This workshop aimed to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for Traumatic Brain Injury (TBI). By convening the relevant stakeholders, the goal was to obtain input on the scientific, clinical, patient and regulatory considerations associated with TBI biomarker development to improve diagnosis and clinical utility for TBI.
- Date, Time and Location
- Federal Register Notice
- Webcast Archive
- Agenda
- Discussion Paper
- Registration
- Contact Us
FDA Campus Information
Webcast Archive
Keynote Address: History and Lessons Learned from Clinical Trials in TBI
Col. Todd E. Rasmussen, MD, FACS
Director of DoD Combat Casualty Care Research Program, US Air Force Medical Corps8:15am-8:20amWorkshop OverviewLakshmi Kannan, PhD
Commissioner’s Fellow, Emergency Preparedness and Medical Countermeasures, Office of Center Director, CDRH/FDATheme 1: Potential and Emerging Biomarkers- Challenges and Opportunities8:20am-8:30amAdvances in TBI BiomarkersGeoff Manley, MD, PhD
Principal Investigator of TED/TRACK-TBI Chief of Neurosurgery, University of California, San Francisco8:30am-8:45amNeuroimaging BiomarkersEsther Yuh, MD, PhD
Associate Professor, Radiology and Biomedical Imaging, University of California, San Francisco8:45am-9:00amNeuroimaging BiomarkersLuca Marinelli, PhD
Program Manager, Healthcare Commercial Partnerships,
GE Global Research Center9:00am-9:15amBio-fluid BiomarkersKevin Wang, PhD
Executive Director, Center for Neuroproteomics and Biomarkers Research Chief of Translational Research, University of Florida, Gainesville9:15am-9:30amBio-fluid BiomarkersRonald Hayes, PhD
Director, Banyan Laboratories
Founder/President, Banyan Biomarkers, Inc.9:30am-9:45amEmerging Biomarkers Cristin Welle, PhD
Assistant Professor, Department of Neurosurgery, University of Colorado, Aurora9:45am-10:00amCorrelation of biomarkers with Clinical OutcomesHarvey Levin, PhD
Scientific Director of Neurorehabilitation: Neurons to Networks TBI Center of Excellence, VA Medical Center Professor of Physical Medicine and Rehabilitation at Baylor College of Medicine, Houston10:00am-10:20amQA 10:20am-10:30amBREAK Theme 2: Regulatory Considerations for Biomarker Development10:30am-10:35amOverview- Pathways at FDA to integrate Biomarkers into Medical Product DevelopmentAllison Kumar – Senior Program Manager, Emergency Preparedness and Medical Countermeasures, Office of Center Director, CDRH/FDA10:35am-10:50amDrug Development Tool- Biomarker Qualification PathwayShashi Amur, PhD
Scientific Coordinator, Biomarker Qualification Program, Office of Translational Sciences, CDER/FDA10:50am-11:00amMedical Device Development ToolKathryn O’Callaghan
Health Scientist, Office of Center Director, CDRH/FDA11:00am-11:10amNeuroimaging Biomarkers: Analytical Clinical ValidationDaniel Krainak, PhD
Biomedical Engineer, Division of Radiological Health, Office of In Vitro Diagnostics, CDRH/FDA11:10am-11:20amIn Vitro Diagnostics: Analytical Clinical ValidationKellie Kelm, PhD
Supervisory Biologist, Division of Chemical and Toxicology Devices, Office of In Vitro Diagnostics, CDRH/FDA11:20am-11:30amClinical Trial Design Considerations Peter Como, PhD
Health Scientist, Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, CDRH/FDA11:30am-11:40amStatistical Issues and ConsiderationsBipasa Biswas, PhD
Mathematical Statistician (Team Leader), Division of Biostatistics, Office of Surveillance and Biometrics, CDRH/FDA11:40am-11:50amCritical Path Public-Private PartnershipsDiane Stephenson, PhD
Executive Director, Coalition Against Major Diseases, Critical Path Institute11:50am-12:05pmQA 12:05am-12:45pmPANEL DISCUSSIONModerator:
- Allison Kumar
Senior Program Manager, Emergency Preparedness and Medical Countermeasures, Office of Center Director, CDRH/FDA
Senior Program Manager, Emergency Preparedness and Medical Countermeasures, Office of Center Director, CDRH/FDA
Panelists:
- Ramon Diaz-Arrastia, MD, PhD
Director of Clinical Research, Center for Neuro and Regenerative Medicine, Uniformed Services University of the Health Sciences, Walter Reed - Christine Mac Donald, PhD
Assistant Professor in the Department of Neurological Surgery, University of Washington - Jamshid Ghajar, MD, PhD, FACS
Director of Stanford Concussion and Brain Performance Center, Stanford School of Medicine President of Brain Trauma Foundation in New York City and Palo Alto - Hao Wang, PhD
Program Director, Office of Translational Research, National Institute of Neurological Disorders and Stroke, NIH - Stuart Hoffman, PhD
Scientific Program Manager, Brain Injury Stroke Programs, US Department of Veteran Affairs - Shashi Amur, PhD
Scientific Coordinator, Biomarker Qualification Program, Office of Translational Sciences, CDER/FDA - Timothy Marjenin
Chief, Neurostimulation Devices Branch
Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, CDRH/FDA
12:45pm-1:30pmLUNCH BREAK
PM Session
TimeTopicSpeakerTheme 3: Advance Knowledge from Patients Experience1:30pm-1:40pm Patient PerspectiveJohnny Cebak, PhD
Iraq War Veteran, Medical student at Lincoln Memorial University1:40pm-1:50pmPatient PerspectiveRebecca Lorraine, Col (Ret.), MS-FNP
Ex-Chief of the US Special Operations Command Clinic, MacDill Air Force Base1:50pm-2:00pmPatient-Centered PerspectiveBen Heywood, MS
Co-Founder, President
PatientsLikeMe2:00pm-2:10pmPatient-Centered PerspectiveSuzanne Schrandt, JD
Deputy Director, Patient Engagement
Patient-Centered Outcomes Research Institute (PCORI)Theme 4: Strategies for improving data standardization, sharing, and application of big data analytics2:10pm-2:20pmData Standardization-Quantitative Imaging Biomarkers Alliance (QIBA)Daniel Sullivan, MD
Professor Emeritus, Department of Radiology, Duke University, Founder and Chair, QIBA2:20pm-2:30pmData StandardizationPatrick Bellgowan, PhD
Program Director, Repair and Plasticity, National Institute of Neurological Disease and Stroke, NIH2:30pm-2:40pmTED MetadatasetGeoff Manley, MD, PhD
Principal Investigator of TED/TRACK-TBI Chief of Neurosurgery, University of California, San Francisco2:40pm-2:50pmTBI RegistriesTammy Crowder, PhD
Neurotrauma Research Portfolio Manager, DoD-Combat Casualty Care Research Program2:50pm-3:00pmBREAK 3:00pm-3:10pmBig data analytics-Palantir Platforms Chloe Coughlin-Schulte
Business Development Team,
Palantir Technologies3:10pm-3:20pmBig data analytics-
TBI Big data and IBM platformPaul Vespa, MD
Director of Neurocritical Care,
Professor of Neurosurgery and Neurology, UCLA School of Medicine3:20pm-3:30pmBig data analytics-
In silico approach Yelizaveta Torosyan, PhD
Health Scientist, Division of Epidemiology
Office of Surveillance and Biometrics, CDRH/FDA3:30pm-3:40pmBig data analytics-
High-Performance Integrated Virtual Environment (HIVE) Vahan Simonyan, PhD
FDA/Lead scientist, Director of Bioinformatics, Principal Investigator, CBER/FDA3:40pm-4:00pmQA 4:00pm-4:40pmPANEL DISCUSSIONModerator Panelist:
- Danica Marinac-Dabic, MD, PhD, MMSc
Director, Division of Epidemiology
Office of Surveillance and Biometrics, CDRH/FDA
Panelists:
- Patrick Bellgowan, PhD
Program Director, Repair and Plasticity, National Institute of Neurological Disease and Stroke, NIH - Geoff Manley, MD, PhD
Principal Investigator of TED/TRACK-TBI Chief of Neurosurgery, University of California, San Francisco - Kevin Crutchfield, MD
Director of the Comprehensive Sports Concussion Program at Brain Spine Institute at LifeBridge Health Care - Col. Dallas C. Hack (Ret.), MD, MPH
Medical Leader, One Mind - Tammy Crowder, PhD
Neurotrauma Research Portfolio Manager, DoD-Combat Casualty Care Research Program - Daniel Sullivan, MD
Professor and Vice Chair for Research, Department of Radiology, Duke University, Founder and Chair, QIBA
4:40pm-4:55pmSummary next stepsLakshmi Kannan, PhD
Commissioner’s Fellow, Emergency Preparedness and Medical Countermeasures, Office of Center Director, CDRH/FDA4:55pm-5:00pmClosing RemarksAllison Kumar
Senior Program Manager, Emergency Preparedness and Medical Countermeasures, Office of Center Director, CDRH/FDA
Discussion Paper
- Discussion Paper: “Advancing the Development of Biomarkers in Traumatic Brain Injury”