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Rep. Slaughter, FDA, Tm Bioscience, Compugen, Teva, Mayo Clinic, U of Minnesota

Rep. Slaughter Testifies Before House Subcommittee Urging For Passage of Stalled Genetic Nondiscrimination Bill
Rep. Louise Slaughter, a Democrat from New York, testified this week before a subcommittee in the US House of Representatives, urging legislators to pass the Genetic Information Non-discrimination Act (H.R. 493).
“For the potential of genetic technology to be realized, we need to make genetic testing something that is commonplace, rather than something that is feared,” Rep. Slaughter said in her testimony to the Health, Employment, Labor, and Pensions Committee’s Education and Labor Subcommittee. “But sadly, ongoing genetic discrimination is making men and women ever less likely to be tested and to participate in clinical trials.”
“GINA will do more than stamp out a new form of discrimination, as important as that is. It will also help our country to be a leader in a field of scientific research that holds as much promise as any other in history.”
GINA has been stalled in the US Congress for 12 years. Although the Senate unanimously voted in favor of the bill when it was introduced in 2003 and 2005, until now the legislation has never before come to a vote in the House due to political opposition.  
Slaughter reintroduced the bill in the House with Rep. Judy Biggert, a Republican from Illinois, as well as with the support of more than 150 representatives. The bill was also reintroduced in the Senate to be marked up last week.
Genetic Alliance CEO Sharon Terry recently told Pharmacogenomics Reporter that the bill has been held up for over a decade because the former chairmen of the three committees with jurisdiction over the bill — Ways and Means, Education and Labor, and Energy and Commerce — would not let it come to a vote.
Now, with a Democratically controlled Congress, President Bush’s recent backing of the bill, and legislators’ emphasis on GINA’s importance for the advancement of personalized medicine, the bill appears to have improved chances of passage.
In a statement this week, Affymetrix lauded the House subcommittee for holding the hearing, ‘Protecting Workers from Genetic Discrimination.’
“We would like to thank the … subcommittee for taking an important first step in the passage of [GINA] with today’s hearing,” said Robert Wells, Affy’s VP of international market groups and corporate affairs. “For the past six years, Affymetrix has played a leading role in helping to prevent the misuse or abuse of genetic information and ensure that the American people continue to benefit from the tremendous advances in genomic technology.”
The array company is part of the Coalition for Genetic Fairness, which also includes as members Genetic Alliance and the American Society of Human Genetics, among others.

In Era of 'Dismal' FDA Performance, It Helps to Be a Companion Dx/Rx Product, Lawyer Says
Financial cutbacks, under-trained and overworked reviewers, widespread risk aversion, and eroding morale at the US Food and Drug Administration are hurting the agency’s ability to effectively review new drugs, according to a prominent regulatory lawyer.
However, pharmacogenomic-based companion drug-diagnostic products can typically overcome this environment because they receive special treatment from senior agency officials, said the lawyer, Bruce Mackler, founder of the Life Sciences Management Group in Rockville, Md.
The FDA “is performing dismally,” Mackler said this week at Biotechnology 2007, a two-day conference sponsored by Law Seminars International held in San Francisco. “The FDA is facing low appropriations, loss of revenue, and more mandates,” he said. “What are they doing? More work for reviewers. They don’t have the time. That’s the problem.”
“Training is not good, [there are] cutbacks in labor,” and there is concern “in the trenches” that superiors will not always stand behind regulatory decisions. This concern has led reviewers to become more “cautious” in their decision making, Mackler said.
According to Mackler, 32 percent of all drugs that the FDA approved in 2006 were “innovative” — that is, new entities — whereas 68 percent were “approvals to changes in older drugs,” which can be updates such as new formulations or delivery systems. “This is because it is safer for the reviewer to make this kind of approval,” he said.
In addition, sponsors won’t necessarily solve these challenges by crossing the Atlantic — a common strategy for drug and diagnostic companies, which view the European Union as a relatively safe and swift launching pad for new products. The reality, said Mackler, is that “no matter how much we complain about the FDA, EMEA [the European Agency for the Evaluation of Medicinal Products] is doing worse.”
For example, 52 drugs approved by the European regulatory body were on average approved by the FDA 11 months earlier, he said. “Everybody for a long time has been saying, ‘Go to Europe and get an early approval,” said Mackler. “The real issue is that the FDA is approving them faster than Europe.”
How will this environment affect pharmacogenomic-based drug discovery? “Drug-device combinations are the thing to do,” Mackler said.
Although approvals of innovative products represented a minority of FDA green lights last year, Mackler said that when it comes to reviewing companion products, officials from the office of FDA Commissioner Andrew von Eschenbach participate in meetings for all stages of the drug-approval process.
“When you have someone from the commissioner’s office sitting in … you get much better input from the division,” said Mackler. “That oversight helps” reviewers become more confident and make better decisions, he added.
Otherwise, he said, “innovations are great, but no one is going to take the risk of telling you what to do until you do it, and then they’ll tell you what you didn’t do right.”
Officials from the FDA did not immediately return an e-mail request seeking comment. However, Felix Frueh, associate director of genomics at the FDA, recently told Pharmacogenomics Reporter that drug/device codevelopment may be the best way to introduce patients and physicians to personalized medicines.

Tm Bioscience to Supply Reagents for Mayo/Medco Warfarin PGx Study
Tm Bioscience said this week that it will supply reagents to Medco Health Solutions and Mayo Collaborative Services for a joint clinical study of warfarin patients.
Under the agreement, Mayo and Medco will use Tm’s Tag-It reagents for P450-2C9 and VKORC1 in a study to determine whether genetic tests can cut costs and improve care for patients taking the blood-thinner warfarin.
In the study, originally announced in December, Medco and Mayo will perform genetic tests on 1,000 individuals taking warfarin, a common blood thinner used to prevent clotting in more than two million US patients each year.
The study aims to use the genetic tests to help physicians administer personalized dosages. One in five warfarin patients suffer “mild to severe” bleeding, said Mayo medical director Thomas Moyer. 
The study is expected to be complete by the end of 2007.
Financial terms of the agreement were not disclosed.
On Feb. 23, Tm shareholders will vote on whether to accept a stock-for-stock acquisition offer from Luminex, which hopes to expand the company’s reagent marketing opportunities through its international sales network.

Compugen to Collaborate with Teva on Toxicity Biomarker Discovery
Compugen this week said it has signed a collaboration with Teva Pharmaceuticals to discover biomarkers that could predict nephrotoxicity.
The agreement also may be expanded to include biomarker development for hepatoxicity and cardiotoxicity, Compugen said.
Under the agreement, Compugen will use its computational tools and nucleic acid testing technologies to analyze biological samples collected by Teva in a preclinical study.
Teva will have a license to use the discovered markers for its internal R&D programs, while Compugen has retained rights to license the markers to other companies, as well as rights for internal use.
Ana Cohen-Dayag, Compugen’s vice president of diagnostic biomarkers, said in a statement that the company will use predictive platforms it developed for immunoassay diagnostic collaborations to develop the biomarkers, which will enable early-stage identification of toxicity. 

Mayo Clinic, U of Minnesota Open $22M Genomics Facility
A Minnesota research collaboration headed by the Mayo Clinic has established a new genomics and bioinformatics facility in Rochester, Minn., the Minnesota Partnership for Biotechnology and Medical Genomics said last week.
The facility, a three-story addition to a space in downtown Rochester, will house genomics research equipment, a bioinformatics lab, and conference rooms to support the partnership’s research initiatives.
The state legislature provided $21.7 million in backing for the facility, which is the product of a partnership involving the Mayo Clinic, the University of Minnesota, and the State of Minnesota.
The Minnesota Partnership said ongoing research includes "anti-cancer drug development, heart disease, pancreatic cancer, neuromuscular diseases, tuberculosis, auto-immune diseases, transplant rejection, drug addiction and tuberculosis."
Describing itself as "a unique collaborative venture," the Minnesota Partnership aims to head the region’s biotech and genomics sector.

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