The safety-efficacy challenge

With a huge amount of pharma’s money wasted on failed products, how can biomarkers help reduce costs and ensure the safety and effectiveness of drugs before they reach the market?

Failure in the pharma industry has a lot to answer for: an astonishing 75% of drug research and development budgets is whittled away on unsuccessful candidates and drug failures. With the cost to bring a new drug to market now approaching $900 million, that’s a lot of money to whittle away. Despite the billions spent on toxicity and seemingly exhaustive testing, post-launch withdrawal of compounds due to adverse side-effects still occurs. Drug company executives are desperately seeking new and timely solutions to produce cheaper, better and faster. As reliable and effective indicators of success, biomarkers are offering the pharma industry some of the answers.

Improving candidate success rates
In efforts to boost productivity and reduce expenditure, biomarkers are playing an increasingly important role in R&D programmes, helping to optimise candidate selection and support critical decision making in drug portfolio management. They enable more discriminating tests of function and toxicity during the early stages of the discovery and development process, removing candidates unfit for the race before they have a chance to compete. This in turn not only actually saves massive amounts of time and unnecessary spending but frees up resources for future champions. The benefits are threefold: improved cost effectiveness, improved pipeline quality and decreased cycle times – cheaper, better, faster.

Histomics: proof-ofconcept and beyond
A growing ‘omics’ of interest in the wider field of biomarkers and biomarker research is histomics. The specificity of immunohistology combined with next-generation laser-confocal imaging allows unique and specific biomarkers to be identified and validated ‘at source’: in the actual organs, tissues or cells of interest. Because immunohistologically-defined biomarkers are generally target or mechanism-specific, they become invaluable aids for target validation, dose testing and optimum dose selection as well as efficacy testing, while helping to assess safety and tolerability. Imaging biomarkers which are disease specific and outcome specific can be used as disease or patient biomarkers in the stratification and identification of responders which greatly enriches proofof- concept studies. As such, these biomarkers can be used to establish new benchmarks in patient stratification. Effective stratification is the key to accelerating clinical development and boosting clinical trial success rates but over and above the need to find economically viable ways to guarantee market success, such approaches represent a giant leap forwards into the realm of personalised medicine: delivering the right therapy to the right patient at the right dose.

Immunohistological biomarkers: detecting toxicity
The specificity and predictive value of protein biomarkers is of special interest in toxicology research where recent studies provide evidence of their virtues as early indicators of possible adverse drug response. The potential impact is enormous: notwithstanding the preemption of complicated and costly post-marketing failures, reducing unnecessary exposure of human subjects to dangerously toxic compounds is paramount. Histologically defined protein biomarkers preformed in the target cells makes them indicators of cellular injury well before other changes can be detected. Where the quantity of biomarker released is in direct correlation with the extent of cellular injury, being able to accurately quantify the biomarker provides precious insight into the immediate effects of the toxin on the cells. Being able to monitor different cell types simultaneously also makes precise localisation of the site of injury possible.

Maximising drug success: innovating forward
As the pharma industry tries to figure out ways to lighten the load and kick up the pace of drug development, specialised CROs such as Biovays are coming up with innovative cost-cutting solutions. One thing is for sure: with the onset of personalised medicine boding the possible end of the blockbuster decades, the need for innovation in pharmaceutical therapeutics has never been greater.

Company profile

A CRO offering specialised research models to a number of industries, Biovays boasts savoir-faire in the localisation and quantification of biomarkers. Harnessing innovative technology and state-of-the-art tools, teams of experts design tailor-made solutions and deliver cutting-edge research within the constraints of the project environment, meeting client demands for accuracy, timeliness and quality.

For more information, visit: www.biovays.com.