We have on Dr. Jim Kovach and Dr. Jaime Garza, also both NFL alumni, for this episode who are incredibly passionate about research, orthobiologics and cellular mediated therapies. It’s a perfect dovetail episode after our Dr. Scott Bruder episode on the FDA Consumer alert on orthobiologics. We discuss further what you can/can’t do in orthobiologics and discuss an innovation in pre-market approval.
Jim Kovach is MD, JD, Executive Director, Translational Entrepreneurship, UC Davis School of Medicine, where he supports physician training in entrepreneurship; and industry outreach to support translational science. He identifies products that are consistent in formulation and can developed, scaled and distributed to help solve challenges in medicine. Dr. Kovach received his medical degree with distinction from the University of Kentucky while simultaneously playing in the National Football League. Dr. Kovach played 7 years in the National Football League as a middle linebacker for the New Orleans Saints and San Francisco 49ers.
Dr. Jaime R. Garza M.D., D.D.S., F.A.C.S. is a native San Antonian with a focus on academics and clinical trials. He has academic appointments as a professor at the University of Texas Health Sciences Center and at Tulane School of Medicine. He is also the President of the Texas Center for Cell Therapy and Research, LLC. A former college football player before entering medical school, Dr. Garza has served as team or tournament physician for several college and professional teams including the NFL’s New Orleans Saints and the and U.S. Olympic track and field team.
-We hear about their involvement in pivotal investigational device exemption (IDE) studies with GID BIO, Inc.. An IDE allows an investigational device to be used in a clinical study to obtain pre-market approval (PME) for class III medical devices. The first study was a safety and feasibility study with the second being a double blind placebo controlled trial at three sites. Tune-in to hear about the technology and the goals of the study outcomes.
-Both are college football and NFL alumni with a passion to educate former players and facilitate outreach to industry. A decade ago, Dr. Garza received emails from NFL alumni about “great stem cell treatments available for free,” yet it wasn’t legitimate. He has since educated alumni and physicians on how they were being targeted and how to protect the NFL Alumni name. It was a significant organizational wake-up call and is now headed in the right direction with the establishment of NFL Alumni Healthcare Committee, for which Dr. Kovach and Dr. Garza serve as senior medical advisors.
For MD’s, capture quick reflections on each learning below & how it applies to your day-to-day to unlock a total of 1 AMA PRA Category 1 CMEs.