Biomarker-Based Drug Discovery
with Reverse Translational Approach
9
Ramesh K. Goyal and Geeta Aggarwal
Abstract
The development of new drugs and their approval has become very low as only
few molecular entities were approved between 2010 and 2019 with an average of
31 drugs/year between 2010 and 2014 and 44 drugs/year between 2015 and 2019.
In 2018 and 2019, the US FDA has approved 59 and 48 new molecular entities
(NMEs), respectively, based on their potential positive impact on quality medical
care and public health. In conventional drug development, the promise of safer
drugs with large quantity is approved notwithstanding that ended in a failure more
than its success, and there is gap in the industry’s ability to predict drug
candidate’s performance early. The attrition in clinical development as a conse-
quence of late clinical trial failure has been very high. The concept of reverse
translational research is one of the steps to overcome the attrition rate in drug
development through the path ‘bedside to bench/clinics to laboratories’ instead of
‘bench to bedside/laboratories to clinics’. It is a science of integrating and
understanding the mechanism of action ‘man to mice to molecule’ through
multiple levels of safety, efficacy and acceptability based on relevant science.
The concept of reverse translation emerged with the advent of genomics and
thereby the significance of cellular and molecular biomarkers. This is based on
targeted therapies involving the development of safe, novel biomarkers, which
have emerged on diagnosis, prognosis and theranostic role. Point-of-care and
in-field advanced technologies for rapid, sensitive and selective detection of
molecular biomarkers have attracted much interest in clinical development
programs. Reverse translational research integrates biomarkers from different
investigations like epigenetic, genomic, proteomics, miRNA and siRNA. The
R. K. Goyal (*) · G. Aggarwal
Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India
e-mail: goyalrk@gmail.com; geetaaggarwal17@gmail.com
# The Author(s), under exclusive license to Springer Nature Singapore Pte
Ltd. 2022
R. C. Sobti, N. S. Dhalla (eds.), Biomedical Translational Research,
https://doi.org/10.1007/978-981-16-9232-1_9
123