Small and emerging biopharma companies develop highly innovative treatment solutions for diseases but often fail when approaching a regulatory milestone. This event organized by the Bayer-MassBio Center for Regulatory Excellence will focus on the regulatory landscape unique to oncology drug development in the US.
During this interactive, virtual session, Bayer will share experiences when approaching the FDA to obtain regulatory approval for oncology therapeutics. Participants will have the unique opportunity to learn from and connect with leaders from Bayer’s Regulatory Affairs teams, who will provide:
- An overview of the FDA’s Oncology Center of Excellence, its structure, and its connections to FDA Divisions (including CDRH)
- Best practices when engaging the FDA
- Key considerations regarding Real-time Oncology Review, Breakthrough Designation, Fast-Track Designation, Orphan Drug Designation, and insight into medical devices/Companion Diagnostics
Following a presentation, the Bayer Regulatory Affairs team will be available to answer questions. To help ensure robust answers from the experts, please email Dr. Hanna Eilken (firstname.lastname@example.org) with your questions by July 15.
About the Center for Regulatory Excellence
The Center for Regulatory Excellence is a first-of-its-kind forum initiated by Bayer and MassBio for startups and academia to interact with and learn from regulatory experts. The Center provides formal mentorship and regular seminars to ensure early identification and mitigation of regulatory issues and optimize the chances of regulatory success.