Name
Pre-Approval Access to Investigational Products
Date & Time
Tuesday, May 23, 2023, 10:00 AM - 12:15 PM
Location Name
Washington A-B (3rd Fl)
Description
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.
- Expanded Access Versus Right-to-Try: What's the Difference - Lisa Kearns
- Best Practices for Biopharma Sponsors in Preparing for Expanded Access - Christine MacCracken and Rafael Escandon
- The Most Personalized Therapies: What are N=1 Studies? - Rafael Escandon
Speakers
Lisa Kearns - Senior Research Associate, Division of Medical Ethics - NYU Grossman School of Medicine
Rafael Escandon - Principal - DGBI Consulting, LLC
Christine MacCracken - Head, Patient Strategies & Solutions - Janssen, Pharmaceutical Company of Johnson and Johnson
Rafael Escandon - Principal - DGBI Consulting, LLC
Christine MacCracken - Head, Patient Strategies & Solutions - Janssen, Pharmaceutical Company of Johnson and Johnson
![Lisa Kearns](http://assets.swoogo.com/uploads/thumb/1154176-60a809978a25f.png)
![Rafael Escandon](http://assets.swoogo.com/uploads/thumb/2130876-634d88c86b262.gif)
![Christine MacCracken](http://assets.swoogo.com/uploads/thumb/2467651-641c919488c36.jpg)
CIP CEU Credits
1.50