Biologics Beyond Today's Markets: The Case for Innovation in Bioprocess R&D to Enable Global Access of Biologics

Stephen Hadley is a Senior Program Officer for Vaccine Development (CMC) in Global Health at the Bill & Melinda Gates Foundation.  In this role he provides technical CMC support to foundation partners involved in product development and makes investments in innovations in bioprocess R&D.  The majority of projects supported by Steve are product or technology investments in recombinant proteins and monoclonal antibodies.  Before arriving at the foundation, he was VP of quality for CMC ICOS Biologics, a biologics contract development and manufacturing organization, and was responsible for oversight of the QA, QC and analytical/formulation development activities for the company.  Prior to CMC, Steve worked for ICOS Corporation as VP of quality and small molecule manufacturing (API and dosage form manufacturing).  Steve worked as a research scientist with the FDA, where he was responsible for evaluating analytical methods for regulatory actions and for performing preapproval inspections of biotechnology companies.  He also held scientist positions in discovery research and analytical quality control at NeoRx Corporation.  Steve received his Ph.D. in Organic Chemistry from the University of Washington and BS degree in Chemistry from the University of Maine.