This novel approach is seen as a way to minimise late phase failures, which can be financially catastrophic for the drug developers. Latest figures reveal that less than one per cent of compounds entering development enter the market.
Integrated exploratory protocols refer to the single flexible procedures that allow preliminary investigation into the safety, tolerability, PK, PD and Proof of Concept (POC)/ Proof of Principal (POP) in healthy subjects.
Integrated protocols usually combine investigation of single and multiple doses in one protocol. The design is individualised and tailored to meet the requirements of the development plan for the compound under investigation.
Speaking at the recent Pabord conference at London's Excel Centre, Dr Colin Vose,director of Strategic Business Development at Quintiles, outlined the advantages of integrated protocols.
"The small, well-controlled robust studies enable investigations into the target population much earlier as well as allow a more rational dose selection for Phase IIb from the POC study."
"Added to fact that researchers can make crucial decisions a lot earlier in the drug discovery process, the overall reduction in time to study completion and cost is substantial," he added.
There has been a 55 per cent increase in critical patch development costs since 2000. Of this figure, over 50 per cent of this cost is incurred in late Phase II/Phase III.
Current figures estimate that $1.7bn (€1.4bn) is required from discovery to launch one successful drug product.
It has gotten to the point where R&D expenditure is outstripping revenues from sales, threatening the very essence of the industry's lifeblood and signalling an end to the era of blockbuster discovery and launch. Clearly big pharma need to look to alternative research methods that are viable and sustainable.
"Advances in the 'omics' (proteomics, genomics, metabolomics) has led to an increase in the number of drug targets," Vose said.
"More importantly, the advances in technology to improve candidate selection for later phase development have been particularly promising. We are seeing the use of biomarkers and surrogate markers such as micro-dosing, imaging techniques and specialised cell culture and receptor binding assays increasingly being utilised."
Vose concluded that integrating a flexible Phase I set of protocols would expedite rapid clinical evaluation to POC, reducing the regulatory authorisation time as well as drug development time and cost.
"You could utilise the clinically relevant markers to investigate potential activity, which not only enables better dose selection for phase IIb but provides for better candidate selection for late phase development."