Feb 12 2010
Biologics, Inc., the leading cancer management company in the
United States, announces that its Oncology Clinical Trial Services
division has been selected by the National Marrow Donor Program®
(NMDP), a nonprofit organization that facilitates unrelated
hematopoietic cell transplants.
Biologics’ Oncology Clinical Trial Services division is providing
pharmacy management services for an NMDP Phase III trial that is
determining the safety and efficacy of filgrastim (Neupogen®)-stimulated
peripheral blood stem cells (PBSC) in hematopoietic cell transplants
involving unrelated donors. The trial is also investigating the effects
of the donation process on the unrelated stem cell donors.
According to the NMDP, PBSC is now used more often than marrow for adult
patients in need of allogeneic and autologous transplants. PBSC donors
receive injections of the drug Neupogen for five days prior to the
donation to stimulate the growth of more blood-forming cells and their
release from the donor’s marrow and into the bloodstream. The blood
cells can then be collected on an outpatient basis, through less
invasive methods than those used in marrow collection.
Biologics is responsible for inventory management and coordination of
the on-time delivery of approximately 200 shipments a month of Neupogen.
More than 50 NMDP donor sites throughout the United States are
participating in the trial, which is conducted under an FDA
investigational new drug protocol. While Biologics’ involvement is
recent, the trial started in 1997. Fifteen-thousand donors are expected
to participate by 2012.
As is the case for many clinical trial protocols, timing is a critical
component for this study. Biologics’ Oncology Clinical Trial Services
division must adhere to the protocol’s time constraints in order to
successfully support the complex transplant schedule. In addition, the
drug must be shipped overnight in temperature-controlled packaging to
ensure the stability of the drug.
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