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P&G Pharma, Lee Hartwell, Oxford, Qualyst, Tm Bioscience, Epidauros Biotechnologie, Reaction Biology, NHGRI, Insilicos, FoxHollow, Rosetta Resolver, Stratagene, Toshiba

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P&G Pharma, Scuttling Internal Discovery, Will End Some Existing Vendor Contracts

Procter & Gamble Pharmaceuticals will retain some of its genomic-related alliances and end others after the company late last month decided to shutter its internal drug-discovery program..

"We are currently evaluating all of our discovery contracts," P&G spokesperson Tom Milliken said in an email message to Pharmacogenomics Reporter sister publication GenomeWeb News this week. "Some of them will remain open as originally planned, and others will not, depending upon the value that each adds to our new strategy." P&GP spokeswoman Paula Koenigs said the company's new strategy involves moving out of drug discovery and into external licensing agreements and drug acquisitions.

P&GP has many R&D collaboration with various genomic-related tool vendors. However, the company could not specify which would be affected by the closure.

The shuttered program means lost opportunities for existing collaborators, potential future allies, or past partners, such as Inpharmatica, which delivered model GPCRs last year to P&GP. The company last week said P&GP's decision closed the door for lead-optimization deals. "We could have expanded," said Vinod Mehta, senior vice president of business development at Inpharmatica. "Those opportunities in lead-optimization were affected."


The Biomarker Bottleneck Is in Discovery, Not Validation, Says Lee Hartwell

Proteomics researchers have not discovered enough cancer-related biomarkers, and they should modify and accelerate their research efforts if protein biomarker identification and validation are to have an impact in battling the disease, according to Nobel laureate Lee Hartwell.

Contrary to one theory that the problem with protein biomarkers lies in validating candidate biomarkers, Hartwell argued that validation and even approval are not the reasons why so few reliable protein biomarkers are known. "I put the problem squarely in discovery," he said yesterday during his talk at the second annual US HUPO meeting, held in Boston this week. "We are not discovering markers effectively."

"Basic science has not had a big impact on cancer yet," said Hartwell, who is also president and director of the Fred Hutchinson Cancer Research Center. "There's an enormous opportunity ... for the whole proteomics industry and technologies to really have an impact on cancer."

He said in particular that improving molecular diagnostics will be the "most important thing" along that path.

Hartwell pointed out that while much scientific effort has gone into finding common SNPs that correlate to risk association for cancer, he believes protein biomarkers will be more effective in risk assessment, early detection, and cancer prevention. "Proteins are going to be even more informative" than the DNA-based diagnostics scientists use today, he said.

The discovery phase for biomarkers should be ramped up and multiplexed, he said. Whereas traditional drug discovery is limited to putting just one therapeutic in a patient or model organism at a time, a single serum or tissue sample from a patient can serve as a test for thousands of biomarkers at once, said Hartwell. Multiplexing in this way could make trials much more high-throughput and accelerate protein biomarker discovery, he said.

Hartwell also highlighted a need for efficient, low-cost assays to develop and validate candidate biomarkers. ELISA tests remain very expensive and time-consuming; scientists need highly sensitive assays that are far less costly and don't require them to develop two antibodies for each protein, he said. "I'm hopeful that within the next couple of years the bottleneck of assay development will not be limiting anymore."

One approach to dealing with this problem, and others related to proteomic technology, is working in very organized teams following the model laid out by the Human Genome Project, Hartwell said. Several such international biomarker-discovery teams already exist — he listed 11 in his talk — that have chosen to tackle a specific cancer. The teams, which are required to include expertise in mass spec, informatics, antibody development, clinical work, and mouse model research, are organized under HUPO. Anyone is welcome to form a team and take part. "I think the main value of participation is going to be learning from one another what works," Hartwell said.


Oxford and Qualyst Pen Metabolism Assay Deal

Oxford Biomedical Research and Qualyst have inked a deal to create a product line of cytochrome P450-inhibition assays to be sold as Accuratet, the companies said this week.

Under the deal, Qualyst is granting Oxford an exclusive license to manufacture and distribute its CYP activity analysis technology.

The first assay to be developed will detect the inhibition of CYP3A4, according to a statement.

Financial details were not revealed.


Tm Bioscience Licenses P450 PGx Marker from Epidauros Biotechnologie

Tm Bioscience said this week that it has taken a co-exclusive commercial license to Epidauros Biotechnologie's patents on a specific biomarker related to the P450-CYP2D6 gene.

Under the terms of the agreement, Tm Bioscience will provide an upfront signing fee and royalties on sales of P450 Tag-It tests that include this biomarker.

Roche Molecular Systems is the only other company that has a license to the CYP2D6 genetic marker, and has incorporated the marker into its AmpliChip CYP2D6 test. Tm Bioscience and Epidauros, which is based in Bernried, Germany, have negotiated an agreement whereby no other licenses for this variant will be granted in the future, the companies said.


Reaction Biology Gets $1.8M from NHGRI for HTS Microarray Technology

The National Institutes of Health has awarded Reaction Biology $1.8 million over four years for development of its microarray-based high throughput screening technology, the company said this week.

The grant is one of eight awarded under RFA RM-04-020, which the National Human Genome Research Institute issued in July 2004 as part of the Molecular Libraries and Imaging Initiative of the NIH Roadmap.

Reaction Biology said that it is the only private corporation to receive an award under the RFA. Other recipients include the University of Texas, the University of Chicago, Harvard University, the University of Houston, the Burnham Institute, UT Battelle, and the University of California, Davis.

Reaction Biology said that the grant will support further development of its spray deposition technology for high-throughput screening reaction activation, as well as the development of enhanced microarray printing technology for use in its DiscoveryDot HTS system.


Insilicos Awarded $400K to Develop Heart Disease Diagnostics

The National Heart, Lung, and Blood Institute has awarded Insilicos a two-year, $400,000 grant to develop a blood test for heart disease, the company said this week.

Insilicos said it would use patent-pending computational and biological methods to analyze blood samples for the test, which will help identify patients at risk for heart attacks.


FoxHollow Licenses Rosetta Resolver for Atherosclerosis Project with Merck

FoxHollow Technologies has licensed the Rosetta Resolver system for research on cardiovascular disease, Rosetta Biosoftware said this week.

FoxHollow will use the application to correlate genetic profiles of human atherosclerotic plaque samples to develop therapies, according to a statement. The data for analysis comes from a September 2005 pharmacogenomic collaboration between FoxHollow and Merck.

Financial details were not released.

Rosetta Biosoftware is a business unit of Rosetta Inpharmatics, which is a wholly owned subsidiary of Merck.


Stratagene's Texas Facility Receives ISO Registration for Medical Devices

Stratagene's manufacturing facility in Cedar Creek, Texas, has been awarded International Organization for Standardization 13485 registration, the company announced this week.

ISO 13485 is the international standard specific to medical device development, production, and servicing.

Stratagene's Garden Gove, Calif., and Edinbugh, Scotland, facilities have already been granted ISO 13485 registration.


Toshiba Licenses DNA Chip Patents to Antara, Says Move is 'Major Step' in Its IVD Plans

Antara Biosciences has licensed from Toshiba patents to its DNA chips and electrochemical DNA analysis system for in vitro diagnosis, Toshiba said last week.

Under the agreement, Antara, a California-based company started by the Tokyo-based Eurus Genomics, will develop the products for US Food and Drug Administration approval.

Toshiba said the deal "is a major step ... toward establishing the methodology as a core methodology for DNA-based diagnostics."

Financial details were not released.


Korean NIH Partners with Affy for Genome-Wide Association Studies

Korea's National Institute of Health will use Affymetrix's Human 500K Mapping Set to perform genome-wide association studies in several disease areas, including diabetes, hypertension, and metabolic syndrome, Affy said last week.

According to Affymetrix, the Korean NIH will work with academic and industry partners to generate more than 10 billion individual genotypes from 20,000 human DNA samples to help identify the genetic causes of these diseases using Affy's technology.

Financial details of the agreement were not discussed.


Helicos BioSciences Closes $40M VC Financing Round

Helicos BioSciences said this week that it has secured $40 million from its current roster of investors to help it develop its DNA sequencing technology.

According to Helicos, the financing was provided by Flagship Ventures, Atlas Ventures, Highland Capital, MPM Capital, and Versant Ventures. The latest funding follows an initial investment of $27 million by the same group of investors, made when the company was founded in February 2004.

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The Scan

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Purnell Choppin Dies

Purnell Choppin, a virologist who led the Howard Hughes Medical Institute, has died at 91, according to the Washington Post.