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Personalized Medicine - scientific & commercial aspects Published on September 2011
Report Summary The aim of personalized medicine or individualized treatment is to match the right drug to the right patient and, in some cases, even to design the appropriate treatment for a patient according to his/her genotype. This report describes the latest concepts of development of personalized medicine based on pharmacogenomics, pharmacogenetics,pharmacoproteomics, and metabolomics. Basic technologies of molecular diagnostics play an important role, particularly those for single nucleotide polymorphism (SNP) genotyping. Diagnosis is integrated with therapy for selection of the treatment as well for monitoring the results. Biochip/microarray technologies are also important and finally bioinformatics is needed to analyze the immense amount of data generated by various technologies. Pharmacogenetics, the study of influence of genetic factors on drug action and metabolism, is used for predicting adverse reactions of drugs. Several enzymes are involved in drug metabolism of which the most important ones are those belonging to the family of cytochrome P450. The knowledge of the effects of polymorphisms of genes for the enzymes is applied in drug discovery and development as well as in clinical use of drugs. Cost-effective methods for genotyping are being developed and it would be desirable to include this information in the patient's record for the guidance of the physician to individualize the treatment. Pharmacogenomics, a term that overlaps with pharmacogenetics but is distinct, deals with the application of genomics to drug discovery and development. It involves the mechanism of action of drugs on cells as revealed by gene expression patterns. Pharmacoproteomics is an important contribution to personalized medicine as it is a more functional representation of patient-to-patient variation than that provided by genotyping.A 'pharmacometabonomic' approach to personalizing drug treatment is also described. Biological therapies such as those which use patient's own cells are considered to be personalized medicines. Vaccines are prepared from individual patient's tumor cells. Individualized therapeutic strategies using monoclonal bodies can be directed at specific genetic and immunologic targets. Ex vivo gene therapy involves the genetic modification of the patient's cells in vitro, prior to reimplantation of these cells in the patient's body. Various technologies are integrated to develop personalized therapies for specific therapeutic areas described in the report. Examples of this are genotyping for drug resistance in HIV infection, personalized therapy of cancer, antipsychotics for schizophrenia, antidepressant therapy, antihypertensive therapy and personalized approach to neurological disorders. Although genotyping is not yet a part of clinically accepted routine, it is expected to have this status by the year 2014. Several players are involved in the development of personalized therapy. Pharmaceutical and biotechnology companies have taken a leading role in this venture in keeping with their future role as healthcare enterprises rather than mere developers of technologies and manufacturers of medicines. Ethical issues are involved in the development of personalized medicine mainly in the area of genetic testing. These along with social issues and consideration of race in the development of personalized medicine are discussed. Regulatory issues are discussed mainly with reference to the FDA guidelines on pharmacogenomics. Increase in efficacy and safety of treatment by individualizing it has benefits in financial terms. Information is presented to show that personalized medicine will be cost-effective in healthcare systems. For the pharmaceutical companies, segmentation of the market may not leave room for conventional blockbusters but smaller and exclusive markets for personalized medicines would be profitable. Marketing opportunities for such a system are described with market estimates from 2010-2020.
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Table of Content TABLE OF CONTENTS 0. Executive Summary 19 1. Basic Aspects 21 Definition of personalized medicine 21 History of medical concepts relevant to personalized medicine 22 Molecular biological basis of personalized medicine 24 The human genome 24 Chromosomes 25 Genes 25 The genetic code 25 Gene expression 25 DNA sequences and structure 26 Genetic variations in the human genome 26 Single nucleotide polymorphisms 27 Single nucleotide polymorphisms 27 Copy number variations in the human genome 27 Insertions and deletions in the human genome 29 Large scale variation in human genome 30 Structural variations in the human genome 30 Mapping and sequencing of structural variation from human genomes 30 1000 Genomes Project 31 Role of DNA sequencing in the development of personalized medicine 32 Human Variome Project 33 Basics technologies for developing personalized medicine 33 Definitions of technologies relevant to personalized medicine 33 Problems with the ICH definitions of pharmacogenomcis and pharmacogenetics 34 Relationship of various technologies to personalized medicine 34 Conventional medicine versus personalized medicine 35 Role of genetics in future approaches to healthcare 36 Genetic medicine 36 Human disease and genes 36 Genetic and environmental interactions in etiology of human diseases 37 Role of genetics in development of personalized medicines 37 Genetic databases 37 Genetic epidemiology 38 Limitations of medical genetics and future prospects 38 Genetics vs. epigenetics 39 Role of systems biology in personalized medicine 39 Systems pharmacology 40
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