How Drug Companies Can Benefit from Pre-Approval Access Programs Webinar, Oct. 24, 2017



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Expanded Access at a Crossroads:
How Drug Companies Can Benefit from Pre-Approval Access Programs
**An FDAnews Webinar**
Oct. 24, 2017 — 1:30 p.m. – 3:00 p.m. ET        

In just the last weeks, the debate over patient access to unapproved drugs had gained national attention. In just the past two months, encouraging signs have come thick and fast:

  • Passage of FDARA, including language encouraging drug developers to engage wider ranges of patients in the clinical development process
  • Senate approval of “Right to Try” legislation, which could allow drug developers to provide pre-approval access to patients without FDA oversight
  • The Expanded Access Drug Summit took place. Its mission was to draft best practices for integration of pragmatic Expanded Access programs into the clinical development process.

Now FDAnews has invited the organizer of that Summit, Jess Rabourn CFA, to show manufacturers how to capitalize on Expanded Access, the hottest trend in drug making.

The key is commercial feasibility. It’s a topic on which Mr. Rabourn wrote the book, literally. He’s author of six papers exploring aspects of commercial feasibility.

Get set for a fast pace. In 90 lightning minutes, Mr. Rabourn will explain the new proposed best practices for integrating Expanded Access into the drug development process in breakthrough disease, and a lot more besides:

  • Unpacking the nest of regulations that govern pre-approval access, including key provisions on cost recovery
  • Debunking common misconceptions that may affect business operations
  • Learning how pre-approval access programs have affected clinical research
  • Parsing prevailing business practices for sponsoring Expanded Access programs, including those that go beyond single-patient scenarios
  • The growing recognition of data value: capturing Real World Evidence and the differentiating factors of treatment response
  • And much more!

How do drugmakers meet 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? This webinar aims to answer those questions and more while keeping the focus on cost recovery, protocol design and data collection.

Meet the Presenter:
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. At the American Academy of Neurology he 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.

Who Will Benefit:
This webinar targets:

1)    Small, pre-revenue drug and biologics makers with therapeutics in development for serious unsolved diseases; i.e. companies with limited resources
2)    Large therapeutics companies with multiple marketed products in addition to investigational-stage products; i.e., companies with high sensitivity to public perception
3)    Precision medicine, big data, and diagnostics companies
4)    Patient advocacy organizations

Within such organizations, job titles include:

  • Director of Clinical Development
  • Director of Medical Affairs
  • CSO (for precision medicine/data companies)
  • CSOs and Public Policy Directors (for advocacy and policy-support groups)

Webinar Details:
Expanded Access at a Crossroads:
How Drug Companies Can Benefit from Pre-Approval Access Programs
**An FDAnews Webinar**
Oct. 24, 2017 — 1:30 p.m. – 3:00 p.m. ET

$287 per site

Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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