BioWorld Today Correspondent

SAN DIEGO - While biomarkers offer the promise of informing drug discovery, reducing attrition in development and improving treatment outcomes, actually qualifying, validating and introducing them to clinical practice is a complex and costly process.

"It is a vast field with thousands of potential candidates that require extreme testing and qualification for practical use," Tom Insel, director of the National Institute of Health's Institute for Mental Health said in a session on "Accelerating the Identification and Development of Biomarkers for Human Health Through Public-Private Partnerships," at the 2008 Biotechnology Industry Organization meeting.

Two parallel public/private consortia have been set up in the U.S. and Europe to bring together pharma and biotech with regulators, academics, public research funders and patient groups, to work on developing biomarkers in a precompetitive environment.

In the U.S., the Biomarkers Consortium was set up in 2006 with the backing of the NIH, the FDA and the Centers for Medicare & Medicaid Services, along with 23 pharma and biotech companies.

Its counterpart in Europe, the Innovative Medicines Initiative, involves 26 pharma companies that are putting in time and research valued at €1 billion (US$1.56 billion) over 10 years. That will be matched by €1 billion from the European Commission, which will be disbursed as grants to academics and small biotechs that partner with pharma on specific peer-reviewed projects.

David Wholley, director of the Biomarkers Consortium, told attendees that the body brings together a diverse group of stakeholders to combine their expertise around a common mission, "and do something none of the partners could do separately."

The consortium is tackling biomarker development along the continuum from discovery to the bedside, focusing on four areas: cancer, inflammation and immunity, neuroscience and metabolic disorders. Proposed programs first are scrutinized for their scientific value before the work program is put in place. To date, four have been approved, three in imaging and one in a biochemical marker.

Two of the approved programs are looking at fluordeoxyglucose positron emission tomography as a biomarker for assessing response to treatment in clinical trials in non-Hodgkin's lymphoma and non-small-cell lung cancer.

The $6.4 million to pay for that is coming from nine pharma and biotech companies with core funding from the National Cancer Institute.

Another approved program, considering the use of adiponectin as a biomarker of predictive glycemic efficacy, will pool data from Phase II trials carried out by pharma giants GlaxoSmithKline plc, Eli Lilly & Co., Merck & Co. Inc. and F. Hoffmann-La Roche.

The information will be analyzed by independent third party statisticians to see if there is a connection, with results due in September.

"It would be hard to do this without the consortium because of antitrust, the need to involve lawyers and so on," said Garry Neil, vice president, corporate office of science and technology at Johnson & Johnson. "Validating biomarkers increases complexity and cost, and that's why the consortium is useful," he added.

According to Neil, the main driver for developing biomarkers is ongoing failure in Phase III, with 50 percent of products getting the ax at that later stage. "Biomarkers have increased earlier attrition, but late-stage surprises are still happening."

Beyond that Phase III focus, biomarkers could revolutionize health care. But much work is needed to realize their value. "We have to contemplate new reimbursement models, to change clinical practice and change product development to include biomarkers," Neil said.

ShaAvhree Buckman, acting head of translational research at the FDA, agreed that the impact of biomarkers will be profound. "While [they] are not new, there is a new sense of their potential to make a contribution across drug discovery and development."

In the past month, the FDA has tested out its pilot process for qualifying biomarkers, using it to assess seven biomarkers of preclinical nephrotoxicity. Buckman said that is a significant advance in the development of FDA structures for dealing with biomarkers.

Meanwhile, the European Innovative Medicines Initiative (IMI) was launched formally in February, and it put out its first call for grant applications in April.

One of the first topics is the qualification of translational safety biomarkers to improve predictability between preclinical and early clinical development. Twelve of the pharma partners will take part in this.

"We are trying to focus on fields of high industry and policy relevance," said Irene Norstedt, head of IMI.