Personalized Medicine, Pharmacogenomics and Human Genome News
Category Topic: Personalized Medicine
Author: Disabled World
Updated/Revised Date: 2022/04/13
Contents: Summary - Introduction - Main - Subtopics - Publications
Synopsis: Personalized medicine is moving us closer to more precise, predictable and powerful medicine, customized for the individual patient. Personalized medicine (PM) is defined as a medical model that proposes the customization of healthcare - with medical decisions, practices, and products being tailored to the individual patient. The term "personalized medicine" is often described as providing "the right patient with the right drug at the right dose at the right time." The use of genetic information has played a major role in certain aspects of personalized medicine (e.g., pharmacogenomics), and the term was first coined in the context of genetics, though it has since broadened to encompass all sorts of personalization measures.
Introduction
Personalized medicine (PM) is defined as a medical model that proposes the customization of healthcare - with medical decisions, practices, and products being tailored to the individual patient. The term "personalized medicine" is often described as providing "the right patient with the right drug at the right dose at the right time." In this model, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient's genetic content or other molecular or cellular analysis. The use of genetic information has played a major role in certain aspects of personalized medicine (e.g., pharmacogenomics), and the term was first coined in the context of genetics, though it has since broadened to encompass all sorts of personalization measures.
Main Document
In personalized medicine, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient's genetic content or other molecular or cellular analysis. The use of genetic information has played a major role in certain aspects of personalized medicine (e.g., pharmacogenomics), and the term was first coined in the context of genetics, though it has since broadened to encompass all sorts of personalization measures. Advantages of Personalized Medicine Include:
- Reduced healthcare costs.
- Reduced probability of negative side effects.
- Ability to make more informed medical decisions.
- Earlier disease intervention than has been possible in the past.
- Focus on prevention and prediction of disease rather than reaction to it.
- Higher probability of desired outcomes thanks to better-targeted therapies.
Human Genome Project:
Personalized medicine is being advanced through data from the Human Genome Project. The Human Genome Project was declared complete in April 2003. An initial rough draft of the human genome was available in June 2000 and by February 2001 a working draft had been completed and published followed by the final sequencing mapping of the human genome on April 14, 2003
The Human Genome Project (HGP) is an international scientific research project with the goal of determining the sequence of chemical base pairs which make up human DNA, and of identifying and mapping all the genes of the human genome from both a physical and functional standpoint. It remains the world's largest collaborative biological project. The project was proposed and funded by the US government; planning started in 1984, the project got underway in 1990, and was declared complete in 2003. A parallel project was conducted outside of government by the Celera Corporation, or Celera Genomics, which was formally launched in 1998. Most of the government-sponsored sequencing was performed in twenty universities and research centers in the United States, the United Kingdom, Japan, France, Germany, and China.
Pharmacogenomics:
Pharmacogenomics is the study of how genes affect a person's response to drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to a person's genetic makeup.
Pharmacogenomics aims to develop rational means to optimize drug therapy, regarding the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Through the utilization of pharmacogenomics, it is hoped that drug treatments can deviate from the "one-dose-fits-all" approach. It attempts to eliminate the trial-and-error method of prescribing, allowing physicians to take into consideration their patient's genes, the functionality of these genes, and how this may impact the efficacy of the patient's current and future treatments (and where applicable, provide an explanation for the failure of past treatments). Such approaches promise the advent of "personalized medicine"; in which drugs and drug combinations are optimized for each individual's unique genetic makeup.
FDA Role and Responsibilities in Personalized Medicine:
The term "personalized medicine" is often described as providing "the right patient with the right drug at the right dose at the right time." More broadly, "personalized medicine" may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.
The U.S. FDA is helping to speed the development of promising new therapeutics by developing regulatory science standards, reference libraries, research methods, and tools that are needed for integrating genetic and other biomarker information into drug and device development and clinical decision-making.
Given the nature of personalized medicine, the FDA places high priority on helping to ensure that the agency, drug manufacturers, physicians, and patients have adequate information about the product and its use. Product labeling and tracking of use in the marketplace are critical to the proper application of personalized medication tools.
Personalized Medicine Facts and Statistics
- Every person has a unique variation of the human genome.
- The FDA has already started to take initiatives to integrate personalized medicine into their regulatory policies.
- In addition to specific treatment, personalized medicine can greatly aid the advancements of preventive care.
- As with any innovation in medicine, investment, and interest in personalized medicine is influenced by intellectual property rights.
- Having the ability to look at a patient on an individual basis allows for a more accurate diagnosis and specific treatment plan.
- Reimbursement policies will have to be redefined to fit the changes that personalized medicine will bring to the healthcare system.
- In order for physicians to know if a mutation is connected to a certain disease, researchers often do a study called a Genome-wide association study (GWAS).
- In 2008, the Genetic Information Nondiscrimination Act (GINA) was passed in an effort to minimize the fear of patients participating in genetic research by ensuring that their genetic information will not be misused by employers or insurers.
Subtopics
Latest Publications From Our Personalized Medicine Category
1: Potential for Intellectual Disability Personalized Medicine as 26 Novel Genes Identified - Study adds to growing knowledge of brain development and functioning and may lead to personalized treatments for intellectual disability and autism spectrum disorders.
2: The Future of Personalized Medicine - New technologies of the 21st century has revolutionized the ways doctors practice medicine in the clinic and in their laboratories.
3: Personalized Medicine for Diabetes Treatment - Precision medicine approach to diabetes prevention using blood sugar levels, waist-to-hip ratios, and without needing new genetic tests.
4: Personalized Treatment for Intellectual Disabilities - Protecting against a type of genetic disruption that causes intellectual disability, including memory impairments and altered anxiety levels.
5: Contracting Human Muscle Grown in Lab - Researchers report first lab grown contracting human muscle which could revolutionize drug discovery and personalized medicine.
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