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San Diego Convention Center

2014年6月15日 (日) 午前 8:30 - 2014年6月19日 (木) 午後 12:45

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

Drug Development with Reimbursement in Mind: Obtaining the Input of Payers to Inform Clinical Trial Design

Session Chair(s)

Charles A. Stevens, JD, MBA

Charles A. Stevens, JD, MBA

Vice President and General Manager

PAREXEL Consulting, United States

Regulatory approval does not lead to commercial success unless sponsors understand the evidence requirements of payers. Sponsors can minimize the risks of reimbursement denial by incorporating payer input into preregistration studies. This session will explore practical ways in which sponsors can seek and obtain actionable payer input during drug development.

Learning Objective : Discuss what clinical evidence payers require in order to grant reimbursement for newly approved drugs; Explore ways to interact with payers during drug development to inform the design of clinical studies; Describe the pros and cons of joint meetings with regulators and payers during drug development in order to agree on clinical studies that will satisfy the needs of both.

Speaker(s)

Andrew  Bate, PhD, MA

Panelist

Andrew Bate, PhD, MA

GlaxoSmithKline, United Kingdom

Vice President, Head of Safety Innovation and Analytics

Brandon T. Suehs, PharmD, PhD

Panelist

Brandon T. Suehs, PharmD, PhD

Comprehensive Health Insights, a Humana Company, United States

Principal Researcher

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