Enhancing the drug development process
pharmafile | November 9, 2005 | Feature | Research and Development |Â Â Â
MEDICAL SOLUTIONS SPONSORED FEATURE
Recently, we have seen a massive increase in our knowledge and understanding of the biochemical mechanisms that, when aberrant, give rise to, and ultimately control cancer and other diseases.
This understanding of the key intermediates controlling physiological phenomena such as cell prolife ration and cell death has produced new and fertile grounds in which to hunt for rationally-based, molecularly targeted drugs.
Simultaneously, the discovery of biomarkers tightly linked to these effects has provided response surrogates to assist in patient selection, so effectively leading to personalised medicine. One company that is leading the way in assisting the pharma and biotech sectors to validate and quantify these new protein biomarkers in human tissue is Medical Solutions plc, based in Nottingham in the East Midlands of the UK.
Medical Solutions is a company world-renowned for its Histopathology expertise. Supported by a network of more than 60 leading Pathologists, the company provides access to a global, fully ethical, tissue acquisition network to support research needs. It has also supported the healthcare sector for many years.
More recently, growing recognition of the potential market for validation and evaluation of new biomarkers in cancer and other diseases, led to the formation of a new division within the company focusing on Drug Development Services.
This Division now provides a range of services from sourcing and processing of normal and diseased tissue from clinical trials or research studies, through to immuno-histochemical staining, and other specialised staining techniques, rapid digitised image acquisition, image analysis, and data presentation in a variety of formats.
Flagship offering
The flagship offering of the Division to the pharmaceutical and biotech sectors remains its high-throughput quantitative immuno-histochemistry.
Medical Solutions believes they have successfully fused the historic strengths of its founder companies to produce a high-tech platform capable of delivering robust numerical data on protein biomarker expression in a way that few – if any – other systems can match.
The high throughput platform that Medical Solutions has set up is impressive. Capable of processing up to many thousands of slides due to a modular approach to upgrading throughput according to demand, samples can be processed from tissue to block, and then sectioned to slide.
Slides are stained on one of two types of automated stainers and fed into a high throughput scanner which scans the total slide producing high resolution images of 0.2micron/pixel. At this point images can be made available to the client anywhere in the world, on their own web browser, to examine using virtual microscopy software.
PharmaClient
Images are analysed at Medical Solutions using their proprietary PharmaClient software, which quantifies stained areas in terms of field fraction of pixels and pixel intensities for entire fields or in different cellular compartments, such as the nucleus, cytoplasm or plasma membrane.
Medical Solutions has recently integrated algorithms into PharmaClient that provide automatic recognition of key structural features of the tissue: for example hair follicles in skin, or malignant epithelial cells in a tumour.
The process, from immunohistochemical staining to generation of numerical data, is now entirely automatic with minimal human intervention, making the process more objective and robust, a necessary requirement particularly for regulatory studies, notes the team at Medical Solutions.
The addition of the automated delineation algorithms and the high-throughput IHC platform has also enabled Medical Solutions to meet tight deadlines in a number of biomarker studies; the use of this program saves valuable time, and cuts staffing costs.
A typical example of the product of this platform would be a a section of normal human skin being immuno-stained on an automated stainer to reveal expression of the EGF receptor, which is seen as areas of brown stain, strongly evident in the membrane regions of epithelial cells within the epidermis, but also within the cytoplasm of some of those same cells.
The histograms will show the final output (in one of several available forms) from the image analysis, providing quantitative information about areas of expression for different compartments of the skin, including the basal and suprabasal layers of the skin, as well as the subcellular distribution (ie, cytoplasm, membrane and nucleus).
Pixel intensity is also measured and can be presented as a histogram. This is of particular importance in oncology studies, where skin is often used as a surrogate, although the technology has been used in a variety of therapeutic areas including inflammation and respiratory disease.
Partnership
It takes more than just the technology to make the whole process work, however. The company does have a core expertise, recognised around the world, in high-throughput IHC and image analysis, but the Drug Development Services team also believe that their ability and willingness to sit down with clients, listen to their needs, and manage projects with them in partnership, enables Medical Solutions to work successfully with many of the major pharmaceutical and biotech companies.
"With the FDA wanting more and more data to support a potential drug entering the market, it has become increasingly important to be able to provide both pharmaceutical and biotech companies with the most comprehensive data possible. We believe that we have got this offering right, and spend a lot of time with our clients to understand exactly what they want, and the best way forward to meeting the milestones they must reach within designated time limits," says Commercial Director Jackie Rodgers.
Indeed, Medical Solutions has gone from strength to strength in the past year, and with this comprehensive offering for Drug Development Services encompassing Pre-clinical and Clinical Trials, Biomarker assay development and validation, it's easy to see that the next year could be very exciting for the company and the clients it supports.
