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Boston Convention and Exhibition Center

2013年6月23日 (日) 午前 8:30 - 2013年6月27日 (木) 午後 12:45

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

The Not So Rare Challenge that Faces Rare Disease Development: Demonstrate Value

Session Chair(s)

Charles A. Stevens, JD, MBA

Charles A. Stevens, JD, MBA

Vice President and General Manager

PAREXEL Consulting, United States

Increased development of orphan products has changed how payer regulators view rare diseases. Rare disorders can now have several products FDA indicated for use; this requires that developers demonstrate the value of these rare disease products.

Learning Objective : Explain how rare disease and orphan products are changing payer regulator views on how to manage these products; Discuss how patient subpopulations, even within rare disorders, can impact overall product value and access; Describe the importance that budget impact models have even in rare disorders.

Speaker(s)

Igor  Gorlach

Panelist

Igor Gorlach

Foley Hoag LLP, United States

Associate

Jim  Long

Panelist

Jim Long

BioSolutia, United States

Co-Founder and Principal

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