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Review
. 2024 Jul 3;17(7):881.
doi: 10.3390/ph17070881.

From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt

Fadya M Elgarhy  1   2 , Abdallah Borham  1 , Noha Alziny  1 , Khlood R AbdElaal  3 , Mahmoud Shuaib  1 , Abobaker Salem Musaibah  1 , Mohamed Ali Hussein  1 , Anwar Abdelnaser  1
Affiliations
Review

From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt

Fadya M Elgarhy et al. Pharmaceuticals (Basel). .

Abstract

Pharmacogenomics (PGx) is the hope for the full optimization of drug therapy while minimizing the accompanying adverse drug events that cost billions of dollars annually. Since years before the century, it has been known that inter-individual variations contribute to differences in specific drug responses. It is the bridge to what is well-known today as "personalized medicine". Addressing the drug's pharmacokinetics and pharmacodynamics is one of the features of this science, owing to patient characteristics that vary on so many occasions. Mainly in the liver parenchymal cells, intricate interactions between the drug molecules and enzymes family of so-called "Cytochrome P450" occur which hugely affects how the body will react to the drug in terms of metabolism, efficacy, and safety. Single nucleotide polymorphisms, once validated for a transparent and credible clinical utility, can be used to guide and ensure the succession of the pharmacotherapy plan. Novel tools of pharmacoeconomics science are utilized extensively to assess cost-effective pharmacogenes preceding the translation to the bedside. Drug development and discovery incorporate a drug-gene perspective and save more resources. Regulations and laws shaping the clinical PGx practice can be misconceived; however, these pre-/post approval processes ensure the product's safety and efficacy. National and international regulatory agencies seek guidance on maintaining conduct in PGx practice. In this patient-centric era, social and legal considerations manifest in a way that makes them unavoidable, involving patients and other stakeholders in a deliberate journey toward utmost patient well-being. In this comprehensive review, we contemporarily addressed the scientific leaps in PGx, along with various challenges that face the proper implementation of personalized medicine in Egypt. These informative insights were drawn to serve what the Egyptian population, in particular, would benefit from in terms of knowledge and know-how while maintaining the latest global trends. Moreover, this review is the first to discuss various modalities and challenges faced in Egypt regarding PGx, which we believe could be used as a pilot piece of literature for future studies locally, regionally, and internationally.

Keywords: PGx; drug approval; personalized medicine; pharmacogenomics; regulatory.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Figure 1
Figure 1
Illustrates the evolving timeline of PGx. Created with BioRender.com (access on 18 January 2024).
Figure 2
Figure 2
The impact of pharmacogenetics implementation in the early and late stages of the drug development process. Created with BioRender.com (access on 18 January 2024).
Figure 3
Figure 3
Factors affecting the effective implementation of Pharmacoeconomics to assess the cost-effectiveness of PGx testing. Created with BioRender.com (access on 18 January 2024).
Figure 4
Figure 4
An illustration of different patient-centric approaches in personalized medicine. Created with BioRender.com (access on 18 January 2024).
See this image and copyright information in PMC

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