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EDUCATION
& TRAINING:
EXPERIENCE:
CURRENT
POSITION:
1997 to
present |
Vice
President, Viral Products, Biologics
Consulting Group, Inc.,
Alexandria, VA. |
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| 1996
to 1997 |
Partner,
Kenimer Associates, Alexandria, VA |
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Consultant
to the biologics industry, including but not limited to:
- Pre-IND/IND
support
- BLA/PLA
support
- Explanation
and guidance on CBER expectations and interactions
- Preclinical
testing evaluation and planning
- Manufacturing
issues
- Labeling
issues
- Stability
protocols/programs/issues
- Special
expertise in Influenza Virus Vaccines
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| 1976
to 1996 |
Supervisor,
Influenza Laboratory, Division of Virology, Center for
Biologics Evaluation and Research (CBER), FDA; Bethesda,
MD |
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- Responsible
for testing, evaluation and regulation of inactivated
influenza virus vaccines, including potency (SRID),
egg safety (inactivation), identity of final vaccine
and seed strains.
- Review
and sign-off on all influenza protocols.
- Responsible
for production and standardization of potency and
serologic test reagents, in collaboration with World
Health Organization (WHO) laboratories.
- Extensive
knowledge in all aspects of influenza vaccines from
production problems to distribution and usage.
- Certified
CBER inspector since 1980.
- Division
IND coordinator for over 10 years, overseeing the
circulation and tracking of IND’s and serving
as regulatory advisor to reviewers and as a liaison
between the research and regulatory divisions.
- Chairman
of influenza licensing committees with extensive experience
in review of original product license applications
(PLA’s), PLA supplements, IND’s and labeling.
- FDA
representative on the Interagency Working Group for
Influenza, helping to design and write the national
pandemic plan for influenza.
- Member
of the organizing committee for the International
Conference on "Pandemic Influenza: Confronting
a Reemergent Threat" held December, 1995 at NIH.
- Expert
advisor and FDA representative on a US manufacturers
tour of production facilities in Central/Eastern Europe
in 1991. Host to visiting scientists from many countries,
including the former Soviet Union, Czechoslovakia,
Hungary and Romania.
- Broad
and extensive understanding of all aspects of the
regulatory process including IND’s, licensing,
labeling review, inspections, product testing and
lot release, compliance actions, as well as knowledge
of foreign regulatory processes and requirements.
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| 1972
to 1976 |
Laboratory
of Rickettsial Diseases, Division of Virology, Bureau
of Biologics, FDA |
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| 1968
to 1972 |
Laboratory
of Viral Immunology, Division of Biologics Standards,
NIH |
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HONORS
AND AWARDS:
| 1992 |
|
FDA
Commendable Service Award |
| 1986 |
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FDA
Commissioners Citation |
| 1979 |
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FDA
Commendable Service Award, Influenza Vaccine Potency Task
Force |
| 1977 |
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FDA
Award of Merit, Influenza Immunization Task Group |
PUBLICATIONS:
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1)
|
Williams,
M. S., Mayner, R. E., et al, 1980. New developments in
the measurement of the hemagglutinin content of influenza
virus vaccines by single-radial-immunodiffusion. Journal
of Biological Standardization, 8: 289-296. |
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2)
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Williams,
M. S., 1993. Single-radial-immunodiffusion as an in vitro
potency assay for human inactivated vaccines. Veterinary
Microbiology, 37: 253-262 |
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3)
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Williams,
M. S., Wood, J. M., 1993. A brief history of inactivated
influenza virus vaccines. In: Options for the Control
of Influenza II., C. Hannoun et al. eds., Elsevier Science
Publishers B.V.: 169-170. |
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4)
|
Wood,
J. M., Williams, M. S., 1998. History of inactivated influenza
vaccines. In: Text Book of Influenza., Nicholson, K. G.,
Webster, R. C., Hay, A. J., eds., Blackwell Health Care
Publishers: 317-323. |
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Paged
Updated:
July 25, 2007
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