This session will open with a Time=Lives Talk by Sandra Abrevaya and Brian Wallach, Co-Founders of I AM ALS, followed by a panel discussion on Policymaking as a Driver of Progress.

Recent efforts to engage US patients in biomedical research have been bolstered by policymakers and congressional action. The 21st Century Cures Act (Cures 1.0), 2016, strengthened the accrual and use of patient experience data as part of the research and regulatory review process. Additional efforts through the FDA Reauthorization Act, 2017, and the Prescription Drug User Fee Act, starting with the fifth reauthorization, included provisions to expand patient-focused drug development and patient engagement. International regulatory and policy-making bodies increasingly emphasize expanding patient engagement and using patient perspectives and data to inform their decisions. Considering legislation currently in progress, this session will examine what stakeholders can expect from the move toward greater representation of patients' voices and perspectives in the product-development cycle. Panelists will explore how existing and pending legislation could fill key gaps and drive progress.

Guests

Sandra Abrevaya

Co-Founder and CEO, Synapticure; Co-Founder, I AM ALS

Brian Wallach

Co-Founder and Board Chair, Synapticure; Co-Founder, I AM ALS

Moderator

Steve Usdin

Senior Editor, Washington, BioCentury

Speakers

Rachele Berria

Vice President, Head of Medical US BioPharmaceuticals, AstraZeneca

Michael Boyle

Senior Vice President and Chief Policy and Advocacy Officer, Cystic Fibrosis Foundation

Theresa Mullin

Associate Director for Strategic Initiatives, Center for Drug Evaluation and Research, US Food and Drug Administration

Yvette Venable

Vice President of Patient Engagement, Institute for Clinical and Economic Review