Healthcare Innovation and FDA Regulation – Webinar Recording/Transcript
With an unprecedented number of new, potentially transformative health technologies coming to market in the U.S., there are growing calls to better align the evidence generation that supports regulatory submission and the payment effort that informs patient use and access. Understand the intersection of healthcare innovation and FDA regulation and you’ll have what you need to come out on top of this revolution.
Who better than to bring you up to speed on the latest developments and trends in this arena than a former FDA Commissioner? Mark McClellan, MD, PhD is currently the Robert J. Margolis Professor of Business, Medicine and Health Policy, and founding Director of the Duke-Margolis Center for Health Policy at Duke University. Dr. McClellan will highlight emerging areas of policy work related to biomedical innovation, medical product regulation and concepts of value — all in service of describing how you can increasingly provide the right treatments and interventions to the right patients at the right time.
Dr. McClellan will provide an overview of value-based healthcare payment and delivery reform concepts and their increasing linkages to the ways in which the U.S. supports faster, more-efficient biomedical innovation.
And he will discuss remaining challenges in the access, coverage and payment processes that, if overcome, could increase the value and improved patient outcomes associated with the use of game-changing health technologies.
- An overview of emerging trends in medical product development, including efforts to further improve development and regulatory review
- The overall landscape of value-based payment and delivery reforms, and what you must know about their growing linkages to medical product development
- Increasing concerns associated with the price for transformative medical technologies like gene and cell therapies, and how these anticipated prices are driving stakeholders to explore new types of contract mechanisms and alternative payment models
- Insight into new policy development areas emerging around challenges with payer coding, coverage and payment processes for innovative medical technologies
- The growing need for a real-world data and evidence-development infrastructure and its anticipated role in improving your development of medical products as well as regulation and care delivery
To rise to the top in this changing landscape of transformative health technologies, you must listen to Dr. McClellan explain the intersection of healthcare innovation and FDA regulation.
Meet Your Presenter
Mark McClellan, MD, PhD is the Robert J. Margolis Professor of Business, Medicine and Health Policy, and founding Director of the Duke-Margolis Center for Health Policy at Duke University. With offices in Durham, NC and Washington, DC, the Duke-Margolis Center is a university-wide, interdisciplinary initiative that is nationally and internationally recognized for its research, evaluation, implementation and educational initiatives to improve health and health policy.
Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services and former Commissioner of the U.S. Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy. These reforms include the Medicare prescription drug benefit, Medicare and Medicaid payment reforms, the FDA’s Critical Path Initiative and public-private initiatives to develop better information on the quality and cost of care. He previously served as a member of the President’s Council of Economic Advisers, senior director for healthcare policy at the White House and Deputy Assistant Secretary for Economic Policy at the Department of the Treasury.
Dr. McClellan is a physician and an economist who has informed and improved a wide range of strategies and policy reforms to advance healthcare, including payment reform to promote better outcomes and lower costs, methods for development and use of real-world evidence and strategies for more effective biomedical innovation. Before coming to Duke, he served as a Senior Fellow in Economic Studies at the Brookings Institution, where he was Director of the Healthcare Innovation and Value Initiatives and led the Richard Merkin Initiative on Payment Reform and Clinical Leadership.
Who Will Benefit
- Quality Specialists
- Regulatory Specialists
- Compliance Specialists
- Vice Presidents of Strategic Planning
- Clinical Trial Specialists
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March 19, 2020