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21st Century Cures: Which Are the Most Transformative Provisions and How Do They Accomplish Major Change?
Session Chair(s)
Nancy Bradish Myers, JD
CEO and Founder
Catalyst Healthcare Consulting, Inc, United States
It is all the buzz in DC! Congress is working with innovators, patients and policy makers to draft legislation and the House plans to these ideas forward early in 2015. The goal is to reform FDA regulatory processes in order to accelerate the discovery, development and delivery of promising new treatments. Which are the most transformative ideas and what important goals will they accomplish? How will this legislative effort dovetail with PDUFA VI negotiations? Join our panel to hear from members of Congress, FDA and other key stakeholders to better understand where this initiative is in the process, and what our panelists believe the most transformative provisions will be.
Learning Objective : Discuss the 21st Century Cures legislative initiative, including what is in and out, at the time of the meeting; Identify what FDA and the participants think are the most transformative provisions including why they were included and who supports the ideas; Discuss regulatory policy that could very well become law including how companies, patient groups, and consultants should help clients, internal and external, prepare to implement them.
Speaker(s)
Panelist
Clay Alspach, JD
Leavitt Partners, United States
Principal
Panelist
Janet Woodcock, MD
United States
Retired, Principal Deputy Commissioner, FDA
Panelist
Ellen Sigal, PhD
Friends of Cancer Research, United States
Chairperson and Founder
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