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Submitter

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Name	Lee Min Goo
Organization	Yonsei University Industry-Academic Cooperation Foundation
Department	Yonsei University Industry-Academic Cooperation Foundation

Date

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Registration Date	2022-04-12

Project Design

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NTIS Number	-
Project Title	Development of Pharmacogenomic Target Sequencing Panel and Its Application to Precision Medicine
Relevance	medical
Description	1st year: Development of candidate gene panels for drug genomic candidates and establishment of cohort for clinical trials ○ Development and sequencing of candidate gene panels for drug genomic target sequencing. - The target capture panel for genes certified as drug response biomarkers by the International Pharmaceutical Genetic Research Network is manufactured with domestic technology. - Target capture The quality test (QC) is performed to improve the reliability of the next generation sequencing panel. - Development of a turn-around time reduction and efficient genetic detection pipeline for rapid diagnosis. ○ Establishment of a patient cohort for clinical verification of genomic biomarkers. - Among many drugs, a database of clinical information and samples of patients related to immunosuppressant tacrolimus drug response, 2) antirecephaly drug response, 3) anti-tuberculosis-induced liver injury is frequently prescribed for clinical treatment in severe patients in Korea. 2nd year: Cohort Selection for Drug Genetic Biomarker Verification and Sequencing Kit Approval by the Ministry of Food and Drug Safety ○ Genetic mutation test that can explain individual drug reactions/side effects through genetic analysis. - Development of a model that can predict 1) anti-tuberculosis-induced liver injury, 2) antiretuberculosis-induced drug response, 3) immunosuppressive drug response, and 3) immunosuppressive drug reaction by integrating drug-related information (drug history, drug concentration), and other phenotypic information. - Target sequencing and optimal biomarker determination in each cohort. ○ Establishment of a clinical trial design cohort in accordance with the guidelines for permission from the Ministry of Food and Drug Safety. - Develop a gene-based precision drug dose/use for each individual and develop a prospective clinical research plan for evaluating its suitability. 3rd year:Biomarker Clinical Usefulness Evaluation and Demonstration of New Medical Technology through Prospective Research ○ Development of sequencing kits for prospective drug genomic clinical research. - Production of an optimal target sequencing panel for prospective clinical trials by regulating the number of genes of the sequencing panel and optimizing the algorithm. ○ Development of diagnostic kits through prospective drug genomic clinical research. - Among the three candidate drugs, the clinical usefulness of gene-based precision drug therapy is evaluated by preferentially conducting prospective studies on drugs that most effectively predict individual drug reactions/side effects (one or more).
Project Data Type *	Targeted Locus (Loci)
Sample Scope *	Multiisolate

Hierarchy

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Umbrella Project	-

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PubMed ID	27727443
DOI	10.1002/cpt.532