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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.
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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,
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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;
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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
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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.
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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
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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
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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
