Each year, G2G attends the Military Health Systems Research Symposium (MHSRS) which brings together military, government, academia, and industry experts to share their latest research findings and challenges on topics, including combat casualty care, military operational medicine, clinical and rehabilitative medicine, medical simulation and information sciences, military infectious diseases, and the radiation health effects. For G2G, this is an opportunity to learn about what is most important to the Department of Defense (DoD) in military medicine to best position current and future clients to meet the needs of our Warfighters. It is also a fantastic networking opportunity to reconnect with and meet new key players in all branches and divisions of military medicine.
MHSRS 2023 came to a close on August 17. We obtained some insights from FDA in one of the final sessions and headed back home. Engaging the FDA early was the key message. If you identified the potential for your product to be a device or drug and the focus of the FDA's regulatory oversight, they recommend that you contact the FDA prior to marketing your product. Early interaction with the FDA on planned non-clinical and clinical studies and careful consideration of the FDA's feedback may improve the quality of premarket submissions, shorten total review times, and facilitate the development process for new devices.
In particular, CBER, the Center within FDA that regulates biological products for human use under applicable federal laws, ensures that biological products are safe and effective and available to those who need them. CBER also provides information to promote the safe and appropriate use of biological products. FDA offers INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice of CBER Products) to further encourage early interaction with sponsors regarding preclinical, manufacturing, and clinic development plans. We have other tips for FDA and Department of Health and Human Services engagement happy to share!
Overall, the G2G team appreciated all our meetings and conversations with dedicated leaders in health innovation and patient care who are paving the way for major advancements. Whether the Department of Defense, the VA, Department of Homeland Security, FDA or the Department of Health and Human Services, all were determined to collaborate, grow and improve current systems and capabilities.
G2G has attended MHSRS for 15 years. We’ve traveled to Fort Lauderdale year after year with half the attendees we see today. As MHSRS outgrew Fort Lauderdale to fit the Gaylord Palms Resort in Orlando over the past several years, increased engagement with private sector innovators has soared. This year MHSRS had 3,800 attendees, 1,400 poster presentations, 460 oral presentations, and covered 65 different topic areas, some of which are traditional trauma care while others are new areas, such as women’s health, AI/machine learning, and sensors. Across the board, the health and safety of the warfighter is the priority and we have relished bringing our amazing clients to this conference to meet leadership and demonstrate how they can fill critical gaps.
Special recognition goes to some key changemakers at MHSRS: ATCC, CEFALY, Humacyte, Nyrada, and Voltron as all made powerful presentations and still others working with the military to make a difference: Focused Ultrasound Foundation, NCBiotech, NeuroWave, TEGA, USP, Voltron, and WHAM. All are working hard to address gaps in research and care for the military and civilian populations.
With dual use for civilian applications a high priority for the Defense Health Agency that now manages all biomedical research and care for service members and their families, collaboration, flexibility, alignment, and patience are key. The government process for executing CRADAs, BAAs and legislative directives all take time, but can be accelerated through quality collaborations often first forged at MHSRS. Ensuring a true match that is aligned with the priorities within each program is vital. We are looking forward to building traction made this year and already can’t wait for MHSRS 2024!
Learn more about G2G’s upcoming webinars here.