Reportlinker Adds Personalized Medicine - Scientific & Commercial Aspects

Jun 03, 2010, 12:25 ET from Reportlinker

NEW YORK, June 3 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Personalized Medicine - scientific & commercial aspects


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 2014.

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 2009-2019.

Profiles of 223 companies involved in developing technologies for personalized medicines, along with 418 collaborations are included in the part II of the report. Finally the bibliography contains over 580 selected publications cited in the report. The report is supplemented by 60 tables and 17 figures.


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

Genetic variations in the human genome 24

Single nucleotide polymorphisms 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

Role of sequencing in the development of personalized medicine 30

Human Variome Project 30

Basics technologies for developing personalized medicine 31

Definitions of technologies relevant to personalized medicine 31

Problems with the ICH definitions of pharmacogenomcis and pharmacogenetics 31

Relationship of various technologies to personalized medicine 32

Conventional medicine versus personalized medicine 32

Role of genetics in future approaches to healthcare 33

Genetic medicine 33

Human disease and genes 33

Genetic and environmental interactions in etiology of human diseases 34

Role of genetics in development of personalized medicines 34

Genetic databases 34

Genetic epidemiology 35

Limitations of medical genetics and future prospects 35

Genetics vs. epigenetics 36

Role of systems biology in personalized medicine 36

Systems pharmacology 37

Systems medicine 38

A personalized approach to environmental factors in disease 38

Reclassification of diseases 39

2. Molecular Diagnostics in Personalized Medicine 41

Introduction 41

Molecular diagnostic technologies 41

PCR-based methods 42

DirectLinear™ Analysis 42

Denaturing high-performance liquid chromatography 43

Multiplex Allele-Specific Diagnostic Assay 43

Representational oligonucleotide microarray analysis 43

Restriction fragment length polymorphism (RFLP) 43

Real-time PCR for detection of CNVs 43

Non-PCR methods 44

Arrayed primer extension (APEX) 44

Enzymatic Mutation Detection (EMD) 44

DNA sequencing 44

Sanger-sequencing technology 45

ABI PRISM® 310 Genetic Analyzer 45

High-throughput paired end transcriptome sequencing 46

Emerging sequencing technologies 46

4300 DNA analyzer 47

Apollo 100 47

"Color blind" approach to DNA sequencing 47

Cyclic array sequencing 48

CEQ™ 8000 48

DeepCAGE sequencing 48

Electron microscope-based DNA sequencing 48

Genometrica sequencer 49

GS-FLEX system (Roche/454) 49

IBS sequencing technology 50

Illumina Genome Analyzer System 51

MegaBACE 500 51

Microdroplet-based PCR for large-scale targeted sequencing. 52

Multiplex amplification of human DNA sequences 52

Nanoscale sequencing 52

Polonator sequencer 53

RainStorm™ microdroplet technology 54

Sequential DEXAS 54

SOLiD technology 54

Sequencing by hybridization 55

Whole genome sequencing 55

Bioinformatic tools for analysis of genomic sequencing data 56

Detection of single molecules in real time 56

Direct observation of nucleotide incorporation 56

Molecular Combing 56

Nanopore sequencing 57

DNA sequence by use of nanoparticles 57

Zero-mode waveguide nanostructure arrays 57

Future prospects of sequencing 57

Biochips and microarrays 58

Application of biochip technology in developing personalized medicine 58

Standardizing the microarrays 60

Biochip technologies 60

GeneChip 60

AmpliChip CYP450 60

Microfluidics 62

Lab-on-a-chip 63

Micronics' microfluidic technology 63

LabCD 63

Microfluidic automated DNA analysis using PCR 63

Integrated microfluidic bioassay chip 64

Electronic detection of nucleic acids on microarrays 64

Strand displacement amplification on a biochip 65

Rolling circle amplification on DNA microarrays 65

Universal DNA microarray combining PCR and ligase detection reaction 65

Protein biochips 66

ProteinChip 66

LabChip for protein analysis 67

TRINECTIN proteome chip 67

Protein expression microarrays 67

Microfluidic devices for proteomics-based diagnostics 68

New developments in protein biochips/microarrays 68

Protein biochips/microarrays for personalized medicine 69

SNP genotyping 69

Genotyping and haplotyping 70

Haplotype Specific Extraction 71

Computation of haplotypes 71

HapMap project 71

Predictingdrug response with HapMap 73

Companies developing haplotyping technology 73

Technologies for SNP analysis 73

Biochip and microarray-based detection of SNPs 74

SNP genotyping by MassARRAY 74

Biochip combining BeadArray and ZipCode technologies 75

SNP-IT primer-extension technology 75

OmniScan SNP genotyping 75

Affymetrix Variation Detection Arrays 76

Use of NanoChip for detection of SNPs 76

DNA sequencing 76

Electrochemical DNA probes 76

Single base extension-tag array 77

Laboratory Multiple Analyte Profile 77

PCR-CTPP (confronting two-pair primers) 78

SNP genotyping on a genome-wide amplified DOP-PCR template 78

TaqMan real-time PCR 78

Non-Enzymatic Amplification Technology 78

SNP genotyping with gold nanoparticle probes 79

Locked nucleic acid 79

Molecular inversion probe based assays 79

Pyrosequencing 80

Reversed enzyme activity DNA interrogation test 80

Smart amplification process version 2 81

Zinc finger proteins 81

UCAN method (Takara Biomedical) 81

Mitochondrial SNPs 82

Limitations of SNP in genetic testing 82

Concluding remarks on SNP genotyping 82

Companies involved in developing technologies/products for SNP analysis 83

Impact of SNPs on personalized medicine 84

Study of rare variants in pinpointing disease-causing genes 85

Optical Mapping 85

Role of nanobiotechnology in molecular diagnostics 86

Cantilevers for personalized medical diagnostics 86

Nanopore-based technology for single molecule identification 87

Role of biomarkers in personalized medicine 87

Biomarkers for diagnostics 88

Biomarkers for drug development 88

Application of proteomics in molecular diagnosis 88

Proteomic strategies for biomarker identification 89

Proteomic technologies for detection of biomarkers in body fluids 89

Protein patterns 89

Layered Gene Scanning 90

Comparison of proteomic and genomic approaches in personalized medicine 90

Gene expression profiling 91

DNA microarrays 92

Analysis of single-cell gene expression 92

Gene expression profiling based on alternative RNA splicing 93

Whole genome expression array 94

Tangerine™ expression profiling 94

Gene expression analysis on biopsy samples 95

Profiling gene expression patterns of white blood cells 95

Serial analysis of gene expression (SAGE) 95

Multiplexed Molecular Profiling 96

Gene expression analysis using competitive PCR and MALDI TOF MS 96

Monitoring in vivo gene expression by magnetic resonance imaging 97

Companies involved in gene expression analysis 97

Monitoring in vivo gene expression by molecular imaging 98

Molecular imaging and personalized medicine 98

Glycomics-based diagnostics 99

Combination of diagnostics and therapeutics 99

Use of molecular diagnostics for stratification in clinical trials 99

Companion diagnostics 100

Companies involved in companion diagnostics 100

Point-of-care diagnosis 102

Companies developing point-of-care diagnostic technologies 103

Point-of-care diagnosis of infections 105

Advantages versus disadvantages of point-of-care diagnosis 106

Future prospects of point-of-care diagnosis 106

Genetic testing for disease predisposition 106

Preventive genetics by early diagnosis of mitochondrial diseases 107

Personal genetic service 107

Role of diagnostics in integrated healthcare 108

Concept of integrated healthcare 108

Components of integrated healthcare 109

Screening 109

Disease prediction 109

Early diagnosis 110

Prevention 110

Therapy based on molecular diagnosis 110

Monitoring of therapy 110

Advantages and limitations of integrated healthcare 110

Commercially available systems for integrated healthcare 111

Future of molecular diagnostics in personalized medicine 111

3. Pharmacogenetics 113

Basics of pharmacogenetics 113

Role of molecular diagnostics in pharmacogenetics 114

Role of pharmacogenetics in pharmaceutical industry 115

Study of the drug metabolism and pharmacological effects 115

Causes of variations in drug metabolism 115

Enzymes relevant to drug metabolism 116

Pharmacogenetics of phase I metabolism 116

CYP450 116

P450 CYP 2D6 inhibition by selective serotonin reuptake inhibitors 118

Cytochrome P450 polymorphisms and response to clopidogrel 119

Lansoprazole and cytochrome P450 119

Glucose-6-phosphate dehydrogenase 119

Pharmacogenetics of phase II metabolism 120

N-Acetyltransferase 120

Uridine diphosphate-glucuronosyltransferase 121

Measurement of CYP isoforms 121

Polymorphism of drug transporters 122

Genetic variation in drug targets 122

Polymorphisms of kinase genes 123

Effect of genetic polymorphisms on disease response to drugs 123

Ethnic differences in drug metabolism 124

Gender differences in pharmacogenetics 124

Role of pharmacogenetics in drug safety 125

Adverse drug reactions 125

Adverse drug reactions in children 126

Adverse drug reactions related to toxicity of chemotherapy 126

Genetically determined adverse drug reactions 126

Malignant hyperthermia 128

Pharmacogenetics of clozapine-induced agranulocytosis 128

Role of pharmacogenetics in warfarin therapy 128

Role of pharmacogenetics in carbamazepine therapy 129

Role of pharmacogenetics in statin therapy 130

FDA consortium linking genetic biomarkers to serious adverse events 130

Therapeutic drug monitoring, phenotyping, and genotyping 131

Therapeutic drug monitoring 131

Phenotyping 131

Genotyping 132

Genotyping vs phenotyping 133

Phenomics 133

Limitations of genotype-phenotype association studies 134

Molecular toxicology in relation to personalized medicines 134

Toxicogenomics 134

Biomarkers of drug toxicity 135

Drug-induced mitochondrial toxicity 135

Companies involved in molecular toxicology 135

Gene expression studies 136

Pharmacogenetics in clinical trials 136

Postmarketing pharmacogenetics 137

Clinical implications of pharmacogenetics 137

Application of CYP450 genotyping in clinical practice 137

Genotype-based drug dose adjustment 138

Examples of use of pharmacogenetics in clinical pharmacology 138

Linking pharmacogenetics with pharmacovigilance 139

Genetic susceptibility to ADRs 139

Linking genetic testing to postmarketing ADR surveillance 139

Recommendations for the clinical use of pharmacogenetics 140

Limitations of pharmacogenetics 140

Pharmacoepigenomics vs pharmacogenetics in drug safety 141

Future role of pharmacogenetics in personalized medicine 141

4. Pharmacogenomics 143

Introduction 143

Basics of pharmacogenomics 144

Pharmacogenomics and drug discovery 144

Preclinical prediction of drug efficacy 146

Pharmacogenomics and clinical trials 146

Impact of genetic profiling on clinical studies 148

Limitations of the pharmacogenomic-based clinical trials 149

Pharmacogenomic aspects of major therapeutic areas 149

Oncogenomics 149

Oncogenes 150

Tumor suppressor genes 150

Cardiogenomics 151

Neuropharmacogenomics 153

Pharmacogenomics of Alzheimer's disease 154

Pharmacogenomics of depression 154

Pharmacogenomics of schizophrenia 154

Companies involved in neurogenomics-based drug discovery 155

5. Role of Pharmacoproteomics 157

Basics of proteomics 157

Proteomic approaches to the study of pathophysiology of diseases 157

Single cell proteomics for personalized medicine 158

Diseases due to misfolding of proteins 158

Therapies for protein misfolding 159

Significance of mitochondrial proteome in human disease 160

Proteomic technologies for drug discovery and development 160

Role of reverse-phase protein microarray in drug discovery 160

Role of proteomics in clinical drug safety 160

Toxicoproteomics 161

Application of pharmacoproteomics in personalized medicine 162

6. Role of Metabolomics in Personalized Medicine 163

Metabolomics and metabonomics 163

Metabolomics bridges the gap between genotype and phenotype 163

Metabolomics, biomarkers and personalized medicine 164

Metabolomic technologies 164

Urinary profiling by capillary electrophoresis 165

Lipid profiling 165

Role of metabolomics in biomarker identification and pattern recognition 166

Validation of biomarkers in large-scale human metabolomics studies 166

Pharmacometabonomics 166

Metabonomic technologies for toxicology studies 167

Metabonomics/metabolomics and personalized nutrition 167

7. Personalized Biological Therapies 169

Introduction 169

Recombinant human proteins 169

Therapeutic monoclonal antibodies 169

Cell therapy 170

Autologous tissue and cell transplants 170

Stem cells 170

Role of stem cells derived from unfertilized embryos 170

Cloning and personalized cell therapy 171

Use of stem cells for drug testing 171

Gene therapy 171

Personalized vaccines 172

Personalized vaccines for viral diseases 172

Personalized cancer vaccines 172

Antigen-specific vaccines 172

Autologous cell vaccines 172

Active immunotherapy based on antigen specific to the tumor 174

Multipeptide cancer vaccines 174

Patient-specific cancer vaccines 174

Personalized melanoma vaccines 175

Antisense therapy 176

RNA interference 176

MicroRNAs 177

8. Personalized Medicine in Major Therapeutic Areas 179

Introduction 179

Management of infections 180

Management of HIV 180

CD4 counts as a guide to drug therapy for AIDS 180

Drug-resistance in HIV 180

Genetics of human susceptibility to HIV infection 181

Measurement of Replication Capacity 182

Personalized vaccine for HIV 182

Prevention of adverse reactions to antiviral drugs 182

Pharmacogenetics and HIV drug safety 183

Pharmacogenomics of antiretroviral agents 183

Role of diagnostic testing in HIV 184

Role of genetic variations in susceptibility to HIV-1 184

Personalized treatment of hepatitis B 184

Personalized treatment of hepatitis C 184

Personalized management of tuberculosis 186

Psychiatric disorders 186

Psychopharmacogenetics 186

COMT genotype and response to amphetamine 187

Genotype and response to methylphenidate in children with ADHD 187

Personalized antipsychotic therapy 188

Personalized antidepressant therapy 190

Pretreatment EEG to predict adverse effects to antidepressants 191

Individualization of SSRI treatment 191

Vilazodone with a test for personalized treatment of depression 192

Neurological disorders 192

Personalized management of Alzheimer's disease 193

Personalized management of Parkinson's disease 194

Discovery of subgroup-selective drug targets in PD 195

Personalized management of Epilepsy 195

Choice of the right AED 195

Pharmacogenetics of epilepsy 195

Pharmacogenomics of epilepsy 196

Drug resistance in epilepsy 196

Future prospects for management of epilepsy 197

Personalized management of migraine 198

Individualization of use of triptans for migraine 198

Personalized management of stroke 199

Use of brain imaging in trials of restorative therapies for stroke 199

Personalized treatment of multiple sclerosis 199

Immunopathological patterns of demyelination for assessing therapy 200

Personalizing mitoxantrone therapy of multiple sclerosis 200

Fusokine method of personalized cell therapy of multiple sclerosis 201

MBP8298 201

Pharmacogenomics of IFN- therapy in multiple sclerosis 202

Cardiovascular disorders 203

Role of diagnostics in personalized management of cardiovascular disease 203

Testing in coronary heart disease 203

SNP genotyping in cardiovascular disorders 204

Cardiovascular disorders with a genetic component 204

Gene variant as a risk factor for sudden cardiac death 206

KIF6 gene test as a guide to management of congestive heart failure 206

SNP Chip for study of cardiovascular diseases 207

Pharmacogenomics of cardiovascular disorders 207

Modifying the genetic risk for myocardial infarction 207

Management of heart failure 208

-blockers 208

Bucindolol 208

BiDil 208

Management of hypertension 209

Pharmacogenomics of diuretic drugs 209

Pharmacogenomics of ACE inhibitors 210

Management of hypertension by personalized approach 210

Pharmacogenetics of lipid-lowering therapies 211

Polymorphisms in genes involved in cholesterol metabolism 212

Role of eNOS gene polymorphisms 212

The STRENGTH study 213

Personalized management of women with hyperlipidemia 214

Thrombotic disorders 214

Factor V Leiden mutation 214

Anticoagulant therapy 215

Antiplatelet therapy 215

Nanotechnology-based personalized therapy of cardiovascular diseases 215

Project euHeart for personalized management of cardiovascular diseases 216

Concluding remarks 216

Personalized management of pulmonary disorders 217

Personalized therapy of asthma 217

Biomarkers for predicting response to corticosteroid therapy 217

Genetic polymorphism and response to 2-adrenergic agonists 218

Genotyping in asthma 218

IgE as guide to dosing of omalizumab for asthma 219

Personalized management of chronic obstructive pulmonary disease 219

Personalized management of skin disorders 220

Genetic testing for personalized skin care 220

Management of hair loss based on genetic testing 220

Personalized therapy of rheumatoid arthritis 220

DIATSTAT™ anti-cyclic citrullinated peptides in rheumatoid arthritis 221

Personalization of COX-2 inhibitor therapy 222

Personalization of infliximab therapy 222

Personalized approaches in immunology 222

Role of Mannose-binding lectin in personalized medicine 223

Pharmacogenetics and pharmacogenomics of immunosuppressive agents 223

Personalized management of patients with lupus erythematosus 223

Personalized management of pain 224

Pharmacogenetics/pharmacogenomics of pain 225

Mechanism-specific management of pain 226

Preoperative testing to tailor postoperative analgesic requirements 226

Personalized analgesics 226

Management of genetic disorders 227

Personalized treatment of cystic fibrosis 227

Personalized management of gastrointestinal disorders 227

Personalized therapy of inflammatory bowel disease 227

Personalized management of lactose intolerance 228

Personalized approaches to improve organ transplantation 228

Personalization of kidney transplantation 229

Personalization of cardiac transplantation 229

Prediction of rejection to tailor anti-rejection medications 230

Personalized immunosuppressant therapy in organ transplants 230

Role of immunological biomarkers in monitoring grafted patients 231

Improved matching of blood transfusion 231

Personalized approach to addiction 232

Genetic polymorphism and management of alcoholism 232

Personalized therapy for smoking cessation 232

Antidepressant therapy for smoking cessation 232

Effectiveness of nicotine patches in relation to genotype 233

Personalized approach to drug addiction 233

Personalized approaches to miscellaneous problems 233

Hormone replacement therapy in women 233

Personalized treatment of malaria 234

Personalized management of renal disease 234

Gene associated with end-stage renal disease 235

Personalized care of trauma patients 235

Personalized anticoagulation 236

Personalized Hyperbaric oxygen therapy 236

Personalized preventive medicine 237

Personalized nutrition 237

Nutrigenomics 238

Nutrigenomics and functional foods 238

Nutrigenomics and personalized medicine 239

Nutrition and proteomics 239

Personalized diet prescription 240

9. Personalized Therapy of Cancer 241

Introduction 241

Challenges of cancer classification 241

Relationships of technologies for personalized management of cancer 241

Impact of molecular diagnostics on the management of cancer 242

Analysis of RNA splicing events in cancer 243

Analysis of chromosomal alterations in cancer cells 243

Cancer classification using microarrays 243

Detection of loss of heterozygosity 244

Diagnosis of cancer of an unknown primary 244

Diagnostics for detection of minimal residual disease 245

DNA repair biomarkers 245

Fluorescent in situ hybridization 246

Gene expression profiling 246

Gene expression profiles predict chromosomal instability in tumors 247

Isolation and characterization of circulating tumor cells 248

Modulation of CYP450 activity for cancer therapy 248

Personalized therapies based on oncogenic pathways signatures 248

Quantum dot-based test for DNA methylation 249

Role of molecular imaging in personalized therapy of cancer 249

Functional diffusion MRI 250

Role of FDG-PET/CT in personalizing cancer treatment 250

Tumor imaging and elimination by targeted gallium corrole 251

Future prospects of molecular imaging in management of cancer 251

Unraveling the genetic code of cancer 251

Cancer prognosis 252

Detection of mutations for risk assessment and prevention 252

Impact of biomarkers on management of cancer 253

VeraTag™ assay system for cancer biomarkers 253

Predictive biomarkers for cancer 253

HER-2/neu oncogene as a biomarker for cancer 253

Oncogene GOLPH3 as a cancer biomarker 254

L-asparaginase treatment of cancer guided by a biomarker 254

Sequencing to discover biomarkers to personalize cancer treatment 254

Determination of response to therapy 255

ChemoFx cell culture assay for predicting anticancer drug response 255

Ex vivo testing of tumor biopsy for chemotherapy sensitivity 256

Genomic approaches to predict response to anticancer agents 256

Gene expression patterns to predict response of cancer to therapy 256

Genomic analysis of tumor biopsies 257

Genotype-dependent efficacy of pathway inhibition in cancer 257

Mutation detection at molecular level 257

Role of genetic variations in susceptibility to anticancer drugs 258

Non-genetic factors for variations in response of cancer cells to drugs 258

Proteomic analysis of tumor biopsies to predict response to treatment 258

Real-time apoptosis monitoring 259

Serum nucleosomes as indicators of sensitivity to chemotherapy 259

Targeted microbubbles to tumors for monitoring anticancer therapy 260

PET imaging for determining response to chemotherapy 260

Tissue systems biology approach to personalized management of cancer 261

Targeted cancer therapies 261

Targeting glycoproteins on cell surface 261

Targeting pathways in cancer 261

Functional antibody-based therapies 261

Personalized radiation therapy 263

Molecular diagnostics combined with cancer therapeutics 264

Aptamers for combined diagnosis and therapeutics of cancer 264

Role of nanobiotechnology in personalized management of cancer 265

Design of future cancer therapies 265

Screening for personalized anticancer drugs 266

Role of epigenetics in development of personalized cancer therapies 266

Personalized therapy of cancer based on cancer stem cells 266

Role of oncoproteomics in personalized therapy of cancer 267

Cancer tissue proteomics 267

Pharmacogenomic-based chemotherapy 267

Whole genome technology to predict drug resistance 267

Anticancer drug selection based on molecular characteristics of tumor 268

Testing microsatellite-instability for response to chemotherapy 268

Pharmacogenetics of cancer chemotherapy 269

CYP 1A2 269

Thiopurine methyltransferase 270

Dihydropyrimidine dehydrogenase 270

UGT1A1 test as guide to irinotecan therapy 271

Role of computational models in personalized anticancer therapy 271

A computational model of kinetically tailored treatment 271

Mathematical modeling of tumor mivroenvironments 272

Molecular profiling of cancer 272

Drug resistance in cancer 273

Detection of drug resistance in cancer by metabolic profiling 273

Determination of chemotherapy response by topoisomerase levels 274

A systems biology approach to drug resistance in colorectal cancer 274

Management of drug resistance in leukemia 274

Overexpression of multidrug resistance gene 275

P53 mutations 275

A chemogenomic approach to drug resistance 276

Systems biology approach to personalizing therapy for drug-resistant cancer 276

Examples of personalized management of cancer 276

Personalized management of brain cancer 276

Biosimulation approach to personalizing treatment of brain cancer 277

Genetics and genomics of brain cancer 277

Prognosis of glioblastoma multiforme based on its genetic landscape 278

Molecular diagnostics for personalized management of brain cancer 279

Personalized chemotherapy of brain tumors 280

Personalized therapy of oligodendroglial tumors (OTs) 281

Personalized therapy of neuroblastomas 282

Personalized therapy of medulloblastomas 283

Personalized management of germ cell brain tumors 283

Personalized management of breast cancer 283

Developing personalized drugs for breast cancer 284

Gene expression plus conventional predictors of breast cancer 285

Her2 testing in breast cancer as a guide to treatment 286

Molecular diagnostics in breast cancer 287

Pharmacogenetics of breast cancer 288

Proteomics-based personalized management of breast cancer 288

Predicting response to chemotherapy in breast cancer 289

Prediction of resistance to chemotherapy in breast cancer 292

Prediction of adverse reaction to radiotherapy in breast cancer 292

Prediction of recurrence in breast cancer for personalizing therapy 293

Prognosistic tests for breast cancer 294

Racial factors in the management of breast cancer 296

TAILORx (Trial Assigning Individualized Options for Treatment) 296

Trends and future prospects of breast cancer research 297

Understanding tumor diversity in mouse mammary cancer model 297

Personalized management of ovarian cancer 297

Personalized management of hematological malignancies 299

Personalized management of acute leukemias 300

Personalized management of chronic lymphocytic leukemia 301

Personalized management of multiple myeloma 301

Personalized management B cell lymphomas 303

Personalized vaccine for follicular lymphoma 303

Personalized management of myelodysplasia 303

Personalized management of hepatocellular carcinoma 304

Personalized management of malignant melanoma 304

Personalized management of gastrointestinal cancer 304

Personalized management of esophageal cancer 304

Personalized management of gastric cancer 305

Personalized management of colorectal cancer 305

Personalized management of liver cancer 308

Personalized management of lung cancer 308

Determination of outcome of EGFR tyrosine kinase inhibitor treatment 308

Testing for response to chemotherapy in lung cancer 310

Testing for prognosis of lung cancer 310

Testing for recurrence of lung cancer 311

Role of a new classification system in the management of lung cancer 311

Personalized management of pancreatic cancer 312

Histone modifications predict treatment response in pancreatic cancer 312

Personlized management of prostate cancer 312

Diagnostics for guiding therapy of prostate cancer 312

Early detection of cancer recurrence and guiding treatment 313

Effects of of lifestyle changes shown by gene expression studies 313

Future of cancer therapy 314

Challenges for developing personalized cancer therapies 314

The Cancer Genome Atlas 315

Role of the International Cancer Genome Consortium 315

Using computer and imaging technologies to personalize cancer treatment 316

Integrated genome-wide analysis of cancer for personalized therapy 316

Companies involved in developing personalized cancer therapy 317

10. Development of Personalized Medicine 319

Introduction 319

Non-genomic factors in the development of personalized medicine 319

Personalized medicine based on circadian rhythms 319

Cytomics as a basis for personalized medicine 320

Intestinal microflora 320

Gut microbiome compared to human genome 320

Metabolic interactions of the host and the intestinal microflora 321

Role of drug delivery in personalized medicine 321

Personalized approach to clinical trials 322

Use of Bayesian approach in clinical trials 322

Individualzing risks and benefits in clinical trials 322

Clinical trials of therapeutics and companion diagnostics 323

Players in the development of personalized medicine 323

Personalized Medicine Coalition 323

European Personalized Medicine Diagnostics Association 324

Role of pharmaceutical industry 325

Production and distribution of personalized medicines 325

Role of biotechnology companies 326

Role of life sciences industries 326

Role of molecular imaging in personalized medicine 327

Molecular imaging for personalized drug development in oncology 327

Molecular imaging and CNS drug development 329

Companies involved in molecular imaging 330

Role of the clinical laboratories 330

Role of the US government in personalized medicine 331

Department of Health and Human Services and personalized medicine 331

Agency for Healthcare Research and Quality 332

Comparative effectiveness research 333

Role of the US Government agencies in personalized medicine 334

NIH's Roadmap Initiative for Medical Research 334

NIH and personalized medicine 335

National Institute of General Medical Sciences 335

National Institute of Standards and Technology 336

Role of the Centers for Disease Control 336

Role of academic institutons in the US 337

Clinical Proteomics Program 337

Coriell Personalized Medicine Collaborative™ 337

Delaware Valley Personalized Medicine Project 338

Evaluation of genetic tests and genomic applications 338

Genomic-Based Prospective Medicine Project 339

Ignite Institute 339

Personalized oncology at Massachusetts General Hospital 340

Pharmacogenetics Research Network and Knowledge Base 340

Quebec Center of Excellence in Personalized Medicine 341

Southeast Nebraska Cancer Center's Personalized Medicine Network 341

UNC Institute for Pharmacogenomics and Individualized Therapy 341

Wisconsin Genomics Initiative 342

Role of healthcare organizations and hospitals 342

Signature Genetics 342

The Mayo Clinic genetic database 342

Research center for personalized medicine at Mt. Sinai Medical Center 343

Role of the medical profession 343

The American Medical Association and personalized medicine 343

Education of the physicians 343

Off-label prescribing and personalized medicine 344

Medical education 344

Public attitude towards personalized medicine 344

Role of genetic banking systems and databases 345

Role of biobanks in development of personalized medicine 345

UK Biobank 346

Biobanking and development of personalized medicine in EU 346

CARTaGENE for biobanks in Canada 347

Personalized medicine based on PhysioGenomics™ technology 347

Role of bioinformatics in development of personalized medicine 348

Exploration of disease-gene relationship 349

Biosimulation techniques for developing personalized medicine 349

Health information management 350

Electronic health records 350

Linking patient medical records and genetic information 351

Management of personal genomic data 351

Personalized prognosis of disease 352

Integration of technologies for development of personalized medicine 352

Global scope of personalized medicine 353

Personalized medicine in the developed countries 353

Personalized medicine in the US 353

Personalized medicine in the EU 354

UK National Health Service and medical genetics 354

Personalized medicine in Germany 355

Personalized medicine in the developing countries 355

Advantages and limitations of personalized medicine 356

Future of p

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