Drew Elias

Company: Johnson & Johnson

Job title: Director, Global Regulatory Lead, Neuroscience

Seminars:

Panel Discussion: Securing Regulatory Buy-In for Precision Psychiatry: What is the Regulatory View on Targeting More Precise Patient Subtypes & How Will This Effect Drug Labels? 3:00 pm

What is the regulatory guidance on how to use biomarkers and outcome measures to identify and target specific patient populations? Do regulators believe it is feasible to develop a selective population initially to confirm the treatment’s utility? How are trial enrichment criteria going to translate in the real world and affect indication statements? What are…Read more

day: Day Two PM

Considerations For How Biomarker-Driven Stratification of Depressive Subtypes Will Be Viewed in the Eyes of the Regulators 4:00 pm

Evaluating the availability of validated or un-validated biomarkers in depression Deciphering the road to regulatory acceptance of a biomarker-identified population Navigating challenges of implementing robust biomarker criteria in the real world Discussing the pathway to commercialization for a precision therapy for mental healthRead more

day: Day Two PM