Collecting Data from EA Treatment for Regulatory Submissions Presentation

Executive Director June Wasser will present Collecting Data from EA Treatment for Regulatory Submissions at the Life Science Compassionate Access Summit at 4:00 pm, Monday, March 18th in Philadelphia. She will focus on: 

  • Defining challenges and opportunities for data collection in an EA setting;
  • Offering perspectives on data collection from different stakeholders; and
  • Are the current EA regulations sufficient?

2018 Innovations in Regulatory Science Awards Dinner

The Reagan-Udall Foundation for the FDA honored two longtime U.S. Food and Drug Administration leaders and an independent public-private partnership as the 2018 recipients of the Innovations in Regulatory Science Awards.

This year’s Innovations in Regulatory Science Awards Dinner, a premier event launched in 2017, brought together leaders in academia, advocacy, industry and government to celebrate the achievements and continued contributions of outstanding regulatory science leaders.

Reagan-Udall Foundation at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE)

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.

Pre-approval Access Webinar

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.

Navigator presentation at CBI's Expanded Access Programs 2018

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