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Category Archives: Pharmacogenomics

PHARMACOGENOMICS: Driving Personalized Medicine

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

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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Table of Pharmacogenomic Biomarkers in Drug Labeling | FDA

AbacavirInfectious DiseasesHLA-BBoxed Warning, Dosage and Administration, Contraindications, Warnings and PrecautionsAbemaciclib (1)OncologyESR(Hormone Receptor)Indications and Usage, Adverse Reactions, Clinical StudiesAbemaciclib (2)OncologyERBB2(HER2)Indications and Usage, Adverse Reactions, Clinical StudiesAbemaciclib (3)OncologyMKI67Indications and Usage, Dosage and Administration, Clinical StudiesAbrocitinibDermatologyCYP2C19Dosage and Administration, Use in Specific Populations, Clinical PharmacologyAdo-Trastuzumab EmtansineOncologyERBB2(HER2)Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAducanumab-avwaNeurologyAPOEWarnings and Precautions, Clinical StudiesAfatinibOncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAlectinibOncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAlglucosidase AlfaInborn Errors of MetabolismGAAWarnings and PrecautionsAllopurinolOncologyHLA-BWarningsAlpelisib (1)OncologyERBB2(HER2)Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAlpelisib (2)OncologyESR(Hormone Receptor)Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAlpelisib (3)OncologyPIK3CAIndication and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAmifampridineNeurologyNAT2Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical PharmacologyAmifampridine PhosphateNeurologyNAT2Dosage and Administration, Use in Specific Populations, Clinical PharmacologyAmitriptylinePsychiatryCYP2D6PrecautionsAmivantamab-vmjwOncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAmoxapinePsychiatryCYP2D6PrecautionsAmphetaminePsychiatryCYP2D6Clinical PharmacologyAnakinraRheumatologyNLRP3Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesAnastrozoleOncologyESR, PGR(Hormone Receptor)Indications and Usage, Adverse Reactions, Drug Interactions, Clinical StudiesAnifrolumab-fniaRheumatologyGene Signature(IFN)Clinical Pharmacology, Clinical StudiesArformoterol (1)PulmonaryUGT1A1Clinical PharmacologyArformoterol (2)PulmonaryCYP2D6Clinical PharmacologyAripiprazolePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical PharmacologyAripiprazole LauroxilPsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical PharmacologyArsenic TrioxideOncologyPML-RARAIndications and Usage, Clinical StudiesArticaine and Epinephrine (1)AnesthesiologyG6PDWarnings and PrecautionsArticaine and Epinephrine (2)AnesthesiologyNonspecific(Congenital Methemoglobinemia)Warnings and PrecautionsAsciminibOncologyBCR-ABL1(Philadelphia chromosome)Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesAtezolizumab (1)OncologyCD274(PD-L1)Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAtezolizumab (2) OncologyGene Signature(T-effector)Clinical StudiesAtezolizumab (3)OncologyEGFRIndications and Usage, Adverse Reactions, Clinical StudiesAtezolizumab (4)OncologyALKIndications and Usage, Adverse Reactions, Clinical StudiesAtezolizumab (5)OncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAtomoxetinePsychiatryCYP2D6Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical PharmacologyAscorbic Acid, PEG-3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, and Sodium SulfateGastroenterologyG6PDWarnings and Precautions, Adverse ReactionsAvapritinib (1)OncologyPDGFRAIndications and Usage, Dosage and Administration, Clinical StudiesAvapritinib (2)OncologyKITClinical StudiesAvatrombopag (1)HematologyF2(Prothrombin)Warnings and PrecautionsAvatrombopag (2)HematologyF5(Factor V Leiden)Warnings and PrecautionsAvatrombopag (3)HematologyPROCWarnings and PrecautionsAvatrombopag (4)HematologyPROS1Warnings and PrecautionsAvatrombopag (5)HematologySERPINC1(Antithrombin III)Warnings and PrecautionsAvatrombopag (6)HematologyCYP2C9Clinical PharmacologyAvelumabOncologyCD274(PD-L1)Clinical StudiesAzacitidine (1)OncologyCBLClinical StudiesAzacitidine (2)OncologyPTPN11Clinical StudiesAzacitidine (3)OncologyRASClinical StudiesAzathioprine (1)RheumatologyTPMTDosage and Administration, Warnings, Precautions, Drug Interactions, Adverse Reactions, Clinical PharmacologyAzathioprine (2)RheumatologyNUDT15Dosage and Administration, Warnings, Precautions, Adverse Reactions, Clinical PharmacologyBelinostatOncologyUGT1A1Dosage and Administration, Clinical PharmacologyBelzutifan (1)OncologyCYP2C19Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical PharmacologyBelzutifan (2)OncologyUGT2B17Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical PharmacologyBelzutifan (3)OncologyVHLClinical StudiesBinimetinib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesBinimetinib (2)OncologyUGT1A1Clinical PharmacologyBlinatumomab (1)OncologyBCR-ABL1(Philadelphia chromosome)Adverse Reactions, Clinical StudiesBlinatumomab (2)OncologyCD19Indications and UsageBoceprevirInfectious DiseasesIFNL3(IL28B)Clinical PharmacologyBosutinibOncologyBCR-ABL1(Philadelphia chromosome)Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesBrentuximab Vedotin (1)OncologyALKClinical StudiesBrentuximab Vedotin (2)OncologyTNFRSF8(CD30)Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesBrexpiprazolePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical PharmacologyBrigatinibOncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesBrivaracetamNeurologyCYP2C19Clinical PharmacologyBupivacaine (1) AnesthesiologyG6PDWarningsBupivacaine (2)AnesthesiologyNonspecific(Congenital Methemoglobinemia)WarningsBupropionPsychiatryCYP2D6Clinical PharmacologyBusulfanOncologyBCR-ABL1(Philadelphia chromosome)Clinical StudiesCabotegravir and Rilpivirine (1)Infectious DiseasesHLA-BClinical StudiesCabotegravir and Rilpivirine (2)Infectious DiseasesUGT1A1Clinical PharmacologyCabozantinibOncologyRETClinical StudiesCapmatinibOncologyMETIndications and Usage, Dosage and Administration, Clinical StudiesCapecitabineOncologyDPYDWarnings and Precautions, Patient Counseling InformationCarbamazepine (1)NeurologyHLA-BBoxed Warning, Warnings, PrecautionsCarbamazepine (2)NeurologyHLA-AWarningsCarglumic AcidInborn Errors of MetabolismNAGSIndications and Usage, Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesCariprazinePsychiatryCYP2D6Clinical PharmacologyCarisoprodolRheumatologyCYP2C19Use in Specific Populations, Clinical PharmacologyCarvedilolCardiologyCYP2D6Drug Interactions, Clinical PharmacologyCasimersenNeurologyDMDIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesCeftriaxone (1)Infectious DiseasesG6PDWarningsCeftriaxone (2)Infectious DiseasesNonspecific(Congenital Methemoglobinemia)WarningsCelecoxibRheumatologyCYP2C9Dosage and Administration, Use in Specific Populations, Clinical PharmacologyCemiplimab-rwlc (1)OncologyALKIndications and Usage, Clinical StudiesCemiplimab-rwlc (2)OncologyCD274(PD-L1)Indications and Usage, Dosage and Administration, Clinical StudiesCemiplimab-rwlc (3)OncologyEGFRIndications and Usage, Clinical StudiesCemiplimab-rwlc (4)OncologyROS1Indications and Usage, Clinical StudiesCeritinibOncologyALKIndications and Usage, Dosage and Administration, Warning and Precautions, Adverse Reactions, Clinical StudiesCerliponase AlfaInborn Errors of MetabolismTPP1Indications and Usage, Use in Specific Populations, Clinical StudiesCetuximab (1)OncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesCetuximab (2)OncologyRASIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical StudiesCetuximab (3)OncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesCevimelineDentalCYP2D6PrecautionsChloroprocaine (1)AnesthesiologyG6PDWarningsChloroprocaine (2)AnesthesiologyNonspecific(Congenital Methemoglobinemia)WarningsChloroquineInfectious DiseasesG6PDPrecautions, Adverse ReactionsChlorpropamideEndocrinologyG6PDPrecautionsCholic AcidInborn Errors of MetabolismAMACR, AKR1D1, CYP7A1, CYP27A1, DHCR7, HSD3B2(Bile Acid Synthesis Disorders)Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesCisplatinOncologyTPMTAdverse ReactionsCitalopram (1)PsychiatryCYP2C19Dosage and Administration, Warnings,Clinical PharmacologyCitalopram (2)PsychiatryCYP2D6Clinical PharmacologyClobazamNeurologyCYP2C19Dosage and Administration, Use in Specific Populations, Clinical PharmacologyClomipraminePsychiatryCYP2D6PrecautionsClopidogrelCardiologyCYP2C19Boxed Warning, Warnings and Precautions, Clinical PharmacologyClozapinePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical PharmacologyCobimetinibOncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesCodeineAnesthesiologyCYP2D6Boxed Warning, Warnings and Precautions, Use in Specific Populations, Patient Counseling InformationCrizanlizumab-tmcaHematologyHBBAdverse Reactions, Clinical StudiesCrizotinib (1)OncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesCrizotinib (2)OncologyROS1Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesDabrafenib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesDabrafenib (2)OncologyG6PDWarnings and Precautions, Adverse Reactions, Patient Counseling InformationDabrafenib (3)OncologyRASDosage and Administration, Warnings and PrecautionsDaclatasvirInfectious DiseasesIFNL3(IL28B)Clinical StudiesDacomitinibOncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesDapsone (1)DermatologyG6PDWarnings and Precautions, Use in Specific Populations, Patient Counseling InformationDapsone (2)DermatologyNonspecific(Congenital Methemoglobinemia)Warnings and Precautions, Adverse Reactions, Patient Counseling InformationDapsone (3)Infectious DiseasesG6PDPrecautions, Adverse Reactions, OverdosageDarifenacinUrologyCYP2D6Clinical PharmacologyDasabuvir, Ombitasvir, Paritaprevir, andRitonavirInfectious DiseasesIFNL3(IL28B)Clinical StudiesDasatinibOncologyBCR-ABL1(Philadelphia chromosome)Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesDenileukin DiftitoxOncologyIL2RA(CD25 antigen)Indications and Usage, Clinical StudiesDesipraminePsychiatryCYP2D6PrecautionsDesfluraneAnesthesiologyNonspecific(Genetic Susceptibility to Malignant Hyperthermia)ContraindicationsDesvenlafaxinePsychiatryCYP2D6Clinical PharmacologyDeutetrabenazineNeurologyCYP2D6Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical PharmacologyDexlansoprazoleGastroenterologyCYP2C19Drug Interactions, Clinical PharmacologyDextromethorphan and QuinidineNeurologyCYP2D6Warnings and Precautions, Clinical PharmacologyDiazepamNeurologyCYP2C19Clinical PharmacologyDinutuximabOncologyMYCNClinical StudiesDocetaxelOncologyESR, PGR(Hormone Receptor)Clinical StudiesDolutegravirInfectious DiseasesUGT1A1Clinical PharmacologyDonepezilNeurologyCYP2D6Clinical PharmacologyDostarlimab-gxlyOncologyMismatch RepairIndication and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesDoxepin (1)PsychiatryCYP2D6Clinical PharmacologyDoxepin (2)PsychiatryCYP2C19Clinical PharmacologyDronabinolGastroenterologyCYP2C9Use in Specific Populations, Clinical PharmacologyDrospirenone and Ethinyl EstradiolGynecologyCYP2C19Clinical PharmacologyDuloxetinePsychiatryCYP2D6Drug InteractionsDurvalumabOncologyCD274(PD-L1)Clinical Pharmacology, Clinical StudiesDuvelisibOncologyChromosome 17pClinical StudiesEculizumab (1)NeurologyACHRIndications and Usage, Clinical StudiesEculizumab (2)NeurologyAQP4Indications and Usage, Clinical StudiesEfavirenzInfectious DiseasesCYP2B6Clinical PharmacologyEfgartigimod Alfa-fcabNeurologyACHRIndications and Usage, Clinical Pharmacology, Clinical StudiesElagolixGynecologySLCO1B1Clinical PharmacologyElbasvir and GrazoprevirInfectious DiseasesIFNL3(IL28B)Clinical StudiesElexacaftor, Ivacaftor, and TezacaftorPulmonaryCFTRIndications and Usage, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesEliglustatInborn Errors of MetabolismCYP2D6Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesElosulfaseInborn Errors of MetabolismGALNSIndications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesEltrombopag (1)HematologyF5(Factor V Leiden)Warnings and PrecautionsEltrombopag (2)HematologySERPINC1(Antithrombin III)Warnings and 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

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PhD Degree Program in Pharmaceutical Sciences and Pharmacogenomics …

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.

Opens

September 1, 2022

Closes

Tuesday, December 1, 2022

Quantitative Biosciences Consortium (QBC)

Image credits: Majed and Thor Swift Photography

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PhD Degree Program in Pharmaceutical Sciences and Pharmacogenomics ...

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Supporting and enhancing the evolving role of MSLs PharmaLive – PharmaLive

Supporting and enhancing the evolving role of MSLs

By Jill Padgett, EdD

Medical science liaisons (MSLs) play an essential and prominent role in the pharmaceutical industry. They form a link between pharmaceutical companies and the medical community, working to ensure that information about new drugs and treatments is disseminated accurately and effectively.

The pace of medical research that were experiencing currently will lead to increased frequency of product launches, more multi-indication brands, and a strong focus on rare disease and specialty care. As a result, the market landscape and corresponding needs of HCPs are becoming increasingly complex. Indeed, in cases such as those involving rare diseases where there may be only a small number of specialists HCPs will place greater reliance on MSLs as a primary resource with respect to innovative therapies.

The landscape is changing in other ways, too. The pandemic has only accelerated the already sizable shift to digital communications. And with the increasingly fast-paced nature of society in general, time-crunched HCPs can be more difficult to engage.

To support the various market changes, the scope of the average MSL function will expand. This article explores the evolving role of MSLs and their value for biopharmaceutical companies, and examines how best to utilize their expertise.

The impact of rare disease on MSLs

A key driver of change is the escalation of therapies in the field of rare diseases. This is accompanied by accelerated timelines as companies rush to get products to market. The increased complexity and urgency can lead to knowledge and communication gaps that MSLs are uniquely poised to bridge. They act as trusted sources for KOLs and HCPs who are facing a range of challenges, including inconsistencies in, and approaches to, care.

Additionally, when it comes to rare disease, there is often minimal data available and few KOLs to consult. This is an area where the MSL role has expanded. They now play a key part in helping to cultivate KOL influencers. There are also other players that MSLs will need to identify because oftentimes, different stakeholders or experts are involved in a patients treatment. The MSLs role now involves understanding what each of those different stakeholders provides in the patient journey, what they need based on their own knowledge of the disease, and their insights and perspectives on the patients care.

MSLs must be able to identify major influencers and handle diverse conversations with each stakeholder. They need to simultaneously take on a holistic and micro view of issues, and be able to draw key insights that are most important for the pharmaceutical company.

Another trend driven by the prevalence of rare disease treatments is the need for MSLs to be well-versed in pharmacogenomics, which studies the impact of genetics on patients response to medications. This can affect small populations, and knowledge of pharmacogenomics can help MSLs personalize conversations with HCPs and increase confidence in a particular therapy based on how patients are expected to respond.

Typically, pharmacogenomics is not a part of an MSL training curriculum, depending on what therapeutic areas theyre working in. However, in rare diseases, it is a critical component of MSL development. In addition to learning about pharmacogenomics, MSLs must also become knowledgeable in personalized medicine, pharmacoeconomics, and evidence-based medicine. With fewer KOLs, they play an important role in educating HCPs and providing in-depth knowledge on these topics.

Building connections that make better health happen

The MSL role is changing from a practical standpoint, too. HCPs, KOLs, and other stakeholders in the field are rapidly shifting toward digital communications. MSLs need to adapt their approach to avoid missing out on timely and effective collaboration opportunities. This might involve an expanded suite of digital tools, increased personalization, or testing various hybrid communication methods.

Post-pandemic, many KOLs have grown accustomed to the virtual environment, some still prefer in-person meetings, while others favor a mixture. To communicate effectively, MSLs must be more versatile, technically savvy, and armed with the necessary digital assets. One way to help MSLs navigate new communication methods is for pharmaceutical companies to ensure they have all the digital tools (e.g., slide decks and digital brochures) and corresponding training necessary to carry out their jobs effectively.

Whats more, many stakeholders today are multidisciplinary as the integration of commercial, medical, and market access teams continue to proliferate within biopharma companies. This means MSLs must tailor their approach to consider multiple viewpoints within the same conversation. In the same vein, MSLs are becoming more closely involved in understanding unmet patient needs.

Determining influential KOL networks is critical, especially in rare disease. MSLs need to undertake a great deal more research in advance to find out the influencer in these networks, for example, to help determine the patient journey and how these patients are finding experts. The new MSL model involves a patient-centric approach to care since there is a larger network of stakeholders who have shifted to focusing on the patient journey rather than the drug.

How biopharmaceutical companies can support the evolving role of MSLs

To support MSLs in their changing roles, there are measures that biopharmaceutical companies can take. The following are our four recommendations.

Most of the existing MSL training programs focus on clinical aspects and knowledge acquisition. Formalizing these cohort, peer-to-peer types of learning activities within their training plan will enhance the application part of their learning experience, which is often missing.

Supporting the evolution of the MSL

Theres no denying that the role of MSLs is evolving, in particular, due to the industrys increased focus on rare disease and specialty care. MSLs are having more specialized conversations with a dynamic group of stakeholders, bringing crucial insights back to pharmaceutical companies, and playing a pivotal role in the development process.

As more new drugs targeting rare disease enter the market, the MSL function will continue to expand. Companies can support MSLs in this new landscape by providing the tools and training they need to carry out their roles effectively. This should include mapping out dedicated training plans that include peer-based learning, an emphasis on enhancing their emotional intelligence skills, and providing the digital assets needed to enhance important conversations.

With the right training in place, MSLs can play an optimal role in educating and engaging key stakeholders, ultimately leading to improved patient outcomes.

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Supporting and enhancing the evolving role of MSLs PharmaLive - PharmaLive

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Top experts to attend Precision Medicine and Functional Genomics conference – Gulf Times

The Precision Medicine and Functional Genomics (PMFG) 2022 conference is all set to take place from September 23 to 26 at St Regis Doha, bringing together researchers, healthcare professionals, policymakers, and community members from different countries.Precision Medicine takes individual variations in genetics, pharmacogenomics, proteomics, microbiome, environmental, lifestyle factors, and others into account, allowing healthcare providers to improve the efficiency and effectiveness of disease prevention, diagnosis, and treatment, Sidra Medicines chief research officer Dr Khalid Fakhro said in a statement.The sixth edition of the annual event, which will be preceded by a pre-symposium Biotech Forum tomorrow (September 22) at Sidra Medicines hospital auditorium, aims to explore the latest developments and innovations in biomedical research and how they translate into precision medicine solutions.According to the organisers, the four-day in-person symposium has pre-and post-conference workshops, as well as a satellite half-day meeting focusing on two major themes: How cellular, organoid, and animal models are being used to facilitate the discovery of basic disease mechanisms and potential cures; and The development of advanced therapies to treat diseases.Over the years, the PMFG series has grown significantly in topics and diversity with a wide range of speakers and a growing audience worldwide. As part of its National Vision 2030, Qatar is committed to building a knowledge-based economy in the biomedical and health sciences. Sidra Medicine supports this goal by actively engaging clinical and scientific expertise to establish a leading model for Precision Medicine in the region, Dr Fakhro said. He noted that the conference also aims to discover how personalised medicine can move from vision to practice and to draft with us the roadmap for a personalised health data ecosystem.Organisers noted that the conference provides an opportunity for participants to: Learn about co-ordinated efforts to develop precision medicine around the world and specifically in the Middle Eastern region, best practices for conducting successful precision medicine clinical trials, learn how advanced diagnostics and personalised treatments improve the quality of care for children with rare and chronic diseases (i.e. immune deficiency, hemoglobinopathy, cancer, etc), understand the value of using cell, organoid, and animals as disease models in biomedical research and learn about modelling of human tissues and diseases and how large-scale data resources, genome sequencing and novel technologies are driving precision medicine.

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Top experts to attend Precision Medicine and Functional Genomics conference - Gulf Times

Posted in Pharmacogenomics | Comments Off on Top experts to attend Precision Medicine and Functional Genomics conference – Gulf Times