Pharmaceutical Development Scientist, Expert Witness and Consultant having more than 40 years’ experience developing pharmaceuticals.
Consultant to Multinational, Big and Virtual Pharma Companies as Author and Reviewer of Documents intended to support Product Development, Manufacturing, and Regulatory Submissions such as Chemical Development, Pharmaceutical Development, and Process Validation Reports, CMC Sections of INDs and NDAs; Project Management; In-licensing opportunities; and Due Diligence. and Law Firms.
Member of NIH NAIAD Panels reviewing Proposals for development of drug products for infectious diseases and terrorist vectors which have no treatment options.
Consultant, Full Time and Adjunct Faculty assistance to Universities.
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, disputes involving failed responsibilities, and patented technologies. Supported Claims Construction, Opined as an Expert with Expert Reports and Testimony at Deposition and Trial.
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 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, 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 for Therics Inc, Novel Drug Delivery/Dosage Form and Tissue Engineering (Bone) Development Company providing a dual operational facility for non-cGMP development and fully cGMP compliant facility for pre-Clinical, Clinical, Demonstration, and Regulatory Batches.
Author of 18 published Manuscripts, 12 Meeting Abstracts, 26 Invited Symposia topics, Seminars and Courses, and 5 Articles in Contract Pharma.
