19- Pharmacoproteomics is the application of proteomics to drug discovery and
development. Discovery of protein biomarkers may serve as a common basis of
diagnostics and therapeutics. Subtyping patients on the basis of protein analysis
may help to match a particular target-based therapy to a particular marker in a
subgroup of patients. - Pharmacometabolomics is the application of metabolomics for study of diseases,
discovery of biomarkers, for development of diagnostics and therapeutics.
Problems with the ICH Defi nitions of Pharmacogenomics
and Pharmacogenetics
The International Conference on Harmonization (ICH) fi nalized a set of defi nitions
that were published as a guideline in 2008 for use by international scientists, com-
panies, and regulators in assessing pharmacogenomics products and services. These
have not been changed since then.
- ICH defi ned pharmacogenomics as “the study of variations of DNA and RNA
characteristics as related to drug response.” - Pharmacogenetics was described as a sub-set of pharmacogenomics, for “the
study of variations in DNA sequence as related to drug response.”
The ICH started the project to remedy the inconsistency of applied defi nitions,
which could lead to confl icting usage and interpretations by regulators, industry,
investors, and ethics groups. However, the defi nition of pharmacogenetics will com-
plicate the situation as it is erroneous. The main reasons for this are: - Pharmacogenetics existed long before pharmacogenomics and cannot be a sub-
set of genomics any more than genetics can be a subset of genomics. - Pharmacogenetics takes into consideration many factors other than variations in
DNA sequences in determining the response to drugs (see Chap. 3 ).
‘Omics’ and Personalized Medicine
Starting as the suffi x of gen omics , ‘omics’ refers to nearly 100 technologies, all of
which are relevant to development of personalized medicine. Some of the important
‘omics’ are described in various chapters of this report. The Genome Institute of
Singapore has launched the POLARIS Program ( P ersonalized O MIC L attice for
A dvanced R esearch and I mproving S tratifi cation), a strategic initiative for embed-
ding ‘omics’ information into the diagnosis and treatment of diseases in Singapore.
The POLARIS consortium will establish certifi ed labs at Singapore General
Hospital as well as develop ‘omics’ platforms, technologies for processing clinical
samples, bioinformatics for data interpretation/results analysis, and reporting to cli-
nicians. It will facilitate the development of personalized medicine.
‘Omics’ and Personalized Medicine