Christina Master, Children’s Hospital of Philadelphia, University of Pennsylvania, Workshop Chair

• Provide concrete examples of how patient-centered approaches are critical to the success of research implementation and clinical practice.
• Highlight the role of patients as leaders, advisors, and partners across all stages of clinical research to ensure the success of its implementation.
• Offer considerations, based on community feedback, to improve the uptake of FDA-cleared diagnostic devices as it relates to issues of reimbursement, portability, and adequacy of the devices for military environments.

Cynthia Grossman, Subject-Matter Expert, Science of Patient Engagement and Real-World Evidence, Moderator

Linda Papa, Orlando Health

Suzanne Schrandt, ExPPect

Kathy Lee, Warfighter Brain Health Initiative, U.S. Department of Defense

Shari Ling, U.S. Centers for Medicare & Medicaid Services (virtual)

Leslie Wise, EvidenceMatters

• What are potential approaches to expand the use of innovative tools and devices for the diagnosis, monitoring, and treatment of TBI?
• How can patients be better integrated along the entire process of innovation?

• Review prevention strategies across the leading causes of TBI (e.g., sports, motor vehicle collisions, and falls in the elderly).
• Identify leading innovations in low-tech and high-tech approaches to TBI prevention in different contexts.
• Discuss future opportunities for personalized approaches that mitigate injury.

Kristy Arbogast, Children’s Hospital of Philadelphia, Moderator

Wesley Ilana Schnapp, TBI Survivor, University of Arizona

Jennifer Langton, National Football League

Richard Kent, University of Virginia

Thurmon Lockhart, Arizona State University

• What are some emerging scientific and technological innovations with the potential to transform TBI protection that you will be watching in the next few years?
• What are some best practices to spur cross-sectoral collaborations in the TBI prevention space that might enhance the transfer of research advances into industry and clinical practice?
• What are some of the main challenges you have faced in your work on TBI prevention, and how are you navigating them?

Christina Master, Children’s Hospital of Philadelphia, University of Pennsylvania, Workshop Chair

• Consider emerging approaches to using large and complex datasets from the EHR, advanced imaging,

Michelle LaPlaca, Georgia Institute of Technology and Emory University, Moderator

Patricia Adell, Real Estate Solutions Group, TBI survivor

Adam Ferguson, University of California, San Francisco

J. Kevin Demarco, Walter Reed National Military Medical Center

Leslie S. Prichep, BrainScope

Uzma Samadani, Oculogica

• What are or will be key promoters or barriers to obtaining FDA clearance via the individual pathways for your innovation (neuroimaging, electrophysiology, de novo device pathway)?
• What are the potential applications of these innovations (singly and in conjunction with other data) in terms of diagnosis, prognosis, and treatment?
• What is the pathway for reimbursement for these innovations?

• Describe recent advances in clinical trial designs that are enhancing the efficiency to evaluate therapeutics for heterogeneous medical conditions, such as TBI.
• Present evolving existent evidence base for pharmacological and nonpharmacological (e.g., neuromodulation) therapies in TBI, including ongoing clinical research and future directions.
• Highlight challenges in translating academic research to therapeutic interventions, including regulatory and industry barriers.

Ramon Diaz-Arrastia, University of Pennsylvania, Moderator

E. Wesley Ely, Caregiver to a family member with TBI, Vanderbilt School of Medicine (virtual)

Roger Lewis, University of California, Los Angeles

Daniel Laskowitz, Duke University

Michel Baudry, NeurAegis

Maheen Mausoof Adamson, Stanford School of Medicine

William Haskins, Gryphon Bio and Owl Therapeutics (virtual)

• What are the most pressing challenges you have faced in your own work developing therapeutics for TBI and related disorders?
• How can regulatory guidelines by FDA best support

Christina Master, Children’s Hospital of Philadelphia, University of Pennsylvania, Workshop Chair