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Session 1: Orphan Drug Development and Its Regulatory Challenges
Session Chair(s)
Jessica E. Foley
Principal & Founder
Gaia Regulatory Sciences, United States
This session will focus on addressing the unique regulatory complexities and challenges specific to orphan drug development. Experts will examine the industry’s perspective on many important issues, including, heterogeneity, natural histories and progression, and endpoints. FDA representatives will provide key information about programs available to expedite the development of orphan products. This session will close with an interactive roundtable discussion that will demonstrate the importance of cooperation and collaboration of all key stakeholders.
Speaker(s)
Regulatory Challenges of Orphan Drug Development
Jessica E. Foley
Gaia Regulatory Sciences, United States
Principal & Founder
Making the Most of What FDA Offers
Larry Bauer, MA, RN
Hyman, Phelps & McNamara, P.C., United States
Senior Regulatory Drug Expert
Gayatri R. Rao, JD, MD
Rocket Pharmaceuticals, Inc., United States
Panel Discussion
United States
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