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Value-Based Evidence Generation: What are the Regulatory and HTA Strategies that Companies Could Take in Development?
Session Chair(s)
Neil McAuslane, PHD, MSC
Scientific 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)
Patient Access to Innovative Medicines: What Strategies are Regulators Using to Encourage Companies to Undertake Value-Based Evidence Development?
Michael Berntgen, PHD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
Value-Based Development: What are the Main HTA Considerations Companies Should be Considering Incorporating into Their Early Development Decisions?
Nicole Mittmann, MSC
Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Chief Scientist and Vice President of Evidence Standards
What are the Challenges Faced by a Company to Align Different Stakeholders’ Perspective of Value into Their Development Decisions?
Indranil Bagchi, PHD, MSC
GSK, United States
Global Head, Pricing & Market Access