Kathleen Francissen

Dr. Francissen serves as the Rapporteur of the ICH Cell and Gene Therapy Discussion Group (CGTDG), which includes 25 member organizations representing 45 countries. In this role, she is responsible for leading the technical discussions, and represents the Biotechnology Innovation Organization (BIO). The scope of the ICH CGTDG encompasses topics in the quality, nonclinical, and clinical disciplines, and focuses on advanced therapy medicinal products (ATMPs) of greater maturity. The remit of the discussion group includes a strategic roadmap with recommendations for new ICH guideline development and/or revisions to existing ICH guidelines to address the technical aspects of cell and gene therapies that require regulatory flexibilities. Kathy has >25 years of experience in biopharmaceutical development. She is the Head of ATMP, Technical Regulatory Policy at Roche and has developed and implemented CMC regulatory strategies to support global clinical studies and market applications. Kathy also co-leads an EISC multi-disciplinary Roche team addressing policy issues and challenges for ATMPs. She co-chaired the CGTP 2024 Symposium and was previously a member of the CASSS Board of Directors.