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Biomarker Consortium Debuts New Protocol As it Preps New Projects, Including Proteomics

The Biomarkers Consortium, a private-public partnership with the goal of supporting biomarker research for new drug development and improved patient care, this week announced a new strategy that comprises a framework for identifying and supporting biomarker-directed research, including proteomic markers.
Given the large amount of research being done in biomarkers, the strategy, called the High-Impact Biomarker Opportunities, is meant to help the consortium sort out the most meaningful and efficacious biomarker projects, officials said.
The announcement, made at the Biotechnology Industry Organization’s International Conference in San Diego this week, comes as the consortium readies to launch five to six new projects, including a proteomics-directed one, as part of its effort to move what it believes are the most promising biomarker research projects through the discovery and validation pipeline and into the clinic and drug companies.
HIBO is the result of changes made by the Biomarkers Consortiumin the way it issues grants to applicants. Created in late 2006, the consortium aims to identify biomarker projects in four disease areas: cancer, neurological, metabolic, and immunity disorders.
That focus remains, but the consortium hopes to streamline and improve how it solicits grant applications by proactively seeking out research that its members believe is more closely aligned with its mission.
During its first year, the consortium received about 50 grant proposals that eventually resulted in the funding of four imaging-oriented projects, David Wholley, the recently appointed director of the consortium, told ProteoMonitor this week.
“But the realization was that what people mostly do in these situations is send in the projects that cannot get funded elsewhere, or they’re very good projects but they don’t quite fit the consortium’s [goals],” he said. “And it takes an awful lot of time and energy to figure out what fits, and what doesn’t, and why.”
The HIBO initiative was designed to remedy this by setting up several criteria for the consortium to use as it considers projects. These include considering whether the research addresses an unmet scientific or medical need; is practical by determining if it can be translated to the clinical setting; and is feasible in terms of funding and other support in order to run its course.
In a statement, Charles Sanders, chairman of the consortium’s Executive Committee and chairman of the board of the Foundation for the National Institutes of Health, which manages the consortium, said that new strategy will result in projects that have the “greatest and most proximal impact on future diagnosis and treatment of patients and drug development, helping the medical community realize the promise of personalized medicine.

The proteomics field is flush with biomarker research, and the consortium is interested in the “low-hanging fruit … taking a look at markers that would not be the subject of a typical NIH R01 grant, but have come enough of a distance to where they really need the joint energies of the NIH, industry, and FDA to push them over the line in [validation].”

“This strategic focus will help ensure the Biomarkers Consortium is implementing the most important biomarker projects with the broadest cross-sector support,” he added.
Four steering committees, one for each of the four disease areas in which the consortium is focused, will decide which projects the consortium will support. Each committee comprises between 10 and 20 individuals from private industry, academia, the non-profit arena, and various government agencies.
Industry partners include Merck, Pfizer, AstraZeneca, and Digilab Biovision; non-profit partners include BIO, the American Association for Cancer Research, and the Advanced Medical Technology Association; government participants include the NIH, the US Food and Drug Administration, and the Centers for Medicare and Medicaid Services.
While each of the consortium’s four original projects centered on imaging technology, most of the projects expected to begin later this year will use biochemical technologies, Wholley said.
Imaging has been a promising area for biomarker research, he said, but “as proteomics and these other technologies mature … there certainly will be an equal emphasis on those over the longer term.”
The consortium has identified about six potential projects and though a final funding decision is pending, Wholley said it’s likely each will move ahead as research funded by the consortium. The proteomics one involves about 70 protein signatures identified by researchers working on the Alzheimer’s Disease Neuroimaging initiative — a five-year, private-public project to develop new treatments for the disease — as promising candidate biomarkers.
The consortium is interested in validating the biomarkers, which were identified in earlier proteomics work, “to figure out how they work in terms of disease progression and in terms of pharmacological intervention, effects, and trials for Alzheimer’s disease,” Wholley said.
Low-Hanging Fruit
The announcement of HIBO comes amid criticism within and without the proteomics community about the quality of work being conducted in the field and the relative poverty of viable candidate markers. At both the international Human Proteome Organization and US HUPO annual conferences, speakers talked at length about the need for more rigorous research criteria [See PM 10/11/07, 10/18/07, and 03/20/08].
The consortium is one means of trying to improve the science of protein biomarker work by ensuring that the most-qualified biomarkers can move through the validation pipeline and possibly beyond, Wholley said. The proteomics field is flush with biomarker research, and the consortium is interested in the “low-hanging fruit … taking a look at markers that would not be the subject of a typical NIH R01 grant, but have come enough of a distance to where they really need the joint energies of the NIH, industry, and FDA to push them over the line in [validation],” he said.
The idea is to further push along research in which “the scientific needs meet those of industry and those of FDA,” Wholley said, and to validate results in “actual practice in such a way that industry is going to use it, and FDA is going to say ‘Yes, this is going to have some relevance for regulatory decision-making.’”
The initial four projects received about $12 million in cash and in-kind funding, Wholley said. Funding amounts for the next group of projects have not yet been determined but should exceed the levels for the original projects, he added.
While the consortium is not focused on tools and instrument development, it is interested in research that validates technology.
“If it’s something that really appropriately belongs in a particular industry pipeline, then we’re not considering those kinds of things,” Wholley said. “Our goal is really to take everything that we work on and then publish the results to make them broadly and immediately and publicly available, so we raise all boats.

“This is really not commercial development,” he added. “If it’s something that a VC should be supporting or a pharmaceutical company should be supporting, then let them do that.”