Panel Discussion: What Tools Can Be Used to Demonstrate Efficacy Through Early-Stage Clinical Trials? Evaluating Digital Biomarkers, EEG, PROs & Fluid Measures to Support with a Richer Analysis of Disease State

• How multimodal digital biomarkers can sensitively capture early treatment signals and behavioral change before traditional clinical endpoints emerge
• The role of EEG and other neurophysiological readouts in demonstrating target engagement and pharmacodynamic effects during first in human and Phase 1/2 trials
• How structured patient reported outcomes enrich early datasets by capturing subjective symptom shifts that complement objective biomarker trends
• How fluid biomarkers – from inflammatory to neurodegenerative signatures – can provide quantifiable, mechanistic insight into early biological response and disease modulation

Speakers:

Peter Stein

Former Director, Office of New Drugs, CDER

FDA

Aaron Koenig

Chief Medical Officer

Delix Therapeutics

P K

Head of Clinical Development, Experimental Medicine, Neuroscience & Mental Health

Boehringer Ingelheim

Jenny Barnett

Co-Founder & Chief Executive Officer

Monument Therapeutics