BioClinica stockholder calls for executives to resign, as CEO says new eclinical push still ramping up
Tuesday, October 26, 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.
In the 11 years since she founded Cincinnati-based Goodwyn IRB, Ellen Kelso says she’s noticed a great deal of non-compliance among investigators on the trials she’s overseen. Those making the mistakes had good clinical practices (GCP) training, but they somehow weren’t able to apply it to real-life situations in the course of a trial, she said.
Institutional Review Boards (IRBs) are central to the system of protecting human subjects who participate in clinical research, yet concerns have been raised that there is no way to measure whether IRBs actually do their job of protecting study volunteers from unnecessary risk of harm.
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.
Major pharmaceutical companies are increasingly forming long-term, strategic partnerships with a small number of global contract research organizations (CROs) in order to cut costs and streamline their outsourced clinical work.
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.
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.
The hyper-intense focus and problem-solving prowess of a person playing an online game can be a thing of beauty. But can that focus be harnessed to speed up the drug development process?