A consortium of eight leading pharmaceutical companies have taken the unprecedented step of agreeing to share preclinical laboratory data in order to improve the testing of medicines before they reach the stage of being tested in humans.
The initiative, set up by the non-profit Critical Path Institute with the US Food and Drug Administration (FDA) serving in an advisory capacity, could not only reduce the chances of an unsafe medicine reaching the clinic, but may also help bring new drugs to market quicker and more cheaply.
In the past decade, spending on pharmaceutical R&D has risen 250% in the USA, while the National Institutes of Health (NIH) budget for biomedical research has doubled. But over the same period the number of innovative new drugs submitted for FDA approval has declined by approximately half.
A pivotal document published by the FDA in 2004 – now dubbed the Critial Path Initiative – concluded that the primary reason for this decline in R&D productivity was the pharmaceutical industry’s inefficient and time-consuming processes for preclinical and clinical testing of drugs. This, it suggested, was the main reason the industry has to spend $800 million to $1.7 billion to bring a new medicine to market.
The Predictive Safety Testing Consortium includes Pfizer, GlaxoSmithKline, Novartis, Bristol-Myers Squibb, Johnson & Johnson, Merck & Co, Schering-Plough, a division of Schering Corp and Roche.
Although pharmaceutical companies have traditionally been reluctant to give away too many details about their R&D operations, the PSTC will allow them to determine which of the lab tests that they have developed individually should be recommended by the FDA to screen drugs.
Dr Janet Woodcock, the FDA’s deputy commissioner for operations, said the effort could help researchers select better initial human doses and monitor side effects in early trials using biomarkers.
“As a result, pharmaceutical companies will be able to learn more from smaller clinical trials, and get new, safer therapies to patients faster and at a lower cost,” she added.
C-Path’s role will be to oversee and coordinate the PSTC and serve as a point-of-contact between the companies, the FDA and academics.
Meanwhile, the FDA has also published a list of 76 research projects that it believes would accelerate the drug development process. Broadly, they cover the development of biomarkers, clinical trial design, bioinformatics, manufacturing, public health needs and paediatrics.