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European Pharmaceutical Contractor
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The industry is under increasing pressure to streamline all phases of new drug development and significant emphasis is being placed on the ability of Phase I to identify and 'kill' unsatisfactory candidates quickly and efficiently. At the same time, this phase must arm the winners with not just safety information, but as much efficacy data as possible to help smooth the transition into later-phase clinical trials. These trends have strategic implications not only in the design of studies and programmes, but also in the organisation of R&D and selection of outsourced development partners.
Key Strategic Role of Phase I in Drug Development
Today, it takes around 15 years to develop a new drug from synthesis to NDA approval, and with the attrition rates associated with this process, the full R&D costs are, on average, more than US$800 million, with most of this being incurred during later phases of clinical development. Subsequent sales revenues are only sufficient to recoup the R&D investment for around a third of all drugs on the market. Therefore, the majority of launched products could have been terminated in R&D with a net financial benefit to the company. These considerations place significant economic emphasis on the selection and backing of only the winning candidate drugs. At the same time, new technologies in drug discovery, such as high-throughput screening, combinatorial chemistry and the 'omics', are generating more and more potential therapeutic targets. The net result is that the industry needs to be increasingly discerning in its selection process, identifying the very best candidate drugs from an expanding reservoir of new chemical entities entering development.
The real challenge is to identify the 'losers' and to stop their development as soon as possible. Apart from time, the key metrics in this process are safety, efficacy and commercial viability. With regards to safety and efficacy, a great deal of information can be obtained from increasingly rigorous in silico, in vitro and animal models available to support discovery and preclinical development phases.
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