Pharmaceutical Drug Development, Toxicology, GLP StudiesPharmacology, Pharmacokinetics, ToxicologyRegulatory Strategy: US & Europe, IND, NDA, BLA etc
Experience
Fifteen years of Pre-Clinical Leadership Experience: Biotech/Pharma leadership role in Toxicology, Pharmacology/PK (preclinical and clinical) including strategic design and management of IND- and NDA/BLA-enabling GLP, non-GLP Toxicology/Safety Pharmacology/TK studies.Signatory on several INDs assuring ‘safe to proceed to human’.Budgeted, planned, managed IND/NDA Pharm/Toxicology programs costing m$ 1-3.Management of dermatology, oncology and immunology NCEs and Biologics’ Toxicology programs (small organics and large protein molecules including Abs, antigens, vaccines and adjuvants, topical, oral and parenteral) from preclinical lab to NDA. Built and lead Pharm/Toxicology groups working on lead selection, Entry into Humans candidates, and PI thro’ PIII/NDA, including project management in small pharma.
