PROGRAM

6:00 – 8:00 pm

Evening Opening Reception

6:30-6:45 pm  

Challenges in PTE Research: The Need for Biomarkers and Research Standards

Severn B. Churn, PhD (Program Director of Synapses, Channels and Neural Circuits NIH, USA)

9:00 am

Welcome and Opening Remarks

Laura Lubbers, PhD (Chief Scientific Officer, CURE Epilepsy, USA); Elisa Zanier, MD (Head of Department, Mario Negri Institute for Pharmacological Research, Italy), Giuseppe Remuzzi, MD (Director of Mario Negri Institute for Pharmacological Research, Italy)

9:20 am

Post-Traumatic Epilepsy: The Lived Experience

Introduction by: Laura Lubbers, PhD (Chief Scientific Officer, CURE Epilepsy, USA) 

         Lived Experience Perspective

Jack Somers (Captain, US Military, retired)

Moment of Silence & Reflection

9:40 am

Clinical PTE: Recent Advances, Challenges and Solutions

Introduction, Session Moderator Ramon Diaz-Arrastia, MD, PhD (Director TBI Clinical Res. Center, University of Pennsylvania, USA)

–  9:45 am – Overview of PTE and Goals of the Conference  Ramon Diaz-Arrastia, MD, PhD (Director TBI Clinical Res. Center, University of
Pennsylvania, USA)

–  10:05 am – Mechanistic Targets for PTE Prevention  Wolfgang Löscher, PhD (Professor, Hanover Medical School, Germany)

–  10:30 am – Advances in the Neuropathological Characterization of PTE following TBI  Victoria Johnson, MBChB, PhD (Assistant Professor, University of Pennsylvania, USA)

–  10:50 am – Predicting PTE Risk: The Development of a Risk Tool for PTE  Amy Wagner, MD (Professor, University of Pittsburgh, USA)

11:10 am – COFFEE BREAK

–  11:40 am – Synthesis of Concepts and Discussion of Next Steps Moderator and Discussant: Ramon Diaz-Arrastia, MD, PhD

Discussion Questions:

1. How will we select the first/best biological mechanisms to test in clinical trials?
2. What supporting data will be required?

12:30 am

Promising Clinical Biomarkers of PTE 

Introduction, Session Moderator: David Brody, MD, PhD (Professor, Uniformed Services University, USA)

–  12:35 pm – Blood-Based Biomarkers of PTE  Kevin Wang, PhD (Vice-Chair for Research, Morehouse School of Medicine, USA)

–  12:55 pm – Immune-Based Biomarkers: Lessons from TBI  Edward Needham, MD, PhD (Consultant Neurologist, Clinical Research
Associate, University of Cambridge, UK)

–  1:15 pm – EEG Biomarkers: Lessons from Acquired Epilepsy in the ICU  Edilberto Amorim, MD (Assistant Professor, University of California, San Francisco, USA)

1:35 pm – LUNCH

– 2:35 pm – Innovations in Brain Imaging: Implications for Post-Traumatic Epilepsy   David Brody, MD, PhD (Professors, Uniformed Services University, USA)

–  2:55 pm – Blood-Borne Protein Biomarkers of Post-Traumatic Epileptogenesis; Gaps and Solutions  Denes Agoston, MD, PhD (Professor, Uniformed Services University, USA)

–  3:15 pm – Synthesis of Concepts and Discussion of Next Steps  Session Moderator and Discussant: David Brody, MD, PhD

Discussion Questions:

1. What criteria must be met to establish that biomarkers are ready for use?
2. What level of characterization and sensitivity threshold is required?

4:20 pm

PTE: The Industry Perspective on Needs for a Clinical Trial

Introduction, Session Moderator: Douglas H. Smith, MD (Robert A. Groff Endowed Professor of Neurosurgery, Director, Center for Brain Injury and Repair, University of Pennsylvania, USA)

–  4:25 pm – Needs for Developing Biomarkers for PTE Clinical Trials William Haskins, PhD (CEO and Co-Founder, Gryphon Bio, USA)

–  4:45 pm – Challenges in the Path to a Clinical Trial: The Startup Perspective  Pavel Klein, MD (Neurologist and Director, Mid-Atlantic Epilepsy and Sleep Center, President and Co-founder, PrevEp, Inc, USA)

–  5:05 pm – Synthesis of Concepts and Discussion of Next Steps Session Moderator and Discussant: Douglas Smith, MD

Discussion Questions:

1. How do we foster collaboration between industry partners and researchers?
2. How do we ensure we address industry needs to move the field forward?

9:00 am

Welcome and Day 1 Recap

Elisa Zanier, MD (Head of Department, Mario Negri Institute for Pharmacological Research, Italy)

9:10 am

Partnering with the Lived Experience PTE Community

Melissa Miller, PhD (Health Services Program Manager, US Department of Defense)

9:30 am

Preclinical PTE: Advances, Challenges and Solutions

Introduction, Session Moderator: David Loane, PhD (Associate Professor, Trinity College Dublin,
Ireland)

–  9:35 am – Neuroinflammation as a Mechanism of Epileptogenesis: Insights from Status Epilepticus Models  Annamaria Vezzani, PhD (Laboratory Head, Mario Negri, Italy)

–  9:55 am – Determining the Validity of Preclinical Animal Models  Aristea Galanopoulou, MD, PhD (Professor, Albert Einstein College of Medicine, USA)

–  10:15 am – Challenges and Advances in Large Animal Models  John Wolf, PhD (Associate Professor of Neurosurgery, University of Pennsylvania, USA)

10:35 am – COFFEE BREAK

11:30 AM – Synthesis of Concepts and Discussion of Next Steps. Discussion Questions:

1. How will we select the first/best biological mechanisms to test in clinical trials?
2. What supporting data will be required?

12:15 pm

Promising Preclinical Biomarkers of PTE, pt1

Introduction, Session Moderator: Kevin Staley, MD (Physician Investigator, Professor, Mass General, Harvard School of Medicine, USA)

–  12:20 pm – Multi-omic Biomarkers of PTE  Firas Kobaissy, PhD (Morehouse School of Medicine, USA)

–  12:40 pm – Imaging Biomarkers of PTE  Federico Moro, PhD (Head of Unit, Mario Negri, Italy)

–  1:00 pm – Preclinical EEG Biomarkers of PTE  Asla Pitkänen, MD, PhD (Professor of Neurobiology, University of Eastern Finland, Finland)

1:20 pm – LUNCH

2:20 pm

Promising Preclinical Biomarkers of PTE, pt2

Session Moderator: Kevin Staley, MD

–  2:25 pm – Developing Treatments for PTE: The Translational View  Terence O’Brien, MD (Professor, Monash University, Australia)

–  2:45 pm – Synthesis of Concepts and Discussion of Next Steps  Session Moderator and Discussant: Kevin Staley, MD

Discussion Questions:

1. When are biomarkers ready for use?
2. What level of characterization and sensitivity threshold is required?

9:00 am

Welcome and Recap

Co-Chair Elisa Zanier, PhD ((Head of Department, Mario Negri Institute for Pharmacological Research, Italy)

9:10 am

Involvement of Affected Individuals and the Public in PTE Clinical Research

Daniel Correa, MD, MS (Assistant Professor, Montefiore Medical Center, Albert Einstein College of Medicine, USA)

9:30 am

Developing the Data Infrastructure Needed for Progress in PTE

Introduction, Session Moderator: Severn B. Churn, PhD (Program Director of Synapses, Channels and Neural Circuits NIH, USA)

–  9:35 am – Federated Platforms/Systems for Validation and Optimization of Preclinical Findings  Joost Wagenaar, PhD (Assistant Professor, University of Pennsylvania, USA)

–  09:55 am – Harnessing the Power of Big Data for PTE Analysis: Next Steps in Multi-Modal Data Analysis and Field-Wide Data Standardization  Dominique Duncan, PhD (Assistant Professor, University of Southern California, USA)

–  10:15 am –Data Sharing and Standardization: Lessons from the Federal Inter-agency TBI Research (FITBIR) Informatics System Hibah Awwad, PhD (Program Director, Traumatic Brain Injury, NINDS, NIH, USA)

–  10:35 am – Discussion (Talk and Discussion) Session Moderator and Discussant: Severn B. Churn, PhD

Discussion Questions: 

1. What considerations must be taken into account, from the researchers’ perspective, to ensure buy-in to federated data ecosystem? 

2. What additional resources or technology are needed to achieve multimodal analysis? 

11:20 am – COFFEE BREAK

11:40 am

The Roadmap to an Interventional Trial for PTE Moderator: Laura Lubbers, PhD (Chief Scientific Officer, CURE Epilepsy, USA), Elisa R. Zanier,
MD (Department Head, Mario Negri Institute, Italy)

Based on discussion during the conference, an outline of a PTE action plan will be presented for discussion. A set of panelists, along with the general audience, will discuss this plan.

Panelists: Christopher Dulla PhD, Daniel Correa MD MS, Douglas Smith MD, Mary Jo Pugh PhD RN, Pavel Klein MD and Ramon Diaz-Arrastia MD PhD.

1:00 pm – ADJOURN