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Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge
Session Chair(s)
Lawrence Liberti, PhD, RAC
Director, D.K. Kim International Center for for Regulatory Science
The Kim Center/ USC DRQS, United States
Part 1 of the DIA-CIRS Workshop
Unmet medical need drives decisions across value chain from investment and prioritization to approval timelines and access discussions but is very vaguely defined. Learn why interpretation matters and how decision makers view the concept.
Learning Objective : Demonstrate how unmet medical need is defined in different countries or regions; Identify how different stakeholders perceive unmet medical need; Discuss the scope of what is defined as unmet medical need based on situational context, issues, concerns, and dilemmas each stakeholder faces in prioritization
Speaker(s)
FDA Definition and How it is Interpreted in Decision-Making
Larry Bauer, MA, RN
Hyman, Phelps & McNamara, P.C., United States
Senior Regulatory Drug Expert
Unmet Medical Need in Economic Evaluation
Karen Lee
Canadian Agency For Drugs & Technologies In Health (CADTH), Canada
Director, Health Economics
Patients View on How the Concept Works
Marc M. Boutin, JD
Novartis , Switzerland
Global Head of Patient Engagement and Advocacy
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