Michael Adams has 25 years of experience in drug development. He currently works as consultant/advisor to Pharmaceutical and biotech companies in CMC development and drug regulatory affairs. Previously, he was SVP of Pharmaceutical Operations at Spectrum Pharmaceuticals, Inc. He is also an Entrepreneur‐in‐residence at CONNECT helping pharma/biotect start up companies. Before joining Spectrum, Michael was Senior Vice President, Drug Development Operations at Anadys Pharmaceuticals, Inc. Michael had responsibility for regulatory affairs, quality assurance, pharmaceutical development and manufacturing, and project management. Previous to Anadys, Michael had been Vice President, Pharmaceutical Sciences at Pfizer, Inc. ‐‐ Global Research & Development in La Jolla, CA since 2000. At Pfizer he led the La Jolla organization responsible for chemical, analytical and pharmaceutical development from compound identification through launch and product enhancement. Previously, he was Vice President, Worldwide Regulatory Affairs, and Quality Assurance & Compliance at Agouron Pharmaceuticals, also in La Jolla, where he put together the firm's Regulatory CMC group. Prior to Agouron, he was the Director of Worldwide Regulatory Affairs, CMC Group, at Bristol‐Myers Squibb, where he managed Regulatory CMC projects in CNS and CV/MD therapeutic areas. Michael earned a Ph.D. in Organic Chemistry at the Massachusetts Institute of Technology in Cambridge, MA.