REVIEW ARTICLE Corresponding Author: B. Larijani Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran Tel: +98 21 , Fax: +98 21 , E-ma il address: larijanib@blogger.com Ethical Issues Surrounding Personalized Medicine: A Literature Review Pooneh Salari1 and Bagher Cited by: 12 21/3/ · Personalized medicine has largely been enabled by the integration of genomic and other data with electronic health records (EHRs) in the United States and elsewhere. Increased EHR adoption across various clinical settings and the establishment of EHR-linked population-based biobanks provide unprecedented opportunities for the types of translational and implementation research that drive Cited by: 45 From Individualized to Personalized Medicine in Diabetes: An Expert Overview Viswanathan Mohan1, Ashok Kumar Das2, Jagat Jyoti Mukherjee3, Krishna Seshadri4, Sujeet Jha5, Sanjay Kalra6 Review ARticle 1Chairman and Chief Diabetologist, Dr. Mohan’s Diabetes Specialities Centre and Madras Diabetes Research Foundation, Chennai, Tamil Nadu; 2Professor and Head of Medicine, JIPMER,
Personalized medicine could transform healthcare (Review)
Personalized medicine PM is currently a particularly novel and exciting topic in the medicine and healthcare industries. It personalized medicine review article a concept that has the potential to transform medical interventions by providing effective, tailored therapeutic strategies based on the genomic, epigenomic and proteomic profile of an individual, whilst also remaining mindful of a patient's personal situation.
The power of PM lies not only in treatment, but in prevention. Increased utilisation of molecular stratification of patients, for example assessing for mutations that give rise to resistance to certain treatments, will provide medical professionals with clear evidence upon which to base treatment strategies for individual patients, personalized medicine review article.
With this development, there will no longer be a dependence on the adverse outcomes of trial and error prescribing methods 12. Currently, when prescribed medication is not effective, the patient may switch to a different medication, personalized medicine review article. This trial and error approach leads to poorer outcomes for patients, in terms of adverse side effects, personalized medicine review article, drug interaction, potential disease progression whilst effective treatment is delayed and patient dissatisfaction 3.
Effective application of PM relies heavily on the availability of rigorous diagnostic tools which allow for the optimal selection of therapeutic product to improve patient outcomes. The products are fully regulated by manufacturers and Food and Drug Administration FDA bodies 5.
According to the FDA, the aim of PM is to elevate benefits and reduce risks to patients personalized medicine review article targeting prevention and treatment more effectively. PM does not seek to establish novel medication for patients, but to stratify individuals into subpopulations that vary in their response to a therapeutic agent for their specific disease.
However, some patients with elevated HER2 are inherently resistant to Herceptin due to mutations to the HER2 gene. Therefore, intelligent molecular characterisation of breast cancer patients at both a genetic and epigenetic level allows for the optimal use of Herceptin through stratification of patients 6. The revolution of PM has created a lucrative opportunity for pharmaceutical companies developing molecular-targeted therapeutics, but also through the optimised use and repurposing of existing drugs and combination therapies.
Adopting PM will alter the approach to diagnosis and treatment, and will lead to increased participation of the patient during and after treatment. For example, active surveillance in prostate cancer gives patients the choice on if they would like curative treatment immediately, with potential complications and discomfort, or wait until there is signs of disease progression 7. This aspect of PM incorporates the circumstances of the patient as an influence on the appropriate treatment strategy for them as a person, personalized medicine review article, not just as a patient.
The advanced commercialization of molecular medicine has produced the novel concept of pharmacogenetics, the application of which is now acknowledged as PM. Molecular targeted therapies include monoclonal antibody MAb based therapeutics like herceptin which targets HER2 in breast cancer but MAb therapies are also used clinically to molecularly target therapies for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and inflammatory bowel disease as well as several types of cancer 8.
Currently, we are seeing the translation of immunotherapy research into clinical practice, including highly PM centric ex vivo modification of immune cells. When these modified dendritic cells are re-infused to the patient, they are able to present PAP to the patient's immune system, directing the body to attack its own tumour 9. With the advent of CRISPR-Cas9, scientists now have even greater ability to engineer cells at a genetic level Ex vivo modifications using CRISPR-Cas9 to gene edit specific oncogenes is already underway 11 and could be used to create treatments based on the unique tumour evolution path of each specific patient.
Clinical trials using CRISPR-Cas9 gene editing have also begun in the USA To fully realise the potential of PM, pharmaceutical companies will need to invest in development of new diagnostic techniques, personalized medicine review article, that will help to stratify patients at a higher resolution, allowing for optimised therapeutic selection and timing. PM requires coordinated adjustments to each aspect of the value chain, from discovery to development and from commercialization to lifecycle management PM is considered to be an innovation in the healthcare system; it is preventive, synchronized and proven 12.
In the current healthcare system, stakeholders and consumers do not yet fully recognise the benefits of PM. Recent studies demonstrate the following challenges to the development of PM: Scientific challenges wherein genetic markers are the most clinically significant, with a poor understanding of the molecular mechanisms of certain diseases 14 ; economic challenges; operational issues difficulty identifying technology and operational systems that will save costs ; and protection of private information during the investigation and development stages 3.
Furthermore, there are policy challenges regarding the association between government research and regulatory agencies PM has the potential to offer improved medication selection and targeted therapy, reduce adverse effects, increase patient compliance, personalized medicine review article, shift the goal of medicine from reaction personalized medicine review article prevention, improve cost effectiveness, and increase patient confidence post-marketing by approving novel therapeutic strategies and altering the perception of medicine in the healthcare system For the development and rapid adoption of PM it is vital that pharmaceutical companies invest in these new technologies and show willingness to work collaboratively with academic research teams.
Identification of more stringent biomarkers and are necessary to inform a pro-active approach to PM. One example is the recent development of liquid biopsies, which can be used to detect DNA circulating in the blood. This type of biopsy is non-invasive, much lower risk than traditional biopsy and has been used to detect disease extremely early.
One of the first uses of liquid biopsy was a test for Down syndrome is pregnant mothers Now studies such as TRACERx are using ctDNA circulating tumour DNA to analyse and predict the tumour evolution of lung cancer Approaches like this will allow medical professionals to apply PM pro-actively by pre-empting the course of tumour evolution and switching patients onto different therapeutics as soon as signs of drug resistance are detected, personalized medicine review article.
This may be able to delay the onset of resistance For long-term purposes, pharmaceutical companies must educate themselves in order to be profitable using the novel diagnostic and treatment methods in markedly reduced volumes. Novel drug development is prohibitively expensive and pharmaceutical companies are increasingly keen to repurpose existing drugs. PM allows for optimisation of treatment regimens and therefore increases the utility of existing products.
All pharmaceutical companies implement PM according to their own methods as follows: i Transitioning from traditional drug methods to PM is not an option, but a necessity. Accept that each molecule in the pipeline will be personalized to precise patient populations, rather than the mass market, personalized medicine review article.
ii PM is an innovative approach towards delivering improved healthcare and reducing overall healthcare costs. This will be achieved by implementing the digitalization of healthcare, by personalized medicine review article the healthcare IT system and with innovative technologies, such as developing single-cell omics, which permits the investigation of different cells in a high throughput manner iii Embedding PM skills into the existing personalized medicine review article system.
The implementation of PM requires a united effort of a broad community of stakeholders, all working towards a primary goal of exploiting breakthrough in science to improve patient care 19 Support smaller-market therapeutic agents that are more likely to succeed. v Access novel capabilities by forming partnerships; for example, contact with world-class diagnostics by corporations with assay developers and different industries. vi Intelligent sales personalized medicine review article with the most up-to-date expertise, personalized medicine review article.
Sales teams will be required to have knowledge of patient history, as well as diagnostic and treatment methods. Furthermore, sales teams must understand molecular analysis and disease pathways. vii Post market surveillance is particularly important in PM to allow more focused clinical trials of pharmaceutical products In addition, in the coming decades, the demand for PM will increase, personalized medicine review article, as consumers will become more educated about this novel treatment approach.
This will encourage the shift from the current medicine module to the novel methods of diagnosis and treatment. Furthermore, currently, clinical trials are time-consuming and require significant manpower; however, in future the concept of clinical trials personalized medicine review article be more advanced and easy to accommodate PM with the help of regulatory approval, personalized medicine review article.
Establish a simple method of identifying and prioritising the disease, which may benefit from the application of novel technology. Additionally, development of joint venture programmes for validation of study designs and biomarker standardisation PM has the potential to fulfil the requirement to improve health outcomes by reducing healthcare costs, drug-development costs and time.
This revolution in the healthcare system will only be possible to achieve by equal contribution of patient and consumers in participating in clinical trials, entrepreneurs and innovators to develop smart tools and analyze the genetic information, regulators by educating consumers and providers, and support essential revolutions in policy and regulation, physicians to understand the disease at the molecular level, academic researchers by accompanying innovative research to uncover new insights at the molecular basis of disease and supporting target-based drug development, IT sector by creating unique electronic tools to collect and secure patient information, stakeholders, payer and policy makers by exploring new business models, novel diagnostics tools, target therapy and other personalized treatment protocols.
PM has the potential to have a positive effect on the healthcare system. In future, with use of the personalized approach, each individual, on the day of their personalized medicine review article, will receive their full genomic information to place into an individual personalized medicine review article record. This information would allow physicians and clinicians to implement more effective healthcare approaches based on patient exposure to different diseases.
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N Engl J Med. Association of the British Pharmaceutical Industry: The stratification of disease for personalised medicines. aspx April 16— Wan JCM, Massie C, Garcia-Corbacho J, Mouliere F, Brenton JD, Caldas C, Pacey S, Baird R and Rosenfeld N: Liquid biopsies come of age: Towards implementation of circulating tumour DNA. Nat Rev Cancer. Jamal-Hanjani M, Hackshaw A, Ngai Y, personalized medicine review article, Shaw J, Dive C, Quezada S, Middleton G, De Bruin E, Le Quesne J, Shafi S, et al: Tracking genomic cancer evolution for precision medicine: The lung TRACERx study.
PLoS Biol, personalized medicine review article. Hood L and Galas D: The digital code of DNA. Khoury MJ, Gwinn M, Yoon PW, Dowling N, Moore CA and Bradley L: The continuum of translation research in personalized medicine review article medicine: How can we accelerate the appropriate integration of human genome discoveries into health care and disease prevention?
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What is Personalized Medicine?
, time: 2:20Personalized Medicine Universe - Journal - Elsevier
As of 1 January the journal has been transferred to the International Society of Personalized Medicine Personalized Medicine Universe, the official peer-reviewed journal of the International Society of Personalized Medicine, aims to publish the highest quality articles 21/3/ · Personalized medicine has largely been enabled by the integration of genomic and other data with electronic health records (EHRs) in the United States and elsewhere. Increased EHR adoption across various clinical settings and the establishment of EHR-linked population-based biobanks provide unprecedented opportunities for the types of translational and implementation research that drive Cited by: 45 From Individualized to Personalized Medicine in Diabetes: An Expert Overview Viswanathan Mohan1, Ashok Kumar Das2, Jagat Jyoti Mukherjee3, Krishna Seshadri4, Sujeet Jha5, Sanjay Kalra6 Review ARticle 1Chairman and Chief Diabetologist, Dr. Mohan’s Diabetes Specialities Centre and Madras Diabetes Research Foundation, Chennai, Tamil Nadu; 2Professor and Head of Medicine, JIPMER,
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