What Does The Spectre Of ‘Big Data’ Offer For The World Of Clinical Trials?
Thanks to the newly proposed 21st Century Cures Act, a fresh era of drug testing and development could be ushered in, with an increasing emphasis of computer systems and technology application and a switch away from research labs.
Big Data Means New Revenue Streams
This means that generic pharma companies could build fresh revenue streams through careful application of so-called Big Data. The critical success factor for CRO organisations is their ability to carry out robust and successful research programmes, allowing differentiation between innovative pharma firms and the manufacturing generics.
However this new Act, which is awaiting Senate clearance in the USA, may level out the playing field somewhat by introducing measures that move the development of new drugs towards computer systems and applications, and away from physical research labs. This revolution in Big Data usage could also support generic manufacturers.
Supporting Health Record Digitisation
The new Act incorporates a range of directives that concern health information and electronic health records. This will support better flows of information and facilitate medical information, by boosting incentives to grow cross-linking between different digital medical record databases and systems.
Electronic Health Records are becoming a vital means of finding new ways to repurpose or reposition existing drugs in order to find new uses for them. A recent study found that two generics, when taken together, could be used to support blood pressure reduction.
By finding new benefits to existing generic treatments, the struggling pharma business model for generics may find it gains new revenues through fresh opportunities – all thanks to the smart application of data. This process is called drug repositioning, and it is likely to move ever faster as a growing number of EHRs are made available for digital analysis, directly and indirectly supporting industry operators such as gandlscientific.com.
Viagra is one of the most well-known examples. Originally created to treat hypertension, today Sildenafil is more commonly associated with its vastly successful treatment of erectile dysfunction and perhaps lesser known treatment of pulmonary arterial hypertension, generating over two billion of USD sales in 2012. As computer driven and repositioned drugs fail to attract the same level of IP as a newly developed chemical entity, generic manufacturers could now benefit from fresh opportunities.