Μάκης Παπαταξιάρχης, 2nd Health Innovation Conference
Pharm-Brochure
1. U.S. Army Medical Research and Materiel Command
Protect the Warrior, Sustain the Force
USAMMDA
1430 Veterans Drive, Fort Detrick, MD 21702
301.619.7056
usammda.pao@amedd.army.mil
Visit our website:
Updated: March 18, 2013
Or contact us at:
Pharmaceutical Systems
Project Management Office
301.619.2051
USAMMDAUS Army Medical Materiel Development Activity
Pharmaceutical Systems
Project Management Office
(PSPMO)
Developing Quality Medical Products
for U.S. Forces
Committed to Aid our Service Members
The Pharmaceutical Systems Project
Management Office (PSPMO) centrally
manages the development and acquisition of
pharmaceutical and biological products (drugs,
vaccines, diagnostics, protective and therapeutic
modalities) for use against infectious diseases
and similar products for combat casualty care.
Current PSPMO efforts focus on the
development of drugs for the prevention and
treatment of the parasitic diseases malaria and
leishmaniasis, the development of vaccines to
prevent viral infections (particularly Dengue and
Adenovirus), diagnostics for infectious diseases
and transfusion transmitted diseases, and blood
replacement products such as freeze-dried
human plasma and cryo-preserved platelets.
U.S. Military Forces must be prepared to serve
anywhere in the world against any threat.
This could result not only in conventional
injuries sustained during combat operations,
but also from exposure to endemic diseases
not commonly found in the United States. The
development of products against these threats
will help save lives, sustain the fighting Force
and enhance return to duty.
The mission of the PSPMO is to manage
DoD resources applied to the advanced
development of pharmaceutical products
(drugs, vaccines, biologicals, diagnostics, and
hemorrhage control and resuscitation products)
for use by the U.S. Military to prevent,
diagnose, or treat infectious diseases and
combat casualties.
The Pharmaceutical Systems
Project Management Office
Mission
USAMMDA is the premier developer of
world class military medical solutions.
Develop and deliver quality medical
solutions to protect, treat, and sustain the
health of Our Service Members.
USAMMDA Mission
USAMMDA Vision
For more information about
PSPMO:
www.usammda.army.mil/
pharmaceutical.html
2. Leishmania
Soliders who contract cutaneous leishmaniasis are
currently evacuated out of theater for treatment.
The present standard of care requires 10-20
daily intravenous injections of Pentostam, an
investigational drug (IND) based on the metal
antimony which is associated with serious side-
effects and toxicity that include vomiting, diarrhea,
pancreatitis, elevated liver enzymes and, at
higher doses, pulmonary edema. As an IND, it
is U.S. FDA approved for use only under an IND
exemption protocol and must be administered
under strict medical surveillance.
Malaria
Currently, there are no vaccines to
prevent malaria. Preventive
medicine measures, such as
vector control, repellents, malaria
chemoprophylaxis, and the use of
permethrin-treated uniforms and bed nets, reduce
the risk of malaria infection.
Dengue
Dengue is the most significant
arthropod-borne viral disease of
man and the most geographically
widespread. The distribution of
dengue virus has increased 30
fold in the past 50 years. The illness caused by
dengue virus is characterized by sudden onset
of fever, severe headache, pain behind the eyes,
generalized joint and muscle aches, lack of
appetite, gastrointestinal disturbances, and rash.
In U.S. troops, it is estimated that each case of
dengue will lead to 14 lost duty days at a cost of
$7,500/case.
Adenovirus Vaccine, Types 4 and 7
The Adenovirus vaccine is used exclusively by
the military to prevent Adenovirus-related acute
respiratory disease (ARD) in soldiers and other
military trainees living in barrack-type environments
during basic training. The vaccine consists of
two orally administered, enteric-coated tablets
containing live adenovirus serotypes 4 and 7.
Prior to the use of adenovirus vaccines, adenovirus
types 4 and 7 accounted for approimately 15,000
cases of ARD each year. Adenoviruses are
associated with pharyngitis, conjunctivitis, atypical
pneumonia, and rhinitis. The development effort for
the Adenovirus Vaccine was conducted primarily
under a contract to Barr Laboratories, Inc. (now
a subsidiary of Teva Pharmaceuticals USA); Barr
is performing post-licensure studies required by
the FDA. Based on the clinical data obtained in
an extensive Phase 3 trial conducted by military
physicians at Fort Jackson, SC, and Great Lakes
Naval Station in Evanston, IL, Barr submitted a
new Biologics License Application (BLA) with the
U.S. FDA. The vaccine was licensed in March
2011.
Cryopreserved Platelets
(CPP)
CPP are human platelets
frozen at -80C in 6%
dimethylsulfoxide (DMSO),
a cellular protectant
during freezing. Due to
the short shelf-life of LSP,
approximately 70% of LSP produced in theatre are
outdated and discarded as waste. CPP will have
a significantly longer shelf-life, thus eliminating
waste and reducing the logistical burden of
supplying platelets to the battlefield.
Other Infectious Disease ProductsAnti Parasitic Products
Combat Casualty Care &
Blood Products
Freeze-Dried Plasma (FDP)
FDP will reduce waste of plasma by eliminating
breakage and outdating after thawing and reduce
the logistical burden associated with storage
requirements for Fresh Frozen Plasma.
Rapid Transfusion
Transmitted Disease
Detection (RT2D2)
The RT2D2 device will
be an FDA-approved
rapid diagnostic test
intended for use as a
blood donor screening assay for transfusion
transmitted diseases in urgent situations where
traditional licensed blood donor screening tests
are unavailable or impractical.
Five minutes for reconstitution