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  4. RegenMedEd Roundtable with FDA’s Office of Therapeutic Products (OTP) - 01/30/2025
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Webcast | Virtual

Event Title
RegenMedEd Roundtable with FDA’s Office of Therapeutic Products (OTP)
January 30, 2025

Date:
January 30, 2025
Time:
1:00 p.m. - 2:00 p.m. ET

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is hosting a webinar on Thursday, January 30th, 2025 from 1:00 – 2:00 p.m. ET. During this webinar, leaders from across OTP will provide information about how the office is helping to advance cell and gene therapy product development through innovation, engagement, and collaboration.

About this Webinar

Since transitioning to a super office structure in March 2023, OTP has remained committed to supporting the advancement of cell and gene therapies. During the webinar, OTP’s Super Office Director, Dr. Nicole Verdun, and other leaders across OTP will:

  • Share how the office has enhanced its capabilities to address the exponential growth in the cell and gene therapy space 
  • Provide an update on OTP’s goals, priorities, and activities for 2025
  • Engage directly with patients, caregivers, and members of the patient community to provide information about OTP’s patient engagement and outreach efforts

Please note, this webinar is geared toward patients, caregivers, and patient advocates and organizations, however, all are welcome to attend.

Meeting Information & Registration

This event is free and open to the public. However, registration is required.

  • Date: Thursday, January 30, 2025
  • Time: 1:00 p.m. – 2:00 p.m. ET
  • Location: The webinar will be held via Zoom.
  • Ask Us a Question: Registrants have the opportunity to submit questions for speakers on the registration page.
  • Get Involved: Use the hashtag #RegenMedEd on social media to share this event with your network.

Please note, the FDA is not able to comment on or answer questions regarding specific investigational products, biologics applications, or draft guidance documents during the event. Further, questions considered inappropriate or out of scope for the event will not be addressed.

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. The 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 Series

This webinar is part of an educational series, RegenMedEd: An FDA CBER OTP Series on Regenerative Medicine. The RegenMedEd series aims to provide foundational information about regenerative medicine therapies, such as cell and gene therapy products, and explore opportunities for patients, care partners, and advocates to engage with FDA to help advance product development of OTP-regulated products. Find previous RegenMedEd event materials, including event recordings and transcripts, on FDA.gov.

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