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Personalized Medicine - Scientific & Commercial Aspects

  • ID: 4748160
  • Report
  • December 2019
  • Region: Global
  • 1135 Pages
  • Jain PharmaBiotech
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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 the 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. Biomarkers play an important role in personalized medicine. Diagnosis is integrated with therapy for selection of treatment as well for monitoring the results. There is an emphasis on early detection and prevention of disease in modern medicine. Biochip/microarray technologies and next-generation sequencing are also important. The concept of personalized medicine described in this report remains the best way to integrate new technologies such as nanobiotechnology for improving healthcare. 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 2023.

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 2018-2028.

Profiles of 339 companies involved in developing technologies for personalized medicines, along with 616 collaborations are included in part II of the report. Finally the bibliography contains over 750 selected publications cited in the report.The report is supplemented by 88 tables and 44 figures.

The report contains information on the following areas:

  • Basic aspects of personalized medicine
  • Role of molecular diagnostics
  • Pharmacogenetics
  • Pharmacogenomics
  • Pharmacoproteomics
  • Personalized biological therapies
  • Personalized non-pharmacological therapies
  • Personalized medicine in major therapeutic areas
  • Personalized Therapy of Cancer
  • Development of personalized medicine
  • Ethical, Legal and Regulatory Aspects of Personalized Medicine
  • Commercial aspects of personalized medicine
  • Companies involved in the development of personalized medicine
Note: Product cover images may vary from those shown
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Part I: Scientific & Commercial Aspects

0. Executive Summary  

1. Basic Aspects
Definition of personalized medicine
History of medical concepts relevant to personalized medicine  
Ayurveda as a personalized healthcare system  
Personalized aspects of ancient oriental systems of medicine  
Evolution of modern personalized medicine  
Molecular biological basis of personalized medicine  
The human genome  
ENCODE  
Chromosomes  
Genes
The genetic code
Gene expression  
DNA sequences and structure
Genetic variations in the human genome  
Single nucleotide polymorphisms  
Copy number variations in the human genome  
Insertions and deletions in the human genome
Large scale variation in human genome  
Structural variations in the human genome  
Mapping and sequencing of structural variation from human genomes
1000 Genomes Project  
Role of DNA sequencing in the development of personalized medicine  
Human Variome Project  
Interconnected genetic and genomic patterns in human diseases
Mitochondrial tRNA and personalized medicine
Molecular alterations in disease  
Basics technologies for developing personalized medicine  
Definitions of technologies relevant to personalized medicine  
Problems with the ICH definitions of pharmacogenomics and pharmacogenetics  
‘Omics’ and personalized medicine  
Relationship of various technologies to personalized medicine  
Conventional medicine versus personalized medicine  
Personalized medicine and evidence-based medicine
Role of genetics in future approaches to healthcare  
Genetic medicine  
Human disease and genes
Genetic and environmental interactions in etiology of human diseases
Role of genetics in development of personalized medicines  
Genetic databases
Clinical Genomic Database  
Genetic epidemiology  
Limitations of medical genetics  
Role of epigenetics in personalized medicine  
Role of systems biology in personalized medicine  
Systems pharmacology
Systems medicine
Synthetic biology and development of personalized medicines
Personalized digital medicine  
Artificial intelligence in personalized medicine
Bioelectronics and personalized medicine
Machine learning and personalized medicine
A personalized approach to environmental factors in disease
Reclassification of diseases  
Translational science and personalized medicine
Personalization of multimodal therapies

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  
ABI PRISM® 310 Genetic Analyzer
High-throughput paired end transcriptome sequencing  
Emerging sequencing technologies
4300 DNA analyzer  
Apollo 100  
Cyclic array sequencing  
CEQ™ 8000
DeepCAGE sequencing
Electron microscope-based DNA sequencing
Genometrica sequencer
GS-FLEX system (Roche/454)
IBS sequencing technology  
Illumina’s sequencing technology
MegaBACE 500  
Microdroplet-based PCR for large-scale targeted sequencing
Multiplex amplification of human DNA sequences  
Nanoscale sequencing  
Next generation sequencing based on Lightning Terminators
Polonator sequencer
RainStorm™ microdroplet technology  
Sequential DEXAS
SOLiD technology
Sequencing by hybridization
Whole genome sequencing
Bioinformatic tools for analysis of genomic sequencing data  
Clinical Genomicist Workspace for managing NGS-based clinical tests
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
Role of DNA sequencing in development of personalized medicine
Role of RNA sequencing in development of personalized medicine  
Biochips and microarrays
Role of biochip/microarray technology in personalized medicine
Applications of biochip/microarray technology in 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 biochips/microarrays  
Protein biochips/microarrays for personalized medicine
SNP genotyping  
Genotyping and haplotyping
Haplotype Specific Extraction  
Computation of haplotypes
HapMap project 
Haplotyping for whole genome sequencing
Predictingdrug response with HapMap  
Companies developing haplotyping technology  
Technologies for SNP analysis
Biochip and microarray-based detection of SNPs
SNP genotyping by MassARRAY
BeadArray technology
SNP-IT primer-extension technology  
Use of NanoChip for detection of SNPs
Electrochemical DNA probes  
Laboratory Multiple Analyte Profile  
PCR-CTPP (confronting two-pair primers)
TaqMan real-time PCR  
Locked nucleic acid  
Molecular inversion probe based assays
Pyrosequencing  
Smart amplification process version 2  
Zinc finger proteins  
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  
Detection of copy number variations  
CNVer algorithm for CNV detection
CNVnator for discovery of CNVs and genotyping  
Study of rare variants in pinpointing disease-causing genes  
Optical Mapping
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
Role of nanobiotechnology in molecular diagnostics
Cantilevers for personalized medical diagnostics  
Role of biomarkers in personalized medicine
Role of biosensors in personalized medicine
Biomarkers for diagnostics  
Biomarkers for drug development  
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
Companies involved in gene expression analysis  
Monitoring in vivo gene expression by molecular imaging  
Molecular imaging and personalized medicine
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  
Direct-to-consumer genetic services
Personalized polygenic risk scores
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
CYP2D6 inhibition by selective serotonin reuptake inhibitors
CYP2D6 genotype and codeine pharmacokinetics  
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 antiplatelet 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  
Biomarkers of drug toxicity  
Drug-induced mitochondrial toxicity  
Companies involved in molecular toxicology  
Gene expression studies  
Pharmacogenetics in clinical trials  
Postmarketing pharmacogenetics
Clinical implications of pharmacogenetics  
Application of CYP450 genotyping in clinical practice  
Genotype-based drug dose adjustment
Pharmacogenomic biomarker information in drug labels
Standardized terminology for clinical pharmacogenetic test results
Use of pharmacogenetics in clinical pharmacology
Application of CYP2C19 pharmacogenetics for personalized medicine
Genotyping for identifying responders to sulfasalazine
HLA alleles associated with lumiracoxib-related liver injury  
Pharmacogenetic basis of thiopurine toxicity  
Tranilast-induced hyperbilirubinemia due to gene polymorphism
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  
Future role of pharmacogenetics in personalized medicine  

4. Pharmacogenomics
Introduction  
Basics of pharmacogenomics  
Pharmacogenomics and drug discovery
Preclinical prediction of drug efficacy  
Next generation sequencing and pharmacogenomics  
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 bipolar disorder  
Pharmacogenomics of schizophrenia
Companies involved in neurogenomics-based drug discovery
Current status and future prospects of pharmacogenomics

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  
Proteins and drug action  
Role of reverse-phase protein microarray in drug discovery
Role of proteomics in clinical drug safety
Toxicoproteomics  
Applications 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
Pharmacometabonomics
Metabonomic technologies for toxicology studies
Metabonomics/metabolomics and personalized nutrition
Metabolomics for personalized medicine  

7. Personalized Biological Therapies
Introduction  
Recombinant human proteins  
Therapeutic monoclonal antibodies  
Cell therapy  
Autologous tissue and cell transplants  
Stem cells
iPSCs for personalized cell therapy
Role of stem cells derived from unfertilized embryos  
Cloning and personalized cell therapy
Use of stem cells for drug testing
Gene therapy  
Gene editing by CRISPR/Cas9 system
Personalized gene therapy for cancer  
Stem cell-based personalized gene therapy for cancer  
Personalized vaccines
Personalized vaccines for viral diseases  
Personalized cancer vaccines
Antisense therapy
RNA interference
MicroRNAs  

8. Personalized Non-pharmacological Therapies
Introduction  
Acupuncture  
Personalized acupuncture therapy
Personalized hyperbaric oxygen therapy  
Personalized nutrition
Nutrigenomics  
Evolutionary basis of nutrigenomics  
Genomics of vitamin D and calcium supplementation
Nutrigenomics and functional foods  
Nutrigenomics and personalized medicine  
Nutriproteomics  
Nutrigenetics and personalized medicine
Personalized diet prescription  
Personalized nutrition and aging  
Personalized diet for diabetics
Role of systems medicine in personalized nutrition
Companies involved in personalized nutrition  
Personalized physical exercise  
Aerobic exercise response variations in individuals  
Exercise-induced muscle hypertrophy and strength variations  
Personalized exercise for prevention of functional decline in the elderly  
Personalized surgery  

9. Personalized Medicine in Major Therapeutic Areas  
Introduction  
Personalized management of infections  
Genetic susceptibility to infections
Management of HIV  
CD4 counts as a guide to drug therapy for AIDS  
Drug-resistance in HIV  
Genetics of human susceptibility to HIV infection  
Measurement of Replication Capacity
Personalized vaccine for HIV
Prevention of adverse reactions to antiviral drugs  
Pharmacogenetics and HIV drug safety
Pharmacogenomics of antiretroviral agents  
Role of diagnostic testing in management of HIV  
Role of genetic variations in susceptibility to HIV-1  
Role of personalized HIV therapy in controlling drug resistance
PhenoSense® to test HIV drug resistance
Sequencing for detecting mutations to personalize HIV therapy  
Personalized treatment of hepatitis B  
Personalized treatment of hepatitis C  
Responders vs non-responders to treatment for hepatitis C
Drug resistance in hepatitis C  
Challenges for personalized management of hepatitis C
Personalized management of tuberculosis  
Personalized management of fungal infections
Psychiatric disorders  
Psychopharmacogenetics/psychopharmacodynamics  
Serotonin genes
Calcium channel gene
Dopamine receptor genes  
COMT genotype and response to amphetamine
Methylenetetrahydrofolate reductase
Genetic loci associated with risk of major depressive disorder
Role of gene mutations in ADHD  
Genotype and response to methylphenidate in children with ADHD  
GeneSight tests for individualized therapy of psychiatric disorders  
Personalized antipsychotic therapy
Pharmacogenetics for personalizing antipsychotic therapy
Patient-derived stem cells for personalizing drugs for schizophrenia  
Personalized antidepressant therapy  
Biomarkers of response to antidepressant treatment
EEG to predict adverse effects and evaluate antidepressant efficacy
GeneSight pharmacogenomic test
Individualization of SSRI treatment
Role of protein sFRP3 in predicting response to antidepressants
Treatment resistant depression
Vilazodone with a test for personalized treatment of depression
Personalized management of alcohol use disorder  
Neurological disorders
Introduction to personalized neurology  
Personalized management of Alzheimer's disease  
Personalized management of Parkinson's disease
Brain imaging for diagnosis of neurodegenerative parkinsonism
Direct-to-consumer genetic testing in PD  
Discovery of subgroup-selective drug targets in PD  
Personalized cell therapy for PD
Pharmacogenetics of PD
Use of wearable sensors to monitor PD response to levodopa therapy  
Personalized management of amyotrophic lateral sclerosis
Personalized management of epilepsy  
Adverse effects of AEDs  
An algorithm for personalized management of epilepsy
 
Biomarkers of epilepsy  
Drug resistance in epilepsy
Genetics/genomics of epilepsy
Pharmacogenomics of epilepsy  
Rasmussen’s encephalitis
Selection of the right AED  
Future of management of epilepsy  
Personalized management of migraine
Individualization of use of triptans for migraine  
Multitarget therapeutics for personalized treatment of headache
Personalized strategy for prevention of migraine attacks
Personalized management of intracranial aneurysms
Personalized management of cerebral vasospasm following SAH
Personalized management of stroke  
Anticoagulation for stroke prevention  
Application of proteomics for personalizing stroke management
Brain imaging for personalized management of stroke
Personalized management of intracerebral hemorrhage  
Revascularization procedures in chronic post-stroke stage  
Personalized cell therapy for management of stroke  
Management of stroke according to stage  
Personalized treatment of multiple sclerosis  
Autologous bone marrow stem cell therapy for multiple sclerosis  
Fusokine method of personalized cell therapy of multiple sclerosis  
Immunopathological patterns of demyelination for assessing therapy  
Personalizing mitoxantrone therapy of multiple sclerosis  
Pharmacogenomics of IFN-β therapy in multiple sclerosis
Preclinical detection of multiple sclerosis in children  
Predictive models of individual treatment response in MS
T cell-based personalized vaccine for MS
Targeting MS therapy to cell type of lesion
Personalized management of traumatic brain injury  
Biomarkers of TBI  
Comparative effectiveness research for management of TBI
CT scores for prognosis and risk stratification of TBI
Personalized management of myasthenia gravis  
Personalized management of pain
Genetic factors in response to pain
Genetic mutations with loss of pain  
Genetic mutations and painful conditions  
Mechanism-specific management of pain  
Gene expression biomarkers for personalizing pain management
Pharmacogenetics/pharmacogenomics of pain  
Personalized management of pain with opioids  
Personalized opioid therapy for noncancer pain
Pharmacogenetics of NSAIDs
Mechanism-specific management of pain  
Preoperative testing to tailor postoperative analgesic requirements
Personalized analgesics
Prediction of response to an analgesic by in vitro iPSC based testing  
Signature of pain on brain imaging
Concluding remarks on personalized management of pain
Personalized management of sleep disorders
Personalized therapy of insomnia  
Future of personalized neurology  
Personalized management of ophthalmic disorders
Proteomics-based personalized management of uveitis
Combining cell and gene therapies for retinal disorders  
Cardiovascular disorders  
Role of diagnostics in personalized management of cardiovascular disease
Cardiovascular disorders with a genetic component
Gene mutations associated with risk of coronary heart disease  
Gene variant as a risk factor for sudden cardiac death
KIF6 gene test as a guide to management of heart disease  
NGS sequencing for management of cardiovascular disorders
Personalized antiplatelet therapy after PCI  
Assessing patients with coronary heart disease
Assessing coronary artery disease for percutaneous coronary interventions
Companion diagnostics for therapy of cardiovascular disorders  
Biomarkers and personalized management of cardiovascular disorders  
Pharmacogenomics of cardiovascular disorders
Nanotechnology-based personalized therapy of cardiovascular diseases
Personalized management of chronic myocardial ischemia  
Management of chronic angina pectoris  
Inflammation as a target for therapy of myocardial ischemia
Personalized management of myocardial infarction  
Management of heart failure  
β-blockers
Bucindolol
BiDil
Management of atrial fibrillation
Treatment targets based on genetic variants  
Selection of personalized therapy for AF  
Management of hypertension  
Adjusting therapy of hypertension to fluctuations of blood pressure
Choice of drugs for hypertension
Control of blood pressure with vagal nerve stimulation  
Correction of causes and risk factors of hypertension  
Genes and hypertension  
Guideline for management of HPN
Improving management of HPN by targeting new pathways  
Individualized therapy of HPN based on risk factors of heart disease  
Personalized management of hypertensive patients with diabetes  
Personalized management of hypertensive patients with albuminuria  
Personalized management of hypertension in the elderly  
Personalized management of hypertension in women  
Pharmacogenomics of diuretic drugs  
Pharmacogenomics of ACE inhibitors  
Prediction of antihypertensive activity of rostafuroxin  
Role of pharmacogenetics in management of hypertension
Scheme for management of hypertension by personalized approach
Personalized lipid-lowering therapies  
NIR spectroscopy of plaques to guide cholesterol-lowering therapy  
Polymorphisms in genes involved in cholesterol metabolism
Role of eNOS gene polymorphisms
Prediction of response to statins  
Personalized management of women with hyperlipidemia  
Therapeutic alternatives in patients with statin intolerance
Treatment of familial hypercholesterolemia  
PCSK9 inhibitors  
Concluding remarks on the personalized cholesterol management
Thrombotic disorders
Factor V Leiden mutation  
Anticoagulant therapy  
Antiplatelet therapy
Personalized management of aortic aneurysms
Clinical trials of personalized therapy of cardiovascular diseases 
Project euHeart for personalized management of heart disease  
Modification of life style factors in management of cardiovascular disorders  
Multimorbidity in patients with cardiovascular disease  
Systems biology approach to personalized cardiology  
Concluding remarks on personalized management of cardiovascular diseases
Personalized management of pulmonary disorders  
Role of genetic ancestory in lung function  
Targeted drug delivery for personalized management of pulmonary disorders  
Personalized therapy of asthma  
Asthma phenotyping for improving therapeutic precision  
Biomarkers for predicting response to corticosteroid therapy  
Genetic polymorphism and response to β2-adrenergic agonists  
Genotyping in asthma  
IgE as guide to dosing of omalizumab for asthma  
Lebrikizumab for personalised treatment of asthma
Personalized management of chronic obstructive pulmonary disease  
Biomarker-guided treatment of COPD
Molecular phenotype-based treatment of COPD  
Personalized management of idiopathic pulmonary fibrosis
Personalized management of skin disorders
Genetic testing for personalized skin care  
Management of hair loss based on genetic testing
Personalized urology  
Personalized approaches in immunology  
Immunological tests in personalized medicine
Antibody profiles
Role of Mannose-binding lectin testing in personalized medicine  
Pharmacogenetics and pharmacogenomics of immunosuppressive agents  
Personalized management of patients with lupus erythematosus
Personalized therapy of rheumatoid arthritis  
Biomarkers and diagnostics for personalizing therapy of rheumatoid arthritis  
DIATSTAT™ anti-cyclic citrullinated peptides in rheumatoid arthritis
Genetics and epigenetic aspects of rheumatoid arthritis  
Personalization of COX-2 inhibitor therapy  
Personalized biological therapy of RA
Personalization of infliximab therapy  
Personalized therapy of RA guided by anti-citrullinated protein antibodies
Variations in the effectiveness of therapies for RA
Personalized management of obesity  
Basics of obesity
Genetics of obesity as a basis for personalized management  
Limitations of personalized approach to management of obesity  
Personalized management of diabetes  
Biomarkers in the management of diabetes
Personalized prediction of postprandial glycemic response
Personalized management of monogenic diabetes  
Selection from multiple options for treatment of T2DM  
Stratification of diabetes into 5 subgroups and personalized medicine
Management of genetic disorders  
Personalized treatment of cystic fibrosis  
Personalized management of Prader-Willi syndrome
Personalized management of gastrointestinal disorders  
Role of microbiome in 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  
Cell-based bioengineered kidney transplant
Personalization of cardiac transplantation
Cell-based regeneration of heart for personalized transplantation
Prediction of rejection for personalizig anti-rejection treatment
Personalized immunosuppressant therapy in organ transplants
Role of immunological biomarkers in monitoring grafted patients  
Improved matching of blood transfusion  
Personalized approaches to addiction
Reversal of cocaine-evoked synaptic plasticity  
Pharmacogenetics of drug 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
Sex differences in smoking as response to stress  
Personalized geriatrics  
Chronological vs biological age  
Pharmacogenetics and adverse drug reactions
Systems pharmacology approach to disorders of aging  
Personalized pediatrics
WGS for personalized management of genetic disorders in critically ill infants
Personalized nephrology
Personalized management of chronic kidney disease  
Genes and chronic kidney disease  
MicroRNAs and chronic kidney disease
Metabolomics and chronic kidney disease
TGF-β1 as a target for therapy of chronic kidney disease  
Proteomics and chronic kidney disease  
Personalized management of renal disease associated with hypertension
ACE inhibitors as renoprotective agents in hypertension
Gene associated with end-stage renal disease and hypertension  
Personalized approach to type I primary hyperoxaluria  
Personalized gynecology  
Female sexual dysfunction  
Hormone replacement therapy in women  
Lower urinary tract disorders in women  
Personalized approaches to miscellaneous problems  
Personalized treatment of malaria
Personalized management of osteoporosis  
Personalized care of trauma patients  
Personalized medical care of astronauts during space flights  
Personalized management of motion sickness
Personalized treatment of rare diseases
Personalized management of DNA repair disorders  
Personalized preventive medicine  

10. Personalized Therapy of Cancer
Introduction  
Epidemiology of cancer  
Development of personalized therapy in cancer  
Challenges of cancer classification
Molecular biology of cancer as basis for personalized management  
Cancer epigenetics/epigenomics and personalized therapy  
Cell division and mitotic spindles
Chromosomes and cancer  
Chromosomal instability
Extrachromosomal DNA and cancer  
DNA damage, repair and cancer
Gene mutations and cancer
Telomeres and cancer
Systems biology of cancer
Relationships of technologies for personalized management of cancer  
Impact of molecular diagnostics on the management of cancer  
A universal NGS-based oncology test system  
Analysis of RNA splicing events in cancer  
Analysis of chromosomal alterations in cancer cells  
Cancer classification using microarrays  
Cancer gene panel for detection of genetic alterations  
Companion diagnostics for cancer  
Circulating tumor cells isolation and characterization
Circulating cell-free DNA for monitoring personalized cancer therapy
Detection of loss of heterozygosity
Detection of rare mutations to guide cancer therapy  
Diagnostics for detection of minimal residual disease
DNA repair biomarkers  
DNA sequencing for prognosis of cutaneous T cell lymphoma  
Fluorescent in situ hybridization
Gene expression profiling
Gene expression profiling in hematological cancers  
Gene expression profiling in prostate cancer
Gene expression profiles predict chromosomal instability in tumors
OnkoMatch tumor genotyping
Synthetic dosage lethality predicts tumor growth and patient survival  
GPS Cancer test
Liquid biopsy 
Targeted digital sequencing
Modulation of CYP450 activity for cancer therapy  
NanoFlares for detection of CTCs  
Pathway-based analysis of cancer  
Conversion of gene-level information into pathway-level information
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
FDG-PET/CT for personalizing cancer treatment
Image-guided personalized drug delivery in cancer  
Optoacoustic imaging and nanoparticles in cancer management  
Tumor imaging and elimination by targeted gallium corrole
Future of molecular imaging in management of cancer  
Unraveling the genetic code of cancer  
Cancer prognosis  
Personalized cancer prevention  
Detection of mutations for cancer risk assessment and prevention  
Impact of biomarkers on management of cancer
HER-2/neu oncogene as a biomarker for cancer
L-asparaginase treatment of cancer guided by a biomarker  
miRNA biomarkers for personalized management of cancer
Oncogene GOLPH3 as a cancer biomarker  
Predictive biomarkers for efficacy of anticancer therapy
Sequencing to discover biomarkers to personalize cancer treatment
VeraTag™ assay system for cancer biomarkers
Determination of response to therapy  
Biomarker-based assays for predicting response to anticancer therapeutics  
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  
Predicting response to checkpoint inhibitors  
RNA Disruption Assay™  
Role of genetic variations in susceptibility to anticancer drugs  
Non-genetic factors for variations in response of cancer cells to drugs  
Profiling of cancer therapy in zebrafish xenografts to predict response
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  
PET imaging with tyrosine kinase inhibitors  
Concluding remarks about predicting response to anticancer therapy  
Molecular diagnostics combined with cancer therapeutics
Aptamers for combined diagnosis and therapeutics of cancer  
Combining diagnosis and therapy of metastatic cancer  
Detection and destruction of CTCs with nanoparticles and X-rays
Molecular profiling of cancer
Targeted cancer therapies  
Targeting angiogenesis in cancer  
Targeting glycoproteins on cell surface  
Targeting pathways in cancer  
Targeted personalized anticancer medicines in clinical use  
Immunotherapy of cancer  
Monoclonal antibodies for personalized management of cancer  
Targeted MAb-based immune therapy of cancer
MAbs targeted to alpha fetaprotein receptor  
MAbs targeted to tumor blood vessels  
MAbs that selectively target cancer  
Velociximab
MAbs for immune activation  
Functional MAb-based therapies
Immunotherapy of dormant cancer  
Combined use of MAbs and cytokines  
Antibody-drug conjugates for personalized therapy of cancer  
Combining diagnostics with therapeutics based on MAbs
Radiolabeled antibodies for detection and targeted therapy of cancer  
Cancer immunotherapy based on suppression of enzymes 
Personalized cancer vaccines
Antigen-specific vaccines  
Active immunotherapy based on antigen specific to the tumor  
Tumor-derived vaccines
FANG vaccine  
MyVax  
OncoVAX  
Tumor cells treated with dinitrophenyl
Prophage  
Melacine  
Patient-specific cell-based vaccines  
Dendritic cell-based vaccines
Adoptive cell therapy
Combination of antiangiogenic agents with ACT  
Genetically targeted T cells for treating B cell malignancies  
Genetic engineering of tumor cells  
Hybrid cell vaccination
Personalized peptide cancer vaccines
Targeting core mutations in cancer  
Current status and future of personalized cancer vaccines
Personalized radiation therapy  
Peptide receptor radionuclide therapy
Use of radiation sensitivity biomarkers in personalized radiotherapy
Use of imaging to monitor radioimmunotherapy of non-Hodgkin lymphoma
Role of nanobiotechnology in personalized management of cancer  
Design of future personalized cancer therapies  
Personalized therapy of cancer based on cancer stem cells
Role of CRISPR-Cas9 in personalized cancer gene therapy  
Role of epigenetics in development of personalized cancer therapies  
Cancer epigenetics and immunotherapy
Selective destruction of cancer cells while sparing normal cells  
Sphingolipids
Hyperbaric oxygen as adjunct to radiotherapy  
Targeting response to transformation-induced oxidative stress  
Targeting enzymes to prevent proliferation of cancer cells
Tissue systems biology approach to personalized management of cancer  
Role of artificial intelligence in personalized management of cancer
Role of oncoproteomics in personalized therapy of cancer  
Cancer tissue proteomics  
Proteomics technologies to guide targeted drug selection for cancer
LC-MS/MS proteomics as a companion diagnostic 
Personalized cancer therapy based on targeted proteomics  
Role of metabolomics in personalized therapy of cancer  
Role of sequencing in personalized therapy of cancer  
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
Modeling signaling pathways to reposition anticancer drugs  
Therapy resistance in cancer  
Mechanism of therapy resistance in cancer
Cancer stem cells and radioresistance  
Expression of P-glycoprotein gene by tumor  
Overexpression of multidrug resistance gene
P53 mutations  
Role of splice variants in resistance to cancer therapy  
Detection of drug resistance
Anaplastic lymphoma kinase
CRISPR for studying mechanism of drug-resistance in cancer  
Metabolic profiling of cancer  
Management of drug resistance in cancer  
Chemogenomic approach to drug resistance
Determination of chemotherapy response by topoisomerase levels
Patient-derived xenograft mouse models in drug resistant cancer  
Resistance to vaccines in cancer recurrence after surgery  
Systems biology approach to drug-resistant cancer  
Personalized therapy of cancer metastases  
Technologies for analysis of CTCs
Microfluidic technologies  
BEAMing technology for analysis of circulating tumor DNA
Technologies for detection of interplay of environments and CTCs
Systemic antitumor effect of localized radiotherapy for cancer metastases  
Diagnosis of cancer of an unknown primary
Personalized management of cancers of various organs/systems
Personalized management of bladder tumors  
Personalized management of brain tumors
Aptamers for selective targeting of tumor initiating cells in GBM  
Bioinformatic approach to personalizing treatment of GBM  
Biosimulation approach to personalizing treatment of brain cancer  
Brain cancer chip for personalized drug screening  
Combination of gene therapy and CAR-T cell therapy for GBM  
Drug resistance in GBM
Genetics and genomics of GBM  
Genomic analysis as a guide to personalized therapy of GBM
Induced neural stem cells for personalized therapy of GBM  
Molecular diagnostics for personalized management of GBM
Personalized vaccine for GBM  
Personalized chemotherapy of GBM
Sex differences in GBM for guiding management
Personalized therapy of oligodendroglial tumors
Personalized therapy of neuroblastomas  
Personalized therapy of medulloblastomas  
Personalized management of germ cell brain tumors  
Personalized management of meningiomas  
Supratentorial hemispheric diffuse low-grade gliomas
Targeted therapy of BRAF V600E mutant papillary craniopharyngioma
Future prospects of personalized therapy of malignant brain tumors
Personalized management of breast cancer  
Biomarker-guided decisions for breast cancer therapy  
Developing personalized drugs for breast cancer
Gene expression plus conventional predictors of breast cancer  
Her2 testing in breast cancer as a guide to treatment
HER2/neu-derived peptide vaccine for breast cancer  
Prediction of cell signaling pathways from gene expression patterns
Trends in treatment patterns and outcomes for DCIS  
Molecular diagnostics in breast cancer  
Molecular classification of infiltrating breast cancer
Monitoring of circulating tumor cells in breast cancer
Pharmacogenetics of breast cancer  
Proteomics-based personalized management of breast cancer  
Predicting response to chemotherapy in breast cancer
Adjuvant endocrine therapy in premenopausal breast cancer
Prediction of resistance to chemotherapy in breast cancer
Prediction of adverse reaction to radiotherapy in breast cancer
Prediction of recurrence in breast cancer for personalizing therapy
Prognostic tests for breast cancer  
Racial factors in the management of breast cancer
RATHER consortium to study personalized approach to breast cancer  
Ribociclib as first-line therapy for HR-positive breast cancer  
TAILORx (Trial Assigning Individualized Options for Treatment)  
Tamoxin therapy for ER-positive breast cancer  
Triple negative breast cancer
Treatment resistance in hormone receptor-positive breast cancer  
Current trends and future of breast cancer research
Understanding tumor diversity in mouse mammary cancer model
Personalized management of ovarian cancer  
Early diagnosis of ovarian cancer  
Determining response to chemotherapy in ovarian cancer  
Prognosis of ovarian cancer based on CLOVAR
Recurrent and drug-resistant ovarian cancer  
Pathway targeted therapies for ovarian cancer  
Repurposing auranofin for treatment of ovarian cancer  
Subtype-specific therapies for epithelial ovarian cancer  
Targeting hematogenous metastasis of ovarian cancer  
Vynfinit ® for platinum-resistant ovarian cancer  
Personalized management of head and neck cancer  
Molecular characterization of head and neck cancer using omics  
Relevance of biomarkers of HPV-related head and neck cancer  
Molecular targeted therapies for HNSCC
Personalized management of hematological malignancies  
B cell malignancies
Personalized management of acute lymphoblastic leukemia  
Personalized management of chronic lymphocytic leukemia
Personalized management of acute myeloid leukemia
Personalized management of chronic myeloid leukemia  
Personalized management of multiple myeloma
Personalized management of myelodysplastic syndrome
Personalized management B cell lymphomas  
Personalized vaccine for follicular lymphoma  
Pharmacoproteomics approach to diffuse large B cell lymphoma  
Companion diagnostic for treatment of lymphoma with Adcentris™
Management of drug resistance in leukemia  
Personalized management of gastrointestinal tumors  
Personalized management of esophageal cancer  
Personalized management of gastric cancer  
Personalized management of gastrointestinal stromal tumors  
Personalized management of colorectal cancer  
Developing personalized therapies for CRC
Molecular diagnosis for guiding personalized management of CRC
Role of staging of CRC in prognosis and management decisions  
Role of biomarkers in personalized management of CRC  
Role of miRNA modeling in personalized management of CRC
Resistance to targeted EGFR blockade in CRC
Sequencing for personalized management of colorectal cancer  
Systems biology approach to drug resistance in colorectal cancer  
Personalized management of liver cancer
Prognosis of HCC in relation to management  
Prediction of recurrence of hepatocellular carcinoma  
Prediction of survival of patients with fibrolamellar HCC
Personalized management of lung cancer
ALK inhibitors for personalized management of NSCLC  
Bronchial genomic classifier for diagnostic of lung cancer  
Companion diagnosis for NSCLC therapeutics  
Copy number variations as a diagnostic tool for lung cancer  
Development of resistance to EGFR inhibitors  
EGFR mutations for predicting response to drugs in lung cancer  
Molecular subtyping of lung cancer
miRNA classifiers as diagnostic/prognostic tools in lung cancer  
Predicting response of NSCLC to drug therapy  
Predicting recurrence of lung cancer for prevention  
Proteomics for discovery of metabolic biomarkers of lung cancer  
Role of a new classification system in the management of lung cancer
Selecting therapy of cancer arising from respiratory papillomatosis  
Sequencing the genomes of SCLC  
Testing for response to chemotherapy in lung cancer  
Testing for prognosis of lung cancer  
Testing for recurrence of lung cancer
Personalized management of malignant melanoma  
Inhibitors of BRAF mutation for metastatic melanoma  
Management of drug-resistant metastatic melanoma
Vaccine for malignant melanoma based on heat shock protein
Personalized management of endocrine tumors  
Adosterone producing tumors
Neuroendocrine tumors  
Parathyroid tumors  
Personalized management of pheochromocytoma and paraganglioma  
Personalized management of osteosarcoma  
Personalized management of pancreatic cancer  
Biomarkers of pancreatic cancer  
Histone modifications predict treatment response in pancreatic cancer 
Transport properties of pancreatic cancer and gemcitabine delivery  
Personlized management of prostate cancer
Assessing susceptibility to prostate cancer by genotyping  
Diagnostics for guiding therapy of prostate cancer  
Detection of prostate cancer metastases
Early detection of cancer recurrence and guiding treatment  
Effects of of lifestyle changes shown by gene expression studies
Epigenetics-based assays for guiding decision to biopsy prostate  
Genomic patterns of aggressiveness of prostate cancer  
Personalized peptide vaccine for prostate cancer
Selection of prostate cancer patients responsive to rucaparib therapy  
Personalized management of thyroid cancer
Future of cancer therapy
Challenges for developing personalized cancer therapies
Personalizing anticancer drug combinations
Cancer Genome Atlas  
Cancer Moonshot  
Blood Profiling Atlas  
NCI collaborations
COLTHERES consortium
Computer and imaging technologies for personalizing cancer treatment
Genomic Cancer Care Alliance  
Integrated genome-wide analysis of cancer for personalized therapy
International Cancer Genome Consortium  
National Cancer Institute of US
Catalog of cancer genes for personalized therapy
NCI-designated Comprehensive Cancer Centers
Role of NCI Genomic Data Commons in personalized cancer therapy  
Precision Oncology Decision Support at MD Anderson Cancer Center  
PREDICT Consortium
Quebec Clinical Research Organization in Cancer  
The San Antonio 1000 Cancer Genomes Project
Companies involved in developing personalized oncology  

11. 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  
Adaptive clinical trials
Bayesian approach in biomarker-based clinical trials  
Clinical trials of therapeutics and companion diagnostics
Clinical trials on selected subpopulations of patients
Clinical trials networks
Creative clinical trial design
Individualzing risks and benefits in clinical trials  
Players in the development of personalized medicine
Personalized Medicine Coalition
Role of pharmaceutical industry
Repositioning of drugs for personalized medicine  
Discovery of personalized medicines
Personalized drug delivery  
Production and distribution of personalized medicines
Role of biotechnology companies  
Role of life sciences industries  
Role of biomedical engineering in wearable devices for personalized healthcare  
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 in personalized medicine
Precision Medicine Initiative  
Department of Health and Human Services and personalized medicine  
Agency for Healthcare Research and Quality
Comparative effectiveness research 
Role of the US Government agencies in personalized medicine  
NIH's Roadmap Initiative for Medical Research  
NIH and personalized medicine
NIH collaboration with the FDA  
NIH and Genetic Testing Registry
National Human Genome Research Institute
National Institute of General Medical Sciences  
National Institute of Standards and Technology  
Role of the Centers for Disease Control
Role of academic institutions and health centers in the US  
Baylor College of Medicine
California Initiative to Advance Precision Medicine
Children’s Hospital of Los Angeles  
Clinical Proteomics Program of NCI & FDA
Coriell Personalized Medicine Collaborative™  
Delaware Valley Personalized Medicine Project
Duke University Medical Center and genomic medicine  
Evaluation of genetic tests and genomic applications  
Indiana University Institute for Personalized Medicine
Inova Center for Personalized Health
Institute of Medicine’s role in personalized medicine
Jackson Laboratory for Genomic Medicine  
Johns Hopkins Center for Personalized Cancer Medicine Research  
Mayo Clinic’s Centers for Individualized Medicine  
Mt. Sinai Medical Center’s Personalized Medicine Research Program  
North Shore University’s Center for Personalized Medicine
P4 Medicine Institute  
Personalized Medicine Partnership of Florida
Personalized oncology at Massachusetts General Hospital  
Personalized oncology at Oregon Health & Science University  
Pharmacogenetics Research Network and Knowledge Base
Southeast Nebraska Cancer Center's Personalized Medicine Network  
Spectrum Health Center for personalized cancer care  
Stanford Center for Genomics and Personalized Medicine  
UAB-HudsonAlpha Center for Genomic Medicine
University of Colorado’s Center for Personalized Medicine
UNC Institute for Pharmacogenomics and Individualized Therapy
Weill Cornell’s Englander Institute for Precision Medicine
Wisconsin Genomics Initiative
Role of academic collaborations with companies  
New York Genome Center  
Role of healthcare organizations  
Role of the medical profession  
The American Medical Association and personalized medicine  
Education of the physicians  
Off-label prescribing and personalized medicine
Medical education  
Role of patients  
Monitoring of patient compliance with therapy  
Public attitude towards personalized medicine  
Patient participation in disease management decisions  
Patient engagement in clinical trials of 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
BBMRI-ERIC
CARTaGENE for biobanks in Canada  
Personalized medicine based on PhysioGenomics™ technology  
Role of bioinformatics in development of personalized medicine
Biosimulation techniques for developing personalized medicine
Biosensing and wearable devices for monitoring of health  
Devices for detection of digital biomarkers  
Digitalized medicine  
Genomic data analysis
Integration of omics data by deep learning
Exploration of disease-gene relationship  
Health information management
Electronic health records
Analysis of -omic and EHR data of the patient
Cost of EHR and savings on healthcare expenses in the US 
EHRs and genome-wide studies  
Linking patient medical records and genetic information  
Management of personal genomic data
Use of EHRs for improving safety of new medicines
Use of EHRs for genetic research  
Use of EHRs for personalized drug discovery and development  
Personalized prognosis of disease  
Integration of technologies for personalized medicine  
Global scope of personalized medicine  
Global Alliance for Genomics and Health  
Personalized medicine in Canada  
Personalized medicine at Ontario Institute for Cancer Research  
Personalized Medicine Partnership for Cancer in Quebec  
Quebec Center of Excellence in Personalized Medicine  
Personalized medicine in the EU
European Personalized Medicine Diagnostics Association  
UK National Health Service and medical genetics  
UK's Precision Medicine Catapult
Personalized medicine in Germany  
Ubiquitous Pharmacogenomics project
Personalized medicine in Israel
Personalized medicine in Japan
Personalized medicine in the developing countries  
Personalized medicine in the Middle East
Personalized medicine in China  
Advantages of personalized medicine
Limitations of personalized medicine
Non-genomic factors in response to drugs
Incidental findings in genetic screening and clinical sequencing  
Future of personalized medicine
Ongoing genomic projects
Understanding the genetic basis of diseases  
Personal Genome Project  
Genome-wide association studies
NHGRI’s genomics vision for 2020
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
Connected health and personalized medicine
Opportunities and challenges
Comparative-effectiveness research and personalized medicine  
Genetic testing and concerns about equality of healthcare
Initiative for delivery for precision medicine  
IGNITE network – implementing personalized medicine in clinical care  
Prospects and limitations of genetic testing  
Personalized medicine and public health  
Pharmacotyping
Medicine in the year 2023  
Concluding remarks about the future of personalized medicine  

12. Ethical, Legal and Regulatory Aspects of Personalized Medicine. 609
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
UNESCO and ethical aspects of personalized medicine  
Genotype-specific clinical trials  
Social issues in personalized medicine  
Race and personalized medicine
Legal issues of personalized medicine  
Gene patents and personalized medicine
Regulatory aspects  
FDA and personalized medicine
FDA oversight of NGS for personalized medicine  
FDA and molecular diagnostics in relation to personalized medicine
CLSI guideline for the use of RNA controls in gene expression assays  
Evaluation of companion diagnostics/therapeutic  
FDA oversight of laboratory developed tests
FDA regulation of multivariate index assays  
FDA guidelines for the role of IVD in personalized medicine
IVD device and drug co-development  
Regulatory aspects of pharmacogenetics
Regulation of direct-to-consumer genetic testing  
Need for regulatory oversight of DTC
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  

13. 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
The rising healthcare costs in the US
Genetic testing and cost of healthcare  
Reducing healthcare costs by combining diagnostics with therapeutics  
Cost-effectiveness of pharmacogenetic testing
Cost-effectiveness of CYP genotyping-based pharmacotherapy  
Cost effectiveness of HIV genotyping in treatment of AIDS
Cost-effectiveness of warfarin pharmacogenomics
Cost-benefit analysis of KRAS and BRAF screening in CRC
Lowering the high costs of cancer chemotherapy  
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  
Segmentation of therapeutic drug markets
Reasons for increase of market values of personalized medicines
Growth of markets relevant to personalized medicine  
Biochips for diagnosis  
Pharmacogenetics  
Pharmacogenomics  
Pharmacoproteomics  
Point-of-Care
SNP market
Markets for personalized medicines according to therapeutic areas  
Market for personalized cancer therapy
Markets for immuno-oncology  
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  

14. 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 1-3: Genetic variations in the human genome
Table 1-4: Examples of systems medicine-based diagnostic/therapeutic approaches  
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: Drugs requiring biomarker/companion diagnostic information in the label  
Table 2-10: Companies involved in companion diagnostics
Table 2-11: Applications of point-of-care diagnosis  
Table 2-12: Companies developing point-of-care diagnostic tests  
Table 2-13: 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 3-11: Pharmacogenomic biomarkers in drug labeling
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: SNPs in genes implicated in response of bipolar disorder to lithium
Table 4-8: A sampling of companies involved in neuropharmacogenomics  
Table 5-1: Applications of pharmacoproteomic biomarkers in personalized medicine  
Table 8-1: Companies involved in personalized nutrition
Table 9-1: Important therapeutic areas for personalized medicine  
Table 9-2: Enzymes that metabolize antipsychotics
Table 9-3: Enzymes that metabolize antidepressants  
Table 9-4: Biomarkers of response to antidepressant treatment  
Table 9-5: Brain imaging for diagnosis of neurodegenerative parkinsonism
Table 9-6: Biomarkers of epilepsy
Table 9-7: Influence of gene polymorphisms on efficacy of antiepileptic drugs
Table 9-8: Biomarkers of stroke  
Table 9-9: Role of cell therapy in management of stroke according to stage
Table 9-10: Gene expression as biomarker of response to IFN-β in multiple sclerosis  
Table 9-11: Biomarkers of traumatic brain injury
Table 9-12: P450 isoforms in the metabolism of drugs used in the management of pain
Table 9-13: Personalized management of neuropathic pain based on mechanism  
Table 9-14: Genes that cause cardiovascular diseases
Table 9-15: Classification of diabetes into 5 clusters  
Table 9-16: Genetic influences on pharmacotherapy of alcoholism  
Table 10-1: Factors that drive the development of personalized therapy in cancer  
Table 10-2: Impact of molecular diagnostics on the management of cancer  
Table 10-3: FDA-approved companion diagnostics for cancer  
Table 10-4: Marketed anticancer personalized medicines  
Table 10-5: Monoclonal antibodies for cancer approved by the FDA  
Table 10-6: Clinical trials of personalized cancer vaccines  
Table 10-7: Future developments in oncology relevant to personalized management  
Table 10-8: Selected companies involved in developing personalized oncology  
Table 11-1: Bayesian versus frequentist approaches in clinical trials  
Table 11-2: Players in the development of personalized medicine  
Table 11-3: Members of the Personalized Medicine Coalition  
Table 11-4: Biobanks relevant to personalized medicine  
Table 11-5: Role of bioinformatics in the development of personalized medicine
Table 11-6: Advantages of personalized medicine for the biopharmaceutical industry
Table 11-7: Advantages of personalized medicine for the patients  
Table 11-8: Advantage of personalized medicine for the physicians
Table 11-9: Advantage of personalized medicine for the healthcare providers  
Table 11-10: Limitations of personalized medicine  
Table 11-11: Recommendations of the Association for Molecular Pathology on incidental findings  
Table 11-12: Methods of translational science that are relvant to personalized medicine
Table 11-13: Companies involved in predictive healthcare  
Table 11-14: Delivery for precision medicine
Table 12-1: Drugs with genetic information in their labels
Table 13-1: Drivers for the development of personalized medicine
Table 13-2: Growth of markets relevant to personalized medicine 2018-2028  
Table 13-3: Markets for personalized medicine according to therapeutic area 2018-2028
Table 13-4: Markets for personalized medicine in major regions 2018-2028
Table 13-5: Lack of efficacy in current therapy  
Table 13-6: Impact of personalized medicine on other industries  
Table 13-7: Strategies to develop personalized medicine  
Table 13-8: 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 sequencing in personalized medicine
Figure 2-2: Role of biochip/microarray technology in personalized medicine  
Figure 2-3: Application of biochips/microarrays in personalized therapy
Figure 2-4: Affymetrix GeneChip technology  
Figure 2-5: Role of CYP450 genotyping in development of personalized medicine  
Figure 2-6: Role of SNPs in personalized medicine  
Figure 2-7: 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 various factors in personalized nutrition
Figure 9-1: Workflow of genotypic resistance analysis for personalized HIV therapy
Figure 9-2: Components of multimodal therapy for neurological disorders
Figure 9-3: Scheme of iPSCs use for personalized cell therapy of Parkinson disease
Figure 9-4: An algorithm for personalized management of epilepsy
Figure 9-5: Algorithm for anticoagulant therapy to prevent stroke in atrial fibrillation
Figure 9-6: Spot sign of extravasation and expansion of intracerebral hematoma  
Figure 9-7: A scheme of personalized therapy of multiple sclerosis  
Figure 9-8: Personalized targeting of therapeutic agents to lesions of multiple sclerosis
Figure 9-9: Essential components of personalized management of pain  
Figure 9-10: Genetic and non-genetic factors affecting efficacy and side effects of opioids  
Figure 9-11: Role of opioid therapy in management of noncancer pain  
Figure 9-11: An algorithm for personalized management of pain  
Figure 9-12: Assessment of stable coronary artery disease  
Figure 9-13: Flow chart of personalized approach to management of atrial fibrillation  
Figure 9-14: A scheme of personalized approach to management of chronic hypertension  
Figure 9-15: Statins for management of blood cholesterol to reduce risk of CVD
Figure 9-16: Basis of personalized approach to idiopathic pulmonary fibrosis (IPF)  
Figure 9-17: Steps in growing a new heart in vitro for transplantation
Figure 10-1: Relationships of technologies for personalized management of cancer
Figure 10-2: Integration of technologies for personalized prevention of cancer  
Figure 10-3: CRISPR-Cas9 in personalized cancer gene therapy  
Figure 10-4: Use of LC-MS/MS to select appropriate targeted therapy for cancer  
Figure 10-5: Personalized cancer therapy based on targeted proteomics
Figure 10-6: Applications of NCI Genomic Data Commons  
Figure 10-7: Workflow for development of gene pages for personalized cancer therapy  
Figure 11-1: Integration of technologies for the development of personalized medicine  
Figure 12-1: Strategy for drug and test co-development
Figure 13-1: Cost of sequencing per genome  
Figure 13-2: Evolution of personalized medicine as a market driver  

Part II

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 

Note: Product cover images may vary from those shown
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