细胞与基因治疗讨论组CGTDG战略路线图交付进展

International Council for Harmonisation of Technical Requirementsfor Pharmaceuticals for Human UseCell & Gene Therapy Discussion Group (CGT DG): Progress toward Delivering a Strategic RoadmapCASSS CMC Strategy Forum JapanKathleen Francissen, Ph.D.BIO10 December 20242Overview❖Describe the Cell & Gene Therapy Discussion Group (ICH CGT DG)❖Provide rationale for CGT DG formation❖Outline the remit❖Describe progress toward deliverables in the Work Plan3Cell & Gene Therapy Discussion Group❖Topic adoption date: August, 2023❖Rapporteur: Dr. Kathleen Francissen, BIO ❖Regulatory Chair: Dr. Melanie Eacho, FDA, United States❖CGT DG Kick-off Meeting: October, 2023❖Work Plan endorsement: December, 2023❖Rapporteur Supporter: Elaine Shults, BIOICH Website4Cell & Gene Therapy Discussion Group❖CGT DG Remit Paper❖CGT DG Work Plan❖CGT DG Roster5Remit Paper❖Remit paper describes scope and timelines❖Final deliverable byOctober,2025625 member organizationsrepresenting 45 countriesICH CGT DG Members7ICH CGT DG