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| Ex Vivo Metrics™: How Drug Studies in Reanimated Human Organs Could Revitalize the Drug Development Process
An editorial by Gerald Curtis, PhD
Fallout from the catastrophic phase I clinical trial of TeGenero’s monoclonal antibody TGN1412 in March 2006,1 in which 6 volunteers suffered life-threatening “cytokine storms,” includes newly tightened regulations in the United Kingdom and renewed concern worldwide about first-in-human trials, particularly for compounds with novel targets or mechanisms of action.
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Editorials
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| DNA
Genotyping from human FFPE Samples |
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In this feasibility study, Applied Biosystems demonstrates how the combined
use Recover All Total Nucleic |
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Acid Isolation Kit and TaqMan SNP Genotyping
Assay can result in high quality, reproducible, and reliable genotyping
data.. Read
more |
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Millipore has
launched the CellCiphr Cytotoxicity Profiling Assay Kit
using human HepG2 cells. This assay panel detects
drug-induced hepatotoxicity and is expected to be used
early in the drug discovery process. read
more
Cartesian Gridspeed, Ltd. announced the
opening of its new sales, marketing and technical support
subsidiary, SLIM Search, Inc. in Mission Viejo,
California. SLIM
Search, Inc. is marketing
its SLIM Search genomic search tool to universities,
government research, and research and development
departments of biotechnology corporations and individual
contributors. read
more
The new Variant Reporter Software from Applied
Biosystems automates detection of variants and
streamlines data analysis process. The software uses
proprietary algorithms to identify genetic variations
based on standardized or user-defined parameters. Results
are presented for validation in a visual format that
allows researchers to simultaneously compare multiple
quality control metrics. More information and a free trial
version are available at:
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Products
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| We invite your comments and feedback for this edition of Biomarker Breakthroughs. Email us at
maloryea@gmail.com |
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Genentech Scientists Use Pathways Software for PD Marker Search
By Malorye Allison
“It’s tremendously important not to waste a patient’s time with a treatment that’s not going to work,” says Walter Darbonne, associate scientist at Genentech. Darbonne and his colleagues are looking for pharmacodynamic biomarkers in preclinical models, using tools including classic immunoassays, western blots, fluorescent-activated cell sorting, and gene expression.
“Pharmacodynamic markers in oncology can be very challenging things to find,” he says. “You can do some preclinical oncology models and try to identify what markers are going to be the most useful. Then you have to take them to the clinic and hope that you are right.” The researchers are specifically looking for markers that indicate a drug has reached a sufficient concentration that it is having its intended effect.
For the last year and a half, the group has also been using Ingenuity Pathways Analysis (IPA) software. They are also beta testing IPA 5.0 (the latest version), which will be released to the market in mid April. The software allows researchers to analyze known targets and markers within known pathways or they can create their own. The manually curated Ingenuity database includes toxicity and chemical data as well as biological data and a large repository of FDA-approved drug information.
“Having a tool like IPA 5.0 lets you further interrogate the data, gives you more confidence, and helps you identify markers that you did not think about before,” says Darbonne.
In one recent case, he says, the group was looking at some preclinical data that was giving confusing information about potential biomarkers. “I put some of that data into the IPA software and it gave me a marker that was central to all that we were seeing. It gave me an additional marker that no one knew or had thought about. That stimulated us to look at the papers behind that marker and take a look at it,” he says.
The 5.0 edition of IPA contains new molecular toxicity and biomarker solutions, and new toxicity, CNS, and messenger RNA information has been incorporated into the Pathways Knowledge Base. The biomarker solution allows identification of biomarkers within gene array or proteomic datasets, ranks markers according to biological context and characteristics, allows identification of markers unique to disease stages, and links biomarkers to disease or drug response.
3-21- 07 - Biomarker Breakthroughs
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