Application of Genome-Based Therapy in Clinical Pharmacy Practice: Prospects and Challenges.
DOI:
https://doi.org/10.65693/j21umas.2025.v4i1.221الكلمات المفتاحية:
Genome-Based Therapy, Clinical Pharmacy, Challenges, A multidisciplinary Effort.الملخص
Genome-based therapy, an innovative approach to personalized medicine, utilizes insights from genomic research to tailor treatments to individual patients. In clinical pharmacy practice, this emerging field holds promise for improving therapeutic outcomes, minimizing adverse drug reactions, and optimizing drug efficacy by integrating pharmacogenomics into patient care. Genome-based therapies include gene editing technologies (e.g., CRISPR-Cas9), gene therapy for rare genetic disorders, and the use of biomarkers for targeted treatments in oncology and other complex diseases. Despite its transformative potential, the application of genome-based therapies faces significant challenges, including ethical concerns, high costs, limited accessibility, and the need for advanced infrastructure and specialized training. Additionally, regulatory hurdles and the scarcity of robust clinical data impede the widespread adoption of these therapies in routine clinical pharmacy practice. This review explores the prospects of genome-based therapies in clinical pharmacy, emphasizing their potential to revolutionize healthcare delivery. It also examines challenges such as ethical dilemmas, policy gaps, and resource limitations, proposing strategies to address these barriers. The integration of genomic tools into clinical pharmacy practice requires a multidisciplinary effort involving pharmacists, clinicians, researchers, and policymakers to ensure equitable access and effective implementation in diverse healthcare settings.
المراجع
Kohn DB, Chen YY, Spencer MJ. Successes and challenges in clinical gene therapy. Gene Therapy. 2023 Nov;30(10):738-46. Cornetta K, Kay S, Urio F, Minja IK, Mbugi E, Mgaya J, Mselle T, Nkya S, Alimohamed MZ, Ndaki K, Bonamino M. Implementation of a gene therapy education initiative by the ASGCT and Muhimbili University of Health and Allied Sciences. Molecular Therapy. 2023 Sep 6;31(9):2561-5. Kumar H, Miryala SK, Anbarasu A, Ramaiah S. Integrated computational approaches to aid precision medicine for cancer therapy: Present scenario and future prospects. InComputational Methods in Drug Discovery and Repurposing for Cancer Therapy 2023 Jan 1 (pp. 403-424). Academic Press. Doudna JA, Charpentier E. The new frontier of genome engineering with CRISPR-Cas9. Science. 2014 Nov 28;346(6213):1258096. Emens LA. Trastuzumab: targeted therapy for the management of HER-2/neu-overexpressing metastatic breast cancer. American journal of therapeutics. 2005 May 1;12(3):243-53. Pozella P. Strategies for increasing EGFR mutation testing of patients with non-small cell lung cancer (Doctoral dissertation, The University of North Carolina at Chapel Hill), 2014, (pp. 1-154). Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomažič J, Jägel-Guedes E, Rugina S, Kozyrev O, Cid JF, Hay P. HLA-B* 5701 screening for hypersensitivity to abacavir. New England Journal of Medicine. 2008 Feb 7;358(6):568-79. Johnson JA, Caudle KE, Gong L, Whirl-Carrillo M, Stein CM, Scott SA, Lee MT, Gage BF, Kimmel SE, Perera MA, Anderson JL. Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for pharmacogenetics-guided warfarin dosing: 2017 update. Clinical Pharmacology & Therapeutics. 2017 Sep;102(3):397-404. Hosseinkhani H, Domb AJ, Sharifzadeh G, Nahum V. Gene therapy for regenerative medicine. Pharmaceutics. 2023 Mar 6;15(3):856. Knoppers BM. Framework for responsible sharing of genomic and health-related data. The HUGO journal. 2014 Dec;8(1):3. Bredenoord AL, Kroes HY, Cuppen E, Parker M, van Delden JJ. Disclosure of individual genetic data to research participants: the debate reconsidered. Trends in Genetics. 2011 Feb 1;27(2):41-7. Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, Fruth B, Meyerhardt JA, Schrag D, Greene C, O'Neil BH, Atkins JN, Berry S. Effect of first-line chemotherapy combined with cetuximab or bevacizumab on overall survival in patients with KRAS wild-type advanced or metastatic colorectal cancer: a randomized clinical trial. Jama. 2017 Jun 20;317(23):2392-401. Garrison Jr LP, Jiao B, Dabbous O. Gene therapy may not be as expensive as people think: challenges in assessing the value of single and short-term therapies. Journal of managed care & specialty pharmacy. 2021 May;27(5):674-81. McCarthy JJ, McLeod HL, Ginsburg GS. Genomic medicine: a decade of successes, challenges, and opportunities. Science translational medicine. 2013 Jun 12;5(189):189sr4.- Mardis ER. The impact of next-generation sequencing on cancer genomics: from discovery to clinic. Cold Spring Harbor Perspectives in Medicine. 2019 Sep 1;9(9):a036269. Owusu Obeng A, Egelund EF, Alsultan A, Peloquin CA, Johnson JA. CYP 2C19 Polymorphisms and Therapeutic Drug Monitoring of Voriconazole: Are We Ready for Clinical Implementation of Pharmacogenomics?. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 2014 Jul;34(7):703-18. Weitzel KW, Elsey AR, Langaee TY, Burkley B, Nessl DR, Obeng AO, Staley BJ, Dong HJ, Allan RW, Liu JF, Cooper-DeHoff RM. Clinical pharmacogenetics implementation: approaches, successes, and challenges. InAmerican Journal of Medical Genetics Part C: Seminars in Medical Genetics 2014 Mar (Vol. 166, No. 1, pp. 56-67). Chen JS, Dagdas YS, Kleinstiver BP, Welch MM, Sousa AA, Harrington LB, Sternberg SH, Joung JK, Yildiz A, Doudna JA. Enhanced proofreading governs CRISPR-Cas9 targeting accuracy. Nature. 2017 Oct 19:550(7676):407-10. Tsai SQ, Joung JK. Defining and improving the genome-wide specificities of CRISPR-Cas9 nucleases. Nature Reviews Genetics. 2016 May; 17(5):300-12. Mulder NJ, Adebiyi E, Adebiyi M, Adeyemi S, Ahmed A, Ahmed R, Akanle B, Alibi M, Armstrong DL, Aron S, Ashano E. Development of bioinformatics infrastructure for genomics research. Global heart. 2017 Jun 1;12(2):91-8. Alyami SM, Alswedan HY, Al Zamanan YY, Al-Harith MM, Almahamedh HS, Almakhalas AJ, Lasloum SM, Almakhlas MS. Comprehensive Review of Pharmaceutical Innovations: The Role of Pharmacists in Modern Healthcare Systems. Journal of Ecohumanism. 2024 Dec 17;3(8):7558-67. Lee KC. Ma JD, Kuo GM. Pharmacogenomics: bridging the gap between science and practice. Journal of the American Pharmacists Association. 2010 Jan 1;50(1):e1-7. Balogun OD, Ayo-Farai O, Ogundairo O, Maduka CP, Okongwu CC, Babarinde AO, Sodamade OT. The role of pharmacists in personalised medicine: a review of integrating pharmacogenomics into clinical practice. International Medical Science Research Journal. 2024 Jan 8;4(1):19-36. Fritsche E, Elsallab M, Schaden M, Hey SP, Abou-El-Enein M. Post-marketing safety and efficacy surveillance of cell and gene therapies in the EU: A critical review. Cell Gene Ther. Insights. 2019;5(11):1505-21. Gaviglio AM, Skinner MW, Lou LJ, Finkel RS, Augustine EF, Goldenberg AJ. Gene-targeted therapies: Towards equitable development, diagnosis, and access. InAmerican Journal of Medical Genetics Part C: Seminars in Medical Genetics 2023 Mar (Vol. 193, No. 1, pp. 56-63). Hoboken, USA: John Wiley & Sons, Inc. AlRasheed MM, AlAli H, Alsuwaid AF, Khalaf S. Ata SI, BinDhim NF, Bakheet D, Khurshid F, Alhawassi TM. Gene therapy knowledge and attitude among healthcare professionals: a cross-sectional study. Frontiers in Public Health. 2021 Nov 15;9:773175. Ohno-Machado L, Kim J, Gabriel RA, Kuo GM, Hogarth MA. Genomics and electronic health record systems. Human molecular genetics. 2018 May 1;27(R1):R48-55. Morrissey C, Walker RL. The ethics of general population preventive genomic sequencing: rights and social justice. In The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 2018 Jan 12 (Vol. 43, No. 1, pp. 22-43). US: Oxford University Press. Rajakumari K, Shri KK, Logesh R, Meenambiga SS, Vivek P, Romauld SI. Global Perspectives on Pharmacogenomics and Drug Discovery. InGenomics-Driven Drug Discovery Through Pharmacogenomics 2025 (pp. 123-166). IGI Global Scientific Publishing. Weitzel KW, Aquilante CL, Johnson S, Kisor DF, Empey PE. Educational strategies to enable expansion of pharmacogenomics-based care. American Journal of Health-System Pharmacy. 2016 Dec 1;73(23):1986-98. Lennerz JK, McLaughlin HM, Baron JM, Rasmussen D, Shin MS, Berners-Lee N, Batten JM, Swoboda KJ, Gala MK, Winter HS, Schmahmann JD. Health care infrastructure for financially sustainable clinical genomics. The Journal of Molecular Diagnostics. 2016 Sep 1;18(5):697-706. ang J, Griffiths E, Tounekti O, Nemec M, Deneault E, Lavoie JR, Ridgway A. Canadian regulatory framework and regulatory requirements for cell and gene therapy products. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective. 2023 Aug 2:91-116.
Abuarij, M., & Al Qtwani, A. (2023). Efficacy of Oral Isotretinoin in Combination with Desloratadine in the Treatment of Acne Vulgaris at Al-Thawrah General Hospital, Sana’a, Yemen . Journal of 21 September University for Medical and Applied Sciences, 2(1), 17-30. https://doi.org/10.65693/masj.2023.v2i1.23
Al-Wesabi, M., & Shamlan, M. (2022). The Effect of Applying Infection Prevention and Control Standards in Sana’a Governorate Hospitals at the Level of Reducing the Spread of Diseases and Epidemics. Journal of 21 September University for Medical and Applied Sciences, 1(1). https://doi.org/10.65693/masj.2022.v1i1.17
Alyahawi, A., Al-Wesabi, M., & ALKaf, A. (2022). Antimicrobial susceptibility of Acinetobacter clinical isolates among ICU Patients in Sana’a City, Yemen. Journal of 21 September University for Medical and Applied Sciences, 1(1). https://doi.org/10.65693/masj.2022.v1i1.14
Alyahawi A, Measar M, Alwesabi M, Alkaf A. (2024). Clinically Significant Statin-Drug Interactions in Older Patients with Chronic Diseases. Pharmaceutical Research - Recent Advances and Trends Vol. 4, B P International, pp.1-21. https://doi.org/10.9734/bpi/prrat/v4/598
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الحقوق الفكرية (c) 2025 Ali Al-kaf، Ali Alyahawi (المؤلف)
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