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Pharma comes together over clinical trials

Drug development has become such a daunting process that the world’s largest and most competitive pharmaceutical companies are banding together to streamline the pathway.

On Wednesday, the companies announced the launch of TransCelerate BioPharma, a nonprofit organization to be located in Philadelphia, Pennsylvania. Its mission will be to overcome the inefficiencies in clinical trials that contribute to the 10- to 15-year-long, $1.2 billion journey that a drug makes from discovery to market.

Pharmaceutical Research and Manufacturers of America


TransCelerate will begin with a handful of projects to set norms for how to describe patients and drug effects in trials. “We [drug companies] will continue to compete when it comes to bringing innovative drugs to market, but by standardizing things, we feel everyone will win,” says Garry Neil, head of TransCelerate.

Doctors who help conduct trials for various companies will require less specific training if the charts they fill out share similar measures, Neil explains. For instance, females might consistently be labeled with an ‘F’ and males with an ‘M’, as opposed to a ‘1’ or ‘0’ sometimes. And if results such as tumor shrinkage, were measured in an identical way study-to-study, companies could more efficiently compare one drug to another when the US Food and Drug Administration (FDA) requests this type of information.

Scientists have attempted to unclog the drug pipeline through various measures over the past two years. In January, the National Institutes of Health (NIH) opened a new center for translational research to help push drugs through the early, pre-clinical phases of development. The FDA has also been presented ways to decrease paperwork involved in submitting a drug, a step that would lessen the load at the tail end of the pipeline.

Streamlining clinical trials has also been a priority for NIH director Frances Collins. Earlier this month, Collins told Nature that one of his highest priorities “is to try to reengineer the way we do clinical trials.” One way that Collins suggested was to aggregate medical records, with patient consent, so that people who want to participate in trials can be located.

Neil concocted the plan for TransCelerate around this time last year when he was corporate vice president for science and technology at Johnson & Johnson. He invites smaller companies to join. The all-star group currently consists of US-based Pfizer, Johnson & Johnson, Bristol-Myers Squibb Co., Eli Lilly, and Abbott Laboratories, and European drugmakers GlaxoSmithKline, AstraZeneca, Sanofi, Boehringer Ingelheim and Genentech.

“The more efficiency we create, the more drugs we can study, and the faster we can get those drugs to patients who need them,” Neil says.


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