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Thursday, June 17 • 12:00pm - 1:00pm
#514 OD: Value-Based Evidence Generation: What are the Regulatory and HTA Strategies that Companies Could Take in Development?

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Component Type: Session
Level: Intermediate

This session will aim to propose how companies can build the value proposition early into development to enable evidence generation that articulates the value during development, review and reimbursement

Learning Objectives

Discuss challenge faced by companies to accommodate different perspectives on value during development, review and reimbursement; Describe approaches that build management or resolution of regulatory or HTA uncertainties into the development space;Identify the strategy to build value into drug development and to effectively articulate the value of new medicines during review and reimbursement.


Neil McAuslane, PhD, MSc


Patient Access to Innovative Medicines: What Strategies are Regulators Using to Encourage Companies to Undertake Value-Based Evidence Development?
Michael Berntgen, PhD

Value-Based Development: What are the Main HTA Considerations Companies Should be Considering Incorporating into Their Early Development Decisions?
Nicole Mittmann, MSc

What are the Challenges Faced by a Company to Align Different Stakeholders’ Perspective of Value into Their Development Decisions?
Indranil Bagchi, PhD, MSc

avatar for Neil McAuslane

Neil McAuslane

Director, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →
avatar for Indranil Bagchi

Indranil Bagchi

Senior Vice President and Head, Global Value and Access, Novartis Oncology, United States
Dr. Indranil Bagchi is Senior Vice President and Global Head of Value and Access at Novartis Oncology. In this role, Indranil drives the overall strategy on value demonstration and market access, through efforts on pricing & reimbursement, health economic modelling, outcomes research... Read More →
avatar for Michael Berntgen

Michael Berntgen

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification... Read More →

Nicole Mittmann

Chief Scientist and Vice President of Evidence Standards, Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Dr. Nicole Mittmann is CADTH’s Chief Scientist and Vice-President of Evidence Standards. At CADTH, Dr. Mittmann leads a diverse portfolio that encompasses Health Economics, Research Information Services, Scientific Affairs, including Scientific Advice and Patient Engagement, and... Read More →

Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044