Medical Devices

Public Workshop - Advancing the Development of Biomarkers in Traumatic Brain Injury, March 3, 2016

Attached is a link to a survey of the TBI workshop: https://www.surveymonkey.com/r/TBI_Workshop. We are requesting your participation in a brief survey that will take 5-10 minutes to complete. We seek feedback from the participants in an effort to improve the content of the workshop topic, process and to help ensure that the experience was worth your effort.

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

This meeting was held March 3, 2016, beginning at 8:00 am – 5:00 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring MD, 20993

Webcast Archive

Transcript

Agenda

AM Session
TimeTopicSpeaker
7:30am-8:00amRegistration  
8:00am-8:05amWelcome RemarksRobert Califf, MD, MACC
Commissioner of Food and Drugs,
FDA
8:05am-8:15amKeynote Address: History and Lessons Learned from Clinical Trials in TBICol. Todd E. Rasmussen, MD, FACS
Director of DoD Combat Casualty Care Research Program, US Air Force Medical Corps
8:15am-8:20amWorkshop OverviewLakshmi Kannan, PhD
Commissioner's Fellow, Emergency Preparedness and Medical Countermeasures, Office of Center Director, CDRH/FDA
Theme 1: Potential and Emerging Biomarkers- Challenges and Opportunities
8:20am-8:30amAdvances in TBI BiomarkersGeoff Manley, MD, PhD
Principal Investigator of TED/TRACK-TBI & Chief of Neurosurgery, University of California, San Francisco
8:30am-8:45amNeuroimaging BiomarkersEsther Yuh, MD, PhD
Associate Professor, Radiology and Biomedical Imaging, University of California, San Francisco
8:45am-9:00amNeuroimaging BiomarkersLuca Marinelli, PhD
Program Manager, Healthcare Commercial Partnerships,
GE Global Research Center
9:00am-9:15amBio-fluid BiomarkersKevin Wang, PhD
Executive Director, Center for Neuroproteomics and Biomarkers Research & Chief of Translational Research, University of Florida, Gainesville
9:15am-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, Aurora
9:45am-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, Houston
10:00am-10:20amQ&A 
10:20am-10:30amBREAK 
Theme 2: Regulatory Considerations for Biomarker Development
10:30am-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/FDA
10:35am-10:50amDrug Development Tool- Biomarker Qualification PathwayShashi Amur, PhD
Scientific Coordinator, Biomarker Qualification Program, Office of Translational Sciences, CDER/FDA
10:50am-11:00amMedical Device Development ToolKathryn O'Callaghan
Health Scientist, Office of Center Director, CDRH/FDA
11:00am-11:10amNeuroimaging Biomarkers: Analytical & Clinical ValidationDaniel Krainak, PhD
Biomedical Engineer, Division of Radiological Health, Office of In Vitro Diagnostics, CDRH/FDA
11:10am-11:20amIn Vitro Diagnostics: Analytical & Clinical ValidationKellie Kelm, PhD
Supervisory Biologist, Division of Chemical and Toxicology Devices, Office of In Vitro Diagnostics, CDRH/FDA
11:20am-11:30amClinical Trial Design Considerations Peter Como, PhD
Health Scientist, Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, CDRH/FDA
11:30am-11:40amStatistical Issues and ConsiderationsBipasa Biswas, PhD
Mathematical Statistician (Team Leader), Division of Biostatistics, Office of Surveillance and Biometrics, CDRH/FDA
11:40am-11:50amCritical Path Public-Private PartnershipsDiane Stephenson, PhD
Executive Director, Coalition Against Major Diseases, Critical Path Institute
11:50am-12:05pmQ&A 
12:05am-12:45pmPANEL DISCUSSIONModerator:
  • Allison Kumar
    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
TimeTopicSpeaker
Theme 3: Advance Knowledge from Patients Experience
1:30pm-1:40pm                       Patient PerspectiveJohnny Cebak, PhD
Iraq War Veteran, Medical student at Lincoln Memorial University
1:40pm-1:50pmPatient PerspectiveRebecca Lorraine, Col (Ret.), MS-FNP
Ex-Chief of the US Special Operations Command Clinic, MacDill Air Force Base
1:50pm-2:00pmPatient-Centered PerspectiveBen Heywood, MS
Co-Founder, President
PatientsLikeMe
2:00pm-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 analytics
2:10pm-2:20pmData Standardization-Quantitative Imaging Biomarkers Alliance (QIBA)Daniel Sullivan, MD
Professor Emeritus, Department of Radiology, Duke University, Founder and Chair, QIBA
2:20pm-2:30pmData StandardizationPatrick Bellgowan, PhD
Program Director, Repair and Plasticity, National Institute of Neurological Disease and Stroke, NIH
2:30pm-2:40pmTED MetadatasetGeoff Manley, MD, PhD
Principal Investigator of TED/TRACK-TBI & Chief of Neurosurgery, University of California, San Francisco
2:40pm-2:50pmTBI RegistriesTammy Crowder, PhD
Neurotrauma Research Portfolio Manager, DoD-Combat Casualty Care Research Program
2:50pm-3:00pmBREAK 
3:00pm-3:10pmBig data analytics-Palantir Platforms Chloe Coughlin-Schulte
Business Development Team,
Palantir Technologies
3:10pm-3:20pmBig data analytics-
TBI Big data and IBM platform
Paul Vespa, MD
Director of Neurocritical Care,
Professor of Neurosurgery and Neurology, UCLA School of Medicine
3:20pm-3:30pmBig data analytics-
In silico approach
Yelizaveta Torosyan, PhD
Health Scientist, Division of Epidemiology
Office of Surveillance and Biometrics, CDRH/FDA
3:30pm-3:40pmBig data analytics-
High-Performance Integrated Virtual Environment (HIVE)
Vahan Simonyan, PhD
FDA/Lead scientist, Director of Bioinformatics, Principal Investigator, CBER/FDA
3:40pm-4:00pmQ&A 
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/FDA
4:55pm-5:00pmClosing RemarksAllison Kumar
Senior Program Manager, Emergency Preparedness and Medical Countermeasures, Office of Center Director, CDRH/FDA

Discussion Paper

Registration to Attend the Workshop

Registration is closed as of February 25, 2016. On-site registration will be available the morning of the workshop. There is no fee to register.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contact:

Allison Kumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5408, Silver Spring, MD 20993, 301-796-6369, email: Allison.Kumar@fda.hhs.gov; or

Lakshmi Kannan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5402, Silver Spring, MD 20993, 240-402-7735, email: Lakshmi.Kannan@fda.hhs.gov

Page Last Updated: 04/21/2016
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