Lisa Kearns, from the Division of Medical Ethics at NYU, will moderate a breakout session on current hot topics related to pre-approval access to experimental therapies.

Topics to be presented and discussed will include a review of the difference between expanded access and Right-To-Try legislation; a review of an "N-of-1" clinical trial, and a discussion of best practices for biopharma companies in drafting and creating expanded access policies and programs.

1. Expanded Access Versus Right-to-Try: What's the Difference - Lisa Kearns
2. Best Practices for Biopharma Sponsors in Preparing for Expanded Access - Christine MacCracken and Rafael Escandon
3. The Most Personalized Therapies: What are N=1 Studies? - Rafael Escandon