Peter Stein
NextStage Pharma Consulting, Former Director, Office of New Drugs, CDER US Food & Drug Administration (FDA)
Seminars
Wednesday 16th September 2026
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
3:15 pm
- 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
