Last December, nearly 40 professionals with the U.S. Food and Drug Administration (FDA) gathered with ISSCR leaders to discuss advances in the development of stem cell therapies. The attendance of FDA leaders – Peter Marks, Director, Center for Biologics Evaluation and Research (CBER), Celia Witten, Deputy Director, CBER, and Wilson Bryan, Director, Office of Tissues and Advanced Therapies (OTAT) – signals how important it is for the agency to discuss scientifically informed recommendations from the ISSCR as new stem cell-based therapies advance.
Meeting with the FDA is one component of the ISSCR’s expanding emphasis on regulatory advocacy, giving members access to, and a voice with, key regulators.
At the December meeting, stem cell science and industry leaders Jacqueline Barry, Debra Webster, Nissim Benvenisty, Malin Parmar, Melissa Carpenter, and Roger Barker led discussions with the FDA in the following areas:
- Donor screening and testing requirements
- Mitigating prion diseases
- Use of genomic sequencing data
- Assaying tumorgenicity of iPSC therapies
- Gene editing and iPSC starting materials
- Use of sham surgical comparators in trials involving stem cell-based therapies
The Society will engage in similar conversations with regulators in the EU and other parts of the world in the coming year. Meanwhile, we continue to monitor and respond to issues affecting the regulation of stem cell-based products worldwide.
The ISSCR’s focus on regulatory advocacy also extends to upcoming and recent scientific programs, helping our community navigate the complex and quickly changing regulatory landscape. The Boston International Symposium, Translating Pluripotent Stem Cell Discoveries to the Clinic: Preclinical, Manufacturing, and Regulatory Strategies for Success, will now take place 17-19 November 2022. And, the recent ISSCR webinar series, The Manufacturing, Engineering, and Regulation of Pluripotent Stem Cell Derived Therapies, is available on demand.
The Society’s work in public policy and advocacy continues to grow alongside accelerated clinical applications in our field. Your support through collaboration, membership, and partnership makes this important work possible. I hope you’ll join us in the year to come as we advocate for regulations that facilitate safe and efficacious therapies.