Personalized medicine or PM is defined as a medical model that proposes the customization of healthcare - with medical decisions, practices, and/or 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.
Knowledge of a patient's genetic profile can help doctors select the proper medication or therapy and administer it using the proper dose or regimen. Personalized medicine is being advanced through data from the Human Genome Project.
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, with respect to 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 affect the efficacy of the patient's current and/or 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.
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 of 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.
U.S. 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.
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.
Click Here for Full List of Documents (4 Items)