Existing Partnerships Accelerate Diagnostic and Treatment Development


Before the global pandemic, the term first responder only referred to law enforcement and emergency medical personnel. COVID-19 may have changed that.
Working with the leaders at the Joint Services, the Defense Health Agency, the Office of the U.S. Army Surgeon General, the Walter Reed Army Institute of Research, and, the U.S. Army Medical Materiel Development Activity (USAMMDA), the Department of Defense’s product development, systems management and acquisition organization, rapidly equipped units with critical care equipment and solutions to mitigate the loss of life and ensure readiness.

After Congress passed the Coronavirus Aid, Relief and Economic Security (CARES) Act, the funding provided allowed USAMMDA to pursue diagnostic and treatment options in the fight against COVID-19. The development of new diagnostics and treatments for infectious diseases falls under the purview of the Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO), and the office quickly engaged with its industry partners to begin the development process. In particular, for the military services to continue their mission, there was an immediate need for diagnostics to detect COVID-19 and treatments for the virus and the side effects it caused.

Established partnerships were beneficial. “We worked closely with U.S. Army Medical Research Acquisition Activity (USAMRAA) which allowed us to get new contracts awarded quickly due to the emergency situation and having pre-existing relationships with the companies made getting the contracts finalized a lot easier, said Dr. Kendra Lawrence, project manager for WPAC PMO."

“As soon as we learned that DHA CARES Act funding was available, we had briefings with the DHA,” said Dr. Lawrence. “We had three programs in our portfolio that we believed we could leverage to support COVID-19 response. We reached out to those partners and asked, what we could do to get on contract quickly, what we could do to get moving quickly and what we could accomplish with the DHA CARES Act funding?”

One of the first technologies, developed by InBios International, Inc., leveraged its lateral flow technology for the development of a SARS-COV-2 Antigen (Ag) Detect and Serology (Ab) Detect rapid test. InBios received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for its SARS-COV-2 Ag Detect test within 10 months. By August 2021, a second EUA authorized human serum, plasma, venous whole blood or finger-stick and provided results in about 20 minutes. Later, during November of 2021, the home test was available and expanded access to include individuals 14 years or older.

Another technology solution from a partner under contract with USAMMDA included BioFire Defense’s FilmArray©, a PCR test which evolved through the pandemic, receiving multiple EUAs as its capabilities and sample types were expanded.

WPAC PMO also worked with Ophirex, Inc., on treatment for one of the leading causes of COVID-related deaths, Acute Respiratory Distress Syndrome (ARDS). Ophirex is developing a broad-spectrum snakebite antidote to treat snakebite envenoming, caused by the same molecule thought to trigger ARDS, so the WPAC team and Ophirex decided to repurpose the drug to treat the condition in COVID-19 patients. A clinical study began on June 30, 2021, to test Varespladib’s viability as a treatment for COVID-19-related ARDS. The study is ongoing and currently in its second phase, with a planned completion date of December 2022.

As an integral part of the U.S. Army Medical Research and Development Command (MRDC) and Army Futures Command, by January 2022, USAMMDA’s Force Health Protection Directorate had treated more than 22,000 treatment courses with the investigational COVID-19 treatments Remdesivir, convalescent plasma and monoclonal antibodies, and COVID-19 therapeutics worldwide. Additionally, ongoing efforts to field and replace critical patient care equipment and materiel remain a priority.

“While we worked on efforts to respond to COVID-19, we also had to ensure all of our other Department of Defense and Army priorities were moving forward [despite COVID-19]. We had to find solutions,” said Lawrence. “Everyone pulled together and looked for ways to leverage technologies as potential applications against COVID-19.”

Team USAMMDA might not look like other first responders, but consider this: In addition to services authorized and employed due to the DHA CARES funding, USAMMDA’s Warfighter Deployed Medical Systems PMO also supplied Warfighters with portable oxygen generators, T1 Hamilton ventilators, infusion pumps, ultra-sonic cleaners, blood fluid warmers, Next-Generation Diagnostic Systems with COVID-19 test kits, and D-cylinder oxygen tanks. When it comes to COVID-19, USAMMDA developed and delivered!

Written By:
Denver Beaulieu-Hains and Scotty Hogan

For more information on USAMMDA and WPAC’s impact on pandemic response, go to: https://mrdc.amedd.army.mil/assets/docs/WPAC_Newsletter_Volume_II_20220412.pdf