October 2010

Site Solutions Summit honors Eli Lilly, PPD with Eagle Awards

Wednesday, October 20, 2010

The complexity of today’s clinical trials, the regulatory burdens and the disease states being tackled make the current drug discovery market a difficult one in which to operate, Dr. Jeffrey Kasher, vice president of clinical development organization for Lilly Research Laboratories at Eli Lilly, told more than 350 industry members last Saturday evening at the Site Solutions Summit in Clearwater Beach, Fla.

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Quintiles expands its Prime Site program with Arizona State, South Korea strategic partnerships

Tuesday, October 12, 2010

Global CRO Quintiles has stepped up expansion of its Global Prime Site program, which forms research partnerships with large hospitals and health systems capable of enrolling hundreds of clinical trial patients each year. Having established prime sites in California and Asia earlier this year, Quintiles has now signed strategic partnerships with Arizona State University (ASU) and the Seoul National University Hospital (SNUH), increasing its number of prime sites to seven.

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Massachusetts solidifies position as a haven for biotech jobs

Thursday, October 7, 2010

Massachusetts has improved its position as a nation-leading biotechnology cluster, increasing jobs not just in research & development, but also in manufacturing. The latest data from MassBio shows Massachusetts was one of just four states that added biotechnology manufacturing jobs in the last decade. Overall, Massachusetts has improved its position within the physical sciences, as defined by industry concentration, by 100 percent.

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FDA issues rule on safety reporting

Tuesday, October 5, 2010

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. “These changes will better protect people who are enrolled in clinical trials,” said Rachel Behrman, M.D., associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. The new rule requires certain safety information be reported to FDA within 15 days of becoming aware of an occurrence, including: findings from clinical or epidemiological studies that suggest a significant risk to study participants; serious suspected adverse reactions occurring at a rate higher than expected; serious adverse events from bioavailability studies that determine what percentage and at what rate a drug is absorbed by the bloodstream, and bioequivalence studies that determine whether a generic drug has the same bioavailability as the brand name drug. The rule also provides examples of evidence suggesting an investigational product may be the cause of a safety problem. Currently, sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event. This complicates and delays the FDA’s ability to detect a safety signal. The examples address when a single event should be reported and when to wait for more than one occurrence.

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