Join us Wednesday morning to kick off the largest one-day biopharma event in the Northeast! The session will start with an introduction to the ISPE Boston Scholarship Foundation and a ceremony for this year’s Boston Chapter Awards recipients. Finally, we will have a keynote session with industry leaders Tim Watson, Head of CMC Regulatory Affairs – Vice President at Gilead Sciences, who will speak about trends in the industry and Katherine Leitch, Vice President, Global Technical Operations at Seres Therapeutics, who will speak on VOWST™ – The CMC journey in a new modality from idea to FDA approval.
Speakers: Timothy Watson, Vice President-Head of CMC Regulatory Affairs, Gilead Sciences Katherine Leitch, Vice President, Global Technical Operations at Seres Therapeutics
Dr. Timothy Watson, Ph.D. is Vice President-Head of CMC Regulatory Affairs, Gilead Sciences. Prior to Gilead, Tim lead Pfizer’ CMC Advisory Office is a collection of global Pfizer technical and regulatory experts that provide guidance & direction to project teams to mitigate regulatory risk & integrate CMC policy with product strategies; while developing and advocating policy positions (internally and externally) in conjunction with QO. The Advisory Office includes in region team members to support AFME, LATAM, A-Pacific portfolio execution and CMC policy, including the Pfizer’s China’s CMC product portfolio team. In addition to Advisory Office responsibilities, Tim has been instrumental in development & implementation of Quality by Design, ICHQ12, etc. & continues to advocate for global regulatory harmonization & mutual reliance serving as a PhRMA representative to several ICH Expert & Implementation Working Groups (EWG & IWG) since 2009. Tim served as a PhRMA EWG member on the ICHQ11 regulatory guidance document for drug substance, the Rapporteur for the ICHQ11 Q&A Starting Material IWG, PhRMA IWG member for the ICHQ7 Q&A team and continues to serve as the PhRMA ICHQ3C EWG lead. Recently, Tim has been nominated to serve as the PhRMA IWG/ EWG lead for ICHQ9 revision (starting in 2020). Tim serves on the Boards of Directors for the International Consortium for Innovation and Quality (IQ), Co-Chairs the ISPE Global Regulatory and Quality Harmonization Council/ and member of Regulatory Steering Committee and appointed as the Pfizer’s lead representative on the PhRMA Global Quality and Manufacturing Work Group (GQM WG). Tim has numerous publications, presentations, and received numerous awards for regulatory contributions (e.g. AAPS Regulatory Section Recognition Award in 2014).
Tim began his career at Marion Merrell Dow (1994) in chemical research and development (CRD) as a API small molecule process chemist, where his responsibilities involved developing new API processes, manufacturing the first GMP API bulk clinical supplies, and technology transfers to commercial facilities/ CROs, etc. In 2000, Tim joined Pfizer, where he continued with process chemistry development responsibilities with a focus on post proof of concept projects and commercialization up until 2009 when he joined CMC. Tim holds a Ph.D. from The Ohio State University, under the direction of Dr. Leo Paquette.
Katherine (Katie) Leitch currently serves as Vice President, Global Technical Operations at Seres Therapeutics. Prior to joining Seres, Katie worked at Alexion for 8 years, most recently as the Senior Director of Global Technical Operations – Product Lifecycle Management and Projects at Alexion supporting both internal and external commercial manufacturing. Katie also held the positions of Director of Plant and Process Engineering for an internal manufacturing site and Director of Environmental, Health, and Safety (EHS) for North America Manufacturing. Prior to joining Alexion, Katie worked for Merck for 14 years with increasing levels of responsibility primarily in technical support roles for vaccine manufacturing. The manufacturing experiences at Merck included working on three facility start-up projects as well as supporting multiple licensed vaccine manufacturing facilities. Katie was a co-founder for the Boston Area ISPE Women in Pharma Subcommittee and has served on the Board of the Boston Area ISPE Chapter. Katie earned both of her engineering degrees from Virginia Tech.