix I: Expert Meeting Participants
for submission of and access to data in databases such as GenBank to
support pandemic origin investigations. Second, policymakers could
encourage the improvement of current, or development of new, genetic
sequence database tools—such as user interfaces or application
programming interfaces (API)—of current databases, or incentivize the
creation of new user interfaces or APIs to help investigators determine a
pandemic’s origin more effectively. 9
The key benefits of developing standardized processes and improving
interfaces for database use include ensuring the consistency and quality
of submitted data to help researchers access and compare genetic
sequences and address the projected future growth in genetic sequence
data. However, standardized processes and interfaces may be difficult
and expensive to develop, and it may be challenging for multiple
stakeholders to agree on what data and interface features are important.
Challenge: The global research community lacks a sufficient and
skilled interdisciplinary workforce. Pandemic origin investigations
require a highly skilled workforce with expertise in multiple fields. We
identified four main reasons it can be hard to develop and retain such a
workforce:
• Demand for workers in relevant fields tends to increase when
pandemics occur and decrease when pandemics end. Likewise,
funding for relevant research tends to fluctuate. This makes it
challenging to keep the workforce in readiness (i.e., available and
proficient) to conduct investigations promptly when pandemics occur.
• Pandemic origin investigations require expertise in multiple fields such
as biology, virology, microbiology, immunology, epidemiology,
ecology, genomics, bioinformatics, and computer science. However,
experts we interviewed told us the current workforce is siloed because
of academic structures, funding priorities, and grant processes. This
makes it challenging to build and maintain the multidisciplinary
workforce necessary to conduct investigations.
• The current uneven global distribution of the workforce leads to
political and logistical challenges during a pandemic. For example, a
2021 study of one country concluded that inadequate sequencing
9An application programming interface (API) enables machine-to-machine communication,
allowing users to obtain real-time data updates.
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Appendix I: Expert Meeting Participants
capacity because of limited skillsets, among other factors, hindered
biosurveillance during the COVID-19 pandemic. 10
• Some researchers told us that they faced criticism because of their
involvement in investigating the origin of a pandemic, particularly
when their conclusions were considered controversial. These
researchers said they and others may be reluctant to participate in
further investigations because of personal and professional risks.
Policy Option: To address this challenge, policymakers could incentivize
the development, retention, and growth of a workforce—including in areas
considered hot spots of emerging infectious disease—with the critical
skills to conduct or support the work of characterizing the likely origin of a
pandemic. One way to implement this policy option is by creating
international partnerships, among other things, and leveraging or creating
training programs to encourage workforce growth and retention.
A sufficient and skilled workforce would ensure that the workforce is not
concentrated in any geographic region. A trained workforce skilled in
origin investigations could also contribute to other areas such as public
health, or other related activities. However, the scientific community may
resist alteration to current academic structures, and it may be challenging
to adapt priorities, processes, and funding in a sufficiently timely manner
needed to respond to a pandemic. As a result, attracting qualified people
into the necessary workforce fields may be challenging if those fields are
marginalized and underfunded.
Cross-Cutting Policy Option: Develop a national pandemic origin
strategy. While the first four policy options may help address the specific
challenges we identified and help improve the ability of researchers to
respond more quickly and effectively to future pandemics, we found that a
national strategy could help to address all of these challenges. For
example, the 2022 National Biodefense Strategy and Implementation
Plan includes an Early Warning priority area that encompasses targets
and corresponding actions related to determining the origin of biological
events, including infectious disease outbreaks. However, augmenting the
2022 Strategy or developing a separate strategy with more specifics,
such as specifying how the lead and support departments and agencies
10M. Dzobo et al., “Inadequate SARS-CoV-2 Genetic Sequencing Capacity in Zimbabwe:
A Call to Urgently Address this Key Gap to Control Current and Future Waves,” IJID
Regions, vol. 1 (2021): ep. 3-4. https://doi.org/10.1016/j.ijregi.2021.09.004.
Page 8 GAO-23-106562
Appendix I: Expert Meeting Participants
will coordinate and collaborate, could better position the nation to play a
leading role in pandemic origin investigations. For example,
• Federal policymakers could augment the 2022 National Biodefense
Strategy to specify how lead and support departments and agencies
will coordinate and collaborate with domestic and international
partners to address pandemic origin investigations; or
• Federal policymakers could develop a new, standalone, national
strategy focused on pandemic origin investigations that describes how
federal entities will coordinate and collaborate with domestic and
international partners on such investigations.
The key benefits of a national strategy with federal coordination and
collaboration leadership include increasing preparedness for future
pandemic origin investigations and mitigating health and economic costs.
However, allocating resources and defining how federal agencies and
others will collaborate may be challenging because of the number and
types of entities with relevant expertise. Further, during nonpandemic
periods, other priorities and needs may arise and make it challenging to
provide sustained resources and support needed for maintaining a
national strategy.
In closing, we found that technologies are mature and available for
helping inform the origin of pandemics, but several non-technological
challenges hinder such investigations. To address these challenges, we
proposed five policy options for consideration. These options would better
position our nation to deal with future pandemics, in particular, by crafting
multilateral agreements for sample and data sharing and developing a
targeted national strategy for pandemic origin investigations.
Chair Griffith, Ranking Member Castor, and Members of the
Subcommittee, this concludes my statement. I would be pleased to
respond to any questions you or other Members may have.
If you or your staff have any questions about this testimony, please
GAO Contact and contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
Staff Contact points for our Offices of Congressional Relations and Public
Affairs may be found on the last page of this statement. Key contributors
Acknowledgments to this testimony include Hayden Huang (Assistant Director), Michael
Dickens (Analyst-in-Charge), Calaera Powroznik, Craig Starger, and
Adam Wells. Additional contributors to the prior work on which this
testimony is based are listed in our January 2023 report.
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Appendix I: Expert Meeting Participants
Appendix I: Expert Meeting Participants
For the report on which this testimony is based, we convened a 3-day
meeting of 27 experts with assistance from the National Academies of
Sciences, Engineering, and Medicine to inform our work on technologies
for determining pandemic origin; the meeting was held virtually March 22–
24, 2022. The experts who participated in this meeting are listed below.
David B. Allison, PhD; Dean, Distinguished Professor and Provost
Professor, Indiana University–Bloomington School of Public Health
Jesse Bloom, PhD; Professor, Basic Sciences Division; Professor,
Herbold Computational Biology Program, Public Health Sciences
Division, Fred Hutchinson Cancer Research Center
Roger Brent, PhD; Professor, Basic Sciences Division; Professor, Public
Health Sciences Division, Fred Hutchinson Cancer Research Center
James Diggans, PhD; Distinguished Scientist, Bioinformatics and
Biosecurity, Twist Bioscience
Joshua Dunn, PhD; Head of Design, Ginkgo Bioworks, Inc.
Livia Schiavinato Eberlin, PhD; Associate Professor, Department of
Surgery, Baylor College of Medicine
Patrick Fitch, PhD; Associate Director of Chemical, Earth and Life
Sciences, Los Alamos National Laboratory
A. Oveta Fuller, PhD; Associate Professor of Microbiology and
Immunology, Medical School at University of Michigan
Gigi Kwik Gronvall, PhD; Senior Scholar, Johns Hopkins Center for
Health Security; Associate Professor, Department of Environmental
Health and Engineering, Johns Hopkins Bloomberg School of Public
Health
India Hook-Barnard, PhD; Executive Director, Engineering Biology
Research Consortium
Katrina Kalantar, PhD; Computational Biology Lead, Infectious
Diseases, Chan Zuckerberg Initiative
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Appendix I: Expert Meeting Participants
Ali S. Khan, MD, MPH, MBA; Dean, College of Public Health, University
of Nebraska Medical Center (UNMC); Former Assistant Surgeon General,
U.S. Public Health Service
Andy Kilianski, PhD; Senior Director for Emerging Infectious Diseases,
International AIDS Vaccine Initiative (IAVI); Adjunct Professor, Schar
School of Policy and Government, George Mason University
Sergios-Orestis Kolokotronis, PhD, MPhil, MA; Assistant Professor,
Department of Epidemiology and Biostatistics, School of Public Health,
The State University of New York (SUNY) Downstate Health Sciences
University
Suresh Kuchipudi, BVSc, MVSc, PhD, PGCHE, FHEA, Dip. ACVM,
MBA; Professor and Endowed Chair in Emerging Infectious Diseases,
Pennsylvania State University; Associate Director, Penn State Animal
Diagnostic Laboratory (ADL)
Jacob Lemieux, MD, DPhil; NIH-funded Physician/Scientist, Division of
Infectious Disease, Massachusetts General Hospital (MGH) and Harvard
Medical School (HMS)
Bronwyn MacInnis, PhD; Director of Pathogen Genomic Surveillance,
Infectious Disease and Microbiome Program, Broad Institute of
Massachusetts Institute of Technology (MIT) and Harvard
Alemka Markotić, MD, PhD; Director, University Hospital for Infectious
Diseases, Zagreb, Croatia; Head of Department for Research and Head
of Clinical Department for Urinary Tract Infections and Full Professor,
Medical School, University of Rijeka and Catholic University Zagreb;
Associate Member, Croatian Academy
Jonna Mazet, DVM, MPVM, PhD; Vice Provost – Grand Challenges,
University of California (UC) Davis; Chancellor’s Leadership Professor of
Epidemiology and Disease Ecology and Founder, One Health Institute,
UC Davis School of Veterinary Medicine
Folker Meyer, PhD; Professor of Data Science, University Hospital,
University of Duisburg-Essen
Tara O’Toole, MD, MPH; Senior Fellow, In-Q-Tel; Director, IQT Lab,
BiologyNext
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Appendix I: Expert Meeting Participants
Rushika Perera, PhD; Associate Professor, Department of Anatomy,
University of California (UC) San Francisco
Brian Plew; Director, Public Health Solutions, Thermo Fisher Scientific
David Relman, MD; Thomas C. and Joan M. Merigan Professor in
Medicine, Professor of Microbiology & Immunology, Senior Fellow, Center
for International Security and Cooperation, Stanford University; Chief of
Infectious Diseases, Veterans Affairs Palo Alto
Health Care System
Aaron Streets, PhD; Assistant Professor in Bioengineering, University of
California (UC) Berkeley; Core Member, Biophysics Program and Center
for Computational Biology, Investigator, Chan Zuckerberg Biohub
David Walt, PhD; Hansjörg Wyss Professor of Bioinspired Engineering,
Harvard Medical School; Professor of Pathology, Brigham and Women’s
Hospital; Core Faculty Member, Wyss Institute at Harvard University
Susan Weiss, PhD; Professor and Vice Chair, Department of
Microbiology and Co-Director, Penn Center for Research on
Coronaviruses and Other Emerging Pathogens, Perelman School of
Medicine, University of Pennsylvania; Governor, American Academy of
Microbiology
(105406)
Page 12 GAO-23-106562
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