Cell and Gene Therapies
There is justified excitement about the emergence and potential of cell and gene therapies (CGT): a number of CGTs have recently received market approval and hundreds more are in preclinical and/or clinical development. As a new therapeutic class, there is still much to learn about the benefits and risks of CGT, necessitating complex decision-making and long-term follow-up in many trials. Many CGTs also have complex manufacturing and/or supply chain challenges. For these reasons and because of the need for specialized clinical expertise, trial sites are often geographically limited. The CGT project aims first to ascertain and characterize the ethical, regulatory, and logistical issues that are arising in the specific context of CGT research and development. We will then work to address and mitigate these challenges through a collaborative, multi-stakeholder approach.
OBJECTIVES
- Identify and characterize ethical, regulatory, and logistical challenges arising in the context of global research and development of cell and gene therapies.
- Employ a multi-stakeholder approach to co-develop actionable and practical mechanisms for addressing these challenges to support efficient, safe, and respectful clinical development of CGT products.
KeY MILESTONES
- December 2023 – MRCT Center Bioethics Collaborative, “Gene Therapies: Probing the Ethics”
project Leadership & sTAFF
- Carolyn Riley Chapman, PhD MS, MRCT Center. Lead Investigator, Brigham and Women’s Hospital and Member of the Faculty, Harvard Medical School.
- Barbara E. Bierer, MD, Faculty Director, MRCT Center.
- Sarah White, MPH, Executive Director, MRCT Center.
Project Resources
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Meeting Summary
February 14, 2024