In September 2022, U.S. Army Medical Materiel Development Activity (USAMMDA) leadership learned of the successful treatment of severe malaria in a U.S. service member* deployed in Djibouti, Africa. The medication used, Malaria Treatment Drug Intravenous Artesunate (MTD-IVAS) was the result of years of test and evaluation funded and managed by USAMMDA’s Warfighter Protection and Acute Care (WPAC) Project Management Office team at Fort Detrick, Maryland.
Their work culminated in receiving FDA approval for MTD-IVAS for treatment of severe and complicated malaria, which can take an otherwise healthy person to the brink of death in a period as short as 24 hours. MTD-IVAS was prepositioned in remote and malaria prone locations as part of the fielding strategy soon after FDA approval. This prepositioning allowed medical providers at Camp Lemonnier Expeditionary Medical Facility to have immediate access to the only FDA-approved drug to treat severe malaria in their pharmacy and stabilize the patient until medevac arrived.
This success, demonstrating the combined efforts of Soldier-Scientists, military logisticians, Army civilians and a host of other military health care professionals, is just the latest example of the hard-earned, real-world application of medical and health care treatments, drugs, blood products and health screenings developed by the WPAC team. It illustrates how Department of Defense investments in military-relevant medical development provides critically needed, life-saving solutions for service members around the globe.
“Our success in developing and delivering critical medical capabilities directly impacts the lives of the Warfighter,” said Kendra Lawrence, Ph.D., the WPAC program manager with USAMMDA. “In this instance, our ability to pre-position product at locations outside the United States ensured that this service member got the treatment needed, on time. It highlights the critical role that our Project Management Office plays in delivering medical solutions to the DoD.”
The WPAC team is composed of approximately three dozen Soldiers, Army civilians and contractors. The core mission: to develop and deliver FDA-approved treatment and prevention products that will save and preserve lives. This type of focus results in a culture of teamwork rather than competition, allowing WPAC to collaborate with a broad group of experts within the DoD, other government agencies, academia and industry to ensure advanced care of ill and injured Warfighters.
“I am very proud to lead a diverse team of personnel,” said Lawrence, herself a former Soldier and Iraq War veteran. “Everyone brings valuable experience and skills to the table to allow us to successfully accomplish our mission.”
MWD and human blood products
The WPAC team continues to modernize, develop, and field more than a dozen medical solutions for the joint military forces. One important capability in development is not for the Soldiers, Sailors, Marines and Airmen who make up America’s deployed forces, but rather for the four-legged service members that often accompany troops on the front lines: Military Working Dogs.
WPAC has been working with both DoD and non-DoD medical technology developers to increase treatment options for MWDs wounded during training and operations. Canines have accompanied men and women into battle for centuries to guard and protect. Modern MWDs are trained to protect Warfighters, detect explosive devices, and alert handlers to the presence of enemy combatants. When MWDs are bleeding, veterinarians and handlers have limited treatment options. To increase survival of MWDs, WPAC is developing freeze-dried canine blood plasma and other canine blood products that can be deployed alongside the MWD, increasing the likelihood that traumatic bleeding does not result in death.
“[Military Working Dogs are] carefully selected, carefully trained, highly capable Warfighters,” said Cliff Snyder, Ph.D., WPAC’s Product Manager for the Canine Blood Products program. “Without access to this type of product, some dogs will die that would otherwise survive. Since military dogs work alongside people as members of a team, the loss of a dog means the loss of the function that the team provides. Whether the function is detection of explosives, security, or something else, that function is gone until the canine team member is returned to duty or replaced.
“The canine blood products family of systems is our approach to providing our canine Warfighters with the standard of care that we seek to provide for people – the best care that can be delivered under the circumstances,” said Snyder.
The canine blood products program is a family of systems, including freeze-dried plasma, freeze dried platelets and an oxygen carrier that complements WPAC’s ongoing efforts to modernize human blood products, including cryopreserved platelets, cold-stored platelets, and freeze-dried plasma.
Blood products are an essential life-saving capability during conflicts. In austere locations, sources of fresh blood products are limited by thin logistical lines and the potential inability to deliver blood when and where it is needed. The ability to rapidly screen blood donors for pathogens and blood type before collecting blood for transfusion may provide forward-deployed units with assurance that emergency blood collection and transfusion are safe, and that an immediate blood supply – their fellow service members – is available.
Broad-Spectrum Snakebite Antidote
There are roughly 600 venomous snake species in the world, with about one-third able to fatally envenomate humans, according to National Geographic. Many of those species that pose a threat are in the Indo-Pacific region, where U.S. Joint Forces continue to focus efforts on countering near-peer competitor advancements. During 2022, the capability to treat snake bite envenoming made a giant leap forward with the FDA’s ‘Fast-Track’ designation of Varespladib, a Broad-Spectrum Snakebite Antidote (BSSA), funded by the Defense Health Program and developed in collaboration with a non-Department of Defense partner, according to Lindsey Garver, Ph.D., deputy project manager for WPAC and. the 2022 Integrated Product Team Chair of the Year for the Medical Research and Development Command.
“The BSSA program seeks to develop a shelf-stable treatment for snakebite envenoming that is safe, easy to use by individuals in far-forward austere environments, and is independent of snake species,” said Garver. “[Antivenom] is typically species-specific – which means you need to know which snake bit you to be treated with the proper antivenom. This also means the military must stock and know how to use multiple types of different antivenom to treat bites from different species. There are some species for which no antivenom even exists, meaning the only treatment is supportive care. This program seeks to provide a solution to all these issues.”
As U.S. Joint Forces continue to develop expeditionary capabilities for the littoral regions of the Indo-Pacific, where logistics trains must extend across hundreds or thousands of miles, a ready solution to treat service members for snakebite envenomation will place an added tool in medic and corpsmen’s aid bags while higher echelon care is arranged, Garver believes.
“This product is really designed to counter the far-forward threat of snakebites,” said Garver. “There is an inverse relationship as one moves into more austere conditions, where the threat of snakebites goes up, and access to higher echelons of care goes down. A successful BSSA product extends easy, effective treatment into those austere conditions, supporting the independent maneuver of small teams and widening the window of time needed for evacuation in the event of a bite.”
While clinical trials are ongoing in the U.S. and India, pre-clinical studies and the mechanism of action of the BSSA drug suggests it can be used worldwide to treat envenoming.
Adenovirus Type 4 and 7 Vaccine
The adenovirus vaccine is the only FDA-approved vaccine to prevent febrile acute respiratory disease (ARD) caused by adenovirus. It is used exclusively by the military to prevent adenovirus-related acute respiratory disease in U.S. service member trainees living in barracks-type environments during basic training. The vaccine is administered to all military and Coast Guard basic trainees and other selected military accessions. Prior to the use of adenovirus vaccines, adenovirus types 4 and 7 accounted for 60 percent of all acute respiratory disease in military recruits who were hospitalized.
In 2022, WPAC PMO established a contract with the manufacturer of the adenovirus vaccine to modernize their manufacturing capability and improve the supply chain. This effort reduces the risk of disruptions from a sole supplier and ensures the product is readily available at Initial Entry Training (IET) sites to maintain operational readiness. The optimization effort improves and modernizes current manufacturing operations and processes necessary to sustain the viability of the adenovirus vaccine production lines. The effort will ensure continuous, reliable, efficient, and effective future supply of the adenovirus vaccine for U.S. military use.
In 2023, the WPAC team is focused on establishing and strengthening relationships with DoD and non-DoD stakeholders and partners to continue developing top-tier preventions, diagnostics, treatments and blood products to enhance Joint Force readiness and enable Warfighters to be ready for the challenges of today and tomorrow. The challenges to the Joint Force medical capabilities will continue to grow, and the WPAC team is primed to address those challenges, according to Lawrence.
“The WPAC PMO is bringing new medical capabilities and solutions into the portfolio in 2023 to meet the challenges of the future and we will continue to mature the technologies that are currently in our portfolio, with an eye for delivery in 2024 and 2025,” said Lawrence.
* The identity of the U.S. service member is not disclosed due to privacy rights afforded by the Health Insurance Portability and Accountability Act.