National and International Pharmaceutical Development Expert: Research and Development, Drug Manufacturing, FDA Regulations, IND, NDA , cGMP, Compliance and Validation

Technical Consultant #705

Summary

Expertise in global product development, technology transfer/validation and business development.
Designed and implemented development and registration strategies in U.S. and International arenas.
Significant experience with all pharmaceutical dosage forms including peptides and novel delivery systems.

Expert Witness

Twenty years of experience as an expert witness for pharmaceutical and formulation matters.

Undisclosed Company, Principal, 1995 - Present

Worldwide Pharmaceutical Development Consulting

Direct and budgets programs in pharmaceutical development and clinical manufacturing, IND to NDA development, manages research and development outsourcing programs and provides U.S. and International preapproval inspection, cGMP compliance and validation support. Experience in business development.
Project leader on development teams responsible for IND to NDA programs with novel solid and parenteral dosage formulations.
Oversight for formulation, analytical method development and clinical supply manufacturing with clinical drug candidates from various sponsor companies.
On-site preapproval inspection, cGMP compliance and auditing support for US and European companies.
Research and development support for biotech and pharmaceutical companies leading to successful regulatory submissions.
Business development and marketing for Research Triangle Institute and Hi-Tech Pharmaceutical Co. (analytical, formulation and contract manufacturing services).

Wallace Laboratories, Cranbury, NJ Director, Pharmaceutical Development, 1990 - 1995

Directed, budgeted ($4,000,000) and organized a new multifaceted development department (30 people, 5 Ph.D.'s and 2 chemical engineers) encompassing preformulation, dissolution analysis, formulation development, process development and clinical packaging.
Planned and executed pharmaceutical efforts leading to multiple IND submissions, four (4) NDA submissions and successful PAI programs.
Coordinated and led all development activities for solid dosage, injectable, intranasal, suspension and novel delivery systems for parenteral and oral administration.
Planned, designed and led successful process and cleaning validation efforts for clinical manufacturing and production at corporate plants.

Rorer Group Inc., (Revlon ) Fort Washington, PA, Director, 1981 - 1990

Pharmaceutical Coordination and Pharmaceutical Technology

Organized and created a pharmaceutical coordination function. Led projects through research, process engineering and registration.
Conducted process engineering and international (EEC and Japan) harmonization registration programs for injectable, aerosol, intranasal (peptide) and controlled release projects (e.g., a major once-a-day anti hypertensive tablet) leading to successful worldwide introductions.
Developed a technical program with worldwide corporate affiliates for manufacturing and registering overseas clinical supplies.

Department Director, Technical Services, 1984 - 1987

Section Head, 1981 - 1984

Organized a team responsible for worldwide pharmaceutical, analytical and microbiological technical services.

Purdue-Fredrick Company, 1977 - 1981

Head Analytical Chemistry, 1979 - 1981

Organized and directed method development and stability groups.
Supervised the preparation of successful ANDA technical submissions for sustained release tablet (Theophylline) and topical liquid products.

Group Leader, Pharmaceutical Development, 1977 - 1979

E.R. Squibb & Sons, New Brunswick, NJ, 1972 - 1977

Research Investigator

Formulation and development of solids and parenterals (including scale-up procedures).
Hands-on role in the formulation, development and coordination of two major cardiovascular products for worldwide manufacture. (Captoril and Corgard) with sales over one billion dollars per year.

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Academic and Professional Affiliations

Awards