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Clinical Genomics: The Impact of Genomic Technology on Clinical Trials and Medical PracticePublished by: CHI Insight Pharma Reports Published: May. 1, 2004 - 136 Pages Table of ContentsExecutive Summary Chapter 1. Introduction 1.1. Genomics in the Clinic -A Vision of the Future -Definition of Clinical Genomics -The Human Genome 1.2. Prec linical Versus Clinical Applications of Genomics 1.3. Impact of Human Genome Information -The Human Genome Project --Brief Timeline of Human Genomics -Major Discoveries About the Human Genome -NIH Forecast of the Impact of Genomics --NHGRI Vision for the Future of Genomics Chapter 2. Promises and Challenges of Clinical Genomics 2.1. The Promise of Clinical Genomics -Advantages of a Genomics Approach -Potential Impact on Medical Practice -Potential Impact on Drug Development 2.2. Challenges in the Field -Scientific Challenges -Technological Challenges -Regulatory Challenges -Legal Challenges --The Biojudiciary Project -Economic Challenges -Sociological and Cultural Challenges Commentary by Geoffrey Ginsburg, Millennium Pharmaceuticals Chapter 3. Clinical Genomics Applications: Prediction, Detection, and Diagnosis Genomic Characteristics with Clinical Applications 3.1. Determining Risk of Disease -Inherited Genetic Variation -Categories of Inherited DNA Diseases -Single-Gene Genetic Disorders -Multifactorial Disorders --Genetic Origin of Cancers 3.2. Predicting Response to Drugs -Pharmacogenomics 3.3. Factors Influencing Response to Drugs -Drug Metabolism -Drug Transporters -Genetic Pol ymorphism of Drug Targets -Genetic Variants with Indirect Effects on Drug Response 3.4. Diagnose and Monitor Diseases -Variation in Gene Expression -Cancer Classification, Diagnosis, and Prognosis --Cancer Genome Anatomy Project 3.5. Detecting Response to the Environment -Toxicogenomics --National Center for Toxicogenomics -Combating Bioterrorism -Infectious Disease Susceptibility 3.6. Identifying Individuals: Paternity and Forensics Testing -Paternity Testing -Forensics -Identifying Remains Chapter 4. Genomic Technologies for the Clinic 4.1. DNA Variation: Detection and Genotyping -Single Nucleotide Polymorphisms (SNPs) -Haplotype Map --HapMap Project -SNP Genotyping Methods -Evaluating SNP Technologies for Clinical Applications -Popular SNP Genotyping Technologies --Selected Companies Providing SNP Technology, Services, or Reagents -Techniques for Identity Testing 4.2. Gene Expression Detection -Measuring Gene Expression -DNA Microarrays -Computational Issues --Microarray Gene Expression Data (MGED) Society -Laser Capture Microdissection -Evaluating the Technologies 4.3. Other Technologies -Molecular Imaging -Gene Therapy -Proteomics Commentary by David Craford, Affymetrix Chapter 5. Current Applications of Clinical Genomics 5.1. Overview -Preclinical Applications 5.2. Applications in Clinical Trials -Early Phase Applications -Banking Blood Commentary by Todd R. Golub, Dana-Farber Cancer Institute 5.3. Applications of Gene Expression Analysis -Oncology Clinical Trials -Breast Cancer Gene Expression Analysis -Future Clinical Medicine Applications of Gene Expression Assays -Technical Limitations -Preclinical Studies 5.4. Applications in Toxicogenomics -Toxicogenomic Application Example #1: TPMT -Toxicogenomic Application Example #2: CYP450s -Future Prospects for Toxicogenomic Applications 5.5. App lications in Cancer -Cancer Application Example #1: Her-2 and Herceptin -Cancer Application Example #2: BRCA1 and BRCA2 Genes 5.6. Applications in Infectious Diseases -Infectious Disease Application Example: HIV Resistance Testing -Other HIV Applications 5.7. Applications in Cardiovascular Disease -Cadiovascular Disease Application Example: Factor V Leiden 5.8. Other Applications -Genomic Profiling -Newborn Screening -Prenatal Testing -Identity Testing -Paternity Testing -Forensics Testing Chapter 6. Business and Strategic Issues 6.1. Overview 6.2. Key Factors Driving Adoption -Patients and Patient Groups -Ma naged Care Providers -Pharmaceutical Industry -Government and Regulatory Authorities -Improved Technologies -Legal System -Proof Applications 6.3. Cost Evaluation of Clinical Genomics -Measuring Costs -Factors Influencing Costs -Comparing Costs to Other Treatment Options -Cost-Benefit and Cost-Effectiveness Analysis -Specific Evaluations 6.4. Regulatory Environment -FDA Draft Guidelines on Pharmacogenomics -"Home-Brew” Testing 6.5. Clinical Genomics Diagnostics Market 6.6. Market Outlook -Toxicogenomics -Oncology -Infectious Disease -Inherited Disease -Identity Screening 6.7. Business Opportunities Commentary by David Wang, First Genetic Trust Appendix. Selected Clinical Genomics Companies Abbott Diagnostics ACLARA BioSciences Agendia Arcturus Ardais deCODE genetics diaDexus EXACT Sciences ExonHit Therapeutics First Genetic Trust Genaissance Pharmaceuticals Gene Logic Genomic Health Genomics Collaborative Gentris Corporation Iconix Pharmaceuticals, Inc. Interleukin Genetics LabCorp Moltox (Molecular Toxicology Inc.) Myriad Genetics, Inc. ParAllele BioScience Perlegen Sciences, Inc. PointOne Roche Molecular Diagnostics SEQUENOM Spectral Genomics, Inc. SurroMed Glossary Index AbstractClinical Genomics: The Impact of Genomic Technology on Clinical Trials and Medical Practice assesses the challenges and future prospects for incorporating genomics technologies into standard clinical practice. The report examines some of the ways in which genomics could directly contribute to clinical practice, evaluates the scientific, technological, legal, and regulatory issues that will have a significant impact on the future adoption of genomics in clinical settings, and discusses the emerging business opportunities that will arise as the widespread application of genomics to clinical drug development, diagnostics, and medical practice comes to fruition.Get Full Details About This Report >> |
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