Join me, Jim DiBiasi (Partner, 3D Communications), Tony Russo (Chairman and CEO Russo Partners), Howard Yuwen (Executive Director, Regulatory Affairs, Alexixon, and moderator David Schull (President, Russo Partners) for a must attend panel discussion:
Thriving, Not Just Surviving: FDA Advisory Committee Meetings
2:30 PM - 3:30 PM on Monday, Apr 22, 2013
Location Building: N426A
Description
For many biotech executives, the term "FDA advisory committee meeting" evokes feelings of fear, even among those with historical experience. Instead of tackling Advisory Committee (Ad Com) hearings as times of opportunity in which their companies can thrive, too many executives are focused on survival. Yet, the fate of their drugs in development can rest heavily on the decisions the FDA's outside advisors. In this dialogue, biopharma executives and industry experts review lessons learned from past experiences, as well as what best practices participants can apply to get ready for and succeed in the advisory committee environment.
Learning Objectives:
- Discuss the integration needed for medical/regulatory affairs for Ad Com success
- Identify necessary and beneficial steps to prepare your company for Ad Com interaction
- Examine lessons learned from a recent case study
Ability Level: Advanced
Learning Objectives:
- Discuss the integration needed for medical/regulatory affairs for Ad Com success
- Identify necessary and beneficial steps to prepare your company for Ad Com interaction
- Examine lessons learned from a recent case study
