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Expanded Access at a Crossroads: How Drug Companies Can Benefit from Pre-Approval Access Programs
Expanded Access is the hottest topic in new-drug development, and now the FDA appears ready to loosen the reins. In rapid succession:
Now, the organizer and chair of that summit meeting, Jess Rabourn CFA, explains how you can get in on the ground floor.
Mr. Rabourn explains the new proposed best practices for integrating cohort Expanded Access into the drug-development process in breakthrough disease, and a lot more besides:
So many unanswered questions. How do you balance the demand for Expanded Access while still supporting clinical research? What are best practices for forging ahead on these programs without slighting ongoing new-drug development? You’ll hear answers to those questions — and more — which keep the focus on cost recovery, protocol design and data collection. Don’t miss out!
This presentation targets:
Within such organizations, job titles include:
Jess Rabourn CFA founded WideTrial, a company that supports and directly sponsors cohort Expanded Access programs in the U.S. He also is Principal Partner of Ax-S Pharma LLC, a consultancy specializing in pre-market access strategies in the U.S. He is a prominent voice on commercial factors of breakthrough drug development and making early-access programs commercially feasible. He is a member of the American Academy of Neurology and was lead author of the Expanded Access section of the submitted draft for FDA's Guidance on ALS Drug Development. He produced and chaired the 2017 Expanded Access Summit, a groundbreaking event focusing on the role of pragmatic access programs in the drug development process.
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