Zachary S. Brooks, PhD, EMBA & Panashe Nyengera
Pharmacogenomics for Smarter Drug Discovery. What if drug development began with the patient already in mind? Pharmacogenomics (PGx) merges genomics with pharmacology to refine drug development by linking genetic variation to drug response. With PGx, drug discovery pipelines can capture gene-drug interactions early in the process, optimize the enrollment of clinical trials, and develop safer, more effective therapeutics.
Preclinical identification of genetic biomarkers reduces late-stage trial failure. Early identification of drug-gene interactions reduces the risk of late-stage trial failures. By uncovering patient-specific genetic biomarkers related to disease etiology and drug metabolism, researchers can pinpoint relevant molecular targets during preclinical trial phases. PGx testing reveals polymorphisms in pharmacogenes, which define enzymes that influence drug efficacy and toxicity profiles. In a study by Grogan et al. (2022), 1,000+ cancer cell lines were screened with genomic profiling and a repurposed drug (selumetinib) was discovered to be uniquely effective against KRAS-mutant tumors. It later advanced to Phase III trials for lung cancer. This targeted development shortens timelines and optimizes resource allocation, making genomic medicine accessible to patients through faster availability of safer drugs.
FDA supports early-phase genomic stratification of patients. Stratifying patients based on PGx profiles increases statistical power to detect efficacy while flagging adverse response propensities. FDA guidance supports genomic stratification during early-phase studies to formally assess gene-drug interactions, establishing a vital pathway toward more predictive clinical designs (Green et al. 2016). By organizing trials using insights into how genes affect drug responses, the risk of data bias shrinks, while measures of drug safety tighten, ensuring drugs align with patients most likely to respond positively.
Preemptive PGx testing enables exclusion of vulnerable patients. Forecasting adverse drug reactions through PGx strengthens safety assessments during clinical development. Variants in genes such as HLA-B*57:01 predispose patients to life-threatening hypersensitivity from drugs like abacavir. Preemptive PGx testing during early-stage trials identifies high-risk genotypes, enabling dose adjustments or exclusion of vulnerable patients. These advances forge a practical route to smarter, safer medications—for patients and healthcare professionals—and fundamentally shift how medicines enter the market (Moore, et al. 2023).
Learn more about UGenome’s Personalized Medication Service, ProPEx, or contact UGenome. You can also find case studies for UGenome’s bioinformatics services Metabolite Identification, Bone Metastasis Risk Analysis in Breast Cancer, Survival Analysis with gene signatures in cancer
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