Biomarkers: Applications & trends that are revolutionizing drug discovery & development

Published Date: 03/08/2010
Category: Drug Discovery & Development

Research Report Decription

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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.

Key Questions Answered:

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 markersReview 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

Companies Mentioned:

Abbott Diagnostics, Affinium Pharmaceuticals, Agennix (formerly GPC Biotech), AlphaGene, Almac Diagnostics, Applied NeuroSolutions, Atheris Laboratories, Aurelium Biopharma, Axaron Bioscience AG, Bushon BioSystems, BG Medicine, Bioanalyte, BioSystems International, Capital Genomix, Caprion Proteomics, Celldex Therapeutics (formerly CuraGen Corp.), Ciphergen Biosystems A/S, CGI Pharmaceuticals, Clinical Data, Compugen, Covance, Cytos Biotechnology, Dako Denmark, deCODE Genetics, Definiens, diaDexus, Entelos, Epigenomics AG, Epitome Biosystems, Epistem, Febit, FoxHollow Technologies, Frantz BioMarkers LCC, Gene Bridges GmBH, Gene Network Sciences, GeneGo , Genset, Genestract, Gentris Corporation, Health Discovery Corp, HistoRx, Human Genome Sciences (HGS), Hunt Biosciences, Hybrigenics SA, Iconix , Illumina, ImaGene GmbH, Immunetrics, Ingenuity, Genset, Genestract, Gentris Corporation, Health Discovery Corp, HistoRx, Human Genome Sciences (HGS), Hunt Biosciences , Hybrigenics SA , Iconix, Illumina, ImaGene GmbH, Immunetrics, Ingenuity Innogenetics NV, Ipsogen, Invitrogen Corporation, KineMed, Kinaxo Biotechnologies GmBH Germany, Kyorin Pharmaceuticals, Lipomics Technologies, Luminex Corporation, MDS Pharma Services, Millennium Pharmaceuticals (Subsidiary of Takeda), Metabolon, Metabometrix Ltd, Metanomics Health Gmbh, Monogram Biosciences, Myriad Genetics, M2Gen (Moffitt Genetics Corp), Nanogen, Neuroimage, Odyssey Thera, Orion Genomics LLC, Ore Pharmaceuticals (Formerly GeneLogic ), Oxford Biotherapeutics, Pacific Biomarkers, Phenomenon Discoveries (PDI), Physiomics Rational Therapeutics plc, Power3 Medical Products, PPD (formerly SurroMed), Predicant Biosciences, Predictive Biosciences, Predictive Diagnostics, Prediction  Sciences, Protagen AG Biotechnology, Protea Biosciences, Proteome Sciences, Proteome Systems, ProteoSys AG, Proventys, PXBioVision (formerly DigiLab BioVisioN), Proventys, QIAGEN, Quintiles, Ribonomics, Rigel Pharmaceuticals, Rosetta Inpharmatics, Rules-Based Medicine, SomaLogic, Serenex, SIRS-Lab GmbH, VirtualScopics, Zyomyx

Paper Highlights:

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. 

• 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.

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.