By Ann Neuer
December 16, 2008 | The Drug Safety Executive Council (DSEC), an organization of drug safety leaders in the biopharmaceutical industry, is bringing a collaborative approach to the development of safer medicines. With the rising cost of R&D and the withdrawal of several high-profile drugs in recent years for safety reasons, DSEC aims to fill a need among its constituent companies looking to re-think how drug safety can be evaluated earlier, so they waste less money on compounds that fail due to unexpected adverse events. A recent DSEC poll indicates that 78% of respondents peg multi-company collaboration as an effective tool for improving the economics of R&D.
According to Eric Glazer, VP marketing for Cambridge Healthtech Associates (CHA)* and DSEC managing director, the best way to launch such an effort is by bringing together representatives of the biopharmaceutical industry seeking to better predict safety outcomes, and vendors anxious to promote new technologies designed for that purpose. Glazer says that DSEC is starting a collaborative technology evaluation (CTE) service that will offer member companies access to new testing methodologies, such as cellular based assays.
“DSEC would serve as a repository for samples of various compounds that pharmaceutical companies produce. These would be compounds with known properties, and in collecting these compounds or powders from members who want to participate, we can build a library of compounds against which new technologies can be evaluated,” Glazer explains.
To perform a robust validation of the technology, approximately 300 compounds or more are needed for testing, a volume beyond the capability of all but the largest companies. However, if each member contributes 20 or 30 compounds and the library is supplemented with well-known public domain compounds, sufficient capacity is created and the screening can provide meaningful outcomes. A DSEC Steering Committee of industry experts would decide which new technologies are “powder worthy,” lingo for worthy of testing.
Participants would receive blinded results of the screen but they would be able to recognize their own powders through assigned code numbers. With these results, participants can perform a correlation analysis to determine how well the new technology could have predicted adverse events based on what is already known about the compound. “This raises the question—would we have done anything differently if we had had this new screen when we originally tested these compounds?” Glazer comments.
To operate the service, DSEC members would pay a stewardship fee and provide enough powder for a year’s worth of testing. Technology providers would also pay a fee and provide the screening service gratis. Glazer remarks, “There is a lot of upside for the providers because if the technology works, they have an established relationship with the pharma companies. All of our projects have resulted in some of our pharma companies turning into clients for the technology providers.”
Ernie Bush, VP and scientific director of CHA and a DSEC program manager, says the new CTE service model should substantially reduce the time and resources needed to evaluate new preclinical safety screening tools, which has been conducted on an ad hoc basis. “Previously, the way it worked is that we would be approached by a vendor who wants to run an evaluation and we would recruit members each time, then collect the compounds and compile the comparator data. With the new model, we hope to do the recruiting cycle, the compound selection, and the data compilation just once. By having everything pre-selected, we expect to shorten the life cycle of CTE projects by half or more, easily from 8-10 months down to 3 or 4,” Bush says.
The service has not yet launched but a handful of member companies have expressed interest and given verbal commitments. Once a few pharma companies have signed, DSEC is ready to start the service.
*Editor’s Note: CHA is a sister organization of eCliniqua’s publisher, Cambridge Healthtech Institute.
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