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Tuesday, June 26 • 10:30am - 12:00pm
#242: Unmet Medical Need: Can the Stakeholders Align? Progress to Date

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-700-L04-P; CME 1.50; IACET 1.50; RN 1.50

Part 2 of the DIA-CIRS Workshop

Unmet medical need definition has been attempted to detangle by different groups. Different elements of a possible criteria is presented as a background for the discussion on Day 3.

Learning Objectives

Describe criteria currently used and identify a core list of criteria that should be used to identify and prioritize unmet medical need; Discuss what constitutes an unmet medical need and determine universal agreement on key characteristics


Inkatuuli Heikkinen, MSc


How Should Unmet Medical Needs be Addressed in the US?
Kenneth I. Kaitin, PhD

Criteria Developed Between Stakeholders in Europe in the DIA Working Group
Claudine Sapède

CIRS Experience and Outcomes of Stakeholder Discussions
Lawrence Eugene Liberti


Inkatuuli Heikkinen

Senior Scientist, DIA
Inkatuuli leads DIA EMEA Scientific Content Development and engages with over 500 volunteers annually. She has a policy background, with academic degrees in public policy and health and pharmacoeconomics. Prior to DIA, Inkatuuli worked as a policy consultant in various organisations... Read More →
avatar for Kenneth Kaitin

Kenneth Kaitin

Director Tufts Center for the Study of Drug Development; Professor of Medicine, Tufts University School of Medicine
Kenneth Kaitin is Professor and Director of the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. He’s also Advisory Professor at Shanghai Medical College, Fudan University. Dr. Kaitin writes and speaks regularly on drug development issues, and... Read More →
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 →

Tuesday June 26, 2018 10:30am - 12:00pm EDT
Room 153ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Forum