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Dr. Rebecca Sheets
Rebecca
Sheets serves as the Vaccine Scientific and Regulatory
Specialist in the National Institute of Allergy and Infectious
Diseases at the National Institutes of Health. In this
role, she formulates regulatory strategy for the Division
of AIDS and the Vaccine Research Center for the pre-clinical
development of research concepts into HIV vaccine candidates
suitable for human clinical trials. Her background in
virology, and specifically, retrovirology, serves to address
HIV vaccine development and adventitious agent testing
in vaccines.
Rebecca Sheets 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 on several medically
important and other viruses, including poliovirus, adenovirus,
Yellow Fever Virus, and retroviruses (specifically,
Murine Leukemia Viruses and Feline Leukemia Viruses).
Her Ph.D. thesis examined the pathogenic mechanisms
leading to feline lymphoma by Feline Leukemia Virus
(FeLV), with the objective of providing a targeted approach
to development of a more efficacious FeLV vaccine.
Prior to obtaining her Ph.D., Rebecca
Sheets also worked in the pharmaceutical industry as
a Clinical Research Associate. 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 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. She came
to FDA in 1993 and brought her technical expertise and
communication, organizational, and leadership skills
to this position. 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). In 1998, she served as acting Branch Chief responsible
for supervision of the review of Investigational New
Drug Applications (INDs) for viral vaccines. In 2000,
she served as acting Microbiology Team Leader in the
Division of Anti-Viral Drug Products in the Center for
Drugs (CDER)/FDA. Her review and evaluation responsibilities
at CBER included the review and evaluation of INDs and
Product/Biological License Applications for candidate
vaccines to prevent or treat Human Immunodeficiency
Virus, rotaviruses, adenoviruses, polioviruses, parainfluenza
viruses, Herpes Simplex Virus Type 2, Cytomegalovirus,
and influenza viruses. She also evaluated two PMAs for
HIV-1 viral load test kits. In addition, she was involved
in several policy working groups on HIV vaccines, HIV/AIDS
immunotherapeutics, vaccine cell substrates, retrovirus
testing, and the joint working group between OVRR and
the Division of AIDS at NIAID for HIV vaccine development. |