Day One - March 6, 2012
8:30 Chair's Opening Remarks
Andreas Jeromin, Ph.D., Director, Business Development and Assay Core Services, Banyan Biomarkers, Inc.
8:40 Biomarkers in Pediatric TBI: Children Are Not Just Little Adults
In this presentation, Dr. Berger will discuss the current state of biomarker research in pediatric TBI with a focus on the differences between adults and children. This will include a discussion of biomarker-based diagnostics in pediatric TBI and how biomarkers are being used and may be used in the future to develop and test novel therapies for pediatric TBI.
Rachel Berger, MD, MPH, Associate Professor of Pediatrics, University of Pittsburgh School of Medicine
Dr. Ponton will review the use of a brain-based assessment to objectively evaluate specific symptoms associated with concussion. Based on EEG activity evoked by a cognitive challenge, Data will be presented illustrating an effective dose-response relationship between the number of concussive events and reduced cortical connectivity. The application of this fast and efficient assessment as an objective, brain-based measure of memory and attention deficits that are frequently reported as symptoms of concussion will be described.
Curtis Ponton, Ph.D., Chief Science Officer, Neuro Assessment Systems
9:40 Presentation TBA
Andreas Jeromin, Ph.D., Director, Business Development and Assay Core Services, Banyan Biomarkers, Inc.
10:10 Refreshment Break/Poster Viewing
10:40 Use of Serum S100B to Diagnose and Manage Mild Traumatic Brain Injury
Dr. Bazarian Will review the use of serum S100B as a screening test for abnormal head CT scan after mild TBI in emergency department settings. He Will also discuss the potential use of serum S100B as a diagnostic adjunct to mild TBI in sports settings and its potential role as a measure of blood-brain barrier damage after TBI.
Jeff Bazarian, MD, MPH, Associate Professor, Department of Emergency Medicine, University of Rochester Medical Center
11:10 The Role of Ectopically Expressed Olfactory Receptors in Traumatic Brain Injury-associated Tauopathy
Dr. Pasinetti will discuss studies from his laboratory suggesting for the first time that down regulation of certain ORs that are ectopically expressed in the brain may causually promote pathophysiological mechanisms underlying TBI clinical complications and, possibly, increase TBI patients' risk of developing Alzheimer's disease. He will also discuss clinically accessible biomarkers that might prove useful for assessing the likelihood of TBI subjects to develop clinical complications, which could provide more sensitive outcome measurements for clinical interventions and, ultimately, the characterization of potential novel therapeutic targets to prevent TBI-associated tauopathy.
Giulio Maria Pasinetti, MD, Ph.D., Professor of Psychiatry, Neuroscience, Geriatrics and Adult Development, Department of Psychiatry, Mount Sinai School of Medicine
11:40 (Tentative Title) Novel Neuroimaging Biomarkers of Traumatic Brain Injury
Ramon Diaz-Arrastia, MD, Ph.D., Professor of Neurology, Uniformed Services University of the Health Sciences, Director of Clinical Research, Center for Neuroscience & Regenerative Medicine
12:10 Lunch
1:20 Patient-Focused Multimodal Neuroimaging Analysis of Cortical and Connectomic Traumatic Brain Injury
In this presentation Dr. Van Horn will discuss emerging work from his multi-center team concerning multimodal neuroimaging processing focused on brain image registration, segmentation, connectomics, and measurement from acute and chronic TBI patients of varying severity with a view toward treatment informatics and outcome prediction.
John Van Horn, Ph.D., Assistant Professor, Laboratory of Neuroimaging, University of California Los Angeles
1:50 Panel Session: New Perspectives on Diagnosis, Diagnostic Development & Biomarkers for Traumatic Brain Injury
Chair: Andreas Jeromin, Ph.D. , Director, Business Development and Assay Core Services, Banyan Biomarkers, Inc.
Rachel Berger, MD, MPH , Associate Professor of Pediatrics, University of Pittsburgh School of Medicine
Jeff Bazarian, MD, MPH , Associate Professor, Department of Emergency Medicine, University of Rochester Medical Center
Giulio Maria Pasinetti, MD, Ph.D. , Professor of Psychiatry, Neuroscience, Geriatrics and Adult Development, Department of Psychiatry, Mount Sinai School of Medicine
Curtis Ponton, Ph.D. , Chief Science Officer, Neuro Assessment Systems
2:40 The Long Term Effects of Traumatic Brain Injury on Social Cognition
Dr. Grafman will describe the long-term cognitive and social consequences of traumatic brain injury. He will then focus on the effects of location of brain injury and genetic polymorphisms on social ability and quality of life.
Jordan Grafman, Ph.D., Director, Traumatic Brain Injury Research Laboratory, Kessler Foundation Research Center
3:10 Refreshment Break/Poster Viewing
3:40 SyNAPSe: A Phase 3, Multi-Center Trial for Severe TBI
This presentation will cover the following:
- An overview of the history of progesterone as a neuroprotective agent as a backdrop leading to the current study.
- Discuss the SyNAPSe clinical trial – what BHR hopes to see and who they hope to help
- Discuss BHR Pharma’s future plans, including a nasal formulation and how that will address an even broader segment of the population
Thomas MacAllister, JD, Ph.D., Chief Executive Officer, BHR Pharma
Dr. Poulsen will describe preclinical results that show significant improvements in behavioral and cognitive assessments following treatment with methamphetamine up to 12 hours after severe TBI. He will also show histological and molecular data indicating potential methamphetamine-mediated mechanisms of neuroprotection. Finally, data describing the impact of methamphetamine treatment on the development of seizures after TBI will be shared.
David Poulsen, Ph.D., Research Associate Professor, University of Montana, Chief Scientific Officer, Sinapsis Pharma
4:40 Cyclosporin A and Cyclophilin Inhibitors in the Treatment of Acute Traumatic Brain Injury
The long odyssey of cyclosporine is almost over. Since its strong neuroprotective properties in TBI were first discovered in the early 1990s, cyclosporine (CsA, also known as Cyclosporin A) has been progressing through various levels of study. Mikael Bronnegard, MD, PhD, will present the scientific evidence supporting NeuroVive’s NeuroSTAT’s (Cyclosporin A) significant positive impact on moderate to severe TBI and outline the path towards approval as a treatment for acute TBI within the next few years.
This presentation will cover the following:
- Cyclosporin A and cyclosporine analogues - preclinical and clinical data
- Phase II/III clinical trial with NeuroSTAT (CsA) in patients with moderate to severe TBI
- R&D and clinical strategy to develop a panel of cyclophilin inhibitors for treatment of acute neurological conditions
- Future path for NeuroSTAT towards approval
5:10 Cocktail Reception
Day Two - March 7, 2012
8:30 Chair's Opening Remarks
8:40 In Search of a Clinical Treatment for Acute Traumatic Brain Injury: The ProTECT III Clinical Trial
This session will review the current state of clinical treatments for acute TBI and discuss a potential novel treatment. An update of the ProTECT III clinical trial will also be provided.
Objectives:
- Describe the impact of traumatic brain injury (TBI) in the US
- Discuss the current challenges that faces TBI research
- Describe the evidence for use of progesterone in acute TBI patients and the ProTECT III clinical trial progress
David W. Wright, MD, FACEP, Associate Professor, Director, Emergency Neurosciences, Department of Emergency Medicine, Emory University School of Medicine
9:10 Development of a p75NTR Antagonist as an Acute Neuroprotective Treatment for Moderate to Severe TBI
This presentation will cover discovery background on the target, pharmacology, preclinical data and provide some overview on the translational medicine approach for clinical development.
Marie-Noelle Castel, Ph.D., Pharm.D., Head, Nervous System Disorders Development Unit, sanofi-aventis
9:40 Development of a Novel Neuroprotective Molecule for Mild TBI/Concussion
In this presentation Mr. Glass will discuss the product development pathway for a neuroprotectant molecule from discovery through early-stage clinical trials. The presentation will cover discovery, pharmacology, oral formulation development, regulatory strategy and clinical trial considerations for NNZ-2566, a synthetic analog of the naturally occurring neuropeptide, IGF-1(1-3).
Larry Glass, Chief Executive Officer, Neuren Pharmaceuticals
10:10 Refreshment Break/Poster Viewing
10:40 Biomarkers Driven Development of Experimental Therapeutics for Traumatic Brain Injury
Raymond Dionne, M.S., D.D.S., Ph.D., Scientific Director, Division of Intramural Research, National Institute of Nursing Research, National Institutes of Health
11:10 Presentation TBA
Christine E. Marx, MD, Associate Professor, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center and Durham VA Medical Center
11:40 Panel Session: Research and Development of New Therapeutics for Traumatic Brain Injury
David Poulsen, Ph.D., Research Associate Professor, University of Montana, Chief Scientific Officer, Sinapsis Pharma
Mikael Brönnegård, MD., Ph.D., Associate Professor, Chief Executive Officer, NeuroVive Pharmaceutical AB
David W. Wright, MD, FACEP, Associate Professor, Director, Emergency Neurosciences, Department of Emergency Medicine, Emory University School of Medicine
Marie-Noelle Castel, Ph.D., Pharm.D., Head, Nervous System Disorders Development Unit, sanofi-aventis
Larry Glass, Chief Executive Officer, Neuren Pharmaceuticals
Christine E. Marx, MD, Associate Professor, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center and Durham VA Medical Center
Thomas MacAllister, JD, Ph.D., Chief Executive Officer, BHR Pharma
12:30 Lunch
1:30 Issues in the Development and Validation of Diagnostic Devices for Traumatic Brain Injury – A Regulatory Perspective
The development of valid diagnostic devices for traumatic brain injury (TBI) poses numerous challenges with respect to proper study design, subject selection (e.g., severity of TBI), and clinical assessment. Currently, no single TBI diagnostic “gold standard” exists making validation of novel diagnostic devices for TBI problematic. Currently, there are no approved TBI diagnostic devices. This presentation will address some of the key issues in the validation of TBI diagnostic devices from a regulatory perspective, including the essential elements required for FDA approval of a TBI diagnostic device.
Peter Como, Ph.D., Lead Reviewer, Neuropsychologist, Divsion of Ophthalmic, Neurological & Ear, Nose & Throat Devices (DONED), Neurodiagnostic and Neurotherapeutic Devices Branch (NNDB), FDA
2:00 Towards an International Collaboration for TBI Research
The international research community has acknowledged the importance of working together to develop better diagnostics and treatments for traumatic brain injury (TBI). An important step toward this goal is the standardization of data elements and tools, and the development of a shared data repository. Another important step is the prioritization of research questions to ensure that future collaborative studies successfully test their hypotheses and achieve their specific aims.
This presentation will provide an overview of some of the major accomplishments and progress towards an international collaboration for TBI research, including updates on the TBI Common Data Elements Project, the Federal Interagency TBI Research (FITBIR) Informatics System, and the EU – USA – Canada Workshop on Comparative Effectiveness Research.
Ramona Hicks, Ph.D., Program Director, Extramural Research Program, NIH/NINDS
2:30 An Overview of the OneMind for Research Campaign
Magali Haas, MD, Ph.D., Partner, Janssen R&D Innovation, Johnson & Johnson, Scientific Advisor, OneMind
3:00 End of Conference