CASSS is an agile, non-profit scientific community whose strength is bringing together professionals from industry, academia, and regulatory agencies to solve scientific and technical problems to advance the field of biopharmaceutical development and honored longtime volunteers John Dougherty and Reed Harris as Distinguished Fellows.
Jamie Moore, Mark Schenerman, and the CASSS Board of Directors will present this lifetime membership award to Dougherty and Harris in January 2024 at the annual Associate Director meeting.
Schenerman shared about Dougherty, “As one of the founders of the CMC Strategy Forum, John conceptualized the framework for a highly successful meeting model that continues today. The CMC Strategy Forum is innovative and unique in the industry because it features not just podium presentations but its raison d’etre is engaging the audience members in discussion through expert moderation. Also unique to the Forum is publishing a paper that summarizes the key discussion points made by industry and health agency spokespersons. John co-hosted the first CMC Strategy Forum on peptide mapping and continued to encourage peers to participate in hosting other topics that arose from WCBP workshops. John co-hosted many CMC Strategy Fora and was instrumental in creating a new European CMC Strategy Forum. As the cultures in the US and Europe are quite different, many hurdles had to be overcome in order to make the CMC Europe meeting the success it is today. John’s dedication and enthusiasm for science and collaboration are an inspiration to all of us and we look forward to his continued participation in CASSS meetings as a Distinguished Fellow.”
When Moore discussed Harris' involvement in the industry, “Reed has been paving the way for the characterization of biologics for over 40 years. He was instrumental in the identification of sequence variants, elucidation of glycosylation species, method development for charge variants, and higher-order structure, just to name a few. He is recognized as a trail-blazing analytical scientist who helped define industry best practices including participating in the first Symposium on the Analysis of Well-Characterized Biotechnology Pharmaceuticals (WCBP) in San Francisco. With over 50 publications, he continued to be influential throughout his career helping to define industry standards for CQAs, QbD, Comparability, and Control Strategies. Reed has been an active member of the CASSS community serving on the WCBP planning committee, co-chairing plenary and workshop sessions, and presenting as a keynote speaker at CE Pharm and HOS. Thank you, Reed, for always asking 'What do we need to measure' – your foundational contributions to well-characterized biologics will continue to play an important role in delivering quality products to patients.”
Dougherty was with Eli Lilly and Company for 25 years before going into consulting with a focus on regulatory affairs for CMC matters. His career spans over forty years in the biopharmaceutical industry focused on regulatory affairs, chemistry manufacturing and control (CMC), product development, and quality control. He is a recognized leader in the global biotechnology CMC community whose influence has impacted the development of CMC regulation of biologic products. Dougherty has been a longtime volunteer at CASSS for the WCBP and CMC Strategy Forums. He was also on the CASSS Board of Directors from 2009-2016.
Harris recently retired from pharma technical development after 25 years at Genentech, a Member of the Roche Group. He has been a long-time volunteer and speaker at CASSS. In addition, he has been an author in over 50 publications on topics that include recombinant protein characterization methods, and the identification of novel or unexpected protein structures. While at Genentech, he was responsible for method development and validation, specifications, QC testing, clinical development and commercial comparability assessments, and physico-chemical characterization. Co-leader of the comparability strategy team and commercial comparability. He also led the development and application of QbD-based tools for CQA assessments and control strategy decisions.
For more information on Distinguished Fellows, click here.