TED Consensus Conference 2 Held at NIH Campus

April 4, 2017 | Day 1

Welcome Remarks | Geoff Manley, MD PhD
Colonel Todd E. Rasmussen, MD USAF MC | Director, U.S. Army Medical Research and Materiel Command's Combat Casualty Care Research Program
Janet Woodcock, MD | Director, Drug Evaluation and Research, Food and Drug Administration
Walter J. Koroshetz, MD | Director, National Institute of Neurological Disorders and Stroke
In Memoriam | Peter Como, MD
Introduction and Objectives of Conference | Geoff Manley, MD PhD
TED FDA Deliverables
 Neuroimaging Biomarkers | Pratik Mukherjee, MD PhD
 Biofluid Biomarkers | Kevin Wang, PhD
 Clinical Outcome Assessments (COAs) | Joseph T. Giacino, PhD
Coffee Break
Overview of COAs | ‘Where we stand with current measures’
 Joseph T. Giacino, PhD | Nancy R. Temkin, PhD | Mike McCrea, PhD
TED Metadataset Update | Stephen Wisniewski, PhD
TED Seed Project Progress Updates
 Joseph T. Giacino, PhD | An Evidence-Based Clinical Outcome Assessment Platform for Validation of TBI Assessment Measures (EB-COP)
 Grant Iverson, PhD | Development and Validation of a Cognition Endpoint for TBI Clinical Trials
 Esther Yuh, MD PhD | CT and MRI Prognostic Biomarkers for Mild to Moderate TBI
 Kevin Wang, PhD | Enhancing the Regulatory Readiness of 5 TBI Blood-based Biomarkers Toward FDA Validation
Boxed lunches served
About the precisionFDA Initiative | A Place for TBI
 Elaine Johanson | Program Manager, precisionFDA Initiative
 Katherine Donigan, PhD | Personalized Medicine | FDA, Center for Devices and Radiological Health
Concurrent Expert Working Group Breakouts
COAs - Room E2 | Imaging Biomarkers - Room E1 | Biofluid Biomarkers - Room F1/F2
Discussion | Key Takeaways from Breakout Sessions
Moderators: Billy Dunn, MD - Director, FDA Division of Neurology Products & Geoff Manley, MD PhD