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Biomarkers: Applications and Trends
Espicom Business Intelligence Ltd, Aug 2010, Pages: 138
While Biomarker research is still in its infancy, great strides have been made in the discovery and utilisation of biomarkers in the development of targeted cancer therapeutics and companion diagnostics. Furthermore, there are still significant opportunities in other disease areas to improve productivity by identifying the most suitable developmental candidates earlier during the R&D process.
Stakeholder engagement is critical:
All stakeholders have an important part to play. Regulators across the globe are in the process of establishing the necessary guidelines and framework in which to assess biomarker data. This in turn should encourage the pharma and diagnostic industries to adopt new technologies which will help to transform the drug and diagnostic development process to a “learn and confirm” model. The application of biomarker techniques will shift attrition rates to earlier in the R&D process, enable the reallocation of resources to high probability candidates and help with the development of diagnostics.
A maturing industry capable of providing real advances is emerging:
Numerous companies and service providers are beginning to emerge which can provide the industry with a host of innovative bioinformatic, chemogenomic, genomic, glycoproteomic, metabolomic, peptidomic, pharmacogenomic, proteomic and transcriptomic technology platforms targeting biomarker discovery, development and qualification. Advances in these fields will continue to drive biomarker research forward increasing sample throughput, enhancing levels of detection and leading to the multiplex detection of multiple biomarker panels for use in preclinical research, the clinic and the commercialisation of diagnostics.
Biomarkers used in clinical trials set to take centre stage:
Despite tough economic conditions, innovative companies continue to attract attention from the investment community – a balance between scientific, regulatory and financial resources will be critical for future growth.
The biomarker discovery segment is the largest revenue generator and accounted for nearly half of sales in 2009. Biomarkers for use in clinical trials, which currently account for a relatively small segment of sales are forecast to grow significantly by 2015 with a CAGR of 37.6%.
Whilst the return on investment is difficult to assess due to the immaturity of the market, key opinion leaders believe biomarkers hold great promise towards the development of a new generation of therapeutics and diagnostics which in the longer term can enhance the personalisation of medicine and help to alleviate the burden of healthcare across the globe.
This new August 2010 report provides a complete appraisal of the emerging importance of Biomarkers in drug development More Information...
With this report you can...
- Understand the current regulatory thinking, support and implications for the pharma industry
- Be up-to-date with the technical challenges arising from the discovery and validation of biomarkers
- Evaluate the application of biomarkers in drug discovery including the increasingly influential fields of proteomics and metabolomics
- Easily assess the use of biomarkers in clinical diagnostics
- Understand the role of biomarkers in clinical development with the examination of response, prognostics, surrogate and predictive markers
Review the players, alliances and acquisitions in this fast growing area. Who’s developing what in key therapy areas such as cancer, cardiovascular, CNS, anti- inflammatory and anti-infective disease
Assess the future development of biomarkers with an evaluation of their application in new disease areas with advanced technology for their identification and qualification
Assess the near, mid and long term impacts of biomarkers
Expert opinions from...
Spiros Vamvakas MD, EMEA
Head of Scientific Advice, Human Medicines Special Areas EMEA expressing his personal views on the importance of biomarkers in drug R&D
Dr Conrad Bessant
Bioinformatics Group, Cranfield University, UK
Dr Michael Merz,
SAFE-T Consortium
Preclinical Safety, Translational Sciences, Head of Safety Networks, Novartis Institutes for BioMedical Research, Basel, Switzerland
Dr Scott Allocco, BA. Biomarker Strategies
President & co-founder of BioMarker Strategies
Sam LaBrie, Ph.D
Rules Based Medicine
VP, Corporate Development, Rules Based Medicine, Inc
Few would contest the need for pharmaceutical research to be productive. Despite significant increases in the cost of drug discovery and drug development, the number of new NCE and biological products reaching the market has not improved. A new way of conducting research has to be found and much hope and investment is being set by Biomarkers.
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