CLINICAL TRIALS
Current Trends in Pharmacogenomics that will shape Clinical Trials The increased relevance of pharmacogenomics in explaining individual differences in drug responses is evident in the market’s projected growth to $9,346.8 million by 2031. The CRISPR Cas-9 gene editing, computer assisted structural simulation and DNA reactivity technology provide key insights for informed trial design, especially in Oncology studies where both germ line and acquired mutations play a role. Ayaaz Hussain Khan, Global Head – Generics, Navitas Life Sciences
Gene variations and pharmacogenomics
Variations in genes that code for specific enzymes, drug targets, or even transporters have been shown to be associated with drug toxicity and may be used for identifying likely responses to drug products. An understanding of such variations that are present from birth, or germline variations, are inherited and are used as biomarkers to understand the pharmacokinetics of drugs. The increased relevance of pharmacogenomics in explaining individual differences in drug responses is evident in the market’s projected growth from nearly US$ 5,000 million in 2020 to US$ 9,346.8 million by 2031 at a CAGR of 5.71 per cent. Inter-individual differences in drug response
T
he complete human genome was published in March 2022, heralding a new era in pharmacogenomics, advancing genome analysis, and unlocking value additions in precision medicine. It received a considerable impetus in the global market when former US President,
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P H A RM A F O C U S A S I A
ISSUE 47 - 2022
Barrack Obama, announced the Precision Medicine Initiative in 2015. According to a McKinsey report, the precision medicine market is set to touch US$ 140 billion by 2026, with the growing demand bringing to the fore the need to conduct pharmacogenomics studies, adding new dimensions to clinical trials.
There are inter-individual differences in the response to drugs that are multifactorial and difficult to predict, but are partly associated with inherited genetic variations. Variations in genes associated with absorption, distribution, metabolism, and excretion (ADME) have been found to be associated with a drug’s pharmacokinetics (PKs) and pharmacodynamics (PDs), affecting various aspects of drug outcome. Gene variations are also associated with drug dosing, toxicity, the extent of effect, and even drug resistance and hypersensitivity.
