Kathleen Francissen

Dr. Francissen has >25 years of experience in biopharmaceutical development, including comparability studies for MAb products and ATMPs, and currently serves as the Head of ATMP Technical Regulatory Policy at Roche-Genentech. Kathy also represents BIO as the rapporteur of the ICH Cell and Gene Therapy Discussion Group (CGTDG) where she is responsible for leading the technical discussions among its 25 member organizations representing 45 countries. The scope of the ICH CGTDG’s work includes topics in quality, nonclinical, and clinical disciplines under a remit to generate a strategic roadmap with specific recommendations for new ICH guidelines or revisions to address areas where regulatory flexibility is needed for ATMPs. The highest priority recommendation by the CGTDG was an annex to ICH Q5E to address the unique challenges for assessing comparability of ATMPs when manufacturing changes are made; BIO put forth a new topic proposal, which was endorsed by the ICH Assembly. Kathy is also a member of the CASSS CGTP Symposium organizing committee and co-chaired the 2024 conference.