The life science and healthcare systems are evolving daily, because of the staggering progress in technology and research. One breakthrough of those innovative efforts is that the inception of ‘’personalised medicine’’, also called the ‘’precision medicine’’ intervention. it's a radical approach to refine the normal diagnostic and treatment methods so as to supply precise, simpler treatment to the patients with minimum risk and price . Although initially perceived as improbable, personalised medicine is becoming more feasible with our improved understanding of genetic science and therefore the advances in related technology.

The motivation

The origin of the personalised medicine era are often traced back to the unfolding of the human genome sequence in 2003. Access to the entire human genome sequence and therefore the advances in genomics, proteomics, bioinformatics, and data-intensive biomedical assays have enhanced our understanding of inter-individual variations profoundly. All this progress led to the thought of individualised therapy wherein the treatment are often tailored to a private supported his/her genetic, environmental exposure, and behavioural profile. during a nutshell, personalised medicine aims to supply the proper medicine to the proper patients at the proper time.

The applications of personalised medicines are far-reaching, affecting this healthcare system and treatment drastically. the most important advantage of personalised medicine is that not only it makes the treatment more specific and effective, but quite that, it's the potential to predict and detect the sooner onset of diseases through its powerful diagnostic biomarker tools. this will help in alarming the physicians beforehand in order that they will start with the preventive treatment well before the disease progression. Besides, the subsequent benefits reveal how personalised medicines can revolutionise the normal healthcare and treatment approach.

Highly targeted therapy with improved medicine selection
Reduced incidences of adverse effects
Reduced patient discomfort encouraging them to stick to the treatment
Focus on proactive treatment rather than reactive ‘’trial-and-error’’ approach
Reduced cost of the general treatment
An opportunity for pharma companies to develop molecular-targeted therapeutics through the optimum use and repurposing of the prevailing and combination therapies

The applications of personalised medicines are more likely to impact therapeutic areas like oncology, cardiovascular diseases, neurodegenerative disease, psychiatric disorders, and metabolic disorders like obesity and diabetes. consistent with researchers, personalised medicine can accelerate the new drug development program reducing the value of the general process. With the assistance of pharmacogenomic data on a replacement molecule and corresponding information about how a patient’s gene affects drug responsiveness, the scientists can identify a subset of patients who are presumably to reply to the treatment or least likely to possess adverse effects in clinical trials. It means there would be a smaller number of patients required to finish the clinical trials, which might reduce the time and price related to such studies dramatically.

The obstacles

Although personalised medicines can shift the tide of the traditional diagnostic and treatment approach, their implementation remains limited and is way from commercial use. to take advantage of the advantages of personalised medicines, the subsequent challenges must be addressed:

Lack of awareness – the complete potential of personalised medicines and their applications isn't yet realised by the present healthcare system, physicians, and patients, which is that the biggest hurdle limiting its widespread use. an excellent deal of efforts is required by all the stakeholders, including entrepreneurs and innovators (development of intelligent tools and analysis of the genetic information), patients (participation in clinical trials), regulators (educate consumers and support policy and regulations), physicians (deep understanding of the disease at the molecular level), academic researchers (gain new insights at the molecular basis of disease to support target-based drug development), IT segment (create a secure data management system to gather patient information).

Limited research – Although we've uncovered the human genome sequence and therefore the tools to expedite the method , there's still a requirement for a more mechanistic understanding of the genetic markers and certain diseases to develop more specific diagnostic tests.

Commercialisation – The innovators and makers are still struggling to spot cost-effective technology and operational systems with additional tools required to commercialise personalised medicines.

High cost – Currently, the treatment with personalised medicines is very expensive because it requires sophisticated techniques and tools along side expertise. this is often another barrier that's keeping the patients from using it on an outsized scale.

Data protection – A highly organised and secure system is required to stay the private information and electronic health records (EHRs) of the individual patients confidential during the investigation and developmental stages. This also involves establishing appropriate healthcare policies and regulations to form sure that the genetic information and EHRs of patients aren't used for any nefarious purpose.

The progress

Despite many challenges, pharma companies have started implementing the precision medicine approach to style highly targeted therapeutic drugs. Here are few examples worth mention.

HER-2 gene – Considered because the ‘’poster child’’ of personalised medicines, the HER-2 gene is liable for a protein that causes a kind of breast cancer. Women who test positive for this gene are likely to reply well to the treatment with Herceptin – a drug for breast cancer.

Warfarin – Anticoagulant drug, warfarin, may be a highly potent medication and must be dosed accurately, for even a small change within the dose can cause life-threatening adverse drug reactions. Warfarin acts on a selected gene, VKORC1, and is metabolised by the enzyme CYP2C9. Any genetic variations within the genes liable for VKORC1 and CYP2C9 proteins can therefore alter the metabolism of warfarin, resulting in excessively high or low plasma drug levels. To avoid such fluctuations, USFDA recommends the dosing of warfarin supported the individual’s genotype of VKORC1 and CYP2C9 proteins.

Imatinib – This drug is employed for the treatment of chronic myelogenous leukemia (CML). Imatinib inhibits the enzyme tyrosine kinase. High levels of this enzyme are found during a particular genotype of individuals affected by CML wherein the tumors show a selected sort of mutation that involves the fusion of two genomic regions, also mentioned as ‘bcr-abl fusion’ or ‘Philadelphia chromosome’. Hence, only those CML patients who show this fusion-specific point mutation are treated by imatinib and is simpler .

Bacteriophage therapy – Bacteriophage are viruses that invade and kill bacterial cells. Scientists are currently investigating the utilization of bacteriophage therapy as a completely unique antimicrobial approach to treat antibiotic–resistant bacterial infections. One method to form this therapy simpler is to use a personalised cocktail of bacteriophage that's unique to the patient’s bacterial strain. This way, one can overcome the resistance of bacterial strains to the normal antibiotics.

Takeaway

There is little question that personalised medicine is simply the start of the healthcare system which will be practiced within the future. Although the research during this area must cover several things, the results of the pioneering work have shown us enormous benefits, which include faster drug discovery programs, reduced development cost, improved diagnostics, and in particular , more specific, safe, and effective treatment for patients. What needs more at this stage is awareness and education amongst all the stakeholders and regulatory support from the FDA also as policymakers.

References

https://pharma-trends.com/2021/04/12/personalised-medicines-where-do-we-...

Author's Bio: 

Pharmaceutical Solutions

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https://www.acg-world.com/