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The Not So Rare Challenge that Faces Rare Disease Development: Demonstrate Value
Session Chair(s)
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)
Panelist
Igor Gorlach
Foley Hoag LLP, United States
Associate
Panelist
Jim Long
BioSolutia, United States
Co-Founder and Principal
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