The second Research, Development, and Regulatory Roundtable (R3) was held at the New York City offices of Ropes & Gray LLP On November 8, 2018. Stakeholders convened to discuss Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.
Roundtable attendees considered the advantages and drawbacks of the two pathways by which patients may request access to investigational therapies.
Among other things, participants explored 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 on Right to Try and Expanded Access.