Registration is now open for the third annual Expanded Access Summit, which will take place January 27–29, 2020, at the National Press Club in Washington, D.C. The summit brings together experts from industry, academia, nonprofits, consultancies, and non-governmental organizations in integrating treatment-use trials into clinical development of new therapies for serious diseases to discuss the latest science, regulations, and innovations on pre-market access to medicines.
The agenda for the three-day summit is focused around three sessions, which include the following sessions, among many others:
- Session A: The Pre-Workshop Global Regulation and Industry Best Practices
- Global Regulatory Landscapes
- Single Patient Expanded Access (EA) and Cohort Expanded Access Programmes: Knowing the difference and what each is intended for
- The Range of Uses for EA: Pharmaceuticals, devices, research-stage, post-research, new-use, new form, etc.
- Session 1: The Global Stakeholder Forum Integrating Expanded Access into the Clinical Development Process
- Meeting the Original Promise of Expanded Access: How far have we come? Are we on the right track?
- Frameworks for Reimbursing Exploratory Treatment for Serious & Life-Threatening Health Conditions: Re-examining “Reasonable and Necessary” care options; coverage with evidence generation
- The Integration of Treatment and Clinical Research: Informing and strengthening the clinical development of novel regulated products through data-generating treatment programs
- Session 2: The Interactive Forum Charting the Course for Modern Clinical Development
- Inclusivity in Clinical Development: Should all medically suited patients be provided the option to participate in the development of a new medicine? If so, how should this be accomplished? What are the barriers?
- Expanded Access for Modern High-cost Therapeutics: New challenges with cutting edge biologics, including cell & gene therapies, nucleotide, and novel antibodies
Suanna Bruinooge, MPH, Division Director, Research Strategy and Operations for ASCO’s Center for Research and Analytics, will share experience with ASCO’s clinical trial (www.TAPUR.org) and the importance of research at the point of care during the session “The Integration of Treatment and Clinical Research: Informing and Strengthening the Clinical Development of Novel Regulated Products Through Data-Generating Treatment Programs,” from 1:45–3 p.m. on January 28.