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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.
Read
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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:
read
more
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
By Malorye Allison
Could new types of cancer tests change the diagnostics
market? Many entrepreneurs disdain diagnostics because
they are seen as too low margin to ever command a
significant reward, unless you are already one of the
leading companies in this field. Now a growing number of
start ups are entering the field with two goals in mind:
introducing new products and changing the way the market
works.
Read More
NEWS BRIEFS
An editorial about FDA's recent review of GSK's
Avandia (rosiglitazone) was published in the New
England Journal of Medicine (free full text
available). The author, Clifford Rosen, calls for approval
of antidiabetic drugs based on long-term clinical
outcomes, not on the surrogate of glycated hemoglobin. He
also says that "none of the several proposed analyses
of the ongoing clinical trials is likely to define an
absolute risk for myocardial ischemic events in patients
with diabetes who are taking this drug." (August 30,
2007) Read
More
A new abnormality --T1 hyperintense lesions -- related
to MS progression and disability was identified
using MR in a recent study in Radiology. Lead
author of the paper was Rohit Bakshi from Harvard Medical
School, Brigham and Women’s Hospital, and Partners MS
Center in Boston. Read
More
Mayo Clinic researchers reported that they have
identified the first immune molecule that appears to play
a role in prostate cancer development and in predicting
cancer recurrence and progression after surgery. The
report on the B7-H3 molecule by Mayo Clinic Cancer Center
appears in Cancer Research.
Read More
CALENDAR
Drug
Development in China,
Sept. 10-12, Philadelphia, PA
Strategies for Launching Discovery and Development
Activities.
Biomarker
Discovery Summit,
Sept. 17-19, Philadelphia, PA
Genomic, Proteomic, Metabolic, and Toxicity Biomarkers.
9-5-07 - Biomarker Breakthroughs
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