continuous, seamless and cyclical process. It observes and interprets studies of each

of the patient by proposing a new hypothesis. This new hypothesis will eventually be

helpful in directing the next reiteration of benchtop therapeutic research and ulti-

mately to get the clinical trial studies to analyse the human experience (Shakhnovich

2018).

The advent of precision medicine with reverse translational research (bedside to

benchtop) and its focus on the identification and grouping of subpopulations, as well

as the tools to identify such populations, led to the concept of precision medicine

drug discovery and development. Rapid progress in reverse translational approach

through genomic sequencing, biomarker identification, data collection and analytics

has accelerated the adoption of trials that test precision medicines, to identify patient

groups who are likely to respond to a therapy by providing a more personalised

approach to treatment. The examples of successful precision medicine drug discov-

ery include Herceptin (trastuzumab) and Gleevec (imatinib), in which biomarker-

based reverse translational approach was used for precision medicine development.

Precision medicines now represent a significant and growing proportion of drugs

in the industry pipeline, particularly in oncology where the majority of therapies in

development are personalised (Chan and Erikainen 2018; Waring and Naylor 2016;

Naylor et al. 2015). The Center for Drug Evaluation and Research (CDER) at FDA

has approved many new molecular entities from 2010 to 2020 (Fig. 9.1). In 2020, till

August 2020, a total of 37 new molecular entities are approved. The maximum

number (59) of new approved drugs was observed in 2018. It is important to note

that in 2005, only 5% of the approved drugs were classified as precision medicines

Number of New Drugs Approved Annually

Percentage of Precision Medicine Drugs Approved

21% in 2014, 28% in 2015, 27% in 2016, 35% in 2017, 42% in 2018 and 25% in 2019

Fig. 9.1 Number of new molecular entities approved by CDER at FDA and percentage of

precision medicine drugs

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