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Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise (2021)

Chapter: Appendix B: Committee and Staff Biosketches

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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Appendix B

Committee and Staff Biosketches

COMMITTEE MEMBERS

Gigi Gronvall, Ph.D. (Co-Chair), is a Senior Scholar at the Johns Hopkins Center for Health Security and an Associate Professor in the Department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health. She is an immunologist by training. During the COVID-19 pandemic, she has led the Center’s ongoing efforts to track the development and marketing of molecular and antigen tests and serology tests and the development of national strategies for COVID-19 serology (antibody) tests and SARS-CoV-2 serosurveys in the United States. She has also written about the scientific response to the COVID-19 pandemic and implications for national and international security. Dr. Gronvall is the author of Synthetic Biology: Safety, Security, and Promise. In the book, she describes what can be done to minimize technical and social risks and maximize the benefits of synthetic biology, focusing on biosecurity, biosafety, ethics, and U.S. national competitiveness—important sectors of national security. Dr. Gronvall is also the author of Preparing for Bioterrorism: The Alfred P. Sloan Foundation’s Leadership in Biosecurity. Through her description of major grants that represented the foundation’s investments in civilian preparedness, public health law, law enforcement, air filtering in buildings, influenza preparedness, and business preparedness, she constructed, for a nontechnical audience, a chronicle of early gains in U.S. efforts to confront the threat of bioterrorism. Dr. Gronvall is a member of the Threat Reduction Advisory Committee, which provides the Secretary of Defense with independent advice and recommendations on reducing the risk to the United States,

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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its military forces, and its allies and partners posed by nuclear, biological, chemical, and conventional threats. In 2014–2015, she led a preparatory group that examined the U.S. government response to the Ebola outbreak in West Africa as a case study for the U.S. Department of Defense’s (DoD’s) strategic role in health security and made recommendations for future DoD actions in response to disease outbreaks. She is also a member of the Novel and Exceptional Technology and Research Advisory Committee, which provides recommendations to the Director of the National Institutes of Health and is a public forum for the discussion of the scientific, safety, and ethical issues associated with emerging biotechnologies. She served as the Science Advisor for the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism from April 2009 until the Commission ended in February 2010. She has testified before Congress about the safety and security of high-containment biological laboratories in the United States and served on several task forces related to laboratory and pathogen security. Dr. Gronvall has investigated and presented policy recommendations on the governance of science to the Biological Weapons Convention in Geneva, Switzerland. In addition to being a life member of the Council on Foreign Relations, Dr. Gronvall is an Associate Editor of the journal Health Security (formerly Biosecurity and Bioterrorism). She is a founding member of the Center. Prior to joining the faculty, she worked at the Johns Hopkins University Center for Civilian Biodefense Strategies. She was a National Research Council Postdoctoral Associate at the U.S. Army Medical Research Institute of Infectious Diseases in Fort Detrick, Maryland. Dr. Gronvall received a Ph.D. from Johns Hopkins University for work on T-cell receptor/MHC I interactions and worked as a protein chemist at the Memorial Sloan Kettering Cancer Center. She received a B.S. in biology from Indiana University, Bloomington.

Alan I. Leshner, Ph.D. (Co-Chair), is the Chief Executive Officer, Emeritus, of the American Association for the Advancement of Science (AAAS) and the former Executive Publisher of the journal Science and the Science family of journals. Before joining AAAS, Dr. Leshner was the Director of the National Institute on Drug Abuse at the National Institutes of Health. He also served as the Deputy Director and the Acting Director of the National Institute of Mental Health, and in several roles at the National Science Foundation. Before joining the government, Dr. Leshner was a Professor of psychology at Bucknell University, where he taught and conducted research on the relationship between hormones and behavior. Dr. Leshner is an elected fellow of AAAS, the American Academy of Arts & Sciences, the National Academy of Public Administration, and many others. He is a member and served as the Vice Chair of the governing Council of the National Academy of Medicine (NAM) (formerly the Institute of Medicine)

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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of the National Academies of Sciences, Engineering, and Medicine. He served two terms on the National Science Board, appointed first by President Bush and then reappointed by President Obama. Dr. Leshner received a Ph.D. and an M.S. in physiological psychology from Rutgers University and an A.B. in psychology from Franklin and Marshall College. Dr. Leshner has received many honors and awards, including the Walsh McDermott Medal from the NAM and seven honorary Doctor of Science degrees.

Jeffrey Baker, Ph.D., holds a bachelor’s degree in biochemistry and molecular biology from Northwestern University, a doctorate in biochemistry from the University of North Texas, and pursued postdoctoral studies at the University of California, Berkeley. He joined Eli Lilly and Company in 1988 and led the development and launch of several first-in-class biologics and supported post-launch manufacturing process development activities. Dr. Baker received the Lilly President’s Award twice, once for work associated with the development and launch of Humalog, the first insulin analog, and once for work associated with the development and launch of drotrecogin alfa, the first recombinant protein therapeutic manufactured from human cells. Dr. Baker left Lilly to be the Senior Director of Manufacturing Science and Technology at MedImmune, a subsidiary of AstraZeneca and, in 2011, was appointed the Deputy Director of the Office of Biotechnology Products in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). Dr. Baker has received six CDER awards or citations for leadership and program development and in 2018 received an FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology products through sustained creative leadership and collaboration.” In 2019, Dr. Baker was detailed to the Advanced Manufacturing National Program Office at the National Institute of Standards and Technology, where he worked with private and interagency biopharmaceutical manufacturing stakeholders to advance biopharma elements of the National Strategic Plan for Manufacturing in the United States. He was recalled to FDA in 2020, where he participated in responses to the global pandemic and Advanced Manufacturing programs in the Office of the Commissioner. He retired from FDA in April 2021. He remains active in the biotech community as a Senior Fellow in the National Institute for Innovation in Manufacturing Biopharmaceuticals, participating in conferences, and working with several universities as a both a lecturer and an advisor on program development.

Brendan Carr, M.D., M.S., is a Professor and the System Chair of Emergency Medicine at the Icahn School of Medicine at Mount Sinai and the Mount Sinai Health System. Dr. Carr, who also has a secondary appointment in the Department of Population Health Science and Policy, is a

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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renowned emergency physician and health policy researcher whose work has focused on building regional systems of care for emergency care and developing innovative delivery system solutions to create a more distributed and accessible acute care delivery system. Dr. Carr joined Mount Sinai from the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia in February 2020, 1 month before the first case of COVID-19 in New York City was diagnosed in the Mount Sinai Hospital Emergency Department. He had a central role in coordinating the Health System’s response to the epidemic, efforts that were recently recognized by Crain’s Healthcare. Dr. Carr earned his M.D. from the Temple University School of Medicine, completed his residency in emergency medicine at the University of Pennsylvania, then fellowships in trauma and surgical critical care as well as the Robert Wood Johnson Foundation Clinical Scholar’s Program, also at the University of Pennsylvania. He previously served on the faculty in emergency medicine, surgery, and epidemiology at Penn as well as the Thomas Jefferson University Health System, where he was a Professor and an Associate Dean for Healthcare Delivery Innovation. He holds master’s degrees in clinical psychology and health policy research and has received research funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and multiple foundations. His research focuses on systems of care for trauma, stroke, cardiac arrest, and sepsis. He has authored more than 150 peer-reviewed publications, received awards both for teaching and for research, and has advised and supported global not-for-profit foundations, the World Health Organization, and the National Academy of Medicine (NAM). In addition to his academic portfolio, Dr. Carr served as the Director of the Emergency Care Coordination Center and as the Senior Advisor within the U.S. Department of Health and Human Services from 2012 to 2020. His federal portfolio focused on improving trauma and emergency care services at the national level, and included working with the U.S. Department of Veterans Affairs and the U.S. Department of Defense to integrate military and civilian health care response during disasters and public health emergencies. In fall 2020, Dr. Carr was elected to the NAM, which is considered one of the highest honors in health and medicine, recognizing individuals who have demonstrated outstanding professional achievement and commitment to service.

Baruch Fischhoff, Ph.D., is the Howard Heinz University Professor in the Department of Engineering and Public Policy and the Institute for Politics and Strategy at Carnegie Mellon University, where he has been since 1987. He has a B.S. (mathematics, psychology) from Wayne State University and an M.A. and a Ph.D. (psychology) from the Hebrew University of Jerusalem. He has served on the U.S. Environmental Protection Agency Scientific Ad-

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
×

visory Board and the Homeland Security Advisory Committee (Chair), the U.S. Department of Homeland Security Science and Technology Advisory Committee, and the U.S. Food and Drug Administration Risk Communication Advisory Committee (Chair). He is an elected member of the National Academy of Sciences and the National Academy of Medicine. He has served on roughly three dozen committees of the National Academies of Sciences, Engineering, and Medicine, including current membership on the Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats and recent membership on the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus. He chaired the Committee on Behavioral and Social Science Research to Improve Intelligence Analysis for National Security and co-chaired the Committee on Future Research Goals and Directions for Foundational Science in Cybersecurity, and the colloquia The Science of Science Communication (I, II, III).

James G. Hodge, Jr., J.D., LL.M., is the Peter Kiewit Foundation Professor of Law at the Sandra Day O’Connor College of Law and the Director of the Center for Public Health Law and Policy at Arizona State University. Through scholarship, teaching, and applied projects, Professor Hodge delves into multiple areas of health law, public health law, global health law, ethics, and human rights. Since 2010, he has served as the Director of the Western Region Office of the Network for Public Health Law, one of five centers nationally funded by the Robert Wood Johnson Foundation. Since its inception, the office has assisted public health lawyers, officials, practitioners, students, and others across 11 states and nationally on more than 4,300 claims. Professor Hodge is a prolific scholar, having published more than 275 articles in journals of law, medicine, public health, and bioethics; 2 books in public health law; 25 book chapters; and guest edited four symposium issues in the Journal of Law, Medicine, and Ethics, Jurimetrics, and the Annals of Health Law. He is regularly ranked among the top 1.5 percent of cited authors in the Social Science Research Network. With others, he has drafted several model public health laws, including the Model State Public Health Information Privacy Act, the Model State Emergency Health Powers Act, the Turning Point Model State Public Health Act, and the Uniform Emergency Volunteer Health Practitioners Act. Professor Hodge is a national expert on emergency legal preparedness, obesity laws and policies, vaccination laws, and public health information privacy. His work on these and other topics has been cited in The New York Times, The Wall Street Journal, The Washington Post, USA Today, U.S. News & World Report, Time, Newsweek, The Atlantic, National Law Journal, NBC News, Baltimore Sun, Dallas Morning News, and additional regional newspapers, social media cites, and journals, including Science, JAMA, New England Journal of Medicine, American Journal of Public Health, and Public Health

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Reports. Professor Hodge regularly publishes a column on public health law for the Journal of Law, Medicine, and Ethics. He advises numerous federal, state, and local governments on public health law and policy issues and has lectured extensively on diverse topics in international locations, including Sydney, Toronto, Barcelona, Geneva, and Dublin. Before joining the College of Law in 2009, he was a Professor at the Johns Hopkins Bloomberg School of Public Health, an Adjunct Professor of law at the Georgetown University Law Center, and core faculty at the Johns Hopkins Berman Institute of Bioethics.

Anjali Joshi, M.S., currently serves as a board member of Lattice Semiconductor, a provider of low-power FPGA products; Iteris, a provider of smart mobility infrastructure and services; and Alteryx, a provider of automated analytics solutions. She was on the board of The McClatchy Company, a newspaper publisher, and MobileIron, a security applications provider until they were acquired in 2020. Until March 2019, Ms. Joshi was the Vice President of Product Management at Google, where most recently she worked on products focused on emerging markets. Earlier she led the product teams for search products, Maps, Translate, News, Finance, and Global Infrastructure. She also led early efforts for Cloud services and Fiber networks. Prior to Google, from 1998 to 2004, Ms. Joshi was the Executive Vice President of Engineering for Covad Communications, Inc., a company providing voice and data communications products and services to consumers and businesses. Before that, she held positions at AT&T Bell Labs, working in the areas of voice and high-speed data from 1989 to 1998. She received a master’s degree in management science and engineering from Stanford University, a master’s degree in computer engineering from the State University of New York, and a bachelor’s degree in electrical engineering from IIT, Kanpur. In 2017, she was awarded the Distinguished Alumni Award from IIT, Kanpur. She has served in advisory roles to many start-ups and on the board of TIE, Silicon Valley.

Kent E. Kester, M.D., was most recently the Vice President and the Head of Translational Science and Biomarkers at Sanofi Pasteur. During a 24-year career in the U.S. Army, he worked extensively in clinical vaccine development and led multiple research platforms at the Walter Reed Army Institute of Research, the U.S. Department of Defense’s largest and most diverse biomedical research laboratory—an institution he later led as its Commander/Director. His final military assignment was as the Associate Dean for Clinical Research in the School of Medicine at the Uniformed Services University of the Health Sciences (USUHS). Dr. Kester holds an undergraduate degree from Bucknell University and an M.D. from Jefferson Medical College. He completed his internship and residency in internal medicine at

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
×

the University of Maryland and a fellowship in infectious diseases at the Walter Reed Army Medical Center. A malaria vaccine researcher with more than 70 scientific manuscripts and book chapters, Dr. Kester has played a major role in the development of the malaria vaccine candidate known as RTS,S. Currently a member of the U.S. Government Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, he previously chaired the Steering Committee of the National Institute of Allergy and Infectious Diseases (NIAID)–USUHS Infectious Disease Clinical Research Program, and has served as a member of the U.S. Food and Drug Administration’s Vaccines and Related Biologics Products Advisory Committee, the NIAID Advisory Council, and the Centers for Disease Control and Prevention’s Office of Infectious Diseases Board of Scientific Counselors. Board certified in both internal medicine and infectious diseases, he holds faculty appointments at USUHS and the University of Maryland and is a Fellow of the American College of Physicians, the Infectious Diseases Society of America, the Royal College of Physicians of Edinburgh, and the American Society of Tropical Medicine and Hygiene.

Monique K. Mansoura, Ph.D., M.B.A., joined The MITRE Corporation, a not-for-profit organization working in the public interest, as the Executive Director for Global Health Security and Biotechnology in September 2017. She brings technical, policy, and business expertise from both the public and private sectors and a systems approach to the complexities of the Global Health Security mission. Her current efforts include particular focus on the sustainability of the biopreparedness industrial base and the public–private partnerships that are vital to national and global health security as well as the bioeconomy. She brings more than two decades of proven success designing and driving missions of international importance through innovative public–private partnerships, particularly in market-challenged environments and an array of skills and perspectives given extensive training and expertise in business, science, and policy. She has been deeply engaged on two of the most vital issues of our times: the Human Genome Project (1996–2001) and Global Health Security (2002–present) for threats, including chemical, biological, radiological and nuclear (CBRN) agents and pandemic/epidemic threats, such as influenza and COVID-19. Her pivotal career transition was driven by a call to service following September 11 and the 2001 anthrax attacks. From January 2002 to 2011, she led strategic policy, programming, and budgeting for a pioneering multibillion-dollar medical countermeasure (MCM) development and acquisition program in the United States that still stands as a model for the world under the authorities of the Project BioShield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006. She was a leader in the design and performance of the Public Health Emergency Medical Countermeasures

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Enterprise (PHEMCE) from its inception through 2011 and drove initial accomplishments, including the development of the inaugural U.S. Department of Health and Human Services’ PHEMCE Strategy and Implementation Plan for CBRN Threats that established a framework for priority setting and established a precedent-setting roadmap for a $5.6 billion civilian MCM program. Following government service, she led an MCM business unit at Novartis Vaccines. She has been a successful executive leader in government, industry, and nonprofit sectors by building effective teams across diverse organizations and functions, developing talent, leveraging multi-stakeholder networks through effective engagement with partners in biotechnology and multinational companies, academia, professional and patient advocacy organizations, and international governments.

Tia Powell, M.D., is the Director of the Montefiore Einstein Center for Bioethics and of the Einstein Cardozo Master of Science in Bioethics program. She holds the Trachtenberg Chair in Bioethics and is a Professor of epidemiology in the Division of Bioethics and Psychiatry. She focuses on bioethics issues related to public policy, dementia, consultation, end-of-life care, LGBT people, and public health disasters. She participated as a member or a leader of numerous national expert groups who developed guidance related to public health disasters, social determinants of health, and community engagement, including the Centers for Disease Control and Prevention, the Society of Critical Care Medicine, and the National Academy of Medicine (NAM). Dr. Powell completed chairing a committee for the National Academies of Sciences, Engineering, and Medicine, the Decadal Survey of Behavioral and Social Science Research on Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias, which will recommend a roadmap for the next 10 years of funded research in this domain. She has worked on multiple prior National Academies committees, including the following related to crisis response during public health disasters: National Workshops on Disaster Management, 2008; Personal Protective Equipment for Health Care Professionals, 2009; Crisis Standards of Care, 2010, and Revised, 2012; and Pre-Positioning Countermeasures Against Anthrax Attack (Co-Chair), 2011. During the current pandemic, she has actively engaged in scholarship and policy development, both at her institution and more broadly to help form an ethically sound response. She served 4 years as the Executive Director of the New York State Task Force on Life and the Law, which functions as New York State’s bioethics commission. Dr. Powell graduated magna cum laude from Harvard-Radcliffe College. At Yale Medical School, she earned the Parker Prize, Yale’s highest award for a graduating medical student. She completed her internship, psychiatric residency, and consultation-liaison fellowship at Columbia. She is a board-certified psychiatrist and a Fellow of The New York Academy of Medi-

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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cine, the American Psychiatric Association, and The Hastings Center. Dr. Powell’s book, Reimagining Dementia, was published in 2019 and featured on numerous media outlets, including Fresh Air with Terry Gross.

Robin Robinson, Ph.D., currently serves as the Chief Scientific Officer for RenovaCare, Inc., directing research and development (R&D) of cellular therapies for wound healing and as an independent consultant to the pharmaceutical and financial sectors in the areas of vaccine, biopreparedness, and infectious diseases. He reentered the biopharmaceutical business sector after retiring in 2016 from federal public service at the U.S. Department of Health and Human Services (HHS), where he served from 2008 to 2016 as the first Director of the Biomedical Advanced Research and Development Authority (BARDA), the Deputy Assistant Secretary for Preparedness and Response, and as BARDA’s Influenza and Emerging Disease Program Director (2004–2008). Dr. Robinson brought BARDA into prominence as one of the top 10 fully integrated R&D organizations worldwide supporting advanced development and acquisition of drugs, vaccines, diagnostics, and medical devices to address the deleterious outcomes of weapons of mass destruction (i.e., smallpox, anthrax, botulism, chemical agents, and radiological threats), pandemic influenza, and emerging infectious diseases, including Ebola and Zika viruses. Thirty-eight of its more than 250 medical countermeasure products that BARDA supported since 2008 were fully approved and licensed by the U.S. Food and Drug Administration (FDA) during his tenure; today that total is 60. In 2013–2015, Dr. Robinson was recognized as one of the top 50 most influential persons worldwide in vaccines by Vaccine Nation. In 2018, Dr. Robinson was recognized by Medicine Maker as one of the top 100 innovators in medicine. Dr. Robinson established a pandemic influenza program beginning in 2004 with scientific and technical experts to implement the national and global strategic plans and policies for the development of new influenza antiviral drugs, vaccines, and diagnostics outlined in the National Strategy for Pandemic Influenza. For his leadership in this role, Dr. Robinson was the recipient of the U.S. Department of Defense’s Clay Dalrymple Award in 2008, the HHS Distinguished Service Award three times, and a finalist for the Service to America Medal in 2009. Prior to federal public service, Dr. Robinson served as the Director of Vaccines at Novavax, Inc. (Rockville, Maryland) from 1995 to 2004, where he led the development of more than 20 vaccines to hepatitis B and E, influenza, HIV, noroviruses, and human papillomaviruses from early development, clinical trials, manufacturing scale-up, and commercialization through FDA licensure. While at Novavax, he developed patented platform vaccine technologies, including virus-like particles and subunit protein vaccines for human pathogens, including malaria, human papillomavirus, hepatitis, and influenza and for prostate,

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
×

melanoma, and cervical cancers. Dr. Robinson pursued his own research in academic medicine as a faculty member in the Department of Microbiology and Immunology at the University of Texas Southwestern Medical School from 1983 to 1992 on the molecular pathogenesis of herpesviruses and HIV. Dr. Robinson received a B.S. in biology from Millsaps College in 1976, an M.D. in 1981 from the University of Mississippi Medical School in medical microbiology under Dr. Dennis O’Callaghan on herpesvirus oncogenesis, and completed in 1983 a National Institutes of Health postdoctoral fellowship at the State University of New York at Stony Brook under Dr. Arnold Levine on molecular mechanisms in oncology. Dr. Robinson also served on the Senior Advisory Group for the World Health Organization on emerging infectious diseases and pandemic influenza (2006–2017). Additionally, he continues to serve as an editorial board member and reviewer for several professional scientific and technical journals on virology, vaccines, public health, and biotechnology. Concurrently, he is a Fellow for Regenerative Medicine and Biomedical Research at the Thought Leadership and Innovation Foundation on regenerative medicines and a member of multiple of Scientific Advisory Boards for biopharmaceutical products.

Lauren Sauer, M.Sc., is an Associate Professor in the College of Public Health in the Department of Environmental, Agricultural, and Occupational Health at the University of Nebraska Medical Center (UNMC) and Core Faculty of the UNMC Global Center for Health Security. She is an Adjunct Associate Professor of emergency medicine in the Johns Hopkins University (JHU) School of Medicine, with a joint appointment in the Johns Hopkins Bloomberg School of Public Health. She has been working in the field of disaster and public health emergency research and education for almost two decades. In addition to her work at JHU, Ms. Sauer has advised national governments, research and response networks, and nonprofit organizations. She is the Director of the Special Pathogens Research Network, the research arm of the National Ebola Training and Education Center, and is an alumni of the Emerging Leaders in Biosecurity program at the Johns Hopkins Center for Health Security, where she is a contributing scholar. She also serves on the American Red Cross Scientific Advisory Committee, where she sits on the Disaster Preparedness Subcommittee, supporting the Red Cross’s operations with a scientifically sound evidence base. She previously served as the Director of Operations for the Johns Hopkins Office of Critical Event Preparedness and Response and the Director of Research for the Johns Hopkins Biocontainment Unit, where she ran the inpatient COVID-19 biobank and served on the COVID-19 research steering committee for JHU. She also previously served as the JHU focal point for its partnership with the World Health Organization Global Outbreak and Alert Response Network. Ms. Sauer’s research focuses mainly

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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on human subjects research in bio-emergencies and acute disasters and immediate post-disaster and post-outbreak infrastructure, including the impact of disasters and outbreaks on health care systems, resource availability and access, and the impact of policy on preparedness and response capabilities. Much of her work is focused on the ethical implementation of human subjects research and navigating the regulatory environment and the way policy, guidance, and new science impact disaster and outbreak-affected populations. Her research has focused on providing health care systems tools that facilitate the implementation of policy requirements and clinical trials in emergencies. Planning tools for hospital bed capacity, patient management, and other disaster- and outbreak-related needs allow hospitals and health care systems to break down complex, potentially unfamiliar concepts into manageable pieces. Additionally, she has focused on the appropriateness of disaster response and aid for affected populations to observe positive and negative effects of the distribution of aid, implementation of response strategies such as novel therapeutics, and other resources, and affected population outcomes.

Julie Swann, Ph.D., is the department Head and the A. Doug Allison Distinguished Professor of the Edward P. Fitts Department of Industrial and Systems Engineering at North Carolina (NC) State University. She is an affiliate faculty in the Joint Department of Biomedical Engineering at NC State and the University of North Carolina at Chapel Hill. Dr. Swann is a Fellow of IISE and a member of INFORMS. Throughout her career, Dr. Swann has conducted research, outreach, and education to improve how health and humanitarian systems operate worldwide. Her work with analytics relates to public health, public policy, epidemiology, infectious disease, supply chain management, and disaster response. This work allowed her to serve as a science advisor for the H1N1 pandemic response at the Centers for Disease Control and Prevention. Recently she co-organized the International Workshop on COVID-19 Lessons to Inform Pandemic Influenza Response for the National Academy of Medicine and she previously spoke at a National Academies of Sciences, Engineering, and Medicine workshop on medical product shortages titled COVID-19 Lessons to Inform Pandemic Influenza Response. Worldwide, she has contributed to the education of thousands of practitioners in health and humanitarian systems through the co-creation and teaching in a professional certificate program at Georgia Tech, teaching in the MASHLM program in Lugano, Switzerland, and co-chairing the annual Health and Humanitarian Logistics Conference. She has consulted with several organizations such as the Bank of Montreal, SCRedesign, Third Bridge, Zoetis, and the Task Force for Global Health. She has collaborated with organizations such as the American Red Cross, The Carter Center, CARE USA, Children’s Healthcare of Atlanta, Emory

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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University Hospital, State Departments of Public Health, and many other companies.

W. Craig Vanderwagen, M.D., RADM, is a retired family physician who spent 29 years as a Commissioned Officer in the U.S. Public Health Service. Raised in the Zuni Pueblo, he spent the majority of his career in Indian Health Service, serving in a variety of local, regional, and national roles in the agency. During that period, he also was deployed for a wide variety of disaster and humanitarian responses, including care for Balkan (Kosovar) refugees, the World Trade Center after September 11, Afghanistan and Iraq (both helping to strengthen civilian health systems), the Indonesian tsunami, and he led health response/recovery efforts after Hurricane Katrina for 3 months. His final assignment in uniform was as the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services from 2006 to 2009 where he participated in the original standup of the Public Health Emergency Medical Countermeasures Enterprise. Since retirement from active duty, Dr. Vanderwagen has provided consulting services to hospitals and state health department on disaster preparedness and response through a company that he co-founded with Fuad El Hibri. He also has equity in a company that builds specialized vehicles (e.g., mobile high containment labs) and a company that builds long-endurance drones for commercial and other uses. He has also served on and chaired boards for two entities in Canada (a nongovernmental organization and a university-based translational organization in vaccine development).

Patricia J. Zettler, J.D., is an Associate Professor at The Ohio State University Moritz College of Law and a member of Ohio State’s Drug Enforcement and Policy Center and its Comprehensive Cancer Center. She writes and teaches about U.S. Food and Drug Administration (FDA) law and policy, torts, and legislation and regulation. Her scholarship has appeared in leading legal and health sciences journals such as the Indiana Law Journal, the Boston College Law Review, JAMA, JAMA Oncology, and Science, and has covered various topics including the regulation of COVID-19 countermeasures. She currently serves on the Presidential Task Force on the Use of Unproven and/or Unethical Cell & Gene Therapies for the International Society of Cell & Gene Therapy and the Black Lives Matter Advisory Committee for the Food and Drug Law Institute. In past years, she has served as a member of the editorial advisory board for the Food and Drug Law Journal (2015–2020), a member of the Task Force to Revise Guidelines for the International Society for Stem Cell Research (2019–2021), and a Consultant to the National Academies of Sciences, Engineering, and Medicine’s Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse (2016–2017). Before entering academics,

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Ms. Zettler served as an Associate Chief Counsel in the Office of the Chief Counsel at FDA. She received her undergraduate and law degrees from Stanford University, both with distinction. She is currently retained as an expert witness by certain plaintiffs in In re Suboxone Antitrust Litigation and In re Opana Antitrust Litigation.

STAFF

Lisa Brown, M.P.H. (Study Director), is a Senior Program Officer on the Board on Health Sciences Policy at the National Academies and develops and manages projects at the National Academies related to solving the nation’s most pressing health security issues. She currently serves as a Director for the Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats and the Security of America’s Medical Product Supply Chain. Previously, she directed several projects, including the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, the Committee on Data Needs to Monitor Evolution of SARS-CoV-2, the Committee on Evidence-Based Practices for Public Health Emergency Preparedness and Response, and the Committee on Strengthening the Disaster Resilience of Academic Research Communities. Prior to the National Academies, Ms. Brown served as a Senior Program Analyst for Public Health Preparedness and Environment Health at the National Association of County and City Health Officials (NACCHO). In this capacity, Ms. Brown served as the project lead for medical countermeasures and the U.S. Strategic National Stockpile, researched radiation preparedness issues, and was involved in high-level Centers for Disease Control and Prevention initiatives for the development of clinical guidance for anthrax and botulism countermeasures in a mass casualty event. In 2015, Ms. Brown was selected as a Fellow in the Emerging Leaders in Biosecurity Initiative at the Center for Health Security, a highly competitive program to prepare the next generation of leaders in the field of biosecurity. Prior to her work at NACCHO, Ms. Brown worked as an Environmental Public Health Scientist at Public Health England (PHE) in London, England. While at PHE, she focused on climate change, the recovery process following disasters, and the impact of droughts and floods on emerging infectious diseases. She received her M.P.H. from King’s College London in 2012 and her B.S. in biology from The University of Findlay in 2010.

Emma Fine is an Associate Program Officer primarily working on the Board on Health Sciences Policy and has worked at the National Academies for 5 years. Within Board, she previously supported research on the COVID-19 pandemic, including work on Rapid Expert Consultations that directly informed the White House Office of Science and Technology Policy. Ms.

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
×

Fine also works with the National Academies’ Division on Behavioral and Social Sciences and Education’s Board on Behavioral, Cognitive, and Sensory Sciences on a project that is designing a tool for intelligence analysts to better understand social polling, attitude measurement, and group behavior in non-Western countries, sponsored by the Office of the Director of National Intelligence (ODNI). Previously, she staffed a project on the Board on Global Health assessing morbidity and mortality from HIV/AIDS in Rwanda. Ms. Fine began her career at the National Academies as an SPA in the National Academy of Medicine’s Leadership Consortium. Prior to joining the National Academies, Ms. Fine interned for the U.S. Department of Health and Human Services in the Office of the Assistant Secretary for Preparedness and Response, where she contributed research to the National Health Security Strategy Implementation Plan and the intersection between terrorism and public health preparedness. In 2016, Ms. Fine graduated from the University of California, Berkeley, where she earned her B.A. in public health and public policy. She is particularly interested in the nexus among public health, intelligence, and national security and she plans to pursue a degree in national security and enter the field of intelligence.

Matthew Masiello, M.P.H., is an Associate Program Officer on the Board on Health Sciences Policy, and has supported the Committee on Reviewing the Public Health Emergency Medical Countermeasure Enterprise. He completed his M.P.H. in May 2021 at Emory University, where he focused on disaster epidemiology and COVID-19 vaccine uptake. His thesis measured COVID-19 vaccine intent among the Emory student body and captured predictors for vaccine uptake and hesitancy. While completing his M.P.H., Mr. Masiello interned at the Council for State and Territorial Epidemiologists, where he supported the Tribal Epidemiology Subcommittee and the Epidemiological Capacity Assessment. Prior to his M.P.H. program, Mr. Masiello spent 3 years at the National Academies supporting four consensus studies across the Health and Medicine Division. He earned his B.A. at American University in May 2016.

Shalini Singaravelu, M.Sc., is an Associate Program Officer on the Board on Health Sciences Policy. Her primary interests are in health security, particularly socio-behavioral approaches to pandemic and epidemic preparedness and response. Prior to joining the National Academies, Ms. Singaravelu managed a portfolio of digital health tools as a Program Manager at IBM. From 2015 to 2019, she was a consultant for the World Health Organization Health Emergencies Programme in Geneva, Switzerland. In this role, she supported preparedness and response to emerging infectious disease epidemics with a focus on operational data systems, risk communication, and community engagement. Before this, she worked on psychosocial sup-

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
×

port programming for HIV-affected orphans and vulnerable children in South Africa. Ms. Singaravelu is currently a part-time Dr.P.H. student in health security at the Johns Hopkins Bloomberg School of Public Health. She received her M.Sc. in global mental health from the London School of Hygiene & Tropical Medicine (2014) and her B.A. in anthropology from Union College (2012).

Margaret (Maggie) McCarthy, M.Sc., is a Research Associate with the Board on Health Sciences Policy. She is currently working with the Committee on the Security of America’s Medical Product Supply Chain and the Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats. In 2018, Ms. McCarthy interned with the National Academies’ Committee on Human Rights and the Office of News and Public Information, where she collaborated with fellow colleagues to organize the Second International Summit on Human Genome Editing. Before rejoining the National Academies as a Research Associate, she previously worked at Brigham and Women’s Hospital in Boston, Massachusetts, as an Infectious Diseases Research Assistant. Currently, she is working part-time with Public Health England on a systematic review involving migrant health and health care utilization across England. Her interests include migration, biosecurity, and European politics. She received her B.A. in international studies from American University and her M.Sc. in global health and development from University College London.

Melvin Joppy is a Senior Program Assistant on the Board on Health Sciences Policy with the Forum on Drug Discovery, Development, and Translation. He was recently a Program Assistant at the U.S. Department of Energy (DOE) working in the Office of Basic Energy Sciences. Prior to DOE, Mr. Joppy served as the Committee Manager for the Presidential Advisory Council on HIV/AIDS within the U.S. Department of Health and Human Services. He received his B.S. in communications from Bowie State University.

Andrew M. Pope, Ph.D., is the senior director of the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine. He has a Ph.D. in physiology and biochemistry from the University of Maryland and has been a member of the National Academies staff since 1982 and the Health and Medicine Division staff since 1989. His primary interests are science policy, biomedical ethics, and environmental and occupational influences on human health. During his tenure at the National Academies, Dr. Pope has directed numerous studies on topics that range from injury control, disability prevention, and biologic markers to the protection of human subjects of research, National Institutes of Health

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
×

priority-setting processes, organ procurement and transplantation policy, and the role of science and technology in countering terrorism. Since 1998, Dr. Pope has served as the director of the Board on Health Sciences Policy, which oversees and guides a program of activities that is intended to encourage and sustain the continuous vigor of the basic biomedical and clinical research enterprises needed to ensure and improve the health and resilience of the public. Ongoing activities include forums on neuroscience, genomics, drug discovery and development, and medical and public health preparedness for disasters and emergencies. Dr. Pope is the recipient of the Health and Medicine Division’s Cecil Award and the National Academy of Sciences President’s Special Achievement Award.

Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Suggested Citation:"Appendix B: Committee and Staff Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response.

Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.

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