Vaccine Pre-clinical Toxicology Testing
Vaccine Designs/Concepts
Correlates of Immunity
Assay Development
Animal Models
Immunologic Adjuvants
Variation
International Studies
Behavior
Ethics
Vaccine Design and Methodologic
Issues
Assay Validation
|
Vaccine Pre-clinical Toxicology Testing
Previous - Acknowledgements
| Next - Additional flowchart detail
About the authors
Polly Chang, Ph.D., Director of the Molecular
Toxicology Program at the Biopharmaceutical Division, SRI International
(http://www.sri.com/biopharm/),
currently serves as Principal Investigator (PI) on the NIAID HIV
vaccine contract NIAID-N01-AI-95375 and has supervised the successful
preclinical safety testing of 6 candidate HIV vaccines under this
program. Working closely with the project management and regulatory
compliance teams in the preparation of the INDs, several of these
vaccines have been approved by the FDA for Phase I clinical trials.
Dr. Chang received her B.A. in mammalian physiology and her M.S.
in Bioradiology/Biophysics, both from the University of California,
Berkeley. She worked as a researcher at Lawrence Berkeley National
Laboratory (LBNL), eventually attaining the position of Principal
Research Associate before returning to the University of California
at Berkeley to obtain her Ph.D. in Biophysics. The focus of her
research was on the interactions of two clinical treatment modalities
(hyperthermia and radiation) and the impact of de novo protein synthesis
in in vitro cellular responses. Her global scientific experience
during the 1990s includes working as a Visiting Scientist at the
National Cancer Center, in Tokyo, Japan, and as a NIH Fogarty Fellow
at the Cancer Biology Department, University of Tokyo Medical Center
in Japan, examining the differential expression of a conserved family
of homeotic genes in multi-step chemical carcinogenesis. In 1997
Dr. Chang joined SRI where, in addition to her vaccine work, she
is currently the PI on a grant from NASA to apply transgenic mouse
mutation models to study the mutagenic potential of charged particle
radiation that mimics exposure that space travelers will receive.
She is examining the expression of key genes that are involved in
cell functions, linking perturbations in cellular systems after
treatments with genotoxic agents to the misregulation of normal
differentiation and pathophysiology. She also supervises a variety
of molecular biology-related projects and serves as Study Director
on several NCI studies to evaluate chemopreventive therapeutics.
She is author or coauthor of over 30 publications.
CDR Rebecca Sheets, Ph.D., (USPHS) (http://www.niaid.nih.gov/vrc/key_sheets.htm)
obtained her B.S. degree in Biology from the California Institute
of Technology; M.S. degree in Cellular, Viral, and Molecular Biology
from the University of Utah School of Medicine, and Ph.D. in Pathology
from the University of Southern California School of Medicine. During
12 years of laboratory experience, she performed research in virology
and viral pathology. Rebecca Sheets also worked in the pharmaceutical
industry as a Clinical Research Associate, prior to obtaining her
Ph.D. Her responsibilities were in the development, monitoring,
and data auditing of clinical trials for cancer adjunct therapy
with a biological cytokine. Dr. Sheets served for 9 years (1993-2002)
as a Scientific Reviewer in the Viral Vaccines Branch of the Division
of Vaccines and Related Products Applications, Office of Vaccines
Research and Review, CBER/FDA, reviewing Investigational New Drug
Applications and Biologics License Applications. In 1994, to foster
her commitment to public health, she became a Commissioned Officer
in the U.S. Public Health Service (Scientist Category), in which
she has been promoted to the rank of Commander (CDR). Since April
2002, Dr. Sheets is currently assigned as a Vaccine Scientific and
Regulatory Specialist in the National Institute of Allergy and Infectious
Diseases at the National Institutes of Health. In this role, she
serves the Division of AIDS and the Vaccine Research Center supporting
the pre-clinical development of research concepts into HIV vaccine
candidates suitable for human clinical trials.
Stuart Z. Shapiro, M.D., Ph.D., is currently a
Medical Officer in the Preclinical Research & Development Branch,
Vaccine & Prevention Research Program, Division of AIDS, National
Institute of Allergy & Infectious Diseases where he provides
scientific, clinical, technical, and budgetary planning, monitoring
and management of grants, contracts, and cooperative agreements
that support HIV/AIDS vaccine development with a focus on programs
designed to facilitate the rapid transition of new vaccine designs
through preclinical development into phase I human trials. Dr. Shapiro
obtained his B.A. degree in Biochemistry from the University of
California at Berkeley (1969), and his Ph.D. (Molecular Biology;
1976; thesis research on retrovirus protein synthesis) and M.D.
(1977) degrees from Albert Einstein College of Medicine of Yeshiva
University. He underwent medical internship training at Los Angeles
County Harbor General Hospital after which he was a postdoctoral
fellow and then a core Staff Scientist in tropical parasitic disease
vaccine development for eight years at the International Laboratory
for Research on Animal Diseases (ILRAD) in Nairobi, Kenya. He continued
in parasitic disease vaccine research as an Assistant Professor
of Veterinary Microbiology/Immunoparasitology and taught immunology
and parasitology at the University of Illinois (Urbana-Champaign)
from 1987 to 1993. In 1993 Dr. Shapiro joined the Division of Viral
Products, Office of Vaccines, CBER, FDA as a laboratory-based reviewer
and Senior Staff Fellow in retrovirology. In 1998, following 4 years
at the FDA, Dr. Shapiro made a brief foray into industry as the
sole proprietor of a regulatory affairs consultancy and vaccine
design company. He came to his present position in DAIDS in September
1999 more fully aware of the difficulties vaccine developers face
in getting their products into clinical trials. He is the author
of a recent review (Shapiro, S.Z., Vaccine 2002; 20: 1261-1280)
that attempts to explain to academic HIV/AIDS vaccine researchers,
in plain English, what the FDA wants from them.
Sally J. Hargus, Ph.D., is currently a Toxicologist
in the Division of Vaccines and Related Products Applications, Office
of Vaccines Research and Review, Center for Biologics Evaluation
and Research, US FDA. She was recruited to FDA in July, 2001, following
5 years working in the pharmaceutical industry as a toxicologist.
Dr. Hargus was a Fellow at the NIH from 1992-1996, in the laboratory
of Lance Pohl, Pharm.D., Ph.D. She graduated from the University
of Rochester School of Medicine and Dentistry in 1992, with a Ph.D.
in Pharmacology.
Marion F. Gruber, Ph.D., is a scientific reviewer
in the Division of Vaccines and Related Products Applications, Office
of Vaccines Research and Review (OVRR), Center for Biologics Evaluation
and Research (CBER), FDA. Dr. Gruber received her B.Sc. in Microbiology
from the University of Ulm, Germany in 1982, and her Ph.D. in Microbiology
from the Christian Albrecht University of Kiel, Germany, 1986. She
joined CBER in 1989 as a research scientist in the Office of Therapeutics
Review and Research. Research interests have included the regulation
of growth factor and cytokine expression of human B cells and monocytes.
Dr. Gruber joined the Office of Vaccine Research and Review of CBER
in 1995, where she is serving as scientific and regulatory reviewer
for numerous Investigational New Drug applications and Biologic
License applications. Dr. Gruber is chairing an inter-agency committee
charged with developing policy and guidance for developmental toxicity
study for preventive vaccines and serves on a number of national
and international committees addressing preclinical safety assessment
of these products. Dr. Gruber has presented CBER at a number of
national and international meetings to discuss CBER policy pertaining
to nonclinical safety evaluation of preventive vaccines and biological
products.
|