Early screening and innovative solutions key to drug development

1st April 2013

Typically, new drug approval is a protracted, expensive and complex process. Approximately 90percent of clinical candidates fail during the development stage with the estimated costs due to poor absorption, distribution, metabolism, elimination or toxicity (ADME/Tox) properties believed to be between US$50m and US$70m.
Innovative solutions and early introduction of ADME/Tox technologies now offer the promise of reducing attrition rates during clinical development. Such advances are poised to help multinational pharmaceutical and biotechnology companies benefit from the ‘fail early, fail cheaply’ syndrome.

“The ADME/Tox technology market is highly competitive and profitable. However, the market also has tendencies to be unstable at times,” says Frost & Sullivan Healthcare Analyst, Amarpreet Dhiman in the company’s new report Strategic Analysis of the ADME/Tox Technologies Markets in Europe.

“It is becoming increasingly clear that the ability to detect issues with pharmacokinetics before the drug moves into clinical testing will ultimately save considerable resources in time and money for pharmaceutical and biotechnology companies.”

Previously, ADME/Tox tests were deployed in the later stages of drug development. However, with the number of drug targets as well as the volume of assay points performed in high-throughput screens expanding, it has become critical to rapidly and efficiently triage potential hits – those having significant ADME and toxicity profiles.
To this end, the introduction of improved ADME/Tox screens as early as possible in the drug discovery process is gaining appeal. Already, innovative technologies and solutions are facilitating ADME/Tox optimisation earlier in the drug discovery pipeline.
This will help yield compounds with good target affinity, reasonable drug-like properties and ensure greater likelihood of acceptable ADME/Tox properties. Moreover, it is likely to accelerate the selection process, reduce the cost of preclinical and clinical studies and boost overall prospects of success.

Already, sophisticated informatics is being widely deployed to manage data for analysis and interpretation. Advanced software with the ability to distil compound leads with promising drug development potential, as well as predict biological properties, have been designed. Complete solutions that include tools are also poised to amplify their presence within the ADME/Tox tools market.

In-silico techniques, complex and accurate models for rationalising and predicting ADME properties, are allowing enhanced prediction of complex systems such as hepatoxicity and cardiotoxicity.

Such computational technologies and predictive solutions are likely to enhance the scope and speed at which drugs develop from a research to clinical stage. At the same time, however, in order for ADME/Tox studies to be truly beneficial, data generation needs to be of high quality, reliable and accurate.

“The key would be to develop tools that facilitate data consolidation and information sharing,” advises Dhiman. “Standardised systems and solutions that integrate data from numerous tools and experiments need to be developed while manufacturers should develop opportunities to offer services in data management, training, tool maintenance and others, functioning as both a service providers and product developers.”

As companies try to decrease costs by increasingly outsourcing drug development functions, failure rates become more controlled, in-silico technologies become more widely adopted and a better understanding of ADME/Tox and pharmacokinetic properties motivates the use of innovative solutions and early ADME/Tox screening. As a result, the European ADME/Tox technologies market will grow from its current size of US$384million to US$776million by 2011.

One key global trend is likely to be the rising uptake of in-vitro screening technologies for screening toxic compounds. A stream of novel compounds moving through the clinical process is likely to support the rapid development of assays for ADME/Tox properties, creating, in turn, significant long-term market growth opportunity for in-vitro screening technologies.

And drug sustainability too

High clinical development costs coupled with declining drug discovery success rates are causing productivity levels to fall in the global pharmaceuticals industry. The imminent patent expiry of several major blockbuster drugs and the related rise of cheaper generic alternatives are further exacerbating the situation.

Despite this, the global pharmaceutical industry offers significant growth opportunity for participants that can build new strategic business models, according to the World Clinical Development Pipelines in the Pharmaceuticals Industry report from Frost & Sullivan.

Estimated at US$554bn in 2004, the global pharmaceuticals market is forecast to register an annual growth rate of 8.2percent from 2004 to 2011 to reach US$967bn.

Such expansion is expected, however, to be based on the ability of pharmaceuticals companies to adapt to changes in patient population, and target diseases of unmet medical need to maximise revenue potential.

For instance, an ageing global population is poised to drive pharmaceutical drugs for indications such as macular degeneration and Alzheimer’s disease. Drugs that address rising multifactorial disorders such as cancer as well as lifestyle disorders such as obesity are also likely to experience strong revenue growth.

Moreover, as patient groups become more fragmented and diagnostic methods improve, the demand for evidence-based personalised treatments is likely to increase.
“It is essential for major pharmaceuticals companies to move from the blockbuster model and adopt new strategies that cater to specific diseases areas and populations,” noted healthcare analyst Phil Webster. “To grow in this new era of
evidence-based personalised medicine, companies should generate a sustainable product pipeline characterised by improved productivity and diversity.”

Market participants need to replace their dependence on a limited number of highly lucrative drug candidates with a more comprehensive and diverse product portfolio. Innovative products that focus on areas of unmet medical need and cover a broad range of disease indications are likely to underpin a strong, sustainable product pipeline. Furthermore, companies need to examine reformulations and investigate new indications for existing blockbuster drugs.

At the same time, the use of computer modelling and biomarker discovery to aid the discovery of promising drug candidates is likely to facilitate an enhanced understanding of the clinical development process and help them to make more informed investment decisions.

“Less investment will be lost through late stage drug candidate failures as more compounds succeed in the clinical development process,” added Webster. “More novel techniques to identify toxic or ineffective drugs early in the development process such as the use of biological models, bioinformatics and biomarkers will drive down development costs, increase revenues and improve overall industry productivity.”

As large pharmaceuticals companies try to enhance their drug development pipelines, mergers, acquisitions and licensing agreements for individual compounds are likely to gain appeal. Mergers and strategic collaborations to invest in existing leads are also likely to diffuse the cost of potential failures, thereby preventing the draining of company resources, concludes the report.





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