2019 State of the Science Summit
Paths to Treatment for Traumatic Brain Injury(s)

June 5-6, 2019  –  Washington, D.C.

Proceedings from the 2019 State of The Science Summit:
Fostering Collaboration to Advance Solutions for Traumatic Brain Injury (TBI)

Cohen Veterans Bioscience is driving the development a Brain Trauma Blueprint to guide a next generation of diagnostics and therapeutics across Traumatic Brain Injury and Post-Traumatic Stress Disorder.  In 2019, we hosted our second State of the Science Summit (SOSS) with over 100 thought leaders to foster consensus around potential paths to treatment for TBI. The goal was to define TBI beyond the typical classifications of mild, moderate or severe, in order to more clearly describe underlying disease mechanisms. The Summit focused on the chronic sequelae of TBI and aimed to identify current knowledge gaps in the etiology and mechanisms of persistent TBI symptoms.

The resulting recommendations create actionable research priorities to be prioritized across the research ecosystem and will be rolled out in the next few months.

Watch Highlights and Presentations
from the 2019 State of the Science Summit

About the 2019 State of the Science Summit

Rationale for the 2019 State of the Science Summit

The Brain Trauma Blueprint is an initiative aimed at accelerating an era of personalized medicine for survivors of brain trauma through a series of invitation-only State of the Science Summits (SoSS). With few FDA-approved treatments for long term neuropsychiatric sequelae of traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD), the development of targeted therapeutics will require clearer understanding of their biological underpinnings. By fostering collaboration across the broader stakeholder community, we will enable translational research gaps to be bridged and achieve solutions sooner for those suffering from trauma-related brain disorders.

Each SoSS includes a review of the landscape drafted by a Scientific Planning Committee, which comprises of key thought leaders with deep expertise in trauma-related brain disorders. The first of the two-day meeting consists of presentations and working sessions discussing the state of the field and major research gaps. The second day includes time to define, refine, and prioritize research gaps.

The trauma-related brain disorder research community has repeatedly lamented the lack of mechanistically targeted therapeutics for TBI. Through breakout and group discussions, consensus around knowledge gaps and strategies to leverage the combined intellectual resources of the scientific and clinical communities will lead to the generation of research priorities that will overcome the gaps and hasten the development of precision-therapeutic options for individuals living with trauma-related brain disorders. This requires advancing knowledge on molecular mechanisms of injury, more refined methods of diagnosis, subtyping patients to better select potential treatments for their disease mechanism, and successfully advancing through clinical trials. A blueprint of past and current research activities can help guide development efforts and accelerate the progression towards a new generation of precision diagnostics and targeted therapeutics.

Historical Context

TBI is currently classified as mild, moderate, or severe and is managed based on a level of consciousness, irrespective of the heterogenic pathophysiology leading to that severity score. The ability of these classifications to predict subsequent patient burden, including neurodegenerative trajectory, is not well understood and can be complicated by subjective measurement techniques, fluctuating presentations and comorbid disorders. Indeed, despite initial hospitalization and inpatient rehabilitation services, about 50% of people with TBI will experience further decline in their daily lives or die within 5 years of their injury; in cases of mild injury where patients often fail to seek help, delayed sequelae may arise leading to cognitive decline or other functional deficits.

While great strides have been made in managing patients after acute brain injuries, particularly those classified as severe, the field is increasingly looking to address the chronic sequelae of mild brain injuries by focusing on identifying the molecular mechanisms underlying the long-term symptoms using animal models2. This requires identifying gaps in our understanding of the presence, presentation, trajectories, and underlying mechanisms of the long-term effects. By leveraging the power of leaders across the brain health spectrum and strengthening the cohesion of the scientific, clinical and patient communities within TBI, the community will have a roadmap to identify the underlying biological processes across TBI injury types, improve patient biotyping and better advance clinical trials. This will translate to precise diagnostics and prognostics for those suffering from brain injuries and ultimately reduce patient burden.

1TBI Model Systems (TBIMS) National Database

Theme of the 2nd Annual State of the Science Summit

The theme of the second State of the Science Summit was Paths to Treatment for Traumatic Brain Injury(s) with a focus on the taxonomy and nosology of the chronic sequelae, challenges and opportunities in clinical practice and development, and etiology and mechanism of persistent symptoms3. As measurement tools advance, research has been able to focus on different types of injury, beyond the mild, moderate, and severe classifications. To augment and support the many efforts across fields and organizations over the past decade, we aim to map a consensus blueprint to drive translational science for TBI.

3Excluding penetrating injury; stroke; acute surgical emergencies

Proceedings from the Second State of the Science Summit

Outcomes Currently Under Development from the Summit

Reviewing the Gaps in Preclinical and Translational Science in Traumatic Brain Injury
Douglas H. Smith, Patrick Kochanek, Susanna Rosi, Retsina Meyer, Chantelle Ferland-Beckham, Eric M Prager, Stephen T. Ahlers, Fiona Crawford

Epidemiology of Chronic Effects of Mild Traumatic Brain Injury
Juliet Haarbauer-Krupa, Mary Jo Pugh, Eric M Prager, Nicole Harmon, Jessica Wolfe, Kristine Yaffe

Phenotyping the Spectrum of Traumatic Brain Injury: A Review and Pathway to Standardization
Mary Jo Pugh, Eamonn Kennedy, Eric M Prager, Jeffrey Humpherys, Kristen Dams-O’Connor, Dallas Hack, Mary Katherine McCafferty, Jessica Wolfe, Kristine Yaffe, Michael McCrea, Adam R Ferguson, Lee Lancashire, Jamshid Ghajar, Angela Lumba-Brown

Biomarker Development to Advance Diagnosis and Treatment of Traumatic Brain Injury
Elisabeth A Wilde, Ina-Beate Wanner, Kimbra Kenney, Jessica Gill, James Stone, Seth Disner, Caroline Schnakers, Andreas Jeromin

Designing Successful Clinical Trials for Traumatic Brain Injury
Lisa A Brenner, Donald G Stein, David Cifu, Allyson Gage, Eric M Prager, David W Wright, Grant Iverson, David L Brody

Implementation Concepts and Strategies to Support the State of the Science Surrounding Traumatic Brain Injury Clinical Care Guidelines
Angela Lumba-Brown, Eric M Prager, Nicole Harmon, Michael McCrea, Michael Bell, Jamshid Ghajar, Scott Pyne, David Cifu

Cohen Veterans Bioscience Executive Leadership Planning Committee

  • Allyson Gage, PhD
    Allyson Gage, PhD

    Allyson Gage, PhD

    Chief Medical Officer
    Cohen Veterans Bioscience

    Allyson Gage, PhD, is a neuroscientist and drug development executive who has over 18 years of experience leading teams in all phases of clinical development. She has been responsible for the overall strategic and clinical development of small molecules, biologics, and cellular therapies for the treatment of central nervous system disorders, including depression, alcohol dependence, Alzheimer’s disease, neuropathic pain, traumatic brain injury, and spinal cord injury. Allyson has a proven track record in partnering with therapeutic area clinicians, US and international regulators, patient groups, and data scientists to translate pre-clinical information into human evaluation, design informative clinical trial protocols, and ensure a regulatory path with approvable and clinically meaningful outcome measures. Prior to joining Cohen Veterans Bioscience, Allyson’s most recent experience was focused in the field of regenerative medicine, working toward the development of a therapeutic for spinal cord injury. Allyson earned her BA from Rutgers College in New Brunswick, NJ, and her MS and PhD in neuroscience from Albert Einstein College of Medicine, New York.

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  • Dallas Hack, MD, Colonel, U.S. Army (Retired)
    Dallas Hack, MD, Colonel, U.S. Army (Retired)

    Dallas Hack, MD, Colonel, U.S. Army (Retired)

    Veterans Science Strategy Advisor (Consulting)
    Cohen Veterans Bioscience

    Dr. Dallas Hack M.D. served as the Director of the US Army Combat Casualty Care Research Program and Chair of the Joint Program Committee for Combat Casualty Care from 2008 to 2014 and as the Senior Medical Advisor to the Principal Assistant for Research and Technology, US Army Medical Research and Materiel Command from 2014 to 2015. He coordinated more than 70% of the DoD trauma research to improve battlefield trauma care of those injured in combat. During this time, the Department of Defense funded more Traumatic Brain Injury research than any organization because of the increasing awareness of the massive burden of Traumatic Brain Injury in the military. He has held numerous military medical leadership positions including Chief of Clinical Services at Fort Knox, KY, Commander of the NATO Headquarters Healthcare Facility, and Command Surgeon at the strategic level during Operations Enduring Freedom and Iraqi Freedom. COL(R) Hack received numerous military awards including the Bronze Star, two Legion of Merit awards, and seven Meritorious Service Medals and was inducted as a Distinguished Member of the Military Order of Medical Merit. He has a BA from Andrews University, a MPH from Johns Hopkins University, a MD from Loma Linda University, a MSS from the US Army War College, and a CPE from the Certifying Commission in Medical Management. He was recognized as the Distinguished Alumnus of the Year by Loma Linda University in May 2015. After retiring from military service, Dr. Hack has consulted with numerous organizations to advance research in Brain Health and transition the progress to improved clinical practice.

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  • Nicole Harmon, PhD
    Nicole Harmon, PhD

    Nicole Harmon, PhD

    Executive Director, Community Partnerships
    Cohen Veterans Bioscience

    Nicole Harmon brings more than 18 years of experience in psychology, philanthropy, patient advocacy, public health, and clinical research, most recently as the Chief Operating Officer and Chief of Staff for Clinical Data Interchange Standards Consortium (CDISC), FDA’s partner for data standards. During her tenure there she transformed CDISC’s financial roadmaps, program management and global brand. Additionally, she developed and managed complex partnerships with leading U.S and International funding partners, U.S. FDA, Japan PMDA, European Medicines Agency, NIH, WHO, EU’s Innovative Medicines Initiatives, Global Patient Foundations and others to drive data standards and sharing initiatives and oversaw grants cultivation and management successfully achieving funding for and administering multiple large-scale projects.  Prior to her time with CDISC, Dr. Harmon evaluated patients with Traumatic Brain Injury and Psychiatric conditions in a post-acute rehabilitation hospital.

    Nicole earned her doctorate in Counselor Education and Supervision at Texas Tech University with dissertation focus on understanding the caregivers experience associated with acquired brain injury following discharge from rehabilitation.

    Nicole joins CVB to oversee development and engagement of strategic partnerships, grant management, events and the Brain Trauma Blueprint to further the CVB mission.    

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  • Retsina Meyer, PhD
    Retsina Meyer, PhD

    Retsina Meyer, PhD

    Manager, Clinical Programs
    Cohen Veterans Bioscience

    Dr. Retsina Meyer pairs pursuit of scientific endeavors with the passionate execution to make real her vision to develop cures for mental illness.

    Dr. Meyer is a translational neuroscientist, scientific founder of Resilience – a startup focused on novel treatments for PTSD and other brain diseases, and is currently consulting Scientific Program Manager for Cohen Biosciences. An active member of the biotech entrepreneurship community, Retsina works on local, national, and international programming to inspire scientist-entrepreneurs. Dr. Meyer has produced over 40 articles, abstracts, and lectures. Her academic discoveries gained international press, earned her a speaking engagement at the local TEDx conference, and served as the instigating discovery to found Resilience.

    As an entrepreneur, Retsina is an alumna of MassBIO’s MassCONNECT program and SpringBoard’s Life Sciences Accelerator and is the 2014 champion of the international OneStart competition awarded by GSK’s SR One.
    She obtained a Neuroscience Ph.D. at MIT where she earned five named fellowships, was a Presidential Fellow, Imperial College of London Global Fellow, and a Graduate Woman of Excellence. She served as a science advocate with the Science Policy Initiative, performing outreach, giving lectures, and meeting with members of congress to appeal for science and scientific funding.
    Prior to her work at MIT, Dr. Meyer was a Fulbright Scholar, serving as a representative of the U.S. to Norway, where she worked in the lab of 2014 Nobel Prize winners Drs. May-Britt Moser and Edvard Moser. She holds bachelor’s degrees in applied mathematics, biochemistry and molecular biophysics, and biopsychology from the University of Arizona where she was a Baver Scholar, and worked in the laboratories of Dr. David Rowe, Dr. Carol Barnes, and Dr. Bruce McNaughton.

    Nicole joins CVB to oversee development and engagement of strategic partnerships, grant management, events and the Brain Trauma Blueprint to further the CVB mission.    

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  • Jessica Wolfe, PhD, MPH
    Jessica Wolfe, PhD, MPH

    Jessica Wolfe, PhD, MPH

    Senior Clinical Advisor, Trauma Research Programs
    Cohen Veterans Bioscience

    Dr. Jessica Wolfe has been a behavioral researcher, neuropsychologist and executive in health sciences and public health for over 30 years.  She is currently a senior consultant to ESC (formerly Executive Service Corps), focusing on non-profit strategy and management and professional Research Associate at Harvard Medical School, Department of Physical Medicine and Rehabilitation.  Prior to that, she served as Senior Research Advisor to Spaulding Hospital Rehabilitation Network’s Institute of Lifestyle Medicine and Senior Research Program Advisor to Partners Healthcare System’s Center for Connected Health where she focused on clinical and research productivity involving wellness and technology innovation.

    Jessica helped found the Department of Veterans Affairs (VA) National Center for PTSD where she subsequently developed and directed the National Center’s Women’s Health Sciences DivisionThere, she led competitively funded, large scale, research initiatives in war trauma, military sexual assault, and Gulf War illnesses.  She has over 70 peer-reviewed scientific publications.

    Jessica received her Doctorate in clinical psychology from Columbia University.  She completed her Master’s in Public Health from Harvard University (HSPH).  Other interests include interactive health technologies, user-centered design (UX), neuroimaging in PTSD and traumatic brain injury (TBI), and stress adaptation across the lifespan.

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Scientific Program Committee

Stephen Ahlers, PhD
Director, Operational and Undersea Medicine Directorate at Naval Medical Research Center

David Cifu, MD
Chairman and Professor at VCU Department of PM&R, National Director for PM&R in Department of Veterans Affairs

Fiona Crawford, PhD
President & CEO, Roskamp Institute

Jam Ghajar, MD, PhD, FACS
President, Brain Trauma Foundation, Clinical Professor of Neurosurgery at Stanford University School of Medicine

Jessica Gill, PhD, RN, FAAN
Deputy Scientific Director of the Division of Intramural Research at the National Institute of Nursing Research

Grant Iverson, PhD
Director, Sports Concussion Program, MassGeneral Hospital for Children; Director, Neuropsychology Outcome Assessment Laboratory, Department of Physical Medicine and Rehabilitation, Harvard Medical School, and Spaulding Rehabilitation Network; Associate Director, Traumatic Brain Injury Program, Home Base, A Red Sox Foundation and Massachusetts General Hospital Program

Michael McCrea, PhD, ABPP
Professor, Neurosurgery and Neurology; Director, Brain Injury Research Program, Medical College of Wisconsin

James Stone, MD, PhD
Vice Chairman of Clinical Research, Associate Professor of Radiology and Medical Imaging, University of Virginia

Elisabeth Wilde, PhD
Associate Professor, Director of Research for Physical Medicine and Rehabilitation, Baylor College of Medicine

Kristine Yaffe, MD
Professor of Psychiatry, Neurology and Epidemiology, Roy and Marie Scola Endowed Chair, Vice Chair of Research in Psychiatry, UCSF

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