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Personalized Medicine - Scientific & Commercial Aspects

  • ID: 4748160
  • Report
  • September 2020
  • Region: Global
  • 1158 Pages
  • Jain PharmaBiotech

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. 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 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 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 2019-2029.

Profiles of 298 companies involved in developing technologies for personalized medicines, along with 583 collaborations are included in the 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 50 figures.

Note: Product cover images may vary from those shown

Part I: Scientific Basis & Technologies

0. Executive Summary

1. Basic Aspects
Definition of personalized medicine
History of medical concepts relevant to personalized medicine
Evolution of modern personalized medicine
Molecular biological basis of personalized medicine
The human genome
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 pathology
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
Machine learning and personalized medicine
Algorithms based on machine learning
Bioelectronics and personalized medicine
A personalized approach to environmental factors in disease
Role of animal models in development of personalized medicine
Animal models for supplementing research on human genomes
Mouse models for personalized medicine
Promise and limitations of animal models for personalized medicine
Role of pets with naturally occuring diseases
Cancer in dogs
Reclassification of diseases
Translational science and personalized medicine
Genome to phenome translation
Personalization of multimodal therapies

2. Molecular Diagnostics in Personalized Medicine
Molecular diagnostic technologies .62
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
IBS sequencing technology
Illumina’s sequencing technology
Ion Torrent's sequencing technology
Life Technologies 3500 series Genetic Analyzer
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
Roche GL-FLEX sequencing
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
AmpliChip CYP450
Micronics' microfluidic technology
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
LabChip for protein analysis
TRINECTIN proteome chip
Protein expression microarrays
Microfluidic devices for proteomics-based diagnostics 93
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
Predicting drug 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
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 31
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
Disease prediction
Early diagnosis
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
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
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
Applications of therapeutic drug monitoring
Genotyping vs phenotyping
Limitations of genotype-phenotype association studies
Molecular toxicology in relation to personalized medicines
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. 167
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
Basics of pharmacogenomics
Pharmacogenomics and drug discovery
Preclinical prediction of drug efficacy
Role of pharmacogenomics in drug discovery and drug delivery
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
Tumor suppressor genes
Pharmacogenomics of Alzheimer's disease
Pharmacogenomics of depression
Pharmacogenomics of bipolar disorder
Pharmacogenomics of schizophrenia
Companies involved in neurogenomics-based drug discovery
Current state and future 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
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
Metabonomic technologies for toxicology studies
Metabonomics/metabolomics and personalized nutrition
Metabolomics for personalized medicine

7. Personalized Biological Therapies
Recombinant human proteins
Therapeutic monoclonal antibodies
Cell therapy 205
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

8. Personalized complementary & Alternative Therapies
Ayurveda as a personalized healthcare system
Taditional Chinese medicine
Personalized acupuncture therapy
Personalized hyperbaric oxygen therapy
Personalized nutrition
Evolutionary basis of nutrigenomics
Genomics of vitamin D and calcium supplementation
Nutrigenomics and functional foods
Nutrigenomics and personalized medicine
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

9. Personalized Medicine in Major Therapeutic Areas
Personalized management of infections
Genetic susceptibility to infections
Personalized use of antibiotics
Personalized management of sepsis
Role of nanobiotechnology in personalized management of infections
Personalized management of viral infections
Genomic epidemiology of viral diseases
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 COVID-19
Molecular diagnosis of COVID-19 235
Genomics of coronaviruses
Genetic susceptibility for severity of COVID-19
Risk factors for cardiac complications of COVID-19
Strategies for developing therapies for COVID-19
Antivirals for COVID-19
Cell/gene therapy for COVID-19
Personalized approach to passive antibody therapy for COVID-19
Personalized vaccines for COVID-19
Personalized management of tuberculosis
Personalized management of fungal infections
Psychiatric disorders
Role of amygdala in personalized psychiatry
Gene polymorphisms as basis of personalized approach to psychiatric disorders
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 for schizophrenia
Pharmacogenetics for personalizing antipsychotic therapy
Patient-derived stem cells for personalizing drugs for schizophrenia
Personalized therapy of bipolar disorder
Personalized antidepressant therapy
Pharmacogenetics/pharmacogenomics of antidepressant therapy
Biomarkers of response to antidepressant treatment
EEG biomarkers for predicting safety and efficacy of antidepressants
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
Personalized management of autism spectrum disorders
Neurological disorders
Introduction to personalized neurology
Individuality of the human brain as a basis of personalized neurology
Gender differences in neurological disorders
Measuring brain health across life span
AI for personalized neurology
Wearable devices for personalized neurology
Role of neuroinformatics in personalized neurology
Personalized management of Alzheimer's disease
Personalized management of Parkinson's disease
Atremorine as personalized dopaminergic therapy for PD
Brain imaging for diagnosis of neurodegenerative parkinsonism
Direct-to-consumer genetic testing in PD
Disease modification 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 selection of targets for deep brain stimulation
Personalized management of Huntington disease
Personalized management of amyotrophic lateral sclerosis
Personalized management of epilepsy
Adverse effects of AEDs
An algorithm for personalized management of epilepsy
Biomarkers of epilepsy
Changes in seizure evolution with circadian timescale
Drug resistance in epilepsy
Genetics/genomics of epilepsy
Pharmacogenomics of epilepsy
Rasmussen’s encephalitis
Selection of the right AED 270
Status epilepticus
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
Biomarkers of stroke
Management of a patient with carotid stenosis a risk for stroke
Anticoagulation for stroke prevention
Management of acute ischemic stroke
Application of proteomics for personalizing stroke management
Brain imaging for personalized management of stroke
Deep learning for prediction of final ischemic stroke lesion from MRI
Intravenous thrombolysis and revascularization in acute 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
Personalizing therapy of MS by use of biomarkers
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
Management of cerebral edema/raised intracranial pressure in TBI
Personalized management of myasthenia gravis
Personalized management of tinnitus
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 306
Companion diagnostics for therapy of cardiovascular disorders
Biomarkers and personalized management of cardiovascular disorders
Clinical biomarkers
Laboratory biomarkers
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
Cell therapy for cardiac repair
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 fibrosis341
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
Closed loop control of type1 DM
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
DNA methylation-based test for monitoring smoking
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
Role of biomarkers and ageotyping
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. 369
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 surgery
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
Development of individualized biological therapies for rare diseases
Personalized management of DNA repair disorders
Personalized preventive medicine
Personalized surgery

10. Personalized Therapy of Cancer
Epidemiology of cancer
Development of personalized therapy in cancer
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
Challenges of cancer classification
Role of staging in personalized management of cancer
Systems biology of cancer
Relationships of technologies for personalized management of cancer
Role 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 lethality
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 . 399
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
Biomarker-based assays for predicting response to anticancer therapeutics
HER-2/neu oncogene as a biomarker for cancer
L-asparaginase treatment of cancer guided by a biomarker . 403
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
Swiss molecular tumor board for individualized, biomarker-based decisions
VeraTag™ assay system for cancer biomarkers
Determination of response to therapy
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
Genetic therapy of cancer
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™
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
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
Tumor cells treated with dinitrophenyl
Patient-specific cell-based vaccines . 426
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
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 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
Manipulation of tumor metabolism for personalizing antitumor effect
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
Thiopurine methyltransferase
Dihydropyrimidine dehydrogenase
UGT1A1 test as guide to irinotecan therapy
Computers and digital technologies for personalized oncology
Artificial intelligence in personalized management of cancer
Computational models of kinetically tailored treatment
Mathematical modeling of tumor microenvironments
Modeling signaling pathways to reposition anticancer drugs
Personalized computational oncology
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 456
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 cancer
Biomarkers of bladder cancer
Selection of optimal anticancer agents for bladder cancer
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
Gene therapy of 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
Personalized PARP therapy of 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 501
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 gastroesophageal 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 530
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 542
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
Current trends and future of personalized oncology
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
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’ Center for Genomic and Computational Biology
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
Consumer genomics
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
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
Clinical decision support systems
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 613
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
Precision medicine project of World Economic Forum
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
European Ubiquitous Pharmacogenomics project
UK National Health Service and medical genetics
UK’s 100,000 Genomes project
UK's Precision Medicine Catapult
Personalized medicine in France
Personalized medicine in Germany
Personalized medicine in Israel
Personalized medicine in Japan
Biobanks in Japan
Companion diagnostics in Japan
Cost-effectiveness of personalized medicine in Japan
Genetic testing in Japan
Initiative on rare and undiagnosed diseases
Personalized medicine in the developing countries
Personalized medicine in the Middle East
Personalized medicine in China
Personalized medicine in India
Personalized medicine in Africa
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
Personal Genome Project
Genome-wide association studies
NHGRI’s genomics vision for 2020
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 for personalized medicine
Comparative-effectiveness research and personalized medicine
Genetic testing and concerns about equality of healthcare
Impact of molecular diagnostics on personalized medicine
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
Medicine in the year 2025
Concluding remarks about the future of personalized medicine

12. Ethical, Legal and Regulatory Aspects of Personalized Medicine
Introduction to ethical issues
Ethical issues of pharmacogenetics
Ethical aspects of genetic information
Ethical issues of whole genome analysis
Privacy issues in personalized medicine
Genetic Information Nondiscrimination Act in the US
UNESCO and ethical aspects of personalized medicine
Genotype-specific clinical trials
Ethical issues in use of digital technologies for personalized medicine
Social issues in personalized medicine
Race and personalized medicine. 648
Legal issues of personalized medicine
Gene patents and personalized medicine
Regulatory aspects
FDA and 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 guidelines for the role of IVD in personalized medicine
FDA oversight of NGS for diagnosis in personalized medicine
FDA’s Clinical Databases Guidance
Analytical Validation Guidance
IVD device and drug co-development
FDA guidelines for personalized oncology
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 (PGx) information in drug labels
FDA guidelines for pharmacogenomics-based dosing
FDA and validation of biomarkers
FDA and predictive medicine

List of 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 haplotyping 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 268
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 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 relevant to personalized medicine
Table 11-13: Companies involved in predictive healthcare
Table 11-14: Delivery for precision medicine
Table 12-1: Drugs with pharmacogenomic information in their labels

List of 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: Pathogen sequencing as guide to personalized management viral infections
Figure 9-2: An integrated approach to viral diseases
Figure 9-3: Workflow of genotypic resistance analysis for personalized HIV therapy
Figure 9-4: Gene-environment interactions leading to an increased risk of cardiac death in COVID-19
Figure 9-5: Components of multimodal therapy for neurological disorders
Figure 9-6: Scheme of iPSCs use for personalized cell therapy of Parkinson disease
Figure 9-7: Antisense approaches for personalized therapy of Huntington disease
Figure 9-8: An algorithm for personalized management of epilepsy
Figure 9-9: Interacting risk factors for stroke
Figure 9-10: Decision for medical vs surgical treatment of carotid occlusive disease
Figure 9-11: Algorithm for anticoagulant therapy to prevent stroke in atrial fibrillation
Figure 9-12: Spot sign of extravasation and expansion of intracerebral hematoma
Figure 9-13: A scheme of personalized therapy of multiple sclerosis
Figure 9-14: Personalized targeting of therapeutic agents to lesions of multiple sclerosis
Figure 9-15: Essential components of personalized management of pain
Figure 9-16: Genetic and non-genetic factors affecting efficacy and side effects of opioids
Figure 9-17: Role of opioid therapy in management of noncancer pain
Figure 9-18: An algorithm for personalized management of pain
Figure 9-19: Assessment of stable coronary artery disease
Figure 9-20: Flow chart of personalized approach to management of atrial fibrillation
Figure 9-21: A scheme of personalized approach to management of chronic hypertension 
Figure 9-22: Statins for management of blood cholesterol to reduce risk of CVD
Figure 9-23: Basis of personalized approach to idiopathic pulmonary fibrosis (IPF)
Figure 9-24: 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

Part II: Markets & Companies

13. Markets for Personalized Medicine
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
Personalized dose reduction of pembrolizumab in cancer
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
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. Companies Involved in Developing Personalized Medicine

15. References

List of Tables

Table 13-1: Drivers for the development of personalized medicine
Table 13-2: Growth of markets relevant to personalized medicine 2019-2028
Table 13-3: Markets for personalized medicine according to therapeutic area 2019-2029
Table 13-4: Markets for personalized medicine in major regions 2019-2029
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
Table 14-1: Top five pharmaceutical companies involved in personalized medicine
Table 14-2: Selected collaborations of companies in personalized medicine

List of Figures

Figure 13-1: Cost of sequencing per genome
Figure 13-2: Evolution of personalized medicine as a market driver

Note: Product cover images may vary from those shown