This session, held March 26, 2021, focused on the preparation of a pre-IND Meeting Package for 505(b)(2) product development, and featured one speaker (Aloka Srinivasan) 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) and one speaker (Candis Edwards) from the pharmaceutical industry. 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 50 (b)(2) pathway by giving participants an opportunity to learn from experts in this field.
Presenter 1:
Aloka Srinivasan, Ph.D., Principal and Managing Partner, RAAHA LLC: To “b2” or not to “b2”: Importance of pre-IND meetings in determination of the pathway for an application
Areas Covered:
This presentation provided an overview of PDUFA Formal Meetings including the following:
- Introduction: Where does a 505(b)(2) fit?
- Need for pre-IND meetings for 505(b)(2) applications
- What constitutes a successful pre-IND meeting for 505(b)(2) applications
- Challenges in preparing for 505(b)(2) related meetings
- Some Case studies for 505(b)(2) applications
Presenter 2:
Candis Edwards, Senior Vice President Regulatory Affairs, Amneal Pharmaceuticals: Preparation for, attendance at, and follow-up of Pre-IND meetings for 5050(b)(2) NDA drug development
Areas Covered:
This presentation provided details on the following steps for a successful pre-IND meeting:
- Preparation
- Building the right meeting team
- Preparing and submitting the meeting request and briefing book
- Meeting rehearsal to plan for an efficient meeting
- Attendance
- Appropriate meeting behavior
- Types of questions to ask
- Meeting follow-up
- Internal summary and FDA meeting minutes