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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
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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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More
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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IN THIS ISSUE - STRATEGY
Breast cancer is considered one of biomarker research’s biggest successes, largely because of
Roche/Genentech/Chugai’s trastuzumab (Herceptin)—a breakthrough therapy that has helped at least a subset of these patients to live much longer. But that specific example also highlights how complex the challenge is. Last week at Cambridge Healthtech Institute’s Beyond Genome meeting, the search for biomarkers to guide breast cancer diagnosis and treatment was one of the major topics.
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NEWS BRIEFS
Abbott and Genentech have formed collaboration for
research, development and commercialization of two of
Abbott's investigational targeted anti-cancer compounds
-- ABT-263 and ABT-869. ABT-263 is a Bcl-2 antagonist,
while ABT-869, is a multi-kinase inhibitor that targets
VEGFR. Both compounds are in Phase I clinical trials in a
number of tumor types. Read
more.
Roche is seeking to acquire diagnostics firm Ventana
Medical Systems Inc. for approximately $3 billion.
Ventana is a leader in histopathology-based diagnostics
and the acquisition will broaden Roche's diagnostic
offerings. A company press release noted that the
"entry of Roche into tissue-based diagnostics is an
important step in Roche's strategy of delivering
personalized healthcare solutions to patients." Read
more.
Pfizer announced the U.S. Food and Drug Administration
(FDA) issued an approvable letter for maraviroc, which
is under review as a therapy for treatment-experienced
patients infected with CCR5-tropic HIV-1. The company also
reported it will continue "discussions with the FDA
to address outstanding questions and finalize the product
labeling as soon as possible." Read
more.
CALENDAR
New
Applications for MDA, August 15-17, Washington DC
Integrating Genetics with "Omics"
CELLutions
Summit, August 20-23, Boston, Mass.
The Future of Stem Cell Sciences
6-27-07 - Biomarker Breakthroughs
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