Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance, and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this, he was VP at the executive team level at PDL BioPharma where he was responsible for the development and implementation of Quality & Compliance strategy across the corporation. Previous to that he led the Quality and Compliance function at Chiron and Immunex Corporations and was Director of Quality Assurance for SmithKline Beecham and for Bayer for their biotechnology and biologics businesses. He has also held positions in research and development, regulatory affairs, process development, and manufacturing at other major pharmaceutical companies. He has successfully licensed products in the biologics, drugs, and device sectors on all 6 continents. Dr. Calcott holds a Doctorate degree in Microbial Physiology and Biochemistry from the University of Sussex in England and completed his post-doctoral work at McGill University in Montreal, Canada. Recently, he was chair of the Regulatory Affairs Committee of BIO and presently serves on the Board of BayBio, a biotechnology industry association in San Francisco. He has been a consultant for 17+ years to various governments, industries, and academic institutions during his career. Dr. Calcott has authored over 80 original research papers, reviews, and books.
Peter Calcott is a broad-based consultant working in pharmaceuticals and biotechnology in the biologics, drug and device areas * Supply Chain - logistics, process, manufacturing, outsourcing * GMP Quality - QMS, assessments, audits, remediation * Clinical Development - audits, assessments, and planning * Regulatory Affairs - submissions, inspections, recalls * Corporate Compliance - governance, risk, and strategy * Government Affairs - for the small start-up as they evolve and grow * Corporate Strategy - due diligence, portfolio analysis, change management * Enterprise e-solutions - PM, business analysis, validation, quality, and executive oversight. Specialties Both tactical solutions and strategic planning and execution for small to large-sized pharmaceutical and biotechnology companies.