Jayden Lee, EMBA, PharmD, BCACP & Husna Rahim, PharmD
Pharmacogenomics and Drug Development: Accelerating the Process Towards Precision Medicine. Will pharmacogenomic testing accelerate the development of new medications? With the rise of costs and risks of drug development, adopting innovative approaches to streamlining clinical trials for new medications is essential. Pharmacogenomics (PGx) is the study of how individuals’ genetic attributes affect their likely response to medications. PGx approaches hold promise in expediting clinical trials and drug development through proteomic profiling, biomarker indications, and targeted regulatory approval for certain groups of patients.
Identification of responders and non-responders guides targeted recruitment. Proteomic profiling refers to the study of proteins present in a biological sample, such as cells, tissues, or body fluids. Early-phase proteomic profiling may reveal signs correlated with response or toxicity to a drug. This early identification of responders and nonresponders can guide the inclusion and exclusion criteria for targeted recruitment, allowing clinical trials to be conducted with smaller sample sizes (Turner et al. 2022).
A biomarker indication is a measurable biological characteristic indicating a disease, condition, or biological process. Incorporating biomarkers into Phase 0 trials enables the identification of populations most likely to benefit, reducing failures in later stages. In addition, proteomic monitoring during Phase I and Phase II can provide pharmacokinetic and pharmacodynamic data valuable for dose selection, patient stratification, and real-time safety monitoring (Veal et al. 2019).
Maximize benefits across populations worldwide. Demonstrating a drug’s efficacy, safety or dosing according to specific genomic biomarkers could facilitate more targeted drug approvals and labels during regulatory review. This tailored pharmacogenomic evidence may help satisfy regulatory requirements more rapidly compared to traditional drug development pathways (Lauschke 2018). Pharmacogenomic data may also open avenues for repurposing existing drugs, as PGx insights can identify patient sub-groups that may respond favorably to a particular medication.
Revolutionizing the future of clinical trials. With continued progress, PGx and proteomics show promise In accelerating the benefits of genomic medicine for patients and healthcare professionals through clinically-actionable insights. The challenges ahead include integrating proteomics concepts into traditional drug development timelines and standardizing biomarker validation. By establishing biobanks, analytics platforms, and specialized studies, basic scientists, clinical researchers, and regulators can overcome these hurdles.
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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