November 2, 2020

(all times Eastern Standard Time (EST))

9:05 am Chairperson’s Opening Remarks

Andreas Jeromin, Ph.D., Chief Scientific Officer, Cohen Veterans Bioscience

9:25 am Center-TBI; Early Results of a Comparative Effectiveness Research Study
In this presentation, Dr. Peul will describe the practice variation in TBI care in Europe. Do differences in surgical & critical care influence outcome? The drawback of observational studies compared to RCT’s can be overthrown by modern mathematical methods. As the observed practice variation in Center-TBI is quite enormous between countries and even within countries there is a great need for evidence-based guidelines. Within this lecture Dr. Peul will present the differences in healthcare infrastructure, timing of surgery and critical care within the Center-TBI cohort of 5400 patients.
Wilco Peul, MD, Ph.D., Professor & Chair, University Neurological Center Holland, UNCH Leiden & The Hague

9:50 am Blood Based Biomarkers of Sports Concussion
In its first phase, CARE has enrolled over 37,000 MSA cadets and NCAA athletes. In addition, over 2,500 3.300 concussed cadets and athletes have undergone detailed post-injury characterization. As the largest prospective concussion study ever conducted, CARE is addressing key knowledge gaps on the six-month natural history of clinical and neurobiological recovery, the acute and sub-acute effects of concussion on brain structure and function, and factors that predict poor outcomes in MSA members and NCAA student-athletes. In this presentation Dr. Gill will present original research as well as explorative data in the CARE Consortium to date.
Michael Roy, MD, MPH, FACP, COL (Ret.), Professor of Medicine and Director of the Division of Military Internal Medicine, Uniformed Services University of the Health Sciences
Jessica Gill, Ph.D., RN, FAAN
, Acting Deputy Director, Division of Intramural Research, Lasker Clinical Research Scholar, Sr. Investigator, National Institute of Nursing Research (NINR), NIH

10:15 am Toward Improved Analytical and Clinical Validation of Neurotrauma Blood Biomarkers
Cheryl Wellington, Ph.D., Professor, Department of Pathology and Laboratory Medicine, Faculty of Medicine, University of British Columbia

10:40 am Refreshment Break/Poster Viewing/Exhibit Viewing

11:10 am Traumatic Brain Injury Testing in the ER

We have lots of questions, but what are the answers?
~5 million annual ER visits, <5% with positive testing? Is this as good as it gets? Questions we should be asking include:
♦ Are you really safe after a negative CT scan of the head?
♦ Can you go home?
♦ Can you go back to work?
♦ What if you get hit again, are you going to be fine?
♦ Are there any other tests that you should be getting?
♦ Do you have acute traumatic encephalopathy?
Objective measures are coming and will change the standard of care for how we currently manage traumatic brain injury. This talk will cover these existing and future directions for acute testing in patients with suspected TBI.
Frank Peacock, MD, FACEP, Associate Chair & Research Director, Emergency Medicine, Baylor College of Medicine

11:35 am Saliva Biomarkers for Adolescent Concussion
Neuronal exosomes within saliva contain brain-related microRNA that can provide a window into the injured brain. Previously, Dr. Hicks and his team have shown that saliva microRNA profiles reflect cerebrospinal fluid microRNA profiles after traumatic brain injury, and that saliva microRNA can be used to predict the severity and duration of concussion symptoms. Here, he will present results from their follow up study, involving over 650 saliva samples from over 300 participants, which continue to demonstrate the promise of this novel, non-invasive class of biomarkers for assessing and managing adolescent concussion.
Steven Hicks, MD, Ph.D., Assistant Professor of Pediatrics, Penn State College of Medicine

12:00 pm Regulatory Guidance for Developers of New Devices for TBI Diagnosis: Blood-based Biomarkers, Imaging and Other Point-of-Care Devices
In this session, Mr. Hoffmann will discuss important considerations that developers of new devices for TBI must take into account during the regulatory process. Topics to be covered include, qualification vs approval and clearance, clinical validation, FDA review timelines, industry/FDA communication and pre-submissions.
Carlos Pena, Ph.D., MS, Director, Division of Neurological and Physical Medicine Devices, Center for Devices & Radiological Health, US Food & Drug Administration

12:25 pm Precision Imaging of Neuroinflammation After Traumatic Brain Injury
Dr. Coughlin will present emerging molecular imaging data that may shape the application of precision medicine in TBI. The presentation will review key concepts in imaging inflammation in the living brain, and will highlight recent data from imaging the neuroinflammatory response after repeated TBI in collision sports. Recent findings will be discussed in the context of informing new therapeutic strategies relevant to treating many types of TBI.
Jennifer M. Coughlin, MD, Assistant Professor, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine

12:50 pm Lunch/Poster Viewing/Exhibit Viewing/Networking

1:35 pm Can Brain Biomarkers Identify a Subset of Moderate to Severe TBI Patients with Improved Outcome After Progesterone Treatment? A Secondary Analysis of the ProTECT III Trial
In this presentation, Dr. Bazarian will:
♦ Review the main findings of the Protect III trial, which were negative
♦ Review the biomarker project embedded within this trial (BioProTECT)
♦ Review methods used to re-analyze the Protect data using biomarker values, and the results
♦ Review implications and limitations of results
Jeff Bazarian, MD, MPH, Professor of Emergency Medicine, Neurology, Neurosurgery, and PHS, University of Rochester
Courtney Jones, Ph.D., MPH
, Associate Professor of Emergency Medicine, Orthopaedics and Public Health Sciences,
 University of Rochester

2:00 pm Use of a Gyrencephalic Animal Model to Study the Effects of Blast Injury and Related Tau Protein Changes
Dr. Juliano will discuss the effect of blast and other injuries on the cerebral cortex of a gyrencephalic animal (the ferret). Using an animal with brain morphology to similar to that of the human is essential to further assess the impact of injury, as these animals possess sulci and gyri, an increased amount of white matter, and the position of the hippocampus in location similar to that of the human. The ferret shows a neuropathologic profile with interesting features that include increased levels of phosphorylated tau and changes in the ratio of the tau isoforms 3R and 4R.
Sharon Juliano, Ph.D., Professor of Anatomy, Physiology and Genetics, Uniformed Services University of the Health Sciences

2:25 pm Extracellular Vesicles and miRNAs as TBI Biomarkers
In this presentation Dr. Sandsmark will present a summary of her team's recent work to use brain-derived extracellular vesicles, their cargo, and whole-blood miRNAs as biomarkers for TBI diagnosis and prognosis.
Danielle Sandsmark, MD, Ph.D., Assistant Professor of Neurology, Division of Neurocritical Care, University of Pennsylvania

2:50 pm End of Day's Sessions

November 3, 2020

(all times Eastern Standard Time (EST))

9:25 am Lessons from the MODEL-AD and TREAT-AD Consortia for Pre-Clinical TBI Research
Over the last several years, the National Institutes on Aging has invested substantial resources to enhance and speed translational research towards developing effective therapeutics for Alzheimer’s disease and related dementias.  This includes the Model Organism Development and Evaluation for Late-Onset Alzheimer’s Disease (MODEL-AD) and Target Enablement to Accelerate Therapy Development for Alzheimer’s disease (TREAT-AD) consortia.  These consortia seek to develop and characterize more predictive animal models of late-onset AD (MODEL-AD) and identify and characterize novel therapeutic targets for Alzheimer’s disease (TREAT-AD).  Given accumulating genetic, epidemiology and systems biology evidence suggesting potential links between traumatic brain injury and Alzheimer’s disease and related dementias,  this presentation will provide an overview of the MODEL-AD and TREAT-AD consortia and the potential to leverage this work to enhance and speed translational research towards developing effective therapeutics for traumatic brain injury.
Bruce Lamb, Ph.D., Roberts Family Chair in Alzheimer's Disease Research, Executive Director, Stark Neurosciences Research Institute, Indiana University School of Medicine

9:50 am One Bite at a Time: Clinical Trials for Specific Symptoms and Deficits of TBI
Despite substantial investment of time and resources, over 30 late-phase clinical trials in traumatic brain injury (TBI) have failed to translate a therapeutic. There are very few solutions based on solid scientific evidence for treating patients with TBI. In recent years, there have been several examples of successful clinical trials focused on one symptom or subdomain at a time, in the specific sub-populations of patients most likely to benefit. Dr. Brody will present an overall framework for future clinical trials and discuss advantages of the “one bite at a time” approach to treating TBI. Exemplar trials will be presented to highlight the importance of trial design, domain-specific outcomes, and patient selection.
David Brody, MD, Ph.D., Director, Center for Neuroscience and Regenerative Medicine, Uniformed Services University of the Health Sciences

10:15 am Novel Therapeutic Routes Undergoing Pre-Clinical Research for Traumatic Brain Injury
Upwards of 5 million people in the U.S. alone are currently living with TBI-related disability, which is characterized by both acute and chronic phases. This presentation will discuss novel therapeutic approaches to both, with the goal of mitigating neuronal damage and neuropsychiatric impairment.
Andrew Pieper, MD, Ph.D., Harrington Investigator, Director of Neurotherapeutic Discovery, Harrington Discovery Institute, University Hospitals
Min Koo Shin, Ph.D., Senior Research Associate, Harrington Discovery Institute, University Hospitals

10:40 am Refreshment Break/Poster Viewing/Exhibit Viewing

11:10 am New Pharmacological Interventions to Reverse Sex-dependent Behavioral and Cell-specific Deficits After Mild Repetitive Head Trauma
Repetitive mild head trauma can recapitulate higher cognitive deficits observed also in humans such as increased risk-taking behavior. We demonstrated that we can fully and permanently reverses sex-dependent behavioral and cellular deficits after mild, repetitive head trauma. We have behavioral data as well electrophysiology and structural and immunohistochemistry data along with the pharmacological intervention.
Susanna Rosi, Ph.D., Professor & Director of Neurocognitive Research, Brain and Spinal Injury Center, Weill Institute for Neuroscience, University of California San Francisco

11:35 am Circuit-targeted Therapeutics for Emotional Dysregulation After Traumatic Brain Injury
Depression and anxiety are major causes of disability after TBI, and traditional psychiatric treatments are less effective for these patients. In this session, I will present novel findings to demonstrate that TBI-associated emotional dysregulation is a unique clinical syndrome defined by a unique pattern of brain circuit abnormalities. These circuit abnormalities can be selectively modulated using transcranial magnetic stimulation, a widely available antidepressant treatment which has shown preliminary efficacy for TBI-associated depression.
Shan Siddiqi, MD, Research Fellow, Instructor in Psychiatry, Harvard Medical School

12:00 pm Pharmacological Augmentation of KCNQ (“M-type,” Kv7) K+ channels as a Novel Approach to Prevent Brain Damage and Dysfunction After Multiple Types of Traumatic Brain Injury
Dr. Shapiro will present his recent findings from his multi-lab project using mouse models that seeks to use pharmacological enhancement of M-type K+ currents in neurons to prevent the deleterious cascade of events that often lead to brain damage and dysfunction. These include the development of acute seizures and long-term epilepsy, a mal-adaptive inflammatory response characterized by microgliosis, astrogliosis and other inflammatory mediators, the breakdown of the normal blood-brain barrier, the wide-spread death of neurons, and cognitive and motor dysfunction. His team's results suggest that this approach has the potential to become a powerful and widespread therapeutic intervention in the clinic, the emergency room and on the battlefield.
Mark Shapiro, Ph.D., Professor, Department of Cellular and Integrative Physiology, Neuroscience Program, University of Texas Health Science Center

12:25 pm Insights into the Neurological Effects of COVID-19
In this presentation, Dr. Sekhon will focus on bridging the understanding between the basic science and clinical neurologic manifestations of COVID-19
Mypinder Sekhon, MD, Clinical Assistant Professor, Division of Critical Care Medicine, University of British Columbia

12:50 pm Lunch/Poster Viewing/Exhibit Viewing/Networking

(NON CME) 1:35 pm Neuroprotection by Intranasal ST266, a Novel Amnion Cell-derived Secretome

ST266 is a novel, cGMP-produced secretome secreted by Amnion-derived Multipotent Progenitor (AMP) cells. AMP cells are produced by culturing a select population of amnion-derived epithelial cells under proprietary conditions. This cell secretome is anti-inflammatory, anti-apoptotic and neuroprotective. We have successfully demonstrated intranasal delivery of this protein mixture to the brain via the olfactory nerves. Neuroprotection in animal models has now propelled this research to human clinic studies.
Larry Brown, Sc.D., Executive Vice President, Chief Scientific Officer, Noveome Biotherapeutics 

(NON CME) 2:00 pm Neuroprotective Peptide for Treatment of Moderate-to-severe TBI
AivoCode is developing a new approach to TBI therapy by using a novel peptide, AC01, identified by in vivo peptide phage display screening in mice with acute brain injury. AC01 possesses a drug-like activity and when given as repeated intravenous injections during the first days after TBI strongly reduces the size of a brain lesion. Moreover, our results suggest a functional improvement after AC1 treatment not seen in the controls, particularly in motor functions. Thus, AC01 is potentially useful in limiting the secondary damage in TBI. We have identified AC01 target present in the proteoglycan complex that is specifically upregulated in and around the glial cells that respond to the injury in mouse and human brain. The scar resulting from the glial response is thought to limit neuronal regeneration in the injury area. The mechanism of action is under investigation, but it seems that the peptide may block adverse effects of the glial response. Validation of the pharmacological activity in a gyrencephalic animal model of brain trauma is underway.
Aman Mann, Ph.D., Founder and Chief Operating Officer, AivoCode

(NON CME) 2:25 pm Objective Assessment of Concussion Using an Electrophysiological-Based Multimodal Biomarker
The need for an objective measure to aid in the clinical diagnosis of concussion is of utmost importance, especially in the absence of a “gold standard” of concussion. This presentation will describe the validation results of a large independent multi-site FDA validation study demonstrating the potential clinical utility of the BrainScope multimodal Concussion Index (CI) which indicates the likelihood of concussion. The CI has electrophysiological (EEG) connectivity data at its core, but also includes cognitive performance and balance features. The CI was also shown to be a stable measure, and that change in CI can be reliably interpreted, suggesting its potential contribution to the assessment of readiness to return to activity.
Leslie S. Prichep, Ph.D., Chief Scientific Officer, BrainScope

2:50 pm End of Day's Sessions

November 4, 2020

(all times Eastern Standard Time (EST))

9:25 am Neural Gain Modulation in Mild TBI:  A Proposed New Direction for Research and Clinical Practice
A holistic understanding of the neurological, cognitive, physical, and psychological sequelae of mild traumatic brain injury (TBI) remains elusive despite substantial research efforts. Dr. Hershaw will describe how effects of TBI on neural gain modulation may underlie the variable constellation of non-specific symptoms observed in acute, sub-acute, and chronic stages post-injury. The goal of this presentation is to introduce a novel theoretical framework that may unify an otherwise fractured understanding of mild TBI and, thus, generate worthwhile and fruitful lines of basic, translational, and clinical research.
Jamie Hershaw, Ph.D., Research Scientist, Defense and Veterans Brain Injury Center

9:50 am Clinical Signatures and Neuropathological Correlates of Post Traumatic Neurodegeneration
This talk will provide an updated overview of current knowledge regarding clinical phenotypes of post-TBI functional and neurocognitive decline, neuropathological processes that may (or may not) represent mechanistic contributors to clinical decline, and clinical-pathological associations. Dr. Dams-O'Connor will also share recent findings from the Late Effects of TBI (LETBI) study.
Kristen Dams-O'Connor, Ph.D., Professor, Director, Brain Injury Research Center, Icahn School of Medicine at Mount Sinai

10:15 am Machine Learning Prediction of Chronic AD-like Alterations in Default Mode Networks Based on the Acute Cognitive Impairment Profiles of Geriatric TBI Patients
By leveraging functional MRI findings and machine learning techniques, Dr. Irimia and his team have uncovered evidence that geriatric mild TBI (mTBI) is associated with fronto-temporo-limbic alterations in the brain's default mode network (DMN), and that these alterations are statistically indistinguishable from similar deviations from normality observed in AD. Such degradation of functional circuits is significantly correlated with acute post-traumatic deficits of working memory, attention and processing speed. These findings establish a statistical association between geriatric mTBI, post-traumatic cognition and AD-like DMN degradation, and advance the important goal of acutely forecasting mTBI patients’ chronic alterations of brain connectivity along AD-like functional trajectories.
Andrei Irimia, Ph.D., Assistant Professor of Gerontology, Biomedical Engineering and Neuroscience, Leonard Davis School of Gerontology, University of Southern California

10:40 am Refreshment Break/Poster Viewing/Exhibit Viewing

11:10 am Lessons Learned from a Pediatric Concussion Specialty Clinic

In this presentation, Dr. Slomine will discuss an interdisciplinary specialty clinic model of care for children with mild traumatic brain injury. Recent findings generated from clinic data including course and predictors of time to recovery in school-aged children and unique symptoms in preschool-aged children will be described. Additionally, the new data about the relationship among physical and cognitive activity and symptom resolution will be discussed.
Beth S. Slomine, Ph.D., ABPP, Co-Director, Center for Brain Injury Recovery, Kennedy Krieger Institute, Associate Professor of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine

11:35 am Long-Term Outcomes Following Pediatric TBI Pre-clinical Studies
While mortality of pediatric TBI has improved, survivors often deal with long-term cognitive and psychosocial deficits in adolescence and adulthood. Unfortunately, there are no pathology-based therapies to limit these deficits in survivors of childhood TBI. One of Dr. Huh's goals is to develop clinically-relevant pre-clinical models of pediatric TBI that demonstrate long-term cognitive and psychosocial deficits and test mechanistic-based therapies with the ultimate goal of translating this to the human population. In this presentation, He will describe recent findings that he and his team have observed in the lab.
Jimmy Huh, MD
, Director of Pediatric Neurosurgical Neurocritical Care - Assoc. Prof of Anesthesiology, Critical Care and Pediatrics, Children’s Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine

12:00 pm TRACK-TBI - Recent Progress and Future Directions
Geoffrey T. Manley, MD, Ph.D., Margaret Liu Endowed Prof. in Traumatic Brain Injury, Weill Institute for Neurosciences, Prof. & Vice Chairman of Neurological Surgery, Co-Director, Brain & Spinal Injury Center, UCSF, Chief of Neurosurgery, Zuckerberg San Francisco General Hospital & Trauma Center

12:25 pm Longitudinal Evolution of Brain Injury Biomarkers: Implications for the Next Generation of Clinical Trials
Ramon Diaz-Arrastia, MD, Ph.D., Associate Director for Clinical Research, Center for Neurodegeneration and Repair, Director of TBI Clinical Research Center, Presidential Professor of Neurology, Penn Medicine

12:50 pm Lunch/Poster Viewing/Exhibit Viewing/Networking

1:35 pm Advancing Reproducibility in TBI Research Through Team Science, Data Sharing, and Transparency: The ENIGMA Brain Injury Initiative
The goal of this presentation is to outline the structure and progress of ENIGMA - the Enhancing NeuroImaging Genetics through Meta Analysis Consortium - and how large-scale efforts such as ENIGMA can advance reliability and accelerate science. At the core of the “replication crisis” is widespread concern about the methods and incentive structures in science broadly and has direct bearing on the reproducibility in TBI research. This talk will use the network neuroscience literature in TBI as an example to understand the challenges in identifying robust and reliable findings in search of TBI biomarkers. The factors contributing to replication failures are discussed as well as solutions, including recent efforts to consolidate the imaging community around prescribed data processing steps to reduce "investigator degrees of freedom". Open-science initiatives like ENIGMA offer a natural framework for addressing these issues including leveraging international datasets, boosting sample sizes, and offering opportunity for replication of findings all while fostering open and transparent science.
Frank Hillary, Ph.D., Professor of Psychology & Neurology, Penn State University

2:00 pm Neurotrauma Priorities to Address Capability Gaps for Acute Management of TBI in Future Combat Operations
Future Multi-Domain Operations will result in significantly delayed casualty evacuation from combat. Dr. J.B. Phillips, Manager of the Neurotrauma Portfolio at Combat Casualty Care Research Program (CCCRP) will discuss the need for closing military-relevant gaps across a broad range of research areas to improve the diagnosis, management and treatment of TBI. Research focused on enhancing capabilities at the point of greatest need, including life-saving interventions to be rendered immediately post-injury, during periods of prolonged care in theater, and during transport/en route care within and from theater. Dr. Phillips will also discuss how CCCRP fits into the US Army Medical Research and Development Command (MRDC) and current/future funding opportunities.
James B. Phillips, MBA, Ph.D., PMP, Combat Casualty Care Research Program, US Army Medical Research and Development Command

2:25 pm Pediatric Acquired Neural Injury: An Evolving Perspective in Neurocritical Care

Traumatic brain injury is one of the leading causes of death and disability in children. In this lecture, the basic principles of age at injury and their considerations as they apply to clinical management will be reviewed along with the complex and unique issues in the acute phase of the management of pediatric traumatic brain injury, including the current recommended evidence based guidelines. Importantly, due to the limited literature in this area, there has been an evolution in thinking as to neurocritical care and second insults  and secondary injury and their contribution to worsened outcomes.  Through advanced multimodal monitoring, earlier recognition of potential pathophysiologic events in children with traumatic brain injury and other neurologically critical situations may provide modern approaches to new and individualized diagnosis and clinical treatment of pediatric injured brain.
P. David Adelson, MD, FACS, FAAP, Director, Barrow Neurological Institute, Chief, Pediatric Neurosurgery/Children's Neurosciences, Phoenix Children's Hospital

2:50 pm End of Conference

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