Pharmaceutical Development Scientist, Consultant and Expert Witness having more than 40 years’ experience developing pharmaceuticals.
Expert Witness for Law Firms and Companies in US Paragraph IV Hatch-Waxman and Canadian Notice of Allegation innovator vs. generic pharmaceutical dosage form patent litigation, in-licensing due diligence, and contract dispute involving commissions and patented technologies. Supported Claims Construction, Consulted as an Expert, Wrote Expert Reports and Testified at Deposition and Trial.
Consultant to Multinational Big, Medium and Virtual Pharma Companies, Academia and NIH. Projects included Product Development Project Management; Preformulation Support (Physical-Chemical Properties Characterization), Author and Reviewer of Chemical Development, Pharmaceutical Development, and Process Validation Reports, CMC Sections of INDs and NDAs.
Pharmaceutical Development Scientist/Manager for 20 years at McNeil Pharmaceutical and the R.W. Johnson Pharmaceutical Research Institute, (Johnson & Johnson Family of Companies) providing Preformulation Physical-Pharmacy support for Formulation Development, pre-Clinical and Clinical Development, Medicinal and Developmental Chemistry, Pharmacology and Biochemistry Departments and Manufacturing; characterizing NCEs resolving problematic NCE and dosage form properties, formulating oral and parenteral products for Clinical, pre-Clinical, and Laboratory Development, anticipating needs, advancing projects, regulatory filings and departmental capabilities; interacting with intramural departments and extramural vendors; keeping projects and filings on schedule.
Pilot Plant Operations Manager for 4 years at Therics Inc, Novel Drug Delivery/Dosage Form and Tissue Engineering (Bone) Development Company. Responsibilities included providing cGMP training, a dual operational facility for non-cGMP R&D activities and a fully functional cGLP and cGMP compliant facility for pre-Clinical, Clinical, Demonstration and Regulatory Stability Batches.
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 18 published Manuscripts, 12 Meeting Abstracts, 26 Invited Symposia Topics, Seminars and Courses, and 5 Articles in Pharmaceutical Magazines.