Healthcare Industry Consultant (1184)
Expertise
Healthcare Industries Business and Technology
Regulatory Affairs Expertise: IND, NIH, and FDA and International Protocol
Technical – Marketing Surveys of New Pharmaceutical and Medical Device Products
Patent/Licensing
Clinical Trials Management
Experience
Over 30 years of hands on and management experience in New Product Development in the health care industries, spanning basic research, technology assessment, patent and licensing, clinical testing and regulatory oversight.
Independent Consultant 1998 to Present
Provides consulting services for clients in the health care and chemical industries. These services include technical/marketing analysis, patent & licensing, clinical testing, and regulatory oversight.
National Institutes of Health 1991 to 1998, Chief, Pharmaceutical and Regulatory Affairs Branch, Division of AIDS, NIAID
Led and managed a staff of 50 professionals who:
Established and implemented regulatory policy and procedures for assuring regulatory compliance in the conduct of human clinical trials sponsored by the Division of AIDS.
Filing IND's, monitoring trial sites, reporting of adverse experiences and distribution of study agents.
Managed about 200 clinical trials involving drugs and vaccines were open at any one time.
Initiated contacts and developed relationships with the international pharmaceutical and biotechnology community involved in HIV/AIDS-related drug and vaccine development.
Negotiated and executed collaborative clinical trials agreements with these companies.
University of Virginia 1986 to 1991 Director of Industry Liaison
Provided the primary University interface with the industrial sector.
Cultivated productive, mutually beneficial relationships with the Industrial Community.
Responsible for the management and transfer of intellectual property of the University and for negotiating industrial grants and contracts.
University Patents, Inc. 1983 to 1986 Director, Life Sciences
Provided patent management and technology transfer services for eight university clients. e.g., Universities of Arizona, Colorado, Illinois, Pennsylvania and Princeton.
Prime mover in the identification, evaluation and marketing of licensing candidates.
McNeil Pharmaceutical (Johnson & Johnson) 1960 to 1983
Senior Director of International Scientific Affairs
Responsible for the regulatory approval and market development of new drugs in Europe.
Directed the efforts of 20 information and regulatory professionals.
Director of the Chemistry Department
Led and directed 150 professionals (BS to Ph.D.) in the design, discovery, development, manufacture and regulatory clearance of new drugs.
Responsible for a budget of over $30 million.
Group Leader for Chemical Development
Organized and led McNeil's first process pilot plant.
Research Scientist in Medicinal Chemistry
Designed and executed basic research in new drug discovery..
Honors & Publications
American Chemical Society
Authored numerous scientific papers.
Inventor on over 20 patents
Education
Post-Doctoral Fellow MIT
Ph.D. Organic Chemistry Rice University
BS Chemistry Brown University