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In this interactive roundtable, you will hear from neurologists, AI experts, and the FDA on their insights into digital biomarkers for trials and clinical endpoints.
You will learn about the pathways to interacting with the FDA, highlights from the FDA's Digital Center of Excellence (CoE's) ongoing work and goals, and thoughts about initiating Digital Health Evidence Accelerator by fostering collaboration between the CoE and EverythingALS and its members.
Get your answers to these topics:
• Can speech be a digital biomarker?
• Regulatory hurdles to digital biomarkers
• Best practices in using digital biomarkers as clinical endpoints
Filled with key insights and audience interaction, this roundtable will provide practical knowledge that you can implement right away!
This is an invite only event.
Speakers
Agenda
Oct 18th 2021 - 4PM EST, 1PM PST
4:00-4:05
4:05-4:40
4:40-5:00
5:00-5:25
5:25-5:30
Welcome and opening remarks
Indu Navar, EverythingALS
EverythingALS speech study update
James Berry, MGH
Ernest Fraenkel, MIT
Raquel Norel, IBM Research
David Suendermann-Oeft, Modality.ai
Collaborating with the FDA Digital Health Center of Excellence
MiRa Jacobs, FDA
Roundtable Survey & Open Discussion
Moderated by Wendy Erler
Closing remarks and next steps
