12:00 AM
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Oct 21, 2013
 |  BioCentury  |  Product Development

TransCelerate up to speed

First-year accomplishments of TransCelerate, pharma's precompetitive consortium

In its first year, the industry's precompetitive experiment TransCelerate BioPharma Inc. has hit key milestones in all five of its initial projects aimed at improving the speed and quality of clinical trials. The biopharma consortium also has increased its membership to 18 companies from 10, and could announce its next set of projects this year.

TransCelerate was founded last year after a group of pharma R&D heads concluded that precompetitive collaboration was best way to solve clinical trial bottlenecks. The hope was that the resulting efficiencies would speed up drug development and lower costs for all members.

So far, TransCelerate has launched a network to facilitate member company access to comparator drugs for clinical trials, which should ensure rapid availability of high-quality drugs for head-to-head studies.

The consortium also has designed and is preparing to launch an online portal that will allow companies and clinical trial investigators to exchange trial data and protocols through a single platform, potentially speeding up investigator and site selection.

TransCelerate has also published white papers and guidelines on trial and data standards, most of which are available to members and non-members alike via the consortium's website (see Featured Links, A22).

A white paper on standards for risk-based monitoring (RBM) of clinical trials should help companies direct resources to the prospective identification and mitigation of risks to patient safety and data quality, while promoting centralized monitoring of the most important parts of a given trial in place of cumbersome comprehensive on-site visits.

The remaining initiatives on the consortium's initial list include clinical trial site qualification and good clinical practice (GCP) training, and clinical trial data standards. The group has published minimum criteria for GCP training of clinical site investigators and staff, and has published standards for collecting and sharing efficacy data from asthma trials.

"A major advance by itself is just the fact that the pharmas taking part in TransCelerate successfully worked together in the first place," CEO Dalvir Gill told BioCentury.

"We've shown that we're not getting bogged down in excessive bureaucracy and instead have created a functioning infrastructure like any working company. On top of that, we've generated concrete outputs for all of our initiatives," he said.

TransCelerate hasn't said what it wants to tackle next, or whether its projects will get more challenging. When it was founded in August 2012, the members prioritized projects they considered most amenable to short-term fixes (see BioCentury, Oct. 1, 2012).

Networking

In August, TransCelerate announced it had reached a key milestone by setting up a network for obtaining comparator drugs and co-therapies for use in clinical trials and completing the first deal under the network. The network allows participating member companies to purchase approved drugs directly from each other for clinical trials, ensuring an adequate and timely supply.

Terry Walsh, head of the comparator network initiative at TransCelerate and head of comparator strategy and planning at GlaxoSmithKline plc, told BioCentury it was rare for companies to get comparator drugs directly from each other except under one-off agreements.

Instead, he said, companies frequently turn to wholesalers and third-party distributors to purchase the needed drugs on the open market. According to TransCelerate, this practice is inefficient, leads to uncertainty about obtaining the necessary quantity of drugs and can result in supply interruptions.

In July, several members of TransCelerate signed a master...

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