The first two sessions (May 13th and May 20th) will focus on the 505(b)(2) NDA pathway for US FDA submission, and will feature speakers that participated in SAAMnow’s successful workshop on Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Business Complexities (October 16-18, 2019, Philadelphia, PA). The workshop highlighted the diversity, simplicity and complexity of the 505(b)(2) application process, and via these webinars we want to continue to fill the basic educational gap in understanding and characterizing the 505(b)(2) pathway by giving participants an opportunity to learn from experts in this field.
Webinar Session 1: Strategies and considerations for successful 505(b)(2) NDA Drug Development
Presenter 1: Eric Kendig, PhD, Director, Regulatory Strategy, Camargo: Pillars of Success for 505(b)(2) Drug Development
Presenter 2: Brendt Stier, MSc, Senior PPD Consulting Director, Global Product Development, PPD: Bridging the gap, study strategies for 505(b)(2) Drug Development
- Five pillars for successful 505(b)(2) product development: science, regulatory, medical, commercial and legal/IP/business.
- 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.