Abstract
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 2012.
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 2007-2017.
Profiles of 225 companies involved in developing technologies for personalized
medicines, along with 416 collaborations are included in the part II of the
report. Finally the bibliography contains over 470 selected publications cited
in the report.The report is supplemented by 56 tables and 17 figures.
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