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Implementation of the FDASIA Patient Provisions

Speakers

James  Valentine, JD, MHS

James Valentine, JD, MHS

Director, Hyman, Phelps & McNamara, PC, United States

James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central to the transition of the FDA Patient-Focused Drug Development (PFDD) program to externally-led meetings, having helped plan and moderated the majority of those, and is also working on novel methodologies for capturing patient experience data. Mr Valentine has also authored an analysis cataloguing FDA's flexibility in assessing efficacy in the approval of drugs for rare, or orphan, conditions.

John  Whyte, DrMed, MD, MPH

John Whyte, DrMed, MD, MPH

Chief Medical Officer, WebMD, United States

Dr. John Whyte is a popular physician, executive, policymaker and writer who has been communicating to the public on important health issues for the past 20 twenty years. He is currently the Chief Medical Officer of WebMD where he helps lead the editorial and strategic direction.

Sara L. Eggers, PhD

Sara L. Eggers, PhD

Director, Decision Support and Analysis Team, OSP, CDER, FDA, United States

Sara Eggers leads the Decision Support and Analysis Team withing FDA’s Center for Drug Evaluation and Research. This team contributes to the development and implementation of initiatives regarding human drug benefit-risk assessment, patient-focused drug development, risk evaluation and mitigation strategies, regulatory decision support, and other efforts. Before joining FDA in 2011, Sara conducted research and consulting in the area of decision science, stakeholder engagement, and risk communication. She has a Ph.D. in Engineering and Public Policy, with an emphasis on decision science, from Carnegie Mellon University

Marc M. Boutin, JD

Marc M. Boutin, JD

Global Head of Patient Engagement and Advocacy, Novartis , Switzerland

Marc Boutin is the Global Head of Patient Engagement at Novartis where he leads a global team implementing an enterprise-wide patient engagement strategy. Before joining Novartis, he was the CEO of the National Health Council where he was deeply involved in health advocacy, policy, and legislation. He has designed and directed numerous advocacy strategies for issues ranging from access to health care to cancer prevention.

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