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Personalized Medicine
Scientific & Commercial Aspects
| Publication Date: September
2008 Publisher: Jain Pharmaceutical Pages: 638
|
Price £2,680.00
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Summary
The aim of personalized medicine or individualized treatment is to match the right drug to the right patient and, in some cases, even to design the appropriate treatment for a patient according to his/her genotype. This report describes the latest concepts of development of personalized medicine based on pharmacogenomics, pharmacogenetics,pharmacoproteomics, and metabolomics.
Basic technologies of molecular diagnostics play an important role, particularly those for single nucleotide polymorphism (SNP) genotyping. Diagnosis is integrated with therapy for selection of the treatment as well for monitoring the results. Biochip/microarray technologies are also important and finally bioinformatics is needed to analyze the immense amount of data generated by various technologies.
Pharmacogenetics, the study of influence of genetic factors on drug action and metabolism, is used for predicting adverse reactions of drugs. Several enzymes are involved in drug metabolism of which the most important ones are those belonging to the family of cytochrome P450. The knowledge of the effects of polymorphisms of genes for the enzymes is applied in drug discovery and development as well as in clinical use of drugs. Cost-effective methods for genotyping are being developed and it would be desirable to include this information in the patient's record for the guidance of the physician to individualize the treatment.
Pharmacogenomics, a term that overlaps with pharmacogenetics but is distinct, deals with the application of genomics to drug discovery and development. It involves the mechanism of action of drugs on cells as revealed by gene expression patterns. Pharmacoproteomics is an important contribution to personalized medicine as it is a more functional representation of patient-to-patient variation than that provided by genotyping.A 'pharmacometabonomic' approach to personalizing drug treatment is also described.
Biological therapies such as those which use patient's own cells are considered to be personalized medicines. Vaccines are prepared from individual patient's tumor cells. Individualized therapeutic strategies using monoclonal bodies can be directed at specific genetic and immunologic targets. Ex vivo gene therapy involves the genetic modification of the patient's cells in vitro, prior to reimplantation of these cells in the patient's body.
Various technologies are integrated to develop personalized therapies for specific therapeutic areas described in the report. Examples of this are genotyping for drug resistance in HIV infection, personalized therapy of cancer, antipsychotics for schizophrenia, antidepressant therapy, antihypertensive therapy and personalized approach to neurological disorders. Although genotyping is not yet a part of clinically accepted routine, it is expected to have this status by the year 2012.
Several players are involved in the development of personalized therapy. Pharmaceutical and biotechnology companies have taken a leading role in this venture in keeping with their future role as healthcare enterprises rather than mere developers of technologies and manufacturers of medicines.
Ethical issues are involved in the development of personalized medicine mainly in the area of genetic testing. These along with social issues and consideration of race in the development of personalized medicine are discussed. Regulatory issues are discussed mainly with reference to the FDA guidelines on pharmacogenomics.
Increase in efficacy and safety of treatment by individualizing it has benefits in financial terms. Information is presented to show that personalized medicine will be cost-effective in healthcare systems. For the pharmaceutical companies, segmentation of the market may not leave room for conventional blockbusters but smaller and exclusive markets for personalized medicines would be profitable. Marketing opportunities for such a system are described with market estimates from 2007-2017.
Profiles of 223 companies involved in developing technologies for personalized medicines, along with 415 collaborations are included in the part II of the report. Finally the bibliography contains over 470 selected publications cited in the report. The report is supplemented by 56 tables and 17 figures.
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Content
- 0. Executive Summary
- 1. Basic Aspects
- Definition of personalized medicine
- Historical evolution of medical concepts
- Molecular biological basis of personalized medicine
- The human genome
- Chromosomes
- Genes
- The genetic code
- Gene expression
- DNA sequences and structure
- Single nucleotide polymorphisms
- Genotype and haplotypes
- Non-SNP genetic variations
- Insertions and deletions in the human genome
- Large scale variation in human genome
- Variation in copy number in the human genome
- Structural variations in human genome
- Basics technologies for developing personalized medicine
- Definitions of technologies relevant to personalized medicine
- Problems with the ICH definitions of pharmacogenomcis and pharmacogenetics
- Relationship of various technologies to personalized medicine
- Conventional medicine versus personalized medicine
- Role of genetics in future approaches to healthcare
- Genetic medicine
- Human disease and genes
- Mass analysis of DNA from whole populations
- Role of genetics in development of personalized medicines
- Genetic databases
- Genetic epidemiology
- Limitations of medical genetics and future prospects
- Genetics vs. epigenetics
- Role of systems biology in personalized medicine
- A personalized approach to environmental factors in disease
- Reclassification of diseases
- 2. Molecular Diagnostics in Personalized Medicine
- Introduction
- Molecular diagnostic technologies
- Direct dideoxy DNA sequencing (DDS)
- Single-stranded conformation polymorphism (SSCP) analysis
- Heteroduplex analysis (HA)
- The WAVE System
- DirectLinear Analysis
- Denaturing high-performance liquid chromatography (DHPLC)
- Denaturing Gradient Gel electrophoresis (DGGE)
- Chemical cleavage mismatch (CCM)
- Multiplex Allele-Specific Diagnostic Assay
- Representational oligonucleotide microarray analysis
- Cleavase Fragment Length Polymorphism (CFLP)
- Restriction fragment length polymorphism (RFLP)
- Arrayed primer extension (APEX)
- Enzymatic Mutation Detection (EMD)
- T cells and molecular diagnosis
- The chorioallantoic membrane assay
- Sequencing
- Multiplex DNA sequencing
- Sequencing in microfabricated high-density picoliter reactors
- Nanopore-based sequencing
- Electrophoresis in nanochannels
- Whole genome sequencing
- Biochips and microarrays
- Application of biochip technology in developing personalized medicine
- Standardizing the microarrays
- Biochip technologies
- GeneChip
- AmpliChip CYP450
- Microfluidics
- Lab-on-a-chip
- Micronics' microfluidic technology
- LabCD
- Microfluidic automated DNA analysis using PCR
- Integrated microfluidic bioassay chip
- Electronic detection of nucleic acids on microarrays
- Strand displacement amplification on a biochip
- Rolling circle amplification on DNA microarrays
- Universal DNA microarray combining PCR and ligase detection reaction
- Protein biochips
- ProteinChip
- LabChip for protein analysis
- TRINECTIN proteome chip
- Protein expression microarrays
- Microfluidic devices for proteomics-based diagnostics
- New developments in protein chips
- Protein chips for personalized medicine
- SNP genotyping
- Haplotyping
- Haplotype Specific Extraction
- Computation of haplotypes
- HapMap project
- Predictingdrug response with HapMap
- Companies developing haplotyping technology
- Technologies for SNP analysis
- Biochip and microarray-based detection of SNPs
- SNP genotyping by MassARRAY
- Biochip combining BeadArray and ZipCode technologies
- SNP-IT primer-extension technology
- OmniScan SNP genotyping
- Affymetrix Variation Detection Arrays
- Use of NanoChip for detection of SNPs
- DNA sequencing
- Electrochemical DNA probes
- Single base extension-tag array
- Laboratory Multiple Analyte Profile
- PCR-CTPP (confronting two-pair primers)
- SNP genotyping on a genome-wide amplified DOP-PCR template
- TaqMan real-time PCR
- Non-Enzymatic Amplification Technology
- SNP genotyping with gold nanoparticle probes
- Locked nucleic acid
- Molecular inversion probe based assays
- Pyrosequencing
- Reversed enzyme activity DNA interrogation test
- Smart amplification process version 2
- Zinc finger proteins
- UCAN method (Takara Biomedical)
- Mitochondrial SNPs
- Limitations of SNP in genetic testing
- Concluding remarks on SNP genotyping
- Companies involved in developing technologies/products for SNP analysis
- Impact of SNPs on personalized medicine
- Optical Mapping
- Role of nanobiotechnology in molecular diagnostics
- Cantilevers for personalized medical diagnostics
- Nanopore-based technology for single molecule identification
- Role of biomarkers in personalized medicine
- Biomarkers for diagnostics
- Biomarkers for drug development
- Application of proteomics in molecular diagnosis
- Proteomic strategies for biomarker identification
- Proteomic technologies for detection of biomarkers in body fluids
- Protein patterns
- Layered Gene Scanning
- Comparison of proteomic and genomic approaches in personalized medicine
- Gene expression profiling
- DNA microarrays
- Analysis of single-cell gene expression
- Gene expression profiling based on alternative RNA splicing
- Whole genome expression array
- Tangerine expression profiling
- Gene expression analysis on biopsy samples
- Serial analysis of gene expression (SAGE)
- Multiplexed Molecular Profiling
- Gene expression analysis using competitive PCR and MALDI TOF MS
- Monitoring in vivo gene expression by magnetic resonance imaging
- Companies involved in gene expression analysis
- Monitoring in vivo gene expression by molecular imaging
- Molecular imaging and personalized medicine
- Glycomics-based diagnostics
- Combination of diagnostics and therapeutics
- Companies combining diagnostics and therapeutics
- Point-of-care diagnosis
- Companies developing point-of-care diagnostic technologies
- Point-of-care diagnosis of infections
- Advantages versus disadvantages of point-of-care diagnosis
- Future prospects of point-of-care diagnosis
- Role of diagnostics in integrated healthcare
- Concept of integrated healthcare
- Components of integrated healthcare
- Screening
- Disease prediction
- Early diagnosis
- Prevention
- Therapy based on molecular diagnosis
- Monitoring of therapy
- Advantages and limitations of integrated healthcare
- Commercially available systems for integrated healthcare
- Future of molecular diagnostics in personalized medicine
- 3. Pharmacogenetics
- Basics of pharmacogenetics
- Role of molecular diagnostics in pharmacogenetics
- Role of pharmacogenetics in pharmaceutical industry
- Study of the drug metabolism and pharmacological effects
- Causes of variations in drug metabolism
- Enzymes relevant to drug metabolism
- Pharmacogenetics of phase I metabolism
- CYP450
- P450 CYP 2D6 inhibition by selective serotonin reuptake inhibitors
- Lansoprazole and cytochrome P450
- Glucose-6-phosphate dehydrogenase
- Pharmacogenetics of phase II metabolism
- N-Acetyltransferase
- Uridine diphosphate-glucuronosyltransferase
- Measurement of CYP isoforms
- Polymorphism of drug transporters
- Genetic variation in drug targets
- Polymorphisms of kinase genes
- Effect of genetic polymorphisms on disease response to drugs
- Ethnic differences in drug metabolism
- Gender differences in pharmacogenetics
- Role of pharmacogenetics in drug safety
- Adverse drug reactions
- Role of pharmacogenetics in warfarin therapy
- Role of pharmacogenetics in carbamazepine therapy
- Malignant hyperthermia
- ADRs related to toxicity of chemotherapy
- FDA consortium linking genetic biomarkers to serious adverse events
- Therapeutic drug monitoring, phenotyping, and genotyping
- Therapeutic drug monitoring
- Phenotyping
- Genotyping
- Genotyping vs phenotyping
- Phenomics
- Limitations of genotype-phenotype association studies
- Molecular toxicology in relation to personalized medicines
- Toxicogenomics
- Companies involved in molecular toxicology
- Gene expression studies
- Transcriptome profiling studies
- Genomics and the prediction of xenobiotic toxicity
- Pharmacogenetics in clinical trials
- Postmarketing pharmacogenetics
- Clinical implications of pharmacogenetics
- Examples of use of pharmacogenetics in clinical pharmacology
- Linking pharmacogenetics with pharmacovigilance
- Recommendations for the clinical use of pharmacogenetics
- Limitations of pharmacogenetics
- Academic research in pharmacogenetics
- Future role of pharmacogenetics in personalized medicine
- 4. Pharmacogenomics
- Introduction
- Basics of pharmacogenomics
- Pharmacogenomics and drug discovery
- Preclinical prediction of drug efficacy
- Pharmacogenomics and clinical trials
- Impact of genetic profiling on clinical studies
- Limitations of the pharmacogenomic-based clinical trials
- Pharmacogenomic aspects of major therapeutic areas
- Oncogenomics
- Oncogenes
- Tumor suppressor genes
- Cardiogenomics
- Neuropharmacogenomics
- Pharmacogenomics of Alzheimer's disease
- Pharmacogenomics of depression
- Pharmacogenomics of schizophrenia
- Companies involved in neurogenomics-based drug discovery
- 5. Role of Pharmacoproteomics
- Basics of proteomics
- Proteomic approaches to the study of pathophysiology of diseases
- Single cell proteomics for personalized medicine
- Diseases due to misfolding of proteins
- Therapies for protein misfolding
- Significance of mitochondrial proteome in human disease
- Proteomic technologies for drug discovery and development
- Role of reverse-phase protein microarray in drug discovery
- Role of proteomics in clinical drug safety
- Toxicoproteomics
- Application of pharmacoproteomics in personalized medicine
- 6. Role of Metabolomics in Personalized Medicine
- Metabolomics and metabonomics
- Metabolomics bridges the gap between genotype and phenotype
- Metabolomics, biomarkers and personalized medicine
- Metabolomic technologies
- Urinary profiling by capillary electrophoresis
- Lipid profiling
- Role of metabolomics in biomarker identification and pattern recognition
- Validation of biomarkers in large-scale human metabolomics studies
- Pharmacometabonomics
- Metabonomic technologies for toxicology studies
- Metabonomics/metabolomics and personalized nutrition
- 7. Personalized Biological Therapies
- Introduction
- Recombinant human proteins
- Therapeutic monoclonal antibodies
- Cell therapy
- Autologous tissue and cell transplants
- Stem cells
- Role of stem cells derived from unfertilized embryos
- Cloning and personalized cell therapy
- Use of stem cells for drug testing
- Gene therapy
- Personalized cancer vaccines
- Patient-specific cancer vaccines
- Personalized cancer vaccines
- Antigen-specific vaccines
- Autologous cell vaccines
- Individual cancers are antigenically distinct
- Autologous HSP70-peptide vaccine
- Personalized melanoma vaccines
- Antisense therapy
- RNA interference
- 8. Personalized Medicine in Major Therapeutic Areas
- Introduction
- Management of viral infections
- Management of HIV
- Differences in response of the body to HIV
- Variations in action of drugs on HIV
- Role of diagnostic testing in HIV
- CD4 counts as a guide to drug therapy for AIDS
- Drug-resistance in HIV
- Measurement of Replication Capacity
- Prevention of adverse reactions to antiviral drugs
- Role of genetic variations in susceptibility to HIV-1
- Treatment of hepatitis B
- Treatment of hepatitis C
- Personalized management of tuberculosis
- Psychiatric disorders
- Psychopharmacogenetics
- COMT genotype and response to amphetamine
- Genotype and response to methylphenidate in children with ADHD
- Personalized antipsychotic therapy
- Personalized antidepressant therapy
- Pretreatment EEG to predict adverse effects to antidepressants
- Individualization of SSRI treatment
- Vilazodone with a test for personalized treatment of depression
- Neurological disorders
- Personalized management of Alzheimer's disease
- Personalized management of Parkinson's disease
- Discovery of subgroup-selective drug targets in PD
- Personalized management of Epilepsy
- Choice of the right AED
- Pharmacogenomics of epilepsy
- Drug resistance in epilepsy
- Future prospects for epilepsy
- Personalized management of migraine
- Personalized treatment of multiple sclerosis
- MBP8298
- SNPs linking response of multiple sclerosis to therapy
- Future prospects for multiple sclerosis
- Cardiovascular disorders
- Role of diagnostics in personalized management of cardiovascular disease
- Testing in coronary heart disease
- Cardiovascular disorders with a genetic component
- Gene variant as a risk factor for sudden cardiac death
- SNP Chip for study of cardiovascular diseases
- Pharmacogenomics of cardiovascular disorders
- Modifying the genetic risk for myocardial infarction
- Management of heart failure
- ?-blockers
- Bucindolol
- BiDil
- Management of hypertension
- Pharmacogenomics of diuretic drugs
- Pharmacogenomics of ACE inhibitors
- Management of hypertension by personalized approach
- Pharmacogenetics of lipid-lowering therapies
- Polymorphisms in genes involved in cholesterol metabolism
- Role of eNOS gene polymorphisms
- The STRENGTH study
- Personalized management of women with hyperlipidemia
- Thrombotic disorders
- Factor V Leiden mutation
- Anticoagulant therapy
- Nanotechnology-based personalized therapy of cardiovascular diseases
- Concluding remarks
- Personalized management of skin disorders
- Personalized therapy of rheumatoid arthritis
- DIATSTAT anti-cyclic citrullinated peptides in rheumatoid arthritis
- Personalization of COX-2 inhibitor therapy
- Personalization of infliximab therapy
- Personalized therapy of asthma
- Genetic polymorphism and response to ?2-adrenergic agonists
- Genotyping in asthma
- Personalized approaches in immunology
- Role of Mannose-binding lectin in personalized medicine
- Pharmacogenetics and pharmacogenomics of immunosuppressive agents
- Personalized immunosuppressant therapy in organ transplants
- Personalized management of pain
- Pharmacogenetics/pharmacogenomics of pain
- Mechanism-specific management of pain
- Preoperative testing to tailor postoperative analgesic requirements
- Personalized analgesics
- Management of genetic disorders
- Personalized treatment of cystic fibrosis
- Personalized management of gastrointestinal disorders
- Personalized therapy of inflammatory bowel disease
- Personalized management of lactose intolerance
- Personalized approach to addiction
- Genetic polymorphism and management of alcoholism
- Personalized therapy for smoking cessation
- Antidepressant therapy for smoking cessation
- Effectiveness of nicotine patches in relation to genotype
- Personalized approach to drug addiction
- Personalized approaches to miscellaneous problems
- Hormone replacement therapy in women
- Personalized treatment of malaria
- Personalized management of renal disease
- Personalization of organ transplantation
- Personalization of kidney transplantation
- Personalization of cardiac transplantation
- Prediction of rejection to tailor anti-rejection medications
- Role of immunological biomarkers in monitoring grafted patients
- Improved matching of blood transfusion
- Personalized care of trauma patients
- Personalized anticoagulation
- Personalized preventive medicine
- Personalized nutrition
- Nutrigenomics
- Nutrition and proteomics
- Nutrigenomics and personalized medicine
- Personalized diet prescription
- 9. Personalized Therapy of Cancer
- Introduction
- Challenges of cancer classification
- Impact of molecular diagnostics on the management of cancer
- Cancer classification using microarrays
- Detection of loss of heterozygosity
- Analysis of RNA splicing events in cancer
- Analysis of chromosomal alterations in cancer cells
- Fluorescent in situ hybridization
- Gene expression profiling
- Unraveling the genetic code of cancer
- Gene expression profiles predict chromosomal instability in tumors
- Diagnosis of cancer of an unknown primary
- Personalized therapies based on oncogenic pathways signatures
- Modulation of CYP450 activity for cancer therapy
- Role of molecular imaging in personalized therapy of cancer
- Diagnostics for detection of minimal residual disease
- Cancer prognosis
- Detection of mutations for risk assessment and prevention
- Impact of biomarkers on management of cancer
- eTag assay system for cancer biomarkers
- Predictive biomarkers for cancer
- HER-2/neu oncogene as a biomarker for cancer
- L-asparaginase treatment of cancer guided by a biomarker
- Determination of response to therapy
- Biopsy testing of tumors for chemotherapy sensitivity
- Genomic analysis of tumor biopsies to predict response to treatment
- Mutation detection at molecular level
- Proteomic analysis of tumor biopsies to predict response to treatment
- Real-time apoptosis monitoring
- ChemoFx Assay for predicting anticancer drug response
- Role of genetic variations in susceptibility to anticancer drugs
- Serum nucleosomes as indicators of sensitivity to chemotherapy
- Targeted microbubbles to tumors for monitoring anticancer therapy
- Targeted cancer therapies
- Targeting glycoproteins on cell surface
- Targeting pathways in cancer
- Functional antibody-based therapies
- Personalized radiation therapy
- Molecular diagnostics combined with cancer therapeutics
- Aptamers for combined diagnosis and therapeutics of cancer
- Role of nanobiotechnology in personalized management of cancer
- Design of future cancer therapies
- Screening for personalized anticancer drugs
- Role of epigenetics in development of personalized cancer therapies
- Personalized therapy of cancer based on cancer stem cells
- Role of oncoproteomics in personalized therapy of cancer
- Cancer tissue proteomics
- Pharmacogenomic-based chemotherapy
- Whole genome technology to predict drug resistance
- Anticancer drug selection based on molecular characteristics of tumor
- Testing microsatellite-instability for response to chemotherapy
- Pharmacogenetics of cancer chemotherapy
- CYP 1A2
- Thiopurine methyltransferase
- Dihydropyrimidine dehydrogenase
- UGT1A1 test as guide to irinotecan therapy
- Role of computational models in personalized anticancer therapy
- A computational model of kinetically tailored treatment
- Mathematical modeling of tumor mivroenvironments
- Molecular profiling of cancer
- Drug resistance in cancer
- Detection of drug resistance in cancer by metabolic profiling
- GRP78 as a predictor for chemoresistance of breast cancer
- A systems biology approach to drug resistance in colorectal cancer
- Management of drug resistance in leukemia
- Overexpression of multidrug resistance gene
- P53 mutations
- A chemogenomic approach to drug resistance
- Examples of personalized management of cancer
- Personalized management of breast cancer
- Genetic testing in breast cancer as a guide to treatment
- Pharmacogenetics of breast cancer
- Molecular diagnostics in breast cancer
- Racial factors in the management of breast cancer
- Proteomics-based personalized management of breast cancer
- Tests for prognosis of breast cancer
- Developing personalized drugs for breast cancer
- Predicting response to chemotherapy in breast cancer
- Prediction of adverse reaction to radiotherapy in breast cancer
- Prediction of recurrence in breast cancer for personalizing therapy
- TAILORx (Trial Assigning Individualized Options for Treatment)
- Future development of gene expression microarrays for breast cancer
- Personalized management of ovarian cancer
- Personalized management of hematological malignancies
- Personalized management of acute leukemias
- Personalized management of chronic lymphocytic leukemia
- Personalized management of multiple myeloma
- Personalized management B cell lymphomas
- Personalized vaccine for follicular lymphoma
- Personalized management of myelodysplasia
- Personalized management of malignant melanoma
- Personalized management of esophageal cancer
- Personalized management of colorectal cancer
- Personalized management of lung cancer
- Determination of outcome of EGFR tyrosine kinase inhibitor treatment
- Testing for response to chemotherapy in lung cancer
- Testing for prognosis of NSCLC
- Testing for recurrence of lung cancer
- Role of a new classification system in the management of lung cancer
- Personlized management of prostate cancer
- Personalized management of brain cancer
- Genetics and genomics of brain cancer
- Molecular diagnostics for personalized management of brain cancer
- Personalized chemotherapy of brain tumors
- Personalized therapy of oligodendroglial tumors (OTs)
- Personalized therapy of neuroblastomas
- Personalized management of germ cell brain tumors
- Future of cancer therapy
- Challenges for developing personalized cancer therapies
- The Cancer Genome Project
- Companies involved in developing personalized cancer therapy
- 10. Development of Personalized Medicine
- Introduction
- Non-genomic factors in the development of personalized medicine
- Personalized medicine based on circadian rhythms
- Cytomics as a basis for personalized medicine
- Intestinal microflora
- Gut microbiome compared to human genome
- Metabolic interactions of the host and the intestinal microflora
- Role of drug delivery in personalized medicine
- Personalized approach to clinical trials
- Use of Bayesian approach in clinical trials
- Individualzing risks and benefits in clinical trials
- Players in the development of personalized medicine
- Personalized Medicine Coalition
- Role of pharmaceutical industry
- Production and distribution of personalized medicines
- Role of biotechnology companies
- Role of life sciences industries
- Role of molecular imaging in personalized medicine
- Molecular imaging for personalized drug development in oncology
- Molecular imaging and CNS drug development
- Companies involved in molecular imaging
- Role of the clinical laboratories
- Role of universities and government support
- Roadmap Initiative for Medical Research
- NIH and personalized medicine
- Role of National Institute of General Medical Sciences
- The National Clinical Genomics Initiative
- Genomic-Based Prospective Medicine Project
- Pharmacogenetics Research Network and Knowledge Base
- Clinical Proteomics Program
- Southeast Nebraska Cancer Center's Personalized Medicine Network
- Quebec Center of Excellence in Personalized Medicine
- Role of healthcare organizations and hospitals
- Signature Genetics
- The Mayo Clinic genetic database
- Research center for personalized medicine at Mt. Sinai Medical Center
- Role of the medical profession
- Education of the physicians
- Off-label prescribing and personalized medicine
- Medical education
- Public attitude towards personalized medicine
- Role of genetic banking systems and databases
- Role of biobanks in development of personalized medicine
- UK Biobank
- CARTaGENE for biobanks in Canada
- Personalized medicine based on PhysioGenomics technology
- Role of bioinformatics in development of personalized medicine
- Exploration of disease-gene relationship
- Health information management
- Electronic health records
- Linking patient medical records and genetic information
- Management of personal genomic data
- Personalized prognosis of disease
- Integration of technologies for development of personalized medicine
- Global scope of personalized medicine
- Personalized medicine in the developed countries
- Personalized medicine in the US
- Personalized medicine in the EU
- Biobanking and development of personalized medicine in EU
- UK National Health Service and medical genetics
- Personalized medicine in the developing countries
- Advantages and limitations of personalized medicine
- Future of personalized medicine
- Ongoing genomic projects
- Understanding the genetic basis of diseases
- Personal Genome Project
- Genome-wide association studies
- The 1000 Genomes Project
- Personalized predictive medicine
- Opportunities and challenges
- Pharmacotyping
- Medicine in the year 2012
- Concluding remarks about the future of personalized medicine
- 11. Ethical and Regulatory Aspects of Personalized Medicine
- Introduction to ethical issues
- Ethical issues of pharmacogenetics
- Genotype-specific clinical trials
- Social issues in personalized medicine
- Privacy issues in personalized medicine
- Race and personalized medicine
- Regulatory aspects
- CLSI guideline for the use of RNA controls in gene expression assays
- MicroArray Quality Control Project
- Regulatory aspects of pharmacogenetics
- FDA and pharmacogenomics
- FDA guidance for pharmacogenomic data submissions
- Joint guidelines of the FDA and EU regulators for pharmacogenomics
- Pharmacogenomic information in drug labels
- FDA guidelines for pharmacogenomics-based dosing
- FDA and validation of biomarkers
- FDA and predictive medicine
- Evaluation of companion diagnostics/therapeutic for cancer
- 12. Commercial Aspects of Personalized Medicine
- Introduction
- Perceived financial concerns
- Personalized medicine and orphan drug syndrome
- Commercial aspects of pharmacogenomics
- Cost of DNA testing
- Cost of sequencing the human genome
- Cost of genotyping
- Cost of pharmacogenomics-based clinical trials
- Business development of pharmacogenomic companies
- Cost of personalized healthcare
- Cost of genetic testing
- Economics of CYP genotyping-based pharmacotherapy
- Cost of personalized medicines
- The rising healthcare costs in the US
- Lowering the cost of healthcare
- Cost effectiveness of HIV genotyping
- Lowering the high costs of cancer chemotherapy
- Reducing the cost incurred by adverse drug reactions
- Overall impact of personalized medicine on healthcare
- Drivers for the development of personalized medicine
- Evolution of medicine as a driver for personalized therapy markets
- Collaboration between the industry and the academia
- Personalized medicine and drug markets
- Impact on drug markets
- Growth of markets relevant to personalized medicine
- Pharmacogenomics
- Pharmacogenetics
- Pharmacoproteomics
- Biochips
- Point-of-Care
- Markets for personalized medicines according to therapeutic areas
- Markets for personalized medicines according to geographical regions
- Market opportunities for personalization of medicine
- Impact of personalized medicine on other industries
- Strategies for developing and marketing personalized medicine
- Education of the public
- Role of the Internet in development of personalized medicine
- 13. References
- Tables
- Table 1 1: Selected terms relevant to the concept of personalized medicine
- Table 1 2: Landmarks in the historical development of personalized medicine
- Table 2 1: Molecular diagnostic technologies used for personalized medicine
- Table 2 2: Applications of biochip technology relevant to personalized medicine
- Table 2 3: Companies developing haplotying technology
- Table 2 4: Technologies for SNP analysis
- Table 2 5: A sampling of companies involved in technologies for SNP genotyping
- Table 2 6: Comparison of proteomic and genomic approaches in personalized medicine
- Table 2 7: Selected methods for gene expression profiling
- Table 2 8: A selection of companies with gene expression technologies
- Table 2 9: Companies combining molecular diagnostics and therapeutics
- Table 2 10: Applications of point-of-care diagnosis
- Table 2 11: Companies developing point-of-care diagnostic tests
- Table 3 1: Pharmacogenetic vs. pharmacogenomic studies
- Table 3 2: Enzymes relevant to drug metabolism
- Table 3 3: Examples of mutation of the enzyme CYP450
- Table 3 4: Frequency distribution of drugs metabolized by major isoforms of CYP450
- Table 3 5: Commonly prescribed medications, which are metabolized by CYP2D6
- Table 3 6: Polymorphisms in drug target genes that can influence drug response
- Table 3 7: Effect of genetic polymorphisms on disease response to drugs
- Table 3 8: Examples of genetically determined adverse reactions to drugs
- Table 3 9: Examples of genotyping and phenotyping in some diseases
- Table 3 10: Companies with novel molecular toxicology technology
- Table 4 1: Role of pharmacogenomics in clinical trials
- Table 4 2: Examples of pharmacogenomics-based clinical studies
- Table 4 3: Tumor suppressor genes, their chromosomal location, function and associated tumors
- Table 4 4: Gene polymorphisms relevant to cardiovascular disease management
- Table 4 5: Companies involved in cardiovascular genomics
- Table 4 6: A sampling of companies involved in neuropharmacogenomics
- Table 8 1: Important therapeutic areas for personalized medicine
- Table 8 2: Enzymes that metabolize antipsychotics
- Table 8 3: Enzymes that metabolize antidepressants
- Table 8 4: Genes that cause cardiovascular diseases
- Table 9 1: Factors that drive the development of personalized therapy in cancer
- Table 9 2: Impact of molecular diagnostics on the management of cancer
- Table 9 3: Selected companies involved in developing personalized cancer therapies
- Table 10 1: Players in the development of personalized medicine
- Table 10 2: Members of the Personalized Medicine Coalition
- Table 10 3: Biobanks relevant to personalized medicine
- Table 10 4: Role of bioinformatics in the development of personalized medicine
- Table 10 5: Advantages of personalized medicine for the biopharmaceutical industry
- Table 10 6: Advantages of personalized medicine for the patients
- Table 10 7: Advantage of personalized medicine for the physicians
- Table 10 8: Limitations of personalized medicine
- Table 10 9: Companies involved in predictive healthcare
- Table 12 1: Drivers for the development of personalized medicine
- Table 12 2: Growth of markets relevant to personalized medicine 2007-2017
- Table 12 3: Markets for personalized medicine according to therapeutic area 2007-2017
- Table 12 4: Markets for personalized medicine in major regions 2007-2017
- Table 12 5: Lack of efficacy in current therapy
- Table 12 6: Impact of personalized medicine on other industries
- Table 12 7: Strategies to develop personalized medicine
- Table 12 8: Role of the Internet in development of personalized medicine
- Figures
- Figure 1 1: Relation of personalized medicine to other technologies
- Figure 2 1: Role of biochips/microarrays in personalized medicine
- Figure 2 2: Affymetrix GeneChip technology
- Figure 2 3: Role of CYP450 genotyping in development of personalized medicine
- Figure 2 4: Role of SNPs in personalized medicine
- Figure 2 5: A scheme of integrated healthcare and personalized medicine
- Figure 3 1: Pharmacogenetics as a link between genotype and phenotype
- Figure 3 2: Role of pharmacogenetic technologies in personalized medicine
- Figure 4 1: Impact of new technologies at various stages of the drug discovery process
- Figure 4 2: Steps in the application of pharmacogenomics in clinical trials
- Figure 7 1: Role RNAi in development of personalized medicine
- Figure 8 1: A hypothetical personalized medicine approach to management of hypertension
- Figure 8 2: A scheme of personalized management of pain
- Figure 9 1: Schematic role of proteomics in personalized management of cancer
- Figure 10 1: enTrust Genetic Banking System of First Genetic Trust
- Figure 10 2: Integration of technologies for the development of personalized medicine
- Figure 12 1: Evolution of personalized medicine as a market driver"
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