Pharmaceutical Systems
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DESCRIPTION

The Warfighter Protection and Acute Care Project Management Office (WPAC PMO) develops and delivers US FDA-approved infectious disease drugs, vaccines, and diagnostics; blood products and components; and drugs for battlefield pain management to protect and sustain the Warfighter. The portfolio includes:

Malaria Prevention Drug (ACAT III)
Tafenoquine (TQ) is the only FDA-approved antimalarial drug that is effective against all stages of all human malaria parasites. It requires less frequent (only weekly) dosing, which will increase compliance and will enhance survivability and sustainability of U.S. Forces.

Intravenous Artesunate (IVAS) (ACAT IV)
This will be an FDA-approved intravenous drug to treat warfighters severe/complicated malaria and will reduce the mortality of Service Members deployed to malaria-endemic areas by 35%. IVAS is safer and more effective than the current therapy, which has now been discontinued, and will replace this drug upon FDA approval. . The IVAS is currently used under a special FDA protocol and it has been used around the world to save hundreds of lives since 2007.

Blood Products (ACAT III)
The blood product portfolio includes Freeze Dried Plasma, Cryopreserved Platelets, Whole Blood Pathogen Reduction, and Cold Stored Platelets. These products will be used to improve hemorrhage treatment control farther forward on the battlefield in patients that are actively bleeding and require massive transfusions. The products in this portfolio will increase survivability and reduce the number of preventable deaths caused by bleeding, estimated to be approximately 24 percent of combat deaths before an injured warfighter reached a Medical Treatment Facility. These life-saving products will also significantly reduce the logistical burden and reduce wastage, compared to current blood products.

Battlefield Pain Management (ACAT III)
The products in this portfolio are designed to treat acute pain close to the point of injury, with minimal side effects. They will be administered by trained medics far forward on the battlefield, during tactical field care and tactical evacuation care.

Adenovirus Vaccine (ACAT III)
This is an FDA-licensed vaccine for the prevention of febrile acute respiratory disease (ARD) caused by Adenovirus Type 4 and Type 7. This vaccine is 99% effective and is administered to military basic trainees. Before this vaccine, Ad4 and Ad7 caused 15,000 ARD cases per year with a loss of 50,000 training days and occasional deaths.

Dengue Tetravalent Vaccine (ACAT III)
This will be a FDA-licensed vaccine to protect warfighters against disease caused by any one of the 4 serotypes of dengue virus, the most rapidly spreading mosquito-borne viral disease in the world. Nearly 28,000 Service Members and DoD civilians are living and/or deployed in dengue-endemic areas. Dengue causes a debilitating illness that results in approximately 14 lost duty days per event and can reduce Soldier performance for months or even result in death.

HIV Vaccines (ACAT III)
This will be an FDA-licensed vaccine to prevent HIV infection in U.S. and allied forces. This vaccine will help to sustain troop readiness (approximately 350 new service members infected per year) and mitigate the financial impact of lifelong treatment (approximately $500 million per year). The vaccine will be globally effective, protecting against multiple subtypes representing over 97 percent of Department of Defense HIV infections.

Human Diagnostic Devices (ACAT IV)
The device products in this portfolio are aimed at testing and diagnosing a variety of military-relevant infectious disease agents as far forward as possible on the battlefield. Early detection and diagnosis of these diseases in Service Members will better inform treatment and evacuation decisions, preserving and improving the health of warfighters and reducing mission degradation.

BENEFIT TO THE SOLDIER

This broad portfolio of blood products, drugs, vaccines, and diagnostics improve the health, deployability, survivability, and lethality of warfighters by countering infectious diseases and enhancing battlefield trauma care.

SPECIFICATIONS

  • FDA approval
  • Each drug, vaccine or blood product has individual technical and logistics specs

PROGRAM STATUS

FY16-FY18: Products are in varying stages of completion. Some have received FDA approval for limited, emergency or humanitarian use, pending full approval.

PROJECTED ACTIVITIES

FY19-FY23: Anticipated products projected to be licensed/fielded beginning in FY19 include Freeze-Dried Plasma, Antimalarial Treatment Drug Intravenous Artesunate, and a Dengue Tetravalent Vaccine.

Contractors and Partners

  • 60° Pharmaceuticals (Washington, DC)
  • AcelRx Pharmaceuticals (Redwood City, CA)
  • Amivas (Silver Spring, MD)
  • Amplyx (San Diego, CA)
  • Barr Labs (Forest, VA)
  • Eurofins Advantar (San Diego, CA)
  • Fast-Track Drugs and Biologics, LLC (North Potomac, MD)
  • InBios International, Inc. (Seattle, WA)
  • Janssen (Belgium)
  • Ophirex Inc (Corta Madera, CA)
  • PPD (Wilmington, NC)
  • State University of New York (Albany, NY)
  • Takeda Pharmaceuticals (Deerfield, IL)
  • Terumo BCT (Lakewood, CO)
  • University of Maryland (Baltimore, MD)
  • Vascular Solutions Inc./Teleflex (Minneapolis, MN)
  • Westa (Rockville, MD)