Webinar Session 2: 505(b)(2) Bridges, Clinical Development Pathways, and Case Studies
When: Tuesday, May 2nd |11:00 am EST (Eastern US)|Duration: 120 minutes
Presenter 1:
Seth DePuy, PhD, Manager, Regulatory Affairs, 505(b)(2) Center of Excellence, Premier Research Consulting: Strategic considerations for bridging in 505(b)(2) development
Presenter 2:
Juan He, MSc.Phm, Vice President, Pharmacometrics, BioPharma Services, Inc: A case presentation of 505(b)(2) clinical development
Presenter 3:
Alicia Baker McDowell, DRSc, MS, Head of Regulatory Strategy, Executive Director, Product Development & Market Access Consulting, Labcorp Drug Development: Clinical considerations for 505(b)(2) NDA pathway
Presenter 4:
Yaning Wang, PhD, CEO, Createrna Science and Technology: Orally inhaled drug products – regulatory perspective on 505(b)(2)
Panelists:
Speakers: Juan He, Alicia Baker McDowell, Yaning Wang
Invited:
Ruth Stevens, PhD, MBA, Senior Advisor to Premier Research, 505(b)(2) Center of Excellence, Premier Research Consulting
Scott Wesselkamper, PhD, Senior Manager, Regulatory Affairs, 505(b)(2) Center of Excellence, Premier Research Consulting
Areas Covered:
- Bridging studies (comparative BA/BE study, PK bridge, CMC bridge, nonclinical safety bridge, “paper” bridge, clinical safety bridge), with focus on the design and requirements for clinical/PK studies.
- Case studies: 505(b)(2) programs for tramadol extended- release tablets and orally inhaled drug products.
- Designs for efficacy studies in various therapeutic areas.
Sponsors:
