Category Archives: Pharmacogenomics

How is pharmacogenomics affecting medical treatment?

Currently, doctors prescribe drugs based mostly on factors such as a patients age, weight, sex, and liver and kidney function. For a few drugs, researchers have identified gene variants that affect how people respond. In these cases, doctors can select the best medication and dose for each patient.

Additionally, learning how patients respond to medications helps to discern the different forms of their diseases.

For many years, NIH-funded scientists, through the Pharmacogenomics Research Network (PGRN), have studied the effect of genes on medications relevant to a wide range of conditions, including asthma, depression, cancer, and heart disease. The research findings are collected in an online resource called PharmGKB. In addition, the Clinical Pharmacogenetics Implementation Consortium (CPIC) was started as a shared partnership between the PGRN and PharmGKB to help lower the barrier to clinical use of pharmacogenetic tests. CPIC creates, curates, and posts freely available, peer-reviewed, evidence-based, updatable, and detailed gene/drug clinical practice guidelines. Another NIH-funded project, the Clinical Genome Resource, aims to define the clinical relevance of genes and variants for use in precision medicine and research.

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Pharmacogenomics - National Institute of General Medical ...

Understanding pharmacogenomics would not be possible without sequencing the genomes of many people and comparing them, and then comparing their response to medicines. But we have also learned that a person's genome sequence is not everything when it comes to medication responses. The human body is a very complicated machine, and the instructions written in our DNA are just part of the process.

There are some cases, as with the breast cancer treatment tamoxifen, where a small study showed that there might be a relationship between someone's response to the medicine and a variant in theCYP2D6gene. However, this finding did not appear to be true in a larger study that involved many more people. That's why at this time, the U.S. Food and Drug Administration (FDA) labeling for tamoxifen does not recommendCYP2D6pharmacogenomic testing, butthe issue is still being reviewedas more research is conducted.

Another gene in the sameCYPfamily, calledCYP2C19, has variations which affect how your body can useclopidogrel(more commonly known as Plavix). This medication is a "blood thinner" which helps prevent blood clots, and thus reduces your risk of strokes or some heart attacks. If yourCYP2C19protein is not working properly due to a mutation in the gene, then you will not be able toprocess clopidogrel, and you need either a different dose or a different medication. As it turns out, these variants inCYP2C19are also more common in those with Asian ancestry. Although testing for variants in this gene is also not routinely recommended, you may wish to speak with your healthcare provider about the test if you are given a prescription for clopidogrel, particularly if you have East Asian family members.

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Pharmacogenomics - Genome.gov

Personalized medicine tailors therapies, disease prevention, and health maintenance to the individual, with pharmacogenomics serving as a key tool to improve outcomes and prevent adverse effects. Advances in genomics have transformed pharmacogenetics, traditionally focused on single gene-drug pairs, into pharmacogenomics, encompassing all 'omics' fields, e.g., proteomics, transcriptomics, metabolomics, and metagenomics. This review summarizes basic genomics principles relevant to translation into therapies, assessing pharmacogenomics' central role in converging diverse elements of personalized medicine. We discuss genetic variations in pharmacogenes (drug-metabolizing enzymes, drug transporters, and receptors), their clinical relevance as biomarkers, and the legacy of decades of research in pharmacogenetics. All types of therapies, including proteins, nucleic acids, viruses, cells, genes, and irradiation, can benefit from genomics, expanding the role of pharmacogenomics across medicine. FDA approvals of personalized therapeutics involving biomarkers increase rapidly, demonstrating the growing impact of pharmacogenomics. A beacon for all therapeutic approaches, molecularly targeted cancer therapies highlight trends in drug discovery and clinical applications. To account for human complexity, multi-component biomarker panels encompassing genetic, personal, and environmental factors can guide diagnosis and therapies, increasingly involving artificial intelligence to cope with extreme data complexities. However, clinical application encounters substantial hurdles, such as unknown validity across ethnic groups, underlying bias in health care, and real-world validation. This review will address the underlying science and technologies germane to pharmacogenomics and personalized medicine, integrated with economic, ethical, and regulatory issues - providing insights into the current status and future direction of health care. Significance Statement Personalized medicine aims to optimize health care for the individual patients with use of predictive biomarkers to improve outcomes and prevent adverse effects. Pharmacogenomics drives biomarker discovery and guides the development of targeted therapeutics. This review addresses basic principles and current trends in pharmacogenomics, with large-scale data repositories accelerating medical advances. The impact of pharmacogenomics is discussed, along with hurdles impeding broad clinical implementation, in the context of clinical care, ethics, economics, and regulatory affairs.

Keywords: Genetic polymorphisms; cancer; developmental pharmacology; drug metabolism; drug-drug interactions; gene regulation/transcription; pharmacogenetics/pharmacogenomics; systems pharmacology.

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PHARMACOGENOMICS: Driving Personalized Medicine

Proteomics

The suffix "-ome" comes from the Greek for all, every, or complete. It was originally used in "genome," which refers to all the genes in a person or other organism. Due to the success of large-scale biology projects such as the sequencing of the human genome, the suffix "-ome" is now being used in other research contexts. Proteomics is an example. The DNA sequence of genes carries the instructions, or code, for building proteins. This DNA is transcribed into a related molecule, RNA, which is then translated into proteins. Proteomics, therefore, is a similar large-scale analysis of all the proteins in an organism, tissue type, or cell (called the proteome). Proteomics can be used to reveal specific, abnormal proteins that lead to diseases, such as certain forms of cancer.

Pharmacogenetics and Pharmacogenomics

The terms "pharmacogenetics" and "pharmacogenomics" are often used interchangeably in describing the intersection of pharmacology (the study of drugs, or pharmaceuticals) and genetic variability in determining an individual's response to particular drugs. The terms may be distinguished in the following way.

Pharmacogenetics is the field of study dealing with the variability of responses to medications due to variation in single genes. Pharmacogenetics takes into account a person's genetic information regarding specific drug receptors and how drugs are transported and metabolized by the body. The goal of pharmacogenetics is to create an individualized drug therapy that allows for the best choice and dose of drugs. One example is the breast cancer drug trastuzumab (Herceptin). This therapy works only for women whose tumors have a particular genetic profile that leads to overproduction of a protein called HER2. (See: Genetics, Disease Prevention and Treatment)

Pharmacogenomics is similar to pharmacogenetics, except that it typically involves the search for variations in multiple genes that are associated with variability in drug response. Since pharmacogenomics is one of the large-scale "omic" technologies, it can examine the entirety of the genome, rather than just single genes. Pharmacogenomic studies may also examine genetic variation among large groups of people (populations), for example, in order to see how different drugs might affect different racial or ethnic groups.

Pharmacogenetic and pharmacogenomic studies are leading to drugs that can be tailor-made for individuals, and adapted to each person's particular genetic makeup. Although a person's environment, diet, age, lifestyle, and state of health can also influence that person's response to medicines, understanding an individual's genetic makeup is key to creating personalized drugs that work better and have fewer side effects than the one-size-fits-all drugs that are common today. (See: Genetics, Disease Prevention and Treatment). For example, the U.S. Food and Drug Administration (FDA) recommends genetic testing before giving the chemotherapy drug mercaptopurine (Purinethol) to patients with acute lymphoblastic leukemia. Some people have a genetic variant that interferes with their ability to process this drug. This processing problem can cause severe side effects, unless the standard dose is adjusted according to the patient's genetic makeup. (See: Frequently Asked Questions about Pharmacogenomics).

Stem Cell Therapy

Stem cells have two important characteristics. First, stem cells are unspecialized cells that can develop into various specialized body cells. Second, stem cells are able to stay in their unspecialized state and make copies of themselves. Embryonic stem cells come from the embryo at a very early stage in development (the blastocyst staqe). The stem cells in the blastocyst go on to develop all of the cells in the complete organism. Adult stem cells come from more fully developed tissues, like umbilical cord blood in newborns, circulating blood, bone marrow or skin.

Medical researchers are investigating the use of stem cells to repair or replace damaged body tissues, similar to whole organ transplants. Embryonic stem cells from the blastocyst have the ability to develop into every type of tissue (skin, liver, kidney, blood, etc.) found in an adult human. Adult stem cells are more limited in their potential (for example, stem cells from liver may only develop into more liver cells). In organ transplants, when tissues from a donor are placed into the body of a patient, there is the possibility that the patient's immune system may react and reject the donated tissue as "foreign." However, by using stem cells, there may be less risk of this immune rejection, and the therapy may be more successful.

Stem cells have been used in experiments to form cells of the bone marrow, heart, blood vessels, and muscle. Since the 1990's, umbilical cord blood stem cells have been used to treat heart and other physical problems in children who have rare metabolic conditions, or to treat children with certain anemias and leukemias. For example, one of the treatment options for childhood acute lymphoblastic leukemia [cancer.gov] is stem cell transplantation therapy.

There has been much debate nationally about the use of embryonic stem cells, especially about the creation of human embryos for use in experiments. In 1995, Congress enacted a ban on federal financing for research using human embryos. However, these restrictions have not stopped researchers in the United States and elsewhere from using private funding to create new embryonic cell lines and undertaking research with them. The embryos for such research are typically obtained from embryos that develop from eggs that have been fertilized in vitro - as in an in vitro fertilization clinic - and then donated for research purposes with informed consent of the donors. In 2009, some of the barriers to federal financing of responsible and scientifically worthy human stem cell research were lifted.

Cloning

Cloning can refer to genes, cells, or whole organisms. In the case of a cell, a clone refers to any genetically identical cell in a population that comes from a single, common ancestor. For example, when a single bacterial cell copies its DNA and divides thousands of times, all of the cells that are formed will contain the same DNA and will be clones of the common ancestor bacterial cell. Gene cloning involves manipulations to make multiple identical copies of a single gene from the same ancestor gene. Cloning an organism means making a genetically identical copy of all of the cells, tissues, and organs that make up the organism. There are two major types of cloning that may relate to humans or other animals: therapeutic cloning and reproductive cloning.

Therapeutic cloning involves growing cloned cells or tissues from an individual, such as new liver tissue for a patient with a liver disease. Such cloning attempts typically involve the use of stem cells. The nucleus will be taken from a patient's body cell, such as a liver cell, and inserted into an egg that has had its nucleus removed. This will ultimately produce a blastocyst whose stem cells could then be used to create new tissue that is genetically identical to that of the patient.

Reproductive cloning is a related process used to generate an entire animal that has the same nuclear DNA as another currently or previously existing animal. The first cloned animals were frogs. Dolly, the famous sheep, is another example of cloning. The success rates of reproductive animal cloning, however, have been very low. In 2005, South Korean researchers claimed to have produced human embryonic stem cell lines by cloning genetic material from patients. However, this data was later reported to have been falsified.

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Genetics vs. Genomics Fact Sheet - National Human Genome Research Institute

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PrecautionsEltrombopag (3)HematologyChromosome 7Adverse ReactionsEltrombopag (4)HematologyChromosome 13Adverse ReactionsEmapalumab-lzsgHematologyPRF1, RAB27A, SH2D1A, STXBP2, STX11, UNC13D, XIAP (Hemophagocytic Lymphohistiocytosis)Clinical StudiesEnasidenibOncologyIDH2Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical StudiesEncorafenib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesEncorafenib (2)OncologyRASDosage and Administration, Warnings and Precautions, Clinical StudiesEnfortumab Vedotin-ejfvOncology

NECTIN4

SERPINC1(Antithrombin III)

ERBB2(HER2)

Indications and Usage, Adverse Reactions, Clinical Studies

Clinical Studies

Indications and Usage, Clinical Studies

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Table of Pharmacogenomic Biomarkers in Drug Labeling | FDA

About the program

The Pharmaceutical Sciences and Pharmacogenomics (PSPG) Graduate Program at the University of California, San Francisco (UCSF) focuses on how to develop effective drug therapies for patients that have a minimum of adverse effects. To do this we give our graduate students solid training in the pharmaceutical-related basic sciences and create an environment in which students can develop into independent and creative scientific problem-solvers. This multidisciplinary graduate program has a dual focus: pharmaceutical sciences and drug development, and pharmacogenomics, which is the application of genetics and genomics to drug action and disposition. The result of this dual focus is that it trains the next generation of scientists to explore new drugs in novel ways.

PSPG welcomes scientists of any race, religion, national origin, gender identity, caregiver and family commitments, political affiliation, sexual orientation, and eligible age or ability. We believe Black Lives Matter and are committed to sustained action to reduce racism and inequity in science. More details:Diversity, Equity, and Inclusion.

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September 1, 2022

Closes

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Quantitative Biosciences Consortium (QBC)

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PhD Degree Program in Pharmaceutical Sciences and Pharmacogenomics ...