02.14.26 -- Cell & Gene Best Of January

Join Cell & Gene Live Chief Editor Erin Harris on February 19, at 11am Eastern for Building Smarter Cell Therapies with AI and Synthetic Biology. In this live event, experts will explore how AI and synthetic biology are being applied to engineer more precise, controllable, and scalable cell therapies. Register for free thanks to support from our sponsor BD Biosciences.

This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

CSL's Dr. Deborah Long and Diego Sacristan highlight HEMGENIX's five-year Phase 3 data as a watershed for hemophilia B gene therapy.

The EU Biotech Act has across-the-pond implications, especially for U.S.-based biotech sponsors developing advanced therapy medicinal products (ATMPs, also called cell and gene therapies), oncology therapies, or other high-complexity modalities. Consultant Jessica Cordes explains.

Artificial intelligence (AI) is rapidly transforming clinical research, with innovative applications in key areas such as real-world evidence generation, regulatory submissions, and biomarker discovery.

Stem cell therapy has already revolutionized the field of oncology. But where do we go from here? Dr. Robert S. Negrin addresses three key areas of CAR T-cell therapy on the brink of innovation.

This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.