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Monday, June 25 • 11:00am - 12:30pm
#123: Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge

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Component Type: Session
Level: Basic
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-698-L04-P; CME 1.50; IACET 1.50; RN 1.50

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 Objectives

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


Lawrence Eugene Liberti


FDA Definition and How it is Interpreted in Decision-Making
Larry Bauer, MA, RN

Unmet Medical Need in Economic Evaluation
Karen Lee

Patients View on How the Concept Works
Marc M. Boutin, JD

avatar for Larry Bauer

Larry Bauer

Regulatory Scientist, Rare Diseases Program, Office of New Drugs, CDER, FDA
Larry Bauer is a Regulatory Scientist in the Center for Drug Evaluation and Research, Office of New Drugs Immediate Office (CDER, OND IO) in the Rare Diseases Program. He provides regulatory expertise internally and externally regarding FDA laws, regulations, guidances and policies... Read More →
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →

Karen Lee

Director, Health Economics, Canadian Agency For Drugs & Technologies In Health (CADTH)
avatar for Lawrence Liberti

Lawrence Liberti

Head, Regulatory Collaborations, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →

Monday June 25, 2018 11:00am - 12:30pm EDT
Room 157AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Session