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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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.
