RAPS Workshop: Rethinking Regulatory Strategy: De-risking Submissions and Addressing Payer Needs with Comprehensive Evidence Planning
Virtual Programs 
Regulatory strategies are often highly focused on activities required to achieve approval or clearance from the US Food and Drug Administration (FDA). However, if pre-market planning ignores eventual reimbursement demands, products can struggle to achieve widespread market adoption.
From the earliest stages of product development, regulatory professionals are uniquely positioned to ensure commercial evidence requirements will be satisfied. This session will focus on key differences in how the FDA and payers evaluate the performance of medical devices through their unique lenses. For emerging technologies in particular, 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. Tailoring a comprehensive evidence plan to address the needs of both stakeholders can help shorten this gap and optimize the potential for commercial success.
Focused areas of discussion will include:
- Key learnings DuVal & Associates has accumulated from product appeals where clinical evidence has been insufficient to support market authorization
- The role of Q-submissions in assessing the appropriateness of clinical study designs
- Typical payer approaches to assessing emerging technologies. Why is “reasonable and necessary” so often incongruent with “safe and effective”?
- Strategies to consider when building evidence plans to increase the likelihood of success with payers and regulators
- Optimizing efforts and communication across organizations to better support market access initiatives
Registration Fees & Deadlines
Present – 20 April 2025: Early Bird Member $300 | Nonmember $350
21 April 2025 – 20 May 2025: Regular Member $350 | Nonmember $415
Learning Objectives
Upon completion of this workshop, participants will be able to:
- Describe the key differences in clinical data requirements between US FDA and payers
- Facilitate development of a comprehensive evidence strategy and communication plan to minimize misunderstandings with FDA and chart an efficient plan for payer coverage
Who Should Attend?
Regulatory Professionals interested in elevating regulatory strategies for commercial success.
- Regulatory Vice Presidents, Directors, Managers and Specialists
- Clinical Research Professionals
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Agenda
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Time |
Topic |
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1:00 pm -1:45 pm |
Lessons Learned from Negotiating FDA Appeals Rooted in Clinical Evidence o Common themes in negative evidence assessments from FDA o Avoiding misunderstandings and pitfalls in the Q-submission process o Addressing issues that arise during a clinical trial and upon submission to FDA o Evidence factors to consider when contemplating an appeal |
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1:45 pm – 2:30 pm |
Payer Evidence Requirements o Brief overview of the US reimbursement system and the role of evidence in supporting coding, payment and coverage determinations o How payers evaluate new technology o Common evidence shortfalls in newly approved technologies
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|
2:30 pm - 2:45 pm |
Break |
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2:45 pm - 3:30 pm |
Strategies to Address FDA and Payers Through Evidence Planning o Presenting a new product in the context of alternative/competing therapies o Ascertaining product-specific payer requirements o Building trials with multiple endpoints & time horizons o Supplementing pivotal studies with complimentary, independent research efforts
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3:30 pm – 4:00 pm |
Questions & Answers |
Speakers
Chris Lyle, MS
Vice President, Evidence Strategy, DuVal & Associates, P.A.
Chris focuses his consulting practice on the intersection of clinical evidence, regulatory requirements, and payer coverage policies to support product approval requirements and demonstrate value to payers and providers. A biostatistician by training, Chris has successfully negotiated study designs with the FDA and several OUS regulatory agencies. Chris has over 25 years of experience in the medical device industry and has supported the development of medical devices, biologics, and pharmaceuticals. Prior to joining DuVal & Associates, Chris was a partner at the JD Lymon Group, a Minneapolis-based reimbursement and market access consulting firm, where he focused on evidence development initiatives to support positive coverage arguments. He spent the prior 12 years at RCRI, a Minneapolis-based device contract research organization, where he held various executive positions including roles overseeing corporate operations, biostatistics, and market access. Before that, Chris was a biostatistician at 3M Company working with 3M Pharmaceuticals and multiple medical device divisions. Chris holds a BA in mathematics from St. Olaf College and an MS in applied statistics from Florida State University. He speaks routinely on evidence strategies and clinical study design to support pre- and post-approval requirements and has served on the community faculty of both Metropolitan State University and the St. Cloud State University Masters of Regulatory Affairs program. He is also a co-founder and Board member of JDL Access, LLC, a prior authorization and patient appeals firm based in Minneapolis.
Mark E. DuVal, JD, FRAPS,
CEO, DuVal & Associates, P.A.
Mark DuVal, J.D., FRAPS, is CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry. Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.