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 volunteer Kathleen Francissen as a Distinguished Fellow.
Wassim Nashabeh, former CASSS Board President and Distinguished Fellow, will present the Lifetime Membership Award to Francissen during the 2026 WCBP Symposium.
When accepting this lifetime membership, Kathleen shared, "The CASSS community has had such an important role throughout my career. There are so many important concepts that get discussed in depth at CASSS conferences, and I’m humbled and delighted to receive this recognition as a Distinguished Fellow of CASSS in the year when we celebrate the first WCBP conference. This is especially meaningful for me since the “well characterized” concept is crucial in the biopharmaceutical field. Today, many cell- and tissue-based medicines are not yet well characterized and face similar challenges to those encountered 30 years ago for recombinant protein products. It’s a privilege to collaboratively share perspectives across the network of CASSS colleagues to drive progress and innovation for cell and gene therapy products. I’d like to express my gratitude to the whole CASSS community and Board of Directors, along with my colleagues at Genentech and Roche and my family for their support.”
Francissen is currently the Global Head of ATMP Policy, Pharma Technical Regulatory Policy at Genentech, a member of the Roche Group, and serves as the Rapporteur of the ICH Cell & Gene Therapy Discussion Group (CGTDG) where she represents the BIO organization and is responsible for leading technical discussions and building consensus to generate a strategic roadmap for future harmonisation of regulations for advanced therapy medicinal products (ATMP). Francissen has >25 years of experience in biopharmaceutical development and has been dedicated to ATMPs since 2016. She has experience with a wide range of ATMP modalities as well as Mab products and antibody-drug conjugates. Early in her career in industry, she was a scientist in the Protein Analytical Chemistry organization, and since then her experience and leadership has been mostly in Regulatory CMC at Genentech-Roche.
Francissen has been a long-time contributor to and leader within the CASSS/WCBP Symposium community. She served on the CASSS Board of Directors, Associate Director, WCBP, CGTP, and CGTP Summit organizing committees. She was the co-chair of the Cell and Gene Therapy Product (CGTP) Symposium in 2018 and the CGTP Summit on Comparability in 2023. She was also the industry co-chair lead for WCBP in 2013 and participated in multiple CASSS CMC Strategy Fora throughout the globe as a session chair, speaker, or panelist over the years. She holds a PhD in microbiology from the University of Illinois, was a postdoctoral fellow at the US Department of Energy, and a Visiting Scientist at the Max Planck Institute for Marine Microbiology in Bremen, Germany.
For more information on Distinguished Fellows, click here.