Historically it has taken about 12 years to take a newly discovered drug to commercialisation. As patents are valid for only 20 years, this leaves a mere 8 years for the pharmaceutical company to realise the fruits of their huge investments before generic companies copy the drug and supply the market with much cheaper versions. The widely accepted cost of drug development in 2009 is about $1 billion. Clearly therefore the Pharmaceutical company has a short time in which to recoup this huge investment.
In the early years of this decade many pharmaceutical companies publicly announced aggressive programmes to reduce the time taken for drug development but there are few signs that this has had any success especially when the reduced productivity of the industry (lower number of new drugs to market) is taken into account. Companies are therefore continually seeking ways that might circumvent the traditional route to market. For example, one tack is to exploit drug polymorphism and develop a new and better physical form of a drug. Another has been to develop a single handed version of the drug where previously both hands (a mixture) have been marketed. When licensing from a biotech, the later the stage of drug development the more desirable the licensing.
Each stage in drug development gets increasingly more expensive. After finding a potential hit in a screen, the early drug development phase of hit to lead follows. This lead drug is then optimised and prepared for pre-clinical evaluation. Drug development during the Pre-Clinical phase is designed to determine a drugs safety profile and prepare the drug for use in clinical trials. Phase 1 clinical trials are the first time during drug development that the drug is used in humans to test safety and tolerability. Larger Clinical Phase 2 studies assess how well the drug works. This is followed by Clinical Phase 3 trials, the most expensive of all, to assess drug effectiveness.
Playing a minor but no less important role are the companies providing drug development services. It is widely recognised that using specialist providers is one way of keeping the critical path of new drug development as short as possible.About the Author:
Onyx Scientific is one of the best resources available for Drug development services.
