View Cart
Global Information, Inc.
US:
+1-860-674-8796
EU:
+32-2-535-7543
SG:
+65-6223-2436
Home
|
Category
|
Publishers
|
Custom Research
|
E-mail Alert
|
About Us
|
Contact Us
|
Site Map
|
Biotechnology
Antibody & Immunity
Biomaterials
Gene Therapeutics & RNAi
Regenerative Medicine
Molecular Targeted Therapeutics
Genome-based Drug Discovery
Biomarker
Biotechnology Equipment
Personalized Medicine
View All Categories
Home
>
Category
>
Biotechnology
> Personalized Medicine - scientific & commercial aspects
Market Research Report
Personalized Medicine - scientific & commercial aspects
Published by
Jain Pharmabiotech
Published
2009/11
Content info
Product code
JAI70924
Price
From
US $ 4000
US $ 4000
PDF By E-mail (Single User License)
How to Order?
PDF by E-Mail
Approx. 1-2 business days
Hard Copy/CD-ROM
Approx. 3-4 business days
If you need expedited delivery, please call us.
Table of Contents
0. Executive Summary 17
1. Basic Aspects 19
Definition of personalized medicine 19
History of medical concepts relevant to personalized medicine 20
Molecular biological basis of personalized medicine 22
The human genome 22
Chromosomes 23
Genes 23
The genetic code 23
Gene expression 23
DNA sequences and structure 24
Single nucleotide polymorphisms 24
Genotype and haplotypes 25
Genetic variations in the human genome 25
Insertions and deletions in the human genome 25
Large scale variation in human genome 26
Variation in copy number in the human genome 26
Structural variations in the human genome 27
Mapping and sequencing of structural variation from human genomes 28
1000 Genomes Project 28
Human Variome Project 29
Basics technologies for developing personalized medicine 30
Definitions of technologies relevant to personalized medicine 30
Problems with the ICH definitions of pharmacogenomcis and pharmacogenetics 30
Relationship of various technologies to personalized medicine 31
Conventional medicine versus personalized medicine 31
Role of genetics in future approaches to healthcare 32
Genetic medicine 32
Human disease and genes 32
Genetic and environmental interactions in etiology of human diseases 33
Mass analysis of DNA from whole populations 33
Role of genetics in development of personalized medicines 33
Genetic databases 34
Genetic epidemiology 34
Limitations of medical genetics and future prospects 34
Genetics vs. epigenetics 35
Role of systems biology in personalized medicine 35
Systems pharmacology 36
Systems medicine 37
A personalized approach to environmental factors in disease 37
Reclassification of diseases 38
2. Molecular Diagnostics in Personalized Medicine 39
Introduction 39
Molecular diagnostic technologies 39
PCR-based methods 40
DirectLinear"! Analysis 40
Denaturing high-performance liquid chromatography 41
Multiplex Allele-Specific Diagnostic Assay 41
Representational oligonucleotide microarray analysis 41
Restriction fragment length polymorphism (RFLP) 41
Real-time PCR for detection of CNVs 41
Non-PCR methods 42
Arrayed primer extension (APEX) 42
Enzymatic Mutation Detection (EMD) 42
DNA sequencing 42
Sanger-sequencing technology 43
Cyclic array sequencing 44
454 Pyrosequencing technology 44
Electron microscope-based DNA sequencing 44
Illumina Genome Analyzer System 45
Multiplex amplification of human DNA sequences 45
Sequencing by hybridization 46
SOLiD technology 46
Whole genome sequencing 46
Bioinformatic tools for analysis of genomic sequencing data 47
Detection of single molecules in real time 47
Direct observation of nucleotide incorporation 47
Molecular Combing 47
Nanopore sequencing 48
DNA sequence by use of nanoparticles 48
Zero-mode waveguide nanostructure arrays 48
Future prospects of sequencing 48
Biochips and microarrays 49
Application of biochip technology in developing personalized medicine 49
Standardizing the microarrays 51
Biochip technologies 51
GeneChip 51
AmpliChip CYP450 51
Microfluidics 53
Lab-on-a-chip 54
Micronics' microfluidic technology 54
LabCD 54
Microfluidic automated DNA analysis using PCR 54
Integrated microfluidic bioassay chip 55
Electronic detection of nucleic acids on microarrays 55
Strand displacement amplification on a biochip 55
Rolling circle amplification on DNA microarrays 56
Universal DNA microarray combining PCR and ligase detection reaction 56
Protein biochips 56
ProteinChip 57
LabChip for protein analysis 58
TRINECTIN proteome chip 58
Protein expression microarrays 58
Microfluidic devices for proteomics-based diagnostics 59
New developments in protein chips 59
Protein chips for personalized medicine 60
SNP genotyping 60
Haplotyping 61
Haplotype Specific Extraction 62
Computation of haplotypes 62
HapMap project 62
Predictingdrug response with HapMap 63
Companies developing haplotyping technology 63
Technologies for SNP analysis 64
Biochip and microarray-based detection of SNPs 65
SNP genotyping by MassARRAY 65
Biochip combining BeadArray and ZipCode technologies 65
SNP-IT primer-extension technology 66
OmniScan SNP genotyping 66
Affymetrix Variation Detection Arrays 66
Use of NanoChip for detection of SNPs 66
DNA sequencing 67
Electrochemical DNA probes 67
Single base extension-tag array 68
Laboratory Multiple Analyte Profile 68
PCR-CTPP (confronting two-pair primers) 68
SNP genotyping on a genome-wide amplified DOP-PCR template 69
TaqMan real-time PCR 69
Non-Enzymatic Amplification Technology 69
SNP genotyping with gold nanoparticle probes 70
Locked nucleic acid 70
Molecular inversion probe based assays 70
Pyrosequencing 70
Reversed enzyme activity DNA interrogation test 71
Smart amplification process version 2 72
Zinc finger proteins 72
UCAN method (Takara Biomedical) 72
Mitochondrial SNPs 72
Limitations of SNP in genetic testing 73
Concluding remarks on SNP genotyping 73
Companies involved in developing technologies/products for SNP analysis 73
Impact of SNPs on personalized medicine 75
Optical Mapping 75
Role of nanobiotechnology in molecular diagnostics 76
Cantilevers for personalized medical diagnostics 76
Nanopore-based technology for single molecule identification 77
Role of biomarkers in personalized medicine 77
Biomarkers for diagnostics 78
Biomarkers for drug development 78
Application of proteomics in molecular diagnosis 78
Proteomic strategies for biomarker identification 79
Proteomic technologies for detection of biomarkers in body fluids 79
Protein patterns 79
Layered Gene Scanning 80
Comparison of proteomic and genomic approaches in personalized medicine 81
Gene expression profiling 81
DNA microarrays 82
Analysis of single-cell gene expression 82
Gene expression profiling based on alternative RNA splicing 83
Whole genome expression array 84
Tangerine"! expression profiling 84
Gene expression analysis on biopsy samples 85
Profiling gene expression patterns of white blood cells 85
Serial analysis of gene expression (SAGE) 85
Multiplexed Molecular Profiling 86
Gene expression analysis using competitive PCR and MALDI TOF MS 86
Monitoring in vivo gene expression by magnetic resonance imaging 87
Companies involved in gene expression analysis 87
Monitoring in vivo gene expression by molecular imaging 88
Molecular imaging and personalized medicine 88
Glycomics-based diagnostics 89
Combination of diagnostics and therapeutics 89
Use of molecular diagnostics for stratification in clinical trials 89
Companion diagnostics 90
Companies involved in companion diagnostics 90
Point-of-care diagnosis 92
Companies developing point-of-care diagnostic technologies 93
Point-of-care diagnosis of infections 95
Advantages versus disadvantages of point-of-care diagnosis 96
Future prospects of point-of-care diagnosis 96
Genetic testing for disease predisposition 96
Preventive genetics by early diagnosis of mitochondrial diseases 97
Personal genetic service 97
Role of diagnostics in integrated healthcare 98
Concept of integrated healthcare 98
Components of integrated healthcare 99
Screening 99
Disease prediction 99
Early diagnosis 100
Prevention 100
Therapy based on molecular diagnosis 100
Monitoring of therapy 100
Advantages and limitations of integrated healthcare 100
Commercially available systems for integrated healthcare 101
Future of molecular diagnostics in personalized medicine 101
3. Pharmacogenetics 103
Basics of pharmacogenetics 103
Role of molecular diagnostics in pharmacogenetics 104
Role of pharmacogenetics in pharmaceutical industry 105
Study of the drug metabolism and pharmacological effects 105
Causes of variations in drug metabolism 105
Enzymes relevant to drug metabolism 106
Pharmacogenetics of phase I metabolism 106
CYP450 106
P450 CYP 2D6 inhibition by selective serotonin reuptake inhibitors 108
Cytochrome P450 polymorphisms and response to clopidogrel 109
Lansoprazole and cytochrome P450 109
Glucose-6-phosphate dehydrogenase 109
Pharmacogenetics of phase II metabolism 110
N-Acetyltransferase 110
Uridine diphosphate-glucuronosyltransferase 111
Measurement of CYP isoforms 111
Polymorphism of drug transporters 112
Genetic variation in drug targets 112
Polymorphisms of kinase genes 113
Effect of genetic polymorphisms on disease response to drugs 113
Ethnic differences in drug metabolism 114
Gender differences in pharmacogenetics 114
Role of pharmacogenetics in drug safety 115
Adverse drug reactions 115
Adverse drug reactions in children 115
Adverse drug reactions related to toxicity of chemotherapy 116
Genetically determined adverse drug reactions 116
Malignant hyperthermia 117
Pharmacogenetics of clozapine-induced agranulocytosis 118
Role of pharmacogenetics in warfarin therapy 118
Role of pharmacogenetics in carbamazepine therapy 119
Role of pharmacogenetics in statin therapy 119
FDA consortium linking genetic biomarkers to serious adverse events 119
Therapeutic drug monitoring, phenotyping, and genotyping 120
Therapeutic drug monitoring 120
Phenotyping 121
Genotyping 122
Genotyping vs phenotyping 122
Phenomics 123
Limitations of genotype-phenotype association studies 123
Molecular toxicology in relation to personalized medicines 124
Toxicogenomics 124
Companies involved in molecular toxicology 124
Gene expression studies 125
Genomics and the prediction of xenobiotic toxicity 126
Pharmacogenetics in clinical trials 126
Postmarketing pharmacogenetics 127
Clinical implications of pharmacogenetics 127
Application of CYP450 genotyping in clinical practice 127
Genotype-based drug dose adjustment 127
Examples of use of pharmacogenetics in clinical pharmacology 128
Linking pharmacogenetics with pharmacovigilance 128
Genetic susceptibility to ADRs 128
Linking genetic testing to postmarketing ADR surveillance 129
Recommendations for the clinical use of pharmacogenetics 129
Limitations of pharmacogenetics 130
Pharmacoepigenomics vs pharmacogenetics in drug safety 130
Academic research in pharmacogenetics 131
Future role of pharmacogenetics in personalized medicine 131
4. Pharmacogenomics 133
Introduction 133
Basics of pharmacogenomics 134
Pharmacogenomics and drug discovery 134
Preclinical prediction of drug efficacy 136
Pharmacogenomics and clinical trials 136
Impact of genetic profiling on clinical studies 138
Limitations of the pharmacogenomic-based clinical trials 139
Pharmacogenomic aspects of major therapeutic areas 139
Oncogenomics 139
Oncogenes 140
Tumor suppressor genes 140
Cardiogenomics 141
Neuropharmacogenomics 143
Pharmacogenomics of Alzheimer' s disease 144
Pharmacogenomics of depression 144
Pharmacogenomics of schizophrenia 144
Companies involved in neurogenomics-based drug discovery 145
5. Role of Pharmacoproteomics 147
Basics of proteomics 147
Proteomic approaches to the study of pathophysiology of diseases 147
Single cell proteomics for personalized medicine 148
Diseases due to misfolding of proteins 148
Therapies for protein misfolding 149
Significance of mitochondrial proteome in human disease 150
Proteomic technologies for drug discovery and development 150
Role of reverse-phase protein microarray in drug discovery 150
Role of proteomics in clinical drug safety 150
Toxicoproteomics 151
Application of pharmacoproteomics in personalized medicine 152
6. Role of Metabolomics in Personalized Medicine 153
Metabolomics and metabonomics 153
Metabolomics bridges the gap between genotype and phenotype 153
Metabolomics, biomarkers and personalized medicine 154
Metabolomic technologies 154
Urinary profiling by capillary electrophoresis 155
Lipid profiling 155
Role of metabolomics in biomarker identification and pattern recognition 156
Validation of biomarkers in large-scale human metabolomics studies 156
Pharmacometabonomics 157
Metabonomic technologies for toxicology studies 157
Metabonomics/metabolomics and personalized nutrition 158
7. Personalized Biological Therapies 159
Introduction 159
Recombinant human proteins 159
Therapeutic monoclonal antibodies 159
Cell therapy 160
Autologous tissue and cell transplants 160
Stem cells 160
Role of stem cells derived from unfertilized embryos 160
Cloning and personalized cell therapy 161
Use of stem cells for drug testing 161
Gene therapy 161
Personalized vaccines 162
Personalized vaccines for viral diseases 162
Personalized cancer vaccines 162
Patient-specific cancer vaccines 162
Antigen-specific vaccines 163
Autologous cell vaccines 163
Multipeptide cancer vaccines 164
Personalized melanoma vaccines 165
Antisense therapy 165
RNA interference 166
MicroRNAs 167
8. Personalized Medicine in Major Therapeutic Areas 169
Introduction 169
Management of infections 170
Management of HIV 170
Genetics of human susceptibility to HIV infection 170
Pharmacogenomics of antiretroviral agents 170
Role of diagnostic testing in HIV 171
CD4 counts as a guide to drug therapy for AIDS 171
Drug-resistance in HIV 171
Measurement of Replication Capacity 173
Prevention of adverse reactions to antiviral drugs 173
Role of genetic variations in susceptibility to HIV-1 173
Pharmacogenetics and HIV drug safety 174
Personalized treatment of hepatitis B 174
Personalized treatment of hepatitis C 174
Personalized management of tuberculosis 175
Psychiatric disorders 176
Psychopharmacogenetics 176
COMT genotype and response to amphetamine 177
Genotype and response to methylphenidate in children with ADHD 177
Personalized antipsychotic therapy 177
Personalized antidepressant therapy 180
Pretreatment EEG to predict adverse effects to antidepressants 180
Individualization of SSRI treatment 181
Vilazodone with a test for personalized treatment of depression 182
Neurological disorders 182
Personalized management of Alzheimer' s disease 182
Personalized management of Parkinson' s disease 184
Discovery of subgroup-selective drug targets in PD 184
Personalized management of Epilepsy 185
Choice of the right AED 185
Pharmacogenetics of epilepsy 185
Pharmacogenomics of epilepsy 186
Drug resistance in epilepsy 186
Future prospects for management of epilepsy 187
Personalized management of migraine 188
Individualization of use of triptans for migraine 188
Personalized treatment of multiple sclerosis 189
Immunopathological patterns of demyelination for assessing therapy 189
Personalizing mitoxantrone therapy of multiple sclerosis 190
Fusokine method of personalized cell therapy of multiple sclerosis 190
MBP8298 191
Pharmacogenomics of IFN-β therapy in multiple sclerosis 191
Cardiovascular disorders 192
Role of diagnostics in personalized management of cardiovascular disease 192
Testing in coronary heart disease 192
SNP genotyping in cardiovascular disorders 193
Cardiovascular disorders with a genetic component 193
Gene variant as a risk factor for sudden cardiac death 195
KIF6 gene test as a guide to management of congestive heart failure 195
SNP Chip for study of cardiovascular diseases 196
Pharmacogenomics of cardiovascular disorders 196
Modifying the genetic risk for myocardial infarction 196
Management of heart failure 197
β blockers 197
Bucindolol 197
BiDil 198
Management of hypertension 198
Pharmacogenomics of diuretic drugs 198
Pharmacogenomics of ACE inhibitors 199
Management of hypertension by personalized approach 199
Pharmacogenetics of lipid-lowering therapies 200
Polymorphisms in genes involved in cholesterol metabolism 201
Role of eNOS gene polymorphisms 201
The STRENGTH study 202
Personalized management of women with hyperlipidemia 203
Thrombotic disorders 203
Factor V Leiden mutation 203
Anticoagulant therapy 204
Antiplatelet therapy 204
Nanotechnology-based personalized therapy of cardiovascular diseases 204
Project euHeart for personalized management of cardiovascular diseases 205
Concluding remarks 205
Personalized management of pulmonary disorders 206
Personalized therapy of asthma 206
Biomarkers for predicting response to corticosteroid therapy 206
Genetic polymorphism and response to β -adrenergic agonists 207
Genotyping in asthma 207
IgE as guide to dosing of omalizumab for asthma 208
Personalized management of chronic obstructive pulmonary disease 208
Personalized management of skin disorders 209
Genetic testing for personalized skin care 209
Management of hair loss based on genetic testing 209
Personalized therapy of rheumatoid arthritis 209
DIATSTAT"! anti-cyclic citrullinated peptides in rheumatoid arthritis 210
Personalization of COX-2 inhibitor therapy 211
Personalization of infliximab therapy 211
Personalized approaches in immunology 211
Role of Mannose-binding lectin in personalized medicine 212
Pharmacogenetics and pharmacogenomics of immunosuppressive agents 212
Personalized management of patients with lupus erythematosus 212
Personalized management of pain 213
Pharmacogenetics/pharmacogenomics of pain 214
Mechanism-specific management of pain 215
Preoperative testing to tailor postoperative analgesic requirements 215
Personalized analgesics 216
Management of genetic disorders 216
Personalized treatment of cystic fibrosis 216
Personalized management of gastrointestinal disorders 217
Personalized therapy of inflammatory bowel disease 217
Personalized management of lactose intolerance 217
Personalized approaches to improve organ transplantation 218
Personalization of kidney transplantation 218
Personalization of cardiac transplantation 218
Prediction of rejection to tailor anti-rejection medications 219
Personalized immunosuppressant therapy in organ transplants 219
Role of immunological biomarkers in monitoring grafted patients 220
Improved matching of blood transfusion 221
Personalized approach to addiction 221
Genetic polymorphism and management of alcoholism 221
Personalized therapy for smoking cessation 221
Antidepressant therapy for smoking cessation 222
Effectiveness of nicotine patches in relation to genotype 222
Personalized approach to drug addiction 222
Personalized approaches to miscellaneous problems 223
Hormone replacement therapy in women 223
Personalized treatment of malaria 223
Personalized management of renal disease 224
Gene associated with end-stage renal disease 224
Personalized care of trauma patients 224
Personalized anticoagulation 225
Personalized Hyperbaric oxygen therapy 225
Personalized preventive medicine 226
Personalized nutrition 227
Nutrigenomics 227
Nutrigenomics and functional foods 228
Nutrigenomics and personalized medicine 228
Nutrition and proteomics 229
Personalized diet prescription 229
9. Personalized Therapy of Cancer 231
Introduction 231
Challenges of cancer classification 231
Relationships of technologies for personalized management of cancer 231
Impact of molecular diagnostics on the management of cancer 232
Analysis of RNA splicing events in cancer 233
Analysis of chromosomal alterations in cancer cells 233
Cancer classification using microarrays 233
Detection of loss of heterozygosity 234
Diagnosis of cancer of an unknown primary 234
Diagnostics for detection of minimal residual disease 235
Fluorescent in situ hybridization 235
Gene expression profiling 235
Gene expression profiles predict chromosomal instability in tumors 237
Isolation and characterization of circulating tumor cells 237
Modulation of CYP450 activity for cancer therapy 238
Personalized therapies based on oncogenic pathways signatures 238
Quantum dot-based test for DNA methylation 239
Role of molecular imaging in personalized therapy of cancer 239
Functional diffusion MRI 239
Role of FDG-PET/CT in personalizing cancer treatment 240
Tumor imaging and elimination by targeted gallium corrole 240
Future prospects of molecular imaging in management of cancer 241
Unraveling the genetic code of cancer 241
Cancer prognosis 241
Detection of mutations for risk assessment and prevention 242
Impact of biomarkers on management of cancer 242
VeraTag"! assay system for cancer biomarkers 242
Predictive biomarkers for cancer 243
HER-2/neu oncogene as a biomarker for cancer 243
Oncogene GOLPH3 as a cancer biomarker 243
L-asparaginase treatment of cancer guided by a biomarker 244
Determination of response to therapy 244
ChemoFx cell culture assay for predicting anticancer drug response 244
Ex vivo testing of tumor biopsy for chemotherapy sensitivity 244
Genomic approaches to predict response to anticancer agents 245
Gene expression patterns to predict response of cancer to therapy 245
Genomic analysis of tumor biopsies 245
Genotype-dependent efficacy of pathway inhibition in cancer 246
Mutation detection at molecular level 246
Role of genetic variations in susceptibility to anticancer drugs 247
Non-genetic factors for variations in response of cancer cells to drugs 247
Proteomic analysis of tumor biopsies to predict response to treatment 247
Real-time apoptosis monitoring 248
Serum nucleosomes as indicators of sensitivity to chemotherapy 248
Targeted microbubbles to tumors for monitoring anticancer therapy 249
PET imaging for determining response to chemotherapy 249
Tissue systems biology approach to personalized management of cancer 249
Targeted cancer therapies 250
Targeting glycoproteins on cell surface 250
Targeting pathways in cancer 250
Functional antibody-based therapies 250
Personalized radiation therapy 251
Molecular diagnostics combined with cancer therapeutics 252
Aptamers for combined diagnosis and therapeutics of cancer 253
Role of nanobiotechnology in personalized management of cancer 253
Design of future cancer therapies 254
Screening for personalized anticancer drugs 255
Role of epigenetics in development of personalized cancer therapies 255
Personalized therapy of cancer based on cancer stem cells 255
Role of oncoproteomics in personalized therapy of cancer 255
Cancer tissue proteomics 256
Pharmacogenomic-based chemotherapy 256
Whole genome technology to predict drug resistance 256
Anticancer drug selection based on molecular characteristics of tumor 257
Testing microsatellite-instability for response to chemotherapy 257
Pharmacogenetics of cancer chemotherapy 258
CYP 1A2 258
Thiopurine methyltransferase 258
Dihydropyrimidine dehydrogenase 259
UGT1A1 test as guide to irinotecan therapy 259
Role of computational models in personalized anticancer therapy 260
A computational model of kinetically tailored treatment 260
Mathematical modeling of tumor mivroenvironments 261
Molecular profiling of cancer 261
Drug resistance in cancer 261
Detection of drug resistance in cancer by metabolic profiling 262
Determination of chemotherapy response by topoisomerase levels 263
A systems biology approach to drug resistance in colorectal cancer 263
Management of drug resistance in leukemia 263
Overexpression of multidrug resistance gene 264
P53 mutations 264
A chemogenomic approach to drug resistance 264
Systems biology approach to personalizing therapy for drug-resistant cancer 265
Examples of personalized management of cancer 265
Personalized management of breast cancer 265
Developing personalized drugs for breast cancer 266
Gene expression plus conventional predictors of breast cancer 266
Genetic testing in breast cancer as a guide to treatment 267
Molecular diagnostics in breast cancer 268
Pharmacogenetics of breast cancer 270
Proteomics-based personalized management of breast cancer 270
Predicting response to chemotherapy in breast cancer 270
Prediction of resistance to therapy in breast cancer 273
Prediction of adverse reaction to radiotherapy in breast cancer 273
Prediction of recurrence in breast cancer for personalizing therapy 274
Prognosistic tests for breast cancer 275
Racial factors in the management of breast cancer 277
TAILORx (Trial Assigning Individualized Options for Treatment) 277
Trends and future prospects of breast cancer research 278
Understanding tumor diversity in mouse mammary cancer model 278
Personalized management of ovarian cancer 278
Personalized management of hematological malignancies 280
Personalized management of acute leukemias 280
Personalized management of chronic lymphocytic leukemia 281
Personalized management of multiple myeloma 282
Personalized management B cell lymphomas 283
Personalized vaccine for follicular lymphoma 283
Personalized management of myelodysplasia 284
Personalized management of hepatocellular carcinoma 284
Personalized management of malignant melanoma 284
Personalized management of gastrointestinal cancer 285
Personalized management of esophageal cancer 285
Personalized management of gastric cancer 285
Personalized management of colorectal cancer 286
Personalized management of liver cancer 288
Personalized management of lung cancer 288
Determination of outcome of EGFR tyrosine kinase inhibitor treatment 288
Testing for response to chemotherapy in lung cancer 290
Testing for prognosis of NSCLC 291
Testing for recurrence of lung cancer 291
Role of a new classification system in the management of lung cancer 291
Personlized management of prostate cancer 292
Benefit of lifestyle changes shown by gene expression studies 292
Personalized management of brain cancer 293
Genetics and genomics of brain cancer 293
Prognosis of glioblastoma multiforme based on its genetic landscape 294
Molecular diagnostics for personalized management of brain cancer 295
Personalized chemotherapy of brain tumors 296
Biosimulation approach to personalizing treatment of brain cancer 297
Personalized therapy of oligodendroglial tumors (OTs) 297
Personalized therapy of neuroblastomas 298
Personalized therapy of medulloblastomas 299
Personalized management of germ cell brain tumors 299
Future of cancer therapy 299
Challenges for developing personalized cancer therapies 300
The Cancer Genome Atlas 300
Role of the International Cancer Genome Consortium 300
Using computer and imaging technologies to personalize cancer treatment 301
Integrated genome-wide analysis of cancer for personalized therapy 302
Companies involved in developing personalized cancer therapy 302
10. Development of Personalized Medicine 305
Introduction 305
Non-genomic factors in the development of personalized medicine 305
Personalized medicine based on circadian rhythms 305
Cytomics as a basis for personalized medicine 306
Intestinal microflora 306
Gut microbiome compared to human genome 306
Metabolic interactions of the host and the intestinal microflora 307
Role of drug delivery in personalized medicine 307
Personalized approach to clinical trials 308
Use of Bayesian approach in clinical trials 308
Individualzing risks and benefits in clinical trials 308
Clinical trials of therapeutics and companion diagnostics 309
Players in the development of personalized medicine 309
Personalized Medicine Coalition 309
Role of pharmaceutical industry 310
Production and distribution of personalized medicines 311
Role of biotechnology companies 312
Role of life sciences industries 312
Role of molecular imaging in personalized medicine 312
Molecular imaging for personalized drug development in oncology 313
Molecular imaging and CNS drug development 314
Companies involved in molecular imaging 315
Role of the clinical laboratories 316
Role of the US government 316
Department of Health and Human Services and personalized medicine 317
Comparative effectiveness research 318
Role of the US Government agencies in personalized medicine 319
NIH' s Roadmap Initiative for Medical Research 319
NIH and personalized medicine 319
National Institute of General Medical Sciences 320
National Institute of Standards and Technology 320
Support from Agency for Healthcare Research and Quality 321
Role of academic institutons in the US 321
Clinical Proteomics Program 321
Coriell Personalized Medicine Collaborative"! 322
Delaware Valley Personalized Medicine Project 322
Evaluation of genetic tests and genomic applications 323
Genomic-Based Prospective Medicine Project 323
Personalized oncology at Massachusetts General Hospital 324
Pharmacogenetics Research Network and Knowledge Base 324
Quebec Center of Excellence in Personalized Medicine 325
Southeast Nebraska Cancer Center' s Personalized Medicine Network 325
Wisconsin Genomics Initiative 325
Role of healthcare organizations and hospitals 326
Signature Genetics 326
The Mayo Clinic genetic database 326
Research center for personalized medicine at Mt. Sinai Medical Center 326
Role of the medical profession 327
Education of the physicians 327
Off-label prescribing and personalized medicine 327
Medical education 328
Public attitude towards personalized medicine 328
Role of genetic banking systems and databases 329
Role of biobanks in development of personalized medicine 329
UK Biobank 329
Biobanking and development of personalized medicine in EU 330
CARTaGENE for biobanks in Canada 330
Personalized medicine based on PhysioGenomics"! technology 331
Role of bioinformatics in development of personalized medicine 331
Exploration of disease-gene relationship 332
Biosimulation techniques for developing personalized medicine 333
Health information management 333
Electronic health records 333
Linking patient medical records and genetic information 334
Management of personal genomic data 335
Personalized prognosis of disease 335
Integration of technologies for development of personalized medicine 335
Global scope of personalized medicine 336
Personalized medicine in the developed countries 336
Personalized medicine in the US 337
Personalized medicine in the EU 337
UK National Health Service and medical genetics 338
Personalized medicine in the developing countries 339
Advantages and limitations of personalized medicine 339
Future of personalized medicine 341
Ongoing genomic projects 341
Understanding the genetic basis of diseases 341
Personal Genome Project 342
Genome-wide association studies 342
The 1000 Genomes Project 343
Genomics of aging in a genetically homogeneous population 343
Translational science and personalized medicine 344
Translation of genomic research into genetic testing for healthcare 344
Long-term behavioral effects of personal genetic testing 345
Personalized predictive medicine 345
Opportunities and challenges 346
Prospects and limitations of genetic testing 346
Pharmacotyping 347
Comparative-effectiveness research and personalized mediine 348
Medicine in the year 2013 348
Concluding remarks about the future of personalized medicine 349
11. Ethical and Regulatory Aspects of Personalized Medicine 351
Introduction to ethical issues 351
Ethical issues of pharmacogenetics 351
Ethical aspects of genetic information 351
Ethical issues of whole genome analysis 351
Ethical aspects of direct-to-consumer genetic services 352
Privacy issues in personalized medicine 354
Genetic Information Nondiscrimination Act in the US 354
Genotype-specific clinical trials 354
Social issues in personalized medicine 355
Race and personalized medicine 355
Regulatory aspects 357
CLSI guideline for the use of RNA controls in gene expression assays 357
MicroArray Quality Control Project 358
Regulatory aspects of pharmacogenetics 359
Regulation of direct-to-consumer genetic testing 359
FDA and pharmacogenomics 360
FDA guidance for pharmacogenomic data submissions 360
Joint guidelines of the FDA and EU regulators for pharmacogenomics 361
Pharmacogenomic/pharmacogenetic information in drug labels 361
FDA guidelines for pharmacogenomics-based dosing 362
FDA and validation of biomarkers 362
FDA and predictive medicine 363
FDA regulation of multivariate index assays 363
Evaluation of companion diagnostics/therapeutic for cancer 364
12. Commercial Aspects of Personalized Medicine 367
Introduction 367
Perceived financial concerns 367
Personalized medicine and orphan drug syndrome 367
Commercial aspects of pharmacogenomics 367
Cost of DNA testing 367
Cost of sequencing the human genome 368
Cost of genotyping 370
Cost of pharmacogenomics-based clinical trials 370
Business development of pharmacogenomic companies 371
Cost of personalized healthcare 371
Cost of genetic testing 371
Economics of CYP genotyping-based pharmacotherapy 372
Cost of personalized medicines 372
The rising healthcare costs in the US 372
Lowering the cost of healthcare 373
Cost effectiveness of HIV genotyping 373
Lowering the high costs of cancer chemotherapy 373
Reducing the cost incurred by adverse drug reactions 374
Overall impact of personalized medicine on healthcare 374
Drivers for the development of personalized medicine 374
Evolution of medicine as a driver for personalized therapy markets 375
Collaboration between the industry and the academia 376
Personalized medicine and drug markets 376
Impact on drug markets 376
Growth of markets relevant to personalized medicine 377
SNP market 377
Pharmacogenomics 378
Pharmacogenetics 378
Pharmacoproteomics 378
Biochips 378
Point-of-Care 378
Markets for personalized medicines according to therapeutic areas 378
Markets for personalized medicines according to geographical regions 379
Market opportunities for personalization of medicine 379
Impact of personalized medicine on other industries 380
Strategies for developing and marketing personalized medicine 381
Education of the public 381
Role of the Internet in development of personalized medicine 381
Marketing companion diagnostics for personalized medicine 382
13. References 383
Tables
Table 1 1: Selected terms relevant to the concept of personalized medicine 19
Table 1 2: Landmarks in the historical development of personalized medicine 20
Table 2 1: Molecular diagnostic technologies used for personalized medicine 39
Table 2 2: Applications of biochip technology relevant to personalized medicine 50
Table 2 3: Companies developing haplotying technology 64
Table 2 4: Technologies for SNP analysis 64
Table 2 5: A sampling of companies involved in technologies for SNP genotyping 74
Table 2 6: Comparison of proteomic and genomic approaches in personalized medicine 81
Table 2 7: Selected methods for gene expression profiling 82
Table 2 8: A selection of companies with gene expression technologies 87
Table 2 9: Companies involved in companion diagnostics 91
Table 2 10: Applications of point-of-care diagnosis 92
Table 2 11: Companies developing point-of-care diagnostic tests 93
Table 2 12: Companies offering genetic screening tests directly to consumers 97
Table 3 1: Pharmacogenetic vs. pharmacogenomic studies 104
Table 3 2: Enzymes relevant to drug metabolism 106
Table 3 3: Examples of mutation of the enzyme CYP450 107
Table 3 4: Frequency distribution of drugs metabolized by major isoforms of CYP450 107
Table 3 5: Commonly prescribed medications, which are metabolized by CYP2D6 107
Table 3 6: Polymorphisms in drug target genes that can influence drug response 113
Table 3 7: Effect of genetic polymorphisms on disease response to drugs 113
Table 3 8: Examples of genetically determined adverse reactions to drugs 116
Table 3 9: Examples of genotyping and phenotyping in some diseases 123
Table 3 10: Companies with novel molecular toxicology technology 125
Table 4 1: Role of pharmacogenomics in variable therapy targets 133
Table 4 2: Role of pharmacogenomics in clinical trials 137
Table 4 3: Examples of pharmacogenomics-based clinical studies 137
Table 4 4: Tumor suppressor genes, their chromosomal location, function and associated tumors 140
Table 4 5: Gene polymorphisms relevant to cardiovascular disease management 141
Table 4 6: Companies involved in cardiovascular genomics 143
Table 4 7: A sampling of companies involved in neuropharmacogenomics 145
Table 8 1: Important therapeutic areas for personalized medicine 169
Table 8 2: Enzymes that metabolize antipsychotics 179
Table 8 3: Enzymes that metabolize antidepressants 180
Table 8 4: Biomarkers of response to interferon-β in multiple sclerosis 191
Table 8 5: Genes that cause cardiovascular diseases 194
Table 9 1: Factors that drive the development of personalized therapy in cancer 231
Table 9 2: Impact of molecular diagnostics on the management of cancer 232
Table 9 3: Selected companies involved in developing personalized cancer therapies 302
Table 10 1: Players in the development of personalized medicine 309
Table 10 2: Members of the Personalized Medicine Coalition 309
Table 10 3: Biobanks relevant to personalized medicine 329
Table 10 4: Role of bioinformatics in the development of personalized medicine 331
Table 10 5: Advantages of personalized medicine for the biopharmaceutical industry 339
Table 10 6: Advantages of personalized medicine for the patients 340
Table 10 7: Advantage of personalized medicine for the physicians 340
Table 10 8: Limitations of personalized medicine 340
Table 10 9: Methods of translational science that are relvant to personalized medicine 344
Table 10 10: Companies involved in predictive healthcare 346
Table 12 1: Drivers for the development of personalized medicine 374
Table 12 2: Growth of markets relevant to personalized medicine 2008-2018 377
Table 12 3: Markets for personalized medicine according to therapeutic area 2008-2018 379
Table 12 4: Markets for personalized medicine in major regions 2008-2018 379
Table 12 5: Lack of efficacy in current therapy 380
Table 12 6: Impact of personalized medicine on other industries 380
Table 12 7: Strategies to develop personalized medicine 381
Table 12 8: Role of the Internet in development of personalized medicine 381
Figures
Figure 1 1: Relation of personalized medicine to other technologies 31
Figure 1 2: Relation of systems pharmacology to personalized medicine 37
Figure 2 1: Role of biochips/microarrays in personalized medicine 50
Figure 2 2: Affymetrix GeneChip technology 52
Figure 2 3: Role of CYP450 genotyping in development of personalized medicine 53
Figure 2 4: Role of SNPs in personalized medicine 61
Figure 2 5: A scheme of integrated healthcare and personalized medicine 99
Figure 3 1: Pharmacogenetics as a link between genotype and phenotype 103
Figure 3 2: Role of pharmacogenetic technologies in personalized medicine 104
Figure 4 1: Impact of new technologies at various stages of the drug discovery process 135
Figure 4 2: Steps in the application of pharmacogenomics in clinical trials 137
Figure 7 1: Role RNAi in development of personalized medicine 166
Figure 8 1: A scheme of personalized approach to management of hypertension 200
Figure 8 2: A scheme of personalized management of pain 214
Figure 9 1: Relationships of technologies for personalized management of cancer 232
Figure 10 1: Integration of technologies for the development of personalized medicine 336
Figure 12 1: Evolution of personalized medicine as a market driver 375
Related Report
Biomarkers - technologies,markets and companies
Cell Therapy - Technologies, Markets and Companies
Global Stem Cell and Advanced Technologies Market
Opportunities in Human Embryonic Stem Cell (hESC) Product Development
RNAi - technologies, markets and companies
Please inform me when related publications are released
US: 1-860-674-8796 EU: 32-2-535-7543 SG: 65-6223-2436
The vertical markets research portal
© 2009, the-infoshop.com by Global Information, Inc. All rights reserved.