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This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice
Session Chair(s)
Andrew Emmett, MPH
FDA Liaison | US Regulatory Policy and Global Intelligence
Pfizer Inc, United States
This panel will explore the blue skies of global regulatory pilot programs, including initiatives on real-world evidence (RWE), model-informed drug development (MIDD), innovative trials, and endpoints. Panelists will educate the audience on new opportunities and best practices for future pilot success.
Learning Objective : Critique new opportunities to participate in regulatory pilot programs at FDA and globally; Outline key lessons learned from pilot program case studies and experiences; Identify best practices to increase the likelihood of success for future pilot programs.
Speaker(s)
Moderator
Danielle Friend Economo, PhD
Johnson & Johnson Innovative Medicine, United States
Senior Director, US Head Regulatory Policy and Intelligence
PDUFA VII Rare Disease Endpoint Advancement Program
Mary Jo Salerno, MPH, MS
FDA, United States
Science Policy Analyst, ORDPURM, OND, CDER
Learnings from FDA PDUFA VII Advancing Real-World Evidence Program
Yueqin Zhao, PhD
FDA, United States
Lead Mathematical Statistician, OB, OTS, CDER
Industry Update
Donna Boyce, MS, RAC
Pfizer Inc, United States
Head and Senior Vice President of Global Regulatory Sciences
Industry Update
Rasika Kalamegham, PhD
Genentech, A Member of the Roche Group, United States
Head, US Regulatory Policy
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