- October 27, 2022
- 11:00 AM - 1:00 PM ET
The FDA Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) hosted a public webinar on Thursday, October 27, from 11:00 a.m. to 1:00 p.m. ET.
“Natural History Studies to Support Regenerative Medicine: A How-To Webinar” brought together researchers, patients, caregivers, advocates, and other important stakeholders to discuss how to organize and execute natural history studies. This event continued the theme of the Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates, held on May 24, 2022, which focused on the importance of natural history studies and how they contribute to improved understanding of rare diseases and to development of regenerative medicine products 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 by helping to inform clinical trials.
About the Webinar
The webinar featured a variety of speakers and panelists to discuss:
- The importance of natural history studies and how they can be used to further rare disease drug development and clinical research
- How to conduct a well-designed natural history study from beginning to end
- Perspectives from researchers, patients, and advocates with firsthand experience organizing, executing, and participating in natural history studies
What is Regenerative Medicine?
Regenerative medicine therapies, such as cell and gene therapies, hold promise for transforming medicine and creating options for patients living with difficult, rare, and often incurable diseases. FDA plays a vital role in facilitating the development of regenerative medicine therapies, as well as in ensuring approved products are safe and effective for patients.
About the RegenMedEd Webinar Series
This webinar is part of an educational webinar series, “RegenMedEd: An FDA CBER OTAT Webinar Series on Regenerative Medicine.” The RegenMedEd webinar series aims to bring together important stakeholders and FDA staff to discuss foundational information about regenerative medicine therapies, such as gene therapy and cell therapy, and explore opportunities for patients, caregivers, and advocates to engage with FDA to help advance drug development.