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In recent history, the pharmaceutical industry has played the major role in devel-
oping most of the innovations in therapy. Major pharmaceutical companies have the
resources to do so. Eventually for clinical applications, the collaborations involve
academic healthcare centers that have the patients. The major incentive for the phar-
maceutical industry to participate in the development of personalized medicine is
the increasing interest and technologies available for developing such medicines. In
future, we will see more competition among the companies in this area as those who
do not remain on the forefront will be at a considerable disadvantage in the future
healthcare market. Companies such as Hoffmann-La Roche are in a good position
to develop such innovative healthcare systems as they have the largest molecular
diagnostic facility and already have products where diagnostics and therapeutics are
packaged together. Individual technologies and data for the development of person-
alized medicine stem mostly from biotechnology companies. Principles of personal-
ized medicine play an important role at all stages of the drug development process.
Personalized Drug Discovery
To start with use of established drugs is being personalized. The next step is discov-
ery of personalized drugs. Assays of drug action typically evaluate biochemical
activity; however, accurately matching therapeutic effi cacy with biochemical activ-
ity is a challenge. High-content cellular assays seek to bridge this gap by capturing
broad information about the cellular physiology of drug action. The detailed infor-
mation contained in genomic expression data is suffi cient to match the physiologi-
cal effect of a novel drug at the cellular level with its clinical relevance. This
capacity to identify therapeutic effi cacy on the basis of gene expression signatures
in vitro has potential utility in drug discovery and drug target validation relevant to
personalized medicine.
The availability of genomic samples in large phase IV trials provides a valuable
resource for further understanding the molecular basis of disease heterogeneity,
providing data that feeds back into the drug discovery process in target identifi ca-
tion and validation for the next generation of improved medicines.
Personalized Approach to Clinical Trials
It is well recognized that average treatment effects estimated by systematic reviews
of clinical trials do not really apply to an individual patient, and might differ in
patient subgroups. This can lead to treatment of patients for whom the treatment is
not effective, and may be harmful. Positive clinical trial results may mask a lack of
meaningful benefi t for those at lower risks of illness, e.g. trials involving statins,
anticoagulant therapies, and some common surgical procedures (Kent et al. 2010 ).
The authors emphasized that the problem of trials masking the “heterogeneity of
20 Development of Personalized Medicine