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Experience
Senior Compliance Manager, Otsuka
America Pharmaceutical, Inc. (1/2005 - present). Responsible for QSR Compliance strategy
and implementation under the Quality System Requirements (QSR) and FDA's new GMPs for the 21st Century for the device launch for this global pharmaceutical company. Also responsible for
FDA inspections and CMC strategy and submissions for devices, drugs and combination products. Managed major SOP re-write and
execution, revamped training program, instituted internal audits, established design and management reviews, supervised consultants,
during period of 100%+ growth.
Adjunct
Professor, Johns Hopkins University, 2001 – present, Introduction to RA in the Masters in BioTech program. This course provides an overview
of RA and its impact on product development. Topics include: RA history, regulatory agencies, how to access regulatory information,
submissions for drugs, biologics, medical devices; GLP, GCP, GMP, QSR; and FDA inspections. http://advanced.jhu.edu/registration/
Manager, Regulatory Affairs, Cambrex Bio
Science (formerly BioWhittaker, now Lonza), 2001-2005
- Preside over compliance effort, warning letter response; obtained FDA recognition of improved compliance during
27% growth of annual sales in company division;
- Manage regulatory issues for new cell therapy division during 45% annual sales growth;
- Assisted in inspection that ended with no items observed on the FDA form 483;
- Advise company officials on regulation of new technology, biological products, devices, drugs, combination products,
and research products; on inspection and compliance.
- Regulatory filings for devices and biologics (BLAs, IDEs, INDs, CMCs, Master Files, supplements and updates):
Plan and manage filings involving complex issues, coordinate project management teams for such filings. Review customer submissions.
- FDA liaison: negotiate with FDA on filing requirements; draft advertising and labeling.
- Communication: Extensive writing for company, customer, and FDA
audiences including submissions, talking points, memoranda; meeting with government and industry officials.
- Advise customers (sponsor-investigators, researchers and companies) on biotechnology development process and
good tissue practices; obtain and summarize regulatory information; provide regulatory strategy.
Regulatory Affairs Consultant: 1999-2001. Advised regulated industry on issues
including regulation of biotechnology, dietary supplements, devices, drugs, combination products, and cosmetics. Advised on inspections, enforcement, labeling, advertising, promotion.
- Prepared submissions for IDEs, INDs, 510ks, PMAs, combinations; printed materials;
- Negotiated with FDA on data integrity, requirements affecting clinical trials;
- Drafted advertising and labeling;
- Wrote memorandum for quality seal on licensed products and implied superiority claim;
- Analyzed FDA performance under PDUFA II;
- Reported on FDA, HHS activities including blood safety and BSE/TSE (“mad cow”).
Attorney, Health Care with Reed Smith Shaw & McClay, 1997-1998.
- Tracked and analyzed the FDA Modernization Act through Congressional committees to passage, reported to clients
and partners on the bill and its changes.
- Advised clients on issues including negotiating with HHS, FDA; data required for product clearance, product
labeling, advertisement and promotion, import/export, user fees.
Regulatory Counselor, Policy Analyst with Food
and Drug Administration (FDA), 1987-1997.
Office
of the Commissioner (OC), Office of the Chief Mediator and Ombudsman. 1993-97
Issues included product clearance, biotechnology
regulation, labeling, advertising and promotion, import and export, user fees, orphan drug designation, procedural requirements,
reimbursement, international issues.
- Advised, mediated between FDA and regulated industry, patient groups, legislators;
- Wrote FDA policy for manipulated autologous cells with scientific team;
- Led multi-disciplined teams evaluating product review, FDA policy for 80 cases annually;
- Responded to applications for review of combination products, including computer-controlled products, medical
imaging products, and tissue-derived therapies.
Executive
Secretariat, Liaison for OC and Center for Food Safety & Applied Nutrition (CFSAN). 1992-93. Member of multi-disciplined team responding to important, controversial events.
·
Managed information, weekly and special briefings for Commissioner on nutrition labeling, dietary
supplements; food supply supplementation, food biotechnology; health claims.
Center
for Biologics Evaluation and Research (CBER). 1989-1992. Legal advisor to
Office of Compliance. Member, multi-disciplined CBER teams responsible for policy
and legal issues. Trained as establishment inspector.
·
Designed regulatory program for human tissue products, and evaluated economic impact;
·
Wrote, cleared rules to disbar applicants involved in fraud; to review applications for data integrity;
to approve new procedures in licensed establishments, to establish a clinical trials databank, to revoke licenses. Prepared
supporting documents.
OC
Office of Health Affairs. 1987-88. Member of team reporting on commercialization
of human tissue products.
·
Prepared, cleared Public Health Services policy in FDA on tissue commercialization.
·
Coordinated inter-agency responses to petitions for patent term extensions.
·
Drafted articles for publication in medical journals.
CFSAN Office of Compliance, summer 1985.
·
Briefed senior CFSAN officials on bills, statutes, and legislative history of laws administered
by FDA and Health and Human Services.
Justice Department, Labor Relations, summer 1984.
·
Prepared cases and memoranda on labor issues, Privacy and Freedom of Information Acts. Briefed
Department officials,
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Prepared witness interviews and depositions, served as management co-representative at arbitration.
Education
University of Maryland School
of Law, Baltimore, MD
21201. Juris Doctorate, May 1986.
GPA B-
University of Maryland,
College Park, MD 20742.
B.S. cum laude, May 1983. GPA 3.8/4.0
Continuing education in UMBC’s Biotechnology Program
Other training
RAPS and Kellogg Management Institute, Executive Development
Program. Northwestern University, Evanston, IL
FDLI Annual meetings, 1988 - present.
Attendee, instructor, session organizer.
RAPS
Annual meetings, 1987 - present. Attendee, instructor, session organizer.
Other training information available on request.
Publications
Published work
is included in the journals of the Food and Drug Law Institute, the Regulatory Affairs Professional Society Focus and Faulkner and Gray's Health Outcomes Resource Sourcebook. Many are reprinted on this Web site. Follow the link for articles and memos.
Awards and Honors
Special
Recognition Award for high level involvement and service to the Regulatory Affairs profession, RAPS 2003, 2006.
FDA Alumni Association Volunteer of the Year, 2005.
Special
Recognition Award, Tissue Product Regulation, FDA 1997;
Special
Recognition Award, Organ and Tissue Transplantation Workgroup, FDA 1993;
Group Recognition
Award for AIDS Clinical Trials Information Service, FDA 1990.
University Awards
Moot Court
Board member, 1984-86;
Journalism
Honor Society, 1983;
Scholarship
Certificate, Arts & Humanities Division, 1983;
University
nominee, Hearst Foundation Editorial Writing Award, 1983;
Dean's List,
all semesters, 1980-83;
Member
of John Marshall PreLaw Honor Society, Alpha Lambda Delta,
and Phi Eta Sigma honor societies, 1980-83.
Other Awards
Who's
Who in American Lawyers;
Who's
Who in American Women;
Who's
Who in American Business.
Interests and Activities
Chesapeake Bay sailor 1974-97, Trans-Atlantic
Sailor
·
Puerto Rico to Maryland,
1981 (15-day trip);
·
Maryland to Portugal,
1978 (31 days);
·
Maryland to Bermuda to Maryland,
1975 (21 days).
Numerous volunteer
projects with youth and adults, international and domestic organizations, 1982-present, including American Field Service AFS
(international student exchange program); Leukemia and Lymphoma Society; Assistant to teacher for English as a Second language;
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Other Information: Authorized to work in the US for any employer; native citizen. Valid US passport.
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