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Wednesday, June 27 • 10:30am - 12:00pm
#345: Unmet Medical Need: Path Forward – Creating a Commonly Agreed Criteria Globally

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Component Type: Workshop
Level: Advanced
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-699-L04-P; CME 1.50; IACET 1.50; RN 1.50

Part 3 of the DIA-CIRS Workshop

The workshop will include roundtable discussions to which each participant will contribute.

Learning Objectives

Identify common criteria that captures the needs of stakeholders; Create a checklist that characterizes unmet medical needs in specific situations


Lawrence Eugene Liberti


Industry Roundtable
Magdalena Bujar, MSc

Industry Roundtable
Indranil Bagchi, PhD, MS

Regulator Round Table
Kristina Larsson, MS

Patient Round Table
Suzanne Schrandt, JD

avatar for Indranil Bagchi

Indranil Bagchi

Vice President and Franchise Head, Global Value and Access, Novartis Oncology
Dr. Bagchi leads efforts to understand payer perspectives and develop the market access strategy for the entire Pfizer portfolio, including the payer value proposition, pricing strategy and reimbursement support across all disease areas and markets. Indranil has two decades of experience... Read More →
avatar for Magda Bujar

Magda Bujar

Manager, Strategic Development, Centre For Innovation In Regulatory Science (CIRS)
Dr Magda Bujar is the Manager of Strategic Development at CIRS. In her current role, she is responsible for developing and executing strategies for engaging with CIRS stakeholders - pharmaceutical companies as well as major regulatory authorities. Magda also initiates and coordinates... Read More →
avatar for Kristina Larsson

Kristina Larsson

Head of Office for Orphan Medicines, European Medicines Agency (EMA)
Kristina Larsson joined the orphan team of the EMA as the Head of Office in July 2014. Before that she spent 8 years as a scientific officer in the scientific advice team of the EMA in charge of the Scientific Advice Working Party secretariat. Before joining the agency she worked... 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 →
avatar for Suzanne Schrandt

Suzanne Schrandt

Director, Patient Engagement, Arthritis Foundation
Suz Schrandt, JD, is Patient Engagement Director at the Arthritis Foundation. She was previously Deputy Director, Patient Engagement for PCORI, where she helped to launch key efforts including the Engagement Rubric. Schrandt's patient engagement focus stems from her own rheumatological... Read More →

Wednesday June 27, 2018 10:30am - 12:00pm EDT
Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Workshop