Critical path thinking

Immune Tolerance Institute, in collaboration with Beckman Coulter, establishes the Center for Critical Path Immunology

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SAN FRANCISCO—With a stated goal of creating a new, more effective model for the development of immune disease-focused therapeutics, the Immune Tolerance Institute (ITI) announced at the end of March a collaboration with Beckman Coulter to establish a Center for Critical Path Immunology. The new center will work with researchers in both academia and industry to identify and develop novel biomarkers to help guide drug development and provide companion diagnostics in an effort to advance critical path science.

"We are aware of the academic centers creating translational research centers in terms of taking the treatments to the patients quicker," says Stephen Hurst, ITI's CBO. "The issue is while those efforts do get research discoveries to benefit patients, they tend to be kept within the centers and are not resulting in new medicines. The FDA Critical Path Initiative is about increasing the number of medicines available not just within those centers, but in the broader healthcare setting."

The new ITI facility, located at Beckman Coulter's Cellular Analysis Business Group in Miami, will integrate genomic, cellular, proteomic and bioinformatics technology under a single roof. The intention is to provide a single lab with integrated, multiple assay platforms that can more effectively translate the identification of biomarkers into therapies to treat a broad range of diseases related to the human immune system.

The center will be equipped by Beckman, but staffed by ITI employees and will be headed by ITI's new CSO, Aaron B. Kantor (see "Kantor appointed chief scientific officer"), for ITI. Initially, the center will consist of a cellular analysis and flow cytometry laboratory with the anticipation of adding a genomics capability with multiplexed mass spectroscopy for real-time PCR feeding assay data into a powerful set of bioinformatics tools.

The bioinformatics piece is key, Hurst notes, because of the challenges of modern drug discovery. "I tell people that what we do is like trying to find a needle in a field with a hundred haystacks and you don't even know what the needle looks like," he says.

According to Dr. Louis Matis, president and CEO of non-profit ITI, the idea for the institute was inspired by the work that has been conducted over the past eight years by the Immune Tolerance Network (ITN). Matis himself was deputy director of ITN from 2000 through 2006. Yet, while the ITN is focused on autoimmune diseases such as asthma, allergy and transplantation with a mission to identify markers of immune tolerance, Matis says ITI's mission is broader.

"In those conditions the disease is exacerbated or mediated by immune activity," Matis says. "The ITI is interested in understanding the underlying biology of those diseases and mechanisms that can be defined better by biomarkers predicting drug safety and efficacy, but we are also very much interested in those conditions where the immune system, properly mobilized, could play a major role as part of a therapeutic armamentarium."

Matis points particularly to some forms of cancer which suppress the immune system and can be partially responsible for disappointing results in clinical trials of some cancer vaccines. Understanding these mechanisms and uncovering associated biomarkers could help guide more targeted approaches, he notes.

To help ITI start on this path, both Matis and Hurst maintain that it would be hard for them to pick a better collaboration than Beckman Coulter, based both on its broad range of tools and instruments to perform the necessary research and its position as a leader in the development of diagnostic tools.

In time, ITI managment intends to have its own free-standing facilities to provide a broad range of research platforms and assays available to those companies and organizations not able to create these capabilities in-house.

Future funding of the organization would come from grants from foundations and public funds, as well as fees generated by performing contract work at its center.

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