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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 more  -  More Editorials

DNA Genotyping from human FFPE Samples

In this feasibility study, Applied Biosystems demonstrates how the combined 
use Recover All Total Nucleic

Acid Isolation Kit and TaqMan SNP Genotyping 
Assay can result in high quality, reproducible, and reliable genotyping 
data..  Read more
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

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We invite your comments and feedback for this edition of Biomarker Breakthroughs. Email us at maloryea@gmail.com
 

 

 

 

 

 

 

 

 

 

 

 

 

IN THIS ISSUE - CASE STUDY

Biomarkers Speeding Cancer Drug Development

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.
Read more

STRATEGY

ARIAD Lifted on $1B Anticancer Deal with
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.
Read More

 

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

Point-of-Care Diagnostics, August 14-15, Washington DC
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
Targeted Immunotherapeutics & Vaccines Summit, August 21-24, Boston, Mass.

7-24-07 - Biomarker Breakthroughs

 



New - Yihan Wang of ARIAD Pharmaceuticals, Inc.

Neil W Gibson of OSI Pharmaceuticals

Jeffrey Settleman Harvard Medical School and MGH Cancer Center

David Bailey of Chemoventures

N Claude Cohen of Synergix

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