Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches: Summary of a Workshop (2010)

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Appendix C Biographies 7 Planning Committee Members: Jennie Hunter-Cevera, PhD (Chair) serves as president of the University of Maryland (MD) Biotechnology Institute. Previously, she had been the director of the Center for Environmental Biotechnology at the E. O. Lawrence Berkeley National Laboratory. She cofounded two small companies that did contract work for large pharmaceutical and biotechnology companies, consulted in a variety of biotechnology fields, and worked at Cetus Corporation and E. R. Squibb and Sons. She served as president of the Society of Industrial Microbiology (SIM), the United States Federation for Culture Collections (USFCC), and the International Marine Biotechnology Association. She served as senior editor of the Journal of Industrial Microbiology. Dr. Hunter-Cevera also served as a member of US Department of Agriculture Secretary Glickman's Genetic Resources Advisory Board and President Clinton's Department of State Council on Genetically Modified Foods. She served as the US representative to the Organisation for Economic Co-operation and Development on biological resource centers. Dr. Hunter-Cevera was elected to the American Academy of Microbiology, was elected a SIM Fellow in 1997, and received the SIM Charles Porter Award and the USFCC/J. Roger Porter Award (in recognition of her expertise in microbial cultures). She has been recognized as one of MD’s Top 100 Women and one of the 50 Most Influential People in MD. Dr. Hunter- Cevera served on Governor Ehrlich's Technology Commission and the Governor's Executive Council for Transition, and chairs the MD Technology Development Corporation Board of Directors. She is a member of the Entremed Board of Directors, the MD Industrial Partnerships, the BioIT Coalition, MDBio, the MD Israeli Development Corporation, and the Center for Emerging Technologies. She also chairs SIM’s Committee on Public Responsibility and Policy. Dr. Hunter-Cevera holds several patents on natural products and enzymes and has written many scientific publications in microbial ecology and screening. She has chaired two National Research Council committees. Edward Arcuri, PhD, is the chief operating officer for VaxInnate, which he joined in June 2007. VaxInnate works to produce novel vaccines for seasonal and pandemic influenza. Dr. Arcuri has expertise in developing vaccines, including completing Food and Drug Administration approval and managing large-scale manufacturing. Previously, he was at Emergent BioSolutions, Inc., where he served as chief operating officer and was directly responsible for all development, manufacturing, and project-management activities. Before his position at Emergent, Dr. Arcuri held executive positions at MedImmune, Inc. where he was instrumental in the manufacture of Synagis, a treatment for respiratory syncytial virus, and FluMist, for protection against viral influenza. He has 7 Affiliations at time of workshop are described in this appendix. 19 

held a variety of executive, scientific, and research positions at Aviron, Inc., North American Vaccine, Inc., SmithKline Beecham, Merck & Co., The Helicon Foundation, and Oak Ridge National Laboratory. Dr. Arcuri graduated with honors with a degree in Biology from the State University of New York at Albany and went on to earn his MS and PhD in biology from Rensselaer Polytechnic Institute. Stephen W. Drew (NAE), PhD, is a former Distinguished Senior Scientist at Merck & Co., Inc., where his responsibilities encompassed technology transfer and the development of new process technologies for pharmaceutical manufacturing. He has now started two companies: Drew Solutions LLC, a direct-consulting company (sole proprietor), and Science Partners LLC, an advocacy company for medicines and technologies. In the Merck Manufacturing Division (MMD), he has been vice president of vaccine science and technology, vice president of vaccine operations, and vice president of technical operations and engineering. Before joining MMD in 1987, he was the senior director of biochemical engineering in the Merck Research Laboratories, a department that he started in 1981. At Merck, he contributed to the process development and manufacture of several conventional and recombinant microbial products, including antibiotics and vaccines. His contributions in synthetic chemistry include the development of several processes for products and intermediates manufactured worldwide. Dr. Drew has expertise in chemical, biologic, and engineering technology for bulk manufacture of pharmaceuticals; capital project engineering; process safety testing and engineering; process control systems; information systems; fermentation and isolation process engineering for injectable antibiotics; anthelmintics; growth permitants; human and animal vaccines, including recombinant biologics; automated fermentation analyses; process control strategies for chemical and biologic processes; nanotechnology, biotechnology, and chemistry; intelligence and threat analysis; sensor systems; and weapons. Dr. Drew received his BS (1967) and MS (1969) in food science from the University of Illinois and his PhD (1974) in biochemical engineering from the Massachusetts Institute of Technology (MIT). He was elected to NAE in 1993 and is a member of several professional organizations in chemical engineering, chemistry, and biology. He has held offices in the American Institute of Chemical Engineers, the American Chemical Society, the American Society for Microbiology, and the Society for Industrial Microbiology and is a Fellow of the American Institute for Medical and Biological Engineering. He has served as chairman of the advisory committee to the Engineering Directorate of the National Science Foundation and served on several of its panels and studies. He has also served the departments of chemical engineering of several universities as a member of review committees and the MIT Center for Biomedical Engineering, Biotechnology Process Engineering Center, and Division of Biological Engineering. Peter A. Patriarca, MD, earned his BS at the University of Notre Dame and his MD at Tulane University School of Medicine and is a board-certified pediatrician. Dr. Patriarca served as a commissioned officer in the US Public Health Service from 1980 to 2000. During that time, he worked at the Food and Drug Administration (FDA), where he served as director of the Division of Viral Products in the Office of Vaccines Research. He also served as division director in the Center for Biologics Evaluation and Research, 20 

where he worked on quality and consistency of chemical-manufacturing controls and clinical reviews and was intimately involved with regulatory decisions and policy affecting the development and approval of numerous investigational products. At the Centers for Disease Control and Prevention, he was a field and clinical investigator, with about 100 peer-reviewed journal publications, and contributed to immunization programs and policy promulgated through the Advisory Committee on Immunization Practices. Dr. Patriarca’s product experience includes vaccines, plasma derivatives, monoclonal antibodies, and small molecules. He has expertise in influenza, poliomyelitis, measles, and pertussis and extensive international experience, vaccine-policy experience, and experience as an investigator in epidemiologic research and large-scale vaccine-efficacy studies. Dr. Patriarca serves as senior clinical consultant for the Biologics Consulting Group, Inc., in Bethesda, MD, where he provides a wide range of regulatory advice to clients in the drug industry, focusing primarily on vaccines and other biologic products. Dr. Patriarca’s specialties include regulatory strategy, product-development strategy, clinical-protocol design, and submission preparation and review. Before working for the Biologics Consulting Group, Inc., Dr. Patriarca was the corporate head and vice president of worldwide regulatory affairs and pharmacovigilance for MedImmune, Inc., from 2001 to 2005. Speakers and Invited Discussants: Brian Kelley, PhD, is the senior director of bioprocess development at Genentech, which is responsible for development, validation, and technology transfer of fermentation, cell- culture, chromatography, and filtration steps for the production of recombinant therapeutic proteins derived from mammalian and bacterial hosts. He joined Genentech in 2007 after working for 15 years at Genetics Institute. From 1992 to 2007, he served as an adjunct faculty member of the Chemical and Biological Engineering department at Tufts University, where he taught two graduate classes each year on principles of cell and microorganism cultivation and protein purification. He obtained his BS in chemical engineering from the University of Wisconsin-Madison, and his PhD from the Massachusetts Institute of Technology. His interests include experimental design and other statistical methods applied to process development, filtration for cell and virus removal, ultrafiltration of high-concentration protein solutions, development of novel affinity chromatography ligands for protein purification, and high-throughput chromatographic development. Dr. Kelley has been active in the American Chemical Society’s Biotechnology Division, chairing sessions on biopharmaceutical-process validation since 1997. He is on the PDA Biotechnology Advisory Board and has chaired the Recovery of Biological Products Board. David Robinson, PhD, is vice president for bioprocess research and development (BPR&D) at Merck and Co. In this position, he leads the area responsible for the clinical bulk-supply manufacturing and process, analytic, and formulation development of Merck's biologic programs—vaccines, therapeutic proteins, and follow-on biologics/Merck BioVentures. The area has supported programs that have led to the approval of over a dozen products, including Merck's cervical-cancer vaccine, Gardasil; 21 

rotavirus vaccine, RotaTeq; and shingles vaccine, Zostavax. Dr. Robinson received his BS in chemical engineering from the University of California, Berkeley and his PhD in chemical engineering from the Massachusetts Institute of Technology. He served as a postdoctoral fellow at the ETH Zurich and held an adjunct faculty position for 10 years in the Columbia University Department of Chemical Engineering. After working for Sandoz in Switzerland and later in New Jersey, Dr. Robinson worked in basic research at Merck in the Cell and Molecular Biology Department in Rahway. He spent a year at Schering- Plough and returned to Merck in 1997 as director in BPR&D, leading the biocatalysis group. He was later senior director and then executive director of BPR&D, chair of the Technology Transfer Team, and cochair of the Project Team for the rotavirus vaccine. Dane Zabriskie, PhD, is vice president of process development at Amgen, Inc. The process-development organization supports the design, startup, and licensure of new plants and products and ensures that Amgen’s manufacturing processes consistently produce safe and effective products in an efficient manner. Dr. Zabriskie came to Amgen in January 2004 from Biogen, where he had worked since 1998, most recently as vice president of the process-development organization. At Biogen, he was responsible for physical product development, including cell-line development, process development and scaleup, pharmaceutical sciences, analytic development, and the preparation of CMC regulatory documents. Before joining Biogen, Dr. Zabriskie spent 14 years with the biopharmaceutical research and development unit of SmithKline Beecham, during which he chaired the Biological Weapons Convention Subcommittee for Pharmaceutical Research and Manufacturers of America. He also cofounded and worked for 5 years at a small biotechnology company and spent 3 years as an assistant professor of chemical engineering at the State University of New York at Buffalo. Dr. Zabriskie received his PhD in chemical and biochemical engineering from the University of Pennsylvania, and he has undergraduate degrees in biochemistry and chemical engineering from Princeton University. Dr. Zabriskie has led the development of more than 20 biopharmaceutical products, including recombinant vaccines, monoclonal antibodies, fusion proteins, and other therapeutic proteins and products from mammalian cell and microbial sources. Leslie Z. Benet (IOM), PhD, is a professor and former chairman of the Department of Biopharmaceutical Sciences at the University of California, San Francisco. His research interests, over 480 publications, and 11 patents are in pharmacokinetics, biopharmaceutics, and pharmacodynamics. His most recent work has addressed the cooperative effects of metabolic enzymes and transport proteins as related to immunosuppressive, anticancer, anti-AIDS, cardiovascular, and antiparasitic drugs and drugs of importance to women’s health. He is a Fellow of the American Association for the Advancement of Science, the American Association of Pharmaceutical Scientists (AAPS), and the Academy of Pharmaceutical Research and Science. He is the chairman of the board of AvMax, Inc., and serves as a consultant to several pharmaceutical and biotechnology companies. Dr. Benet is a recipient of the AAPS Distinguished Pharmaceutical Scientist Award, the American Pharmaceutical Association Higuchi Research Prize, the American Society for Clinical Pharmacology Rawls-Palmer Award for Progress in Medicine, the International Pharmaceutical Federation (FIP) Høst-Madsen Medal, the University of California, San Francisco Distinguished Clinical Research 22 

Lectureship, and six honorary doctorates. He previously served as chair for the Food and Drug Administration (FDA) Center for Biologics and Research External Peer Review Committee, the FDA Expert Panel on Individual Bioequivalence, and the FIP Board of Pharmaceutical Sciences and as a member of the FDA Science Board and the Board of Directors of the Institute for One World Health and the Board of Directors of the American Foundation for Pharmaceutical Education . Dr. Benet has served as the chair or a member of various IOM committees; he is a member of the Forum on Drug Discovery, Development and Translation. He served as the chair of the National Academies committee that produced the report Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Jonathan Coffman, PhD, is a laboratory head overseeing the development of downstream processes for protein therapeutics at Wyeth BioPharma. He has been responsible for the transfer of over ten molecules to downstream clinical manufacturing. His work has influenced the development of all the downstream processes of protein therapeutics developed at Wyeth over the last 5 years. He has been the Development Team leader coordinating the overall development and technology transfer for two clinical molecules. Dr. Coffman has made numerous contributions to the development and transfer of purification processes for manufacturing of biologic products, including Wyeth's platform two-column-antibody purification process, and the regular use of high- throughput screening in downstream process development. Dr. Coffman received a PhD in chemical engineering from the University of Wisconsin. He has served in various capacities in the American Chemical Society Division of Biochemical Technology: he has been 2003 division program cochair, division secretary in 2004–2006, and Web Seminar Program coordinator since 2005, and he has been named the 2010 cochair for recovery of biologic products. He received the James M. Van Lanen Distinguished Service Award from the division in 2008. Philip E. Coyle III, MS, served as assistant secretary of defense and director of operational test and evaluation in the Department of Defense (DOD). In this capacity, he was the principal adviser to the secretary of defense and the under secretary of defense for acquisition, technology, and logistics on test and evaluation in DOD. Mr. Coyle has 30 years of experience in testing and test-related matters. From 1959 to 1979 and again from 1981 to 1993, he worked at the Lawrence Livermore National Laboratory in Livermore, California, where he served as an associate director. In the Carter administration, Mr. Coyle served as principal deputy assistant secretary for defense programs in the Department of Energy; he had oversight responsibility for the department’s nuclear-weapons testing programs. The International Test and Evaluation Association awarded Mr. Coyle the Allan R. Matthews Award, its highest award, for his contributions to the management and technology of testing and evaluation. He was awarded the Defense Distinguished Service Medal by DOD Secretary Perry and the Bronze Palm of the Defense Distinguished Service Medal by Secretary Cohen. Mr. Coyle received an MS (1957) in mechanical engineering and a BA (1956) from Dartmouth College. He is now affiliated with Science Strategies. 23 

Denise L. Faustman, MD, PhD, has worked in autoimmunity for over 15 years and has made some of the key discoveries regarding the role of MHC class I antigen presentation in immunity. Her earlier research achievements include introducing the concept of modifying antigens on donor tissues to prevent their rejection, which is now in clinical trials for diverse human diseases treatable with cellular transplantation. In 2001, her laboratory reversed type 1 diabetes in mice with end-stage disease, and this project is now being translated into clinical trials. Her current research continues to focus on uncovering new treatments for type 1 diabetes and to search for therapies for other autoimmune diseases, including Crohn disease, lupus, scleroderma, rheumatoid arthritis, Sjögren syndrome, and multiple sclerosis. Dr. Faustman is director of the Immunobiology Laboratory at the Massachusetts General Hospital (MGH) and an associate professor of medicine at Harvard Medical School. After completing her internship, residency, and fellowships in internal medicine and endocrinology at the MGH, Dr. Faustman became an independent investigator at the MGH and Harvard Medical School in 1987. She is a member of the American Association for the Advancement of Science and has served on IOM committees. In 2003, Dr Faustman was honored by the National Institutes of Health and the National Library of Medicine with the Changing the Face of Medicine Award. She was one of 300 American physicians honored for achievement in medicine, past and present. In 2005, she received the Oprah Achievement Award for Top Health Breakthrough by a Female Scientist. In 2006, she was awarded the Women in Science Award, given by the American Medical Women's Association and Wyeth Pharmaceutical Company to a female physician who has made exceptional contributions to medical science through basic-science publications and leadership in the field. Phil Gomez, PhD, MBA, has more than 15 years of experience in bringing drugs and biologics to market, working in both industry and government. He joined PRTM Management Consultants from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, where he established the Vaccine Production Program in 2001, growing it to over 150 staff and completing the 126,000-ft2 Vaccine Pilot Plant. During his 6-year tenure at the National Institutes of health (NIH), his group manufactured over 40 bulk pharmaceutical compounds and more than 15 candidate vaccines using innovative collaborations with industry to forward the development of vaccines against HIV, Ebola virus, Marburg virus, West Nile virus, severe acute respiratory syndrome, and influenza. Before going to NIH, Dr. Gomez spent over 9 years at Abbott Laboratories, Sanofi Pasteur, and Baxter Healthcare in positions of increasing responsibility, leading process and product development organizations and project teams for multiple biologic products. Dr. Gomez received an AB from Dartmouth College, an MS and a PhD in chemical engineering from Lehigh University, and an MBA from the Smith School of Business at the University of MD. Dr. Gomez earned the NIH Director’s Award in 2007 for the establishment of the Vaccine Pilot Plant and rapid production of a pandemic influenza vaccine. Charles H. Hobbs, DVM, is the director of toxicology at the Lovelace Respiratory Research Institute. Dr. Hobbs’s primary research interests are in the long-term biologic effects of inhaled materials and the mechanisms by which they occur. His experience covers inhaled nuclear and chemical toxicants and infectious diseases. His research has 24 

covered physical and chemical characterization of airborne toxicants, in vitro mechanistic and toxicologic studies and long-term studies in laboratory animals of the relationships between dose to critical tissues and resulting biologic effects, and the important mechanisms active in determining these relationships. Dr. Hobbs has also been heavily involved in research management. He has focused on the direction and use of multidisciplinary teams of personnel to address complex problems. Previously, he was associate director and assistant director of the Inhalation Toxicology Research Institute, and vice-president of Lovelace Biomedical and Environmental Research Institute. Before that, he took a leave of absence from the Lovelace Biomedical and Environmental Research Institute to be a scientist in the Division of Biomedical and Environmental Research of the US Energy Research and Development Administration, and he has worked as an assistant director and toxicologist at the Inhalation Toxicology Research Institute at the Lovelace Foundation for Medical Education and Research. Dr. Hobbs received his DVM in 1966 from the Colorado State University in Fort Collins and professional certifications in veterinary medicine from Colorado, Wyoming, and New Mexico. He became a diplomate of and received certification in general toxicology from the American Board of Veterinary Toxicology in 1972 and 1981, respectively. Pascal Longchamp, PhD, MBA, leads the worldwide business effort of Evolva as vice president of business development. He holds a PhD in microbiology and genetics from the University of Lausanne and did postdoctoral studies at the University of California, Berkeley. He was then engaged in anthrax studies at Lawrence Berkeley National Laboratory before joining Maxygen Inc. in the Silicon Valley, where he was involved in the Defense Advanced Research Projects Agency’s Unconventional Pathogen Countermeasure program. That exposure to the biodefense field raised his awareness of the potential threat of microorganisms. After leaving Maxygen Inc. to become director of business development at Phyllom, he obtained an MBA and joined Evolva, a young biotechnology company that had invented a technology for applying directed evolution principles to small molecules for the pharmaceutical industry. Soon after joining Evolva, Dr. Longchamp recognized the potential of the technology for the biodefense industry. After a successful application to the Transformational Medical Technologies Initiative of the Defense Threat Reduction Agency (DTRA), Evolva is now applying its novel drug- discovery engine to generate novel immunomodulators, antivirals, and antibacterials for DTRA. James D. Marks (IOM), MD, PhD, is professor of anesthesia and pharmaceutical chemistry at the University of California, San Francisco. He is board-certified in internal medicine, anesthesia, and critical-care medicine. From 1996 to 2001, he was the medical director of the Medical-Surgical Intensive Care Unit at San Francisco General Hospital, and he continues to attend in the intensive-care unit and operating rooms there. Dr. Marks is a pioneer in antibody engineering, in which he has developed widely used technology for generating and optimizing human therapeutic antibodies. He directs a research group that is using antibody gene-diversity libraries and display technologies to dissect the molecular basis of infectious diseases and cancer and to develop novel antibody-based therapeutic approaches for these diseases. His research in oncology has elucidated the effects of antibody biophysical properties on tumor targeting, and his laboratory has 25 

generated a novel antibody-based drug that is being commercialized for breast-cancer therapy. His laboratory works to develop antibody-based therapies for the biothreat agent botulinum neurotoxin. Dr. Marks has served on Department of Health and Human Services and National Institute of Allergy and Infectious Diseases expert advisory panels on the botulinum neurotoxins. He has more than 110 publications in antibody engineering and is an inventor on 62 issued or pending patents. He was elected to IOM in 2006. Mark Schenerman, PhD, is vice president for analytic biochemistry at MedImmune and is responsible for structural and biologic characterization of preclinical and clinical products, stability and release testing of clinical products, technology transfer to quality control, and continuing product-development support. Since joining MedImmune in 1994, Dr. Schenerman has played an integral role in developing the company’s analytic biochemistry function, and he leads a team of more than 90 scientists supporting all stages of product development. Before joining the company, Dr. Schenerman held positions in biologics development and research and development at Bristol-Myers Squibb Company and as a postdoctoral associate at Cornell University. He earned his bachelor’s degree in medical technology at the University of Maryland and his doctorate in biochemistry and molecular biology at the University of Florida. 26