Digital Biomarkers - Embracing Their Application to Advocate and Advance Personalized Treatment of CNS Disorders

Session Description

Development of a range of digital biomarkers to improve treatment of psychiatric and neurologic disorders is an active area of privately and publicly funded research. There is a need for clinical pharmacologists to be aware of this work so that they can participate in its development, and advocate for digital biomarker application in the therapy of an increasing burden to global humankind of CNS disorders.
This session will consist of three, 15-minute talks regarding the development of digital biomarkers for a range of CNS disorders. The talks will cover applications in sleep disorders, Parkinson's disease, Alzheimer's disease, schizophrenia and other neuropsychiatric conditions. Two of these talks will discuss how these biomarkers are used to promote clinical trial diversity and application of real world evidence to improve development and use of CNS therapeutics. The third talk will be delivered by a representative of the FDA to discuss regulatory expectations for approval of digital biomarkers, with emphasis on CNS disorders, but not limited to CNS.

Learning Objectives

1. Upon completion, participants will be able to articulate, verbally and in writing, what a digital biomarker is, its application as a translational tool in research of treatment of CNS disorders, and regulatory perspective of its application.

2. Upon completion, participants will be able to identify and advocate regarding how digital biomarkers may be used in their own research and clinical development endeavor.

Session Schedule

1:30 PM - 1:40 PM ET
Introduction
Mathangi Gopalakrishnan, PhD

1:40 PM - 1:45 PM ET
Audience Polling
Mathangi Gopalakrishnan, PhD

1:45 PM - 1:55 PM ET
Validation of Digital Biomarkers in Neurological Diseases
Jasmin Imsirovic, PhD

1:55 PM - 2:05 PM ET
Digital Biomarkers in Clinical Pharmacology: Advancing the Development of Precision Therapeutics
Gina Pastino, PhD

2:05 PM - 2:15 PM ET
The Use of Digital Biomarkers in Clinical Trials Submitted to Regulatory Agencies
Andrew Potter, PhD

2:15 PM - 2:30 PM ET
Q&A and Closing Remarks