Webinar Session 3: Secrets to Successful Pre-IND Meetings for 505(b)(2) NDA Drug Development

Webinar Session 3: Secrets to Successful Pre-IND Meetings for 505(b)(2) NDA Drug Development

When: Wednesday, May 3^rd |11:00 am EST (Eastern US)|Duration: 120 minutes

Presenter 1:

Aloka Srinivasan, PhD, 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

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

Presenter 3:

Angela Drew, PhD, Director of Regulatory Strategy, 505(b)(2) Center of Excellence, Premier Research Consulting: Recovering from an unsatisfactory/disastrous pre-IND meeting

Panelists:

Speakers: Aloka Srinivasan, Candis Edwards, Angela Drew

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:

This presentation will provide 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

• • 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

• Inadequate pre-IND examples and recovery plan for unsatisfactory meetings
• Some Case studies for 505(b)(2) applications