Fort Detrick, MD –
Strong partnerships are an invaluable element to success in the Chemical, Biological, Radiological, and Nuclear (CBNR) defense space. Requiring a solid foundation, fruitful partnerships are built on open communication and transparency and are often forged through events which bring together like-minded professionals ready to push the boundaries of innovation to quickly find solutions to present challenges. This past June, the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), hosted such an event, specifically focused on Chemical Biological Incident Preparedness and Response (CBIPR). Held at the Community Activities Center at Fort Detrick, Maryland, the CBIPR Industry Day served as a vital opportunity for industry and U.S. government (USG) representatives to discuss the current shortage of Large Animal Research Models (LARM) in the Department of Defense (DOD) research space and explore possible ways of working together to amend negative impacts the current supply chain crisis is having on science and technology (S&T) and advanced development (AD) efforts.
“LARMs have always played a central role in the development of medical countermeasures (MCMs) as crucial models for studying diseases, testing vaccines, and developing therapeutics,” said Mr. Camilo Morales, Acting Director of Medical Research, Development, and Acquisition from the Office of the Deputy Assistant Secretary of Defense for Chemical and Biological Defense, during his opening remarks. “While there are ongoing efforts to reduce or eliminate the use of animal models where possible, LARMs will continue to be critical in safety and efficacy testing in the chemical/biological defense space.”
Efforts to replace, reduce, and refine the use of animals in drug and vaccine development are highly supported, and the federal government and scientific community continue to work together to develop and validate non-animal test models, when scientifically feasible. However, new drug and vaccine testing technologies to help realize this vision at a broad scale are still many years in the future. Currently, the uncertainty of a consistent supply of LARMs on a yearly basis can drastically impact numerous pre-clinical drug testing efforts – which poses a serious threat. The COVID-19 pandemic not only underscored the importance of vaccine research and development, but it also exposed vulnerabilities and gaps in our supply chain, hindering progress, and our Nation’s ability to conduct critical biomedical research.
“We’re here for national defense,” said COL Matthew Clark, Joint Project Manager for the JPM CBRN Medical during his opening remarks. “Everything that we do matters; making sure that our country, our ideals, and our way of life is sustained and supported as we drive forward. You are all here to be a partner for the globe; to network and brainstorm novel ways to meet our shared needs to deliver capabilities rapidly, and to support one another so that we can be the most effective organization for our Nation and for the world.”
Above, COL Matthew Clark, Joint Project Manager for the JPM CBRN Medical provides opening remarks during the event.
The U.S. military has been a leading proponent of vaccine development since its founding, and DOD collaborations have historically led to the successful development of multiple vaccines to benefit both military and public health. Through new program initiatives, the JPM CBRN Medical is working to address the current crisis for S&T and AD efforts through strategic sourcing, ensuring the continued development of treatments for the thousands of unmitigated diseases affecting our warfighters.
“The forward-looking efforts led by our JPM CBRN Medical team are important to our mission at the JPEO-CBRND and across the Chemical Biological Defense Program, including our S&T counterparts in the Defense Threat Reduction Agency’s Joint Science and Technology Office, said Ms. Nicole Kilgore, Deputy Joint Program Executive Officer, JPEO-CBRND. “Today’s industry day, and the outcomes from today’s conversations, aim to ensure we are proactively understanding program needs and working with our vendors to plan for those requirements.”
The mission of the JPM CBRN Medical is to deliver safe, effective, and affordable medical solutions to counter CBRN threats to the Joint Force, and much of the development within the organization is made possible through the U.S. Food and Drug Administration (FDA) Animal Rule. In the unique case of MCM development for potential bioterror threats where human challenge studies (i.e., exposing people to the threat agent) are not ethical or feasible, the FDA can allow product development, and ultimately grant product approval, based on humane and well-controlled animal studies. The use of LARMs in biomedical research is driven by the imperative need to reduce human suffering and improve the quality of human life. To continue critical research efforts within the organization, there is a pressing need to stabilize the LARM supply chain to help ease schedule and cost pressures, and the JPM CBRN Medical seeks to do just that.
Throughout the day, presentations were given by five industry vendors, focusing on each company’s approaches to stabilize the LARM supply chain and ways that they could partner with the DOD. The event proved a success, with over 60 USG and industry partner personnel in attendance.
“Partnerships are key to solving the supply chain bottlenecks that affect the development of MCMs to meet current and emerging threats,” said JPM CBRN Medical Chief Technology Officer Dr. Angela Nunley. “It is critical that we work together to mitigate this pressing issue facing biomedical research in the United States, ensuring the continued development of treatment for the thousands of unmitigated diseases affecting not just our warfighters, but public health.”
For those interested in seeking further information, please reach out to the JPM CBRN Medical Communications team:
usarmy.detrick.dod-jpeo-cbrnd.list.communications@army.mil.