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Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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B

Participant Biographies

N. LEIGH ANDERSON, PH.D., is Founder and CEO of the Plasma Proteome Institute, Washington D.C. (www.plasmaproteome.org). The institute aims to foster a comprehensive exploration of the proteins of human blood plasma (the plasma proteome), improved quantitation of potential disease markers, and the rapid application of novel protein measurements in clinical diagnostics. Dr. Anderson obtained his B.A. in Physics with honors from Yale and a Ph.D. in Molecular Biology from Cambridge University (England) where he worked with M. F. Perutz as a Churchill Fellow at the MRC Laboratory of Molecular Biology. Subsequently he founded (with Dr. Norman Anderson) the Molecular Anatomy Program at the Argonne National Laboratory (Chicago) where his work in the development of 2-D electrophoresis and molecular database technology earned him, among other distinctions, the 1983 Pittsburgh Analytical Chemistry Award. Prior to founding PPI, Dr. Anderson was Chief Scientific Officer at Large Scale Biology Corporation, whose proteomics division he founded in 1985, and co-led a successful Nasdaq IPO based largely on the proteomics technology platform. More recently Dr. Anderson has developed novel technologies for quantitation of protein biomarkers using mass spectrometry, receiving the 2009 HUPO Distinguished Achievement Award in Proteomic Science. Dr. Anderson currently serves as a Principal of Anderson Forschung Group LLC, a member of the Board of Directors of Luna Innovations (a developer of novel sensors and materials), associate editor of the journal Clinical Chemistry, and

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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sits on numerous scientific advisory boards. Dr. Anderson has published more than 150 scientific papers, one book, and 32 patents.

MARIETTA ANTHONY, PH.D., is at the Critical Path Institute (C-Path), which builds collaborative partnerships in a new model of drug development and in support of FDA’s regulatory mission. She is the associate director of the Arizona Center for Education & Research on Therapeutics (CERT), which focuses on drug safety. Dr. Anthony was a senior health policy analyst at three federal agencies—the Agency for Healthcare Policy and Research, the Food and Drug Administration, and the National Institutes of Health. Additionally, Dr. Anthony was in the Department of Pharmacology at Georgetown University and later, Vice President of Health Sciences in Women’s Health the University of Arizona. Dr. Anthony served on an IOM panel on women’s health research.

PHYLLIS ARTHUR, M.B.A., joined the Biotechnology Industry Organization (BIO) in July 2009 as the Director of Healthcare Regulatory Affairs. In this role Ms. Arthur is responsible for working with member companies in vaccines and biodefense on policy, legislative, and regulatory issues. Prior to joining BIO, Ms. Arthur worked in numerous marketing and sales positions for Merck & Co Inc. in their Vaccine Division. Over her 16-year career in vaccines, Ms. Arthur launched several exciting new vaccines in the United States and internationally, worked closely with clinical and academic thought leaders in infectious diseases and oncology, and ran a large sales organization of over 75 representatives and managers. Before graduate school, Ms. Arthur worked as a research assistant for two economists at the Brookings Institution in Washington, D.C. 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.

LESLIE Z. BENET, PH.D., Professor, Department of Biopharmaceutical Sciences, UCSF, has received honorary doctorates from six universities: Uppsala (1987), Leiden (1995), Illinois at Chicago and PCP&S (1997), Long Island (1999), and Athens (2005). During 1986, Dr. Benet founded and became the first president of the American Association of Pharmaceutical Scientists (AAPS). Elected to IOM membership in 1987, he has chaired the following committees: Clinical Applications of Mifepristone RU486 and Other Antiprogestins; Pharmacokinetics and Drug Interactions in the Elderly and Special Issues in Elderly African-American Populations; and Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents. His many awards

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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include AAPS Distinguished Pharmaceutical Scientist (1989);American Association of Colleges of Pharmacy Volwiler Research Achievement (1991); American Society for Clinical Pharmacology and Therapeutics Rawls-Palmer Progress in Medicine Award (1995); American Pharmaceutical Association Higuchi Research Prize (2000); AAPS Wurster Award in Pharmaceutics (2000); International Pharmaceutical Federation Høst-Madsen Medal (2001); Pharmaceutical Sciences World Congress Research Achievement award; and Controlled Release Society Career Achievement in Oral Drug Delivery (2004). His research interests, more than 470 publications, and 11 patents are in the areas of pharmacokinetics, biopharmaceutics, drug delivery, and pharmacodynamics. He is listed among the 250 most cited pharmacologists worldwide and is in the top 5 percent in NIH research funding over the past 25 years.

LAUREN E. BLACK, PH.D., is employed by Charles River Laboratories (CR) as a Senior Scientific Advisor in CR’s Navigator Services. She left FDA and now consults internationally on drug program strategy, biologics, translational research, and safety programs. She has over 20 years’ experience in drug development, clinical risk mitigation, regulatory negotiations, and strategic planning. Dr. Black graduated from Carnegie Mellon University and studied physiologic responses to opiates/shock. With a doctorate in Pharmacology and Toxicology from the VCU School of Medicine, she did her postdoctoral work at NIH/NINDS, publishing in the area of dopamine receptor regulation. In 1991, Dr. Black went to FDA/CDER (Drugs) as a Reviewing Pharmacologist and reviewed over 40 INDs. Her reviews supported NDA approvals for Aldara, Abreva, Flumadine, Prograf, CellCept, Neoral, and Rapamune. These latter drugs include the primary immunosuppressants still used in transplantation. She worked on committees producing FDA guidance on immunotoxicology, rheumatoid arthritis, xenotransplantation, biologics, and oligonucleotides. She represented FDA views on risk assessment and safety programs at scientific conferences. In 1995, Lauren transferred to FDA/CBER (Biologics) where she reviewed protein drugs for chronic diseases such as Crohn’s, RA (Humira), MS (Tysabri), and psoriasis (Amevive). She promoted the use of homolog monoclonals for nonclinical safety evaluation. This novel safety program approach supported the marketing approvals for Remicade, Raptiva, and Cimzia. She also reviewed several monoclonals that caused cytokine release in patients. Dr. Black was invited to brief the Dermatologic Advisory Committee on risk mitigation employing PK/PD-based dose regimens. She co-led the committee that produced the FDA guidance on first-in-human starting dose. These efforts presaged the later CHMP guidance on high-risk therapeutics. In CBER, Dr. Black reviewed over 400 INDs and eight marketing applications,

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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including Carticel, the first FDA-approved cell/regenerative medicine product. She also reviewed bone marrow, human, and xenogeneic cell-based products for severe and life-threatening diseases of both adults and children. She addressed the Advisory Panel on xenotransplantation on preclinical support for clinical trials. Dr. Black participated in working groups on Tissue Engineering and co-authored the nonclinical section of the CBER guidance on xenotransplantation products. This document remains the only FDA guidance pertaining to nonclinical evaluation of cellular products. Dr. Black has subsequently published and taught in the areas of risk assessment, protein and cell therapy, translational medicine, and immunotoxicology. She is a full member of the Society of Toxicology. Additionally, she serves on advisory boards for pharma and NIH. Dr. Black is Chair of the Special Biologics-Expert Working Group, a BIO/BioSAFE committee. She is a CR delegate to the International Life Sciences Institute/HESI and a member of the NC3Rs committee on nonhuman primate use in biologics development. Dr. Black owns no stock in any pharmaceutical development firms.

LUCIANA BORIO, M.D., is a Senior Advisor for Medicine and Public Health in the Office of the Chief Scientist, U.S. Food and Drug Administration (FDA) and Acting Director of the Office of Counterterrorism and Emerging Threats, where she is leading the implementation of FDA’s Medical Countermeasures Initiative. Dr. Borio joined the FDA in 2008 as a medical reviewer in the Office of Vaccine Research and Review, Center for Biologics Evaluation and Research. Prior to joining the FDA, Dr. Borio was a Senior Associate at the Center for Biosecurity of UPMC and Assistant Professor of Medicine at the University of Pittsburgh from 2003–2008, where she worked to develop policies to improve the nation’s preparedness for bioterrorism and to support threat assessments, medical countermeasure development, and medical response plans. Prior to that, she was a Senior Fellow at the Johns Hopkins University Center for Civilian Biodefense Strategies and Assistant Professor of Medicine in the Division of Infectious Diseases at Johns Hopkins University. Dr. Borio served at the U.S. Department of Health and Human Services (HHS) as an Advisor on Biodefense Programs from 2001–2008. At HHS, she implemented and managed mathematical modeling projects to assess the health effects of bioterrorism on civilians and to inform medical countermeasure procurement activities for the Office of Preparedness and Response. Dr. Borio is an infectious disease physician and continues to practice medicine at Johns Hopkins Hospital. She serves on the Pandemic Influenza Task Force of the Infectious Diseases Society of America. She has previously served on their Global and Public Health Committee and on the National Research Council’s committee on Methodological Improvements to the

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Department of Homeland Security’s Biological Agent Risk Analysis. She has lectured and published extensively on infectious diseases and biodefense. Dr. Borio is a member of the Infectious Diseases Society of America. Dr. Borio received a B.S. in 1992 and an M.D. in 1996 from the George Washington University. She completed residency in 1999 in Internal Medicine at the New York Presbyterian Hospital-Cornell Medical Center, and subsequently completed a combined fellowship in Infectious Diseases (at Johns Hopkins University) and Critical Care Medicine (at the National Institutes of Health).

DR. JOHN BRADLEY, M.D., received his pediatric infectious diseases training at Stanford University. He has focused his research on the clinical aspects of infectious diseases with antibacterial, antiviral, and antifungal agents. He served on the American Academy of Pediatrics Committee on Infectious Diseases from 2004–2010, helping to create national policies for infectious diseases in pediatrics. He is currently on the Pediatric Infectious Diseases Society Council. Dr. Bradley is also currently the Chair of the AAP/IDSA/PIDS/ATS Writing Group for Guidelines for Pediatric Community-Acquired Pneumonia. He is on the FDA’s Advisors and Consultants Staff, having served for six years on the AntiInfective Drug Advisory Committee. He sits on the Infectious Diseases Society’s Task Force on Antimicrobial Drug Availability, whose charge is to bring together members of Congress, FDA, and the pharmaceutical industry to facilitate antibiotic discovery and approval for antibiotic-resistant bacterial pathogens. Representing IDSA, he is a member of the FNIH Biomarkers Consortium, charged with assisting develop current clinical trial designs for ABSSSI, CABP that are acceptable to FDA, academia, and the pharmaceutical industry. He has testified on behalf of the American Academy of Pediatrics before the House Subcommittee on Health (Waxman) on the need for new antibacterial agents for children. He has been the Director of the Division of Infectious Diseases at Rady Children’s Hospital–San Diego for the past 22 years, and is Chief, Division of Infectious Diseases, Department of Pediatrics, at the University of California, San Diego School of Medicine.

D. BRUCE BURLINGTON, M.D., an infectious disease internist, is a well-known independent consultant on pharmaceutical product development and regulatory affairs. He has special interests in helping companies plan development of their drugs based on FDA and European Union requirements; prepare for meetings with FDA or its advisory committees; develop risk management plans; conduct product due diligence evaluations;and set up process, organizations, and staffing plans to achieve their regulatory obligations. He has been a senior executive in both FDA

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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and the pharmaceutical industry. He blends long experience in development strategy with insightful analysis of the underlying medical problems, patient needs, how the results will be viewed by FDA and EMEA, and what outcomes will result in commercial success. Dr. Burlington was Executive Vice President and worldwide head of Regulatory Affairs, Human Safety, and Quality at Wyeth. He led the company in the development and U.S. and global registration of many products as well as improving Wyeth’s compliance posture. He also successfully navigated the company through an FDA consent degree. During these 8 years, as a member of many Wyeth governance councils and committees, including the executive licensing, capitol expenditure, and commercial councils, he participated broadly and in depth analyzing the complex business forces driving industry. Before joining Wyeth, Dr. Burlington served at FDA for 17 years. He was the first physician named as director at of the Center for Devices and Radiological Health (CDRH) where he led major changes, increased the rigor of clinical investigation for medical devices, and championed innovations in how the center could work more productively with industry. Before that he was a research immunologist and then a manager in both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). In these centers he had responsibility for viral vaccines, investigational biologics, BLA review, NDA approvals, and generic drugs. As medical Deputy Director in CDER (acting), he also oversaw policy and compliance decisions for pharmaceuticals. Dr. Burlington is a frequent public speaker on drug development, risk management, and how to work successfully with regulators. He has organized and chaired numerous symposia and courses in the field including the American Course in Drug Development and Regulatory Science, and has been a member of several trade association and public committees as well as four boards of directors (currently AstraZeneca and Cangene) and three pharmaceutical company scientific advisory boards.

DRUSILLA BURNS, PH.D., graduated from Tulane University with a major in chemistry. She received her Ph.D. in biochemistry from the University of California, Berkeley, after which she completed a postdoctoral fellowship at the National Institutes of Health. She then joined the Center for Biologics Evaluation and Research, FDA, where she is currently Chief of the Laboratory of Respiratory and Special Pathogens. Her research focuses on microbial pathogenesis, host response, and vaccines against bacterial diseases. She has served on the editorial boards of Infection and Immunity and the Journal of Biological Chemistry, and has served as an Editor of Infection and Immunity. At FDA, she is involved in the regulation of anthrax, pertussis, and other bacterial vaccines.

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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GAIL H. CASSELL, PH.D., is a Visiting Professor in the Department of Social Medicine, Harvard Medical School, and Vice President of TB Drug Discovery of the not-for-profit Infectious Disease Research Institute in Seattle. Dr. Cassell has recently retired as Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company in Indianapolis, Indiana. She is former Charles H. McCauley Professor and Chair of the Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from the National Institutes of Health (NIH) during the decade of her leadership. She obtained her B.S. from the University of Alabama in Tuscaloosa and in 1993 was selected as one of the top 31 female graduates of the twentieth century. She obtained her Ph.D. in microbiology from the University of Alabama at Birmingham and was selected as its 2003 Distinguished Alumnus. She is past President of the American Society for Microbiology (the oldest and single largest life sciences organization, with a membership of more than 42,000). She was a member of the NIH Director’s Advisory Committee and of the Advisory Council of the National Institute of Allergy and Infectious Diseases. She was named to the original Board of Scientific Councilors of the Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), and served as chair of the board. She recently served a 3-year term on the advisory board of the Director of CDC and as a member of the Secretary of Health and Human Services’ Advisory Council of Public Health Preparedness. Currently she is a member of the FDA Science Board. Since 1996 she has been a member of the U.S.–Japan Cooperative Medical Science Program, responsible for advising the respective governments (U.S. State Department/Japanese Ministry of Foreign Affairs) on joint research agendas. She has served on several editorial boards of scientific journals and has authored more than 250 articles and book chapters. Dr. Cassell has received national and international awards and an honorary degree for her research in infectious diseases. She is a member of the IOM. Dr. Cassell has been intimately involved in the formulation of science policy and legislation related to biomedical research and public health. For 9 years she was chair of the Public and Scientific Affairs Board of the American Society for Microbiology; she has served as an advisor on infectious diseases and indirect costs of research to the White House Office of Science and Technology Policy, and has been an invited participant in numerous congressional hearings and briefings related to infectious diseases, antimicrobial resistance, and biomedical research. She has served two terms on the Liaison Committee on Medical Education (LCME), the accrediting body for U.S. medical schools, as well as other national committees involved in establishing policies on training in the biomedical sciences.

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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She recently completed a term on the Leadership Council of the School of Public Health of Harvard University. Currently she is a member of the Executive Committee of the Board of Visitors of Columbia University School of Medicine, the Executive Committee of the Board of Directors of the Burroughs Wellcome Fund, Research!America, and the Advisory Council of the Johns Hopkins School of Nursing.

MAY C. CHU, PH.D., is the Director of the Laboratory Science Policy and Practice Program Office (LSPPPO). Dr. Chu draws upon her public health laboratory, applied research experiences as well as her laboratory program policy and practice experience to lead the LSPPPO. Dr. Chu began her career with CDC in the Division of Vector-Borne Infectious Diseases in Ft. Collins, Colorado as a Research Microbiologist analyzing the molecular epidemiology of dengue viruses and continued there as the chief of the Bacterial Zoonotic Diseases Diagnostic and Reference Section focusing on diagnostic/applied research on plague and tularemia and supporting diagnostic research work on borreliosis. Just before joining LSPPPO in November 2010, Dr. Chu completed 6.5 years service at the World Health Organization (WHO) where she served as team leader for Laboratory Alliances and Biosafety in the International Health Regulations Coordination Department and briefly served as the Associate Director for Laboratory Science in the Division of Preparedness and Emerging Infections, National Center for Emerging and Zoonotic Infectious Diseases. LSPPPO is positioned to champion for quality laboratory services serving the public health agenda through facilitating, coordination and supporting cross-cutting laboratory functions that impact policy and practice. A facilitated global discussion on the direction of how laboratory services should look like by“2020 and beyond” is critical in austere times against a background of rapidly evolving technological advances. The resources within LSPPPO and the strong partnerships with CDC colleagues and external stakeholders are critical to this effort. Dr. Chu serves as the Chair of the International Board of the American Society for Microbiology that focuses on promoting microbiology and to connect the microbiologists. Dr. Chu received her B.S. from Michigan State University majoring in Microbiology and Public Health. She received her doctorate degree in Tropical Medicine and Medical Microbiology from the John A. Burns School of Medicine, University of Hawaii at Manoa.

ED COX, M.D., M.P.H., is currently the Director of the Office of Antimicrobial Products within the Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Dr. Cox received his undergraduate degree in chemistry from the University of North Carolina at Chapel Hill and his medical degree from the University of North

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Carolina School of Medicine. He completed an internship and residency in Internal Medicine at the Hospital of the University of Pennsylvania in Philadelphia. He went on to complete a fellowship in Infectious Diseases at the National Institute of Allergy and Infectious Diseases at the NIH in Bethesda, Maryland. Dr. Cox is board certified in Internal Medicine and Infectious Diseases.

CHARLES DAITCH, PH.D., is Founder and President, Akonni Biosystems. Dr. Daitch has 20 years experience encompassing a broad range of disciplines including chemistry, biology, biosensors and chemical/biological defense. He directs multidisciplinary teams of scientists focused on the development of infectious disease diagnostic tools that implement novel sample preparation, molecular recognition, and optical-based detection technologies. Dr. Daitch has significant experience in sensor system product development employing (1) automated miniaturized bio-molecule purification and signal amplification in complex samples, and (2) integration of such microfabricated components as microarrays, thermal electric control, microfluidic fluid flow, and electro-optical detection. He brings strong product development and R&D experience from the NIH/FDA, the USDA, and Sandia National Labs. Dr. Daitch was recruited by HandyLab Inc., a microfluidics diagnostics company, to serve on the executive management team as Vice President of R&D. In this role, he assisted in strategic planning, business alliances and agreements, and R&D collaborations. Prior, Dr. Daitch launched a biodefense R&D business unit for Veridian Corporation, a premier defense contractor, and led the growth of the operation to 24 employees and $5M in annual revenue. He has four U.S. patents, 17 peer-reviewed publications, and has served as principle investigator on over $12 million in government grants and contracts.

DEBBIE DRANE, B.SC., has been with CSL in the R&D Division for over 25 years. During this time she has had a number of roles and has substantial experience in most areas of vaccine development. In particular she has worked on CSL’s proprietary ISCOMATRIX adjuvant for many years in both technical and management positions, playing a key role in the successful development of the technology. As the SVP R&D reporting to the CSO, Ms. Drane is responsible for all activities related to the ISCOMATRIX adjuvant technology including research, manufacturing and commerialization as well as maintaining successful relationships with major partners of the technology such as Merck and Pfizer.

DAVID J. ECKER, PH.D., is a Divisional Vice President and a General Manager at Abbott. Dr. Ecker was the founder of Ibis Biosciences, now a

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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subsidiary of Abbott Molecular, Inc., and was a co-founder of Isis Pharmaceuticals. Along with his core team, he was a primary inventor of the Ibis technology and Ibis T5000 (formerly TIGER) technology, now commercially marketed as the Abbott PLEX-ID. The technology was developed for infection control, infectious disease diagnostics, and biological weapons defense and human and microbial forensics, sponsored by DARPA, CDC, NIAID, FBI, DHS, and other U.S. government agencies. He is currently responsible for Abbott’s Ibis site in Carlsbad, California, which has approximately 80 employees. He is responsible for the science, patents, business development, strategic direction, and the management of corporate and government partnerships. Dr. Ecker has over 28 years of experience in the pharmaceutical and biotechnology industry in drug discovery and diagnostic platform technology development. Dr. Ecker received a B.A. in Biology and Chemistry from the College of New Jersey, NJ, and his Ph.D. in Biochemistry from Utah State University, Utah.

RAMON FELCIANO, PH.D., is the Founder and SVP of Research, Ingenuity Systems. Dr. Ramon Felciano was born in San Francisco, California. He holds a Ph.D. and M.S. in Biomedical Informatics, a B.S. in Computer Science, and a B.A. in English and French Literature from Stanford University. While at Stanford, Dr. Felciano performed research on semi-automated methods for designing intelligent user interfaces; scientific information visualization; and distributed, knowledge-based biomedical information systems. His doctoral research (with Dr. Russ Altman) focused on automatic generation of biomedical graphics and their use as the bases for biomedical user interfaces. Dr. Felciano is a founding member of the RiboWeb, a seminal project to build a World Wide Web-based knowledge base to support collaborative molecular biology over the Internet. Dr. Felciano’s other research efforts include a patented user-tracking technology for the World Wide Web; and a formal study of Human Error in Medicine and its impact on the design of biomedical information systems. Dr. Felciano co-founded Ingenuity in 1998 to improve human health by increasing research productivity in the scientific enterprise. Dr. Felciano leads the company’s strategic R&D and collaborations in countermeasures research; systems biology; and predictive analytics for drug and biomarker discovery, large-scale scientific data integration, scientific drug discovery services, and research informatics for distributed drug discovery and development. The resulting scientific tools deliver systems biology expertise to biologists, chemists, clinical researchers, and informatics specialists in global pharmaceutical R&D organizations as well as government, academic, and not-for-profit research institutions. Ingenuity’s technology and discovery approach has been validated by tens of thousands of global researchers that have successfully applied the

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Ingenuity platform and discovery approach across all major therapeutic research areas to improve discovery insights and speed time to market for drugs and diagnostics. Prior to founding Ingenuity, Dr. Felciano co-founded SUMMIT, the Stanford University Medical Media and Information Technologies lab, where he held the position of Associate Director for 4 years, and Digital Alchemy, a strategic research and design consultancy based in San Francisco, California.

WILLIAM E. FOGLER, PH.D., has extensive experience in translational research with a proven track record of designing and managing multiple therapeutic projects from discovery through early clinical evaluation. His insightful understanding of applied therapeutics was honed during a decade-long tenure as an innovative investigator at the National Institutes of Health during which he held a dual appointment at the National Cancer Institute’s Cancer Therapy Evaluation Program and Laboratory of Experimental Immunology. He joined Intrexon from EntreMed, Inc., of Rockville, Maryland, where he served as Senior Director of Translational Research. Dr. Fogler received his Ph.D. in Pathology from the University of Maryland at Baltimore, School of Medicine; his M.S. in Biomedical Science from Hood College in Frederick, Maryland;and his B.S. in Biology from the University of Maryland at College Park. He is an accomplished scientist-inventor with 68 peer-reviewed publications, 16 book chapters, and 15 patents to date.

RICHARD FORSHEE, PH.D., is the Associate Director for Research for the Office of Biostatistics and Epidemiology at the Center for Biologics Evaluation and Research in the U.S. Food and Drug Administration. He provides leadership and support across a range of research projects on genomics, bioinformatics, clinical trial research, and other areas. Previously, Dr. Forshee developed quantitative risk assessment models to improve the understanding of the likely public health impact of risk management options for biologics products, such as blood products, vaccines, and human cell and tissue products. He has recently given presentations to the Blood Products Advisory Committee on risk assessments of selective testing strategies for Trypanosoma cruzi and on the public health impact of hypothetical home-use HIV tests with different performance characteristics. Dr. Forshee has published numerous scientific articles on public health issues. Before joining FDA, he was a Research Associate Professor and the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.

HENRY L. FRANCIS, M.D., is Deputy Office Director, Office of Surveillance and Epidemiology, at FDA’s Center for Drug Evaluation and Research

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Food (CDER). In October 2007, Dr. Francis joined the Office of Surveillance and Epidemiology (OSE) in CDER. Dr. Francis works with the OSE director to lead five divisions of pharmacy and clinical scientists in the detection and study of adverse medical events occurring after the release of new drugs into the American health market, also called the postmarket period. Dr. Francis’s specific interest is in the development of data-mining techniques to enhance pharmacovigilance capabilities in national medication use and health care databases. Prior to working in FDA, Dr. Francis was a basic and clinical researcher in the National Institute of Allergy and Infectious Diseases. As an AIDS clinical investigator, he worked in several clinical and epidemiologic research projects conducting AIDS and tropical research projects in the Democratic Republic of the Congo (DRC, formerly known as Zaire) and other projects in the Caribbean and the South Pacific. In the DRC, Dr. Francis was the Director of the U.S. Public Health Service &Belgian Project SIDA (AIDS research) Research Laboratories in Kinshasa. Dr. Francis served as the first Director of the National Institute on Drug Abuse’s (NIDA) Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA). CAMCODA’s mission was to establish sustainable AIDS-specific research projects in coordination with the other NIDA projects investigating drug abuse prevention and treatment. As a clinician, Dr. Francis was an assistant professor of medicine at the Johns Hopkins University School of Medicine’s Division of Infectious Diseases where he served as the Principal Medical Officer of the Broadway Women’s Drug Use Center and as the Ryan White Title III investigator and Medical Director of the Baltimore City Department of Health’s Sexually Transmitted Diseases clinics. Dr. Francis was born in Waterbury, Connecticut, is a graduate of Amherst College, and received his M.D. from the Howard University College of Medicine in Washington, D.C. He completed his Internal Medicine residency training at the Long Beach Veterans Administration Hospital in California and his infectious diseases specialty training at the Johns Hopkins Hospital Division of Infectious Diseases, Baltimore, Maryland.

DAVID M. FRUCHT, M.D., was born in Maryland. He attended the University of Virginia, receiving an interdisciplinary B.A. degree in the Echols Scholars Program in 1986. He attended Duke University for medical school and internal medicine residency training, which he completed in 1993. He then undertook infectious diseases training at NIAID/NIH (1993–1997), while conducting research on patients with immunodeficiencies in the laboratory of Dr. Steven Holland. From 1997 to 2001, he pursued a second research fellowship program studying mechanisms of signal transduction in the laboratory of Dr. John O’Shea. Subsequently, he joined the

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Division of Monoclonal Antibodies as a principal investigator where he has studied the mechanisms of action of anthrax lethal toxin. Dr. Frucht’s laboratory has published numerous original research papers and review articles related to anthrax toxin. Over the past year he was awarded two U.S. patents for the development of new anthrax toxin bioassays. Since 2008, Dr. Frucht has served as the Chief of the Laboratory of Cell Biology. In this capacity, he has either primary or supervisory oversight for nearly all monoclonal antibodies used as MCMs in the United States. In addition to his routine duties, Dr. Frucht is a commissioned officer in the U.S. Public Health Service, having deployed on several disaster missions including Hurricane Katrina.

JOHN GLASS, PH.D., is a Professor in the JCVI Synthetic Biology Group. Glass is part of the Venter Institute team that recently announced the creation of a synthetic bacterial cell. In reaching this milestone the Venter Institute scientists developed the fundamental techniques of the new field of synthetic genomics including genome transplantation and genome assembly. His expertise is in molecular biology, microbial pathogenesis, RNA virology, and microbial genomics. At the JCVI he led the mycoplasma minimal genome, genome transplantation projects, and projects studying other mycoplasma and ureaplasma species. He has also participated in environmental genomics and viral metagenomics work. Glass and his Venter Institute colleagues are now using these and new synthetic genomics approaches to create cells and organelles with redesigned genomes to make microbes that can produce biofuels, pharmaceuticals, and industrially valuable molecules. Additionally, Glass is leading a new Venter Institute effort that uses synthetic genomics methods to improve the speed of production and efficacy of influenza virus vaccines. Glass is an adjunct faculty member of the University of Maryland at College Park Cellular and Molecular Biology Program. Prior to joining the JCVI Dr. Glass spent 5 years in the Infectious Diseases Research Division of Eli Lilly. There he directed a hepatitis C virology group and a microbial genomics group (1998–2003). Glass earned his undergraduate (biology) and graduate degrees from the University of North Carolina at Chapel Hill. His Ph.D. work was on RNA virus genetics in the laboratory of Gail Wertz. He was on the faculty and did postdoctoral fellowships in the Microbiology Department of the University of Alabama at Birmingham in polio virology with Casey Morrow and mycoplasma pathogenesis with Gail Cassell (1990–1998). On sabbatical leave in Ellson Chen’s lab at Applied Biosystems Inc. (1995–1997) he sequenced the genome of Ureaplasma parvum and began his study of mycoplasma genomics.

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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BASIL GOLDING, M.D., was born in Johannesburg, South Africa. He attended WITS Medical School and received his M.B. B.Ch. in 1968. He specialized and is board certified in Internal Medicine and Rheumatology. He performed research as a fellow at NIH and FDA. In 1995 he was appointed Chief, branch of Plasma Derivatives, and in 2004 Director, Division of Hematology, OBRR/CBER. He has published over 50 papers in peer-reviewed immunology journals and is currently involved in Toll-like receptor research.

HANA GOLDING, PH.D., is the Chief of the Laboratory of Retrovirus Research at the Division of Viral Products, Center for Biologics Evaluation and Research (CBER), FDA. Dr. Golding received her bachelor’s degree at the University of Jerusalem, Israel, and her Ph.D. degree from Oregon Health Sciences University. She also received postdoctoral training at the Experimental Immunology Branch of the National Cancer Institute. Dr. Golding has authored more than 100 research papers and book chapters on immunology, virology, and infectious diseases topics. Main areas of expertise are vaccines against viral pathogens including HIV, smallpox, and influenza, adjuvants mode of action, impact on immune responses, and biomarkers of in vivo toxicity.

JESSE L. GOODMAN, M.D., M.P.H., became Chief Scientist and Deputy Commissioner for Science and Public Health of FDA in 2009. He has broad responsibility for and engagement in leadership and coordination of the agency’s crosscutting scientific and public health efforts. From 2003 to 2009, he was Director of FDA’s Center for Biologics Evaluation and Research (CBER), which oversees medical and public health activities critical to U.S. and global preparedness concerning the development, evaluation, safety, quality, and availability of biologics. A graduate of Harvard, he received his M.D. from the Albert Einstein College of Medicine and did residency and fellowship training at the Hospital of the University of Pennsylvania and at UCLA (where he was also Chief Medical Resident). Prior to joining FDA, he was Professor of Medicine and Chief of Infectious Diseases at the University of Minnesota, where he directed the multihospital infectious diseases research, training, and clinical programs, and where his NIH-funded laboratory first isolated and characterized Anaplasma phagocytophilum, the infectious agent causing a new tick-borne disease, human granulocytic ehrlichiosis. He has authored numerous scientific papers and edited the book Tick Borne Diseases of Humans published by ASM Press in 2005. Dr. Goodman has been elected to the American Society for Clinical Investigation and to the Institute of Medicine of the National Academy of Sciences, where he is a longstanding member of the Forum on Emerging Threats. He is an

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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active clinician and teacher who is board certified in Internal Medicine, Oncology and Infectious Diseases and is Staff Physician and Infectious Diseases Consultant at both the National Naval and Walter Reed Army Medical Centers, and is Adjunct Professor of Medicine at the University of Minnesota.

GIGI KWIK GRONVALL, PH.D., is a Senior Associate at the Center for Biosecurity of UPMC and an Assistant Professor of Medicine at the University of Pittsburgh. She is a term member of the Council on Foreign Relations, serves on the American Association for the Advancement of Science (AAAS) Committee on Scientific Freedom and Responsibility, and has been selected to participate in the European Union Visitors Pro-gramme for 2011. Dr. Gronvall’s work addresses the role of scientists in biodefense—how they can diminish the threat of biological weapons and how they can contribute to an effective technical response against a biological weapon or a natural epidemic. Dr. Gronvall served as the Science Advisor of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism from April 2009 until the commission ended in February 2010. She is an Associate Editor of the quarterly journal Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. Dr. Gronvall received a B.S. in biology from Indiana University, Bloomington, and a Ph.D. from Johns Hopkins University.

RICHARD J. HATCHETT, M.D., is Chief Medical Officer and Deputy Director for Strategic Sciences and Management at the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services. His primary responsibilities include oversight of programs relating to strategic science and innovation, strategic affairs and reporting, the development of science and preparedness policy, human resources, communications, and organizational marketing. Previously, he served as Director for Medical Preparedness Policy on the White House National Security Staff where he worked on a wide array of issues related to medical countermeasures development, the 2009 H1N1 pandemic, and pandemic preparedness more broadly. In 2005–2006, he served as Director for Biodefense Policy on the White House Homeland Security Council and was a principal author of the National Strategy for Pandemic Influenza Implementation Plan. In this capacity, he helped set policy and devise strategies to mitigate the consequences of a pandemic and promote pandemic preparedness. From 2005 to 2011, he served as Associate Director for Radiation Countermeasures Research and Emergency Preparedness at the National Institute of Allergy and Infectious Diseases. Dr. Hatchett completed his undergraduate and medical educations at Vanderbilt University, an internship and residency in Internal

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Medicine at New York Hospital–Cornell Medical Center, and a fellowship in Medical Oncology at the Duke University Medical Center.

JUDITH HEWITT, PH.D., is Chief of the Research Resources Section in the Office of Biodefense Research Affairs, DMID/NIAID/NIH. Her group is responsible for several resources within the Division of Microbiology and Infectious Diseases, namely contract programs providing animal models of infectious diseases, microbiology and infectious diseases biological resource repository, and in vitro assessments for antimicrobial activity. These programs all build upon successful prior efforts dedicated to biodefense, which are now being broadened to provide critical infrastructure capabilities for all pathogens of interest to DMID. Dr. Hewitt earned her Ph.D. from Johns Hopkins University and completed postdoctoral fellowships at NICHD and the Cleveland Clinic Foundation before taking positions at the University of Maryland and NIAID, where she ran transgenic and knockout mouse facilities focused on developing models for immunological studies.

SALLY HOJVAT, PH.D., M.SC., currently holds the position of Director of the Division of Microbiology Devices, in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety, at FDA. Prior to joining FDA in 2003, Dr. Hojvat’s experience included 18 years in the U.S. IVD industry where she held positions in the areas of IVD development and support, quality control, scientific affairs, and clinical research. Dr. Hojvat received a B.Sc. (Hons) from the University of Wales, UK, a M.Sc. in Microbiology from the University of Alberta, Canada, and a Ph.D. in Biochemistry from Loyola University Medical School, Chicago. She also completed postdoctoral training fellowships in Clinical Chemistry from Loyola Medical School and Pharmacology from the University of Chicago.

ROBERT HOUSE, PH.D., is President of DynPort Vaccine Company LLC (DVC), a biotechnology firm in Frederick, Maryland, that manages product development programs for U.S. government agencies and provides consulting and technical and program management services to the biotechnology and pharmaceutical industries. The DVC portfolio includes innovative solutions for public health threats, particularly vaccines and therapeutics to protect against emerging infectious diseases, biological and chemical warfare threat agents, and seasonal and pandemic influenza. Prior to joining DVC, Dr. House worked at Covance Laboratories in Madison, Wisconsin, and IIT Research Institute in Chicago, Illinois, where he managed programs in immunotoxicology and safety assessment of pharmaceutical and biotechnology products. He has more than 20 years of experience in biomedical research and development, specializing in the assessment of inadvertent and therapeutic immunomodula-

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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tion. Dr. House earned his Master of Science in Public Health and Ph.D. degrees in Medical Parasitology from the University of North Carolina at Chapel Hill School of Public Health. He is the author or co-author of more than 100 journal articles, book chapters and books covering immunology, toxicology, infectious disease and biodefense, and has participated in numerous working groups and expert panels in the field of immunotoxicology and biodefense. He is a frequent speaker at scientific conferences and university courses, and is a board member of the Tech Council of Maryland.

JEAN HU-PRIMMER, M.S., is a Senior Advisor for Regulatory Policy in the Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, U.S. Food and Drug Administration (FDA). She serves as Acting Director of the FDA Medical Countermeasures Initiative (MCMi) Regulatory Science, where she is leading the strategic development and coordinating the implementation of FDA’s MCMi Regulatory Science program. Ms. Hu-Primmer began civil service career as a as a researcher-reviewer in the Division of Viral Products, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research (CBER), FDA. During the early years of her tenure with the federal government, Ms. Hu-Primmer worked as a research scientist both at FDA CBER and at the Centers for Disease Control and Prevention in the area of influenza vaccine development and the pathogenesis of influenza viruses, including influenza A/H5N1 respectively. In the latter capacity, she worked to better understand host-virus interactions and the genetic/antigenic determinants of virulence specific to highly pathogenic avian influenza (HPAI) viruses. Ms. Hu-Primmer furthered her federal career as a regulatory affairs scientist for the National Institutes of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases, and her responsibility included management of the entire influenza vaccine regulatory portfolio for the Division-sponsored clinical trials. Her regulatory submissions for the clinical development of the H5N1 vaccine provided the basis for the licensure of the sanofi pasteur H5N1 vaccine in the U.S. pandemic vaccine stockpile. In her current capacity, Ms. Hu-Primmer continues to serve as an Agency-wide subject matter expert related to influenza and influenza countermeasures as the chair of the FDA Pandemic Flu Task Force. She is the Agency focal point coordinating all influenza activities across the medical product Centers, and is the Agency representative to various influenza working groups constituted within the federal government. Likewise, as acting Director for the FDA MCMi Regulatory Science, she speaks on behalf of the Agency regarding the progress of various regulatory science projects and programs. Ms. Hu-Primmer holds a B.S. in microbiology from Cornell University and a M.S. in cellular and molecular biology from the Univer-

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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sity of West Florida, completing a postgraduate defense regarding the enhancement of the degradation of aromatic chlorinated hydrocarbons using a cloned bacterial hemoglobin gene in Burkholderia cepacia.

PATRICK IVERSEN, PH.D., was born in Carlsbad, New Mexico. He attended Westminster College with a major in Biological Sciences, completed his Ph.D. in Biochemical Pharmacology at the University of Utah School of Medicine, and completed postdoctoral training at the Eppley Institute for Cancer Research in Omaha. His experience in drug development extends back nearly 20 years with the initial seven years as a professor of pharmacology at the University of Nebraska Medical Center (UNMC). Thereafter, he worked on programs from 1990 to 1997 involving RNA therapeutics for cancer with leukemia as a primary area of investigation. He left UNMC in 1997 and led programs in cardiovascular disease, drug metabolism, muscular dystrophy, and antiviral drug development at AVI BioPharma. He developed broad experience in nearly every project from drug discovery, intellectual property protection, hypothesis development and study design, publication of scientific findings, preclinical toxicology design and evaluation, and preparation of IND and clinical protocols. He has served on multiple NIH study sections, reviewed for 37 different journals, and consulted more than a dozen different biotechnology companies.

PRAVIN R. JADHAV, PH.D., FCP, is Team Leader and Expert Regulatory Scientist in the Division of Pharmacometrics of the Office of Clinical Pharmacology at the U.S. food and Drug Administration (FDA). He has worked on aspects of exposure–response to aid in important regulatory decisions such as drug–drug interactions, dose adjustment in special populations, evidence of effectiveness, benefit/risk, and labeling issues. He has several publications in peer-reviewed journals and presentations at international conferences. He has received several awards and honors at FDA, including the FDA Outstanding Service Award in 2008. Dr. Jadhav received his BPharm and MPharm from India, and a Ph.D. in Pharmaceutical Sciences from the Medical College of Virginia Commonwealth University in May 2006. He is a Fellow of the American College of Clinical Pharmacology.

J. KEVIN JUDICE, PH.D., is President and CEO, Achaogen. In addition to setting corporate strategy and building the leadership team, as President and CEO, Dr. Judice has also served as the company’s Chief Scientific Officer. In this role, he has been responsible for the overall scientific strategy, research priorities, and portfolio management. Previously, Dr. Judice held positions of increasing responsibility at Genentech and Theravance. As one of the first 10 employees at Theravance, he played a key role in defining the company’s scientific strategies and led the team that discov-

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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ered telavancin, a new antibiotic for the treatment of multidrug-resistant “superbugs.”Dr. Judice graduated magna cum laude with a B.S. in Chemistry from Texas A&M University. Following that, he received his Ph.D. in Organic Chemistry from UCLA and was an NIH postdoctoral fellow at UC Berkeley. In 2008, Dr. Judice was selected as a Henry Crown Fellow by the Aspen Institute. He is an author and inventor on over two dozen scientific papers and patents.

MICHAEL KATZE, PH.D., has over 30 years of experience as a virologist and is a leader in applying genomic and proteomic technologies to the study of virus–host interactions and the innate immune response. He is an author of over 220 papers and reviews, of which over 50 are related to the use of functional genomic approaches to study virus–host interactions. He heads a laboratory of over 35 individuals and has considerable administrative credentials and experience managing large research endeavors. Dr. Katze is Program Director of a NIDA P30 Center focused on using genomic and proteomic technologies to study hepatitis C virus (HCV) and HCV-associated liver disease. This Center includes 23 key personnel and 23 other significant contributors from over a dozen academic institutions and three corporations. In addition, Dr. Katze serves as Associate Director at the Washington National Primate Research Center and is Head of the Center’s Division of Functional Genomics and Infectious Disease, which is focused on developing genomic and proteomic resources for use in nonhuman primate research. In October 2008, Dr. Katze was awarded a NIAID contract to use systems biology approaches to develop computational models of the host response to respiratory virus infection.

GEORGE KORCH, PH.D., is a Senior Science Advisor for the Principal Deputy Assistant at the Office of Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services and is a Visiting Professor in the Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health. Dr. Korch retired from the U.S. Army Medical Department in 2008, where he had served in a number of leadership roles, including the Commander of the U.S. Army Medical Research Institute of Infectious Diseases and the Director of the Department of Defense Medical Chemical and Biological Defense Research Program. He also served as one of the first Directors of the National Biodefense Analysis and Countermeasure Center, Department of Homeland Security. His area of expertise is in viral and rickettsial zoonotic diseases and in medical countermeasure development (vaccines, therapies, and diagnostics) for biodefense needs. He serves or has served on such committees as the Institute of Medicine’s Forum on Microbial Threats, the State of Maryland’s Life Sciences Advisory Board,

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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and with the Standards Development Committee for the American Type Cell Culture. Dr. Korch attended Boston University where he earned a B.S. in biology in 1974, followed by postgraduate study in mammalian ecology at the University of Kansas from 1975 to 1978. He earned his Ph.D. in immunology and infectious diseases from the Johns Hopkins School of Hygiene and Public Health in 1985, followed by postdoctoral experience at Johns Hopkins from 1985 to 1986.

MICHAEL KURILLA, M.D., PH.D., is the director of the Office of Biodefense Research Affairs and associate director for Biodefense Product Development for the National Institute of Allergy and Infectious Diseases (NIAID). His primary role is to provide overall institute coordination for product development of medical countermeasures against bioterror threats. At the University of Virginia, he was an assistant professor of pathology as well as co-director of the Laboratory of Molecular Diagnostics and associate director for clinical microbiology. Dr. Kurilla moved to the private sector working in anti-infective drug development at Dupont Pharmaceuticals, Bristol-Myers Squibb, and Wyeth. He subsequently joined NIAID as a medical officer. In 2005, he was named to his current positions within NIAID. He received his undergraduate degree in chemistry from the California Institute of Technology. He earned his M.D.-Ph.D. from Duke University. Dr. Kurilla took his postgraduate medical training in pathology at the Brigham & Women’s Hospital in Boston, Massachusetts, and a postdoctoral fellowship with Dr. Elliott Kieff at Harvard Medical School as a Life Sciences Research Foundation fellow, followed by a Markey Scholar Award.

ELIZABETH LEFFEL, PH.D., M.P.H., is the Director of Non-Clinical Sciences for PharmAthene, Inc. In this role, she oversees research to ensure licensure of biodefense medical countermeasures under the FDA Animal Rule. Prior to joining PharmAthene, Dr. Leffel was the Senior Aerobiologist at the National Biodefense and Analysis Countermeasures Center where her primary responsibility was the establishment of an aerosol capability in Biosafety Level 3/4 laboratories. As the Chief of the Aerosol Research Center and Principal Investigator at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), her research focused on developing inhalation animal models for a number of biothreat agents. Dr. Leffel has served on the design committee for a BSL-3/4 lab, participated in progressing a BSL-3/4 lab from construction to preoperational level and served on biosafety committees for different institutions. She has published numerous manuscripts in peer-reviewed journals and written two book chapters. In 2007, she was earned a Department of Defense Science Technology Engineering and Math Award for her directorship

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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of educational programs. Dr. Leffel received a Ph.D. in Toxicology and Pharmacology from the Medical College of Virginia, a M.P.H. from The George Washington University, and a B.S. degree in Biochemistry from Virginia Tech.

C. RICK LYONS, M.D., PH.D., is currently the Director for Colorado State Infectious Disease Center. For the last 16 years Dr. Lyons was in the Department of Internal Medicine at the University of New Mexico Health Science Center in Albuquerque, New Mexico. He was Professor of Medicine and Director of the Center for Infectious Disease and Immunity. His research during that time focused on the application of molecular biology techniques to animal models of infection in order to move therapeutics for infectious diseases from basic science into human use. Over the last 10 years his work has focused on developing animal models for multiple biothreats in a variety of species. Dr. Lyons received his B.S. in Biochemistry from Washington State University in 1976; his Ph.D. in Immunology and Microbiology at University of Texas Southwestern in Dallas, Texas, in 1981, and subsequently his M.D. from UT Southwestern in 1987. He performed his internship, residency and fellowship in Hematology/Oncology at the Brigham and Women’s Hospital in Boston, Massachusetts. He has received funding from NIH, DARPA, and the Department of Defense related to studying different aspects of host pathogenesis in various animal models of infection.

COLONEL CHRISTIAN MACEDONIA, M.D., is a military physician currently serving as the Medical Sciences Advisor to the Chairman of the Joint Chiefs of Staff. Dr. Macedonia works primarily in support of the chairman’s efforts to improve the quality and availability of the best medical services America has to offer our Forces. He works broadly with interagency partners through his association with the National Security Council and with the nation’s top research universities in this endeavor. His particular areas of published research include medical simulation, advanced medical imaging, fetal developmental biology, expedition medicine, and telemedicine. Dr. Macedonia is a Fellow of the Explorers Club recognized for his work on altitude medicine on Mt. Everest with NASA as well as the marine archeological expedition to the RMS Titanic in 2000. Dr. Macedonia holds a bachelors degree in chemistry from Bucknell University, a doctor of medicine degree from the Uniformed Services University, and he completed his residency in obstetrics and gynecology at Madigan Army Medical Center. He completed fellowship training at Georgetown University in maternal-fetal medicine followed by a research fellowship in bioinformatics at the National Institutes of Health. Colonel Macedonia is the recipient of many military awards and commendations

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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including the Combat Action Badge and the Bronze Star Medal for his service in Iraq’s Anbar Province as the Deputy Commander and Chief of the Medical Staff of the 115th Combat Support Hospital. His other honors include membership in the Alpha Omega Alpha Honor Medical Society, The Heroes of TRICARE Award, The Bockman Award, The NIH Award for Clinical Trainees, The Skelton Award, The “A” Proficiency Designator, and the Order of Military Medical Merit.

ALAN J. MAGILL, M.D., FACP, FIDSA, is a Program Manager at the Defense Advanced Research Projects Agency (DARPA) where he initiates innovative and disruptive technology research and development programs. His current portfolio includes a $100M influenza vaccine program. He recently retired from 27 years active duty service in the U.S. Army. He was formerly the Director of the Division of Experimental Therapeutics at the Walter Reed Army Institute of Research (WRAIR) in Washington, D.C. Dr. Magill is ABIM board certified in internal medicine and infectious diseases. He has spent the last 20 years developing new generations of vaccines, diagnostics, and drugs directed against malaria and leishmaniasis. He has lived and worked in South America, Africa, and Southeast Asia. Dr. Magill previously served as the Head of Parasitology at the Naval Medical Research Center Detachment (NMRCD) in Lima, the Head of Clinical Research for the Malaria Vaccine Development Unit of the U.S. National Institutes of Health, and the Science Director for WRAIR. He has dual academic appointments as Associate Professor of Medicine and Associate Professor of Preventive Medicine and Biometrics at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland. He is a faculty member for the Gorgas Course in Clinical Tropical Medicine in Lima, Peru, continues to be a sought-after speaker on travel and tropical medicine-related topics, and a participant in numerous national and international advisory committees and workshops. He is an active member of the American Society of Tropical Medicine and Hygiene, serving as a Councilor in 2003–2006, the current Courses Director, and is the immediate Past President of their Clinical Group. Dr. Magill is the current (2009–2011) President of the International Society of Travel Medicine (ISTM) where he has been a member since 1992, serving as the Associate Chair of the Scientific Program Committee at CISTM9 (2005) in Lisbon and at CISTM10, (2007) in Vancouver. He is the Lead Editor of the 9th edition of Hunter’s Tropical Medicine, the premier clinical textbook of clinical tropical medicine. He is also a Medical Editor of the CDC Health Information for International Travel (the yellow book) for 2010 and 2012. He has authored more than 65 peer-reviewed publications, 125 abstracts, and 13 book chapters.

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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MURRAY MALIN, M.D., M.B.A., is the Acting Director of the Medical Countermeasure initiative at the Center of the Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA). A graduate of the University of Michigan, Dr. Malin received his M.D. from the Medical College of Ohio and did his residency and fellowship training in Anesthesiology and Critical Care at the Georgetown University Hospital in Washington, DC. While practicing anesthesiology, Dr. Malin earned his M.B.A. from the George Washington University in 2002, and began working as a Medical Officer in the Office of Compliance at CDRH in 2007, in which he was responsible for assessing risk and classification of recalls associated with defective medical devices.

KENNETH MANDL, M.D., M.P.H., has innovated and published extensively in the areas of personally controlled health records, disease outbreak detection, bio- and pharmacosurveillance, and national health information infrastructure. Recognized for his teaching and research, he has received the Barger Award for Excellence in Mentoring at Harvard Medical School and the Presidential Early Career Award for Scientists and Engineers, the highest honor bestowed by the United States government to outstanding scientists and engineers. Mandl co-directs a CDC Center of Excellence in Public Health Informatics. He is a leader of the SMArtPlatforms project—part of a major federal initiative seeking to create an “app store” for health. Mandl is a member of the Advisory Committee to the Director of the CDC and of Lister Hill Center Board of Scientific Counselors at the National Library of Medicine. He is an attending physician in pediatric emergency medicine, a faculty member in the Harvard Medical School Center for Biomedical Informatics, and affiliated faculty at the Harvard-MIT Division of Health Sciences and Technology.

LISA MATHIS, M.D., is a Pediatrician who attended the University of California, Davis, as an undergraduate with a B.S. in Physiology, and then attended the Uniformed Services University of Health Sciences (USUHS), F. Edward Hebert School of Medicine, and completed her Pediatric Residency at UC Davis. She has worked at FDA for 12 years and currently serves as the Director for the Pediatric and Maternal Health Staff in the Office of New Drugs. She also practices general pediatrics at the National Naval Medical Center in Bethesda, Maryland, and serves as an adjunct professor of medicine at USUHS. She is also the Deputy Team Leader on a rapid deployment team.

SUSAN MCCUNE, M.D., is the Deputy Director in the Office of Translational Sciences (OTS) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). She joined the

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Agency in 2003 in CDER’s Office of Counter-Terrorism and Pediatric Drug Development, Division of Pediatric Drug Development. From 2005 through 2009, Dr. McCune held the positions of Associate Director and team leader in the Office of Counter-Terrorism and Emergency Coordination. She joined OTS in February 2010. OTS comprises the Office of Biostatistics, the Office of Clinical Pharmacology, and the Immediate Office, which provides oversight to CDER research involving human subjects, CDER regulatory science research, and the CDER Computational Science Center. OTS is responsible for providing coordination for Critical Path initiatives across CDER in partnership with individual CDER offices. Dr. McCune received her medical degree from George Washington University following her undergraduate degree at Harvard University. She completed her internship, residency, chief residency, and neonatal fellowship at Children’s National Medical Center in Washington, D.C. She is board certified in Pediatrics and Neonatal/Perinatal Medicine. For 15 years, while practicing academic pediatric and neonatal medicine at Johns Hopkins and Children’s National Medical Center, Dr. McCune continued her molecular biology research on adrenergic receptor ontogeny and expression in models of newborn brain injury in the Lab of Developmental Neurobiology, NICHD, NIH. In addition, she has a Masters in Education Technology Leadership from George Washington University, and certificates in Public Health from Georgetown and Regulatory Science from USC.

DONNA L. MENDRICK, PH.D., is the Director of the Division of Systems Biology at the National Center for Toxicology Research (NCTR), a research arm of FDA. Her division incorporates genomics, proteomics, metabolomics, bioinformatics, and in silico modeling approaches to answer the needs of FDA in terms of drug and food safety and improving the understanding of human disease. Her FDA committee assignments include the Senior Science Council, Critical Path Steering Committee, Tox21, and the Interagency Coordination Committee on the Validation of Alternative Methods (ICCVAM). Dr. Mendrick is a member of the Society of Toxicology’s Disease Prevention Task Force. She was an Assistant Professor of Pathology at Harvard Medical School and Brigham and Women’s Hospital. She joined Human Genome Sciences and, as a Group Leader in Pharmacology, oversaw multiple project teams, toxicity studies, pharmacology studies, etc. Prior to joining FDA, she was a Scientific Fellow and Vice President of Pharmacogenomics at Gene Logic where she oversaw pharmacogenomics and spearheaded its toxicogenomics effort. For the latter, she formed a pharmaceutical consortium to help guide the development of the program. Dr. Mendrick has over 25 years of experience in the fields (in alphabetical order) of immunology, pathology, pharma-

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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cogenomics, pharmacology, toxicology, and toxicogenomics employing small molecule drugs, recombinant therapeutic proteins, and monoclonal antibodies. Dr. Mendrick has published on the use of pharmacogenomics, metabolomics, and proteomics to identify biomarkers. She currently is a committee member of the Predictive Toxicology Discussion Group at the New York Academy of Sciences and is past President of the National Capital Area Chapter of the Society of Toxicology. Dr. Mendrick was on the Editorial Board of the Journal of Histochemistry and Cytochemistry for 8 years, a member of the NIH SBIR Immunology Study Section for 8 years, and a member of the Board of Directors of the National Kidney Foundation of Massachusetts for 4 years.

NANCY MESSONNIER, M.D., obtained her M.D. degree from the University of Chicago and completed a residency in internal medicine at the University of Pennsylvania. Dr. Messonnier joined CDC in 1995 as an Epidemic Intelligence Service Officer in the Meningitis and Special Pathogens Branch. Dr. Messonier’s research has focused on bacterial meningitis and other vaccine preventable diseases (including Neisseria meningitidis, Haemophilus influenzae, and Bordatella pertussis) and bacterial zoonoses in the United States and internationally, evaluation and development of vaccines, and surveillance for infectious diseases. She is currently responsible for the CDC Anthrax Vaccine Research Program (AVRP) and co-author for the recently published ACIP guidelines for use of anthrax vaccine. In 2001, she played a leadership role the field investigation of the first identified bioterrorism-related case of Bacillus anthracis in Florida. She made critical contributions in the field in Washington, DC, as well as in evaluation of the overall epidemiology of the outbreak. She led the evaluation of antimicrobial postexposure prophylaxis for B. anthracis among 10,000 individuals exposed to B. anthracis, as Primary Investigator, developed a new protocol for postexposure prophylaxis with antibiotics and anthrax vaccine for persons exposed to B. anthracis spores in the event of a new attack.

LINDA A. MILLER, PH.D., is the Director of Clinical Microbiology in Infectious Diseases Medicines Discovery and Development at GlaxoSmithKline (GSK) Pharmaceuticals. Dr. Miller joined GSK in 1994. She obtained her Ph.D. in 1987 from the University of Pennsylvania, and also has a Master’s Degree from the Medical College of Pennsylvania. Dr. Miller directs the Clinical Microbiology group at GSK that includes Anti-bacterial and Anti-viral drug development and has responsibilities across the Infectious Diseases pipeline from discovery to development and throughout the life cycle of the drugs. Her focus at GSK includes clinical microbiology, antimicrobial resistance, resistance modeling, surveillance, and science policy.

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Her previous experience includes her role as Director of Clinical Microbiology and Clinical Immunology at Holy Redeemer Hospital and Medical Center in Pennsylvania and her position as the Clinical Immunologist for The Bryn Mawr Hospital, Bryn Mawr, Pennsylvania. Dr. Miller is the current chair of Division A, Antimicrobial Agents and Chemotherapy, for the American Society for Microbiology (ASM) and also is a member of the ASM’s International Membership Committee. She was President of the Eastern Pennsylvania Branch of the ASM from 1992 to 1994, and has recently co-chaired two symposia for the Eastern PA Branch of the ASM. Her research and specialty areas include global antimicrobial surveillance systems, antimicrobial susceptibility testing, in vitro methodologies, susceptibility testing breakpoints, bacterial identification methodologies, immunofluorescence science policy, and drug life cycle management.

ROBERT C. NELSON, PH.D., FISPE, was a career Public Health Service officer with 21 years at the U.S. Food and Drug Administration. He served as a new drug reviewer, drug abuse scheduling expert, epidemiology team leader, Director of the Center for Drug Evaluation & Research (CDER) Staff College, and as Associate Director, Office of Epidemiology & Biostatistics, before his retirement in 1998. He was responsible for the reengineering of the CDER postmarketing program and designed, managed and implemented the Adverse Reaction Reporting Systems (AERS). Dr. Nelson also led the comprehensive regulatory rewrite of all safety regulations (“The Tome”) in the United States, and ensured ICH compatibility.

ROBERT M. “SKIP” NELSON, M.D., PH.D., is currently the Senior Pediatric Ethicist/Lead Medical Officer in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. After receiving his M.D. degree from Yale University, Dr. Nelson trained in pediatrics (Massachusetts General Hospital), neonatology, and pediatric critical care (University of California, San Francisco). He has a Master of Divinity degree from Yale Divinity School and a Ph.D. in The Study of Religion from Harvard University. Dr. Nelson is a former Chair of the FDA Pediatric Advisory Committee and the Pediatric Ethics Subcommittee. He was a member of the Subcommittee on Research Involving Children of the Secretary’s Advisory Committee on Human Research Protections, and the Human Studies Review Board of the Environmental Protection Agency. Dr. Nelson was a member of the Committee on Clinical Research Involving Children of the Institute of Medicine, and former Chair of the Committee on Bioethics of the American Academy of Pediatrics. Dr. Nelson is the editor of the American Journal of Bioethics (AJOB)–Primary Research, which publishes empirical research in bioethics. Immediately prior to joining FDA, he was Professor of Anesthesiol-

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

ogy, Critical Care and Pediatrics, at the Children’s Hospital of Philadelphia and University of Pennsylvania School of Medicine. Dr. Nelson’s academic research explored various aspects of child assent and parental permission, including risk perception and voluntary choice, and was funded by the Greenwall Foundation, the National Institutes of Health, and the National Science Foundation.

ED NUZUM, D.V.M., PH.D., During the time Dr. Nuzum served in the U.S. Army from 1971 to 1998 he was a member of the Army Transportation Corps and the Army Veterinary Corps and held positions as diverse as Platoon Leader, Aircraft Maintenance Officer, and Pentagon Medical Staff Officer. While in the Army he served as a helicopter pilot, he received the D.V.M. degree from Kansas State University in 1982 and his Ph.D. degree from the University of Kansas Medical Center in 1990, and held research and management positions at the U.S. Army Medical Research Institute of Infectious Diseases and the U.S. Army Walter Reed Army Institute of Research. From 1998 to 2002 Dr. Nuzum was a Senior Scientist and Product Development Team Leader with DynPort Vaccine Company where he worked on vaccinia immune globulin and vaccines for smallpox and Venezuelan equine encephalitis. From 2002 to present Dr. Nuzum has been with the Office of Biodefense Research Affairs (OBRA), a part of the NIAID Division of Microbiology and Infectious Diseases. In 2004 he was made Chief of the Biodefense Vaccines and other Biological Products Development Section (BVBPDS), which is responsible for planning, implementing, and evaluating advanced biologics product development efforts involving extramural research contracts and interagency agreements. A major focus at NIAID has been the development of anthrax vaccines and associated animal models. Dr. Nuzum has over 30 years experience in veterinary clinical, medical research, and research management experience.

GERALD PARKER, D.V.M., PH.D., M.S., is the principal deputy assistant secretary to the assistant secretary for preparedness and response. Since March 2003, he has been detailed to the Department of Homeland Security. During his career, he has held a variety of positions, including assistant deputy for research and development and research director for the Medical Chemical and Biological Defense Research Program at the U.S. Army Medical Research and Materiel Command. In this role, he led joint service and interagency programs responsible for developing research investment strategies and sustaining unique capabilities to develop a broad range of medical countermeasures. He is a former commander and deputy commander of the U.S. Army Medical Research Institute of Infectious Diseases, the lead DoD medical research laboratory for medical

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

biological defense. In these positions, he directed the technology-based research and development of vaccines, diagnostics, and drugs, along with the development of medical defense strategies and the training of health care providers against biological warfare agents and highly infectious organisms requiring special containment. Dr. Parker graduated from Texas A&M University with a B.S. in veterinary medicine and a degree of doctor of veterinary medicine. He holds a doctorate in physiology from Baylor College of Medicine in Houston, Texas, and an M.S. degree in resourcing the national strategy from the Industrial College of the Armed Forces.

VIKRAM S. PATEL, PH.D., joined FDA in 2010 as a Deputy Director in the Division of Drug Safety Research in CDER. At FDA he is responsible for guiding safety-related preclinical research, including research in the area of toxicology, computational sciences, pharmacokinetics, drug metabolism, and transporters. Prior to joining FDA Dr. Patel was a Senior Director of Discovery Pharmacokinetics at Wyeth. He is currently serving as a member of the National Acadamies Committee for Animal Models for Assessing Countermeasures to Bioterrorism Agents. Dr. Patel has extensive experience in drug discovery and development. He has expertise in the areas of pharmacokinetic/pharmacodynamic modeling and simulations, physiological modeling (including biomarker modeling and simulations), drug metabolism, in vitro/in vivo correlations, and in-drug formulation and delivery. He developed and established a GLP preclinical PK section at Procter and Gamble Pharmaceuticals and developed Macro-bid, a sustained release product currently marketed worldwide. Dr. Patel received his Ph.D. from the University of Houston in 1984.

CARL PECK, M.D., obtained a B.A. in mathematics and chemistry from the University of Kansas in 1963 and the M.D. in 1968. Following training in internal medicine, he undertook a research fellowship in clinical pharmacology at the University of California San Francisco (1972–1974). From 1974 to 1980, Dr. Peck was employed at the Letterman Army Institute of Research, San Francisco, California, as Chief of the Army Blood Preservation Research Program. In 1980, Dr. Peck became Director of the Division of Clinical Pharmacology and, Professor, Departments of Medicine and Pharmacology, Uniformed Services University, Bethesda, Maryland. Dr. Peck joined FDA as Director, Center for Drug Evaluation and Research, in October 1987. He was promoted to Assistant Surgeon General in the Public Health Service in October 1990. Retiring from FDA in late 1993, Dr. Peck was appointed “Boerhaave” Professor of Clinical Drug Research at Leiden University in The Netherlands. In 1994 Professor Peck joined the faculty of the Georgetown University Medical Center, as the

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

founding Director of the Center for Drug Development Science. In 1999, Dr. Peck received the FDA Distinguished Alumnus Award. Sweden’s University of Uppsala conferred an honorary doctorate degree (Doctor Honoris Causa) to Dr. Peck in January 2002 in recognition of “outstanding contributions to the science of drug development.” Dr. Peck founded NDA Partners LLC in 2003, and in 2004, CDDS moved to UCSF, located in the UC-Washington Center. Throughout his career, he has mentored more than 40 postdoctoral fellows and graduate students and co-founded the American (2007) and Chinese (2009) Courses in Drug Development and Regulatory Science (ACDRS, CCDRS). Dr. Peck’s research interests center on optimizing informativeness, efficiency, speed, and economy of drug development and regulation using advanced concepts and techniques of clinical pharmacology, trial designs, and pharmacostatistical modeling and simulation to generate causal evidence of effectiveness and safety. He is an author of more than 150 original research papers, chapters, and books.

MARY K. PENDERGAST, J.D., LL.M., is President of Pendergast Consulting, which provides legal and regulatory advice to biopharmaceutical companies, patient groups, professional and advocacy organizations, governments, and academic and financial institutions. Ms. Pendergast professional focus is on strategic and tactical issues that relate to drug and device policy and development. Prior to her current position, she was Executive Vice President Government Affairs of Elan Corporation. She has held positions as a corporate officer, devising and implementing regulatory strategies for product development and compliance; was liaison to BIO and PhRMA; and testified for BIO before Congress on PDUFA reauthorization. She was Deputy Commissioner and Senior Advisor to the Commissioner at the Food and Drug Administration involved in FDA’s efforts to regulate emerging areas, such as biotechnology, cellular and tissue-based therapies, genetic testing, xenotransplantation, and acute-care research, and served as FDA’s “crisis manager,” handling sensitive and precedent-setting situations. She also held the position of Associate Chief Counsel for Enforcement at the FDA Office of the General Counsel in which she supervised a wide variety of enforcement and defensive litigation involving FDA programs and products under FDA’s jurisdiction;and was an attorney at the Office of the General Counsel, Department of Health and Human Services and as special assistant to the Department’s General Counsel. Ms. Pendergast is on the boards of directors of ARCA biopharma, Inc., AesRX, and the Arch Foundation.

JOHN H. REX, M.D., received his M.D. degree from Baylor College of Medicine (1982), trained in Internal Medicine at Stanford University

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

Hospital (1984–1987), and trained in infectious diseases at the National Institute of Allergy and Infectious Diseases (1987–1992). John served on the faculty of the University of Texas Medical School at Houston from 1992 to 2002 during which time his work focused on laboratory studies of novel antifungal agents, clinical trials of novel antifungal agents, and hospital epidemiology. John joined AstraZeneca in 2003, and he currently serves as Vice President, Clinical Infection. In addition to his AZ role, he is the industry representative on the FDA Anti-Infective Drug Advisory Committee, is Chair of the Area Committee on Microbiology for the Clinical Laboratory Standards Institute (CLSI, formerly NCCLS), is a Highlights Advisor for Nature Reviews Microbiology, serves on several editorial boards, was formerly an editor for Antimicrobial Agents and Chemotherapy, and is an Emeritus Editor for www.doctorfungus.org, a nonprofit website devoted to dissemination of information about medical mycology.

ERIC ROSE, M.D., is an academic physician and entrepreneur with interests in drug discovery, biodefense, clinical evaluative research, and health policy. Since 2007 he has been the Executive Vice President for Life Sciences at MacAndrews & Forbes and CEO of Siga Technologies, Inc., a developer of antiviral drugs directed at potential agents of bioterror. He was appointed in 2007 to the National Biodefense Scientific Board, which advises the HHS Secretary on biodefense, influenza, and emerging diseases. In 2008, he assumed the chairmanship of the Department of Health Policy at the Mount Sinai School of Medicine. From 1994 through 2007, he served as Surgeon in Chief at New York-Presbyterian Hospital/Columbia and Chairman of the Department of Surgery at the Columbia University College of Physicians and Surgeons, where he held a distinguished professorship. An accomplished heart surgeon, researcher, and entrepreneur, Dr. Rose grew one of the nation’s premier departments of surgery while managing, investigating, and developing complex medical technologies ranging from heart transplantation and novel approaches to Alzheimer’s disease to bioterrorism. He has authored or co-authored more than 300 scientific publications and has received more than $25 million in NIH support for his research. Dr. Rose pioneered heart transplantation in children, performing the first successful pediatric heart transplant in 1984, and has investigated many alternatives to heart transplantation, including cross-species transplantation and man-made heart pumps. Siga has received more than $100 million in federal research support since he joined the company, developing antiviral drugs for smallpox, dengue, and Lassa fever. He received both his undergraduate and medical degrees from Columbia University.

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

STEPHEN RUBERG, PH.D., received his B.A. in mathematics from Thomas More College, an M.S. in statistics from Miami University (Ohio), and his Ph.D. in biostatistics from the University of Cincinnati. Steve has spent 30 years in the pharmaceutical industry and just completed his 11 year anniversary at Lilly. During his career, he has served as a statistician for all phases of drug development from discovery through postmarketing. He has worked on drug development programs across numerous therapeutic areas. In 1994, Steve was elected as a Fellow of the American Statistical Association, and he has published widely in statistics and biological/medical journals. He has held significant leadership roles across the industry: Deputy Chair and co-author of ICH-E9–Statistical Principles for Clinical Trials; chaired PhRMA Biostatistics and Data Management Committee; helped found CDISC (the Clinical Data Interchange Standards Consortium) and served as its first Chairman of the Board; chaired the Board of Governors for the Ohio State University Mathematical Biosciences Institute;and was appointed to the Board or Directors of the National eHealth Collaborative. In 2009, he was named Scientific Leader for the Eli Lilly Advanced Analytics Hub.

HARVEY RUBIN, M.D., PH.D., received his Ph.D. in Molecular Biology from the University of Pennsylvania in 1974 and his M.D. from Columbia University in 1976. He was a House Officer in Medicine at The Peter Bent Brigham Hospital in Boston and did his fellowship in infectious diseases at Harvard and the Brigham. He is currently Professor of Medicine at the University of Pennsylvania with secondary appointments in the Departments of Microbiology, Biochemistry, and Computer and Information Sciences. His research on the basic biology of tuberculosis and other bacteria and the mathematical modeling of complex biological systems has been funded by the NIH, NSF, DARPA, the Global Alliance for TB Drug Discovery, and the DoD. He has published over 90 papers in peer-reviewed journals as well as numerous scientific reviews and book chapters. Dr. Rubin served on a number of national and international scientific review panels including those for the NIH, NSF, NASA Intelligent Systems Program, DARPA, and the Medical Research Council, South Africa. He was a member of the United States National Science Advisory Board for Biosecurity (NSABB) and the Department of Defense/National Academy of Sciences Biological Cooperative Threat Reduction Program. He is the Chair, Scientific Advisory Board, Incentives for Global Health. Dr. Rubin is the Director of Penn’s Institute for Strategic Threat Analysis and Response (ISTAR). ISTAR is dedicated to identifying, analyzing, and solving policy, scientific, and technical issues that contribute to regional, national, and international security.

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

ESTELLE RUSSEK-COHEN, PH.D., is the acting division director in the Division of Biostatistics in the Center for Biologics Evaluation and Research (CBER) in the Office of Biostatistics and Epidemiology. She came to CBER in February 2010 as Deputy Division Director. Before that she was a team leader in the Diagnostic Devices Branch of the Division of Biostatistics, in FDA’s Office of Surveillance and Biometrics at the Center for Devices and Radiological Health. Dr. Russek-Cohen received a Ph.D. in Biostatistics from the University of Washington, Seattle. Dr. Russek-Cohen was a professor in the University of Maryland’s Biometrics Program for 26 years and Director of the Biometrics Program for her last five years at College Park when she retired in 2004 and came to FDA. At UM, she regularly collaborated with scientists and epidemiologists on infectious disease research. She also spent a year of sabbatical leave and several summers at the Biometric Research Branch of the National Cancer Institute working on statistical issues in clinical trials. Her current interests in statistics include the assessment of safety of CBER-regulated products and statistical issues in personalized medicine. She is a fellow of the American Statistical Association.

ALAN SHAW, PH.D., joined VaxInnate from the Merck Vaccine Research Division where he was Executive Director of MVD’s Public Policy, Public Health, and Medical Affairs Department. Prior to this, he was the Executive Director of Virus & Cell Biology at Merck Research Laboratories, responsible for all the aspects of live virus vaccine research, as well as technical aspects of development and production. His responsibilities covered research and early development of recombinant protein-based vaccines. Dr. Shaw was instrumental in the development of a combination measles-mumps-rubella-varicella vaccine (ProQuad), a live oral rotavirus vaccine, (RotaTeq), human papillomavirus vaccine (Gardasil), and zoster vaccine (Zostavax), as well as numerous early-stage experimental vaccines. He has over 15 years of experience in the development, testing manufacturing, and implementation of vaccines in the United States, Europe, and in international programs. Prior to joining Merck, Dr. Shaw worked on vaccines for hepatitis B and Plasmodium falciparum as well as cytokines, cell trafficking, and natural inhibitors of inteleukin-1 at Biogen, SA, in Geneva, Switzerland.

DAVID SIEGEL M.D., FAAP, received his bachelor’s degree in biological sciences from SUNY at Stony Brook, attended medical school at New York Medical College, and completed his pediatric residency at the Montifiore Hospital of the Albert Einstein School of Medicine. He has had a multifaceted career spanning 40 years as a clinician, educator, and administrator in academic and community-based settings. As a clinician he became one

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

of the first EMTs in the country and worked as a pediatrician in the outpatient, emergency, and inpatient settings. As an educator/administrator he became an ambulatory attending at the Children’s National Medical Center immediately following completion of his residency program; he then had a major role in the development and management of a new pediatric residency program at INOVA Fairfax Hospital for Children, and was the inpatient director at Connecticut Children’s Hospital. Following the events of September 11, 2001, while working in the emergency department at Children’s National Medical Center, he initiated and managed the development of a pediatric disaster preparedness education and training program (CBRNE focus), conducted through a grant from HRSA. Dr. Siegel joined the National Institute of Child Health and Human Development in October 2007. A major role of his functioning as a medical officer in the Obstetric and Pediatric Pharmaceutical Branch at NICHD has been the identification of WMD-related medical countermeasures gaps as well as the facilitation of the development of WMD-related medical countermeasures for pregnant women and children. He is the obstetric/pediatric representative from NIH on various Biomedical Advanced Research and Development working groups as well the NIH representative to the Federal Education and Training Interagency Group. As a child advocate he is a federal liaison to both the National Commission on Children and Disasters and the American Academy of Pediatrics’Disaster Preparedness Advisory Council.

LT. COL. DANIEL J. WATTENDORF, M.D., USAF, joined DARPA as a Program Manager in the Defense Sciences Office in 2010. His interests focus on applying methodological advances in genomics and biotechnology to optimize health and prevent disease—specifically to achieve simple solutions that improve health care at the point of care, anywhere. He holds a B.S. in microbiology from Cornell University and a medical degree with distinction from George Washington University. He completed a residency in family medicine at the National Capital Consortium; a residency in clinical genetics at the National Human Genome Research Institute (NHGRI) at NIH; a fellowship in clinical cytogenetics at Georgetown University; and a fellowship in health policy from the Office of the Director, NHGRI, NIH. Lt. Col. Wattendorf previously served as Director, Air Force Medical Genetics Center, and program manager for an Advanced Concept Technology Demonstration integrating advanced diagnostics and informatics with surveillance systems to rapidly detect natural and hostile pathogens in the Office of the Air Force Surgeon General. In addition to his DARPA programs, he is a geneticist at the National Naval Medical Center and the Cancer Genetics Branch, National Cancer Institute, NIH.

Suggested Citation:"Appendix B: Participant Biographies." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

JEFFREY WETHERINGTON, PH.D., attended Rutgers University from which he earned a Ph.D. in statistics. He is currently at GlaxoSmithKline where he is directing a group that provides statistical analysis and modeling, and clinical trials simulation expertise to early-phase drug discovery and development activities for new medicines targeted at infectious diseases.

CAROLYN WILSON, PH.D., received her Ph.D. in Genetics from George Washington University while working in the laboratory of Dr. Robert Gallo for her dissertation research. For her postdoctoral fellowship, she worked in the laboratory of Dr. Maribeth Eiden identifying viral and cellular factors influencing viral entry. She joined the Division of Cellular and Gene Therapies at the FDA Center for Biologics Evaluation and Research in 1993. As a researcher-reviewer in DCGT, she reviewed INDs and developed policy and guidance documents in two novel product areas: gene therapy and xenotransplantation. More recently, Dr. Wilson has served as the Associate Director for Research at CBER. As ADR, Dr. Wilson ensures that CBER’s research is relevant, of high quality, and provides CBER with the appropriate scientific expertise, tools, and data to support regulatory decision making and policy development. Dr. Wilson still maintains her own laboratory program studying retroviruses that are either used as vectors for gene therapy clinical trials or are of concern in the xenotransplantation setting.

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Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary Get This Book
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Whether or not the United States has safe and effective medical countermeasures--such as vaccines, drugs, and diagnostic tools--available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures.

During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools.

Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.

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