FDA Debarment Failures a Wake-Up Call for CROs, Drug Sponsors

After Congressional hearings on the antibiotic Ketek, a Congressional committee issued a scathing report on the FDA’s debarment process. The min-ority committee charged that debarment proceedings against individuals are inconsistent and haphazard. Staffers uncovered cases where individuals convicted of a felony related to the development or approval of a drug product were not debarred, while other individuals with similar circumstances or convictions were debarred. In response to Congressional concerns, sponsor companies and CROs should examine their processes and improve investigator selection and training methods to avoid potential debarment or disqualification proceedings.

CROs: The Promise of Biotech and Beyond

CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and others have been working hard to cater to biotech clients for several years. Those efforts should continue to pay off in 2008, which looks to be a good year for biotechs. With large pharmaceutical companies emphasizing biotech products more than ever, large CROs can leverage their expertise in biologics for additional work with existing customers. They can also take advantage of their global infrastructure in emerging markets. But there are some warning signs concerning sustained growth.

Innovative Medicines Initiative Gets Underway During DIA EuroMeeting

The afternoon session on the first day, March 3, of the DIA Euro-Meeting in Barcelona called “Innovative Medicines Initiative: The EU Commission/EFPIA Public-Private Initiative—Up and Running?” answered affirmatively the question it posed in its title.

Eye On: Osteoporosis

In osteoporosis, the density and quality of bone are reduced, with loss of bone mineral density (BMD) and changes to bone structure causing bones to become more porous, brittle and highly susceptible to fracture. Bones at the hip, spine and wrist are particularly vulnerable to osteoporotic fracture. CenterWatch has identified a pipeline of 15 drugs in various stages of development for osteoporosis. Many of these are novel formulations of PTH or target hormonal pathways in other ways, whereas others capitalize on recent advances in understanding of bone metabolism.

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