High and rising clinical development costs, coupled with declining drug discovery success rates and slowing corporate earnings growth have forced pharmaceutical companies to re-evaluate their drug development process in order to reduce attrition rates, shorten drug development timescales and remain competitive.

Over the next decade biomarkers are expected to radically alter the way in which pharmaceutical companies determine the economic viability of their drug discovery process. The use of biomarkers to aid the discovery of promising products will:

• Create an enhanced understanding of the clinical development process and
• Help to facilitate the shift towards 'personalised’ medicine

InVenio™ Technology will be a key tool that enables pharmaceutical and biotechnology companies to:

1.  Make a step change in the discovery of novel drug targets – The identification of new protein biomarkers may be the entry point for new drug discovery programmes:

• a protein biomarker may present a target for a new drug entity to be created to impact upon progress of a disease;

• unravelling the biochemistry behind the particular levels of protein biomarkers can provide significant insight into the underlying mechanisms of the disease process and allow scientists to intervene with a therapeutic drug at the correct point in the disease’s progression.

2.  Reduce the costs of drug discovery and clinical trials and shorten drug development times translating into higher sales associated with  longer patent protection in the market by:

• Streamlining the drug discovery process by identifying whether a potential drug will be effective on a significant proportion of the population and eliminating those that will not be from the discovery pipeline earlier than can be achieved with current technologies.

• Reducing the size and timescales of clinical trials by identifying biomarkers that can be used as surrogate end-points for clinical trials thus reducing the number of patients required per clinical trial and/or the length of the clinical trial and hence both increasing the speed of a drug to market and reducing the costs of clinical trials.

3.  Improve the regulatory success rate for market approval and develop combined drug/diagnostic tests needed for personalised prescribing – for example, if it can be demonstrated that a drug will be effective for patients that have a specific protein biomarker, but not for those without this, it would be possible to provide a test for the specific biomarker that could be taken before a specific drug was prescribed, hence significantly increasing the effectiveness of the drug.

By streamlining the drug development process and reducing the size of patient cohorts and time required for clinical trials it has been estimated that:

• The cost of development of an average drug may be reduced by as much as $80m 

• This would result in a cost saving to a pharmaceutical company of the order of $500m  per annum.

Achieving a reduction in the time to market impacts significantly on the period that a therapeutic may be marketable prior to expiry of patents. For blockbuster drugs this could be worth in excess of $1.5bn per annum.