Lesley Pickford

WORK HISTORY

EDUCATION

ABOUT LESLEY PICKFORD

30 years in Biopharmaceutical R&D. Strategy, project and program management. Building teams and leadership, through executive management level, reporting to CEO/CMO. Key roles in M&A activity at several companies and as a consultant. Strategic planning and competitive analysis to support Business Development. Global Regulatory Affairs and Strategy: Head of Department; subject matter expert (SME) for clinical and nonclinical FDA and ex-US filings and interactions. Medical writing and Documentation.Decision-making responsibilities for INDs, CTAs and NDAs, approved BLAs and MAAs. Prepared many successful regulatory meeting packages and led FDA interactions.GXP expertise. Established R&D departments. Planned and managed translational pharmacology and DMPK programs. In-house and CRO laboratories. Drug discovery through Phase 3 clinical trials, enabling product approvals. Therapeutic indications include rare and orphan diseases, CNS, autoimmune, oncology, CV and metabolic disorders. Small molecules and biologics, including MAbs,biosimilars and gene therapies, delivered by various routes and systems. Board Member, Bio E2E; 20••••07; CTETA, 19••••93.Employment Summary:2013 present: Principal BioPharma Partner, Senior Consultant in BioPharmaceutical Practice for CRO, VCs and BioPharma clients, Oceana Associates, Palo AltoFellow, Bell Mason Group: BioPharmaceutical domain expertise for new Ventures and Corporate Venture Capital 20••••21: Director, Head Medical Writing, Regulatory Affairs Department, Adverum Biotechnologies, Redwood City, CA20••••15: Senior VP Drug Development, Retrotope Inc, Los Altos20••••14: VP Preclinical Safety & Pharmacology, Biotie Therapies,(formerly Synosia Therapeutics, acquired by Acorda), S San Francisco, CA 20••••06: Director Nonclinical R&D & Research Fellow, J&J PRD / ALZA, Mountain View, CA20••••03: Vice President, Research, Calyx Therapeutics, Director Pharmacology, Corixa / Coulter Pharmaceutical, S San Director Toxicology, Connetics Corporation, Palo Alto, CA19••••94: Senior Scientist, Preclinical R&D, Nycomed Salutar, Sunnyvale, CA19••••92: Postdoctoral Fellow, Depts. of Pathology and Psychiatry & Behavioral Sciences, Stanford U. School of MedicineBSc (Honours, first class) 1981, PhD, Medical Biochemistry (Pharmacology), Flinders U. of South Australia (1988), MBA, Santa Clara U, Leavey School of Business (2005)