Nov 08, 2018
Research, Development, and Regulatory Roundtable (R3) on Expanded Access vs. Right to Try: Practical, Legal, and Regulatory Considerations.
8:30 AM to 12:30 PM
Location: New York, NY
We will discuss the advantages and drawbacks of the two pathways by which patients may now request access to investigational therapies, considering the perspectives of both pharmaceutical companies and of largely academic healthcare facilities. Among other things, we will consider the impact of each pathway on long-term drug development, the resources necessary for handling requests in a timely and consistent manner, and the optimal contents of organizational policies.