Post Doctoral Training Cancer Drug Toxicity, Univ Texas, Austin

PhD, Pharmacology and Toxicology, Univ Calif, Davis, CA 1990

DVM (BVSc) India, 1984

• Regulatory Strategy: US & Europe, IND, NDA, BLA
• Board Certified Regulatory Professional (RAC) and Board Certified Toxicologist
  
• Pharmaceutical Drug Development, Toxicology, DMPK GLP Studies

• 17 years of Non-Clinical Drug Development and Regulatory Strategy Experience
• FDA/EMEA filings, meetings, removal of clinical holds: IND, NDA, BLA, 505b2 filings.
• NCEs & Biologics
  
• Biotech/Pharma leadership 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’.
• Management of dermatology, oncology and immunology NCEs and Biologics’ Toxicology programs from preclinical lab to NDA.
• Lead selection, Entry into Humans candidates, and PI thro’ PIII/NDA, including project management in small pharma.