EDUCATION:
| Ph.D. |
|
Massachusetts
Institute of Technology; Cell Biology (1978) |
| B.S. |
|
State
University of New York at Stony Brook; Biology (1973) |
| Non-degree: |
|
Biochemical
Regulatory Engineering Program Concentration; University
of Maryland Baltimore County (1996) |
| Continuing
Ed.: |
|
Course
work and training in FDA law and various aspects of cGMP |
SUMMARY
OF EXPERTISE
| Over
the course of my academic and professional career, I have
progressed from basic research through increasingly applied
research in somatic cell/medical genetics and identification
of epitopes for vaccine development, to cell line safety
testing for biopharmaceuticals in a natural evolution
toward regulatory review. From 1974 through 1988, I worked
in the field of gene expression, employing a series of
developmental and disease-related systems. Since then,
I have expanded on this foundation, applying knowledge
gained in the research environment to the design and execution
of protocols to satisfy regulatory concerns surrounding
product safety, and to the interpretation of the resulting
data. Most recently, I have participated directly in the
FDA’s regulatory activities in application review, policy
development, and international regulatory coordination.
These efforts were initially individual; each successive
level was accompanied by expanded collaboration, additional
supervisory responsibilities and increased responsibility
for interfacing with clients, manufacturers and international
regulatory agencies. During this time, as researcher,
reviewer and manager, I have acquired experience with
a wide range of disciplines and technologies, sponsors
and products, submissions and processes, with the goal
of bringing safe and effective products to the public
in a timely manner. |
CURRENT
POSITION:
May 1998 to present: |
|
Director,
Therapeutics, Biologics Consulting Group iNC..
- Responsible
for the scientific and regulatory review and analysis
of a wide range of therapeutic products at all stages
of product development, from pre-IND development through
post-marketing.
- Provide
regulatory, scientific and manufacturing analysis
and support, develop product-and facility-related
regulatory documents for submission, review SOPs and
validation packages, and perform facilities audits.
|
Dec.
1994 to
Apr. 1998 |
|
Chief,
Hybridoma and Hematologic Products Branch, Division
of Application Review and Policy, Office of Therapeutics
Research and Review, CBER.
- Products
under the purview of my branch included:
- monoclonal
antibodies for therapeutic or in vivo diagnostic
use
- thrombolytics
- hematologic
growth factors
- devices
used with or for therapeutic purposes, assigned
to CBER by intercenter agreement.
- Reviewed
scientific and regulatory analyses prepared by my
staff, as well as agency correspondence, related to
both market and investigational submissions, for scientific
and regulatory accuracy.
- Responsible
for the quality assurance review of the scientific
and regulatory bases for approval of biologic and
medical device submissions, including review of applicable
labeling.
- Responsible
for assuring adherence to review deadlines for market
applications, by providing guidance on the managed
review process to both branch members and other Center
personnel. This often involved building consensus
among individuals with highly diverse personal and
professional styles.
- Acted
as a liaison between the biotech industry and the
agency, routinely providing consultative services
to a broad cross-section of the biotech industry at
all stages of product development, from pre-clinical
submission through post-marketing.
- Responsible
for assuring equity of the workload among my staff,
assigning projects based on scientific and regulatory
expertise
- Maintained
an open-door policy and held frequent discussions
with branch members and others to keep current with,
and provide guidance on, all aspects of the projects
ongoing within the branch
- Encouraged
staff to pursue training programs and professional
development to both broaden and deepen their scientific
and regulatory strengths, and to participate in intra-
and inter-center activities in their areas of expertise.
Through this mechanism, branch members developed versatility
and independence, coupled with a strong sense of "team",
in a collegial and highly productive atmosphere. The
resulting work products were of high quality, complete
and submitted in a timely fashion
- Responsible
for hiring actions and staff evaluations and was the
direct supervisor of five doctoral level scientific/regulatory
reviewers and one secretarial support staff individual.
- Served
as member of the ICH Expert Working Group on Quality
of Biotechnology Products, serving as the FDA lead
on the viral safety and cell substrates documents,
and represented the Center in the discussions on the
quality portion of the Common Technical Document
- Organized
the 1995 CBER workshop on viral safety and cell substrate
issues, in collaboration with industry and international
regulatory agencies
- Considered
a resource on cell substrate issues, providing information
both within and outside my immediate office
- Participated
in Center managed review and strategic planning committees,
- Gave
scientific and policy presentations internally, before
agency committees and before regulated industry
- Led
and performed facility inspections, while continuing
to have primary responsibility, as described in the
following position description, for a limited number
of regulatory submissions
|
Feb.
1992 to
Dec. 1994 |
|
Microbiologist,
Hybridoma and Hematologic Products Branch, Division
of Application Review and Policy, Office of Therapeutics
Research and Review, CBER.
- Had
regulatory responsibility for a wide variety of monoclonal
antibodies, hematologic growth factors, cytokines
and devices both within the investigational phase
as well as post-licensure.
- Performed
reviews as well as coordinated review teams, formulating
and drafting review letters and working with the team
to adhere to review time lines. Depending on the product,
the regulatory mechanism under which it is reviewed,
and the stage of development, submissions have been
in the form of INDs, Master Files, Product, Biologic
and Establishment License Applications and PMAs.
- Interfaced
with a broad cross-section of the biotech industry,
at all stages of product development from pre-clinical
submission through post-marketing.
- Member
of the ICH Expert Working Group on Quality of Biotechnology
Products as the FDA lead on the viral safety and cell
substrates documents and chaired the CBER/CDER group
working on the ICH virus and cell substrate documents.
- Member
of internal committees to draft the Cell Substrates
and Monoclonal Antibodies PTCs
- Served
as a resource on cell substrate issues, providing
information both within and outside my immediate office.
- Responsible
for assuring adherence to review deadlines for market
applications by providing guidance on the managed
review process; this often involved building a consensus
among individuals with highly diverse work styles.
- Led
and participated in facilities inspections.
|
Jan.
1989 to
Feb. 1992 |
|
Study
Director, Microbiological Associates, Rockville,
MD.
- Areas
directed: biochemical retrovirology, electron microscopy
and mycoplasma and sterility testing
- Responsible
for managing multiple simultaneous GLP-compliant studies
as varied as reverse transcriptase assays, co-cultivation
and induction protocols with multiple endpoints (including
infectivity assays)
- Responsible
for scanning and transmission electron microscopic
analyses (on both cells and cell culture fluids)
- Responsible
for assays for mycoplasma contamination in cell cultures
and culture fluids as well as in raw materials, and
assays to assure the sterility of both production
substrates and final product formulations.
- Served
as study director for a number of studies designed
to evaluate viral clearance utilizing at least six
different viruses to challenge a diverse collection
of columns and buffer systems, as well as studies
designed to evaluate mycoplasma clearance.
- Have
considerable experience working with members of the
industry and academia to design and implement testing
protocols for a wide variety of products.
- Worked
closely with firms to design studies to address specific
concerns expressed by regulatory agencies, and have
prepared documents for submission to these agencies.
At the time I left, I was working with the director
of the QA unit to bring the laboratory into compliance
with applicable cGMP requirements.
- Served
as direct supervisor of one supervisory, three mid-level
and one entry-level technical personnel
- Responsible
for hiring actions and staff evaluations.
- Responsible
for multipartite studies performed by any additional
personnel required to complete the study.
|
July
1988 to
Jan. 1989 |
|
Senior
Scientist, IGEN Incorporated, Rockville, MD.
- Molecular
biology department project involved the design and
synthesis of expression vectors for a series of proprietary
antibody constructs.
- Responsible
for providing oligonucleotides to be used in conjunction
with a proprietary detection technology for nucleic
acid analyses, using an Applied Biosystems Model 380B
DNA synthesizer .
- Member
of a team tasked with the identification and preliminary
evaluation of potential targets for catalytic antibody
development.
- Involved
in the final review process for the applications literature
accompanying release of the initial system utilizing
IGEN’s proprietary detection technology.
|
Sept.
1982 to
July 1988 |
|
Research
Chemist, Walter Reed Army Institute of Research (WRAIR),
Washington, DC.
- Within
the Division of Communicable Diseases and Immunology,
my work involved the study of the kinetics of induction
of mRNA synthesis in response to treatment with several
cytokines.
- Within
the Division of Biochemistry, my work involved regulation
of cell surface membrane components of parasitic protozoa
for immunoprophylactic or chemotherapeutic studies.
- Supervised
the operation of an Applied Biosystems Model 380B
DNA synthesizer, utilizing synthesized oligonucleotides
in collaborative projects with the malaria vaccine
and bacterial toxin programs.
- Non-research
duties included
- Served
as a liaison for several contracts
- Participated
in contract review boards.
- Supervised
two technicians and four summer personnel.
|
HONORS
AND AWARDS:
| 1996 |
|
Center
Director’s Award for Policy Development - for ICH
participation |
| 1997 |
|
Group
Recognition Award for the Monoclonal Antibodies
Points to Consider - for development of the Monoclonal
Antibodies PTC |
| 1996
- 1997 |
|
Performance
awards for ICH participation |
| 1995 |
|
Performance
award for organizing the CBER International Viral
Safety Workshop |
|
Page
Updated:
July 25, 2007
|
