A Biomarker Strategy is a Must to Succeed in Today's Extremely Competitive Drug Development Environment Read More inside Toxicity Biomarkers: Promising Tools for Accelerated Drug Development.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c47910) has announced the addition of Toxicity Biomarkers: Promising Tools for Accelerated Drug Development to their offering. In the wake of several notorious drug withdrawals caused by unsuspected toxicities, pharmaceutical companies are searching for ways to minimize the escalating risks and costs of drug development. Biomarkers of toxicity offer the hope of producing safer drugs while cutting costs and time to market and are inspiring some novel collaborations. Get the Answers You Need to Shape Your Strategy Drug development productivity is declining while costs rise. What factors contribute to this situation? How big a role does toxicity play? How can toxicity biomarkers change the equation? The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. is encouraging identification and validation of biomarkers. What initiatives are under way? What companies are developing toxicity biomarkers? Who are their collaborators? A biomarker strategy is a must to succeed in today's extremely competitive drug development environment. What challenges do companies face? What is the time frame for the realization of toxicity biomarkers? What are the technologies to watch? What is the recommended course of action for the near and long term? Scope of This Spectrum Report Uses of toxicity biomarkers: Drug development, clinical trials, aid in go/no-go decision making, identify off-targets, select lead compound, choose the best animal model, identify interspecies biomarkers of toxicity, stratify strat·i·fy v. strat·i·fied, strat·i·fy·ing, strat·i·fies v.tr. 1. To form, arrange, or deposit in layers. 2. patients, adjust schedule/dose. Potential biomarkers: Alpha-glutathion S-transferase, kidney injury molecule-1, troponins, inhibin in·hib·in n. A peptide hormone secreted by the follicular cells of the ovary and the Sertoli cells of the testis that inhibits secretion of follicle stimulating hormone from the anterior pituitary. B. Initiatives and organizations: Critical Path initiative, C-Path Institute, International Life Sciences Institute, Health and Environmental Science Institute, Predictive Safety Testing Consortium, Eureka, Consortium for Metabonomic Toxicology, Drug- Induced Liver Toxicity Network, Voluntary Genomics Data Submission, Biomarker Qualification Pilot Process. Challenges: Technical issues, biomarker validation, bioinformatics, intellectual property. Content Outline: Executive Summary Strategic Considerations Stakeholder Implications Drug Toxicity: An Ongoing Challenge for Developers Drawbacks of Traditional Approaches to Toxicology Applications and Benefits of Biomarkers of Toxicity in Drug Development What Is a Biomarker? Why Use Biomarkers of Toxicity? Toxicogenomics: Technologies for Identifying Biomarkers of Toxicity Gene Expression Profiling Microarray technology is often used for gene expression profiling. It makes use of the sequence resources created by the genome sequencing projects and other sequencing efforts to answer the question, Proteomics Metabolic Profiling Genotyping Examples of Potential Biomarkers of Toxicity a-Glutathion S-Transferase in Hepatotoxicity hepatotoxicity (hepˑ·  ·tō·t Kidney Injury Molecule-1 in Nephrotoxicity neph·ro·tox·ic·i·ty n. The quality or state of being toxic to kidney cells. nephrotoxicity(ne·fr Troponins in Cardiotoxicity Inhibin B in Testicular testicular /tes·tic·u·lar/ (tes-tik´u-lar) pertaining to a testis. tes·tic·u·lar adj. Of or relating to a testicle or testis. testicular pertaining to the testis. Toxicity Challenges in Integrating Biomarkers of Toxicity into Drug Development Technical Issues Biomarker Validation Bioinformatics/Integration Intellectual Property The Critical Path Initiative and Biomarker Discovery Biomarker discovery is the process by which biomarkers are discovered. It is a medical term. Many commonly used blood tests in medicine are biomarkers. The way that these tests have been found can be seen as biomarker discovery. Industry Trends Collaborative Agreements Aureus The aureus (pl. aurei) was a gold coin of ancient Rome valued at 25 silver denarii. The aureus was regularly issued from the 1st century BC to the beginning of the 4th century AD, when it was replaced by the solidus. Pharma, ChemAxon, Sanofi-Aventis, and Budapest University of Technology and Economics History The legal predecessor of the university was founded in 1782 by Emperor Joseph II, named Institutum Geometrico-Hydrotechnicum (Institute of Geometry and Hydrotechnics). BG Medicine Ciphergen Biosystems Clinical Data Gene Logic Iconix Biosciences Metabometrix RxGen Consortia International Life Science Institute Health and Environmental Science Institute Predictive Safety Testing Consortium Consortium for Metabonomic Toxicology Drug-Induced Liver Injury Network Outlook for Biomarkers of Toxicity Tables 1. Select Drug Withdrawals Due to Safety Issues, 1997-2005 2. Metabolizing Enzymes Implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in Drug-Induced Toxicity 3. Biomarker Classification 4. Profiled Companies Active in Development of Biomarkers of Toxicity 5. Profile of the Affymetrix/Iconix ToxFX Chip Figures 1. Reasons for Termination of New Compounds 2. Applications and Benefits of Biomarkers of Toxicity in Drug Development 3. Schematic Example of Using DNA Microarray Technology in Biomarker Discovery 4. 2DGE/MS-Based Protein Analysis Scheme in Biomarker Discovery 5. Framework for Data Integration from Different Technology Platforms Companies Mentioned: Abbott Aegerion Pharmaceuticals Affymetrix Amgen AstraZeneca Aureus Pharma Bayer BG Medicine Boehringer Ingelheim Bristol-Myers Squibb Budapest University of Technology and Economics Cambridge Antibody Technology ChemAxon Ciphergen Clinical Data Consortium for Metabonomic Toxicology C-Path Institute Drug-Induced Liver Injury Network Eli Lilly Environmental Science Institute Enzon Pharmaceuticals Eureka Food and Drug Administration GeneLogic GlaxoSmithKline Iconic Biosciences Icoria Imperial College, London International Life Science Institute Isis Pharmaceuticals Johnson & Johnson Liver Toxicology Biomarker Study Merck Metabometrix Micromet Mitsubishi Pharmaceuticals National Institutes of Health Novartis Pfi zer Pharmacia Predictive Safety Testing Consortium Roche RxGen Sanofi -Aventis Schering-Plough University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli. http://upenn.edu/. Address: Philadelphia, PA, USA. Warner-Lambert Waters Wyeth-Ayerst Technologies Bioinformatics DrugMatrix database Gas chromatography gas chromatography (GC) Type of chromatography with a gas mixture as the mobile phase. In a packed column, the packing or solid support (held in a tube) serves as the stationary phase (vapour-phase chromatography, or VPC) or is coated with a liquid stationary phase Gene expression profi ling Genesis Enterprise System Genotyping KnowTox Liquid chromatography Mass spectrometry mass spectrometry or mass spectroscopy Analytic technique by which chemical substances are identified by sorting gaseous ions by mass using electric and magnetic fields. Metabolic profi ling (metabolomics, metabonomics) Nuclear magnetic resonance nuclear magnetic resonance: see magnetic resonance. nuclear magnetic resonance (NMR) Selective absorption of very high-frequency radio waves by certain atomic nuclei subjected to a strong stationary magnetic field. spectroscopy Open Array platform PrimaTox Proteomics SNP SNP Scottish National Party Noun 1. SNP - (genetics) genetic variation in a DNA sequence that occurs when a single nucleotide in a genome is altered; SNPs are usually considered to be point mutations that have been evolutionarily assay Systems toxicology ToxExpress ToxFX Analysis ToxShield For more information visit http://www.researchandmarkets.com/reports/c47910 Source: Decision Resources |
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