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 development and implementation of Quality & Compliance strategy across the corporation. Previous to that he was Chief Quality Officer and 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.