2015, Number 4
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Rev Invest Clin 2015; 67 (4)
Application of Genomic Technologies in Clinical Pharmacology Research
Reyes León-Cachón RB, Ascacio-Martínez JÁI, Gómez-Silva M, Piñeyro-Garza E, González-González E, Pogue G, Simón-Buela L, Barrera-Saldaña HA
Language: English
References: 41
Page: 212-218
PDF size: 220.11 Kb.
ABSTRACT
Technology is the basis of scientific progress and is an essential component for continued competitiveness in industry. The
development of a new drug candidate is a long and expensive process, in which a molecule undergoes several stages of research
(both pre-clinical and clinical) before being approved for commercialization. Scientific progress has revolutionized the pharmaceutical
industry and reshaped the processes by which new drugs are discovered, investigated, and developed. Currently, the
influence of genomic variations in drug metabolism must be better understood to predict an individual´s response to a given
treatment. Employing genomics tools, an individual’s genetic profile may be obtained and used as the basis for prescription of
the best treatment option, thus personalizing medicine. In this review, we discuss how current mainstream genomic technologies
used in clinical pharmacology research can accelerate the identification of populations that can benefit the most while reducing
adverse events.
REFERENCES
Niazi GA, Riaz-ud-Din S. Biotechnology and Genomics in Medicine - A Review. World J Med Sci. 2006;1:72-81.
Steiner M, Bugen DH, Kazanchy B, et al. The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities. In: RegentAtlantic Capital L, Fiduciary Network L, eds. 1st ed. Dallas, TX: Fiduciary Network, LLC; 2007.
Gómez-Viquez H, Rico-Flores G. El paradigma de biotecnología y la medicina genómica: ¿Un obstáculo o una oportunidad de integración para la industria farmacéutica mexicana? In: Martínez AM, Alba PLLd, Garnica AG, Rodríguez SE, Guanajuato CdCyTd, Valdés Py, eds. Innovación y competitividad en la sociedad del conocimiento. 1st ed. México, DF: Plaza y Valdés; 2009.
Augen J. The evolving role of information technology in the drug discovery process. Drug Discov Today. 2002;7:315-23.
Kraljevic Pavelic S, Saban N. Evolving ‘-omics’ technologies in the drug development process. Expert Opin Drug Discov. 2007; 2:431-6.
Moridani MY, Araujo RP, Johnson CH, Lindon JC. The -Omics in Drug Development. In: Bonate PL, Howard DR, eds. Pharmacokinetics in Drug Development: Advances and applications. New York, NY: Springer; 2011.
Newman DJ, Cragg GM. Natural products as sources of new drugs over the 30 years from 1981 to 2010. J Nat Prod. 2012; 75:311-35.
Farnsworth NR, Akerele O, Bingel AS, Soejarto DD, Guo Z. Medicinal plants in therapy. Bull World Health Organ. 1985; 63:965-81.
Hughes T, Luffer-Atlas D, Yingling J, Leonard J, Gombar C, Ragland K, et al. Drug Discovery and Development: UNDERSTANDING THE R&D PROCESS. 2007. Available from: Pharmaceutical Research and Manufacturers of America, Washington, DC.
Suzanne White Junod. Celebrating a Milestone: FDA’s Approval of First Genetically-Engineered Product. Silver Spring, MD: U.S. Food and Drug Administration; 2007. Available at: http:// www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm 081964.htm. 2014.
Verjan-García N. Biotechnology, beginning with recombinant DNA toward a personalized medicine. Orinoquia. 2009;13:69-74.
Baye TM, Wilke RA. Mapping genes that predict treatment outcome in admixed populations. Pharmacogenomics J. 2010;10:465-77.
McGuire AL. 1000 genomes on the road to personalized medicine. Per Med. 2008;5:195-7.
Leon-Cachon RB, Ascacio-Martinez JA, Barrera-Saldana HA. Individual response to drug therapy: bases and study approaches. Rev Invest Clin. 2012;64:364-76.
Cavallari L, Lam Y. Pharmacogenetics. In: DiPiro J, Talbert R, Yee G, Matzke G, Wells B, Posey L, eds. Pharmacotherapy: A Pathophysiologic Approach. 9th ed. New York, NY: McGraw-Hill; 2014.
Eichelbaum M, Ingelman-Sundberg M, Evans WE. Pharmacogenomics and individualized drug therapy. Annu Rev Med. 2006; 57:119-37.
Urzúa-Traslaviña C, Moreno-Treviño M, Martínez-Treviño D, Barrera-Saldaña H, León-Cachón R. Relationship of mitochondrial DNA haplogroups with complex diseases. J Genet Genome Res. 2014;1:1-5.
Moreno-Trevino MG, Leon-Cachon RB, Gonzalez-Salazar F, et al. Real-time PCR detection of the recessive dystrophic epidermolysis bullosa-associated c.2470insG mutation in unrelated Mexican families. Arhc Med Res. 2014;45:596-9.
Pacheu-Grau D, Gomez-Duran A, Lopez-Perez MJ, Montoya J, Ruiz-Pesini E. Mitochondrial pharmacogenomics: barcode for antibiotic therapy. Drug Discov Today. 2010;15:33-9.
Andersson TB, Sjoberg H, Hoffmann KJ, et al. An assessment of human liver-derived in vitro systems to predict the in vivo metabolism and clearance of almokalant. Drug Metab Dispos. 2001;29:712-20.
U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies. In: Pharmacology C, ed. Silver Spring, MD: U.S. Food and Drug Administration; 2011.
A map of human genome variation from population-scale sequencing. Nature. 2010;467:1061-73.
Krebs JE, Kilpatrick ST, Goldstein ES. Genes XI. 11th ed. Sudbury, Massachusetts: Jones and Bartlett Publishers; 2012.
Madsen BE, Villesen P, Wiuf C. Short tandem repeats and genetic variation. Methods Mol Biol. 2010;628:297-306.
Slebos RJ, Kibbelaar RE, Dalesio O, et al. K-ras oncogene activation as a prognostic marker in adenocarcinoma of the lung. N Engl J Med. 1990;323:561-5.
Kitzmiller JP, Groen DK, Phelps MA, Sadee W. Pharmacogenomic testing: relevance in medical practice: Why drugs work in some patients but not in others. Cleve Clin J Med. 2011;78:243-57.
Huang RS, Ratain MJ. Pharmacogenetics and pharmacogenomics of anticancer agents. CA Cancer J Clin. 2009;59:42-55.
Mega JL, Close SL, Wiviott SD, et al. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 2009; 360:354-62.
Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008;358:568-79.
Goetz MP, Kamal A, Ames MM. Tamoxifen pharmacogenomics: The role of CYP2D6 as a predictor of drug response. Clin Pharmacol Ther. 2008;83:160-6.
Lim JS, Chen XA, Singh O, et al. Impact of CYP2D6, CYP3A5, CYP2C9 and CYP2C19 polymorphisms on tamoxifen pharmacokinetics in Asian breast cancer patients. Br J Clin Pharmacol. 2011;71:737-50.
Largillier R, Etienne-Grimaldi MC, Formento JL, et al. Pharmacogenetics of capecitabine in advanced breast cancer patients. Clin Cancer Res. 2006;12:5496-502.
Preissner S, Kroll K, Dunkel M, et al. SuperCYP: a comprehensive database on Cytochrome P450 enzymes including a tool for analysis of CYP-drug interactions. Nucleic Acids Res. 2010;38(Database issue):D237-43.
U.S. Food and Drug Administration. Table of Pharmacogenomic Biomarkers in Drug Labeling. Silver Spring, MD: U.S. Food and Drug Administration; 2015. Available at: http://www.fda.gov/ Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ ucm083378.htm. 2015.
Barrera-Saldaña H, GM-G, Rivera-Pérez J, Rojas-Martínez A, Vázquez-Alemán R. Genética humana y molecular en México. Ciencia y Desarrollo. 1991;XVII:68-80.
Progenika Biopharma SA. Design, development and production of molecular biology tests. 2014. Available at: http://www.progenika. com.
Tejedor D, Castillo S, Mozas P, et al. Reliable low-density DNA array based on allele-specific probes for detection of 118 mutations causing familial hypercholesterolemia. Clin Chem. 2005;51:1137-44.
Alcazar-Gonzalez GA, Calderon-Garciduenas AL, Garza-Rodriguez ML, et al. Comparative study of polymorphism frequencies of the CYP2D6, CYP3A5, CYP2C8 and IL-10 genes in Mexican and Spanish women with breast cancer. Pharmacogenomics. 2013;14:1583-92.
Garces-Eisele SJ, Cedillo-Carvallo B, Reyes-Nunez V, et al. Genetic selection of volunteers and concomitant dose adjustment leads to comparable hydralazine/valproate exposure. J Clin Pharm Ther. 2014;39:368-75.
European Medicines Agency. Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories. London, UK: EMEA; 2007.
Kung S, Xiaofan L. The clinical use of pharmacogenomic testing in treatment-resistant depression. Primary Psychiatry. 2010; 17:46-51.