Potential Benefits For Pharma/Biotech companies:
As an alternative to traditional outcomes of mortality or morbidity, surrogate biomarkers, including pharmacogenetic markers, can be used to shorten clinical trials and thus drug development cycles, giving extra years at peak sales. Developing surrogates into approved diagnostic tests can then help products reach peak sales faster or achieve higher peak sales through market expansion. Alternatively, diagnostic tests can be used to increase efficacy or minimize adverse drug events within an objectively defined treatment population, thus facilitating sales of a premium priced "niche" medicine that is differentiated from generic or proprietary competitors. The return on investment for pharma/ biotech is astonishing, e.g., investment of ~$5million by Aventis in the tailored development and regulatory approval of Pharmanetics' Enox Test has the potential to double the current ~$1billion pa sales of Lovenox.
Potential Benefits For Diagnostics Companies:
The pharmaceutical sector is a major purchaser of diagnostic services. Historically, pharma companies seeded diagnostic companies to diagnose conditions for which their medicines were being developed. However, during the 1980s and 1990s the two industries have operated largely independently. Now with the pressure on pharma companies to expedite delivery of more efficacious, safer & cost-effective medicines, the integration of diagnostics into the drug development pipeline makes a significant difference. The attraction of developing a diagnostic product with a large earnings potential exclusively for a pharma company is obvious. Diagnostic-type products can benefit the entire drug development spectrum as well as supporting drugs in the market place.
Potential Benefits For Contract Reseach Organisations:
Offering clinical support services that include the application of disease and pharmacodynamic surrogates is an underdeveloped opportunity for CRO's. Utilisation of surrogates, or carefully-selected diagnostics, that shorten clinical programmes and/or enhance clinical decisions will differentiate the proactive CRO. In addition, the clinical validation of a novel biomarker can be a source of revenue through IP, particularly in a therapeutic areas where diagnosis and/or monitoring response is limited.
Potential Benefits For Reference Laboratories:
Develop services for pharma companies.
There are additional opportunities for biotechnology and biomarker discovery companies through association with any of the above sectors. IML can undertake this work in contract labs.
