WORLD'S LARGEST HUMAN CELL BANK IS LOCATED IN NJ
Adverse reactions to drugs costs the United States $135 Billion annually. There are over two million people effected by adverse reactions annually. According to the FDA on average only 50% of drugs are 100% effective. As it pertains to cancer drugs, they only are 20% effective according to the FDA. So, how does one optimize these percentages? The Coriell Institute for Medical Research in Camden, NJ is helping do just that.
Many Americans are familiar with the drug Clopidogrel (Plavix). This is a medication commonly prescribed to prevent blood clots particularly after cardiac events, is a medication metabolised by the gene cytochrome P450 2C19 (CYP2C19).
The manufacturers of Plavix, Bristol – Myers Squibb and Sanofi, are being sued by the attorneys general of five US States: Hawaii; California; Louisiana; Mississippi; and West Virginia.
The Hawaiian case is based on the fact that the manufacturers knew in 1998 that certain genetic variations would put patients at risk of further cardiac problems. For these patients, the medication would be ineffective or partially effective. By failing to disclose this information approximately 38%-79% of the population of Pacific Islanders and 40%-50% of East Asians in Hawaii are at risk. It is estimated that 48.6% of Hawaiians taking Plavix are at risk and significant damages are being sought to compensate the State and individuals that have been affected by the manufacturers’ lack of disclosure.
Patients with variations in CYP2C19 who are at risk according to their gene variant, should either be given a different dose of Plavix, or a different medication altogether as the normal dose is not sufficient. Some Patients, who could take a normal dose of Plavix because of their genetic makeup, need to be cautioned on taking other medications that are dependent on CYP2C19 for metabolism (e.g. certain heartburn medications and some psychiatric drugs). These normal (extensive) metabolisers may not get the full benefit of Plavix either.
In 2010 the FDA added a boxed warning for Plavix. The FDA states: “People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These “poor metabolizers” may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.” (2)
The FDA warning recommended that doctors should gene test patients for variations in CYP2C19 to identify variations that would make Plavix ineffective, but to date this has not been widespread practice amongst medical practitioners in the United States.
Launched in 2007, the Coriell Personalized Medicine Collaborative (part of the Coriell Medical Institute for Medical Research) is a long-term research study exploring the usefulness of genetic information in clinical decision-making and health management. A true collaboration, the study – often called the CPMC – is a multiparty effort of volunteer study participants, physicians, scientists, ethicists, genetic counselors, pharmacists, information technologists, and hospital and academic partners. It has nearly 8,500 individuals enrolled and provides personalized reports to participants revealing their genetic and non-genetic risks for complex disease, like heart disease and diabetes, and for likely reactions to medications, such as blood thinners. Study participants are enrolled through partnerships with respected research centers across the nation, including Stanford University, Boston University, and University of Pennsylvania. The study has also been engaged by the United States Air Force to bring personalized medicine to U.S. service members.
This link below is how one can enroll their patients or a patient can enroll themselves if they meet the criteria.
https://cpmc.coriell.org/how-to-enroll/overview
In addition to seeking to understand the utility of personal genome information in the delivery of patient care, the CPMC study team is also committed to educating patients, medical professionals, and the public on genomics and personalized medicine. The study also aims to contribute to the evidence-based research required to inform policies and regulations, e.g., third-party payer practices; encourage the development of companion diagnostics; identify new genetic associations; integrate genomic data into both electronic medical records and clinical decision-support tools; and establish recommendations for best practices.
They ultimately believe that the success of personalized medicine depends on its ability to demonstrate its value to the healthcare system, to the industries that develop its products, and to patients. The CPMC research study is striving to be a model for the ethical, legal, and responsible implementation of best practices in personalized medicine.
The Coriell Institute for Medical Research, was founded in 1953 and based in Camden, New Jersey. It is an independent non-profit research center dedicated to the study of the human genome. Expert staff and pioneering programs in the fields of personalized medicine, cell biology, cytogenetics, genotyping, and biobanking drive their mission.
Dr Lewis Coriell's pioneering techniques for characterizing, freezing, and storing cell cultures in liquid nitrogen constitute one of the greatest contributions to modern human research. Today, the Coriell Biobank is regarded as the most diverse collection of cell lines and DNA available to the international research community. In addition to these high-quality biospecimens, Coriell also maintains tissue, plasma, serum, urine, and cerebrospinal fluid. They essentially are the Amazon.com of stem cells.
Few organizations have the history of innovations in repository science that have been developed and implemented at Coriell. For more than 60 years, Coriell has set the standard in biobanking services, including the experimental design, collection, processing, distribution, cryogenic preservation, and information management of human biomaterials used in research. By developing and maintaining biorepositories as national and international resources for the study of human diseases, aging, and neurological disease, Coriell is committed to providing the scientific community with well-characterized cell cultures, lines and DNA preparations annotated with rich phenotypic data.
The Coriell Biobank has allowed both Coriell scientists, and research investigators around the world, to advance research programs in genetics and cell biology. Since the first repository – a National Institutes of Health collection – was established at Coriell in 1964, millions of cell lines and DNA samples have been distributed to researchers in 66 countries and more than 7,000 peer-reviewed papers have been published citing over 12,000 biospecimens from the Coriell Biobank. Coriell's repositories provided support to the Human Genome Project, a worldwide program to map the entire human genome, and to the International HapMap Project, a project providing an efficient tool to identify disease-causing genes.
The emerging field of personalized medicine draws upon a person’s genomic information to tailor treatments and prescription drug dosing to optimize health outcomes. The Coriell Personalized Medicine Collaborative (CPMC) research study is seeking to understand the usefulness of genetic risk and pharmacogenomics in clinical decision-making and healthcare management.
Coriell has a distinguished history in cell biology. They are building upon this expertise by playing an important role in induced pluripotent stem (iPs) cell research. Somatic cells can be reprogrammed into the embryonic state. This enormous scientific discovery was performed by Dr Shinya Yamanaka. He won the Noble Prize in 2012 for his discovery.
Induced pluripotent stem cells are powerful cells which can be made from skin or blood cells, and they are revolutionizing the way human disease is studied and how drugs are developed. Skin cells from a patient diagnosed with heart disease are being genetically reprogrammed into stem cells, and then transformed into beating cardiac cells.
Researchers can now examine the heart-diseased cells to better understand the progression of heart disease and develop treatments and cures. Drug efficacy and safety can also be tested in this laboratory environment, providing an efficient model of drug discovery that delivers drugs to patients sooner. This technology, called "disease in a dish," offers researchers the potential to study the myriad of human diseases, including Alzheimer's disease, muscular dystrophy, and diabetes.
The mission of the Stem Cell Biobank (SCB) at the Coriell Institute for Medical Research is to provide scientists with the opportunity to bank their pluripotent stem cell lines at the SCB, and to develop in-house induced pluripotent stem cell (iPSC) lines for distribution to researchers. Established in 2008, the SCB has developed core capabilities to maintain, characterize, bank, and distribute important stem cell resources. The SCB performs extensive identification and characterization testing for all submitted human induced pluripotent stem cell (iPSC) and mouse embryonic stem cell (mES) lines. The identification and quality control measures include karyotype analysis, microsatellite analysis for parental cell line identity matching, sterility testing, and assessment of viability after cryopreservation. Pluripotency characterizations performed by SCB vary depending upon the distributing repository.
Each characterized human iPSC line and mES line released for distribution is provided with a Certificate of Analysis, which includes information regarding characterization and quality of the line, images and links to original publications. As the debate on the use of fetal embryos was occurring, this science leap frogged that drama. The human iPSCs distributed by Coriell are strictly for research purposes and cannot be used in human subjects.
In addition to pioneering cutting-edge research initiatives, Coriell offers custom research services – including cell culture, cytogenetic analyses, and molecular biology – to the scientific community. Furthermore, Coriell’s Genotyping and Microarray Center is one of the nation’s largest centers, with high-throughput DNA analysis, CLIA-certified genotyping platforms systems from Illumina and Affymetrix.
Essential to the Institute’s support of international scientific research is the Coriell Biobank. From this renowned cell bank, they manage and distribute the world’s most diverse collection of cell lines, DNA, and other biological resources. The Coriell Biobank provided support to the Human Genome Project, a worldwide program to map the entire human genome, and to the International HapMap Project, a project providing an efficient tool to identify disease-causing genes. They have recently partnered with IBM to analyze genomes.
The promise of stem cell research applies to understanding the progression of human disease and the ability to cure disease, reverse injury and better target therapies to optimize our health outcomes. Induced pluripotent stem (iPS) cell technology has the ability to revolutionize the way human disease is studied. Creating iPS cell lines from various rare and common disease states, as well as from various populations, will open the doors for pre-clinical research studies. By understanding how a drug will effect a patient (and the other drugs they are on as well), before they take it, will decrease medical costs in the United States significantly. The risk reporting algorithm that the Coriell Institute has developed has the ability to analyze the risk associated with a drug based on a patients personal genetics. A simple swab of ones mouth will give the information needed to safeguard a patients reaction to a drug. It will tell a physician what the risk associated with that drug is before they give it to the patient. If the risk is high, the algorithm has the ability to recommend alternative solutions for the physician. It looks are all the drugs the patient is on as well and analyzes what reaction can happen with those as well. This is the direction that medicine is taking, cutting edge with a focus on positive patient outcomes.
Recognized as one of the world's leading sources for research-grade iPS cell lines, Coriell has fortified that position by embarking on an ambitious initiative with the California Institute for Regenerative Medicine (CIRM), a foremost proponent of stem cell science. As part of a $10M research grant award by CIRM, Coriell launched a satellite biobank facility on the West Coast in early 2014 to store, manage and distribute biosamples from 3,000 individuals, that will then be used to create 9,000 well-characterized iPS cell lines. Coriell California processes samples from subjects enrolled at several different research and academic centers, including Stanford University and UCLA, and will oversee international distribution through the Coriell Biorepositories catalog.
In addition to the collections of human induced pluripotent stem cells, Coriell also banks mouse embryonic stem cells which were created to study transcription factors and their effects in the context of gene regulatory networks. Coriell began banking stem cells for research use in 2006, with funding from the state of New Jersey. Following the advent of new stem cell technologies, the Stem Cell Biobank at Coriell has been contracted by multiple agencies, including National Institute of General Medical Sciences, National Institute of Neurological Disorders and Stroke, National Institute of Aging, as well as academic scientists to perform in-house human induced pluripotent stem cells and mouse embryonic stem cells generation and characterization. In addition, the Stem Cell Biobank has cryopreserved hematopoietic progenitor cells and mononuclear cells from umbilical cord blood are available as custom service orders.
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