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Published by: Visiongain
Published: Jul. 1, 2002 - 150 Pages
Table of Contents
1. Introduction to Personalized Medicines
1.1 Biomedical Advances in the 21st Century & Achievements of the Human Genome Project
1.2 What is Personalized Medicines?
1.2.1 Personalized Medicines & Interindividual Differences in Drug Response
1.3 Pharmacogenomics & Pharmacogenetics defined The Pharmacogenomics Revolution will consist of 3 R&D areas
1.3.1 Pharmacogenetics
1.3.2 Pharmacogenomics
1.4 The Promise of Pharmacogenomics in Personalized Medical Therapy The Promise of Pharmacogenomics
2. Pharmacogenomics & Genomic Technologies for Analyzing DNA
2.1 Bioinformatics
2.2 Microarray Technology (DNA chips)
2.2.1 Potential Applications of DNA Microarray Technology & Gene Expression Studies
Table 1. Potential uses of Microarray Technology for the Diagnosis, Prognosis & Treatment or Prevention of Diseases, resulting from Genetic Mutations/Proto-Oncogene over-expression
3. Genomic Research Focus on Genetic Polymorphisms
3.1 Single Nucleotide Polymorphisms (SNPs)
3.2 Companies & Organizations engaged in SNP research
3.3 The SNP Consortium
3.3.1 Companies & Academic Centers in the SNP Consortium
3.3.1(a) Pharmaceutical Companies
3.3.1(b) Academic Centers
3.3.1(c) Other companies
3.4 Food & Drug Administration Guidelines on Genetic Polymorphism Research
4. The Influence of Polymorphisms on Drug Metabolism & Clinical Therapy
Table 2. Selected Examples of Clinically Important Polymorphisms
4.1 Receptor & Enzyme Polymorphisms that affect Drug Metabolism
Table 3. Selected Genes with well-established Responder & Non-Responder Phenotypes
4.2 Beta2-Adrenergic Receptor Polymorphisms
4.3 N-Acetyltransferase 1 & 2 (NAT1, NAT2)
4.3.1 Slow Acetylators
4.3.2 Rapid Acetylators
4.4 Dihydropyrimidine Dehydrogenase (DPD)
4.5 Cholesteryl Ester Transfer Protein (CETP)
4.6 Angiotensin-Converting Enzyme (ACE)
4.7 Serotonin Transporter (5-HTT)
4.8 Multi-drug Resistance Protein MDR-1 (Pgp)
4.9 Thiopurine Methyltransferase (TPMT)
TPMT activity - White/African Americans
Graph 1. TMPT Activity in White/African American Population
5. Cytochrome P450 Isoenzymes
Table 4. Cytochrome P450 enzymes involved in Xenobiotic Metabolism
5.1 CYP2D6
5.1.1 Polymorphic Variations of CYP2D6
5.1.2 Increased Risk of Adverse Drug Reactions in Poor Metabolizers
5.1.3 Drugs Metabolized by CYP2D6
Table 5. Selected CYP450 Subtypes (isoenzymes) that Influence Drug Response
5.2 CYP3A
5.3 CYP2C19 Frequency of CYP2C19 Poor Metabolizer phenotype
5.4 CYP1A2
5.4.1 Theophylline
5.5 CYP2E1
5.6 CYP2C9
Table 6. Substrates, Inhibitors & Inducers of Cytochrome P450 Isoenzymes
6. Benefits of Pharmacogenomics
6.1 Anticipated Benefits of Pharmacogenomics in Facilitating Drug Development
6.1.1 Identify People that Respond to Drug Treatments
6.1.2 Develop Targeted Drugs for Specific Genetic Groups
6.1.3 Reviving Failed Drug Candidates & Expanding Indications for Existing Therapeutic Medications
6.1.4 Predict Adverse Reactions & Identify Genotypes that Correlate to Adverse Drug Response or Side Effects
6.1.5 Facilitate the Drug Approval process & Reduce Time to Market
6.1.6 Minimize the Failure of Drugs in Late Developmental Stages
6.1.7 Creating a New Market of Therapeutic Products
6.1.8 Cheaper Drug Development
Table 7. Selected Drugs submitted for Approval or in Phase III Development & Discontinued in 2000 due to Lack of Efficacy or for safety Reasons
Table 8. Selected Drugs withdrawn from the Market due to Adverse Side Effects
6.2 Implications of Pharmacogenomics on Drug Revenues, Marketing & Development
6.3 Benefits of Pharmacogenomics in Clinical Trials
6.4 Benefits of Genetic Profiling in Clinical Therapy & Pharmacogenomics to Patients
6.4.1 Advanced Warning of Patient Susceptibility to Disease
6.4.2 Eliminate Standardized Trial & Error and 'One Size Fits All' Approaches to Drug Prescriptions
6.4.3 Accurate Doses with Medications Tailored to Patients' Genotypes
6.4.4 Prescription of Drug Types Appropriate to Specific Genotypes
7. Pharmacogenomics in Action
7.1 Examples of Applied Pharmacogenomic Knowledge in Clinical Therapy
7.1.1 Liver Enzymes
7.1.2 Infectious Disease
7.1.3 Alzheimer's Disease
7.1.4 Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency
7.1.5 Codeine
7.1.6 Breast Cancer
7.1.7 Pravastatin (Pravachol)
7.1.8 Oral contraceptives
7.2 The Potential of Pharmacogenomics to Improve Drug Efficacy & Safety
7.3 Costs associated with Adverse Drug Reactions Case Study: Withdrawal of Romozin by Glaxo Wellcome in 1997
7.4 Pharmacogenomics to Reduce the Risk of Adverse Drug Reactions Deaths Caused by Adverse Drug Reactions in the US
8. Limitations of Genomics & Personalized Medicines
8.1 Widespread Genotyping & the Creation of a Genetic Database
The Pharmacogenetics Knowledge Base (PharmGKB)
8.2 Distinguishing Environmental Factors from Genetic Factors in Drug Response
8.3 Understanding Complex Interactions of Drugs
8.4 Popular Misconceptions, Public Fear of Genetics & Ethical Issues
8.5 Public Acceptance of Genetic Profiling (Genotyping)
Table 9. Public Acceptance of Genotyping to Identify Predisposition to Disease
Graph 2. Do you think developing technology to map the genome is morally wrong?
Graph 3. If you had access to your genetic code, would you want to know what diseases you were predisposed to?
Graph 4. Would you want your health insurer to know?
Graph 5. Would you want the government to know?
9. Establishing Guidelines for Genomic Research & Genetic Screening
9.1 Guidelines for the Genetic Screening of Adult-Onset Disorders
9.2 National Society of Genetic Counselors' Guidelines for Genetic Testing
9.3 NSGC Recommendations for Protocols relating to Predisposition Genetic Testing
9.3.1 Multidisciplinary Approach
9.3.2 Pre-Test Education & Genetic Counseling
9.3.3 Post-Test Education & Counseling
9.3.4 Laboratory Issues
10. Academic Research in Personalized Medicines & Pharmacogenomics
Table 10. Pharmacogenetic Research Projects Funded by the NIGMS & other NIH components in 2000
11. The Impact of Genomics on the Pharmaceutical Industry
11.1 Mounting Pressures on Companies to Invest in Pharmacogenomics
11.1.1 Four Factors that Drive Investment in Pharmacogenomics
11.2 Impact of Genomic R&D
11.3 Impact of Genomics on Drug Applications
11.4 Impact of Genomics on Drug Discovery
11.5 Impact of Genomics on Internal Regulations
11.6 Regulatory Guidelines for Genetic Testing & Genotype-Specific Drug Development
12. Milestones in Personalized Medicines
12.1 Discovery of Genetic Markers linked to Statin Drug Response
12.2 Side Effect of AIDS Medication Linked to Genes
12.3 Direct to Consumer Pharmacogenetics Marketing - CYP2D6 Gene Tests
13. Genomics-Based Products & Genetic Disorder Medications in the Pipeline
Table 11. Genomically Derived Compounds in development
Table 12. Products in the Pipeline for Genetic Disorders
14. Pharmacogenomic Clinical Trials
14.1 Asthma Therapy
14.2 Schizophrenia Therapy
14.3 Case Study: Herceptin Therapy for Breast Cancer
14.3.1 FDA Approval of a Genotype-Specific Therapy
14.3.2 Herceptin's Mechanism of Action
14.3.3 Herceptin Clinical Trials in Progress
14.3.4 NICE Approves Herceptin for Advanced Breast Cancer Treatment
14.3.5 Adverse Side Effects of Herceptin
14.3.6 Herceptin Highlights the Potential Benefits & Limitations of Personalized Medicines
15. Companies Engaged in Pharmacogenomic Research & Personalized Medicines
15.1 Overview of Companies involved in the Development of Personalized Medicines
15.2 The Personalized Medicines Revolution
15.3 Collaborations in the Field of Pharmacogenomics & Research Areas in the Development of Personalized Medicines
15.4 Selected Companies engaged in Pharmacogenomics & Personalized Medicines
Table 13. Companies engaged in Pharmacogenomic Research & Developing Technologies or Targeted Drug Products for Personalized Medicines
15.5 Total Revenues, R&D Allocation & Expenditures of Pharmacogenomic Research and Genomic Technology Companies
Table 14. Revenues & Expenditures of Selected Companies with a Research Focus on Genomics, including Pharmacogenomics
Graph 6. Leading Companies in the Personalized Medicines Revolution by Total Revenues
Graph 7. Leading Companies in the Personalized Medicines Revolution by R&D Allocation
Graph 8. Revenues of Selected Companies Developing Personalized Medicine Products
Graph 9. R&D Allocations of Selected Companies Developing Personalized Medicine Products
16. Company Profiles
16.1 deCODE Genetics
Company Vision
16.1.1 Market
16.1.2 Finance
16.1.3 Research Focus/Company Highlights
16.1.3(a) Gene Discovery and Drug Development
16.1.4 Key Product(s)/Services
16.1.5 Collaborations & Alliances
16.2 Genaissance Pharmaceuticals
Company Vision
16.2.1 Market
16.2.2 Finance
16.2.3 Research Focus/Company Highlights
16.2.4 Key Product(s)/Services
16.2.4(a) HAP Technology to Identify Genetic Markers
16.2.5 Collaborations & Alliances
16.3 Celera Genomics
Company Vision
16.3.1 Market
16.3.2 Finance
16.3.3 Research Focus/Company Highlights
16.3.3(a) Developments to support Celera Genomic's drug discovery
strategy
16.3.3(b) Celera Genomic's therapeutic discovery/research focus
16.3.3(c) The company's therapeutic discovery focus may be categorized
into 5 main areas
16.3.4 Key Product(s)/Services
16.3.5 Collaborations & Alliances
16.3.5(a) Research Collaborations for Drug Discovery & Development
16.3.5(b) Platform Technology Collaborations
16.3.5(c) Genomic Discovery Collaborations
16.4 Genentech
Company Vision
16.4.1 Market
16.4.2 Finance
16.4.3 Research Focus/Company Highlights
16.4.3(a) Genentech's research focus: Oncology
16.4.3(b) Genentech's research focus: Immunological disease
16.4.4 Key Product(s)/Services
16.4.5 Collaborations & Alliances
16.5 Incyte Genomics
Company Vision
16.5.1 Market
16.5.2 Finance
16.5.3 Research Focus/Company Highlights
16.5.3(a) Gene Discovery and Drug Development
16.5.4 Key Product(s)/Services
16.5.4(a) Incyte LifeSeq database services
16.5.4(b) Other database products
16.5.4(c) Resources for single nucleotide polymorphism (SNP) discovery
16.5.5 Collaborations & Alliances
16.6 Millennium Pharmaceuticals
Company Vision
16.6.1 Market
16.6.2 Finance
16.6.3 Research Focus/Company Highlights
16.6.3(a) Technologies utilized by the company to form a platform
16.6.3(b) Scientific research & product pipeline focus
16.6.3(c) Millennium's Focus on Proteasome Inhibition for Cancer Therapy
16.6.4 Key Product(s)/Services
16.6.4(a) Therapeutic products
16.6.5 Collaborations & Alliances
16.6.5(a) Therapeutic collaborations
16.6.5(b) Technology Transfer Collaborations
16.6.5(c) Millennium Predictive Medicine Collaborations
17. visiongain Analysis
17.1 The Potential of Pharmacogenomics & Personalized Medicines
17.2 Recent Milestones & Discoveries in the Development of Personalized Medicines
17.3 Fertile Grounds in Personalized Medicine R&D
17.4 Companies & Academic Institutions engaged in Pharmacogenomics
17.5 Pharmacogenomic research & its Impact on the Pharmaceutical Industry
17.6 Outlook of the Pharmaceutical Industry in the Advent of Pharmacogenomics
Appendix 1
Glossary of Genomic Terms
Appendix 2
About visiongain
Companies Mentioned in this Report
Aastrom Biosciences
Abgenix
ACLARA BioSciences Actelion
Affymetrix AgGen
Agilent Technologies
Alkermes
Alliance Pharmaceutical
Alpha Therapeutic
American Home Products
Amersham BioSciences/Pharmacia Biotech
Amgen
Applied Biosystems
AstraZeneca
Aurora Biosciences/Biosystem
Aventis Pharma
Axys Pharmaceuticals
Bayer
BD (formerly Becton Dickinson)
Biogen
BioMarin Pharmaceutical
Bio-Technology
Boehringer Ingelheim
Bristol-Myers Squibb
Caliper Technologies Celera Genomics
Cellegy Pharmaceuticals
COR Therapeutics
Corning
Cortex Pharmaceuticals
CuraGen
DAKO
deCODE Genetics
Eli Lilly
Epoch Biosciences
Exelixis
Galapagos Genomics NV
Genaissance Pharmaceuticals
Gene Logic
Genentech
Genicon Sciences Corporation
Genmab
Genome Therapeutics
Genset
Genteric
Genzyme Biosurgery Geron
Glaxo Wellcome
Human Genome Sciences
Hyseq IBM
Illumnia
Immunex
ImmunoGen
Incyte
Incyte Genomics/Pharmaceuticals Intermune
Invitrogen
Isis Pharmaceuticals
Lexicon Genetics
Lynx Therapeutics Maxim Pharmaceuticals
Merck
Microcide Pharmaceuticals Millennium Pharmaceuticals
Motorola
Myriad Genetics
NEN Life Science Products
Network Appliance
Novartis
Novazyme Pharmaceuticals
Odyssey Pharmaceuticals
Orchid BioSciences
PerkinElmer
Pfizer
Pharmacia & Upjohn
Pharming Group
Rigel, Inc Roche Bioscience
Rosetta Inpharmatics Schering-Plough
Seattle Genetics
Secant Technologies
Sensus Corporation
Sequenom
Silicon Genetics
SmithKline Beecham
SomaLogic
Spotfire
StemCells
Sumitomo Pharmaceuticals
Syrrx
Taisho Pharmaceutical
Tanox
Technology Collaborations
Third Wave Technologies Transgenomic Transkaryotic Therapies
Urogenesys
Variagenics
VaxGen
Visible Genetics
Vysis
XOMA
Institutes, Organizations & Associations mentioned in this Report
American Medical Association
Brigham & Women's Hospital
British Medical Association
Center for Disease Control
First Genetic Trust
Food & Drug Administration
Georgetown University Medical Center
Human Genome Project
Mayo Foundation
National Cancer Institute
National Health Service
National Heart, Blood and Lung Institute
National Human Genome Research Institute
National Institute of Health
National Library of Medicine
National Society of Genetic Counselors
NIGMS - National Institute of General Medical Sciences
PharmGKB
SNP Consortium
Stanford University School of Medicine
University of California
University of Chicago
University of Houston Law Center
Yale University Center
Yale University
AbstractThis visiongain report provides you with the most comprehensive guide to personalized medicines, numerous multicolored graphs and uniquely
compiled tables containing industry facts and figures - can you afford
to be without it?.
Several companies are leading the pharmacogenomics revolution, which
promises to:
- Optimize the efficacy of therapeutic compounds
- Minimize adverse drug reactions and associated long-term costs
- Enhance the cost effectiveness of clinical trials
- Facilitate drug discovery, development, and approval
- Despite the infancy of personalized medicines, genotype-specific
medications is no longer a fiction of the future, but a reality of the
present.
A prime example of the potential benefits of applying genomic knowledge
to clinical therapy is the selective use of Herceptin drug in breast
cancer patients with genotypes that confer positive response to
pharmacological therapy.
This report will answer key questions such as:
- Which companies are leading the personalized medicine revolution?
- What R&D areas are set to show considerable growth?
- What are the benefits of investing in pharmacogenomics?
- Will a research focus on personalized medicine lead to dramatic changes
in clinical therapy?
- How will a pharmacogenomic approach improve the effectiveness of
clinical therapy, minimise adverse reactions and incurred costs from
drug failures in developmental phases?
- What are the knock-on effects of the Human Genome Project on current research?
This report presents an extensive and detailed guide to the development
of personalized medicines with its related research areas and technology that span the biotechnology, diagnostics, bioinformatics,
pharmacological and genomic markets. With 150+ pages, full-colour graphs, tables, case studies, cutting-edge research studies, clinical trials, key industry figures and facts, company profiles, R&D areas, this report provides an introduction to the principles of pharmacogenomics and a detailed guide to personalized medicines that is set to show considerable growth. By drawing on detailed profiles of companies leading the revolution, this report examines the wide range of areas that are ultimately linked to the development of personalized medicines and how they effect your business today.
Why you must buy this report:
- Identify the level of competition and key players in the
personalizedmedicines revolution
- Insight into the potential benefits of pharmacogenomic research
- Forecast of emerging R&D areas
- How to enhance clinical trials and maximise product development
potential
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