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Biotechnology Summit In Frisco

Future triumphs over serious diseases will come from further studies of the human genome, despite the disappointing experiences of some drug firms so far, a pioneer in the field said Tuesday at the biotechnology industry's annual conference in San Francisco.

Research on variations in DNA sequences between sick and healthy people has identified tens of thousands of genes that play a role in causing illness, said Dr. Francis Collins, director of the National Institutes of Health's National Human Genome Research Institute.

Drug developers joining Collins in a panel discussion at the BIO 2004 convention at the Moscone Center, however, said the abundance of information produced by the Human Genome Project and follow-up research has overwhelmed companies with choices of genes to go after, without yet boosting the rate of new drug approvals.

"We are now drowning in targets,'' said Toni Schuh, chief executive of Sequenom Inc. of San Diego, which uses rapid gene-sequencing technology to aid its own drug discovery and help other firms set research priorities. "There must be a desperate need for a navigation tool among all these targets.''

Companies that try to develop drugs based on intriguing new leads from genomic research have often faced drawn-out studies and high failure rates, said Nicholas Dracopoli of Bristol-Myers Squibb.

"I think our optimism has led us ahead of what the technology could deliver,'' Dracopoli said. Firms are now focusing greater resources on a more limited number of gene targets, he said. They're also hedging their bets by balancing their efforts between newly discovered genes and better-known disease mechanisms.

It's been only four years, Collins noted, since a draft of the human genome sequence was released, and a year since the final sequence was completed. Even with the genome, developing a drug that's effective and safe can take a decade.

"I think there was a bit of over-optimism and, I think, naive belief that the genome would result in cures for disease in a week,'' Collins said.

But he said the tools of genetic analysis have become faster, cheaper and more accurate. They can be used to sort out the crucial disease genes to block and can help researchers evaluate the genetic make-up of individuals to predict which patients will do best on which medicines, he said. "I would be amazed if the genome hasn't made a major contribution to medicine by 2015,'' he said

 
US Food and Drug Administration approves health claim for barley

The US Food and Drug Administration (FDA) has authorized use of a health claim for the role of beta-glucan soluble fiber from barley in reducing the risk of coronary heart disease. The interim final rule was published in the Federal Register on December 23, 2005 and is in response to a petition submitted by the National Barley Foods Council. Authorized use of the interim claim in barley food labeling is effective immediately.

The National Barley Foods Council submitted a health claim petition to the FDA in 2004 requesting that the agency amend the existing “Soluble fiber from certain foods and coronary heart disease health claim” at CFR 101.81 to include barley as a source of beta-glucan soluble fiber associated with reducing the risk of coronary heart disease. The claim is based on consuming 3 grams of beta-glucan soluble fiber daily.

In its review of the scientific evidence provided in the Council’s petition, the FDA noted that five clinical trials testing the impact of consuming whole grain barley and dry milled barley products consistently reported statistically significant lower serum total and LDL-cholesterol levels. In the trials, subjects consumed diets in which whole grain barley or dry milled barley product ingredients replaced wheat and rice ingredients. The lowest daily dietary intake of barley beta-glucan soluble fiber that significantly lowered serum total and LDL-cholesterol reported in the trials was three grams per day. A 2004 study reported a 6 percent and 8 percent reduction in LDL cholesterol following consumption of diets containing barley with 3 grams and 6 grams of beta-glucan soluble fiber, respectively. For more specific information on barley clinical trials, click here.

The FDA has identified several sources of barley beta-glucan soluble fiber that are eligible for the health claim. These include whole grain barley, barley bran, barley flakes, barley grits, barley flour, barley meal, sieved barley meal and pearl barley produced from clean, sound dehulled or hulless barley using standard dry milling techniques. To qualify for the health claim, a food made from these sources must contain at least 0.75 grams of barley beta-glucan soluble fiber per serving.

In its decision to issue the interim ruling, the FDA took into consideration the fact that coronary heart disease continues to be the leading cause of death and permanent disability in the United States. The FDA noted that allowing manufacturers of qualifying barley food products to use an interim health claim prior to a final ruling may result in a reduction in the risk of heart disease by helping at-risk consumers make healthier food choices now.

“Research has long shown that barley holds tremendous potential as a healthful food choice,” says Mary Sullivan, executive administrator of the National Barley Foods Council. “The scientific evidence on barley beta-glucan soluble fiber and its ability to reduce cholesterol is indeed significant and we are pleased that the FDA agrees with the findings and has authorized this claim. We expect to see a definite increase in new barley foods product development as this grain offers food manufacturers great versatility in its use as a viable and heart-healthy ingredient in prepared foods for all day-parts. It is indeed an exciting time for the US barley industry.”
The National Barley Foods Council is a not-for-profit 501 (a) organization based in Spokane, WA. Its membership is comprised of five state barley producer groups including the Idaho Barley Commission, Montana Wheat and Barley Committee, North Dakota Barley Council, Oregon Grains Commission and the Washington Barley Commission.

Federal Register:
Full transcript of the FDA’s interim final ruling:
Click here

 
Some developing countries are advancing biotech research

6 May 2005 – Most of the genetically modified (GM) crops commercialized in developing countries have been acquired from developed countries, but several developing countries are doing significant research in the biotechnology of both GM and non-GM crops, the United Nations agricultural agency said today.

Using a two-year-old database, FAO-BioDeC, which has about 2,000 entries from 71 developing countries, the Food and Agricultural Agency (FAO) predicts that some of these countries could soon have new GM crops, such as virus-resistant papaya, sweet potato and cassava, as well as rice tolerant of such abiotic stresses as salinity and drought.

The database stores “updated baseline information on the state-of-the-art of crop biotechnology products and techniques, which are in use, or in the pipeline in developing countries,” FAO says.

“Information was obtained from published literature, surveys carried out by ISNAR (International Service for National Agricultural Research) as well as information collected by FAO through fact-finding missions and expert consultations.”

It shows that Argentina, Brazil, China, Cuba, Egypt, India, Mexico and South Africa are leading the research advances on such crops as banana, cassava, cowpea, plantain, rice and sorghum, and on traits needed for food security, such as abiotic stress tolerance and quality. China is also working on improving goats.

The database also points out research gaps, FAO says. No research was reported on resistance to the tiny worm-like creatures called nematodes, despite the considerable losses they cause, and no research was being done on reducing post-harvest losses.

Many non-GM biotechnologies are being used commercially, but only a few studies have been carried out to assess their socioeconomic impact, it adds.

 
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