During the ICPE conference, our Executive Director, June Wasser, will be discussing the importance of the Foundation’s IMEDS (Innovation in Medical Evidence Development and Surveillance) program, which provides a framework and entry point for private-sector entities, such as regulated industry and other researchers into FDA’s Sentinel System. Wasser will be joined by Jeffrey Brown, PhD, of Harvard Pilgrim Health Care Institute, which serves as the analytics center for IMEDS studies.

Stop by booth #622 to learn more about the Foundation and our programs including, Innovation in Medical Evidence Development and Surveillance (IMEDS), the Expanded Access Navigator, and our Fellowship initiative.

The Reagan-Udall Foundation for the FDA's Executive Director, June Wasser, was a presenter on a June 6th webinar sponsored by Johnson & Johnson and NYU Langone Health. She explained how patients use the Foundation's Expanded Access Navigator. The Navigator was launched in June 2017 and serves as a clearinghouse of neutral information on the process physicians use to request expanded access to investigational therapies under development by biopharmaceutical companies.

We have reached room capacity so registration to attend the meeting is now closed. We look forward to seeing those who registered before April 19th and thank everyone for your support of the Reagan-Udall Foundation for the FDA. The public is still invited to submit written comments to the Foundation in advance by emailing them to eshaefer@reaganudall.org before May 3rd.

Executive Director June Wasser's talk on the Evolving Scope of the Expanded Access Navigator starts at 11am, Wednesday March 28th and includes an update on its expansion into rare diseases. This year's Expanded Access Programs focus is "Design Sustainable Early Access Programs to Manage Global Complexities and Advance Real-World Evidence" and the two-day event takes place at the Embassy Suites by Hilton in Old Town Alexandria VA. Register at www.cbinet.com/eap

Stop by the foundation's table at NIH's Rare Disease Day on March 1st for a demonstration of the Expanded Access Navigator. It's a website that focused initially on oncology but is adding resources for the rare disease community in 2018.

New analytic tools and methods enhancements have unlocked access to more diverse sources of data than ever before, improving the quality of evidence for safety surveillance. That’s why each year FDA and key leaders from across the Sentinel System stakeholder community invite the public and investigators to attend a public meeting on using electronic healthcare data for post market risk identifications and analysis of medical product safety.

Senator Mike Enzi's remarks reminded attendees that Congress named the Reagan-Udall Foundation for the FDA after two leaders fighting neurodegenerative disorders.

Curious about public-private partnerships and the Reagan-Udall Foundation for the FDA? Happy to schedule a presentation on our history, vision, mission and opportunities.

Inaugural Reagan-Udall Foundation for the FDA Innovations in Regulatory Science Awards Gala 

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