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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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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
CSO Koen Kas and his colleagues are building a protein biomarker discovery platform to find novel markers for blood-based diagnostic tests. As serum is both complex and disproportionately laden with certain proteins, they need tools to pick “needles” from a protein haystack. For this, they’ve brought on some elegant new technology, including special tagging chemistry and towering chromatography columns.
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NEWS BRIEFS
23andMe, Inc., a privately held, early stage personal
genetics company announced it had closed its Series A
Preferred Stock Financing, which included investments
from, among others, Genentech, Inc., Google Inc., MDV-Mohr
Davidow Ventures and New Enterprise Associates. Terms of
the financing were not disclosed. Read
Amgen intends to appeal a negative review from the
European Committee for Medicinal Products for Human Use (CHMP)
for the marketing authorization application (MAA) for
Vectibix (panitumumab). The application targets patients
with metastatic colorectal cancer (mCRC) who have failed
chemotherapy. Read
A new report in the New England Journal of Medicine
concluded rosiglitazone (GSK’s Avandia) was associated
with a significant increase in the risk of myocardial
infarction and with an increase in the risk of death from
cardiovascular causes that had borderline significance. Read
A study published in the Journal of the American Medical Association found more correlations between clinicopathological features and the loss of
heterozygosity/allelic imbalance in samples from breast tumor stroma than in epithelium, suggesting that stromal genomicalterations may help account for clinical diversity in this form of cancer. Read
CALENDAR
Protein Kinase
Targets, June 4 - 6, Boston, MA
Drug Discovery and Design
Structure Based
Design, June 6 - 8, Boston, MA
Sophisticated Approaches to Drug Discovery
World Pharmaceutical
Congress, June 11 - 13, Philadelphia, PA
Trends in Pharmaceutical Development
Beyond Genome, June
20 - 22, San Francisco, CA
Top Ten Challenges in the Post-Genome Era
Nucleic Acid-Based
Technologies, June 25 - 27, Baltimore, MD
Meeting the Demands
5-30-07 - Biomarker Breakthroughs
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