How Do You See The Current Revolution In Process Development And Manufacturing Of Cell And Gene Therapies Changing The Regulatory Landscape For Approvals Of Personalized Medicines?

THE EXPLOSION OF CELL AND GENE THERAPY (CGT) DEVELOPMENT WILL CONTINUE to result in precision medicines being a substantial percentage of all new medicines approved. Sequencing tools to enable patient-specific decisions are also on the rise. Yet, approvals of precision medicines will require even more robust and thoughtful clinical studies to assess the complexity of these products, especially the combination of treatments that are likely to increase as we tackle more heterogeneous diseases. In 2020, the FDA approved 19 personalized medicines representing about 39% of all newly approved therapeutic molecular entities and accounting for more than a third of new drug approvals for three of the last four years. Nine related FDA guidance documents were finalized in 2020 and 2021, all of which address the Agency’s Next Generation Sequencing framework.

CHARLENE BANARD is the former global head of cell & gene therapy, technical operations at Novartis.