A Medical Device Daily

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:

• Vidoop (Portland, Oregon), a provider of identity and authentication solutions to the healthcare and financial services industries, reported its authentication solution will be available to Microsoft (Redmond, Washington) HealthVault users to access and share health information online.

"Our objective is to give our customers choice and make their Web experience easier, while helping them safeguard their privacy," said George Scriban, senior product manager, Health Solutions Group, Microsoft. "We're happy to be working with Vidoop to give HealthVault users the option of using their log-in and authentication solutions with their HealthVault account."

HealthVault enables consumers to share health data with family members, healthcare providers and others they trust, and use it to make more informed healthcare decisions. Vidoop gives HealthVault users another option for secure login to easily access and control their personal information and medical records online. Vidoop's ImageShield replaces the traditional password field with an array of photos that are different with every login. When the ImageShield is presented, the consumer selects the images that fit pre-selected secret categories and are granted access to their medical records.

"Strong authentication does not have to be a source of frustration for healthcare providers or patients," said Joel Norvell, co-founder and CEO of Vidoop. "Our solution effectively defends against prevalent forms of hacking with a straightforward, intuitive process that limits access to personal information to authorized users."

Vidoop offers its single sign-on solution at no charge at www.myVidoop.com. Once a personal account is created, a simple registration process restricts access to that user's web browser. Strong authentication is achieved with a combination of a shared secret and a device activation method.

"The weakest point in Internet security is the front line – where users log-in – but with strong authentication the front line can become the strongest point," said Scott Kveton, Vidoop's VP of engineering.

• 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.

"Extending and expanding our agreement with Novartis enables us to continue providing innovative nucleic acid tests that protect the world's blood supply from dangerous pathogens, while benefiting from our partner's extensive global commercial presence," said Hank Nordhoff, Gen-Probe's chairman/CEO. "At the same time, it enables us to deliver significant additional economic value to our shareholders while minimizing financial and operational risk and potential disruption to an outstanding business."

Since 1998, Gen-Probe and Novartis have developed nucleic acid tests and instrumentation that have been used by blood banks to screen more than 125 million blood donations in the U.S. alone. These tests have intercepted thousands of units of blood that were infected with HIV-1, hepatitis C and B, and West Nile virus, thereby preventing life-threatening diseases from being passed along to transfusion recipients, the companies noted.

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.

• The Louisiana Department of Health and Hospitals (DHH; Baton Rouge) said it has tapped Upp Technology (Downers Grove, Illinois), a provider of healthcare IT solutions, to improve its emergency response and preparedness initiatives.

Upp has provided the industry's original Inventory and Resource Management System (IRMS) to the Louisiana DHH to manage critical inventories throughout the state's public health facilities and provide real-time information sharing with government and public health personnel statewide. The implementation included three regional warehouses, multiple clinics and central receiving points for delivery of the Centers for Disease Control and Prevention's (CDC) Strategic National Stockpile.

In addition, IRMS will streamline the registration, triage, and treatment of patients during large-scale events while monitoring vital patient and inventory data to ensure crisis response remains swift and proactive, according to Upp. Louisiana's solution also includes IRMS' architecture, which combines both a web-deployable application and mobile IRMS Go-Kits to ensure critical emergency management and response operations are performed regardless of the conditions, the company noted.

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