Session Speakers
Evidence Development Challenges Posed by FDA and Payers
Most regulatory strategies focus on achieving approval or clearance. But too often, lack of concordance between sponsors and FDA in the Q-submission process can complicate, extend, and imperil regulatory reviews. Subsequently, widespread payer coverage routinely lags product approval - often for years. This presentation will show you how to tailor a comprehensive evidence plan to address the needs of both stakeholders to help shorten the gap.
Mark DuVal, CEO, DuVal & Associates, P.A.
Mark DuVal, J.D. is CEO of DuVal & Associates, P.A., a law firm specializing in regulatory, compliance, and marketing counsel for medical device, pharmaceutical, biotech, food, and nutritional supplement companies. He provides strategic regulatory advice, develops compliance and marketing programs, counsels on reimbursement, and represents clients before the FDA on product approvals, clearances, clinical trials, and policy matters.
Previously, Mark served as General Counsel for 3M Pharmaceuticals and Drug Delivery Systems, including an international assignment in the U.K., and later worked in Corporate Compliance at Medtronic. He earned his J.D. from William Mitchell College of Law and his B.A. from St. Cloud State University.
Mark serves on multiple industry boards, advises St. Cloud State’s Regulatory Affairs program, and is a frequent national speaker and author on FDA regulatory, reimbursement, and compliance issues.
Chris Lyle, Vice President, Evidence Strategy, DuVal & Associates, P.A.
Chris focuses his consulting practice at the intersection of clinical evidence, regulatory requirements, and payer coverage policies, helping clients secure product approvals and demonstrate value to payers and providers. A trained biostatistician with over 25 years in the medical device industry, he has successfully negotiated study designs with the FDA and international regulatory agencies.
Before joining DuVal & Associates, Chris was a Partner at the JD Lymon Group, focusing on evidence development for market access, and spent 12 years at RCRI in executive roles overseeing operations, biostatistics, and market access. He began his career as a biostatistician at 3M Pharmaceuticals.
Chris holds a B.A. in Mathematics from St. Olaf College and an M.S. in Applied Statistics from Florida State University. He frequently speaks on evidence strategies and clinical study design and serves as a co-founder and Board member of JDL Access, LLC.
