From target discovery through to FDA approval, quantitative biomarker analysis streamlines drug development and boosts drug approval success rates.

In a world of accelerating change and increasing uncertainty, the pharmaceutical industry is expected to do more with less: to develop new, more effective and safer treatments while optimising resources, reducing time to market and guaranteeing success. It’s not surprising when on average as much as $800 million is spent over a ten-year period to introduce a new drug – a hefty sum for a hefty schedule. Rising to today’s industry challenges is no easy task.

Externalise to optimise

Research scientists and industry experts are looking for new solutions in terms of science and technology, and business model. They are turning to external service providers in their search for specialist knowledge, innovative approaches and cost-effective alternatives.

As increasingly specific and reliable indicators of disease states and drug efficacy, imaging biomarkers are emerging as the new stars of drug discovery and development programmes.

Molecular biomarker imaging

The use of tissue biomarkers in the validation of new drug candidates has many advantages, particularly in the early stages of discovery and development. Their role in proof-of-concept testing facilitates more effective decision-making and accelerates the drug development process while increasing the probability of success.

Candidate selection is optimised early to pre-empt failures and focus research on the most promising therapeutic solutions. Investing time and money in better R&D portfolios saves time and money: molecular tissue imaging can increase cost-effectiveness, decrease cycle time and improve drug pipeline quality significantly – in theory. In practice, even expert qualitative analysis falls victim to its inherent strength, subjectivity. The lack of objectivity, accuracy and site-specific measurement calls for new technological tools and new approaches combined with more traditional qualitative methods.

Specialisation and innovation

Biovays has developed standalone image analysis software, Biovays ImagePro (BIP), which is dedicated to qualitative and quantitative analysis of biological phenomena. This software is designed to analyse laser confocal microscopy or videomicroscopy digital images and quantify the effects of candidates on different cellular targets in human and animal tissue, as well as cell culture. Highly accurate, site-specific quantification of biological targets in real time and automated high throughput screening are made possible.

Quantitative biomarker analysis

Microscopic digital imaging of fluorescent labelling gives a precious insight into different kinds of biological processes occurring in tissues and cell cultures. The image analysis performed using Biovays ImagePro is not denaturalising and allows users to observe biological phenomena in the cells in which they take place. Biovays ImagePro was first developed to investigate G protein-coupled receptor endocytosis and was successfully validated on both simulated and real images.

Biovays ImagePro investigations have since been extended, enabling the company to carry out rapid and accurate assessment of changes in localisation and quantification of target molecule expression occurring in processes such as cell differentiation, migration, inflammation and secretion of active molecules following stimulation – all may be influenced by candidates. Image analysis using Biovays ImagePro allows the research team to get more information from the image. For example, users can assess the proportion of target molecule expression in a given cellular or subcellular component (biomarker colocalisation analysis).

Research excellence

Harnessing state-of-the-art technology, Biovays can deliver state-of-the-art solutions. Via its technical and imaging platform the company is able to generate incomparable quantitative data from the analysis of protein biomarkers in tissue, leveraging a host of benefits across the drug development continuum. Biovays’ mission is to help clients leverage these benefits and focus on their core business.

Company profile

As a CRO offering highly specialised research models to several industries, Biovays boasts unique savoir-faire and expertise in the localisation and quantification of biomarkers.

Employing state-of-the-art technology and innovative thinking, it develops tailor-made protocols and performs cutting edge research within the constraints of the project environment.