Massive Breast Cancer Study Aims for More Informed Treatment Decisons

Posted by: Stephen DeSantis

  A story in the Chicago Tribune today reports on a new National Cancer Institute (NCI) study planning to enroll over 10,000 women with breast cancer, in order to better understand when the use of chemotherapy is warranted in preventing their tumors from returning after surgery. The study, called TAILORx (Trial Assigning IndividuaLized Options for Treatment Rx) is design to determine whether an individual gene, thought to be associated with the risk of relapse for women with early-stage breast cancer, can be used to aid doctors in choosing treatments with the greatest likelihood of success. The study is sponsored by the National Cancer Institute (NCI), and coordinated by the Eastern Cooperative Oncology Group (ECOG)...

SFBC Exits Florida

Posted by Steve Zisson

It should comes as no surprise that SFBC is getting out of Florida after its Miami phase I unit performed so poorly last quarter.  Current SFBC officials—the former heads of PharmaNet—needed to stop the bleeding before the whole company was in jeopardy. Its later phase business is still holding its own.

SFBC International decided May 17 to end its early phase business in Florida after county officials wouldn't extend a review of some planned renovations to its troubled Miami phase I unit. The phase I unit has been the subject of numerous stories detailing serious issues with structural safety and questionable recruitment of undocumented workers as trial participants.

Rising Stars in the Central Labs Market

Posted by: Stephen DeSantis

Last month, the first part in our two-part series on the central laboratory market discussed its role in the global pharmaceutical outsourcing industry and reviewed the industry's current market share distribution and revenue forecasts. Estimates now show that the clinical trial central laboratory market is growing at a double digit pace; roughly 13% a year for the next four years.

Our article also explored some of the key challenges central labs face operating in a playing field constrained by tight margins, rising sponsor pricing pressures, and a logistically complicated global market. Larger labs with high volume capabilities can leverage these abilities in order to streamline their operations and reduce costs. And central laboratory players must tackle issues such global expansion in emerging regions such as Asia and Latin America can be a critical factor in choosing a central lab vendor.