Listed in Pharmacy & Pharmacology
• Pharmaceutical Development Scientist, Expert Witness and Consultant having more than 30 years experience developing pharmaceuticals..
• Expert Witness for US and Canadian Pharma Companies and Law Firms in Hatch-Waxman type pharmaceutical patent litigation, in-licensing due diligence, and contract dispute suit involving patented technologies.
• Consultant to clients including Big, Medium and Virtual Pharma Companies, Academia and US Government. Projects included Product Development, Project Management, Preformulation Support, Author and Reviewer of Chemical Development, Pharmaceutical Development, and Process Validation Reports, CMC Sections of INDs, NDAs and CTD.
• Pharmaceutical Development Scientist/Manager for 20 years for Johnson & Johnson Family of Companies providing Preformulation/Physical Pharmacy support for pre-Clinical, Formulation, Clinical Development and Manufacturing Departments by anticipating their needs and resolving API and dosage form problems, advancing projects, regulatory filings and departmental capabilities; providing intra-mural support to non R&D and Manufacturing Departments, and working with extra-mural vendors to keep projects and filings on schedule.
• Pilot Plant Operations Manager for 4 years for a novel Drug Delivery and Tissue Engineering (Bone) Development Company developing unique drug delivery systems, dosage forms and tissue (bone) replacements. Responsible for providing all laboratory services and establishing a cGMP facility for manufacturing products and a cGMP mindset among the users.
• Core specialties include CMC Development issues, Preformulation, Physical-Pharmacy, Analytics, cGMP Operations, Project Planning and Management.
• Overall Experience has resulted in highly developed management and writing skills; extremely wide range of direct and indirect product development experiences in multi-national large, medium, small and virtual Pharma companies.
• Author of 15 published Manuscripts, 12 Meeting Abstracts, 21 Invited Symposia, Seminars and Courses, and 5 Articles in Pharmaceutical Magazines.