The State of Protection, Innovation & Communication at FDA

The State of Protection, Innovation & Communication at FDA – FDA Watch

Shelly and Wayne chat with Ron Bartek, Co-Founder and President of Friedreich's Ataxia Research Alliance, and Ralph Hall, CEO of Hall Strategies, LLC. Together, they discuss the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes, such as those surrounding vaccines, animal testing, expedited approvals, and right-to-try guidance, might be coming; and much more. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.  Music by Dvir Silver from Pixabay.

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Shelly and Wayne chat with Ron Bartek, Co-Founder and President of Friedreich’s Ataxia Research Alliance, and Ralph Hall, CEO of Hall Strategies, LLC. Together, they discuss the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes, such as those surrounding vaccines, animal testing, expedited approvals, and right-to-try guidance, might be coming; and much more.

This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.

About Our Guests

Ron Bartek

Ron Bartek is Co-Founder and President, Friedreich’s Ataxia Research Alliance (FARA); Former Director & Chair, National Organization for Rare Disorders; past President and current member of BOD, Alliance for a Stronger FDA; Co-Founder and Chair of the BOD of the NCATS Alliance; Co-Founder and Chair of steering committee, Pediatric Inclusion Alliance; former BOD, Alliance for Regenerative Medicine; four-year member NIH/NCATS National Advisory Council; former Co-Chair, NCATS Cures Acceleration Network Review Board; four-year member, NIH Neurological Institute National Advisory Council; recognized by FDA Office of Orphan Product Development as one of “30 Heroes changing lives of rare disease patients”; former member, FDA/CTTI Patient Engagement Collaborative; former Partner/President, government affairs firm Mehl, Griffin & Bartek; 20 years in federal executive and legislative branches in defense, foreign policy and intelligence (six years on House Armed Services Committee staff); four years at U.S. State Department; one year on U.S. Delegation to Intermediate-Range Nuclear Forces Treaty negotiations with Soviet Union, Geneva; six years as CIA analyst; after graduation from U.S. Military Academy, West Point, four years as Army Officer, company Commander in Korea and Infantry and Military Intelligence Officer in Vietnam; MA/Russian Area Studies, Georgetown University.

Ralph Hall

Ralph Hall leads Hall Strategies assisting clients with FDA matters. Prior positions include Leavitt Partners, teaching at the University of Minnesota Law School, and senior positions with Guidant Corporation.  

He has testified before Congressional committees and authored approximately 40 articles. Hall served as CEO of a start-up medtech entity and is a co-inventor on six patents.

He graduated from the University of Michigan Law School.