James Kelly
Chief Medical Officer Oragenics
Dr. James Kelly is Chief Medical Officer of Oragenics, Inc., a biotechnology company focused on revolutionizing neurological care through its proprietary technology providing intranasal delivery of medications aimed at treating brain-related conditions. He is an academic behavioral neurologist with a career focus on traumatic brain injury (TBI) including clinical care, research, education and administration.
Dr. Kelly is Professor Emeritus of Neurology and Physical Medicine and Rehabilitation at the University of Colorado Anschutz Medical Campus in Aurora, CO. His immediate past position was Executive Director of the Marcus Institute for Brain Health (MIBH), a specialized treatment program funded by the Marcus Foundation to care for US military Veterans and First Responders with persistent symptoms of TBI. He was also National Director of the Avalon Network TBI Medical Programs for which the MIBH served as the clinical coordinating center.
Prior to founding the MIBH, he was Director of the National Intrepid Center of Excellence (NICoE) at Walter Reed National Military Medical Center in Bethesda, MD. As its founding Director, he led the creation of an innovative interdisciplinary team of healthcare professionals who blended high-tech diagnosis and treatment with complementary and alternative medical interventions in a holistic, integrative approach to the care of U.S. military personnel with the complex combination of TBI and psychological conditions such as post-traumatic stress, depression, and anxiety. In this role, Dr. Kelly was frequently called upon by leaders of the Military Health System in the Pentagon, the U.S. Congress, the Department of Veterans Affairs, and numerous military facilities in the continental U.S. and abroad. He twice traveled to Afghanistan to advise and assist at military hospital programs and forward operating base medical units.
Dr. Kelly is President of Kelly Neuroscience Consulting, LLC and co-owner of Valor Industries which manufactures hockey helmets. He is the Chief Medical Scientist of the Chicago-based Invisible Wounds Foundation and Chief Medical Advisor for the Greenhill Antiballistic Corporation. He holds US patents on helmet liners and the transmission of signals from helmet motion sensors.
Seminars
- Understand the scientific rationale for targeting concussion and traumatic brain injury through intranasal direct-to-brain delivery
- Explore the challenges of generating translational, safety, and clinical evidence to support progression of a novel neurological therapy into human studies
- Learn lessons from advancing a clinical-stage intranasal program, including regulatory strategy, development planning, and building confidence in direct CNS delivery
- Identify the critical scientific, translational, and clinical evidence gaps that remain before nose-to brain delivery can achieve widespread regulatory acceptance and commercial adoption
- Understand what regulators still need to see regarding reproducibility, biodistribution, imaging, clinical outcomes, and direct CNS exposure before confidently supporting nose-to-brain claims
- Debate whether current preclinical models, analytical tools, imaging technologies, and translational approaches are sufficient to predict human outcomes and support development decisions
- Separate genuine scientific progress from industry hype by examining which technologies, pathways, and approaches are producing meaningful evidence versus those that continue to face significant validation challenges
