Appendix B

Biographical Sketches of the Workshop Planning Committee and Speakers

PLANNING COMMITTEE BIOSKETCHES

KENT E. KESTER, M.D. (co-chair), is currently Vice President, Translational Medicine, at IAVI. He was previously Vice President and Head, Translational Science and Biomarkers at Sanofi Pasteur, the vaccine business unit of the Sanofi Group. Prior to this, in the context of 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. 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). During his military service, Dr. Kester was appointed as the lead policy advisor to the U.S. Army Surgeon General in both Infectious Diseases and in Medical Research & Development. In these capacities, he worked extensively in the interagency environment and developed a variety of Army and DoD medical policies related to infectious diseases.

Dr. Kester holds an undergraduate degree from Bucknell University and an M.D. from the Sidney Kimmel Medical College, Thomas Jefferson University, completing his internship and residency in internal medicine at the University of Maryland and a research fellowship in infectious diseases at the Walter Reed Army Medical Center. Currently a member of the U.S. Government Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB), the Department of Veterans Affairs Health Services Research & Development Service Merit Review

Board, the National Academy Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, and the CEPI Scientific Advisory Committee, he previously chaired the Steering Committee of the NIAID/USUHS Infectious Disease Clinical Research Program, and has served as a member of the FDA Vaccines & Related Biologics Products Advisory Committee (VRBPAC), the NIAID Advisory Council, and the CDC Office of Infectious Diseases Board of Scientific Counselors. He is a Vice Chair of the National Academy of Medicine Forum on Microbial Threats. Board-certified in both internal medicine and infectious diseases, Dr. Kester holds faculty appointments at USUHS and the University of Maryland, and is a fellow of the American College of Physicians, the Royal College of Physicians of Edinburgh, the Infectious Disease Society of America, and the American Society of Tropical Medicine and Hygiene, where he also serves as the Society’s Secretary-Treasurer. He is a member of the clinical faculty at the University of Maryland Shock Trauma Center in Baltimore and the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA.

BETSY WONDERLY TRAINOR (co-chair) brings over a decade of experience in the diagnostics industry, focused mainly on the validation and implementation of infectious disease diagnostics. Trainor has a background in clinical and behavioral research that started during her undergraduate studies at Cornell University. Her work initially focused on HIV in Africa and then on infectious diseases, globally, including HCV, TB, and Ebola. In addition to leading diagnostic validation studies, she has led the commercialization of diagnostic product lines and a variety of global partnerships on behalf of both private and public entities. She has supported the development of global guidelines and negotiated deals with large donor organizations as well as private entities. Trainor has recently led business development efforts at multiple innovative diagnostic companies, including Daktari Diagnostics and Aldatu Biosciences, in addition to leading product validation and implementation efforts at the Foundation for Innovative New Diagnostics (FIND) and the World Health Organization (WHO). She is looking forward to putting her experience to good use in supporting the CARB-X mission.

JOHN BILLINGTON, J.D., M.P.H., is Head of Commercial Pipeline and Health Security Policy and Advocacy in the global corporate government affairs department of GSK. In this role, he is responsible for the company’s policy and advocacy strategy for the commercial pipeline at the enterprise level, including a focus on pandemic preparedness and antimicrobial resistance (AMR). Prior to this role, Billington was director of science policy for the global vaccines business and director of U.S. vaccines policy before that. Before joining GSK, he was Director of Health Policy at the Infectious

Diseases Society of America (IDSA). At IDSA, Billington served as lead subject matter expert on vaccines, antibiotics, and medical countermeasures policy. He also launched and coordinated the U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR), a national stakeholder partnership to advance U.S. and global policies and practices in response to AMR. Earlier in his career, John was a manager in the health reform practice at Avalere Health, a health policy advisory firm. He was also a legislative fellow for health policy in the office of U.S. Senator Sherrod Brown of Ohio. He received his Juris Doctor and Master of Public Health degree from the Ohio State University in Columbus, Ohio. He received his undergraduate degree from Colgate University in Hamilton, New York.

CAREY-ANN BURNHAM, Ph.D., D(ABMM), FIDSA, F(AMM), is currently Chief Clinical Officer, Pattern Bioscience, and Professor of Pathology & Immunology, Washington University in St. Louis School of Medicine. She was previously Professor of Pathology & Immunology, Pediatrics, Molecular Microbiology, and Medicine at Washington University in St. Louis School of Medicine and Vice Chair for Faculty Mentoring & Advancement in Pathology & Immunology. In addition, for 11 years she served as Medical Director of the system clinical microbiology laboratory at Barnes-Jewish Hospital in St. Louis and the program director for the Medical and Public Health Microbiology Fellowship at Washington University. At Washington University, her research program focused on the development of new diagnostics for infectious diseases, antimicrobial resistance, and transmission and epidemiology of antimicrobial resistant microorganisms. Burnham is actively involved in several editorial roles, including serving as an editor for the Journal of Clinical Microbiology, Clinical Microbiology Newsletter, and Clinical Microbiology Procedures Handbook, 5^th ed. Burnham has held leadership roles in professional societies, including the American Society for Microbiology, Clinical and Laboratory Standards Institute; the American Academy of Microbiology; and the Academy of Clinical Laboratory Physicians and Scientists. In 2020, Burnham received the prestigious American Society for Microbiology Award for Research and Leadership in Microbiology. Burnham has published more than 200 articles in the area of diagnostic and clinical microbiology.

PAUL EDER, PH.D., is a Senior Scientific Officer and leads the Concept Acceleration Program for Diagnostics in the Division of Microbiology and Infectious Diseases (DMID) at NIAID. Previously he served for eight years as a Senior Medical Diagnostics Advisor at the Biomedical Advanced Research and Development Authority (BARDA) inside the U.S. DHHS. For seven years prior he served as the Director of Assay Development at Qiagen, where he used a Bill and Melinda Gates Foundation grant to create the

first WHO pre-qualified HPV screening test for utility in resource-limited communities worldwide. He completed postdoctoral fellowships in nuclear tRNA transport at the Howard Hughes Medical Institute at the University of Pennsylvania and in catalytic RNA with Nobel laureate Sidney Altman at the Department of Biology at Yale University. His Ph.D. is in biochemistry from the University of Iowa.

DEBORAH HUNG, M.D., works at the interface of chemical biology, genomics, and bacterial pathogenesis to establish new paradigms for an antibiotic based on the essential biology required for a pathogen to cause disease within the host. Using her training as a synthetic chemist, bacterial geneticist, and clinical physician, she explores approaches to disrupting the pathogen–host interaction. Dr. Hung is a physician-scientist at the Broad Institute of MIT and Harvard, the Department of Molecular Biology at the Massachusetts General Hospital, and the Department of Genetics at Harvard Medical School, and is the Co-Director of the Infectious Disease and Microbiome Program at the Broad Institute. She is an attending physician at the Brigham and Women’s Hospital in Boston in infectious diseases and critical care medicine.

AMANDA JEZEK is currently the Senior Vice President for Public Policy and Government Relations at the Infectious Diseases Society of America (IDSA), which represents more than 12,000 ID physicians and scientists. Amanda oversees IDSA’s public policy and government relations department, with responsibility for policy development and advocacy on IDSA priority issues, including antimicrobial resistance, the infectious diseases workforce, pandemic preparedness and response, immunizations, federal funding, and other issues relating to public health and biomedical research. Jezek has been with IDSA since 2011, previously serving as IDSA’s Government Relations Director. Prior to joining IDSA, she was the Deputy Director for Federal Affairs at the March of Dimes Foundation. In this capacity, Jezek led the March of Dimes’ policy development and lobbying efforts on all issues related to access to healthcare for women of childbearing age, infants, and children, including the Foundation’s work on the Affordable Care Act. She also lobbied for Mental Health America and worked as a legislative assistant and press secretary for U.S. Representative Grace Napolitano (D-CA). Jezek holds a B.A. in Political Science from Dartmouth College.

ROBIN PATEL, M.D.(CM), D(ABMM), FIDSA, FACP, F(AAM), graduated from Princeton University with a B.A. in Chemistry and graduated from McGill University with an M.D. She completed a residency in Internal Medicine and fellowships in Infectious Diseases and Microbiology at Mayo Clinic. She is the Elizabeth P. and Robert E. Allen Professor of Individualized

Medicine, Professor of Medicine, Professor of Microbiology, Director of the Infectious Diseases Research Laboratory, and Co-Director of the Clinical Bacteriology Laboratory at Mayo Clinic. Dr. Patel is a Fellow of American Academy of Microbiology, Past President of the American Society for Microbiology, a past associate editor for Clinical Infectious Diseases, and course director for the Mayo Clinic Alix School of Medicine microbiology. She is also the Laboratory Center Director for the NIH’s Antibacterial Resistance Leadership Group. Her research focuses on clinical bacteriology diagnostic testing, antimicrobial resistance, and microbial biofilms.

RIBHI SHAWAR, PH.D., currently serves as the branch chief at the Division of Microbiology in the Office of In Vitro Diagnostic and Radiological Health (OIR) at the Center for Devices and Radiological Health (CDRH) at the FDA where he specializes in the area of antimicrobial susceptibility testing and detection of resistance. Dr. Shawar has a Ph.D. in medical microbiology and an M.Sc. in medical parasitology. He has been a certified diplomate by the American Board of Medical Microbiology (ABMM) for 25 years and was recently elected as a Fellow of the American Academy of Microbiology (F-AAM). Dr. Shawar is a recognized clinical microbiologist with diverse experience in hospital settings, diagnostic and pharmaceutical microbiology, and anti-infective drug development with strong knowledge in regulatory aspects, both in antimicrobial drug products and infectious disease diagnostics. Dr. Shawar has authored multiple publications in peer reviewed journals, has served or currently serves as advisor to several CLSI sub-committees and is the recipient of multiple awards including GSK Gold Award and most recently the FDA’s Outstanding Service Award for his pioneering role in the creation of the FDA-CDC AR Isolate Bank. He served for two terms as Chair of the ABMM Standards and Examinations Committee (Parasitology) and as member of the editorial board of the Journal of Clinical Microbiology. Prior to joining FDA, Dr. Shawar served in multiple roles at various institutions including Baylor College of Medicine, VA Medical Center in Houston, PathoGenesis Corporation, Chiron (Novartis) in Seattle, and GlaxoSmithKline in Philadelphia.

SUSAN VAN METER was named ACLA President in March 2022. She previously served as Executive Director of AdvaMedDx where she directed the policy, advocacy, communications, regulatory, payment and legislative strategy and operations of the association, which represents manufacturers of in vitro diagnostic (IVD) clinical tests in the U.S. and abroad. In this role, she also developed the association’s robust response to the COVID-19 pandemic and ongoing advocacy efforts. Prior to her role at AdvaMedDx, Van Meter served as the Senior Vice President of Federal Relations at the Healthcare Association of New York State (HANYS), where she was

responsible for developing their priorities and strategies to further the interests of their hospital and health system members. She also previously worked in the Centers for Medicare & Medicaid Services’ (CMS) Office of Legislation. Van Meter holds undergraduate and graduate degrees from Villanova University and Boston University, respectively.

SPEAKER BIOSKETCHES

PHYLLIS ARTHUR is Vice President for Infectious Diseases and Emerging Science Policy at the Biotechnology Innovation Organization (BIO). In this role Ms. Arthur is responsible for working with member companies in vaccines, antimicrobial resistance, molecular diagnostics and biodefense on policy, legislative, and regulatory issues. Ms. Arthur joined BIO in July 2009 as the Director of Healthcare Regulatory Affairs. Prior to joining BIO, she worked in numerous marketing and sales positions for Merck & Co. Inc. in their Vaccine Division. Over her 16-year career at Merck, Ms. Arthur launched several exciting new vaccines in the United States and internationally, including the first HPV vaccine, GARDASIL. During her years in marketing, she worked closely with clinical and academic thought leaders in infectious diseases, oncology, and public health. In addition, Ms. Arthur also led a large vaccine sales organization of more than 75 representatives and managers covering 14 states. Before graduate school, Ms. Arthur worked as a research assistant for two economists at the Brookings Institution in Washington, DC. There she conducted economic analyses related to savings and investment policies for the OECD countries. Ms. Arthur received her B.A. in 1987 in economics and international politics from Goucher College and her M.B.A. in 1991 from the Wharton School of Business at the University of Pennsylvania.

RITU BANERJEE, M.D., PH.D., is professor in the Division of Pediatric Infectious Diseases at Vanderbilt University Medical Center. She is the Director of the Antimicrobial Stewardship Program and Director of Clinical Services for Pediatric Infectious Diseases at Vanderbilt’s Children’s Hospital. She received her M.D. and Ph.D. degrees from Washington University in St. Louis and then completed Pediatrics residency and Pediatric Infectious Disease fellowship at the University of California, San Francisco. She is a member of many national committees through the Pediatric Infectious Diseases Society, the American Academy of Pediatrics, the Infectious Diseases Society of America, and the Antibacterial Resistance Leadership Group. Dr. Banerjee conducts federally funded clinical research about antibiotic stewardship and implementation and outcomes of rapid diagnostics for infectious diseases.

DANIEL BAUSCH, M.D., MPH&TM, FASTMH, is the Senior Director of Emerging Threats and Global Health Security at FIND, the global alliance for diagnostics (www.FINDdx.org), in Geneva, Switzerland, leading FIND’s efforts on pandemic preparedness and response. He is trained in internal medicine, infectious diseases, tropical medicine, and public health. Dr. Bausch specializes in the research and control of emerging tropical viruses, with more than 25 years’ experience in Sub-Saharan Africa, Latin America, and Asia combating viruses such as Ebola, Lassa, hantavirus, and SARS coronaviruses. Previously, he served as Director of the United Kingdom’s Public Health Rapid Support team (2017-2021), a joint effort by Public Health England and the London School of Hygiene & Tropical Medicine to respond and conduct research to prevent and control outbreaks of dangerous infectious diseases around the world. He has also held posts at the World Health Organization in Geneva, Switzerland; U.S. Naval Medical Research Unit No. 6 in Lima, Peru; Tulane School of Public Health and Tropical Medicine in New Orleans, USA; and the U.S. Centers for Disease Control and Prevention in Atlanta, USA. In addition to his role at FIND, Dr. Bausch holds an appointment as a Professor of Tropical Medicine at the London School of Hygiene and Tropical Medicine and is the current President of the American Society of Tropical Medicine and Hygiene (www.ASTMH.org). He places a strong emphasis on capacity development in all his projects and has a keen interest in the role of the scientist in promoting health and human rights. Dr. Bausch is fluent in English, French, and Spanish.

JOHN BILLINGTON, J.D., M.P.H., is Head of Commercial Pipeline and Health Security Policy and Advocacy in the global corporate government affairs department of GSK. In this role, he is responsible for the company’s policy and advocacy strategy for infectious diseases at the enterprise level, with a focus on pandemic preparedness and antimicrobial resistance (AMR). Prior to this role, Billington was director of science policy for the global vaccines business and director for U.S. vaccines policy before that. Before joining GSK, he was director of health policy at the Infectious Diseases Society of America (IDSA). At IDSA, he served as lead subject matter expert on vaccines, antibiotics, and medical countermeasures policy. He also launched and coordinated the U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR), a national stakeholder partnership to advance U.S. and global policies and practices in response to AMR. Earlier in his career, Billington was a manager in the health reform practice at Avalere Health, a health policy advisory firm. He was also a legislative fellow for health policy in the office of U.S. Senator Sherrod Brown of Ohio. Billington received his Juris Doctor and Master of Public Health degree from the Ohio State University in Columbus, Ohio. He received his undergraduate degree from Colgate University in Hamilton, New York.

BRADLEY BURNAM is Founder and CEO of Turn Therapeutics, a biotechnology company addressing critical patient needs across advanced wound care, infectious disease, and dermatology. In an attempt to treat his own recurring, antibiotic-resistant skin infection, Burnam developed the first patented method for permanently and stably fusing polar, water-soluble ingredients in petrolatum without an emulsifier. This process, known commercially as PermaFusion®, enabled Burnam to stably suspend broad-spectrum, liquid antimicrobials into a petrolatum carrier. The initial commercial embodiment, which became Turn’s first FDA cleared product, is a non-cytotoxic, petrolatum-based, broad-spectrum antimicrobial ointment with the physical consistency/safety profile of OTC topical antibiotics. PermaFusion® has since enabled Burnam to create Turn’s growing product portfolio and therapeutic pipeline, including multiple FDA cleared advanced wound products and a lead therapeutic, non-antibiotic topical candidate intended to be indicated for the treatment of antibiotic resistant skin infections. Burnam is a self-taught regulatory and formulation expert who singlehandedly facilitated Turn’s first three FDA clearances. He is a regular guest lecturer at UCLA and was a keynote speaker at the 2019 UCLA commencement. He holds a bachelor’s degree from UCLA and a master’s degree from Stanford University.

KAREN CARROLL, M.D., is professor of pathology at the Johns Hopkins University School of Medicine. Her areas of clinical expertise include medical microbiology and infectious diseases. Dr. Carroll serves as the Director of the Division of Medical Microbiology and the Director of the ACGMEaccredited fellowship program in medical microbiology in the Department of Pathology.

Dr. Carroll earned her M.D. from the University of Maryland School of Medicine. She completed her residency at the University of Rochester Medical Center, performed a fellowship in medical microbiology at the University of Utah, and performed another fellowship in infectious disease at the University of Massachusetts Medical School.

Her research interests include the evaluation of novel diagnostic platforms, diagnosis of bloodstream infections/sepsis, and the diagnosis and epidemiology of healthcare-associated infections, such as MRSA and Clostridium difficile. More recently Dr. Carroll has collaborated with researchers on novel rapid microfluidics platforms and next generation sequencing technologies for detection of a variety of pathogens. She has participated in programs to foster appropriate test utilization and diagnostic stewardship.

TRACEY L. COHEN is Distinguished Visiting Scholar at the University of Miami Miller School of Medicine Institute for Bioethics & Health Policy.

As a healthcare attorney, Ms. Cohen has represented national and Florida healthcare systems in regulatory compliance, peer-review, transactional, and litigation matters. Ms. Cohen also has practiced as an intellectual property attorney, overseeing the intellectual property portfolios of major healthcare institutions, corporations, and individuals.

Ms. Cohen served as an Adjunct Professor of Law at Nova Southeastern University Broad College of Law for six years, where she created curriculum and taught courses in intellectual property law. She is also a legal writer and has published articles for Nolo, a division of Martindale-Hubbell.

Ms. Cohen received her B.A. in philosophy from Brandeis University and her J.D. from the University of Florida Levin College of Law, where she was the recipient of a Book Award in Legal Research and Writing and sat on the Senior Editorial Board of the University of Florida Journal of Law and Public Policy. Ms. Cohen also holds a Master of Science in bioethics from Columbia University.

PAUL EDER, PH.D., is a Senior Scientific Officer and leads the Concept Acceleration Program for Diagnostics in the Division of Microbiology and Infectious Diseases (DMID) at NIAID. Previously he served for eight years as a Senior Medical Diagnostics Advisor at the Biomedical Advanced Research and Development Authority (BARDA) inside the US DHHS. For seven years prior, he served as the Director of Assay Development at Qiagen, where he used a Bill and Melinda Gates Foundation grant to create the first WHO pre-qualified HPV screening test for utility in resource-limited communities worldwide. For that he won the Qiagen Sydney Brenner R&D Award for outstanding accomplishment in global R&D. He completed postdoctoral fellowships in nuclear tRNA transport at the Howard Hughes Medical Institute at the University of Pennsylvania and in catalytic RNA with Nobel laureate Sidney Altman at the Department of Biology at Yale University. His Ph.D. is in biochemistry from the University of Iowa. He holds ten issued patents and has authored 25 publications and reviews.

NICHOLAS G. EVANS, PH.D., is Associate Professor of Philosophy at the University of Massachusetts Lowell. A 2020–2023 Greenwall Foundation Faculty Scholar, he currently conducts research on the ethics of emerging technologies, with a focus on national security issues. He is best known for his research on “dual-use research” in the life sciences and has recently begun work examining research ethics concerns arising from the performance enhancement of active military personnel, funded by the U.S. Air Force Office of Scientific Research.

In addition to his work on emerging technologies, Evans is a recognized expert in public health ethics, writing on the ethics of social distancing, research ethics during health emergencies, and the use of force in

pandemic response. His 2016 collection, Ebola’s Message: Public Health and Medicine in the 21st Century received favorable reviews in Nature. In late 2021 he will publish a new, sole-authored work on pandemic preparedness with The MIT Press titled, War on All Fronts: A Theory of Just Health Security.

Prior to his appointment at the University of Massachusetts, Evans completed postdoctoral research at the Perelman School of Medicine at the University of Pennsylvania. In 2015, he held an Emerging Leaders in Biosecurity Initiative Fellowship at the UPMC Center for Health Security, Baltimore. He also previously served as a policy officer with the Australian Department of Health and Australian Therapeutic Goods Administration.

DIANE FLAYHART is the Global Program Leader AMR at the Antimicrobial Resistance Fighter Coalition/BD. She leads efforts for the Antimicrobial Fighter Coalition, a global organization that aspires to change behaviors across the globe that will maintain the effectiveness of antibiotics for future generations. The Coalition seeks to substantially increase awareness of drug-resistant infections and encourage action across a wide range of stakeholders, including policymakers, health agency officials, professional societies, clinicians, patients, and family members. The Coalition is mobilized by BD where Flayhart has served roles of increased responsibility focused on marketing and commercial excellence since 2007. She started her career at Johns Hopkins Medical Institution working as a medical technologist in the Microbiology Laboratory. Flayhart completed her master’s degree in Business Administration at the Johns Hopkins University.

GREG FRANK, PH.D., is Director, Global Public Policy with Merck, where he leads Merck’s global antimicrobial resistance (AMR) policy. Previously Dr. Frank served as Senior Director, Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), where he led several infectious diseases policy issues, including AMR and vaccine regulatory policy. Prior to BIO, Dr. Frank led science and diagnostics policy as Program Officer for Science and Research Policy at the Infectious Diseases Society of America (IDSA).

Dr. Frank serves on the Leadership Council of the National Institute of Antimicrobial Resistant Research and Education (NIAMRRE) and the expert advisory committee for the Partnership to Fight Infectious Diseases. He is a board member on the AMR Industry Alliance. Previously, Dr. Frank has served on the U.S. Presidential Advisory Committee on Antibiotic Resistant Bacteria (PACCARB) and joined expert advisory committees of the Access to Medicines Foundation AMR Benchmark, the Global AMR R&D Hub, and the Duke-Margolis Center for Health Policy Antimicrobial Incentives & Payment Reform Project.

Dr. Frank received his doctorate in immunology at the University of Pittsburgh and pursued his postdoctoral training at the Laboratory of Viral Diseases at the National Institute of Allergy & Infectious Diseases.

ALEX GRENINGER, M.D., PH.D., M.S., M.PHIL., is assistant director of the UW Medicine Clinical Virology Laboratory and a UW assistant professor of laboratory medicine. Dr. Greninger focuses on genomic and proteomic characterization of a variety of human viruses and bacteria, with a focus on respiratory viruses and human herpes viruses. He has discovered a number of new human and animal viruses. His basic science lab at South Lake Union uses genomically informed approaches to understand human infectious diseases. Dr. Greninger earned his M.D. and Ph.D. from UC San Francisco, his M.S. in immunology from Stanford, and his M.Phil. in epidemiology from Cambridge University in England. Dr. Greninger has clinical interests in facilitating clinical trial testing for respiratory viruses and human herpesviruses.

JOE LARSEN, PH.D., is Vice President, Clinical Development at Locus Biosciences where he leads development programs for Locus’s clinical stage assets. Previously, Dr. Larsen was Vice President, Strategic Portfolio Development at Venatorx Pharmaceuticals, a biotechnology company focused on the development of novel antibiotics. Prior to that, Dr. Larsen spent ten years in the federal government, including serving as Deputy Director of Chemical, Biological, Radiological and Nuclear (CBRN) medical countermeasures at the Biomedical Advanced Research and Development Authority (BARDA), where he oversaw the $2.8B Project Bioshield fund for the late-stage development and procurement of medical countermeasures. Dr. Larsen received his Ph.D. in microbiology and immunology at the Uniformed Services University of the Health Sciences and a B.A. in microbiology from the University of Kansas.

JACLYN LEVY is the Director of U.S. Policy at the AMR Action Fund, where she works to support policy solutions and market reforms related to antimicrobial R&D, pull incentives, stewardship, and access. She joined the Fund from the Infectious Diseases Society of America (IDSA), where she served as Director of Public Policy and advanced a broad portfolio of research, diagnostics, and public health policy issues. Prior to IDSA, Levy worked as a biosecurity analyst for the U.S. Department of Homeland Security and as a scientific editor and consultant. She has over a decade of experience in federal and global policy and advocacy work and has authored numerous publications on pandemic preparedness, antimicrobial resistance, molecular diagnostics, and biomedical R&D. Levy holds an M.S. in bio-hazardous threat agents & emerging infectious diseases from Georgetown

University and a B.A. from The George Washington University. She was a 2020 Atlantic Council Millennium Fellow.

JOSEPH LUTGRING, M.D., works as a medical officer for the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention. He is a graduate of Indiana University School of Medicine. He is board certified in internal medicine, infectious diseases, and medical microbiology. He has interests in diagnostic stewardship, antimicrobial resistance, and working on topics at the intersection of clinical infectious diseases and the microbiology laboratory.

ALITA MILLER, PH.D., is the Chief Scientific Officer at Entasis Therapeutics, where she has played a key role in the discovery and development of several novel antibacterial agents, including ETX0462, sulbactam-durlobactam and zoliflodacin. She has more than 20 years of experience in antibacterial research, first at Pfizer, where she led both large and small molecule discovery projects, and then at AstraZeneca, where she was Head of Microbial Genetics and Genomics. Dr. Miller obtained a B.A. in chemistry from Kalamazoo College and a Ph.D. in biochemistry & molecular biology from the University of Chicago. Her postdoctoral training was in the DiRita Lab at the University of Michigan.

KEVIN OUTTERSON, J.D., LLM, teaches health care law at Boston University, where he codirects the Health Law Program. He serves as the founding Executive Director and Principal Investigator for CARB-X, an >$800M international public–private partnership to accelerate global antibacterial innovation. Key partners in CARB-X include the US government (BARDA & NIAID), the Wellcome Trust, the German Federal Ministry of Education and Research (BMBF), the UK government (GAMRIF), and the Bill & Melinda Gates Foundation. Professor Outterson’s research work focuses on the law and economics of antimicrobial resistance, particularly push and pull incentives for antimicrobials. He served as a senior author on many key research reports on antibiotic innovation, including Chatham House, ERG, DRIVE-AB, and the Lancet Commission. Professor Outterson was given the 2015 Leadership Award by the Alliance for the Prudent Use of Antibiotics for his research and advocacy work. He has testified before Congress, Parliamentary working groups, the WHO, and state legislatures. Since August 2016, he leads CARB-X, the world’s most innovative antibiotic accelerator.

JEAN PATEL, PH.D., currently serves as the principal scientist, scientific affairs, at Beckman Coulter. Prior to her role at Beckman Coulter, Dr. Patel served as the science team lead, antibiotic resistance coordination and strategy unit, at the Centers for Disease Control (CDC), where she led

implementation of its Antibiotic Resistance Laboratory Network and the CDC and FDA Antibiotic Resistance Isolate Bank.

Dr. Patel has served as chair and vice chair of the Clinical and Laboratory Standards Institute Subcommittee for Antimicrobial Susceptibility Testing and works with the World Health Organization (WHO) to develop technical guidance for detecting resistance and strengthening global surveillance of antimicrobial resistance.

ROBIN PATEL, M.D.(CM), D(ABMM), FIDSA, FACP, F(AAM), graduated from Princeton University with a B.A. in chemistry and from McGill University with an M.D. She completed a residency in internal medicine and fellowships in infectious diseases and microbiology at Mayo Clinic. She is the Elizabeth P. and Robert E. Allen Professor of Individualized Medicine, Professor of Medicine, Professor of Microbiology, Director of the Infectious Diseases Research Laboratory, and Co-Director of the Clinical Bacteriology Laboratory at Mayo Clinic. Dr. Patel is a Fellow of the American Academy of Microbiology, past president of the American Society for Microbiology, a past associate editor for Clinical Infectious Diseases, and course director for the Mayo Clinic Alix School of Medicine microbiology course. She is also the Laboratory Center Director for the NIH’s Antibacterial Resistance Leadership Group. Her research focuses on clinical bacteriology diagnostic testing, antimicrobial resistance, and microbial biofilms.

DAVID (DAVE) PERSING, M.D., PH.D., is Executive Vice President and Chief Scientific Officer at Cepheid and in 2017 was appointed Chief Scientific Officer (CSO) for the Danaher Diagnostics Platform. He has spent most of his 30-year career in biomarker discovery, translational medicine, and innovation in the diagnostics space. As CSO, Danaher Diagnostics Platform, he has the responsibility for providing scientific, medical, and strategic input to the Diagnostics’ Operating Companies and Platform leadership. He also has the responsibility for development of new clinical processes, technologies, or products that advance patient care, innovation, and competitive positioning of the Danaher Diagnostics group of operating companies.

Persing joined Cepheid in 2005 and has since focused on the enable-ment of molecular diagnostic technology to meet global needs in infectious diseases and oncology. He conducted his scientific and medical training with Don Ganem and Nobel laureate Harold Varmus at the University of California, San Francisco. After residency training in clinical pathology at Yale University, he held leadership roles in academia and industry starting in the early 1990s with the design, implementation, and scaleup of the first PCR reference laboratory at the Mayo Clinic. His interest in the democratization of molecular diagnostic methods has been longstanding, starting in 1993 with his publication of the first of five widely adopted textbooks

to include PCR protocols and guidelines for laboratory operations. He has published more than 300 peer-reviewed articles and reviews, including multiple articles in the New England Journal of Medicine, Science, and PNAS. In 2020, he was named to the Fierce Pharma list of the 22 most influential scientists in the fight against COVID-19. To maintain a connection with the latest trends in translational medicine, Persing also serves as Consulting Professor of Pathology at Stanford University School of Medicine. He obtained his M.D. and Ph.D. degrees from UCSF in 1988.

MELINDA PETTIGREW, PH.D., is the Anna M. R. Lauder Professor of Epidemiology and the Interim Dean at the Yale School of Public Health. Pettigrew conducts both laboratory and epidemiologic studies. Her work focuses on how disruptions of homeostasis in the respiratory and gastrointestinal microbiota influence colonization resistance, development of antibiotic resistance, and risk of bacterial infections. Additional research seeks to identify epidemiologic and genetic factors that influence whether opportunistic pathogens asymptomatically colonize or cause diseases such as pneumonia and exacerbations of chronic obstructive pulmonary disease.

Pettigrew is nationally known for her research and leadership in her roles on the steering and executive committees for the Antibiotic Resistance Leadership Group (ARLG). The ARLG is a National Institutes of Health sponsored initiative that supports a national network of scientists to develop, implement, and manage a clinical research agenda to combat the public health crisis of antimicrobial resistance. As the associate director of the Scientific Leadership Core for the ARLG, she leads efforts to implement and integrate principles of diversity, access, equity, and inclusion throughout the network.

A graduate of Grinnell College, Pettigrew received her Ph.D. from Yale University in 1999. She conducted a postdoctoral fellowship at the University of Michigan prior to joining the Yale School of Public Health faculty in 2002. Pettigrew’s research has been supported by grants from the National Institutes of Health, the Centers for Disease Control and Prevention, and private foundations. In addition to her research, she is highly regarded for her teaching. She has received the Yale School of Public Health Distinguished Teaching Award and the Inspiring Yale Award. She also serves on the editorial board of the scientific journal mBio.

VALÉRIE RAYMOND SCHWARTZMANN, PHARMD, has been the Director of the Companion Diagnostics Program at bioMérieux since 2014. The objective of this program is to forge close partnerships with healthcare industries (drugs, vaccines, medical and surgical equipment) in order to deliver diagnostic tests with high medical value as well as to support drug prescription and improve patient care in the context of personalized medicine.

Prior to this position, Schwartzmann was Marketing Director of “Acute & Critical Care” within the Immunoassay Unit of bioMérieux. She helped develop a marketing strategy centered on the medical value of products, for clinicians, patients, and diagnostic laboratories. She has acquired 14 years of experience in sales and marketing both at local and corporate levels, mainly in the field of diagnostics but also in the field of medical devices and pharmaceutical products (Roche Diagnostics—commercial organization, Fresenius HemoCare—Marketing Director and Responsible Pharmacist).

Schwartzmann is a Doctor of Pharmacy and a former intern at the Hospitals of Lyon. She completed her training with a DEA in analytical Chemistry, an AEU in toxicology, and a certificate in pharmacovigilance.

WILLIAM “BILL” RODRIGUEZ, M.D., is the Chief Executive Officer of FIND, the global alliance for diagnostics. He previously served as Chief Medical Officer between 2015 and 2017. He joined from the Draper Richards Kaplan Foundation, a global venture philanthropy firm supporting early-stage, high-impact social enterprises. As a medical doctor, he has extensive experience across both private and public sectors, founding his own diagnostics company, Daktari Diagnostics—a venture-backed start-up company developing portable diagnostics for HIV, HCV, tuberculosis, typhoid, and maternal health for use in low- and middle-income countries. He is a highly respected figure in the global health community, serving as advisor to the World Health Organization, Bill & Melinda Gates Foundation, national governments on global HIV, tuberculosis, Ebola and COVID-19, as well as numerous established and start-up for-profit and not-for-profit social enterprises focused on global health. He is a graduate of Brown University and the Yale University School of Medicine.

KRISTIAN ROTH, PH.D., is the Deputy Director in the FDA’s Division of Microbiology Devices. He received his Ph.D. in analytical chemistry from the University of California Riverside, studying surface bound porphyrin molecules, then completed a postdoc at the University of California Santa Barbara studying the materials synthesis properties of large protein conjugates with Professor Dan Morse. Afterward he moved to the Seattle area to join CombiMatrix, a startup diagnostics company targeting infectious diseases using DNA microarray detection. There, he worked on developing nucleic acid amplification assays for the detection and differentiation of influenza, using a novel microfluidic cartridge coupled with electrochemical array detection. Dr. Roth then moved to the Maryland area to join Meso Scale Discovery, developing platforms for the detection of influenza, hepatitis, and radiation biodosimetry. In 2011, he started at the FDA as a scientific reviewer and was involved in the writing of guidance documents for assay migration and multiplex infectious disease detection, then later served as Branch Chief

in the Multiplex Bacteriology and Medical Countermeasures branch in the Division of Microbiology (DMD). Dr. Roth has also been a stakeholder in DMD’s emergency response to the recent Ebola and Zika outbreaks.

KIM SCIARRETTA, PH.D., is the Launch Office Branch Chief within the Division of Research Innovation and Ventures (DRIVe), Biomedical Advanced Research and Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR), within the United States Department of Health and Human Services (HHS). Previously Dr. Sciarretta was a project officer within the BARDA CBRN Division, and prior to that, was a technical consultant to multiple U.S. government agencies. Dr. Sciarretta was one of the inaugural members of DRIVe and is leading efforts towards improving patient outcomes for sepsis through strategic interagency activities and critical technology investments with external partners. Dr. Sciarretta received her Ph.D. from the University of Chicago in molecular genetics and cell biology. Her expertise broadly spans medical countermeasure development, biochemistry, synthetic biology, advanced manufacturing, and chemical and biological defense technologies.

DIANE SHADER SMITH has had a vibrant career as a writer, speaker, publicist, and fundraiser with an extensive roster of clients that includes products, personalities, services, and celebrities.

In 2017, Shader Smith’s daughter Mallory died at the age of 25. This would prove to be the inflection point in Shader Smith’s life as this catastrophic loss would lead her on a new path, one that was both unexpected and transformative. Since then, Shader Smith’s work has used Mallory’s posthumously published memoir, Salt in My Soul, and the documentary of the same name to address the following topics: AMR and the urgent global health crisis antimicrobial resistance poses, phage therapy, the power of the patient voice, the opioid epidemic and the need for balance, insurance obstacles and access to healthcare, narrative medicine, storytelling to improve health outcomes, the role of the caregiver, and memoir as medicine.

Shader Smith has given more than 250 talks across the United States—on Capitol Hill, at the White House Office of Science and Technology Policy, at national and international conferences, grand rounds in many hospitals, to lay and medical audiences in Australia, the UK, Paris, and Brussels, NATO, members of the European Union, and a TEDx Talk among others.

Shader Smith has been interviewed by many major media outlets including The New York Times, Forbes, NPR, The Los Angeles Times, The Today Show, and The Hollywood Reporter, among others. She has raised more than 6 million dollars for basic science research with a focus on phage therapy.

ANTHONY D. SO, M.D., M.P.A., is the second professor of the practice and Founding Director of the Innovation+Design Enabling Access (IDEA) Initiative at the Johns Hopkins Bloomberg School of Public Health. The IDEA Initiative fosters innovation and design of new technologies for greater health access and impact. As Director of the Strategic Policy Program of ReAct—Action on Antibiotic Resistance, he works with a global network dedicated to meeting the challenge of antimicrobial resistance, and his program serves as the Secretariat to the Antibiotic Resistance Coalition.

He served as one of the co-conveners of the UN Interagency Coordination Group on Antimicrobial Resistance that delivered recommendations to the UN Secretary General in 2019. Most recently, he was co-chair of the Technical Working Group aligning pharmaceutical innovation incentives to achieve fair pricing for the 2021 WHO Fair Pricing Forum and currently is a member of the Technical Advisory Group of WHO’s COVID-19 Technology Access Pool. He also has served as a member of the Antibiotic Resistance Working Group of the U.S. President’s Council of Advisors in Science and Technology and as part of the WHO expert Technical Consultation on In Vitro Diagnostics for Antimicrobial Resistance.

His research and policy work on collaborative R&D models and incentives for innovation has received support under a Robert Wood Johnson Investigator Award in Health Policy Research.

He contributed to the Lancet Infectious Diseases Commission on Antibiotic Resistance, co-edited the Chatham House’s Working Group’s report, Towards a New Global Business Model for Antibiotics: Delinking Revenues from Sales, and co-authored “A Framework for Costing the Lowering of Antimicrobial Use in Food Animal Production” for the UK Review on Antimicrobial Resistance.

SUSAN VAN METER was named ACLA President in March 2022. She previously served as Executive Director of AdvaMedDx where she directed the policy, advocacy, communications, regulatory, payment and legislative strategy and operations of the association, which represents manufacturers of in vitro diagnostic (IVD) clinical tests in the U.S. and abroad. In this role, she also developed the association’s robust response to the COVID-19 pandemic and ongoing advocacy efforts. Prior to her role at AdvaMedDx, Van Meter served as the Senior Vice President of Federal Relations at the Healthcare Association of New York State (HANYS), where she was responsible for developing their priorities and strategies to further the interests of their hospital and health system members. She also previously worked in the Centers for Medicare & Medicaid Services’ (CMS) Office of Legislation. Van Meter holds undergraduate and graduate degrees from Villanova University and Boston University, respectively.

CRAIG WHITEFORD, M.S., PH.D., leads a diverse set of R&D Scientists for BD Integrated Diagnostic Solutions (IDS), who have developed diagnostic tests for blood stream infections, Tuberculosis (ID/DST), bacterial identification & antibiotic susceptibility, enteric diseases, respiratory diseases, sexually transmitted infections, and oncology. Over the past 18 years, Dr. Whiteford has held both R&D and project management roles, from which he has driven WW product development from ideation to the launch for the BD MAX Molecular platform as well as various phenotypic platforms inclusive of the BACTEC, MGIT, Phoenix, Phoenix AP as well as Kiestra laboratory automation system, which consist of robotics and artificial intelligence (AI)driven software that is transforming the way clinical laboratories operate. With his keen interest in infection diseases, he has also led several technology sensing and development teams. Successfully serving BD in many different roles, his teams have developed more than a dozen IVD devices. He worked closely with Regulatory Affairs, Medical/Clinical Affairs, and Quality Affairs to develop strategies for clinical trials as well as regulatory bodies’ submission (FDA, China, Japan, ANVISA, CE regulations). Before coming to BD, he worked as a lab manager for a pediatric oncology lab at the National Cancer institute within the National Institutes of Health, researching, developing, and deploying one of the largest microarray technologies and research efforts at the National Institutes of Health.

Dr. Whiteford holds a Bachelor of Science in biology & mMicrobiology, Master of Science, and a Ph.D. in microbiology from Kansas State University.