The Food and Drug Administration, in Partnership with the Department of the Army, Accelerated Review and Approval of Life-saving Countermeasure Against Chemical Warfare AgentsFOR IMMEDIATE RELEASE
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THE FOOD AND DRUG ADMINISTRATION, IN PARTNERSHIP WITH THE DEPARTMENT OF THE ARMY, ACCELERATED REVIEW AND APPROVAL OF LIFE-SAVING COUNTERMEASURE AGAINST CHEMICAL WARFARE AGENTS
FREDERICK, MD, July 31, 2018 – The Food and Drug Administration (FDA) approved the Atropine Autoinjector, a life-saving countermeasure against chemical nerve agents, on July 9, 2018. Leading up to the FDA’s determination of full approval for this critical medical countermeasure, the FDA and Department of Defense (DoD) worked in close partnership pertaining to safety and efficacy requirements.
The resultant FDA approval decreases reliance on a sole source drug product and device manufacturer, and ensures that DoD, U.S. government stakeholders, and international partners can quickly and cost-effectively produce and procure the Atropine Autoinjector for the treatment of chemical nerve agent poisoning.
The U.S. Army’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), which is the advanced development component of the DoD’s Chemical and Biological Defense Program (CBDP), successfully delivered this medical countermeasure capability to enable Joint Force readiness and warfighter health protection, as well as to support domestic civilian preparedness and resilience. In accomplishing this milestone, the JPEO-CBRND worked closely with performers Ology Bioservices and international partner Rafa Laboratories Ltd. to develop and manufacture this critical nerve agent medical countermeasure.
Over the past 15 years, the threat of nerve agent attacks has increased for U.S. and allied troops, civilians, and first responders, and the DoD has been addressing this challenge of protecting troops and providing life-saving treatment from morbidity and mortality posed by these agents. Delivering effective nerve agent medical countermeasures is essential for ensuring that the Joint Force maintains mission effectiveness and its ability to deliver lethality in the face of combat. To confront challenges posed by a range of CBRN agents, the DoD’s CBDP enterprise develops a suite of products that together forms an integrated layered defense against wide ranging CBRN threats and their potential to inflict negative impacts to health and national security objectives. Integrated layered defense products include non-medical (e.g., boots, suits, masks, gloves, detection equipment, and information systems) and medical (e.g., preventative pre-treatments and post-exposure therapies) products that come together to form a system of CBRN protective and survivable defense capabilities. The new FDA-approved Atropine Autoinjector is the central medical capability component in the Department’s integrated layered defense against life- and mission-threatening nerve agents.
“By accelerating development and successfully receiving FDA approval of this autoinjector product, we are increasing readiness for U.S. Service Members and first responders against deadly nerve agent threats,” said Joint Project Manager for Medical Countermeasure Systems (JPM-MCS), Colonel David P. Hammer. “Our Chemical Defense Pharmaceuticals’ team is a perfect example of the Department of Defense’s ability to rapidly deliver medical countermeasures against chemical threats to the warfighter.”
The mission of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) is to protect the Joint Force from weapons of mass destruction through the development and delivery CBRN defensive capabilities. These capabilities include a range of products that form a robust integrated and layered defense, shielding the joint force from harm and obstacles posed by CBRN hazards. Integrated layered defense capabilities include physically protective measures that prevent or reduce negative impacts sustained by military personnel or equipment in contact with CBRN agents, medically-focused preventive measures (prophylaxis) and treatments that act at physiological levels, CBRN agent detection and information systems that communicate hazards to military decision makers. The Joint Project Manager for Medical Countermeasure Systems (JPM-MCS) is the component of the JPEO-CBRND with the responsibility and mission to develop safe, effective, and innovative medical solutions to counter traditional and emerging CBRN threats.
About Ology Bioservices
OLOGY DESCRIPTION 2
Ology Bioservices is a leading full-service Contract Development Manufacturing Organization (CDMO) manufacturing the highest quality biopharmaceutical products for government and commercial clients. It was founded in 1999 as an integrated biopharmaceutical company with a focus on development and manufacturing as well as having expertise in preclinical and clinical development, formulation optimization, and cGMP manufacturing of biopharmaceutical products and medical devices. In 2013, the Department of Defense (DoD) awarded the company and its team of partners and collaborators a contract to provide all of the core services necessary to establish a Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) facility dedicated to meeting the specific needs of the DoD. It specializes in process development, quality control testing, and cGMP manufacturing of bulk drug substances to development, scale-up, and production using proprietary platform technologies. 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 has 20 years of experience developing and manufacturing drugs and biologics for the U.S. Government, with over $500M in government contracts. The Ology Bioservices team has decades of experience manufacturing, developing and licensing vaccines and protein/antibody therapeutics.