REdI Annual Conference 2024: CBER (Biologics) Innovation in Medical Product Development (Day 1 of 2)

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

6:15 CBER Track Welcome - Larissa Lapteva, MD, MHS, MBA
16:43 Session 1: Introductions of Brian Stultz, MS and Gopa Raychaudhuri, PhD
19:13 Regulatory Approach for Gene Therapies: Incorporating Human Somatic Genome Editing - Brian Stultz, MS
44:22 Facilitating Development of Gene Therapies for Rare Diseases - Gopa Raychaudhuri, PhD
1:21:20 Q&A with Session 1 Speakers
2:47:27 Session 2: Introduction of Lorrie McNeill
2:48:11 Overview of CBER’s Office of Communication, Outreach and Development - Lorrie McNeill
3:04:22 Session 2: Introduction of Scott A. Brubaker
3:05:38 HCT/P Donor Screening/Testing and Requests for Exemption - Scott A. Brubaker
3:51:49 Q&A with Session 2 Speakers
4:25:23 Session 3: Introduction of Cara Pardon, MS
4:26:53 Types of Regulatory Submissions - Cara Pardon, MS
5:00:05 Session 1: Introduction of Karen Jackler
5:01:15 Patient Engagement - Karen Jackler
5:41:16 Q&A with Session 3 Speakers
6:01:04 Day One Closing