- May 24, 2022
- 11:00 AM - 3:00 PM ET
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) hosted a public workshop on Tuesday, May 24, 2022, from 11:00 a.m. - 3:00 p.m. ET.
The meeting brought together patients, caregivers, advocates, and other important stakeholders to discuss the purpose and importance of natural history studies. FDA staff and panelists discussed how natural history studies contribute to improved understanding of diseases and drug development, including regenerative medicine treatments such as gene and cell therapies.
Natural history studies follow a group of patients over time to collect health information on a particular disease. These studies can play an invaluable role in facilitating greater understanding of diseases and help to inform clinical trial design.
About the Workshop
This workshop was the second annual patient engagement meeting hosted by FDA CBER OTAT.
The workshop featured a variety of speakers and panelists to discuss:
- Natural history studies and why they are important for the development of regenerative medicine therapies.
- Perspectives from patients and advocates with firsthand experience participating in natural history studies.
- Opportunities for patients, advocates, and other important stakeholders to get involved in natural history studies and help advance clinical research for gene and cell therapies.
- How organizations, including FDA, support natural history studies.
- Opportunities to engage directly with CBER and others at FDA.
- Zoom Webinar Recording for Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates
What Is Regenerative Medicine?
Regenerative medicine therapies, such as gene and cell therapies, hold promise to transform medicine and create treatment options for patients who are living with difficult, even incurable diseases. The FDA plays a vital role in facilitating the development of regenerative medicine therapies and is committed to helping speed development of these groundbreaking treatments.
About the RegenMedEd Event Series
This workshop is part of OTAT’s educational webinar series, RegenMedEd, which engages patients, caregivers, and advocates on the topic of regenerative medicine. The RegenMedEd series aims to bring together patients, caregivers, patient advocates, and FDA staff to discuss foundational information about regenerative medicine therapies, such as gene therapy and cell therapy, and explore opportunities for stakeholders to engage with FDA to help advance drug development.