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This article is the first of two on strategic regulatory intelligence for cell and gene therapies (CGTs). It will examine how gaps between product approvals and patient access remain despite significant evolutions in the CGT landscape. Longer approval timelines and increasing product withdrawals underscore the need for robust regulatory intelligence frameworks that integrate geopolitical considerations, real-world evidence (RWE), artificial intelligence/machine learning (AI/ML) tools, and multistakeholder collaboration to build an effective regulatory strategy. The article examines the role of regulatory intelligence in advancing effective regulatory strategy across the full CGT and advanced therapy medicinal product (ATMP) lifecycles, including innovative clinical trial designs, chemistry, manufacturing, and controls (CMC) optimizations, and postauthorization surveillance across major global jurisdictions. The second article explores global CGT pricing and reimbursement models.

This is the second of two articles on cell and gene therapies (CGTs). CGTs are among the most transformative and commercially complex therapeutics with their curative potential and one-time administration model. However, their extremely high research, development, and manufacturing costs create a unique set of regulatory and market access challenges not adequately addressed by the existing frameworks. The article synthesizes comparative regulatory intelligence across five major jurisdictions and discusses the corresponding health technology assessments (HTA), payer expectations, and reimbursement landscapes governing commercial access for approved CGT products. The first article focuses on the role of strategic regulatory intelligence in shaping CGT strategy across the development lifecycle.