NMDP Phase III filgrastim trial: Biologics to provide pharmacy management services

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.