Wired: Unhappy With New Stem Cell Source? Then Stop Having Sex

From Wired Blog Network:

Unhappy With New Stem Cell Source? Then Stop Having Sex
By Brandon Keim January 28, 2008 | 12:52:02 PM

http://blog.wired.com/wiredscience/2008/01/disapprove-of-n.html

Scientists have produced embryonic stem cells from embryos that would otherwise be thrown away.

The findings, published yesterday in Nature Biotechnology by researchers from Children's Hospital Boston, raise hopes -- again -- of an ethically acceptable source for the potentially miraculous, highly controversial cells.

If the latest cells don't satisfy critics, says a prominent bioethicist, the critics might want to stop having sex.

Embryonic stem cells, or ESCs, have the power to become any other type of cell. They might someday be used to replace diseased or failing tissue. But the best source for ESCs is week-old human embryos. The embryos are destroyed during harvesting, drawing charges of murder from religiously conservative critics. President Bush has limited federal funding for ESC research, and the controversy has slowed ESC progress in the United States.

The last several months have produced a few alternatives to old-fashioned ESCs. Researchers in Japan and the United States made ESC-equivalents from adult skin cells; another group figured out how to get ESCs without harming embryos more than they already are by a common gene-screening technique. However, neither ESC source is ready for prime time: so-called reprogrammed cells aren't medically viable, and the harm caused by blastomere biopsy still provokes ethical objection. Old-fashioned ESC sources are still best; the controversy continues.

Enter the Children's Hospital Boston researchers, who showed that "flawed" embryos, hundreds of thousands of which are produced every year by in-vitro fertilization clinics, can be used to generate embryonic stem cells. The embryos, too genetically defective to be implanted in a woman, are usually discarded; they were previously considered too defective to make ESCs. Since the embryos can't ever become people, and are headed for the incinerator anyways, how could it be wrong to destroy them in research?

I put this question to University of Pennsylvana bioethics professor Arthur Caplan. Said Caplan,

I think it makes eminent good sense. Clinics are constantly putting aside embryos that don't look right or are developing incorrectly. Occasionally those embryos are used in training embryologists. So it seems to me not to be a big moral step to say, "Why not use them for research purposes?"

Some would say they're still disabled -- so they're not persons, but disabled persons. That's a bogus metaphor. They're not disabled, they're inabled. They lack potential. They can't become anything in terms of human growth. Their programming is so seriously wrong that they're not believed capable of becoming a fetus. I think the position that a severely abnormal embryo headed for destruction might not be used in research just doesn't take seriously the moral need for doing some research. It's turning a moral position that might be defensible -- non-destruction -- into a moral fetish.

There's no way you can avoid creating malprogrammed embryos. Nature does it. It's going to happen in the clinic, too. So to object, you're going to have to move toward a position that says, "No sexual activity for fear that we might make malformed embryos naturally." Again, I think it's an incoherent position. In nature, many eggs and many embryos don't work. Of human eggs, about 5 percent work properly. In nature, I believe around 20 percent of embryos work properly. You have tremendous loss of both eggs and embryos. Reprodction is a very difficult thing to make work properly by sexual relations. It fails far more often than it works. If you're going to fetishize the embryos, you're going to say, "I can't have sexual relations because I have to preserve every embryo."

That likely won't prove a popular position, though it would certainly settle the whole stem cell debate in a few generations. (Insert your riff on the Shakers here.)

However, Caplan cautioned that "the very things that make these embryos unavailable for making babies might turn out to disqualifying in terms of whether they can make useful stem cells." The Nature Biotechnology study was an excellent proof of principle, but we still need to see if the cells work.

Icahn Goes to War With Biogen-Idec

From Bloomberg News:

Icahn Targets Biogen With Board Candidates, Criticism

By Luke Timmerman and Elizabeth Lopatto

Jan. 28 (Bloomberg) -- Billionaire investor Carl Icahn said he plans to nominate three people to Biogen Idec Inc.'s board and criticized the company's earlier attempt to find a buyer as ``flawed.''

Biogen refused to let bidders talk to Irish drugmaker Elan Corp., its partner in the multiple sclerosis treatment Tysabri, Icahn said today in a regulatory filing. Biogen's sale process also included a confidentiality agreement ``so restrictive'' that it prevented potential acquirers from bidding, Icahn said.

Biogen, based in Cambridge, Massachusetts, lost more than $5 billion in market value on Dec. 13 after abandoning its plan to sell the company when it received no offers. Biogen started looking for a buyer in October after Icahn offered $23 billion for the company and said it was worth more.

``Biogen's recent purported attempt to find a suitor was not conducted in a way to enhance the success of the endeavor,'' Icahn said in the filing. ``We believe the process was flawed in a number of key respects and that the process was run to placate us and other large shareholders.''

The company fell 79 cents, or 1.3 percent, to $58.13 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The stock has gained 22 percent in the past 12 months.

Nominees

Icahn's nominees are Alexander J. Denner, who manages investments controlled by Icahn; Anne B. Young, a neurology professor at Harvard Medical School, and Richard Mulligan, a genetics professor at Harvard Medical School. Denner and Mulligan are directors at ImClone Systems Inc., a biotechnology company controlled by Icahn, who serves as its chairman.

``We ran what can only be described as a comprehensive, thorough sale process that was in keeping with industry standards,'' Naomi Aoki, a Biogen spokeswoman, said today in a telephone interview in response to Icahn's announcement.

Biogen's board currently has 12 members, four of whom are standing for election this year, Icahn said in the statement. Icahn's group, Icahn Partners LP, and its affiliates also proposed a change in the bylaws to permanently set the size of Biogen's board at 12 members, Biogen said.

Biogen's board said in a statement today it will review Icahn's notice and ``consider it in light of the best interests of all shareholders of the company.'' No date has been set for the annual meeting, which has traditionally been in April or May, Aoki said.

Increased Holdings

Icahn held 12.4 million shares, or 4.2 percent, of Biogen, as of Jan. 25, he said today in a regulatory filing. The investor is known for buying into companies he deems undervalued and pressing for changes or a sale. As of Sept. 30, he owned 8.8 million shares, according to data compiled by Bloomberg.

``I'm sure he's trying to influence the management team,'' Eric Schmidt, an analyst with Cowen & Co., said in a telephone interview today. ``He may also be rabble-rousing to increase awareness that this is still an acquisition candidate.''

Besides questioning the sale process, Icahn said he reserves the right to oppose any bids Biogen may make to buy a smaller company. That could make Biogen less attractive to potential acquirers, Icahn said.

Last year, Icahn increased his holdings of MedImmune Inc. by almost 50 percent before the company agreed to be bought by AstraZeneca for $14.7 billion. Icahn also has holdings in other biotechnology companies, including Telik Inc. of Palo Alto, California, and AdventRx Pharmaceuticals Inc. of San Diego.

Icahn was named ImClone's chairman and five of his associates were elected directors in October 2006 after he engineered a takeover of the company's 10-member board and the ouster of Joseph Fischer as chief executive officer. Denner served as head of an executive committee until last August, when John H. Johnson was appointed ImClone's CEO.

``One big difference is that Icahn owns a much smaller piece of Biogen than he did ImClone, and Biogen has a much more stable organization,'' Schmidt said. ``I just think it's going to be more of an uphill battle as he's a smaller stockholder and the management is more entrenched and stable.''

Barr Labs Takes Lead on Corporate Income Tax Bill

From the RTD:

Bill would reduce tax on makers

Tuesday, Jan 29, 2008 - 12:08 AM

By JOHN REID BLACKWELL
TIMES-DISPATCH STAFF WRITER

Companies with manufacturing in Virginia could see significant reductions in their state corporate income tax under legislation proposed in the General Assembly.

The Virginia Manufacturers Association is backing a bill introduced by Del. Kathy J. Byron, R-Campbell, to change how the income tax on manufacturers is calculated. Under the proposal, manufacturers could opt to pay income tax based only on their sales in Virginia.

The income tax is now calculated using a formula that includes sales, property and payroll, a system that supporters of the legislation said discourages manufacturing investments, contributing to the state's loss of 125,000 manufacturing jobs since 1992.

The proposed change, proponents said yesterday, would give manufacturers an incentive to locate or expand here, and keep Virginia competitive with 17 other states that have adopted similar changes to their tax codes.

"During this time of economic uncertainty, we need to be doing everything -- and I mean everything -- we can to encourage companies to do even more business in Virginia and create more jobs," Byron said yesterday at a news conference with lawmakers from Southside Virginia, a region hit hard by job losses in the textiles and furniture industries. The legislation has been referred to the House finance committee.

Supporters said the impact on state tax receipts would depend on how many manufacturers opted for the sales-only formula. If the legislation had been in effect in 2003, it would have reduced state tax collections by $36 million, the state tax department said.

Executives with Barr Laboratories, a pharmaceutical company with a 600-employee plant in Bedford County, said the current tax structure penalizes the company for investing in the state.

"The more we invest, and the more people we hire, the higher our marginal tax rate, which doesn't make sense to us," said Bruce Downey, the company's chairman and chief executive officer. Barr is expanding its plant and plans to add about 200 employees, but Downey said future expansions are more likely if Byron's legislation passes.

HB 1514-- Would Change Virginia's Corporate Income Tax for Manufacturers

Legislation Announced to Bolster
Manufacturing Jobs and Investment


RICHMOND, VA – To improve Virginia’s attractiveness as a place for manufacturers to invest and thrive, legislation was introduced by Delegate Kathy Byron to make the Commonwealth’s tax structure more favorable to business and more competitive with other states.

HB 1514 - Single Sales Factor provides the option for manufacturers’ corporate income tax to be based on sales, rather than the current three-part apportionment formula of sales (double-weighted), payroll and property. This more favorable tax structure is attractive to companies with high employment numbers and significant property. Seventeen states, including two competing southern states (Georgia and South Carolina), have adopted some form of the single sales factor. The change would be effective July 1, 2009.

“Virginia has been voted the #1 state to do business and we are very proud of that distinction,” said Delegate Kathy Byron. “But being the best means that you have to constantly find ways to make yourself better and that’s the main reason why I introduced House Bill 1514.”

“According to a recent economic analysis, Virginia will actually save money over time under this bill because the new hiring and capital that will take place will produce more state and local taxes than we will lose by giving the companies the flexibility to choose the single sales factor system. In other words – the benefits far outweigh the costs,” said Delegate Lacey Putney, Chairman of House Appropriations.

Bruce Downey, CEO of Barr Pharmaceuticals said, “We are proud that Barr continues to expand in Virginia with a $62 Million investment in Bedford County. Delegate Byron’s legislation will only further enhance Virginia’s opportunity to attract additional capital investment to the Commonwealth.”

“The Virginia Manufacturers Association and manufacturers across the Commonwealth applaud this effort to help our industry to compete in the production of world class products in the Commonwealth of Virginia,” said Rick Higbie, VMA Chairman.

“This legislation continues those positive efforts to strengthen our competitive edge in this increasingly global economy,” noted Speaker Howell. “We look forward to our friends in the Virginia business community being able to expand, grow and create more jobs because of Delegate Byron's legislation.”


# # #

Mass Governor's Biotech Job Growth Predictions Raise Eyebrows

From the Boston Globe:

Job growth prediction raises eyebrows
Patrick sees 250,000 added in life sciences

By Todd Wallack, Globe Staff | January 26, 2008

Governor Deval Patrick raised some eyebrows during his State of the State address Thursday by saying his $1 billion life-sciences initiative would create 250,000 jobs over the next decade - twice as many jobs as the state added from all sources over the past decade.

"On the face of it, it looks huge," said Alan Clayton-Matthews, a University of Massachusetts at Boston associate professor who helps track the state's economy. "I have no idea how these numbers were arrived at."

The state has about 3.2 million workers; 250,000 new jobs would represent an 8 percent increase - on top of any natural growth expected without legislation.

"It sounds very ambitious," said John Bitner, chief economist for Eastern Investment Advisors in Boston, noting the state has traditionally had a hard time attracting workers because of its high cost of living and harsh winters.

Damon Barglow, a healthcare analyst at Eastern Investment Advisors, said it's possible legislation could create as many as 100,000 jobs, assuming the investment is well-targeted and every new life-sciences job spawns several more in other sectors.

But Barglow said even that projection is ambitious. Of Patrick's 250,000 estimate he said: "I don't see how he gets there."

Kofi Jones, spokeswoman for the Executive Office of Housing and Economic Development, said the Patrick administration is confident it can achieve the 250,000 new jobs in even less time - by 2015 - if the Legislature approves the proposal without major changes.

"It's a comprehensive piece of legislation that seeks to strengthen the industry on several levels," from academic research to tax incentives for companies, she said.

The administration calculates one-third of the new jobs would be in the life-sciences sector. The sector currently employs 60,000 to 75,000 people. The rest of the new jobs would come in other areas, including retail and construction, as the life-sciences sector grows.

Jones said the agency assumed that for every job created in life sciences, two more would be created in other sectors, a multiple it obtained from Boston Consulting Group. State officials said other studies used significantly higher multiples to calculate the economic benefit of adding life-sciences jobs.

Jones said the administration examined current growth projections and estimated the rates would significantly increase with additional investment. Although Patrick's proposal calls for spending an average of $100 million a year over 10 years, state officials say companies and universities could leverage much of that money to bring in even more dollars.

The Massachusetts Biotechnology Council and the Massachusetts Medical Device Industry Council said Patrick's legislation would create jobs, but they aren't sure how many. "We have no projections," said Peter Abair, director of economic development for the biotech council.

There is also debate about whether the $1 billion is calibrated for maximum impact.

Many industry officials predict life sciences will grow with or without legislation. A recent report by Northeastern University's Center for Labor Market Studies projected the biopharmaceutical industry will generate more than 12,000 jobs from 2004 to 2014.

The drug industry sponsored the study.

WaPo: Area Schools Heed Science Industry's Warning

From the Post:

Area Schools Heed Science Industry's Warning
PSM Degree Programs Aim to Produce Business-Savvy Workforce to Keep U.S. Tech Sector Competitive

By Valerie Strauss
Washington Post Staff Writer
Monday, January 28, 2008; B01

Universities in the Washington region are in the forefront of a movement to train more people to enter science and technology professions and meet what industry leaders call an urgent need to expand the workforce to keep the U.S. economy competitive.

At least eight schools in Virginia, the District and Maryland are offering or drawing up plans for a two-year professional science master's degree. The PSM program is designed to provide more advanced training in science or mathematics -- with a dose of business skills -- and entice more students who receive bachelor of science degrees to stay in the field without having to pursue a doctorate. Most college graduates with four-year science degrees leave the field and don't return.

The PSM degree, sometimes described as a science version of the MBA degree, is being hailed as one of the most promising innovations in graduate education in years. Last year, Congress provided funding for schools to establish or improve PSM programs through the America Competes Act.

"This has national implications for leveraging our academic resources and our professional talent to deliver economic health for the nation," said Richard G. Donnelly, chairman of the department of information systems and technology management at George Washington University and co-director of the school's PSM program.

GWU launched its molecular biotechnology master's program in the fall, and Towson University will graduate its first class of 28 students in the forensic science PSM program in the spring.

American University began a PSM program in 2004 with three branches: biotechnology, applied computing, and environmental science and assessment. The University of Maryland recently launched several offerings, and Georgetown University is sponsoring with Virginia Tech a PSM program in biomedical technology, development and management that will begin in the fall. Virginia Commonwealth University in Richmond has a PSM program in bioinformatics.

"I want to join the biotechnology industry, and I looked around the world for the right program," said Mandeep Kaur Gill, who received a bachelor of science degree and a master's in biology in her native India and is in GWU's program.

"This had everything," she said, including opportunities to study science, business, marketing and computer science.

In 1997, as industry leaders complained that U.S. schools were not producing enough properly trained graduates to enter the science and technology fields, the Alfred P. Sloan Foundation began to encourage schools to take a new approach.

Providing seed money for master's programs in science and math, the New York-based foundation set guidelines that provide schools some structure but also offer flexibility. Universities have long offered advanced training in these fields. But the program requires more work across disciplines and business training to help make graduates marketable. Sloan left engineering out of its grant specifications because, said Carol B. Lynch, PSM director at the Council of Graduate Schools, "engineers get it and already understand the value of a master's degree."

About 1,300 students are enrolled in PSM programs at more than 50 schools nationwide, officials say. The programs have graduated 1,200. The Washington area has the most programs, Lynch said.

That it took a foundation, and not a school, to get the ball rolling is not entirely surprising, educators said, despite a broad agreement that the country needs more trained scientists.

PSM supporters expected -- and met -- resistance from some educators, who thought the science course requirements were too limited or who did not want PSM students in their classrooms because they didn't think the students had done the prerequisite courses.

In addition, universities are tradition-bound institutions. It can be difficult for schools, especially state-run systems, to get approval to start something new. Schools don't like to force experts in one field to change their focus or unwillingly collaborate outside their discipline.

"In general, institutions of higher ed pay lip service to interdisciplinary studies," said Ali Eskandarian, an associate dean at GWU who oversees its PSM program.

Eskandarian said GWU leaders backed the initiative, which could help boost the workforce for the prospering technology corridor in Maryland and the growing technology presence in Northern Virginia. He said Donnelly and physicist Mark E. Reeves created a true interdisciplinary program, sometimes sitting in each other's classes to offer different perspectives.

Reeves said he teaches the physics component -- the physics of biotechnology -- in an unorthodox way. Ninety percent of physics courses deal with inanimate systems, he said, but his course looks at living systems.

The physics component attracted Srishti Jain, who said she considered programs in California, Boston and elsewhere before deciding on GWU's combination of science and entrepreneurship.

"This is actually the future of biotechnology," she said.

At Towson, officials chose forensic science for the new degree because of the growth of the homeland security industry and the demand for 10,000 more forensic scientists over the next decade, said Mark Profili, the school's PSM director.

The degree was initially confusing to many students, educators say, and might still be.

"People didn't understand what it was," said Christopher Tudge, a professor who directs American's PSM program. "Students wanted to know if they had to get a PhD after this."

He added: "Once the brand-new gets out there and people realize what its specific function is, I think it is going to be a very popular program in all schools."

Cel-Sci Releases Letter to Shareholders

CEL-SCI CORPORATION RELEASES LETTER TO SHAREHOLDERS

VIENNA, VA, JANUARY 28, 2008 – The following letter is being released by CEL-SCI CORPORATION (AMEX: CVM) to its shareholders:

Dear Fellow Shareholders:

Our Company underwent a wonderful transformation last year from an intermediate stage company in its development to a late-stage biotechnology company. We are now one of a very select number of companies that have a completely novel medicine with blockbuster potential ready to go into a Phase III clinical trial. Our position is further enhanced by the fact that we are well capitalized and that we are building our own manufacturing facility close to Baltimore, Maryland. This facility will be capable of producing between $500 million and $600 million worth of Multikine® cancer drug per year, with the ability to triple production within about one year. The construction of the facility is scheduled for completion in the 3rd quarter of 2008.

Company highlights of 2007:

- FDA clearance of Multikine for Phase III clinical trial in head and neck cancer

- Raised U.S. $15 million

- Multikine granted Orphan drug designation in U.S.

- Started build-out of manufacturing facility for Multikine to support upcoming Phase III study and commercial sale

- Started planning and pricing of our global clinical trial designed to lead to marketing approval for Multikine



We expect 2008 to be another very positive year. We plan to contract with one or more Clinical Research Organizations to run our 800 patient Multikine Phase III trial which we expect to start in the last quarter of 2008. It will be run as an open label study (a study in which it is apparent which patients receive Multikine versus those who do not). The open label design will give us the opportunity to get early indications of how successful our study will be.

We look forward to moving into the new facility later this year and we anxiously await the first indications from the open-label Phase III clinical trial with Multikine in advanced primary (not yet treated) head and neck cancer, representing a large unmet medical need and a disease in dire need of new and non-toxic treatments.

Thank you for your continued support. We invite you to visit our new website at www.cel-sci.com to learn more about our breakthrough work in empowering immune defenses to defeat cancer.

MiddleBrook Wins FDA Approval

Congratulations to Ed Rudnic and his team at MiddleBrook! This is from the Washington Post:

Monday, January 28, 2008; Page D02

Just 24 hours after MiddleBrook Pharmaceuticals received approval to market its once-daily amoxicillin treatment for strep throat, the company announced that it would raise $21 million in a private placement of stock.

The Germantown firm took advantage of last week's sharp boost in share prices, which rose 139.2 percent on Thursday following the Food and Drug Administration's approval of Moxatag.

MiddleBrook said it will sell 8.75 million shares at $2.40 a piece, a discount of about 25 percent to Thursday's record closing price of $2.99. The deal also includes five-year warrants to buy 3.5 million shares of common stock at an exercise price of $3 a piece.

Investors in the offering include existing shareholders and new investors.

"We believe the proceeds from this financing will provide sufficient capital to operate our business in 2008 and afford the company greater flexibility and leverage as we seek to complete a strategic transaction over the coming months," Edward M. Rudnic, president and chief executive, said in a written statement.

Amoxicillin has to be taken three or four times a day to be effective. But each Moxatag tablet contains three time-released doses of medicine.

Wyeth to Cut 5,000 Jobs?

From FierceBiotech:

Wyeth mulls 5,000 job cuts

Welcome Wyeth to the layoff parade. The drugmaker is plotting cutbacks, including job cuts that could amount to 10 percent of its 50,000-strong workforce. Because the company is just beginning to hash out the details, no hard numbers are yet available. According to a Wyeth spokesman, the plans will be announced in March.

Wyeth, of course, is facing the same pressures as other pharma companies who've laid off thousands of workers. Take generic competition: The active ingredient in the company's biggest-selling drug, Effexor XR, goes off patent this June, and Sun Pharmaceutical is readying a generic version. Meanwhile, its blockbuster heartburn med Protonix faces a copycat from Teva Pharmaceutical Industries, which is threatening to launch its version even as the companies dispute its patent protection in court. Wyeth and Teva declared a truce till next Thursday while they try to negotiate a settlement.

And in prepping for layoffs, Wyeth joins a veritable roll call of the biggest names in the business. Merck, Pfizer, Bristol-Myers Squibb, Amgen, GlaxoSmithKline--everyone who's anyone is doing it.

HGS Stock Tumbles on Bad Side Effects Report

From FierceBiotech:

Human Genome Sciences watched its stock take a dive this morning after an independent data monitoring committee noted lung-related side effects in patients receiving 1200-microgram injections of the hep C drug Albuferon every two weeks. Patients at that dosage level in the Phase III trial are being shifted to a 900-mcg injection every two weeks. HGS says it still expects to have late-stage data on the drug in the spring of 2009, with a marketing application to follow in late 2009. But that was no comfort to investors, who took a 22 percent bite out of its stock as Wall Street in general got off to another rocky start.

Virginia's CIT Gap Funds names new investment advisors

Virginia's CIT Gap Funds names new investment advisors
January 23, 2008
HERNDON, VA--The Center for Innovative Technology (CIT) today announced two additions to its GAP Funds Advisory Board and Investment Committee. Eric Koefoot is the newest member of the CIT GAP Tech Fund Investment Advisory Board, while John Uhrin joins the CIT’s GAP BioLife Investment Committee.

Eric Koefoot is an experienced software executive and Internet pioneer, having either founded or served as a senior executive for early-stage Internet companies since 1996. John Uhrin is a venture partner at Harbert Management Corporation with more than 25 years of pharmaceutical and biotechnology industry experience.

“Our GAP Funds successes are grounded in the experience and guidance of successful early stage investment counselors,” noted Peter Jobse, CIT president and CEO.

Eric Koefoot was most recently the founding CEO and Publisher of U.S. News Ventures, a branded internet publishing company.

John Uhrin is active in the technology transfer efforts of numerous universities and a board member or advisors to a number of regional life science focused organizations. Before joining HMC, Uhrin was employed by BioCryst Pharmaceuticals, Inc., where he served as VP of Corporate Development.

CIT GAP Funds is a family of venture funds designed to bridge the gap between "family and friends" funding and early-stage equity investments for Virginia-based technology and life science companies.

On the Web: www.cit.org

Scientists Produce Embryo Clones from Skins Cells

From the AP & IHT:

Scientists produce embryo clones of 2 men, using skin cells in step toward stem cell goal

The Associated Press
Thursday, January 17, 2008

NEW YORK: Scientists in California say they have produced embryos that are clones of two men, a potential step toward developing scientifically valuable stem cells.

The new report documents embryos made with ordinary skin cells. But it is not the first time human cloned embryos have been made. In 2005, for example, scientists in Britain reported using embryonic stem cells to produce a cloned embryo. It matured enough to produce stem cells, but none were extracted.

Stem cells were not produced by the new embryos either, and because of that, experts reacted coolly to the research.

"I found it difficult to determine what was substantially new," said Doug Melton of the Harvard Stem Cell Institute. He said the "next big advance will be to create a human embryonic stem cell line" from cloned embryos. "This has yet to be achieved."

Dr. George Daley of the Harvard institute and Children's Hospital Boston called the new report interesting but agreed that "the real splash" will be when somebody creates stem cell lines from cloned human embryos.

"It's only a matter of time before some group succeeds," Daley said.

Korean scientist Hwang Woo-suk claimed a few years ago that he'd created such cell lines, but that turned out to be a fraud.

Dr. Samuel Wood, a co-author of the new paper and chief executive of Stemagen Corp. of La Jolla, California, said he and his colleagues are now attempting to produce stem cell lines from the embryos.

The work was published online Thursday by the journal Stem Cells.

Scientists say stem cells from cloned embryos could provide a valuable tool for studying diseases, screening drugs and, perhaps someday, creating transplant material to treat conditions like diabetes and Parkinson's disease.

But critics raise objections. The process "involves creating human lives in the laboratory solely to destroy them for alleged benefit to others," said Richard Doerflinger, spokesman for the U.S. Conference of Catholic Bishops.

Citing the earlier work in Britain, he also said that as a scientific advancement, the new work was "very limited."

Other objections to cloning include concerns about health risks and exploitation if large numbers of women are asked to provide eggs.

Those objections are one reason that an alternative route to stem cells made headlines last November. Scientists reported a relatively simple way to turn skin cells directly into stem cells. This direct reprogramming carries a theoretical risk of cancer for the recipients of tissue from these cells, however, and many scientists have urged that work continue on the cloning technique as well.

The cloning approach involves inserting DNA from a person into an egg, and then growing the egg into an embryo about five days old before extracting the stem cells. At that stage, the embryo is a sphere of about 150 cells.

In the new work, researchers took skin cells from Wood and another volunteer and produced three embryos with DNA matching the men's. Further DNA testing on one of these embryos strengthened the case that it was a clone, researchers said.

___

On the Net:

Journal Stem Cells: http://stemcells.alphamedpress.org

Information on stem cells: http://stemcells.nih.gov/

WaPo: Senate Democrats Raise Own Allowance

Senators Raise Their Daily Allowance by $29
Delegates, Citing Budget Woes and Fears of Political Retaliation, Say They Won't Follow Suit

By Tim Craig
Washington Post Staff Writer
Thursday, January 17, 2008; B06

RICHMOND, Jan. 16 -- At a time of layoffs and salary freezes throughout state government, Democratic Senate leaders have pushed through a $29 increase in the daily allowance given to senators and some of their staff members during the legislative session.

Leaders of the Republican-controlled House said they are not going to follow the Senate's lead because of the budget situation and concerns that an increase could be used against them in a future campaign.

Under the rules approved last week by Senate leaders, senators who live outside Richmond will receive a $169 housing and food subsidy every day that the legislature is in session, including weekends, in addition to their $18,000 annual salary. The increase is effective for the current 60-day legislative session, which began last week.

Last year, when Republicans controlled the Senate, senators received a $140 per diem allowance. Legislative assistants who move to Richmond during the session are also eligible for the money, which is tax free if used for housing.

"All the hotel costs went up, and this was my decision," said Senate Majority Leader Richard L. Saslaw (D-Fairfax). "A lot of these young [assistants] can barely make ends meet."

The Senate per diems, which cost taxpayers $773,000 a year, correspond to Internal Revenue Service guidelines for temporary housing costs in Richmond. Under Virginia law, delegates' and senators' daily allowances cannot exceed IRS guidelines, but they can be less.

GOP House leaders have decided to keep delegates' per diem at last year's rate, $135. That means senators will earn about $1,700 more than delegates this year. Delegates are paid $17,640 a year.

"It's going to be tough on our members, but our philosophy is, it is tough to ask groups to take cuts in their budgets and then turn around and do a per diem increase," said House Majority Leader H. Morgan Griffith (R-Salem). He said that it would cost $360,000 to raise the House allowance to $169.

Because of the slumping housing market, there is a $300 million shortfall in this year's budget. Gov. Timothy M. Kaine (D) has ordered an across-the-board 5 percent cut in many agency budgets, which has resulted in a few dozen layoffs. He is also not giving teachers and state employees a raise this year.

On Tuesday, state Finance Secretary Jody M. Wagner told lawmakers that revenue continues to lag behind projections, which has prompted Kaine to suggest that he might have to make additional cuts.

The House's decision to forgo the per diem increase is about more than budget woes.

During last fall's campaign, House Democrats targeted several incumbents by sending out mailers and running TV advertisements that criticized them for supporting a pay raise for legislators. "Danny Marshall opposed increasing the minimum wage while voting to increase his own salary," said one mailer aimed at Del. Daniel W. Marshall III (R-Danville).

Legislative salaries have not been raised in more than 15 years. The Democratic ads were referring to House GOP leaders' decision last year to raise the per diem by $5.

House Republicans were outraged at the ads, saying that Democrats violated a long-standing tradition of keeping per diems and pay raises out of political discussions.

The Democrats "took something that was not partisan and turned it into a political issue," Griffith said.

When they found out this week that the Senate was increasing its per diem, several House Democrats approached Speaker William J. Howell (R-Stafford) and other GOP leaders to ask whether they could also get an increase.

"We were like, 'Why? So you can beat us up again?' " Griffith asked.

House Minority Leader Ward L. Armstrong (D-Henry) distanced himself from the ads.

"Every one of us has our own take on what is fair," Armstrong said. "I don't know how much longer we have to talk about a campaign that was over in November. This is the 'o8 session."

Some Democratic delegates are clamoring for the extra money.

On Wednesday, Del. Kenneth R. Melvin (D-Portsmouth) told his House colleagues that he will circulate a resolution supporting a raise in the House, saying that a small amount of money could make a difference in people's lives.

"I don't think this issue should be partisan," he said. "Now is the time for the adults on both sides to get together and work on this issue."

Saslaw said he doesn't blame House Republicans for resisting calls to raise the allowance this year. Saslaw said that Senate Democrats, who picked up the four seats in the election needed to regain the majority, steered clear of using pay raises as an issue because they thought it was an unfair charge to make against GOP incumbents.

"They cut off their own noses," Saslaw said, referring to House Democrats.

FDA Says Milk from Cloned Cows Safe

FDA Issues Documents on the Safety of Food from Animal Clones
Agency Concludes that Meat and Milk from Clones of Cattle, Swine, and Goats, and the Offspring of All Clones, are as Safe to Eat as Food from Conventionally Bred Animals

After years of detailed study and analysis, the Food and Drug Administration has concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. There was insufficient information for the agency to reach a conclusion on the safety of food from clones of other animal species, such as sheep.

FDA today issued three documents on animal cloning outlining the agency's regulatory approach – a risk assessment; a risk management plan; and guidance for industry.

The documents were originally released in draft form in December 2006. Since that time, the risk assessment has been updated to include new scientific information. That new information reinforces the food safety conclusions of the drafts.

In 2001, U.S. producers agreed to refrain from introducing meat or milk from clones or their progeny into the food supply until FDA could further evaluate the issue. The U.S. Department of Agriculture will convene stakeholders to discuss efforts to provide a smooth and orderly market transition, as industry determines next steps with respect to the existing voluntary moratorium.

The agency is not requiring labeling or any other additional measures for food from cattle, swine, and goat clones, or their offspring because food derived from these sources is no different from food derived from conventionally bred animals. Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading.

Because clones would be used for breeding, they would not be expected to enter the food supply in any significant number. Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace. At this time, the agency continues to recommend that food from clones of species other than cattle, swine and goat (e.g., sheep) not be introduced into the food supply.

An animal clone is a genetic copy of a donor animal, similar to an identical twin, but born at a different time. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence. Due to their cost and rarity, clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding.
Risk assessment

The risk assessment finds that meat and milk from clones of cattle, swine, and goats, and food from the sexually reproduced offspring of clones, are as safe to eat as food from conventionally bred animals. The science-based conclusions agree with those of the National Academy of Sciences, released in a 2002 report. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They found the methods FDA used to evaluate the data were adequate and agreed with the conclusions set out in the document.

The risk assessment presents an overview of assisted reproductive technologies widely used in animal agriculture, the extensive scientific information available on the health of animal clones and their sexually reproduced offspring, and an assessment of whether food from clones or their sexually reproduced offspring could pose food consumption risks different from the risks posed by food from conventionally bred animals. These conclusions were first presented in draft documents over a year ago. Since then, the agency has updated the risk assessment with data that became available, as well as taking into account comments from the public comment period.

"After reviewing additional data and the public comments in the intervening year since the release of our draft documents on cloning, we conclude that meat and milk from cattle, swine, and goat clones are as safe as food we eat every day," said Stephen F. Sundlof, D.V.M., Ph.D., director of FDA's Center for Food Safety and Applied Nutrition. "Our additional review strengthens our conclusions on food safety."
Risk management plan

The risk management plan outlines measures that FDA has taken to address the risks that cloning poses to animals involved in the cloning process. These risks all have been observed in other assisted reproductive technologies currently used in common agricultural practices in the United States.
FDA is currently working with scientific and professional societies with expertise in animal health and reproduction to develop standards of care for animals involved in the cloning process. Although the agency is not charged with addressing ethical issues related to animal cloning for agricultural purposes, FDA plans to continue to provide scientific expertise to interested parties working on these issues.
Guidance for industry

The guidance for industry addresses the use of food and feed products derived from clones and their offspring. It is directed at clone producers, livestock breeders, and farmers and ranchers purchasing clones, and provides the agency's current thinking on use of clones and their offspring in human food or animal feed.

In the guidance, FDA does not recommend any special measures relating to the use of products from cattle, swine, or goat clones as human food or animal feed. Because insufficient information was available on clones from other species, e.g., sheep clones, to make a decision on the food consumption risks, the guidance recommends that food products from clones of other species continue to be excluded from the human food supply. The guidance states that food products from the offspring of clones from any species traditionally consumed for food are suitable to enter the food and feed supply.

For more information, visit http://www.fda.gov/cvm/cloning.htm.

Atlanta Biotech CEO Fundraiser for Obama

This is from a NYT article...

One of Mr. Obama’s fund-raisers, Kirk Dornbush, president of Iconic Therapeutics, a biotech company in Atlanta, said, “The contributions reflect the simple calculus of the health care industry, making a bet that Democrats will control the White House and both houses of Congress after the next election.”

http://www.nytimes.com/2007/10/29/us/politics/29health.html

Wired Mag: Where the Candidates Stand on Science...

Where the candidates stand on science...

Democratic Presidential candidates Hillary Clinton, Barack Obama and John Edwards have similar science platforms. Each wants to cut greenhouse gas emissions by 80% by 2050, increase research funding and limit political interference in scientific matters.

What do their Republican counterparts say? Below is the across-the-aisle followup to our earlier post on Science's roundup of prominent Presidential candidates' positions on science.

Rudy Giuliani. It's hard to know what Giuliani wants, since he wouldn't let his advisers talk to Science about specific issues. Historically, he's mixed pragmatism and a love of numbers with an ideological preference for non-government solutions. He supports embryonic stem cell research if it doesn't involve cloning and, unique among Republicans, is pro-choice. As New York City's mayor, his science initiatives were boldy framed but foundered because of shoddy follow-through -- a pattern apparently repeated in his run for President, where he has suggested an across-the-board boost for domestic energy production and signaled belief in climate change without spelling out what he plans to do.

John McCain. When scientists say climate change is an urgent problem, the senator from Arizona listens to them; he's made it a central issue in his platform, and over the last several years has drawn the ire of Bush administration officials for criticizing their mishandling of climate change science and policy. He was an architect of the recently-passed energy bill. Like Giuliani, he supports embryonic stem cell research but not cloning; other science issues haven't caught his attention.

Mike Huckabee. The Arkansas governor who once pardoned Keith Richards tends towards personal conservativism balanced by political pragmatism. He's doesn't believe in evolution, but is ambivalent about pushing that belief in schools. His unexpectedly progressive policies on health care earned him liberal praise, and he's framed climate change as a matter of religious conscience; however, his actual climate change proposals emphasize further research over concrete steps.

Mitt Romney. The pro-life Massachusetts governor opposes embryonic stem cell research and isn't certain that people are responsible for climate change, but was instrumental in pushing for commercial biotech in Massachusetts and joined with seven other Northeastern states on a regional CO2-cutting program -- the first of its kind. However, he later pulled out of the agreement and also vetoed an embryonic stem cell research bill. He's pledged to increase energy efficiency research but is otherwise quiet on climate change.

Fred Thompson. Though he's supported federal science projects that benefit his home state, the Tennessee senator seems generally uninterested in science issues. He jumped to ascribe credit for the recent de-differentiation stem cell breakthrough to President Bush's research restrictions and has downplayed the importance of climate change and human responsibility for it.

For the leading Democrats' positions, see this post. I'm also going to contact the candidates excluded by Science -- Republicans Ron Paul, Alan Keyes and Duncan Hunter, as well as Democrats Dennis Kucinich, Mike Gravel, Chris Dodd and Joe Biden -- for more about their science platforms.

Here is a release from AAS: http://www.eurekalert.org/pub_releases/2008-01/aaft-upc010208.php

From last month...

Commonwealth Biotechnologies, Inc. Business Unit, Fairfax Identity Laboratories, Gains International ISO 17025 Accreditation for DNA Forensic Services

RICHMOND, Va., Dec 28, 2007 (BUSINESS WIRE) -- Fairfax Identity Laboratories (FIL), a business unit of Commonwealth Biotechnologies, Inc. (NASDAQ Capital Market:CBTE) is pleased to advise the market that it has been granted international ISO 17025 accreditation of its DNA Forensic laboratory. This certifies that FIL has been audited and has met or exceeded all of the international standards for accreditation. The certification covers forensic casework, relationship, and CODIS offender database testing. The accreditation was received from Forensic Quality Services-International (FQS-I), the country's longest established provider of ISO accreditation to forensic science testing laboratories. FIL has held FQS national accreditation since 1997. The new ISO17025 accreditation makes FIL eligible to bid on a much broader array of forensic contract opportunities both nationally and internationally.

"This accreditation is an acknowledgement of FIL's commitment to the highest standards to which we have always adhered. We look forward to continuing our service to the forensic and law enforcement communities," commented Charles Kelly, Director of FIL.

"The accreditation from FQS-I should open new doors for FIL in the international DNA Forensic testing market and establishes us as one of the elite Labs for forensic testing," added Thomas Reynolds, Executive Vice President and Business Unit Manager for FIL.

About Commonwealth Biotechnologies, Inc:

The CBI group of companies offers cutting-edge research and development products and services to the global life sciences industry. CBI now operates four distinct business units: (1) CBI Services, a discovery phase contract research organization; (2) Fairfax Identity Laboratories, a DNA reference business; (3) Mimotopes Pty, Ltd, Melbourne, Australia, a peptide and discovery chemistry business; and (4) Exelgen, Ltd, Bude, UK, a medicinal and synthetic discovery chemistry business. Collectively, CBI companies employ over 115 staff in world-class laboratories. For more information, visit CBI on the web at www.cbi-biotech.com.

About FIL:

Fairfax Identity Labs ("FIL"), a business unit of CBI, offers comprehensive genetic identity testing, including paternity, forensic, Convicted Offender DNA Index System ("CODIS") analyses and Clinical Genetic testing services. Since 1990, FIL has been at the forefront of DNA profiling techniques and innovations, and has continued to meet and exceed all industry standards. FIL is accredited by the American Association of Blood Banks, FQS-I, the New York State Department of Public Health, and is CLIA certified.

Forward Looking Statements:

Any statements contained in this release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties as identified in the CBI's filings with the Securities and Exchange Commission. These forward-looking statements are generally identifiable by use of the words "may," "will," "should," "expect," "anticipate," "estimate," "believe," "intend" or "project" or the negative thereof or other variations thereon or comparable terminology. Actual results, events or performance may differ materially. No statement herein should be considered an offer of any securities. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as the date hereof. Specifically, there can be no guarantee that Fairfax Identity Labs will receive contracts because of its new accreditation status. A number of factors, including customer demand, industry trends, armed conflict, and terrorist activities could alter these trends referenced herein. CBI undertakes no obligation to publicly release the results of any revisions to these forward looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

SOURCE: Commonwealth Biotechnologies, Inc.

Commonwealth Biotechnologies, Inc.
Dr. Paul D'Sylva
CEO
858-550-0959 Ext. 106

Top 10 Biotech Stocks for 2008

Top 10 Biotech Buzz Stocks for This Year
By Adam Feuerstein
Senior Writer
1/14/2008 12:22 PM EST
URL: http://www.thestreet.com/newsanalysis/biotech/10398390.html

BOSTON -- The JPMorgan Healthcare Conference is always the first biotech investment meeting of the year, and probably the most important in terms of attendance and overall buzz.

Every January, thousands of industry players network "under the clock" in the lobby of the Westin St. Francis Hotel just off San Francisco's Union Square. Institutional investors elbow their way through gridlocked halls and meeting rooms to hear presentations from biotech companies that hope their stock will be the next to catch fire.

But what happens after the conference ends and all those investors and industry types head home? Is the excitement and enthusiasm sustainable? Do the "hot" stocks of the conference stay hot?

To answer these questions, let's devise an experiment. I've created the Biotech Buzz Portfolio, a list of 10 biotech companies with the best-performing stock prices during the conference, which ran from Jan. 6-10.

Since each of the companies in this portfolio (with one exception) made presentations at the conference and saw their stock price rise significantly during that week, I assume there is at least some correlation between the two events.

That's how I'm defining "biotech buzz" for matters of this test.

I plan to check in with these stocks on a semiregular interval throughout the year to see how they're performing. Can these stocks sustain the early momentum throughout the year? Or, is the buzz transient and of little interest to investors once the memories of parties, crowded hallways and Powerpoint slides fade?

A few words about the "holdings": Isis Pharmaceuticals (ISIS) didn't present at the conference, but nonetheless, made a large splash with its Genzyme (GENZ) partnership announced on Jan. 6, the first day of the conference.

And Isis CEO Stanley Crooke seemed to be everywhere in the hotel, talking up investors and the media. For that reason, I included the company here.

Biogen Idec (BIIB) made the list because I wanted at least one large-cap, profitable biotech stock in the portfolio. Biogen Idec was the top performer in that class, so it replaces Atherogenics (AGIX) for the final spot.

I also limited the portfolio to biotech companies, loosely defined as any company developing drugs (excluding Big Pharma). That means diagnostic companies and medical device firms were not considered.

Since this is the introductory column for the Biotech Buzz Portfolio, here is a brief description of each stock, in order:

Pharmasset (VRUS) : This company develops antiviral drugs to treat hepatitis C, hepatitis B and HIV. The company's stock rocketed recently on positive data from a phase II study of its hepatitis C drug R7128 combined with interferon and ribavirin (the current standard of care for hepatitis C).

R7128 is being developed in a partnership with Roche, and there has been some speculation that the Swiss drug maker could buy Pharmasset outright.

Researchers Create New Rat Heart

http://www.iht.com/articles/2008/01/13/america/heart.php

Researchers create new rat heart in lab
By Lawrence K. Altman
Sunday, January 13, 2008

Medicine's dream of growing new human hearts and other organs to repair or replace damaged ones received a significant boost Sunday when researchers at the University of Minnesota reported success in creating a beating rat heart in a laboratory.

Experts not involved in the Minnesota work called it "a landmark achievement" and "a stunning" advance. But they and the Minnesota researchers cautioned that the dream, if it is ever realized, is still at least 10 years away.

Doris Taylor, head of the team that created the rat heart, said that she followed a guiding principle of her laboratory: "Give nature the tools and get out of the way."

"We just took nature's own building blocks to build a new organ," Taylor said of her team's report in the journal Nature Medicine. The researchers removed all the cells from a dead rat heart, leaving the valves and outer structure as scaffolding for new heart cells injected from newborn rats.

Within two weeks the new cells formed a new beating heart that conducted electrical impulses and pumped a small amount of blood.

With modifications, scientists should be able to grow a new human heart by taking stem cells from a patient's bone marrow and placing them in a cadaver heart that has been prepared as a scaffold, Taylor said in a telephone interview from her laboratory in Minneapolis. The early success, she said, "opens the door to this notion that you can make any organ: kidney, liver, lung, pancreas - you name it and we hope we can make it."

"Doris Taylor's work is one of those maddeningly simple ideas that you knock yourself on the head, saying, Why didn't I think of that?" said Todd McAllister, of Cytograft Tissue Engineering in Novato, California.

His team has used a snippet of a patient's skin to grow blood vessels in a laboratory, and then implanted them to restore blood flow around a patient's damaged arteries and veins.

The field of tissue engineering has been growing rapidly. For many years, doctors have used engineered skin for burn patients.

Engineered cartilage is used for joint repairs. Researchers are investigating use of stem cells to repair cardiac muscle damaged by heart attacks. Also, new bladders grown from a patient's own cells are being tested in the same patients.

Taylor is a newcomer to tissue regeneration. She began her professional career at the Albert Einstein Medical School in the Bronx, investigating gene therapy and then cell therapy. She said she switched to tissue regeneration when she realized that the limiting step in trying to generate an organ was not the number of cells needed, but the complexity of creating a three-dimensional structure. "The heart is a beautiful organ, and it's not one that I thought I'd ever be able to build in a dish," she said.

Her view changed about three years ago when she recalled that cells are removed from human and pig heart valves before those valves are used to replace damaged human ones.

As she contemplated replacing the old rat cells with new ones, Taylor followed another of her mantras: "Trust your crazy ideas."

Progress came in fits and starts.

"We made every mistake known, did every experiment wrong and had to go back and do them right," Taylor said.

She poured detergents like those in shampoos in the rat's arteries to wash out the heart cells and then injected neonatal cardiac cells. The first two detergents she tested failed. But a third concoction led to a clear, translucent scaffold that retained the heart's architecture.

After injecting the young rat heart cells into a scaffold, she electrically paced them and created an artificial circulation as the equivalent of blood pressure to make the heart pump and produce a pulse. The steps also helped the cells mature. Tests like examining slices of the heart under a microscope showed they were living cells.

To test the biological compatibility of the new hearts, the team transplanted them into the abdomen of immunologically unrelated live rats. The hearts were not immediately rejected. A blood supply developed. The hearts beat regularly. And cells from the host rats moved in and began to re-line the blood vessels, even growing in the wall of the hearts.

Taylor is now conducting similar experiments on pigs as a step toward human work.

"Working out the details in a pig heart made a lot more sense" because the anatomy of the porcine heart is the closest to humans and because pigs are plentiful, she said.

"The next goal will be to see if we can get the heart to pump strongly enough and become mature enough that we can use it to keep an animal alive" in a replacement transplant, Taylor said.

As for human hearts, the best-case scenario would be to obtain them from cadavers, remove their cells to make a scaffold, and then inject bone marrow, muscle or young cardiac cells from a patient. The process of repopulating the scaffold with new cells would take a few months, she said.

The body continually replaces its proteins every few months, so the hope is that the body will create a matrix that it recognizes as its own.

One potential problem is that anti-rejection drugs might be required to prevent adverse immune reactions from the scaffold. In that case, Taylor hopes such therapy would be needed only temporarily.

Many things that work in experiments on animals fail in humans because of the species barrier. McAllister, of Cytograft Tissue Engineering, said that in Taylor's case "the principal problem in escalating it to humans is one of scale, not of cell biology, and that is an easier problem to solve potentially."

"If it works," Taylor said, "it means that there'll be many more organs available for transplants."

Because the components of the biologic matrix differ for every organ, Taylor expects that scientists will be able to do tests to answer two fundamental questions: Can a stem cell be placed anywhere in the body and still produce a heart, kidney or other organ? Or must a stem cell be placed in its anatomic position to do so?

Such tests might include taking stem cells from one organ, say, a kidney, and putting them in a kidney, liver or heart to begin to understand whether the stem cells are innately committed to produce kidneys or whether they will convert to produce livers or hearts.

McCain to Pharmaceutical Innovators: Drop Dead

This is from TownHall.com:

McCain to Pharmaceutical Innovators: Drop Dead
By Timothy Lee
Friday, January 11, 2008


Voters will be pardoned for speculating whether aliens have somehow captured Senator John McCain, nominally a Republican candidate for President, and replaced his mind with that of Democratic class-warrior candidate John Edwards.

The latest evidence came during the January 5, 2008 Republican candidates’ debate in Manchester, New Hampshire, when Senator McCain slurred the pharmaceutical industry as “the big bad guys.” Thus, in addition to his dubious positions on tax cuts, waterboarding of terrorists and McCain/Feingold’s free speech restrictions, he has now gone on record attacking America’s pharmaceutical companies, which constitute one of this country’s most innovative and valuable industries.

In doing so, Senator McCain also joined the chorus demanding importation of medicines from foreign countries, which is one of the most deceptive and dangerous policy ideas in our present political climate. Consider the following exchange between himself and Mitt Romney, in which McCain descends into his best conspiracy theorist impression:

McCain: Why shouldn’t we be able to reimport drugs from Canada? It’s because of the power of pharmaceutical companies…

Romney: Don’t turn the pharmaceutical companies into the big bad guys.

McCain: Well, they are.

Romney: No, actually, they’re trying to create products to make us well and make us better, and they’re doing the work of the free market. And are there excesses? I’m sure there are, and we should go after excesses. But they’re an important industry to this country. But let me note something else, and that is the market will work. And the reason healthcare isn’t working like a market right now is you have 47 million people that are saying, “I’m not going to play. I’m just going to get free care paid for by everybody else.” That doesn’t work. Number two, the buyer doesn’t have information about what the cost or quality is of different choices they could have. If you take the government out of it to a much greater extent, you’d get it to work like a market and we’ll rein in costs.

No, Senator McCain, pharmaceutical innovators are not “the big bad guys,” and importation of foreign drugs is a terrible idea.

In reality, America’s pharmaceutical and biotechnology companies invest literally billions of dollars each year to invent and perfect new medicines that save lives and allow Americans to live more comfortably, longer, and healthier. There is not a single person in America who hasn’t benefited personally from these remarkable innovations, or has family members or friends who have.

And while importation of drugs may superficially sound like a good idea, it is actually quite pernicious. Especially at a time when America’s trade deficit receives so much hysteria from politicians and the mainstream media.

For starters, importation of foreign drugs will flood the market with dangerous counterfeit knockoffs from across the globe. As tragically illustrated by recent stories of contaminated lead-paint toys, toothpastes, dog food and other products, this is a potentially serious problem. Further, even drugs imported from such countries as Canada often themselves originate from places like Pakistan, Bulgaria, Argentina and South Africa. This inherent safety risk precisely explains why every single Food & Drug Administration commissioner since 1969 has opposed importation.

Second, importation will undermine American medical innovation. The pharmaceutical industry remains one in which America continues to lead the world. It creates revolutionary life-saving and life-improving drugs, but this requires gigantic up-front investments of money, time and research. In 2006 alone, pharmaceutical innovators invested an estimated $55 billion in such research and development, and provided millions of valuable jobs. If our nation’s pharmaceutical and biotechnology companies suddenly cannot recoup their investments due to a flood of foreign counterfeits and artificially-discounted drugs, the reward for investing in innovation will wither along with thousands of high-paying and high-tech jobs. Obviously, this is hardly the time to be taking such a risk.

Third, allowing importation of foreign drugs will exacerbate our current litigation and “jackpot justice” crisis facing America and the healthcare industry. If pharmaceutical companies, pharmacists, hospitals and physicians are suddenly exposed to even more lawsuits because opportunistic trial lawyers blame them for harm caused by foreign counterfeits or knockoffs, healthcare costs and crippling runaway litigation will only skyrocket further.

Fourth, legalizing importation of foreign drugs will only increase the already-overburdened FDA’s caseload. In doing so, the FDA’s ability to protect American consumers’ safety will be further undermined.

Simply put, there is already too much regulation and persecution of the pharmaceutical industry, not too little. Allowing importations to flood the market and gain a free ride on the backs of American pharmaceutical innovators will only undermine this critical enterprise.

Senator McCain, please reconsider your slur against America’s invaluable pharmaceutical industry, and renounce your ill-advised position toward it and importation of foreign drugs. One irresponsible class-warrior candidate in the style of John Edwards is more than enough.



Timothy Lee is the director of legal and public affairs at the Center for Individual Freedom, a free-market and constitutional advocacy organization based in Alexandria, Virginia.

Long time COO of Insmed, Ron Gunn, to depart company

More news on Insmed...

Form 8-K for INSMED INC

4-Jan-2008

Change in Directors or Principal Officers


Item 5.02. Departure of Directors or Principal Officers: Election of Directors, Appointment of Principal Officers.

Effective January 3, 2008, Ronald D. Gunn resigned his position as Executive Vice President and Chief Operating Officer of Insmed Incorporated. (the "Company"). On January 11, 2008 Mr. Gunn will terminate all employment with the Company to pursue a business opportunity with a privately held firm.

The information contained herein, including the Exhibit attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Insmed Awarded $2.1 Million by Muscular Dystrophy Association

Insmed Awarded $2.1 Million by Muscular Dystrophy Association

RICHMOND, Va., Dec 12, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), today announced that it has been awarded a grant of $2,087,325 from the Muscular Dystrophy Association (MDA). The grant is expected to cover a substantial portion of the external costs associated with Insmed's 24-week Phase 3 enabling trial in patients with Myotonic Muscular Dystrophy (MMD).

Insmed, a development stage biopharmaceutical company with extensive expertise in biologics and orphan drug development, decided to initiate the Phase 3 enabling trial based on promising results from an ongoing open-label, dose-escalation trial of IPLEX™ in MMD. To date, up to 70% of patients have reported improvements in one or more of several symptoms commonly associated with Myotonic Muscular Dystrophy. Furthermore, patients undergoing a standardized 6 minute walk test, a well accepted FDA endpoint for endurance, have significantly improved their walking distance (p<0.03).

"The Muscular Dystrophy Association is pleased to announce its support for IPLEX™, which shows early stage promise in this debilitating disease, and we look forward to working closely with Insmed to further its clinical testing," said Sharon Hesterlee, MDA, VP of Translational Research for the Muscular Dystrophy Association.

"We are delighted to have a well-respected organization such as the MDA take an active role in the development of IPLEX™ for this important indication," said Geoffrey Allan Ph.D., Insmed's President and Chief Executive Officer. "We believe third party commitments such as this clearly demonstrate the significance of our results to date and the validity of this approach to treat patients with this severely debilitating disease."

About the Muscular Dystrophy Association (MDA)

The Muscular Dystrophy Association www.mda.org is a voluntary health agency working to defeat more than 40 neuromuscular diseases through programs of worldwide research, comprehensive services, and far-reaching professional and public health education.

About Myotonic Muscular Dystrophy

Myotonic Muscular Dystrophy is a genetic disease characterized by endurance loss, muscle wasting, weakness, pain, cognitive impairment and gastro-intestinal dysfunction. There is currently no cure for the disease, which affects approximately 37,000 individuals in the U.S., and no specific treatment has been discovered to satisfactorily reverse or ameliorate the common symptoms associated with the disease.

About IPLEX™

IPLEX™ was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency (Primary IGFD). IPLEX™ (rhIGF-I/rhIGFBP-3), is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also being investigated for various other indications with unmet medical needs.

Insmed to Appeal Delisting Notification From Nasdaq

Insmed to Appeal Delisting Notification From Nasdaq

RICHMOND, Va., Dec 26, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it has requested a hearing before a Nasdaq Listing Qualifications Panel to appeal an earlier Staff Determination to delist the Company's common stock from the Nasdaq Global Market.

Insmed received a letter from the Nasdaq Stock Market ("Nasdaq") on December 20, 2007 indicating that the Company has failed to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share for continued listing of the Company's common stock on the Nasdaq Global Market as set forth in Marketplace Rule 4450(a)(5) (the "Staff Determination"). As a result, the Company's common stock is subject to be delisted from the Nasdaq Global Market on December 31, 2007. Following procedures set forth in the Nasdaq Marketplace Rule 4800 series, Insmed has requested a hearing before a Nasdaq Listing Qualifications Panel (the "Panel") to review the Staff Determination. The hearing request will stay the delisting of the Company's common stock, pending the decision of the Panel, allowing it to continue to trade on the Nasdaq Global Market. There can be no assurance however, that the Panel will grant Insmed's request for continued listing on the Nasdaq Global Market.

In the event that the Panel denies the Company's request for continued listing on the Nasdaq Global Market, the Company's common stock could be eligible to trade on the Nasdaq Capital Market or the OTC Bulletin Board.

New Podcast: Israel and Biotechnology

Virginia Bioscience Podcast: Donna Edmonds

This edition of the Virginia Bioscience Podcast features Donna Edmonds, executive director of the Virginia Bioscience Commercialization Center (VBCC) in Richmond, Virginia.

The VBCC, based at the Biotech Park in Richmond, will serve as a key entry point for Israeli bioscience companies seeking to enter U.S. markets. The Center will be able to provide Israeli companies the full compliment of services required to commercialize products in the US market.

Mrs. Edmonds is also a board member of the Virginia Biotechnology Research Park Authority, the VCU Intellectual Property Foundation, Critical Diagnostics, and a founding board member of the Virginia Biosciences Development Center. She is also a member of the medical advisory board of AHURA Scientific.

The host is Henry Wixon, a partner specializing in intellectual property issues at the law firm of WilmerHale in Washington, DC and a member of the board of directors of the Virginia Biotechnology Association. The conversation, led by VaBIO’s executive director Mark Herzog, lasts approximately 25 minutes.

http://www.vabio.org/virginia-bioscience-podcast-donna-edmonds

Maryland: We are Number 1

Life science ‘summit’: We’re No. 1
Franchot convenes conference to help industry
by Steve Berberich | Staff Writer

Backed by a new report, Comptroller Peter V.R. Franchot opened his life science ‘‘summit” Thursday by proclaiming Maryland the No. 1 state in the field.

A parade of top leaders of life science industries then spent the next four hours offering an audience of 150 at the Columbia Sheraton a list of reasons to be worried that the state is not doing enough to maintain its predominance.

Franchot said Maryland’s economic future success must be tied to the life sciences. A former state delegate from Montgomery County, he has been planning the conference since he took office in January.

‘‘As the state’s chief fiscal officer, it is very important to focus on the life sciences industry jobs,” he said.

Franchot’s conference came just two months after the inaugural meeting of Gov. Martin O’Malley’s Maryland Life Sciences Advisory Board, which is charged with creating a plan to develop the industry.

The two initiatives may appear similar, but Franchot said his meeting has a different purpose. He is trying to develop an information exchange by leaders to help keep jobs and maintain a strong tax base in life sciences, he said.

‘‘It would not be wise if we were content to rest on our laurels,” Franchot said.

Attending the summit were representatives from 64 companies in many industries, including health care, law, finance, construction, manufacturing, tourism, education, telecommunications, real estate, engineering, government contracting, information technology, biotechnology and aerospace.

Franchot pinned his declaration on Maryland’s stature in life sciences on a new report, commissioned by his office for about $10,500 from Sage Policy Group Inc. It concludes that Maryland holds the lead in life sciences by combining investments in state and federal government and university research as well as investments in biotechnology-related companies.

Many in attendance remarked that the report gives a truer picture of Maryland’s position than other studies, which commonly rank the state as about fifth in biotech companies or workers.

The report covered more than massaging state rankings, however.

It said the number of life science-oriented venture capital deals in the Washington, D.C.-Baltimore region increased 121.5 percent from 1997-2001 to 2002-2006.

That was ‘‘the best performance” in the nation, and much higher than the second-place region, San Francisco, where the number of deals increased a ‘‘relatively lackluster 37.7 percent.”

The value of those investments in this region grew 134.3 percent over that period, according to the report. That was also the highest increase in the nation, well above the second-place area, Boston-New England, with 90.0 percent.

However, warned Matt Zuga, managing director of Red Abbey Venture Partners, ‘‘We don’t have the entrepreneurial community that they have in Silicon Valley and other areas in the country.”

State government bureaucracies hold down biotech investments, he said. Still, the good news is that a record amount of venture capital is now available for ‘‘good opportunities” in life sciences.

‘‘And good health care should be recession-proof,” Zuga said.

‘Capture the heartsand minds of our kids’

The real future of life sciences in Maryland rests with its 1 million schoolchildren, said James Pitts, vice president of Northrop Grumman, which provides bio-agent detectors in post offices.

It is ‘‘critically important to capture the hearts and minds of our kids, or all this won’t matter,” Pitts said.

If not, the United States will lose its position in the industry to other nations that graduate more college students with life science degrees. China, for example, graduates as many as 700,000 engineers a year, while the United States graduates 70,000, Pitts said.

William Kirwan, chancellor of the University System of Maryland, said state leaders need to break down petty ‘‘regionalism” between campuses of universities, agencies of governments and sectors of industries.

‘‘We don’t have the spirit or culture to promote a robust investment climate for helping startup companies,” Kirwan said.

In other words, what Maryland needs is the right kind of sneeze, said William Brody, president of Johns Hopkins University.

If someone sneezes at Stanford University, he said, someone else cultures it and clones it, gets venture funding and makes a vaccine, he said. On the other hand, if someone sneezes at Johns Hopkins, someone might clone it, then get a National Institutes of Health grant and write several scientific papers. There needs to be more commercial follow-through in Maryland, Brody said.

Rita Colwell, chairwoman of Canon U.S. Life Sciences and founder of the University of Maryland Biotechnology Institute in 1986, said the U.S. position in life sciences is ‘‘the silent Sputnik,” referring to the national alarm of the 1960s following the Soviet Union’s launch of the space orbiter in 1957. The United States is facing ‘‘incredible” completion internationally, Colwell said.

Del. Brian J. Feldman (D-Dist. 15) of Potomac, who co-chairs a new legislative biotech caucus, said Maryland needs to worry about competition among states, such as a new $1 billion investment in Massachusetts in biotechnology. Some of the $40 billion in Maryland’s pension fund should be invested in life sciences, Feldman said.

The $6 million biotech tax credit that Feldman co-sponsored ‘‘was a very modest step,” he said. Franchot immediately promised to meet with State Treasurer Nancy Kopp (D) to discuss Feldman’s proposal.

Franchot said that ‘‘Marylanders should not be discouraged by what other states are investing in to build their life science because the foundation for life sciences in this state is ‘light years’ ahead of them. We not only have good jobs but the foundation provides career ladders.”

Real estateand education

A leading life science real-estate agent, Robert Scheer, owner of Scheer Partners of Rockville, said that from his perspective, the state has done a ‘‘terrific job in building the life science sector, but we are slipping.”

‘‘In my mind, commercial real estate is diagnostic of the state of life science health,” Scheer said. In the sector, rental rates have dropped about 10 percent and vacancies have been high, at almost 10 percent for the past several years, he said.

The industry’s success rests on the region’s educated workforce, according to the Sage report.

‘‘More than virtually any other economic segment, the vibrancy of biosciences depends upon the quality and quantity of human capital. The state⁄region is arguably home to the nation’s most highly qualified and educated workforce,” the report states. ‘‘For instance, in 2005, the Washington-Baltimore metro region led the nation in the share of adults with advanced degrees (18.5 percent), significantly higher than second place Boston (16.3 percent).”

The report said Maryland’s bioscience sector generated $29 billion in annual economic output, $11 billion in income and nearly $600 million in state taxes. The average job supported directly by the state’s life science industry pays $108,000.

Jonathan Lederer, director of the University of Maryland Medical Biotechnology Center in Baltimore, said that ‘‘from strictly a scientist’s standpoint, this is one of the best places around. That we are well supported by high officials of the state government is a key.

”

New Name= New Mission?

New name new mission?

Chesapeake Regional Tech Council expanding its reach
January 4, 2008
By Allan Maurer

ANNAPOLIS, MD—Just outside the immediate Potomac region surrounding Washington, DC, the Chesapeake Regional Tech Council in Anne Arundel County, Maryland no longer sees itself as a single-county organization.

Since 1992, the organization formally known as the Anne Arundel Tech Council supported the expanding technology sector both locally and beyond its borders. It changed its name to the Chesapeake Regional Tech Council to reflect the increasingly regional nature of its membership and concerns.

“I think it’s a great name change,” says Michael Ryan, president of South River Technologies, who took the helm as the council’s president Jan. 1.

Since 2005, the council saw its membership grow from 74 to more than 229 under the leadership of Laura Willoughby, executive director. About 30 percent of its membership is from outside county borders.

“We’ve been regional in nature the past few years,” Ryan tells Techjournal South, “and we changed the name to suit our membership base.”

He points out that the region has intertwining connections, ranging from the high number of government contractors in the Chesapeake area to the way people commute from Northern Virginia to DC or Maryland’s Montgomery County to work.

“Our tight connection and proximity to the federal government means there is an abundance of contractors and agencies that work directly with the government to provide technology for building aircraft, tanks, secure networks, data transmission and more,” Ryan says.

The area does have a weakness in workforce development, says Ryan. “We have all these great tech companies (more than 1,500) in the area trying to find workers. One of the things we’ll see in the next three to five years due to the base (U.S. Armed Forces) realignment initiative is that we’ll have a ton of jobs coming into the area. It’s a struggle to find quality people.

“The closure of bases that were previously in Virginia or New Jersey or elsewhere is bringing agencies and contractors here. So an already tight job market will get even tighter when those organizations move into town. Workforce development is a key factor on everyone’s plate.”

Seed funding is also “a little tight” in the region, Ryan notes. “There’s no shortage of ideas, that’s for sure,” he says.


Ryan says the region is doing a good job of helping entrepreneurs and startups succeed.

He points to the Chesapeake Innovation Center, an incubator that focuses on homeland security startups ranging from biotechnology firms tackling ways to combat anthrax threats to IT companies. Its tenants, among others, include:

BeCrypt USA, a security software company formed to meet the growing demand for high-level encryption products for personal computers and PDAs from the international government and corporate marketplace.

CINTT, a professional services firm that provides intelligence analysis, intelligence analysis training, and analytical technology to the U.S. Intelligence Community, and MGB, which has developed the ProductAcoustic Signature System (PASS) handheld container inspection device.

Graduate companies, among others, include PharmAthene, which is developing countermeasures to a range of biological and chemical threats with potentially lethal effects.

Goals for the council, Ryan says, is to further diversify and expand its growing membership and bring more value to its members through networking events and quality programs.

Wa Po: Biotech Surge Shows Manufacturing Still Key to Economy

In N.C., A Second Industrial Revolution
Biotech Surge Shows Manufacturing Still Key to U.S. Economy

By Peter S. Goodman
Washington Post Staff Writer
Monday, September 3, 2007; A01

PITTSBORO, N.C. -- Until the late 1950s, the low-slung brick building in the center of this minuscule town was home to the Kayser-Roth hosiery mill. Some 400 workers tended to clattering looms, churning out pantyhose.

"It was the best employer in town," said Nancy May, a former worker.

The hosiery mill is gone now, along with much of the Carolina textile industry -- a casualty of the global reordering that has concentrated production in Asia and Latin America. But the old brick building is still here and still making products -- albeit modern varieties that could scarcely have been imagined a half-century ago: Today, the site is occupied by a biotechnology company, Biolex Therapeutics.

Inside, 90 workers harness expensive laboratory equipment and a plant called duckweed, a bane to local ponds, to develop a drug for a serious liver ailment. Even the lowest-paid lab technician takes home far more than the seamstresses earned. If the start-up succeeds, its product will be substantially more lucrative than pantyhose.

As lawmakers pursue legislation aimed at softening the blow from factory closures, and as the downside of trade emerges as a talking point in the 2008 presidential campaign, it might seem that manufacturing is a dying part of the U.S. economy. But the retooling of this old brick building on Credle Street underscores how, despite its oft-pronounced demise, American manufacturing is in many regards stronger than ever.

The United States makes more manufactured goods today than at any time in history, as measured by the dollar value of production adjusted for inflation -- three times as much as in the mid-1950s, the supposed heyday of American industry. Between 1977 and 2005, the value of American manufacturing swelled from $1.3 trillion to an all-time record $4.5 trillion, according to the Bureau of Economic Analysis.

With less than 5 percent of the world's population, the United States is responsible for almost one-fourth of global manufacturing, a share that has changed little in decades. The United States is the largest manufacturing economy by far. Japan, the only serious rival for that title, has been losing ground. China has been growing but represents only about one-tenth of world manufacturing.

But if the big picture is brighter than many realize, American manufacturing is nevertheless undergoing fundamental change that is exerting enormous pressure on workers.

Imports are rising, now representing a third of all manufactured goods consumed in the country, up from 10 percent in the 1970s.

American exports are rising even faster than imports, but companies face intense price competition, with China, India, Brazil and dozens of other low-wage countries now part of a global marketplace for labor and materials. Manufacturers are redesigning production lines to make them more efficient, substituting machinery for people wherever possible.

So while American manufacturing is not declining, manufacturing employment has been shrinking dramatically. After peaking in 1979 at 19 million workers, the American manufacturing workforce has since dropped to 14 million, the lowest number since 1950.

A stark educational divide has emerged on the factory floor, as skills and training separate winners from losers. In 1973, more than half of all American manufacturing workers failed to complete high school, and only 6 percent attended some college, according to the National Association of Manufacturers. By 2001, nearly half completed high school and one-fourth attended some college.

North Carolina encapsulates the forces remaking American manufacturing. Between 2002 and 2005, the state lost 72,000 manufacturing jobs, about three-fourths in textiles, furniture-making and electronics, according to the North Carolina Commission on Workforce Development. At the same time, the state has become a rising powerhouse in lucrative new manufacturing sectors such as biotechnology, pharmaceuticals and sophisticated textiles.

As they grapple with change, North Carolina's workers and factory owners are helping answer a pressing question: What does the future hold for manufacturing in the United States?
Adapting to a New Market

"We didn't see it coming," the furniture man grimly declared.

Michael K. Dugan once ran Henredon Furniture Industries, which operated a plant in Spruce Pine, a former mining town in the rugged mountains in the western part of the state. There the company made hand-carved wooden bedroom furniture, once employing more than 1,000 people. Many lacked high school diplomas and some were illiterate, yet the factory provided a way for these workers to support families and to acquire modest homes and cars. It paid roughly $14 an hour, plus health and pension benefits.

Henredon's four-poster beds retailed for about $5,000 in the early 1990s, Dugan recalled. A few years later, similar models started showing up from the Philippines for less than $2,000. Now they can be found for $799, produced by workers in southern China who earn as little as 40 cents an hour.

Henredon first trimmed its workforce. Three years ago, it shut down the plant, eliminating the last 350 positions and adding to a wave of layoffs in surrounding Mitchell County, which has had roughly one-fifth of its jobs wiped out since 2000, according to the Employment Security Commission of North Carolina.

Many of the storefronts in Spruce Pine's brick downtown are empty. Restaurants and shops have closed, succumbing to a dearth of local spending power.

"The kids are moving out," said Brenda Smith, a youth pastor at a teen center. "They can't find anywhere to work. There's Wal-Mart, and that's about it."

For 26 years, Phillip Wilson worked at Henredon as a master carver. Now, on most days, he wakes before dawn and drives to his new job -- the 5:30 a.m. shift as a prison guard at the medium-security Mountain View correctional facility. His pay is down 15 percent, forcing him into a second job at a used-appliance store to make ends meet.

Throughout the state, and indeed the nation, laid-off factory workers are typically able to find new jobs but mostly for lower pay. A June 2002 study published by the North Carolina Justice and Community Development Center found that workers who lost manufacturing jobs in 1999 and 2000 were earning 72 percent of their previous salaries six months later.

Furniture-making is typical of the manufacturing sectors that are shrinking in the United States. For many, labor represents a relatively high proportion of total costs, making them vulnerable to foreign competition. If factories cannot automate, they die.

The textile industry has been particularly aggressive in replacing people with machines. A half-century ago, a typical North Carolina textile worker operated five machines at once, each capable of running a thread through a loom at 100 times a minute. Now machines run six times as fast, and one worker oversees 100 of them.

With machines increasingly occupying the center of production, manufacturers want highly trained, literate workers at the controls. To meet the demand and help workers secure jobs, North Carolina has beefed up course offerings at its community colleges.

Three years ago, it set up Bionetwork, a training program based in community colleges, to feed workers into the state's growing biotech sector.

"All of the skills are closely tied to the workplace," said Norman Smit, Bionetwork's recruitment director.

Smit seeks students from declining areas of manufacturing. Given intensive training and a willingness to adapt, a textile or furniture worker can become a better-paid biotech technician, he says. As proof, he points to Regina Whitaker.

Ten years ago, straight out of high school, Whitaker went to work at a yarn texturing plant in Yadkinville, in the Piedmont region. Her mother had worked there for 30 years.

From midnight until 8 a.m., Whitaker tended to whirring machinery, alternately wishing for another job and worrying that she would actually have to find one: Her company was opening plants in China and Brazil and laying people off in Yadkinville.

"I couldn't see spending my life there," Whitaker said.

In January 2003, she enrolled in the first associate degree classes offered in biotechnology at Forsyth Technical Community College. Now 28, she graduated in July 2004 and was hired as a lab technician at Targacept, a biotech start-up in Winston-Salem that was spun off from R.J. Reynolds Tobacco. Where the tobacco giant had researched the use of nicotine to make people crave cigarettes, Targacept is focusing on the nicotine receptors in the brain to develop drugs for Alzheimer's disease and schizophrenia.

Whitaker said her salary is "significantly more" than the $13.40 an hour she made at the yarn factory.

"I'm not struggling now," she said. "Before, it was paycheck to paycheck."
Textile Firm Finds a Niche

Glen Raven Custom Fabrics was another Carolina textile operation whose future seemed in doubt. In the early 1990s, the company was still concentrated on products under siege from foreign competition -- pantyhose, luggage fabric and yarn for apparel. Throughout the Carolinas, other textile companies were vanishing.

Glen Raven managed to endure and prosper by refocusing on specialty industrial fabrics for outdoor furniture, boats and awnings -- expensive goods that require customization, high-end machinery and technical expertise.

Economists suggest this is the future for successful U.S. manufacturers: zeroing in on high-value products that tap America's technological advantages to offset high labor costs. This strategy has fostered a boom in exports of American-made industrial engines and machinery, aerospace gear and pharmaceuticals.

North Carolina has embraced this approach, aggressively pushing biotechnology development. In the past decade, the number of biosciences firms in the state has jumped to 386 from 131, and the number of workers has more than doubled from 20,000 to 47,000, according to the North Carolina Biotechnology Center, a government arm that promotes the industry.

At Research Triangle Park, a sprawling complex outside Raleigh-Durham, Biogen Idec has established one of the larger biomanufacturing facilities in the United States, making sophisticated pharmaceuticals. Entry-level workers with the necessary training earn $27,000 to $35,000 a year. Experienced production workers can make considerably more.

For Glen Raven, the focus on high-technology production has turned its factory floors into lonely expanses. In Norlina, N.C., a red-brick factory just down Route 1 from the town's lone traffic light, 225 people once made pantyhose, pushing baskets of nylon across the floor by hand. Now, 156 workers man computers that control acres of robotic arms and bobbins producing yarn.

The refashioning has positioned Glen Raven to profit from what many portray as the mortal threat to the Carolina textile industry: China now buys growing volumes of the company's products. Last year, North Carolina exported $52 million of textiles and fabrics to China, a fivefold increase from 2003.

Chinese factories increasingly use Glen Raven's fabrics to make sun umbrellas and upholstery for lounge chairs, sending many of these finished goods back across the Pacific to the United States.

The workers at these Chinese factories typically make less in a month than the price of a sun umbrella at an American retailer. Glen Raven's success allows the company to pay its American workers $10.50 to $22 an hour, plus benefits. Even at those wages, labor represents only 5 percent of the overall cost of turning fiber into fabric.

Put another way, the efficiency of the machines that have eliminated jobs at its plants has allowed Glen Raven to pay the remaining workers enough to afford cars, health care and homes. Some of those homes boast patios and lawns now shaded by sun umbrellas made in China using fabric woven just down the road.