Resilience, Vanderbilt University Medical Center to Develop, Manufacture Monoclonal Antibody for Treatment, Prevention of Infection With COVID-19 Virus for Department of Defense
ALACHUA, Fla.–(BUSINESS WIRE)–The Department of Defense (DOD) awarded a contract valued at $14 million with Resilience Inc., a biologics contract development and manufacturing organization (CDMO), to develop and manufacture a monoclonal antibody for treatment and prevention of infection with the COVID-19 virus.
This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs with funding from the Defense Health Agency.
Under this program, Resilience will work with Vanderbilt University Medical Center (VUMC) in Nashville, Tennessee to develop and manufacture the monoclonal antibody. The aim of the program is to rapidly and efficiently deliver the antibody to the Department of Defense.
Peter Khoury, PhD, MBA President and CEO, Resilience
Peter H. Khoury, Ph.D., President and Chief Executive Officer of Resilience, noted, “We are tremendously honored to be working with the Department of Defense and Vanderbilt University Medical Center to rapidly respond to this crisis. The Advanced Development and Manufacturing Facility operated by Resilience stands ready to meet the needs of the U.S. warfighter and the nation at large.”
“The global health crisis we’re seeing unfold right now with the coronavirus disease 2019 is exactly the kind of scenario the medical countermeasures Advanced Development and Manufacturing Facility was built for,” said Douglas Bryce, Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear (CBRN) Defense. “It gives DOD and interagency partners like Health and Human Services, along with our partners in industry and academia, the ability to respond quickly and develop the treatments our warfighters need to fight COVID-19 so they can continue protecting the nation.”
Matthew Hepburn, M.D., Joint Project Lead CBRN Defense Enabling Biotechnologies, added, “This contract represents the realization of the prior investment in the DOD Advanced Development and Manufacturing Facility, in order to respond to biological threats and pandemics. The Resilience team will now endeavor to make a product to keep DOD personnel safe.”
Under the proposed terms of a pending agreement with VUMC, researchers in the Vanderbilt Vaccine Center (VVC) will be tasked in this program with rapid antibody discovery efforts as a performance site for the Pandemic Prevention Platform (P3) network of the U.S. Defense Advanced Research Projects Agency (DARPA).
“Our team has been pushing 24/7 to isolate human monoclonal antibodies for SARS-CoV-2, and we are gratified to have the partnership of Resilience and the support of the U.S. DOD to prepare clinical grade antibody materials for rapid testing in clinical trials,” said James Crowe, M.D., director of the Vanderbilt Vaccine Center.
“This collaborative effort with the U.S. DOD Enabling Biotechnologies Office is a natural extension of our current effort to rapidly discover and deploy protective monoclonal antibodies for SARS-CoV-2 through the DARPA Pandemic Prevention Program (P3),” added VVC Associate Director Robert H. Carnahan, Ph.D. “Partnering with Resilience will allow these antibodies to quickly move towards human clinical trials in the coming months.”
[The information contained in this press release does not necessarily reflect the position or the policy of the U.S. government and no official endorsement should be inferred.]
About Resilience, Inc.
Resilience is a privately held, full-service Contract Development Manufacturing Organization (CDMO) serving both government and commercial clients, specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in its state-of-the-art, Department of Defense Advanced Development and Manufacturing Facility in Florida. The company’s infrastructure provides unique services to its clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as CGMP manufacturing up to Biosafety Level 3 (BSL3). Resilience has 20 years of experience developing and manufacturing drugs and biologics for the U.S. Government, with over $500M in government contracts awarded. The team at Resilience has decades of experience manufacturing, developing and licensing vaccines and protein/antibody therapeutics. For more information, visit the company’s website at www.ologybio.com.
About the JPEO-CBRND
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological and nuclear defense equipment and medical countermeasures. As an effective acquisition program, we put capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment; championed by innovative and state-of-the-art solutions. JPEO Enabling Biotechnologies (EB) is an organization established for the purpose of providing medical solutions, during a crisis, against future threats.
About Vanderbilt University Medical Center
Vanderbilt University Medical Center (VUMC) is one of the largest academic medical centers in the Southeast. The biomedical research program at the Vanderbilt University School of Medicine is among the nation’s top 10 in terms of National Institutes of Health peer review funding. As part of VUMC’s research enterprise, the VVC is participating in DARPA’s Pandemic Protection Platform (P3) program, a five-year cooperative agreement to develop protective antibody treatments that can be rushed to health care providers within 60 days after the outbreak of viral diseases anywhere in the world.