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How Medical Writing and Regulatory Strategy Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot
Session Chair(s)
Robin Whitsell
President
Whitsell Innovations, Inc., United States
This session will explore the FDA START program for accelerating rare disease therapies. Three speakers from companies involved in the START pilot and an FDA representative will provide insights.
Learning Objective : Explain the objectives of the FDA START Program and its role in supporting rare disease development; Discuss how the cadence of medical writing and regulatory affairs shifts for those participating in the START program.
Speaker(s)
Panelist
Wei Liang, PhD
FDA, United States
Chief, Regulatory Operations Staff, OTP, CBER
Panelist
Quyen Tran, PharmD
FDA, United States
Science Policy Analyst, OND, CDER
Panelist
Paulette Robinson, PhD, RAC
Neurogene Inc., United States
Senior Director, Regulatory Affairs
Panelist
Madiha Khalid, PhD
Larimar Therapeutics, United States
Senior Director, Medical Writing
Panelist
Jhon Cores, PhD
Moderna, Inc, United States
Associate Director, Medical Writing
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