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Personalized Medicine - Scientific and Commercial Aspects
Jain PharmaBiotech, Nov 2009, Pages: 681
Executive Summary
1. Basic Aspects
Definition of personalized medicine
History of medical concepts relevant to personalized medicine
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
Genetic variations in the human genome
Insertions and deletions in the human genome
Large scale variation in human genome
Variation in copy number in the human genome
Structural variations in the human genome
Mapping and sequencing of structural variation from human genomes
1000 Genomes Project
Human Variome Project
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
Genetic and environmental interactions in etiology of human diseases
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
Systems pharmacology
Systems medicine
A personalized approach to environmental factors in disease
Reclassification of diseases
2. Molecular Diagnostics in Personalized Medicine
Introduction
Molecular diagnostic technologies
PCR-based methods
DirectLinear™ Analysis
Denaturing high-performance liquid chromatography
Multiplex Allele-Specific Diagnostic Assay
Representational oligonucleotide microarray analysis
Restriction fragment length polymorphism (RFLP)
Real-time PCR for detection of CNVs
Non-PCR methods
Arrayed primer extension (APEX)
Enzymatic Mutation Detection (EMD)
DNA sequencing
Sanger-sequencing technology
Cyclic array sequencing
454 Pyrosequencing technology
Electron microscope-based DNA sequencing
Illumina Genome Analyzer System
Multiplex amplification of human DNA sequences
Sequencing by hybridization
SOLiD technology
Whole genome sequencing
Bioinformatic tools for analysis of genomic sequencing data
Detection of single molecules in real time
Direct observation of nucleotide incorporation
Molecular Combing
Nanopore sequencing
DNA sequence by use of nanoparticles
Zero-mode waveguide nanostructure arrays
Future prospects of 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
Profiling gene expression patterns of white blood cells
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
Use of molecular diagnostics for stratification in clinical trials
Companion diagnostics
Companies involved in companion diagnostics
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
Genetic testing for disease predisposition
Preventive genetics by early diagnosis of mitochondrial diseases
Personal genetic service
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
Cytochrome P450 polymorphisms and response to clopidogrel
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
Adverse drug reactions in children
Adverse drug reactions related to toxicity of chemotherapy
Genetically determined adverse drug reactions
Malignant hyperthermia
Pharmacogenetics of clozapine-induced agranulocytosis
Role of pharmacogenetics in warfarin therapy
Role of pharmacogenetics in carbamazepine therapy
Role of pharmacogenetics in statin therapy
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
Genomics and the prediction of xenobiotic toxicity
Pharmacogenetics in clinical trials
Postmarketing pharmacogenetics
Clinical implications of pharmacogenetics
Application of CYP450 genotyping in clinical practice
Genotype-based drug dose adjustment
Examples of use of pharmacogenetics in clinical pharmacology
Linking pharmacogenetics with pharmacovigilance
Genetic susceptibility to ADRs
Linking genetic testing to postmarketing ADR surveillance
Recommendations for the clinical use of pharmacogenetics
Limitations of pharmacogenetics
Pharmacoepigenomics vs pharmacogenetics in drug safety
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 vaccines
Personalized vaccines for viral diseases
Personalized cancer vaccines
Patient-specific cancer vaccines
Antigen-specific vaccines
Autologous cell vaccines
Multipeptide cancer vaccines
Personalized melanoma vaccines
Antisense therapy
RNA interference
MicroRNAs
8. Personalized Medicine in Major Therapeutic Areas
Introduction
Management of infections
Management of HIV
Genetics of human susceptibility to HIV infection
Pharmacogenomics of antiretroviral agents
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
Pharmacogenetics and HIV drug safety
Personalized treatment of hepatitis B
Personalized 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
Pharmacogenetics of epilepsy
Pharmacogenomics of epilepsy
Drug resistance in epilepsy
Future prospects for management of epilepsy
Personalized management of migraine
Individualization of use of triptans for migraine
Personalized treatment of multiple sclerosis
Immunopathological patterns of demyelination for assessing therapy
Personalizing mitoxantrone therapy of multiple sclerosis
Fusokine method of personalized cell therapy of multiple sclerosis
MBP8298
Pharmacogenomics of IFN-b therapy in multiple sclerosis
Cardiovascular disorders
Role of diagnostics in personalized management of cardiovascular disease
Testing in coronary heart disease
SNP genotyping in cardiovascular disorders
Cardiovascular disorders with a genetic component
Gene variant as a risk factor for sudden cardiac death
KIF6 gene test as a guide to management of congestive heart failure
SNP Chip for study of cardiovascular diseases
Pharmacogenomics of cardiovascular disorders
Modifying the genetic risk for myocardial infarction
Management of heart failure
b-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
Antiplatelet therapy
Nanotechnology-based personalized therapy of cardiovascular diseases
Project euHeart for personalized management of cardiovascular diseases
Concluding remarks
Personalized management of pulmonary disorders
Personalized therapy of asthma
Biomarkers for predicting response to corticosteroid therapy
Genetic polymorphism and response to b2-adrenergic agonists
Genotyping in asthma
IgE as guide to dosing of omalizumab for asthma
Personalized management of chronic obstructive pulmonary disease
Personalized management of skin disorders
Genetic testing for personalized skin care
Management of hair loss based on genetic testing
Personalized therapy of rheumatoid arthritis
DIATSTAT™ anti-cyclic citrullinated peptides in rheumatoid arthritis
Personalization of COX-2 inhibitor therapy
Personalization of infliximab therapy
Personalized approaches in immunology
Role of Mannose-binding lectin in personalized medicine
Pharmacogenetics and pharmacogenomics of immunosuppressive agents
Personalized management of patients with lupus erythematosus
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 approaches to improve organ transplantation
Personalization of kidney transplantation
Personalization of cardiac transplantation
Prediction of rejection to tailor anti-rejection medications
Personalized immunosuppressant therapy in organ transplants
Role of immunological biomarkers in monitoring grafted patients
Improved matching of blood transfusion
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
Gene associated with end-stage renal disease
Personalized care of trauma patients
Personalized anticoagulation
Personalized Hyperbaric oxygen therapy
Personalized preventive medicine
Personalized nutrition
Nutrigenomics
Nutrigenomics and functional foods
Nutrigenomics and personalized medicine
Nutrition and proteomics
Personalized diet prescription
9. Personalized Therapy of Cancer
Introduction
Challenges of cancer classification
Relationships of technologies for personalized management of cancer
Impact of molecular diagnostics on the management of cancer
Analysis of RNA splicing events in cancer
Analysis of chromosomal alterations in cancer cells
Cancer classification using microarrays
Detection of loss of heterozygosity
Diagnosis of cancer of an unknown primary
Diagnostics for detection of minimal residual disease
Fluorescent in situ hybridization
Gene expression profiling
Gene expression profiles predict chromosomal instability in tumors
Isolation and characterization of circulating tumor cells
Modulation of CYP450 activity for cancer therapy
Personalized therapies based on oncogenic pathways signatures
Quantum dot-based test for DNA methylation
Role of molecular imaging in personalized therapy of cancer
Functional diffusion MRI
Role of FDG-PET/CT in personalizing cancer treatment
Tumor imaging and elimination by targeted gallium corrole
Future prospects of molecular imaging in management of cancer
Unraveling the genetic code of cancer
Cancer prognosis
Detection of mutations for risk assessment and prevention
Impact of biomarkers on management of cancer
VeraTag™ assay system for cancer biomarkers
Predictive biomarkers for cancer
HER-2/neu oncogene as a biomarker for cancer
Oncogene GOLPH3 as a cancer biomarker
L-asparaginase treatment of cancer guided by a biomarker
Determination of response to therapy
ChemoFx cell culture assay for predicting anticancer drug response
Ex vivo testing of tumor biopsy for chemotherapy sensitivity
Genomic approaches to predict response to anticancer agents
Gene expression patterns to predict response of cancer to therapy
Genomic analysis of tumor biopsies
Genotype-dependent efficacy of pathway inhibition in cancer
Mutation detection at molecular level
Role of genetic variations in susceptibility to anticancer drugs
Non-genetic factors for variations in response of cancer cells to drugs
Proteomic analysis of tumor biopsies to predict response to treatment
Real-time apoptosis monitoring
Serum nucleosomes as indicators of sensitivity to chemotherapy
Targeted microbubbles to tumors for monitoring anticancer therapy
PET imaging for determining response to chemotherapy
Tissue systems biology approach to personalized management of cancer
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
Determination of chemotherapy response by topoisomerase levels
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
Systems biology approach to personalizing therapy for drug-resistant cancer
Examples of personalized management of cancer
Personalized management of breast cancer
Developing personalized drugs for breast cancer
Gene expression plus conventional predictors of breast cancer
Genetic testing in breast cancer as a guide to treatment
Molecular diagnostics in breast cancer
Pharmacogenetics of breast cancer
Proteomics-based personalized management of breast cancer
Predicting response to chemotherapy in breast cancer
Prediction of resistance to therapy in breast cancer
Prediction of adverse reaction to radiotherapy in breast cancer
Prediction of recurrence in breast cancer for personalizing therapy
Prognosistic tests for breast cancer
Racial factors in the management of breast cancer
TAILORx (Trial Assigning Individualized Options for Treatment)
Trends and future prospects of breast cancer research
Understanding tumor diversity in mouse mammary cancer model
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 hepatocellular carcinoma
Personalized management of malignant melanoma
Personalized management of gastrointestinal cancer
Personalized management of esophageal cancer
Personalized management of gastric cancer
Personalized management of colorectal cancer
Personalized management of liver 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
Benefit of lifestyle changes shown by gene expression studies
Personalized management of brain cancer
Genetics and genomics of brain cancer
Prognosis of glioblastoma multiforme based on its genetic landscape
Molecular diagnostics for personalized management of brain cancer
Personalized chemotherapy of brain tumors
Biosimulation approach to personalizing treatment of brain cancer
Personalized therapy of oligodendroglial tumors (OTs)
Personalized therapy of neuroblastomas
Personalized therapy of medulloblastomas
Personalized management of germ cell brain tumors
Future of cancer therapy
Challenges for developing personalized cancer therapies
The Cancer Genome Atlas
Role of the International Cancer Genome Consortium
Using computer and imaging technologies to personalize cancer treatment
Integrated genome-wide analysis of cancer for personalized therapy
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
Clinical trials of therapeutics and companion diagnostics
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 the US government
Department of Health and Human Services and personalized medicine
Comparative effectiveness research
Role of the US Government agencies in personalized medicine
NIH's Roadmap Initiative for Medical Research
NIH and personalized medicine
National Institute of General Medical Sciences
National Institute of Standards and Technology
Support from Agency for Healthcare Research and Quality
Role of academic institutons in the US
Clinical Proteomics Program
Coriell Personalized Medicine Collaborative™
Delaware Valley Personalized Medicine Project
Evaluation of genetic tests and genomic applications
Genomic-Based Prospective Medicine Project
Personalized oncology at Massachusetts General Hospital
Pharmacogenetics Research Network and Knowledge Base
Quebec Center of Excellence in Personalized Medicine
Southeast Nebraska Cancer Center's Personalized Medicine Network
Wisconsin Genomics Initiative
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
Biobanking and development of personalized medicine in EU
CARTaGENE for biobanks in Canada
Personalized medicine based on PhysioGenomics™ technology
Role of bioinformatics in development of personalized medicine
Exploration of disease-gene relationship
Biosimulation techniques for developing personalized medicine
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
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
Genomics of aging in a genetically homogeneous population
Translational science and personalized medicine
Translation of genomic research into genetic testing for healthcare
Long-term behavioral effects of personal genetic testing
Personalized predictive medicine
Opportunities and challenges
Prospects and limitations of genetic testing
Pharmacotyping
Comparative-effectiveness research and personalized mediine
Medicine in the year 2013
Concluding remarks about the future of personalized medicine
11. Ethical and Regulatory Aspects of Personalized Medicine
Introduction to ethical issues
Ethical issues of pharmacogenetics
Ethical aspects of genetic information
Ethical issues of whole genome analysis
Ethical aspects of direct-to-consumer genetic services
Privacy issues in personalized medicine
Genetic Information Nondiscrimination Act in the US
Genotype-specific clinical trials
Social 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
Regulation of direct-to-consumer genetic testing
FDA and pharmacogenomics
FDA guidance for pharmacogenomic data submissions
Joint guidelines of the FDA and EU regulators for pharmacogenomics
Pharmacogenomic/pharmacogenetic information in drug labels
FDA guidelines for pharmacogenomics-based dosing
FDA and validation of biomarkers
FDA and predictive medicine
FDA regulation of multivariate index assays
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
SNP market
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
Marketing companion diagnostics for 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 involved in companion diagnostics
Table 2-10: Applications of point-of-care diagnosis
Table 2-11: Companies developing point-of-care diagnostic tests
Table 2-12: Companies offering genetic screening tests directly to consumers
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 variable therapy targets
Table 4-2: Role of pharmacogenomics in clinical trials
Table 4-3: Examples of pharmacogenomics-based clinical studies
Table 4-4: Tumor suppressor genes, their chromosomal location, function and associated tumors
Table 4-5: Gene polymorphisms relevant to cardiovascular disease management
Table 4-6: Companies involved in cardiovascular genomics
Table 4-7: 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: Biomarkers of response to interferon-b in multiple sclerosis
Table 8-5: 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: Methods of translational science that are relvant to personalized medicine
Table 10-10: 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 2008-2018
Table 12-3: Markets for personalized medicine according to therapeutic area 2008-2018
Table 12-4: Markets for personalized medicine in major regions 2008-2018
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 1-2: Relation of systems pharmacology to personalized medicine
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 scheme of personalized approach to management of hypertension
Figure 8-2: A scheme of personalized management of pain
Figure 9-1: Relationships of technologies for personalized management of cancer
Figure 10-1: Integration of technologies for the development of personalized medicine
Figure 12-1: Evolution of personalized medicine as a market driver
14. Companies Involved in Developing Personalized Medicine
Introduction
Profiles
Collaborations
Tables
Table 14-1: Top five companies involved in personalized medicine
Table 14-2: Selected collaborations of companies in personalized medicine
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