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Message 373970 - Posted: 22 Jul 2006, 5:32:09 UTC
Last modified: 28 Nov 2006, 4:27:10 UTC

(Continued from here)

Stem cell institute to get loan from state
Schwarzenegger OKs $150 million for research


By Terri Somers
San Diego Union-Tribune

July 21, 2006

Gov. Arnold Schwarzenegger yesterday authorized a $150 million loan to the state's stem cell institute, giving it money to make research grants while continuing to fight legal challenges that threaten its existence.

The move came a day after President Bush used his veto power for the first time in his presidency to quash a law that would have expanded federal funding for embryonic stem cell research.

Schwarzenegger said the state cannot afford to wait to fund the critical science.

“I remain committed to advancing stem cell research in California, in the promise it holds for millions of our citizens who suffer from chronic diseases and injuries that could be helped as a result of stem cell research,” Schwarzenegger said in a letter authorizing the loan.

Stem cell institute President Zach Hall said the loan will give the financially challenged organization enough money to fund at least one round of grants.

Since the lawsuits were filed, the institute has been running on philanthropic donations and loans. Earlier this year it secured the funding to issue just one $14 million round of grants, for training stem cell scientists.

Institute Chairman Robert Klein said the governor had not sought to issue a loan previously because lawsuits challenging the constitutionality of the stem cell institute put its continued existence in jeopardy.

On April 21, the institute won its first round in court when an Alameda County Superior Court judge affirmed its constitutionality.

Opponents are appealing that decision, which is expected to extend the legal wrangling for one more year. That will continue to stymie the state's ability to sell bonds to finance the institute.

However, Klein said that after the institute received a strong decision from the court, the governor felt it was on strong-enough legal footing to give it the loan.

Schwarzenegger's Democratic opponent in November's gubernatorial election, Phil Angelides, said yesterday that as state treasurer he has helped the stem cell institute stay afloat. He said that as a member of the agency's finance committee, he launched the effort to solicit loans, known as bond anticipation notes.

“For the past year, while I was fighting for immediate funding for the California Institute of Regenerative Medicine, the governor failed to lift a finger to stand up to the anti-research activists who thwarted the will of the voters and blocked Proposition 71,” Angelides said, referring to the ballot measure that created the agency.

Schwarzenegger's communications director, Adam Mendelsohn, said the governor acted because of Bush's veto and “because it's the right thing to do to keep California out in front.”

The institute anticipates having the state loan money in hand within a few months and to make the next round of grants in early 2007, Hall said.
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Message 373973 - Posted: 22 Jul 2006, 5:38:15 UTC
Last modified: 22 Jul 2006, 5:40:18 UTC

Look how similar these two quotes are. The one below in bold is by Yaron Brook. This one here is from Swarzenegger, one day after Brook's press release.

“I remain committed to advancing stem cell research in California, in the promise it holds for millions of our citizens who suffer from chronic diseases and injuries that could be helped as a result of stem cell research,” Schwarzenegger said in a letter authorizing the loan.

-------------------------------------------------

Ayn Rand Institute Press Release
http://www.aynrand.org/

Opponents of Embryonic Stem Cell Research Are Opponents of Human Life
July 20, 2006

IRVINE, CA--"President Bush's claim that embryonic stem cell research violates 'the dignity of human life' is morally obscene," said Yaron Brook, executive director of the Ayn Rand Institute.

"This research has the potential to rescue millions of individuals from painful and life-threatening diseases. Anyone who places the welfare of a few undifferentiated cells above that of actual human beings cannot claim to value human life.

"There are no rational grounds for ascribing rights to an unconscious cluster of cells smaller than a grain of sand. But the opposition to embryonic stem cell research is not based on reason--it's based purely on religious dogma. From the development of anesthesia to the introduction of birth control, religion has consistently opposed scientific and medical progress. Today, with their assaults on evolution, cloning, and stem cell research, the religious right is attempting to drag us back to the Dark Ages.

"Anyone who values human life must stand up for science and against President Bush's attempt to impose his religious agenda on America."

### ### ###


Copyright © 2006 Ayn Rand® Institute. All rights reserved.
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Message 374044 - Posted: 22 Jul 2006, 8:08:11 UTC - in response to Message 373973.

Look how similar these two quotes are.

Methinks it's a conspiracy... ;)
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Message 374046 - Posted: 22 Jul 2006, 8:10:09 UTC - in response to Message 374044.

Look how similar these two quotes are.

Methinks it's a conspiracy... ;)
Exactly! lol

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Message 376282 - Posted: 24 Jul 2006, 11:18:49 UTC

Tulane stem cell unit lines up trials
Patient's cells may be used to heal
Thursday, July 20, 2006
By Leslie Williams

Tulane University introduced on Wednesday the latest addition to its expanding medical ventures: a million-dollar Good Manufacturing Practice facility that will grow large numbers of adult stem cells that one day may be used to treat long-term, debilitating diseases.

Already, stem cells grown at the facility on the 21st floor of the former Tidewater building at 1440 Canal St. are scheduled to be used in trials in Atlanta and New Orleans, said Dr. Darwin Prockop, medical director of the facility.

Adult stem cells produced at the facility will be used in trials in October for patients in Atlanta with injured spinal cords, Prockop said.

In about six months in New Orleans, adult stem cell therapy trials are scheduled for people suffering from heart disease and diabetes, he said.

The field of gene therapy has "taken off," Prockop said. "It's a big day for us, a big step forward."

Six years ago, Prockop was lured to Tulane from his post as director of the Gene Therapy Center at MCP Hahnemann University in Pennsylvania.

Paul Whelton, Tulane's senior vice president for health sciences, called Prockop the "father figure and forerunner of this whole area of gene therapy in the days when they called it molecular medicine."

"When we were doing strategic planning several years ago, thinking what are the areas we are going to focus on . . . our faculty came back and said there was one area where we don't have real strength now, but we think it's so important we must be in it," Whelton recalled. "And they said to me the best person in the world who leads this area is Dr. Prockop . . . and in about six years he has done such a magnificent job."

Each of the trials in New Orleans likely will include six to 10 people.

Embryonic cells have nothing to do with the procedure.

"We deal with cells that we get from the patient we are treating. We get bone marrow from the patient," said Prockop, who also is the director of Tulane's Center for Gene Therapy. "It's a rather simple procedure: needle, syringe and local anesthesia. It hurts a little bit, but not so much. You get a teaspoon of bone marrow, bring it up to the 21st floor of this building where the GMP facility is, and the crew we have there will produce about 300 million cells. And those are the cells that go back into the same patient. And they're marvelous cells . . . . they have this ability to find a place in the body with damaged tissue and fix it."

The Good Manufacturing Practice facility, which officially opened Wednesday, was set up with about $1 million, money primarily from Tulane University, the Louisiana Gene Therapy Research Consortium and the National Institutes of Health. So far, it has a $700,000 annual operating budget and a staff of seven people.

The 25-story building at 1140 Canal St. also houses Tulane University's School of Public Health and Tropical Medicine and administrative offices of Tulane's Health Sciences Center.

Repairing damaged cells

The stem-cell manufacturing facility is supported by Tulane University's $25 million Center for Gene Therapy, Whelton said. Scientists believe stem-cell therapy or regenerative medicine over time may one day repair damaged cells in the bone, brain, heart, lung and kidney.

Stem cells offer the possibility of a renewable resource to treat diseases such as cancer, Alzheimer's, Parkinson's, osteoarthritis and diabetes, said Prockop, who was thanked for his work Wednesday by District B Councilwoman Stacy Head.

Her husband, she said, has juvenile diabetes and may one day benefit from the stem-cell work in New Orleans.

Prockop agreed.

"Our results from animal experiments suggest we can help," he said.

In about six months, the treatment for diabetes may be outpatient, said Prockop, who brought Donald Phinney, an associate professor of microbiology, with him when he left Pennsylvania for a Tulane University that, he said, was supportive of stem-cell research and an educational community in New Orleans that was investing money into such research and building facilities to support it.

Phinney conducts research at Tulane's Primate Center with monkey stem cells and brain diseases.

Other researchers on Dr. Prockop's team, who work at the Tulane Center for Gene Therapy, include:

-- Bruce Bunnell, an associate professor of pharmacology who works with viruses that are used to transport the stem cells into the body.

-- Carl Gregory, an assistant professor of medicine who creates conditions favorable to manufacturing cells and using them to treat cancer of the bone in animals.

-- Radhika Pochampally, an assistant professor in pharmacology who works on obtaining the most effective stem cells.

"Back in the year 2000, there were few believers in these cells. Now there are many believers out there," Prockop said.

"The field that's taking off most is heart disease, and there now must be something like 2,000, perhaps 3,000, patients being treated with bone-marrow cells for heart disease of various kinds," he continued. "We're not the first, but we want to be the best. And we'd like people with these diseases . . . to come here to New Orleans, Louisiana -- not to fly off to Bangkok, which is advertised on the Internet for patients. We want them here, because we think . . . we have the best cells."

. . . . . . .

Leslie Williams can be reached at lwilliams@timespicayune.com or at (504) 826-3358.
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Message 376637 - Posted: 24 Jul 2006, 22:43:21 UTC

EU to fund embryo cell research

Ministers from European Union member states have agreed to continue funding research on embryonic stem cells.
Some countries oppose the research, but scientists say the cells are the key to treating diseases such as Alzheimer's and Parkinson's.
.....
Last week US President George W Bush used his veto for the first time to limit federal funding for the research.
......
Together the eight countries could have blocked adoption of the EU's 54bn euro (£37bn) research budget for 2007-13, of which stem cell research forms a very small part.


I'm convinced that if Europe can form a better trading coalition, they can become an economic power house that exceeds all others. With this research, they may have a chance to lead the world in medical research as well.
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Message 376648 - Posted: 24 Jul 2006, 22:52:25 UTC - in response to Message 376637.
Last modified: 24 Jul 2006, 22:55:48 UTC

EU to fund embryo cell research

Ministers from European Union member states have agreed to continue funding research on embryonic stem cells.
Some countries oppose the research, but scientists say the cells are the key to treating diseases such as Alzheimer's and Parkinson's.
.....
Last week US President George W Bush used his veto for the first time to limit federal funding for the research.
......
Together the eight countries could have blocked adoption of the EU's 54bn euro (£37bn) research budget for 2007-13, of which stem cell research forms a very small part.


I'm convinced that if Europe can form a better trading coalition, they can become an economic power house that exceeds all others. With this research, they may have a chance to lead the world in medical research as well.

Not a chance..
If they have more liberal non religious views that influcence thier research policies then they will certainly excel there...until the U.S. wakes up.

Economically? They are going to go through great growing pains. The collective systems there are relentlessly opposed to imagination, creation, increased profits and technology.

The EU loves to laugh at the U.S. as an example of a failure of 'capitalism'. Our 4% unemployment rate compared to France's 15% (even that is understated, France calculates differently),



Americans never think like that. The Japanese are perhaps sharper but slower to respond, but Americans are BOLDER.....and all is right with the world.
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Message 376667 - Posted: 24 Jul 2006, 23:14:37 UTC - in response to Message 373970.

Everyone is freaking out over stem cell thing... just like hundreds of years ago they where freaking out over people disecting dead bodies, and know what in the long run what we gained from that kind of experimentation advanced and improved our life by leaps and bounds. Once again, scienctific advancment is being held back by a few ignorant fools.
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Message 376816 - Posted: 25 Jul 2006, 1:14:31 UTC

The politics of stem cell research

ROBERT D. NOVAK
THE CHICAGO SUN-TIMES

July 24, 2006

The White House was poised last Tuesday to make the best of a bad political situation. While President Bush would cast his first veto on a popular embryonic stem cell research bill, the political sting was supposed to be diminished by him simultaneously signing an alternative measure. But that scenario was ruined when the second bill was defeated in the House.

The president's aides were stunned. The bill directing the National Institutes of Health to pursue research that would not kill human embryos, as the vetoed bill would, passed the Senate Tuesday, 100-0, and there was no warning of failure in the House. So, instead of the contemplated signing ceremony Wednesday, Bush directed the NIH to proceed with research anyway – an indication the defeated legislation was not needed.

Last week's convoluted congressional developments, though raising questions of life, death, morality and religion, reflected election-year politics. Seasoned Democratic political operatives regard stem cell research as the most important issue affecting the 2006 elections. They believe Bush's sustained veto will alienate normally Republican voters in swing congressional districts, winning Democrats control of the House. The president's aides, while disagreeing with this analysis, planned to mitigate the political fallout by what amounted to a simultaneous sign-and-veto ceremony.

Why, then, would the usually partisan Senate Democratic Leader Harry Reid go along with the Republican plan? Because it is extremely difficult to get anything done in the Senate, and Reid was willing to pass what he described as a meaningless bill to avoid obstruction and filibuster on the major measure.

But Rep. Diana DeGette of Colorado, lead Democrat on stem cell research, recommended that the alternative bill be opposed as a diversion. Even so, a clear majority of the House favored it. The killer was opposition by Rep. Michael Castle, Delaware's only House member, who leads the liberal faction of moderate Republicans (mostly from the Northeast). While small in number, Castle's followers frequently represent the House's balance of power.

Such was the case last week. If the alternative bill (sponsored by Rep. Roscoe Bartlett of Maryland) went through the regular procedure, it would be subject to a “recommittal motion” by Castle just before passage attempting to combine it with the Castle-DeGette bill originally passed by the House. That version surely would pass. So, Republican leaders avoided this disaster by trying to pass the Bartlett bill under a procedure that barred amendments but required a two-thirds vote.

The result was mass confusion on the House floor. The Republican whip operation was inactive, regarding the bill as a “conscience vote” (as abortion measures are). Democrats similarly were freed of the party lash, with 58 voting for the bill. Many members of both parties seemed confused by a procedure often used to commemorate routine anniversaries. It fell 13 votes short of the 186 (two-thirds of those present) needed for passage. Conservative Rep. John Linder of Georgia later said he was mixed up and voted no when he should have voted yes.

The bill would have passed save for the defection of 15 Republicans, including Linder. He was one of four Republicans who also voted against Castle-DeGette. The other three – Jeff Flake of Arizona, John Hostettler of Indiana and Ron Paul of Texas – based their votes on conservative/libertarian principles. Eleven Republicans who voted for Castle-DeGette and against Bartlett consisted of Castle and like-minded moderates. In their ranks were three members from Connecticut – Nancy Johnson, Christopher Shays and Rob Simmons – who are targeted by the Democratic campaign to take over the House.

The Republican high command went into panic mode Wednesday. There was talk about putting the bill through the regular order, but Castle's threatened recommittal had not disappeared. The president was urged to issue an executive order, but his brief Wednesday statement served much the same purpose without raising rancor. Unfortunately, it also missed the original goal of a publicly proclaimed alternative.

While advocates contend that the alternative approach actually offers better prospects for quick progress against disease, scientific arguments were lost amid the political give-and-take last week. George W. Bush cast his first veto on moral and theological grounds, but fell short of mitigating the political impact by not getting an alternative approach through Congress.
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Message 392558 - Posted: 9 Aug 2006, 3:48:42 UTC
Last modified: 9 Aug 2006, 3:48:54 UTC

Gates Foundation hit up for stem cell research funds

BLOOMBERG NEWS

August 4, 2006

Two U.S. lawmakers are asking the Bill & Melinda Gates Foundation to fund research on embryonic stem cells after President Bush vetoed legislation that would have allowed new federal funding.

Reps. Diana DeGette, D-Colo., and Michael Castle, R-Del., asked the Seattle-based foundation in a letter yesterday to make stem cell research a “top priority.” The pair said the research may lead to new cures.

“It seems to fit within the guiding principle of your foundation 'every life has equal value,' ” the lawmakers, who have sponsored stem cell funding legislation, wrote in the letter.

The request to the Gates Foundation is part of a push by supporters of stem cell research to go around federal funding limits by using private and state money. California voters two years ago endorsed a plan to spend $3 billion over 10 years on the research. Scientists at Harvard University and other schools are seeking private dollars.

Scientists say stem cells, which can develop into any type of tissue in the body, may hold the key to finding treatments for Parkinson's disease, diabetes, spinal chord injury and other now-incurable illnesses.

The legislation vetoed by Bush on July 19 would have eased limits the president imposed in 2001 by allowing the government to fund studies of stem cells culled from embryos left over after fertility treatments.

Bush said the legislation would have crossed a “moral boundary” by the “taking of innocent human life in the hope of finding medical benefits for others.” Obtaining the cells requires destruction of human embryos.

The Gates Foundation, created in 2000, is the nation's largest charitable organization with about $29.2 billion in assets.
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Message 403951 - Posted: 23 Aug 2006, 0:54:59 UTC

Doctors try to kick-start growth of knee cartilage
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Message 404394 - Posted: 23 Aug 2006, 14:32:00 UTC - in response to Message 376648.

EU to fund embryo cell research

Ministers from European Union member states have agreed to continue funding research on embryonic stem cells.
Some countries oppose the research, but scientists say the cells are the key to treating diseases such as Alzheimer's and Parkinson's.
.....
Last week US President George W Bush used his veto for the first time to limit federal funding for the research.
......
Together the eight countries could have blocked adoption of the EU's 54bn euro (£37bn) research budget for 2007-13, of which stem cell research forms a very small part.


I'm convinced that if Europe can form a better trading coalition, they can become an economic power house that exceeds all others. With this research, they may have a chance to lead the world in medical research as well.

Not a chance..
If they have more liberal non religious views that influcence thier research policies then they will certainly excel there...until the U.S. wakes up.

Economically? They are going to go through great growing pains. The collective systems there are relentlessly opposed to imagination, creation, increased profits and technology.

The EU loves to laugh at the U.S. as an example of a failure of 'capitalism'. Our 4% unemployment rate compared to France's 15% (even that is understated, France calculates differently),



Americans never think like that. The Japanese are perhaps sharper but slower to respond, but Americans are BOLDER.....and all is right with the world.



It depends on how you mean "slower". Japanese corps typically work with three to four layers of management as opposed to US corps' average of 24 layers. So, a Japanese company can react more quickly to market demands, but perhaps more slower in other ways.

In my book, if one values human life, then one should give meaning to those emryos that are going to be destroyed anyhow....notthis "we want our religious cake and eat iot too."

Religion and politics have no place in government and science...yet they're oddly there.
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Message 405564 - Posted: 25 Aug 2006, 2:00:31 UTC

New stem cell method found
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Message 407444 - Posted: 26 Aug 2006, 20:32:59 UTC

Stem Cell Breakthrough Won't Satisfy Religious Conservatives
August 24, 2006

Irvine, CA--"The researchers at Advanced Cell Technology should be congratulated for their scientific breakthrough," said Dr. Yaron Brook, executive director of the Ayn Rand Institute. "But their new method of creating stem cell lines will not stop religious opposition to scientific progress."

In developing a method of extracting embryonic stem cells without destroying the embryo, the team was, in part, trying to address the concerns of those opposed to the destruction of embryos. As the team leader said: "There is no rational reason left to oppose this research."

"But there has never been a rational reason to oppose embryonic stem cell research," said Dr. Brook. "The opposition comes mainly from religious conservatives and is--by their own declaration--based on faith, not on reason. It is based on the irrational belief that a mere clump of cells is a full-fledged human being."

"There is no rational reason to morally oppose this research, and its potential to produce treatments for such diseases as diabetes, Alzheimer's, and Parkinson's is ample reason to morally support it.

"It is a mistake to try to appease religious conservatives on this issue. What they are opposed to, fundamentally, is science as such."

### ### ###

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Message 413066 - Posted: 2 Sep 2006, 1:16:18 UTC

Stem cell triumph isn't – embryos were destroyed

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Message 413144 - Posted: 2 Sep 2006, 1:58:25 UTC

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Message 431603 - Posted: 6 Oct 2006, 2:43:16 UTC

Foundation-held stem cell patents to be re-examined
High fees, restrictive guidelines have objectors seeking reversal


By Terri Somers
Union-Tribune

October 4, 2006

The U.S. Patent and Trademark Office has agreed to re-examine patents that give the University of Wisconsin's Alumni Foundation the exclusive rights to all human embryonic stem cells used for research.

In granting the re-exam, the patent office said it found that consumer groups raised substantial questions as to whether the three patents on embryonic stem cells should have been issued.

The consumer advocates contend the patents require all researchers in the United States working with embryonic stem cells – whether at a university, private research lab or drug discovery company – to pay exorbitant fees and adhere to such restrictive guidelines that researchers are effectively being handcuffed.

The groups also argue that Wisconsin's science was not unique enough to have been worthy of a patent. They submitted previously published papers documenting the research of other scientists who worked on embryonic stem cells before University of Wisconsin scientist James Thomson filed for his first patent.

“We're pleased the (patent office) has decided to re-examine these patents,” said John M. Simpson, of the Foundation for Taxpayer and Consumer Rights in Santa Monica. “The patents should never have been issued in the first place.”

Joining in the request for a re-examination are the New York-based Public Patent Foundation and Jeanne Loring, a stem cell researcher at the Burnham Institute in La Jolla.

The patents at issue were granted to University of Wisconsin researcher James A. Thompson in 1998, 2001 and last April. The patents cover the scientific recipe for pulling embryonic stem cells out of days-old primate embryos that are a cluster of 100 to 200 cells. These embryonic stem cells eventually morph into all cell types in the body, including nerve, blood and bone.

The hope and hype are that these cells can be used to test new drugs that are problematic to test on people, and that they might eventually be used to produce new cells to cure diseases such as diabetes, Parkinson's and Alzheimer's.

Beth Donley, executive director of WiCell Research Institute, which was formed to commercialize the Wisconsin patents, said the institute has provided a free license and stem cells to 324 research groups, Donley said.

“(The) stem cell patents do not inhibit research; in fact, they support and encourage it,” she said.

The consumer advocates say the patents, and the fees being charged to use the science they cover, are driving researchers and philanthropic funding overseas, where the patents are not legally recognized.

For instance, the Juvenile Diabetes Research Foundation is giving more money to researchers overseas because its philanthropic dollars go further where scientists are unfettered by the patents, Richard Goldstein, the organization's chief scientific officer, said earlier this year.

Many scientists and biotech insiders contend that this brain drain is giving other countries an advantage in the research that may one day lead to a lucrative industry providing treatments for some of the most devastating diseases.

Although there are 1.5 million patents active in the United States, the patent office receives only 400 to 500 requests annually to re-examine patents, said Brigid Quinn, a spokeswoman for the office. A re-examination can result in no change to the patent or a dismissal of all or part of a patent.

She said about 90 percent of re-examination requests are granted.

In each of the three Wisconsin patents to be re-examined, there are several scientific elements, also known as “claims.”

Some of the claims are for a method of deriving the stem cells and keeping them alive in different types of culture. Others are “composition of matter” claims, which seek ownership of all embryonic stem cells no matter what method is used to derive them and keep them alive.

It is the composition of matter claims that give the patents such sweeping control, said biotechnology patent lawyer John Wetherell, of Pillsbury Winthrop Shaw Pittman in San Diego. If a scientists develops another method for deriving embryonic stem cells and keeping them alive, the right to the cells would still be owned by the Wisconsin foundation under the composition of matter claim, Wetherell said.

The consumer groups asked the patent office to review all of the claims in each of the foundation's embryonic stem cell patents, and the patent office has agreed to do so.

Third-party requests for patent re-examination, like the ones filed challenging the Wisconsin patents, are successful in having the patent either changed or completely revoked about 70 percent of the time, Simpson said.

It can take up to a year for the patent office to complete the re-examination and decide whether to change the patent.
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Message 431605 - Posted: 6 Oct 2006, 2:44:37 UTC

Stem cell plans include creation of embryo bank

By Terri Somers
Union-Tribune

October 5, 2006

California's stem cell institute yesterday unveiled its plans for spending $3 billion in a 149-page, no-hype document that sets what experts and patient advocates described as conservative and attainable goals.

Not one stem cell therapy is expected to be approved for market within the next 10 years of state-funded stem cell research under the proposal. But the plan would allocate funding for jump-starting embryonic stem cell research and the creation of a statewide embryo bank.

More than $1.6 billion would be directed toward scientific research, with the rest going toward facilities, infrastructure, training and public outreach.

In the first few years, the institute would make millions of dollars available for studying tissue engineering, the auto-immune system and the development of human eggs and embryos. Later, after basic scientific discoveries are made, there would be $451 million with which research institutes and private industry could begin early-stage clinical trials on animals and humans.

“We didn't set out consciously to be cautious, but we did want to set goals that we think we can achieve with some luck,” said Zach Hall, president of the institute, formally known as the California Institute for Regenerative Medicine.

Taxpayer advocacy groups that have been monitoring the state's stem cell effort since the voter initiative was approved in 2004 said they appreciated the plan's educational tone.

“During the Proposition 71 campaign, proponents implied that miraculous cures were just around the corner,” said John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights in Santa Monica.

“This plan acknowledges just how difficult the task ahead is and is a welcome change from the hype that has all too often been associated with stem cell research,” Simpson said. “Californians are entitled to an honest assessment of the prospects for research they are funding.”

Some patient advocates, eager for cures that will knock out the deadly diseases affecting them or their loved ones, called the plan too conservative.

“Because they're so often criticized for overpromising, which I don't think they do, I think they've overcompensated in the wrong direction,” said Don Reed of Fremont, who heads the Roman Reed Foundation, named for a son who was paralyzed in a sports accident.

“I think they will go a lot farther than they state in the plan,” Reed said. “I expect my son to walk in 10 years.”

For the past 10 months, a committee of scientists, academics, patient advocates and biotechnology industry insiders met regularly to develop the road map that will guide the kind of research that taxpayers will fund and how it will be funded.

Balancing the hope and urgency of patient advocates with the financial realism of biotechnology insiders and the caution of scientists was one of the difficult hurdles that faced the committee.

The strategic plan will be discussed Tuesday and Wednesday by the 29 members of the institute's governing board, who are expected to make revisions before adopting a final strategic plan.

Since it can take up to a dozen years and $1 billion to bring a new therapy to market, the committee starts out its plan by saying that it does not expect to be able to fully fund a stem cell therapy.

However, it does aim to fund the creation of a pipeline of scientific discoveries that improve understanding of stem cell biology as well as the creation of several therapy candidates that may someday result in marketable products.

“The plan includes funding for many parallel programs,” Hall said. “I think it gives us a very rich pipeline so that the work can go on well after 10 years.”

San Diego-based stem cell scientists who will be applying for funding from the institute were enthusiastic after reading the proposal.

“I think many of the five-year goals we are well on track for accomplishing, which probably means we'll be able to make the 10-year goals as well,” said Evan Snyder, a stem cell researcher at the Burnham Institute in La Jolla.

“I also think there's a good appreciation (in the plan) for the fact that developing therapies depends on good fundamental knowledge of disease process and how cells work,” Snyder said.

He and his Burnham Institute colleague Jeanne Loring said they were excited with a plan to provide about $182 million to interdisciplinary teams of scientists. Some of these teams will start out with a plan of addressing a specific disease.

In the early years, an important part of the institute's program will encourage scientist-initiated, curiosity-driven science relevant to the development of embryonic stem cell therapies. Limited federal funding for stem cell research makes the institute's funding of this what-if science imperative, the strategic plan states.

Loring, one of many people interviewed by the committee drafting the plan, was enthusiastic to see that the funding included grants for scientists looking for many different ways to grow embryonic stem cell lines.

A consumer advocacy group, however, said the plan doesn't provide enough funding in that controversial area of stem cell research.

“It's surprising that out of billions of dollars for research, the plan shortchanges research into alternative sources of potent stem cells,” said Jesse Reynolds, of the Center for Genetics and Society.

“Spending more on work that might lead to potent stem cell lines without destroying embryos or requiring eggs would be better 'bang for the buck.' Research in this area could lead to opening up the restricted federal funds – worth hundreds of millions of dollars,” Reynolds said.

Recognizing that stem cell research will influence society in ways other than new therapies, the committee proposes to sponsor empirical research and conferences that take a more theoretical approach to dealing with moral issues. The report budgets $25.5 million for those programs.

Jesse Reynolds, a spokesman for the Center for Genetics and Society in Oakland, said that isn't enough.

“The human genome project, which was a similar magnitude as (the stem cell institute), set aside 3 percent of its budget to study the ethical, legal, and social implications of their work,” Reynolds said. “Stem cell research holds potential to alleviate suffering, but raises a host of profound issues. By allocating less than 1 percent to examining these implications, the (institute) is overlooking a critical area.”

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Message 435487 - Posted: 13 Oct 2006, 5:21:33 UTC

Board talks about criteria for 15 grants
Geography debated in stem cell funding


By Terri Somers
Union-Tribune

October 12, 2006

LOS ANGELES – How will California's $3 billion for stem cell research be divvied up around the state: Will most of the money go to cities such as San Diego and San Francisco that are hubs to large concentrations of scientists, or will it be scattered around so all geographic regions get a taste?

It's a question that scientists, local politicians and business leaders have been talking about mostly behind the scenes since before the state's stem cell initiative passed in 2004.

But it percolated to the surface yesterday at a meeting of the state stem cell institute's board, turning what could have been a quick reading of interim guidelines for small facilities grants into a lengthy discussion.

The California Institute for Regenerative Medicine plans to issue a request for applications from scientists, research institutes and universities that want a piece of more than $32 million that will eventually be made available for “minor renovations and construction” to create lab space that would be shared with scientists from different institutions.

Before the institute can seek those requests, its governing body needs to approve the procedures and criteria it would use to select grant recipients. Final criteria and guidelines are still in the works and are expected to take months to complete.

A total of 15 grants will be made. Five will be larger than the other 10, because they will include money for education and training. Each grant will provide up to $2 million for capital costs and between $200,000 and $800,000 to cover personnel and supply costs.

Under interim guidelines, the applications would first be scored on criteria, including scientific merit and how well the proposed project fits with the stem cell institute's mission.

The guidelines say the review could include consideration of the geographic location of the proposed shared lab – a point that drew concern from some board members.

“I don't think this group should be making geographic decisions; we are too conflicted,” said David Baltimore, a Nobel laureate who is one of the institute's 29 board members.

Board member Duane Roth, who runs Connect in San Diego, agreed.

Review committees composed of experts from outside San Diego would judge the applications on merit. That's an unbiased process, Roth said. Judging them on geographic merit adds an opportunity for bias, he said.

“Anytime you have adjustments being made after something's been judged on merit, it is going to wind up getting contentious,” Roth said. “It's a problem if it's not blatantly transparent.”

The board has shown geographic biases before.

Roth recalled that the vote on the location of the institute's headquarters – whether in San Diego or San Francisco – was ultimately decided by a vote in which the majority of board members selected what was geographically convenient for them.

Roth suggested that if geography would be a big factor, applicants should compete for grants regionally.

Hall, however, successfully argued that because these are shared grants, geography should be a determining factor so that as many scientists as possible have access to facilities.

It could be used to determine the grant recipient when two projects are scored very closely, Hall said.

But these shared grants should also be the exception to the rule, Hall said. “Our job should always be sure that we are servicing out scientific mission,” Hall said.

The geographic criteria were approved.

Hall and Roth said they don't expect geography to play a role in the future, when the board plans to have more funding available to facilities and begins offering large, multimillion dollar grants for construction of facilities.

It is undoubtedly an issue that many academics and business boosters in San Diego will watch.

Earlier this year, the four largest research institutions on the Torrey Pines Mesa created a consortium under which they will work together on stem cell research and jointly apply for state funding. The group's leaders want large sums of grant money to be directed at large centers of excellence, on the theory that taxpayers will then get the biggest bang for the buck.

If money is peppered around the state in an effort to be fair to all constituencies, regardless of whether they are established and respected stem cell research programs, San Diego insiders worry that California will have nothing to show for its investment when the money is gone.
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Message 440940 - Posted: 21 Oct 2006, 0:23:28 UTC

Novocell says it has manipulated stem cells to fight diabetes

By Terri Somers
Union Tribune

October 20, 2006

The tiny San Diego biotechnology company Novocell announced yesterday that it has learned how to efficiently use human embryonic stem cells to create pancreatic cells that produce insulin and other hormones.

The work is a big step toward creating a kind of transplant treatment for people with Type 1 diabetes, a degenerative disease in which the ability of the pancreas to secrete insulin erodes over time.

Chief Executive Alan Lewis said it is expected to be at least 2009 before Novocell undertakes large clinical trials in humans.

“We believe this is going to be a major stepping stone for human embryonic stem cell research and a major stepping stone for treating diabetes,” Lewis said in an interview yesterday.

Human embryonic stem cells turn into all the different cell types in the body, forming tissue, blood, bone and neurons. But learning how to turn embryonic cells into the different cell types is one of the many complicated questions being tackled by scientists around the globe.

Novocell's work, which was published yesterday in the online version of the journal Nature Biotechnology, is the first documentation of the successful differentiation of human embryonic stem cells into pancreatic cells that produce the five endocrine hormones. Others have reported turning animal cells and other types of cells into insulin producing cells.

Menlo Park-based Geron, another stem cell company, has said that it, too, has derived insulin-producing cells from human embryonic stem cells. However, that company has not published its findings.

Novocell's work, started in 2004, has been funded through private investors, including the Juvenile Diabetes Research Foundation and venture capital funds, because federal funding restrictions on embryonic stem cell research prevented the company from using grants from the National Institutes of Health, Lewis said.

He said Chief Scientific Officer Emmanuel Baetge replicated the way pancreatic cells grow in the womb in a petri dish.

To create true pancreatic cells, Novocell scientists had to first coax the embryonic stem cells to turn into the specific lineage of cells that later create the pancreas, liver, lungs, intestine and other internal visceral organs, Baetge said.

Baetge said their work blew a hole in the notion held by opponents of embryonic stem cell research who say adult stem cells can produce the same scientific results.

Once the cells created the proper lineage, Novocell figured out how to add and subtract growth factors over 16 to 20 days, to lead them down several more steps of development until they finally become pancreatic cells, Baetge said.

So far, the cells have developed to the stage of fetal pancreatic cells, Lewis said.

While they respond to other stimulants in the body and produce insulin, they are not able to respond to the level of sugar in the blood, he said. That is because in the womb, it is the mother's pancreas that is controlling her blood sugar and the nutrients for the baby, Baetge said.

The next step for Baetge and his team is to get a more mature stage of the pancreatic cells and coax them to create bundles, like the islets in the body, which then produce insulin and other pancreatic hormones in reaction to the presence of blood glucose, he said.

The problem with transplants is that the body's immune system views the transplant as a foreign and attacks it. In Type I diabetes, the patient's immune system is attacking its own pancreas.

Novocell scientists have developed a method of encapsulating the pancreatic cells in a polymer that prevents the body's immune system from viewing it as foreign matter and attacking it. The immune system response to organs and cells in other transplant therapies require patients to take immune system-suppressing drugs to prevent rejection. Those drugs often bring with them many unpleasant side effects. And they cannot be used on children with diabetes, Lewis said.

After showing the Food and Drug Administration data from Novocell's work transplanting encapsulated pancreatic cells in primates, the company was allowed last year to inject encapsulated cadaver cells into two humans, Lewis said.

So far those continue to produce insulin and the patients are not taking any immuno-suppressant drugs, he said.
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