PANDEMIC RESPONSE
How interesting then, that for all the capital, human and other- wise, invested in remdesivir, the story behind its acquisition reveals not only the importance of USAMRDC’s various scien- tific and legal processes, but also highlights the relationship between all the many functioning organizations surrounding— and connected to—USAMRDC.
COLLABORATIVE PARTNERS “Working together in this space is imperative,” said Mark Hick- man, a senior scientist with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). “No one organization can possibly tackle the complexities of this mission alone.”
As a frequent collaborator with USAMRDC, JPEO CBRND’s Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) is the perfect place to start when telling the story of remdesivir. Located at Fort Detrick, Maryland, JPM CBRN Medical staff enjoys a close rela- tionship with many of USAMRDC’S internal organizations, notably USAMRDC’s U.S. Army Institute for Infectious Diseases (USAMRIID) and Walter Reed Army Institute of Research. Tasked with facilitating the advanced development and acquisi- tion of medical countermeasures, the overall mission of the JPM CBRN Medical team is to provide the U.S. military with safe and innovative medical solutions to counter chemical, biological, radiological and nuclear threats. It is by leveraging the organi- zation’s many relationships across private industry that brought remdesivir to the table in the first place.
According to Hickman, initial research on remdesivir began back in 2009, as it was initially developed and tested to help fight Ebola virus disease—a purpose for which, notably, it was deemed reasonably effective, according to JPM CBRN Medical leadership. Regardless, given the drug’s efficacious track record against other types of coronaviruses over the years, its application to COVID- 19 was, in the words of leadership, an obvious avenue to pursue.
Hickman added that, during in vitro studies on coronaviruses isolated from bats and human lung cells, remdesivir displayed “significant” activity. Additionally, during in vivo rodent studies
“From cooperative agreement to first patient treatment was 21 days. That’s very fast. It’s definitely a record.”
EMERGENCY USE
Remdesivir, pulled from its shipment package, bears the notice of the emergency use authorization printed in bold type halfway down the label. (Photo courtesy of Lt. Col. Sandi K. Parriott)
of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, the virus that causes COVID-19), the early therapeutic admin- istration of remdesivir significantly reduced lung viral load, improved clinical signs and enhanced respiratory function.
Once those facts were available, it was just a matter of picking up the phone. For JPM CBRN Medical, it was only natural to call USAMMDA.
“Tey happened to mention to us that [remdesivir] had some value with coronaviruses,” said Parriott, noting Force Health Protec- tion’s “consistently productive” collaborative efforts with the team at JPM CBRN Medical, led by Lt. Col. Chuck DiTusa and Rachel Overman. “Tis effort with remdesivir has highlighted how well DOD organizations can work together.”
As a result, the two groups launched an effort with Gilead to create an expanded access program to provide infected Soldiers access to remdesivir (an effort aligned with Force Health Protection’s oper- ational mission to provide investigational drugs for emergency use to the warfighter in response to a high-consequence threat). Tat effort—allowed under a dedicated expanded access protocol that's been in place since March—specifically permits the investiga- tional use of remdesivir for active-duty personnel diagnosed with moderate-to-severe novel coronavirus infection (with all doses provided by Gilead at no cost to the government). Additionally,
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