CRO contribution proves essential in cutting R&D costs
by 2013, the pressure is on to reduce R&D development time and
cost without sacrificing clinical success rate.
That was the view of Dr Christopher Milne, associate director of the Tufts Center for the Study of Drug Development (CSDD) in Boston, who believes that outsourcing is the best option in achieving these objectives.
Drug development times, especially the clinical phase, have almost tripled in the last four decades, pushing up development costs sky high. Added to the fact the number of new drugs have not significantly increased despite the technology investment, outsourcing is suddenly looking like an attractive proposition.
Big Pharma clearly agree. According to an earlier Tufts study, during 2003-05, clinical trials for new drug candidates carried out by the ten top selling US drug companies rose by 52 per cent, following a 21 per cent decline from 1993-97 to 1998-02.
Indeed, the adoption of outsourcing certain processes in the R&D process has culminated in statistics, which suggest that of the six specific broad therapeutic categories analysed, oncology/immunologic and CNS had the greatest shares of new drugs entering clinical testing during the 1993-02 period.
In addition, respiratory, oncology/immunologic, and systemic anti-infective drugs had the highest clinical approval success rates for the 1993-02 period.
However, quantifying the contribution contract research organisations (CRO) has made to these statistics was the focus for Milne, who pointed towards a pioneering study by Joseph Dimasi.
According to the study to reduce drug development costs by $100m, drug developers must reduce the time taken to develop the drug by 18.9 per cent. To reduce costs by $200m, developers would need to reduce time taken by 41.3 per cent.
The study went further. In order to save $100m, developers would expect a clinical success rate reduction of 25.2 - 25.6 per cent - a massive drop considering the success rates are relatively low even with a generous budget.
A $200m reduction would result in a clinical success rate reduction of 30.4 - 31.7 per cent.
"Currently, the average cost to develop and win market approval for a new drug in the US is $802m," said Milne.
"Drug companies need to adopt a new R&D paradigm that stresses better, faster, and cheaper. Blockbuster drugs may be a desirable goal, but they require large user populations to generate large revenues."
While blockbusters account for over one third of sales worldwide in 2005, Milne pointed to unmet medical needs worldwide, with 5000-8000 rare diseases still without an effective treatment.
Milne also pointed to the 50 per cent non-compliance rate for chronic disease treatments, which represented a future opportunity for new drug development.
