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Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
May 14-15, 2018 | Montreal, Canada
Global Summit on
Biopharma & Biotherapeutics
I
dentifying pharmacogenomic biomarkers for therapeutic
and safety outcome to biological therapy, echoes
advancement towards personalized medicine in the 21st
century. Biologics though regarded as “designer” drugs,
produce desired therapeutic effect only in a fraction of
the treated population, since genetic and non-genetic
factors jointly influence variability in response to biological
treatment. The demographic diversity and complexity in
the prevalence of genomic variants (SNPs and non-SNPs
polymorphisms) pose major challenges in development
of suitable prognostic pharmacogenomic biomarkers as
predictors of response to bio-therapeutic agents. However,
a substantial number of pharmacogenomic markers have
helped in appropriate patient selection for antineoplastic,
anticoagulant, anticonvulsant, cardiovascular and anti-HIV
therapies. The pharmacogenetic screening, thus serves
as a useful diagnostic tool integrating individual’s genetic
information with the existing prescribing model to optimally
treat the patients. Biologics are large complex molecules
with rapidly changing stability profile which intensify the
response variation due to genetic polymorphism. Non-clinical
challenges, such as hemocompatibility, immunotoxicity,
biodistribution, tumorigenicity, contamination etc., faced
during biologics development prohibits designing a single
testing strategy for all products. Adopting pharmaceutical
‘Quality by Design’ partly addresses these challenges
enhancing safety and performance of biological products.
Also, identifying useful predictive biomarkers will have a
significant impact on drug development and successful
outcome of new biologics. Healthcare authorities have
stressed upon developing pharmacogenomic biomarker
tests in clinical practice complementing the information
available from clinical trials warranting greater success rate
of high cost biological therapy.
e:
agarwalakdr@gmail.comEmerging role of pharmacogenomic biomarkers in biological therapy and safety
Agarwal A K
Gulf Medical University, UAE