Pharmaceutical industry heavyweights are teaming up to address a challenge that's long vexed drugmakers: how to improve the way experimental drugs are tested so they can get approved, and reach patients, faster.
Ten top U.S. and European drugmakers said Wednesday that they have started a nonprofit organization, called TransCelerate BioPharma, to collaborate on the problem.
Research productivity across the industry has been declining while costs have been rising over the past few decades. About 5,000 to 10,000 potential drugs fail for every one approved, although all but about five of those compounds are scrapped by the time costly tests in people begin.
Including all the failed drugs, the cost of getting one approved has risen from about $140 million in the 1970s to more than $1.2 billion, according to the industry group Pharmaceutical Research and Manufacturers of America. That's partly because the process from finding a compound to getting it approved by regulators takes 10 to 15 years.
TransCelerate will aim to shorten that time and reduce costs along the way, initially by developing strategies to make it easier and quicker to set up and run clinical tests of experimental drugs.
That will include developing standard methodology for collecting data from patient tests and ensuring that study participants are protected, as well as setting standards for qualifying clinic sites and investigators to work on studies. Another goal is to increase the number of researchers at hospitals and universities qualified to conduct trials, because that will give more patients the chance to participate in them.
"It will enable everybody to develop new drugs faster and better," said the group's acting CEO, Garry Neil. "If this helps to reduce costs, then maybe we can investigate more drugs."
That's clearly needed, as the number of innovative drugs approved each year has been declining.
The group's participants include U.S. drugmakers Pfizer Inc., Johnson & Johnson, Bristol-Myers Squibb Co., Eli Lilly and Co. and Abbott Laboratories, along with European drugmakers GlaxoSmithKline PLC, AstraZeneca PLC, Sanofi SA, Boehringer Ingelheim Corp. and Genentech, a unit of The Roche Group.
Neil, a former vice president for science and technology at Johnson & Johnson, said he expects to have initial results next summer. He expects more drugmakers to join in the multimillion-dollar collaboration down the road.
TransCelerate also will collaborate with several industry groups focused on creating innovative medicines and setting standards for study data, as well as government regulators including the U.S. Food and Drug Administration.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, praised the collaboration, saying in a statement that it has the promise "to strengthen the industry and its ability to develop innovative and much-needed therapies for patients."
Scientists and other staff at the participating drug companies currently are working from their corporate offices, but the group plans to open a headquarters in Philadelphia later this year.
Linda A. Johnson can be followed at —http://twitter.com/LindaJ_onPharma