Jason Warfel, PhD, is a director in the commercial biologics analytical methods and strategy group at Bristol Myers Squibb (BMS). As chair of the commercial specification committee at BMS he develops technical strategy for specifications for a diverse biologics pipeline. He is an active member of the EFPIA and ISPE working groups promoting patient-centric specifications and developing recommendations for ICH Q6 improvements. Previously, Jason was the strategic analytical lead for several key biologics molecules at BMS where he oversaw analytical strategy for multiple succesful new marketing applications and major lifecycle submissions. Prior to joining BMS, Jason was a post-doctoral staff fellow and CMC regulatory reviewer at FDA/CBER. He is an author on over 20 research publications and received the Maurice Hilleman award from the National Foundation for Infectious Diseases. Jason holds a PhD in Microbiology and Immunology from Georgetown University, Washington, DC.