Companies share secrets to reduce unforeseen phase I problems
pharmafile | April 26, 2006 | News story | Research and Development |
Eight of the industry's leading companies have begun work on a unique new project to help overcome one of the biggest obstacles to developing new drugs.
The recently unveiled Predictive Safety Testing Consortium will see companies share information previously considered commercially sensitive in an attempt to better predict how new experimental drugs will work in the human body.
The new US-based project has been a long time in planning, but has taken on new meaning following the unexpected and nearly fatal side-effects seen in the UK trial of TeGenero's novel drug TGN-1412.
Even without new safety concerns around monoclonal antibodies, most drugs fail to show efficacy in humans. Currently, nine out of ten compounds developed in the laboratory fail when they reach phase I clinical trials because they behave differently in people than they do in animals or the test tube.
Until now, each pharmaceutical company has worked alone on developing methods for predicting how drugs will act in the human body, but now companies have agreed to share information.
The unprecedented project has been co-ordinated as part of the FDA's Critical Path Initiative (or C-Path), a major project aiming to streamline drug discovery and research over the next five years.
The Consortium's members will share their methods for screening pre-clinical drugs, with the hope that a new industry standard test can be devised, helping to identify the best candidates earlier and thus cut costs and accelerate development times.
The nine companies participating in the consortium are: Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche, Schering-Plough and SRI International (a non-profit company participating as a founding partner of C-Path).
"This is a concrete example of the power of the collaborative nature of the Critical Path Initiative, our road map for modernising the development of medical products, said Dr Janet Woodcock, the FDA's deputy commissioner for operations.
"The use of predictive safety biomarkers in early animal and laboratory studies will strengthen the product's safety screening before it is introduced into humans. It will also enable researchers to better select initial human doses, and monitoring for side effects in early trials. 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."
The consortium was created because predictive safety tests developed by each individual company are of limited value to the FDA, since the methods used have not been independently validated.
The FDA has gone to considerable lengths to ensure the C-Path initiative is successful, setting it up last year as an independent non-profit research and education institute with its own chief executive, Dr Raymond Woosley.
"C-Paths mission is to accelerate the development of safe medical products, and to foster education and training in applied research and regulatory sciences," says Woosley.
The Predictive Safety Testing Consortium is an excellent example of the value of the 'neutral ground' that C-Path creates for the industry and FDA to focus on the science that is important for drug development. This is just the first of many projects that C-Path plans to support."
C-Path was set up to tackle rising costs and falling productivity in drug discovery and development. It says US pharmaceutical research and development spending has risen 250% over the last 10 years and the National Institutes of Health (NIH) budget for biomedical research has doubled. Despite this increase in spending, numbers of innovative new therapies submitted for FDA approval has declined by approximately 50%.
Following the incident involving TeGenero's drug, some have questioned the wisdom of accelerating this stage of drug development, but if better predictive tests of safety in humans can also be developed, the initiative would be judged a considerable success.
