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Monday, October 1 • 2:00pm - 5:00pm
Workshop B — Add Orphan Indications to Accelerate Development

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By demonstrating a new orphan indication for an existing therapeutic, you may be able to
lengthen the period of exclusivity. By comparing the orphan approvals for both older and
newer drugs, you can get a clearer picture of how viable this is as a business model.

• Target orphan drug indications to obtain extended periods of exclusivity for blockbuster
therapeutics
• Anticipate changes now that politicians and payers expect this
• Weigh the prospect of changes to the orphan drug program, either legislatively or at
the FDA level
• Review orphan strategies to build value

Speakers
avatar for Sanuj Ravindran

Sanuj Ravindran

CEO, PELLEPHARM
avatar for Neal Simon

Neal Simon

CEO, AZEVAN PHARMACEUTICALS


Monday October 1, 2018 2:00pm - 5:00pm EDT
Hilton Boston Logan Airport