IN THIS ISSUE - CASE STUDY

Identifying Responders to EGFR Inhibitors and Future Directions for Development

Interview with Neil W. Gibson, OSI Pharmaceuticals

Can patients most likely to respond to EGFR inhibitors be preselected? In this exclusive Webcast, Neil W. Gibson, VP Research, OSI Pharmaceuticals talks about the evidence to date, new biomarkers, new strategies for combining cancer therapies, and differences between AstraZeneca’s gefitinib (Iressa) and OSI’s Tarceva (erlotinib, co-marketed with Genentech and Roche). (Running time approx.8 minutes)

View Webcast

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

Monogram Bioscience has launched its Trofile co-receptor tropism assay following FDA approval of Pfizer’s novel HIV therapy, Selzentry (maraviroc). Trofile was the pivotal test used for patient selection for Selzentry's clinical development program and the two companies are engaged in a collaboration agreement to make Monogram's assay available worldwide. In a first for an HIV drug approval, the FDA approved label requires that tropism testing to identify patients infected with R5 virus guide the use of Selzentry.(Aug. 6) read more

An article in The New England Journal of Medicine discusses how genome-wide scans are leading to a burst of medical knowledge but require robust statistical methods. The authors conclude that "As we delve further into the genome in the search for networks of interacting gene variants and interactions between these networks and environmental factors, much more sophisticated methods of statistical analysis are likely to be required." (Aug. 2) read more (Subscription required for full text)

Ensemble Discovery Corporation and Roche will apply Ensemble’s proprietary diagnostic technology (DNA-Programmed Chemistry) to analyze combinations of Epidermal Growth Factor Receptors (EGFRs) in cancer tissues. The goal of the collaborative project is to create a sensitive test to detect receptor dimers in human cancer tissue samples and thus optimize therapy. (July 30) read more

The Food and Drug Administration has re-issued its Draft Guidance for Industry, Clinical Laboratories, and FDA Staff regarding In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) . The comment period for this guidance ends August 27^th. (July 26) read more

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.