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B Participant Biographies n. l e i g h a n d e r s o n , P h .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. Subse- quently he founded (with Dr. Norman Anderson) the Molecular Anat- omy 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 pro- teomics 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 Distin - guished Achievement Award in Proteomic Science. Dr. Anderson cur- rently serves as a Principal of Anderson Forschung Group LLC, a member of the Board of Directors of Luna Innovations (a developer of novel sen- sors and materials), associate editor of the journal Clinical Chemistry, and 99
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100 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT sits on numerous scientific advisory boards. Dr. Anderson has published more than 150 scientific papers, one book, and 32 patents. M a r i e t ta a n t h o n y , P h .d. , is at the Critical Path Institute (C-Path), which builds collaborative partnerships in a new model of drug devel - opment 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 Insti- tutes of Health. Additionally, Dr. Anthony was in the Department of Phar- macology 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. P h y l l i s a rt h u r , M.b.a., joined the Biotechnology Industry Organiza- tion (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 econo- mists at the Brookings Institution in Washington, D.C. There she con- ducted 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. l e s l i e Z . b e n e t , P h .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
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101 APPENDIX B 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 Pharmaceu - tical 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 publi - cations, and 11 patents are in the areas of pharmacokinetics, biopharma- ceutics, 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. l a u r e n e . b l a c k , P h .d., is employed by Charles River Laborato- ries (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 immunotoxi- cology, rheumatoid arthritis, xenotransplantation, biologics, and oligo - nucleotides. 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 sev - eral 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,
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102 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT 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 work - ing 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 Toxicol - ogy. 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. l u c i a n a b o r i o , M.d., is a Senior Advisor for Medicine and Public Health in the Office of the Chief Scientist, U.S. Food and Drug Adminis - tration (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 Assis - tant Professor of Medicine at the University of Pittsburgh from 2003–2008, where she worked to develop policies to improve the nation’s prepared- ness for bioterrorism and to support threat assessments, medical coun- termeasure 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 procure- ment 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
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103 APPENDIX B Department of Homeland Security’s Biological Agent Risk Analysis. She has lectured and published extensively on infectious diseases and biode- fense. 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 Medi- cine 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). d r . j o h n b r a d l e y , 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 Infec - tious 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 Con- sultants Staff, having served for six years on the AntiInfective Drug Advi- sory 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 facili - tate 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 phar- maceutical 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, Depart- ment of Pediatrics, at the University of California, San Diego School of Medicine. d. b r u c e b u r l i n g t o n , 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 evalu- ations; and set up process, organizations, and staffing plans to achieve their regulatory obligations. He has been a senior executive in both FDA
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104 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT and the pharmaceutical industry. He blends long experience in develop - ment strategy with insightful analysis of the underlying medical prob- lems, 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 devel- opment 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 cham- pioned 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 pharmaceu- ticals. 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. d r u s i l l a b u r n s , P h .d., graduated from Tulane University with a major in chemistry. She received her Ph.D. in biochemistry from the Uni - versity 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 Edi- tor of Infection and Immunity. At FDA, she is involved in the regulation of anthrax, pertussis, and other bacterial vaccines.
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105 APPENDIX B 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, Uni - versity of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from the National Insti- tutes 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 Com - mittee and of the Advisory Council of the National Institute of Allergy and Infectious Diseases. She was named to the original Board of Scien - tific 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, anti - microbial resistance, and biomedical research. She has served two terms on the Liaison Committee on Medical Education (LCME), the accredit - ing body for U.S. medical schools, as well as other national committees involved in establishing policies on training in the biomedical sciences.
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106 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT 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 pro - gram 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 molecu- lar 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 Coor- dination Department and briefly served as the Associate Director for Laboratory Science in the Division of Preparedness and Emerging Infec - tions, 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 support - ing 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 Antimicro- bial 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
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107 APPENDIX B 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 disci - plines 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 detec- tion technologies. Dr. Daitch has significant experience in sensor sys - tem product development employing (1) automated miniaturized bio - molecule purification and signal amplification in complex samples, and (2) integration of such microfabricated components as microarrays, ther- mal electric control, microfluidic fluid flow, and electro-optical detec- tion. 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 busi- ness 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 sub - stantial 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 report - ing 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 Man- ager at Abbott. Dr. Ecker was the founder of Ibis Biosciences, now a
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108 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT subsidiary of Abbott Molecular, Inc., and was a co-founder of Isis Phar- maceuticals. Along with his core team, he was a primary inventor of the Ibis technology and Ibis T5000 (formerly TIGER) technology, now com - mercially marketed as the Abbott PLEX-ID. The technology was devel- oped for infection control, infectious disease diagnostics, and biologi- cal 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, Ingenu- ity 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 Com- puter 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 biomedi- cal 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 mem - ber of the RiboWeb, a seminal project to build a World Wide Web-based knowledge base to support collaborative molecular biology over the Inter- net. 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, sci - entific 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
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109 APPENDIX B 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 Informa - tion 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 Insti - tutes 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 Sci - ence 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 Evalua- tion and Research in the U.S. Food and Drug Administration. He provides leadership and support across a range of research projects on genom- ics, 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 charac - teristics. 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
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122 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT 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 Coordi - nation. 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 Computa - tional 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 Washing - ton, D.C. She is board certified in Pediatrics and Neonatal/Perinatal Medicine. For 15 years, while practicing academic pediatric and neona - tal 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 Wash - ington 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 Biol- ogy at the National Center for Toxicology Research (NCTR), a research arm of FDA. Her division incorporates genomics, proteomics, metabo - lomics, bioinformatics, and in silico modeling approaches to answer the needs of FDA in terms of drug and food safety and improving the under- standing 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 Alterna- tive Methods (ICCVAM). Dr. Mendrick is a member of the Society of Toxicology’s Disease Prevention Task Force. She was an Assistant Profes - sor 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, pharma - cology 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 devel- opment of the program. Dr. Mendrick has over 25 years of experience in the fields (in alphabetical order) of immunology, pathology, pharma-
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123 APPENDIX B cogenomics, pharmacology, toxicology, and toxicogenomics employing small molecule drugs, recombinant therapeutic proteins, and monoclonal antibodies. Dr. Mendrick has published on the use of pharmacogenom- ics, 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 Founda- tion of Massachusetts for 4 years. nancy Messonnier, M.d., obtained her M.D. degree from the Univer- sity 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 Patho- gens 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 vac - cines, 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 iden - tified bioterrorism-related case of Bacillus anthracis in Florida. She made critical contributions in the field in Washington, DC, as well as in evalu- ation 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 Infec- tious 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 Mas - ter’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, anti - microbial resistance, resistance modeling, surveillance, and science policy.
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124 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT Her previous experience includes her role as Director of Clinical Microbi- ology 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 surveil- lance 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 offi- cer 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 imple - mented 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 pediat - ric 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 Subcom- mittee. 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 Environmen- tal 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 bioeth- ics. Immediately prior to joining FDA, he was Professor of Anesthesiol -
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125 APPENDIX B ogy, Critical Care and Pediatrics, at the Children’s Hospital of Philadel- phia 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 Prod- uct 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 Prod- ucts Development Section (BVBPDS), which is responsible for planning, implementing, and evaluating advanced biologics product development efforts involving extramural research contracts and interagency agree - ments. 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 manage- ment 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 Secu- rity. During his career, he has held a variety of positions, including assis- tant 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
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126 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT 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 infec- tious 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 metabo- lism, and transporters. Prior to joining FDA Dr. Patel was a Senior Direc - tor 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 exten- sive experience in drug discovery and development. He has expertise in the areas of pharmacokinetic/pharmacodynamic modeling and simula - tions, physiological modeling (including biomarker modeling and simu - lations), drug metabolism, in vitro/in vivo correlations, and in-drug for- mulation 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 train - ing 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 Insti - tute 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 Medi - cine and Pharmacology, Uniformed Services University, Bethesda, Mary - land. 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
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127 APPENDIX B 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 “outstand - ing 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 Consult- ing, 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 liai - son 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 liti - gation 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
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128 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT 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 cur- rently 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 Sci- ences 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 dis - eases. 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 pro- fessorship. 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 sup- port 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.
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129 APPENDIX B 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 postmarket- ing. 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 bio - logical/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 Stan - dards Consortium) and served as its first Chairman of the Board; chaired the Board of Governors for the Ohio State University Mathematical Bio- sciences 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 Med - icine 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 sci - entific 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.
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130 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT estelle russek-cohen, Ph.d., is the acting division director in the Divi- sion 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 Biostatis - tics 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 work - ing on statistical issues in clinical trials. Her current interests in statistics include the assessment of safety of CBER-regulated products and sta- tistical 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 Execu - tive 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 vac - cines. 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 sci- ences 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 multifac- eted career spanning 40 years as a clinician, educator, and administrator in academic and community-based settings. As a clinician he became one
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131 APPENDIX B of the first EMTs in the country and worked as a pediatrician in the out - patient, 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. Fol - lowing the events of September 11, 2001, while working in the emer- gency department at Children’s National Medical Center, he initiated and managed the development of a pediatric disaster preparedness edu- cation 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 counter- measures 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 Commis- sion 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 solu - tions 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 resi- dency 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 Uni- versity; 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 infor- matics 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.
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132 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT 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 Cellu - lar 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 pro - vides 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.