A Diagnostics & Imaging Week

The National Institutes of Health (NIH) said it has awarded three contracts for pilot projects to improve informatics support for researchers conducting small- to medium-sized clinical studies. Each of the two-year contracts, which will total up to roughly $4 million, represents a collaboration among individuals at three or more institutions that receive NIH Clinical and Translational Science Awards (CTSA).

Administered by the National Center for Research Resources (NCRR), one of the CTSA program goals is to advance collaborations in clinical and translational research by interdisciplinary teams of investigators. These collaborations help enable the translation of rapidly evolving information developed in basic biomedical research into treatments and strategies to improve human health.

Informatics support includes systems that store, process and facilitate the exchange of information. The pilot projects will be led by Case Western Reserve University (Cleveland); University of Washington (Seattle); and Vanderbilt University (Nashville, Tennessee).

"These projects, which will build on the existing strong informatics expertise at the institutions, will promote new ways in which to enable researchers to collaborate and communicate across the CTSA consortium and with other partners in their research," said NCRR Director Barbara Alving, MD. "The projects are one important part of a larger effort to achieve the potential of clinical and translational science and reduce the time it takes to develop new treatments for disease."

The Case Western Reserve University project, headed by Susan Redline, MD, and G.Q. Zhang, PhD, includes investigators from the Marshfield Clinic, University of Wisconsin (Madison), and the University of Michigan (Ann Arbor).

This team will develop Physio-MIMI, an informatics infrastructure for collecting, managing and analyzing diverse data types across institutions. Researchers will be able to more effectively and efficiently collaborate in national studies that include many complex data sources and types, such as heart or brain monitoring data and genomic information. A key component of the system will allow secure, safe and regulated transfer of information from clinical care systems and research databases.

The University of Washington project, led by Nicholas Anderson, PhD, will develop a mechanism allowing researchers at three large, geographically distributed medical centers to easily access large shared data sets to assist in designing research studies and generating hypotheses. This team, which includes investigators from the University of California-Davis, and the University of California, San Francisco, will extend Harvard University's (Cambridge, Massachusetts) i2b2 software architecture to support cross-institution searches. This project will provide model policies and procedures to advance multi-institutional sharing of clinical data in support of research.

The Vanderbilt University project, headed by Paul Harris, PhD, includes investigators from Oregon Health and Sciences University (Portland) and Mayo Clinic (Rochester, Minnesota). This team will extend the capabilities of the Research Electronic Data Capture (REDCap) system. REDCap is a software toolset that provides research teams with an easy workflow to rapidly develop secure, web-based applications for collecting, managing and appropriate sharing of clinical study data.

The project's enhancements will make the system useful to a significantly greater number of studies and facilitate national and international collaborations. REDCap currently supports about 300 studies across an international consortium of 31 institutions.

Software resulting from these pilot projects will be freely available to biomedical researchers, educators and institutions in the nonprofit sector, the agency said. The terms of availability will permit broad adoption of the tools and also allow for commercialization of enhanced or customized versions.

The funding for these pilot projects is provided by the NIH Roadmap for Medical Research/Common Fund.

Booz Allen Hamilton, a strategy and technology consulting firm, provided facilitation and logistical support for the pilot project contract awards through a contract with NCRR.

According to the agency, NIH CTSAs currently support 38 medical research institutions sharing a common vision to reduce the time it takes for laboratory discoveries to become treatments for patients, engage communities in clinical research efforts and train the next generation of clinical researchers.

In other agreements/contracts news:

Gen-Probe (San Diego) said it has agreed to extend and expand its blood screening collaboration with Chiron (Emeryville, California), a Novartis (Basel, Switzerland) business, ensuring the companies will work together to develop and commercialize molecular technologies designed to safeguard the world's donated blood supply until the year 2025.

Unlike standard serological testing, nucleic acid testing (NAT) detects viral RNA and DNA during earlier stages of infection, shortening the window period from infection to detection. Scientific models estimate that NAT reduces the infectious window period of HIV-1, HCV and HBV from 35% to 91%, compared with standard serological methods, according to the companies.

The collaboration between Gen-Probe and Novartis was established in 1998, and was scheduled to expire in 2013. Under the original terms of the agreement, the companies shared revenue from the sale of blood screening assays. Gen-Probe was responsible for manufacturing costs, while Novartis was responsible for commercial expenses. The companies shared R&D costs.

Under the revised agreement, Gen-Probe will continue to be primarily responsible for R&D and manufacturing. Novartis will remain responsible for sales and marketing of the products, but will collaborate more closely with Gen-Probe on sales, marketing and distribution strategies. In addition to sharing R&D costs, the companies will share manufacturing expenses. Gen-Probe also will receive a percentage of end-user revenue that escalates gradually from 2009 until 2015, and remains constant thereafter.

Novartis also has agreed to help fund development of Gen-Probe's Panther instrument, a fully automated molecular testing platform, for the blood-screening market. The companies also have agreed to evaluate, using Gen-Probe's technologies, the development of companion diagnostics for current or future Novartis medicines.

• Mirna Therapeutics (Austin, Texas), a subsidiary of Asuragen, and the University of Texas M. D. Anderson Cancer Center Science Park Research Center (Smithville, Texas) have entered a collaboration to investigate microRNAs in human prostate cancer. The principal investigators for the study are Dean Tang, MD, PhD, associate professor in the division of carcinogenesis and adjunct associate professor in the College of Pharmacy, The University of Texas and David Brown, PhD, director of discovery, from Mirna.

According to Mrina, Tang has been a pioneer in identifying and characterizing prostate cancer stem cells and evaluating their role in the initiation, progression, and metastasis of human prostate cancer. Tang is actively pursuing therapeutic strategies for inducing senescence and apoptosis in prostate cancer stem cells.

Brown brings several years' experience developing technologies for the isolation, detection, and functional characterization of small RNA including microRNAs (miRNAs), the company noted. He has been applying these technologies at Mirna and Asuragen to identify miRNAs as diagnostic and therapeutic targets in human diseases, particularly cancer.

Asuragen is a diagnostic company and molecular biology service provider, focused on molecular oncology and genetic diseases, with emphasis on miRNA.

Response Genetics (Los Angeles), a company focused on the development of molecular diagnostic tests for cancer, reported signing a nonexclusive license with Roche Diagnostics (Indianapolis) for the use of Response Genetics' polymerase chain reaction (PCR) analysis to assess human epidermal growth factor type 2 (HER2) gene expression.

The company noted that the accurate measurement of HER2 gene expression can assist physicians with treatment decisions for patients with cancers in tissues such as breast.

Aspyra (Calabasas, California) said that it has contracted with Glendale MRI Institute (Glendale, California), a multi-modality imaging center, to upgrade the center's existing Aspyra PACS to the most current release, version 6.4, as well as implement the company's RIS solution, thereby resulting in the use of Aspyra's integrated RIS/PACS solution by the center.

Glendale MRI has been an Aspyra PACS customer since 2003. Performing more than 10,000 studies annually, the center offers various outpatient imaging services, including MRI, PET/CT, CT, Bone Densitometry and Ultrasound.

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