Contract Research Organisations' (CROs) contribution to drug development has never been more crucial with faster development, earlier decisions on project failures, and higher approval success rates becoming the norm amongst outsourcing partnerships.
That was the view of Dr Christopher Milne, associate director of the Tufts Center for the Study of Drug Development (CSDD) in Boston, who was making the keynote speech at the Pabord conference in London last week. In it, Milne attempted to quantify and identify key drivers of growth in clinical research outsourcing, particularly since 2000, as well as quantify the impact of outsourcing on drug development and the role that it has played in public health.
Global drug development spending is expected to top $105bn (€82bn) by 2010 with 40 per cent of this business expected to be dished out in outsourcing contracts.
Milne pointed towards the escalating cost of new drug development that has been the driving factor towards the switch to outsourcing. Costs have soared from $0.8bn in 1997 to an expected $1.9bn by 2013.
Added to the increase in the time it takes to reach final approval phase from preclinical studies, companies are finding the outsourcing approach is saving huge amounts both in time and cost.
According to a study by the Tufts CSDD in 2005, preclinical phases in the 1960's took approximately five years to complete compared to a figure of 5.8 years for the 2000's.
Likewise, Tufts found the clinical phase period jumped from 1.9 years to a whopping 5.9 years within the same period. However, Milne pointed out that approval phase had actually decreased averaging 2.4 years in the 60's to 1.5 years for the present day.
"In an attempt to ease the serious bottlenecks that have formed during the drug development cycle, drug firms see outsourcing as a possible route in easing the congestion." "Bottlenecks are forming at the discovery stage, where targets and biomarkers need to be validated. Also, the clinical stage has become more time consuming with factors such as adaptive CTs, exploratory INDs, dosing and attrition determining trial design."
Milne also pointed to a study carried out by Joseph Dimasi in the journal PharmacoEconomics, which stated that in order to reduce the cost of the clinical trials the amount of time taken for the testing must also be reduced.
The study showed that to reduce drug development costs by $100m, the drug developers must reduce the time taken to develop the drug by 18.9 per cent.
Likewise, to reduce the drug development costs by $200m, the drug developers would need to reduce the time taken to develop the drug by 41.3 per cent.
Pharma companies are turning to CROs in an effort to implement these time and financial savings and are carving out a reputation for faster development times.
"We found that high CRO usage projects were submitted more than 30 days closer to the projected submission date," he said.
"High usage projects offered a development speed advantage across all measures, most notably during the close-out phase."