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it hopes other pharmaceutical companies will join in the collaboration.
The initiative is intended to alleviate the red tape that Big Pharmas impose on principal investigators overseeing sponsored clinical trials, says Andreas Koester, a San Diego-based executive heading the Janssen R&D initiative. Before such trials can begin, Koester says a pharmaceutical sponsor typically requires the investigator to submit a multitude of prequalification documents—laboratory training records, equipment certifications, and even the CVs of scientists overseeing the trial.
It is not uncommon, Koester says, for 20 different companies running 20 different trials to require the principal investigator to submit 20 different sets of documents. “About 70 percent of investigators only do one or two trials, and then call it quits,” Koester says.
The move to establish a one-stop repository for such data is part of the mission established for TransCelerate BioPharma, a nonprofit company created by Janssen and nine other companies earlier this year. Garry Neil, TransCelerate’s newly appointed CEO, is quoted in the Janssen statement as saying, “Industry collaboration, including pre-competitive data sharing, is critical to ensuring continued progress to improve industry-wide clinical trial practices.”
While Janssen expects to realize some cost savings by doing things faster and more efficiently, Koester tells me, “The cost savings of an undertaking like this will really only materialize when it gets to be broad in scope.”
TransCelerate has identified centralizing and standardizing the process of site prequalification and training as one of five key projects the industry needs to accomplish to improve the quality of clinical studies. The 10 founding members of TransCelerate are Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche’s Genentech division, and Sanofi. Other companies are being encouraged to join the effort.