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DIA 2021 Global Annual Meeting


Value-Based Evidence Generation: What are the Regulatory and HTA Strategies that Companies Could Take in Development?

Session Chair(s)

Neil  McAuslane, PhD, MSc

Neil McAuslane, PhD, MSc

  • Director
  • Centre for Innovation in Regulatory Science (CIRS), United Kingdom
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 Objective : 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.

Speaker(s)

Michael  Berntgen, PhD

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

Michael Berntgen, PhD

  • Head of Scientific Evidence Generation
  • European Medicines Agency, Netherlands
Nicole  Mittmann, MSc

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

Nicole Mittmann, MSc

  • Chief Scientist and Vice President of Evidence Standards
  • Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Indranil  Bagchi, PhD, MSc

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

Indranil Bagchi, PhD, MSc

  • Senior Vice President and Head, Global Value and Access
  • Novartis Oncology, United States