Meet IQ's Leadership
Margaret Faul, PhD, IQ Consortium Chair
Margaret received her B.Sc. and M.Sc degrees from University College Dublin, Ireland. In 1987 she moved to the United States where she received her Ph.D. degree in Synthetic Organic Chemistry from Harvard University with Professor David A. Evans. In 1993 Margaret joined the Chemical Process group at Eli Lilly and Company and in 2003 went to Amgen Inc, in Thousand Oaks, CA where she is currently Vice President of Drug Product Technologies within the Process Development organization.
During her 25-year career Margaret has leveraged her technical experience to support programs across all stages of development from preclinical to commercial focused on the process development and supply of drug substance and drug product for clinical trials and the commercial market. Margaret has experience working with Commercial Manufacturing Organizations worldwide and an ability to work with partners during licensing activities to ensure seamless integration and development of programs with the partner company. Margaret has a strong knowledge of GMP, regulatory and compliance issues as they relate to the development of pharmaceutical products. She has received numerous awards in recognition of her leadership and mentorship including the Earle B. Barnes Award for Leadership in Chemical Research Management from Dow Chemical Company and the American Chemical Society and a HBA Rising Star Award.
At Amgen Margaret has invested significant effort in evolving a Green chemistry culture focused on implementation of greener and more sustainable chemical processes towards the development of novel drug substances. These efforts resulted in Amgen being awarded the Presidential Green Chemistry Challenge Award in 2017 in recognition of their work in development of an improved Green Process for Commercial Manufacture of Etelcalcetide.
Margaret has a strong scientific reputation and has invested significantly in supporting external scientific efforts. She is a member of the Board of Directors of the International Consortium for Innovation and Quality in the Pharmaceutical Industry and Chair of the Enabling Technologies Consortium. Margaret has a strong publication record being an author/co-author of more than 150 peer reviewed publications, presentations and patents. Margaret has served as a symposium organizer and session chair for several major process chemistry events and is has been a member of the Editorial boards for Science of Synthesis, Organic Synthesis, Journal of Organic Chemistry and Organic and Biomolecular Chemistry.
Timothy Watson, PhD, IQ Consortium Vice-Chair
Dr. Timothy Watson, PhD is an Executive Director and Global Leader of the CMC Advisory Office at Pfizer. The 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 PhD from The Ohio State University, under the direction of Dr. Leo Paquette.