October 10, 2024 - 8:45 AM ET

Maryland Tech Council's BioInnovation Conference

Expedited FDA Approval and Expanded Access Tools: Getting Products to Patients

This event has already occurred.
Bethesda North Marriott Hotel & Conference Center

Justin Coen will be moderating a session at the Maryland Tech Council’s BioInnovation Conference in Bethesda on October 10, 2024, “Expedited FDA Approval and Expanded Access Tools: Getting Products to Patients.” In this session, four panelists will examine regulatory pathways for faster FDA approval and greater access to patients for investigational drugs. The discussion will provide a substantive overview of expedited approval mechanisms, including fast track, breakthrough therapy, priority review, and accelerated approval (Subpart H), as well as expanded access INDs. The panel will also feature examples from the industry on how these tools can be leveraged to increase patient access and speed FDA approval.

Moderator:  

Justin Coen, Partner, Venable LLP

Panelists:
Jacqueline Corrigan-Curay, Principal, FDA’s Center for Drug Evaluation and Research (CDER)
Renee Beaver, Director of Corporate Counsel, Otsuka

Michael Matthews, Director of Regulatory Affairs and R&D, Sabin Vaccine Institute
Melissa Robb, Senior Director Regulatory Strategy, REGENXBIO

For more information, click here.