USAMMDA team marks 2023 successes, sets stage for 2024 and beyond
As the year draws to a close, team members with the U.S. Army Medical Materiel Development Activity (USAMMDA) are reflecting on their achievements while preparing for the challenges to come in the new year.
USAMMDA supports the U.S. Department of Defense (DoD) as its premier medical developer, modernizing the technologies, treatments, and programs that will enable lifesaving efforts at and near the front lines of future wars. Based at Fort Detrick, Maryland, under the U.S. Army Medical Research and Development Command (USAMRDC), USAMMDA works with medical experts and stakeholders from the Army, Navy, Air Force, Marines, and Special Forces, as well as the U.S. Food and Drug Administration (FDA) and private sector partners, to develop and deliver medical solutions to Warfighters across the globe.
2023 ends with several milestone successes for USAMMDA's individual Project Management Offices (PMO), setting the foundation for future growth while highlighting USAMMDA's continued focus on modernization to better meet the needs of the U.S. joint force, according to Col. Andy Nuce, the unit's commander.
"This year our team made substantial progress in positioning the organization toward both long-term and sustained success fulfilling DoD and U.S. Army materiel requirements," said Nuce. "We began the year with the clear focus of continuing our organizational restructuring while leaning into our ongoing transition to the Defense Health Agency and simultaneously strengthening our relationship with the Assistant Secretary of the Army for Acquisition, Logistics and Technology."
Warfighter Expeditionary Medicine and Treatment
USAMMDA's Warfighter Expeditionary Medicine and Treatment (WEMT) PMO team, which works to field FDA-cleared or approved medical devices, drugs, and biologics for joint service end users, continued to build on its reputation as a hub of innovation, developing new capabilities while improving existing capabilities to meet the needs of Warfighters at and near the front lines, according to Caitlyn Felkoski, WEMT's acting project manager.
WEMT works with partners in academia, the medical development industry, and organizations within the DoD to leverage the PMO team's inherent expertise in meeting frontline treatment needs. During 2023, the PMO hosted two Industry Day events with Johns Hopkins University/Applied Physics Laboratory (JHU/APL) to bring key stakeholders together to explore new development avenues and validate existing lines of effort within WEMT, said Felkoski.
"Our partnership with JHU/APL, which is a DoD-sponsored University Affiliated Research Center for the Navy, allows the WEMT PMO to coordinate with academia and industry, working together to overcome obstacles facing a number of our medical products in development," said Felkoski. "One of the primary advantages of our relationship with JHU/APL is that they bring to the table a vast amount of knowledge and experience that can help us address the various challenges faced by our nation's military."
WEMT is focused on innovation, including the development of biological manufacturing capabilities through the work of BioFabUSA, a DoD-sponsored Manufacturing Innovation Institute whose members include commercial and academic entities.
"Since its establishment in 2017, the BioFabUSA program has been focused on bridging the gap between early scientific research and later-stage product development by advancing critical technologies to enable large-scale biological manufacturing efforts," said Felkoski.
Notably in 2023, EpiBone, a commercial member of BioFabUSA, achieved FDA clearance to begin testing its laboratory-developed bone and cartilage in humans. This marks a significant advancement in the potential treatment of osteoarthritis – a degenerative disease in which the tissues in the joint break down over time due to injury or aging. Currently, the only FDA-approved therapies for osteoarthritis and similar conditions involve treatment of symptoms but do not address underlying conditions like degradation of cartilage tissue, according to Felkoski. This product would help reduce the number of lost duty days for service members suffering from osteoarthritis.
Warfighter Protection and Acute Care
The Warfighter Protection and Acute Care (WPAC) PMO team's strategic focus is finding medical solutions for service members across the continuum of care. The team works with DoD, medical development industry, and academic partners to develop, deliver, and field FDA-approved preventions, diagnostics, and treatments for U.S. Warfighters.
In August, a WPAC development team received the Defense Health Agency award for Program Management during the Military Health System Research Symposium, DoD's premier scientific meeting, for its work to develop a Broad-Spectrum Snakebite Antidote (BSSA). The award was the capstone for the development team in a yearslong program to protect against the threat of snakebites in austere environments like the Indo-Pacific region, where venomous snakes are often found. It also exemplified the WPAC team's all-hands approach to its development mission, according to Kendra Lawrence, Ph. D., WPAC Project Manager.
"The strength of the WPAC team lies in its mission focus, collaborative approach, and vision to help enable combat casualty care capabilities at or near the point of injury," said Lawrence. "This award symbolizes the dedication of our team in developing and delivering the highest quality medical solutions and capabilities for our men and women in uniform."
BSSA was only one of several vital lines of effort for the WPAC team this year. Another high-visibility partnership included the Soldiers of the Alaska-based 11th Airborne Division, the Arctic Angels. During the Joint Pacific Multinational Readiness Center exercise at Fort Wainwright in April, members of the WPAC blood products team tested the strength of its Freeze-Dried Plasma (FDP) program and collected insights to help shape the future development of lifesaving blood products for the joint force, said Lindsey Garver, Ph.D., deputy project manager with WPAC.
"FDP provides a shelf-life and storage conditions that allow it to be used as far forward as Role 1," said Garver, referring to medical care provided by medics, corpsmen, and medical officers at the unit level. "It can be stockpiled at various roles of care, offering a significant logistical advantage over whole blood for hemorrhage control. It is one of several blood components USAMMDA has in development to supplement the blood supply on the battlefield."
WPAC is leading development efforts for both human and canine FDP, working with stakeholders across the DoD and non-DoD medical development partners. A critical component of the FDP development process is the feedback gained through "touchpoints" to assess both the current needs of frontline medical providers and the utility of FDP in its current state of development. Responses from potential end-users like the medical providers with 11th Airborne Division help the WPAC team refine their approach during all phases of development, according to Garver.
"FDP is one component of blood that can be used for transfusion; it can also be used to maintain a service member at or near the point of injury as a bridge to transfusion," said Garver. "In the case of the 11th Airborne Division partnership, it allowed us to understand how FDP would be used in an Arctic environment; how the product and packaging held up during airborne operations with combat medics; and whether it performed to standard at both point of injury and battalion aid station levels of care. There is significant interest in ensuring that a safe and substantial blood supply is available to our Warfighters in environments with contested logistics and evolving battlefield scenarios, and FDP is a critical part of that effort."
Warfighter Readiness, Performance, and Brain Health
The effects of brain trauma on service members and veterans have been a major focus of the DoD and partner agencies, including the Department of Veterans Affairs, over the past 20 years. USAMMDA's Warfighter Readiness, Performance, and Brain Health (WRPBH) PMO team has an array of programs and partnerships dedicated to improving brain health, including the Analyzer Traumatic Brain Injury (ATBI) program and the Posttraumatic Stress Disorder Drug Treatment (PTSD DT) program.
ATBI is a device designed to help assess, triage, and manage TBI closer to the point of injury than ever before, according to product manager Damien Hoffman. The program includes an FDA-cleared blood test that is commercially available for health care systems in the United States for clinical, non-military uses to provide objective data regarding the presence of TBI. The ATBI team is working with DoD stakeholders and partners to form-fit the device and test it for military application – including simulated and real-world assessments of the device in field environments.
"Soldier touchpoints provide real, direct feedback from the intended end-user community," said Hoffman, who travelled to Fort Hunter Liggett, California, in June 2023 for the Global Medic Combat Support Training Exercise. "These events provide opportunities for Warfighters to familiarize themselves with the medical products they might see in their sets, kits, and outfits, while facilitating interactions between future users and materiel developers to identify potential areas for improving integration within operational medicine.
"Events like Global Medic also provide development teams the opportunity to see the results of their hard work in the hands of the Warfighter, which is a rewarding experience that's impossible to get through a paper exercise," he added.
While ATBI is a new capability to medical providers across the joint force, it is one of many approaches for developing the technologies that will be deployable, user-friendly, and widely applicable for the Warfighters of 2030, 2040 and beyond, according to Bobbie Mortimer, deputy project manager with WRPBH.
"TBIs are a major area of concern for combat medical care and a focus of Army medical development," said Mortimer. "During future combat operations, enemy weapons and exposure to blast or concussive events during operations will present challenges to frontline medical providers. The ATBI program is part of our effort to research, develop, and field modern solutions for future combat medical care challenges."
Another major highlight for the team is the ongoing clinical trial to assess the efficacy of drugs to treat PTSD. In keeping with the DoD's focus on holistic brain health, WRPBH launched this trial in 2023 to explore drug treatments for service members and veterans suffering from PTSD. The trial will include 15 to 20 clinical sites within the United States and is planned to include up to 600 subjects during the testing of the first three drugs over approximately three years, according to Kimberly del Carmen, Ph.D., a health science product manager with WRPBH.
"PTSD is heterogenous in nature, meaning that no single biological cause is common to all individuals with PTSD," said del Carmen. "For that reason, we don't think there will be one 'magic pill' that will work for everyone, so we're employing an innovative testing strategy called an Adaptive Platform Trial."
This clinical trial platform design allows for an accelerated schedule in which multiple drugs are simultaneously and sequentially tested. As the trial progresses, drugs that fail will be replaced with new candidates, and those that are successful will "graduate" to the next stage of development. The goal of the trial is to obtain FDA approval of one or more novel therapeutics for the treatment of PTSD, as well as recommendations for the off-label use of drugs that are FDA-approved for conditions other than PTSD.
*The laboratory assay for TBI point-of-care biomarker effort has been funded by the U.S. Army and is managed by USAMMDA's Warfighter Readiness, Performance, and Brain Health Project Management Office.
Force Health Protection
In July 2023, USAMMDA's Force Health Protection (FHP) Division executed an exclusive license agreement to transfer the legacy Special Immunizations Program (SIP) Investigational New Drug regulatory sponsorship and all associated products to two non-DoD development partners with the intent to commercially develop multiple vaccines. The agreement supports the April 2022 decisions by the USAMRDC commanding general and the Deputy Assistant Secretary of Defense for Chemical and Biological Defense to sunset the SIP by end of fiscal year 2023.
This achievement was made possible through the combined efforts of FHP; the USAMMDA Office of Research and Technology Applications; the DoD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense; and USAMRDC's Office of Medical Technology Transfer, Office of Regulated Activities; and Office of the Staff Judge Advocate, according to Tami Pratt, FHP's SIP program manager.
The SIP at Fort Detrick began as an immunization program to provide an additional measure of protection for laboratory workers against occupational infections. Both licensed and investigational vaccines were used as part of the overall safety program to protect Fort Detrick personnel, Pratt said. Over time, the SIP extended the use of its investigational vaccines to laboratory workers and first responders throughout the United States and Canada. The program was discontinued due to rising costs, dwindling supply, and regulatory constraints.
"The Special Immunizations Program played an important role in offering additional protection to laboratory workers involved in U.S. biodefense research," said Pratt. "The transfer of the SIP portfolio to the private sector in lieu of destruction is a 'win-win' for us. The agreement not only provides for potential royalty fees but will continue the more than 60-year legacy of the SIP and save tens of thousands of dollars in destruction costs, maximizing the DoD's long-term investment in the program."
Medical Field Systems
In July 2023, USAMMDA's Warfighter Deployed Medical Systems and Warfighter Health, Performance, and Evacuation project management offices were combined. The new PMO, Medical Field Systems, remains responsible for the day-to-day management, procurement, and sustainment of fielded devices. The reorganization consolidated the programs and focus areas of WDMS and WHPE under the same umbrella, giving USAMMDA a more efficient mechanism for developing field-worthy technology and treatments for frontline care providers in austere locations across the globe.
One of the latest innovations from MFS is the inclusion of portable CT scanners into field deployable units. These scanners are engineered to function in austere and resource-limited settings, providing crucial diagnostic imaging closer to the point of injury. This technology allows for rapid and accurate assessment of internal injuries, which is vital for surgical planning and intervention. In 2023, MFS continued to field CT scanners to the force and train biomedical equipment technicians and operators to ensure military medical providers are prepared for operational use and maintenance of the CT scanning systems.
Also noteworthy is the new Expeditionary Deployable Oxygen Concentration System (EDOCS). Built for military use in austere environments, EDOCS is a commercially produced oxygen-generation unit that takes in ambient air and produces approximately 93 percent medical grade oxygen. It can be used in the field to provide oxygen to medical treatment facilities. To prepare for the Army's 2024 fielding of EDOCS, USAMMDA coordinated operational and service training in September 2023 to allow Army Medical Logistics Command team members to learn more about the system and its maintenance requirements.
"We continue to maneuver the developing landscape, meeting the needs of our partners across the joint force," said Nuce, commenting on the past year's successes. "I am incredibly proud of every member of the USAMMDA team and can't wait to see what we accomplish in 2024."
USAMMDA develops, delivers, and fields critical drugs, vaccines, biologics, devices, and medical support equipment to protect and preserve the lives of Warfighters across the globe. USAMMDA project managers guide the development of medical products for the U.S. Army Medical Department, other U.S. military services, the Joint Staff, DHA, and the U.S. Special Forces community. The process takes promising technology from DoD, industry, and academia to U.S. forces, from the testing required for FDA approval or licensing to fielding and sustainment of the finished product. For more information, visit usammda.health.mil or dvidshub.net/unit/USAMMDA.