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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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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 - CASE STUDY
By Malorye Allison
Many types of companies are betting biomarkers will
accelerate drug development, but the biggest frontier for
their use is oncology. Now, a new wave of compounds, such
as Exelixis’ XL880, Avalon’s AVN944, and SuperGen’s
MP470, are starting to demonstrate when and how such
markers are the most useful.
STRATEGY
Merck & Co.
By Laurie Sullivan
ARIAD Pharmaceuticals and Merck & Co. recently
announced their $1-billion collaboration to develop and
commercialize AP23573, ARIAD’s novel mTOR inhibitor, for
use in cancer. We talked to Timothy P. Clackson, Ph.D.,
Senior Vice President and Chief Scientific Officer at
ARIAD, who explained why mTOR is such an important target.
Clackson also described what the alliance with Merck
signifies for the future of AP23573 and for ARIAD in
general.
NEWS BRIEFS
Thirty companies, non-profit trade associations,
and advocacy groups, now hold ontributing membership in
The Biomarkers Consortium. To date, these
organizations have committed an aggregate of nearly $2
million to fund the first year of the central activities
of the consortium which is managed be the Foundation for
the National Institutes of Health. read
more
Illumina, Inc. announced a large-scale
collaboration with the Institute of Translational
Medicine and Therapeutics at the University of
Pennsylvania, the Broad Institute, and the National Heart,
Lung, and Blood Institute’s Candidate-gene Association
REsource (CARe) Consortium to develop a customized chip
for vascular disease. (July 23) read
more
The Wall Street Journal reports that the
choice of Severin Schwan as the next CEO at Roche
points to a new emphasis on diagnostics there. (July 20) read
more (subscribers only)
The Wall Street Journal reports that the
House Judiciary Committee has passed a "sweeping
overhaul of U.S. patent laws…" Pharmaceutical
and biotechnology companies were generally opposed to the
changes proposed. (July 19) read
more (subscribers only).
Pfizer announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines
Agency (EMEA) issued a positive opinion recommending
marketing authorization for Celsentri (maraviroc), the
first CCR5 antagonist for use in combination with other
antiretroviral agents for treatment-experienced adult
patients where only CCR5-tropic virus is detectable. (July
19) read
more
Affymetrix and Children's Research Institute in
Milwaukee have entered a five-year strategic alliance to
analyze up to 25,000 genomic samples. Scientists at
Children's Research Institute will use Affymetrix
technology to analyze the genomic information of
consenting patients. (July 17) read
more
Panacea Pharmaceuticals has launched LC Detect,
a serum-based lung cancer diagnostic test the company says
should facilitate the identification of lung cancer, even
among individuals with early-stage disease. (July 17) read
more
A genome-wide association study published in Nature
online has linked a new genetic variation in KIAA0350
with type 1 diabetes. The study was conducted at
Children’s Hospital of Philadephia and McGill
University. (July 15) read
more (abstract only)
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
7-24-07 - Biomarker Breakthroughs
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