Here is a link to the comments on the nonprofit intellectual property regulations that are to be discussed at tomorrow's IP task force at San Francisco International Airport. The comments were not available on the CIRM web site at the time of the posting of the "California Biomed" item below.
Another remote location has been added for the meeting, this one in Elk Grove, Ca., south of Sacramento.
Monday, August 28, 2006
ACT, CIRM and the Test of Time
Christopher Thomas Scott, executive director of the Stem Cells in Society program at Stanford University, has offered the following commentary. Scott is also the author of "Stem Cell Now."
Will ACT save embryonic stem cell research? No way.
Advanced Cell Technology's announcement in Nature last week wound up the rhetoric—yet again—surrounding embryonic stem cell research. The Alameda, California, company claims an embryonic stem cell line can be made without harming a human embryo. The ACT technique is modeled after an in vitro fertilization (IVF) diagnostic test called PGD. The test plucks one cell out of a two day-old embryo containing eight cells or so. The cell’s DNA is screened for dozens of deadly diseases. If the test is positive, the embryo is discarded. If no disease genes are detected, the embryo—which quickly makes a new cell to replace the missing one—is implanted. The procedure seems safe: more than a thousand children have been born since the test was unveiled in the early 1990’s.
From a scientific perspective, the ACT paper is interesting, but not groundbreaking. The researchers repeated a method they perfected earlier in mice using human cells; that’s no mean feat. They claim the type of cell they used—called a blastomere—produced an embryonic stem cell line. If other labs can repeat the result and if the lines can make different, functional cell types, that's pretty cool.
But the thing that has tongues wagging is what happens to the embryo. Until now, embryos must be killed in order to make an embryonic stem cell line, a process opponents equate to murder. Here, finally, seems to be a way around the moral morass. Removing one cell to make a cell line causes no ill effects, embryo-wise. Robert Lanza, who led the ACT group, said, "This will make it far more difficult to oppose this research.”
Problem solved? Not by a long shot. Scientists are already picking apart the ACT results. It isn't clear what stage of embryo was used, and the embryos didn’t survive because Lanza’s method removed all the blastomeres, rather than just one. Most of the cells failed to do anything at all, hinting that some are better than others at generating a line. Finally, the embryos used represent a narrow genetic range: most couples who frequent IVF clinics are Caucasian and infertile.
The ethical ‘solution’ is pretty much a non-starter. Religious conservatives who believe that an eight-cell corpuscle is a human being with rights, object to anything that treads on those rights, especially a technique that sucks out one-eighth of its biological material. Hard-line Catholics argue that the blastomere itself is a person simply because it has the potential to become one. Imagine a cell kicking and screaming on the way to a Petri dish, and you get the idea.
A reporter asked me what this means for California stem cell research. The moral hairsplitting and rickety nature of frontier science are just two of many reasons why the California Institute of Regenerative Medicine mustn’t lose focus on proven methods used to derive embryonic cell lines. The ACT result must stand the test of time and be compared to other technologies and new discoveries. Who knows which will work the best for therapies? We need hundreds of laboratories, thousands of lines, and millions of dollars to find out.
Will ACT save embryonic stem cell research? No way.
Advanced Cell Technology's announcement in Nature last week wound up the rhetoric—yet again—surrounding embryonic stem cell research. The Alameda, California, company claims an embryonic stem cell line can be made without harming a human embryo. The ACT technique is modeled after an in vitro fertilization (IVF) diagnostic test called PGD. The test plucks one cell out of a two day-old embryo containing eight cells or so. The cell’s DNA is screened for dozens of deadly diseases. If the test is positive, the embryo is discarded. If no disease genes are detected, the embryo—which quickly makes a new cell to replace the missing one—is implanted. The procedure seems safe: more than a thousand children have been born since the test was unveiled in the early 1990’s.
From a scientific perspective, the ACT paper is interesting, but not groundbreaking. The researchers repeated a method they perfected earlier in mice using human cells; that’s no mean feat. They claim the type of cell they used—called a blastomere—produced an embryonic stem cell line. If other labs can repeat the result and if the lines can make different, functional cell types, that's pretty cool.
But the thing that has tongues wagging is what happens to the embryo. Until now, embryos must be killed in order to make an embryonic stem cell line, a process opponents equate to murder. Here, finally, seems to be a way around the moral morass. Removing one cell to make a cell line causes no ill effects, embryo-wise. Robert Lanza, who led the ACT group, said, "This will make it far more difficult to oppose this research.”
Problem solved? Not by a long shot. Scientists are already picking apart the ACT results. It isn't clear what stage of embryo was used, and the embryos didn’t survive because Lanza’s method removed all the blastomeres, rather than just one. Most of the cells failed to do anything at all, hinting that some are better than others at generating a line. Finally, the embryos used represent a narrow genetic range: most couples who frequent IVF clinics are Caucasian and infertile.
The ethical ‘solution’ is pretty much a non-starter. Religious conservatives who believe that an eight-cell corpuscle is a human being with rights, object to anything that treads on those rights, especially a technique that sucks out one-eighth of its biological material. Hard-line Catholics argue that the blastomere itself is a person simply because it has the potential to become one. Imagine a cell kicking and screaming on the way to a Petri dish, and you get the idea.
A reporter asked me what this means for California stem cell research. The moral hairsplitting and rickety nature of frontier science are just two of many reasons why the California Institute of Regenerative Medicine mustn’t lose focus on proven methods used to derive embryonic cell lines. The ACT result must stand the test of time and be compared to other technologies and new discoveries. Who knows which will work the best for therapies? We need hundreds of laboratories, thousands of lines, and millions of dollars to find out.
Sunday, August 27, 2006
What About WARF: Chapter Two
Is The Bee really a turkey?
So says patent lawyer Lawrence B. Ebert (sort of), who takes serious exception to a piece in the Sacramento newspaper about WARF and the ACT techniques widely reported last week.
In language that we will not repeat here, Ebert declared that The Bee and those it quoted are wrong about how the ACT technique might affect WARF patents.
So says patent lawyer Lawrence B. Ebert (sort of), who takes serious exception to a piece in the Sacramento newspaper about WARF and the ACT techniques widely reported last week.
In language that we will not repeat here, Ebert declared that The Bee and those it quoted are wrong about how the ACT technique might affect WARF patents.
California Biomed Still Concerned About CIRM IP
The California biomedical industry wants changes in the state's stem cell agency's plans to divide up the spoils from inventions created by nonprofit research funded by CIRM.
The California Healthcare Institute, BIOCOM, five different California-linked biomed firms and a national group, BIO, all filed objections last week to various aspects of the proposed intellectual policy regulations, which are up for discussion on Tuesday.
Arrayed against them virtually alone was the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., which said:
David Gollaher, president of the institute, said aspects of the proposed regulations "present unnecessary, improper or overly burdensome requirements likely to undermine the commericail collaboration necessary for the development of new products."
Lila Feisee, managing director of BIO, wrote that "damaging provisions" in the IP rules place CIRM in the position of "standing in the way of the goals it seeks to achieve."
A key item for the businesses is a change in language involving what is known as the research use exemption. In July, the businesses said, the CIRM IP Task Force removed language that would have would have required grant recipients to allow California research institutions use CIRM-financed inventions for research purposes at no cost."
The IP group deleted the provision after business groups objected that it would remove incentives to develop commercial research tools. Somehow similar language has crept back into the proposed rules, in a move that "appears to contradict the public record," according to a letter signed by Applied Biosystems, BIOCOM, Invitrogen Corp., Isis Pharmaceuticals, Sangamo Biosciences and Target Discovery.
Joydeep Goswami, vice president of stem cells and regenerative medicine for Invitrogen, warned that taxpayers should not have to pay "four times" for use of CIRM research.
The California Healthcare Institute, BIOCOM, five different California-linked biomed firms and a national group, BIO, all filed objections last week to various aspects of the proposed intellectual policy regulations, which are up for discussion on Tuesday.
Arrayed against them virtually alone was the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., which said:
"In essence, taxpayers ought not to pay for the same research twice, and research institutions that they fund should not be prevented from non-commercial access to publicly funded research."The foundation referred to the controversy over an IP provision that would allow California research institutions to use CIRM funded inventions at no cost. But the California Healthcare Institute, which represents the state's biomedical industry, also objected to attempts to provide CIRM-funded therapies at low cost and to provisions for the state to receive roughly 25 percent royalties on CIRM-funded inventions.
David Gollaher, president of the institute, said aspects of the proposed regulations "present unnecessary, improper or overly burdensome requirements likely to undermine the commericail collaboration necessary for the development of new products."
Lila Feisee, managing director of BIO, wrote that "damaging provisions" in the IP rules place CIRM in the position of "standing in the way of the goals it seeks to achieve."
A key item for the businesses is a change in language involving what is known as the research use exemption. In July, the businesses said, the CIRM IP Task Force removed language that would have would have required grant recipients to allow California research institutions use CIRM-financed inventions for research purposes at no cost."
The IP group deleted the provision after business groups objected that it would remove incentives to develop commercial research tools. Somehow similar language has crept back into the proposed rules, in a move that "appears to contradict the public record," according to a letter signed by Applied Biosystems, BIOCOM, Invitrogen Corp., Isis Pharmaceuticals, Sangamo Biosciences and Target Discovery.
Joydeep Goswami, vice president of stem cells and regenerative medicine for Invitrogen, warned that taxpayers should not have to pay "four times" for use of CIRM research.
"If licensing is made unattractive by overbroad...patent protection carve outs, taxpayers will pay four ways: First, they will fund the development of the invention; second, they will have to pay for the development and distribution of the IP; third, they will pay for the royalty revenues lost to the state because the IP has not been commercialized, and finally, they will suffer the costs of not getting research tools and therapeutics to researchers an patients as rapidly and effectively as possible."John M. Simpson, stem cell director of the taxpayer foundation, told the California Stem Cell Report:
"While we might like to think that universities are benevolent and act in the broad public interest, you just need to look at the way the Wisconsin Alumni Research Foundation is asserting its stem cell patents to understand this isn't so.Simpson also spoke to the issue of IP for businesses:
"I think administrators at California institutions are just as likely to be blinded by dollar signs in their eyes as those in Wisconsin.
"We need a research use exemption. It's possible to craft one that meets biotech's concerns and fulfills the vital public interest of keeping all publicly funded research available to other researchers."
"For-profit IP regulations are going to be much more difficult to craft because there is a greater possibility of abuse.On Tuesday, the IP Task Force is scheduled to meet in San Francisco, with remote sites in Los Angeles, Stanford and Irvine, to discuss both non-profit and for-profit regulations. Here is the Task Force Agenda.
"Funds will almost certainly be given for projects that are much closer to developing products for commercialization and clinical use than is the case with grants to universities and nonprofit institutions.
"That means it's imperative that provisions in the for-profit IP regulations guarantee access and affordability for all Californians to any drugs and cures that are developed as a result of Prop 71 funding to companies. There must be a provision that prevents unfair, egregious profiteering."
Somewhat Differing Views On ACT
Murky and optimistic – two terms applied to the prospects of Advanced Cell Technology, the only island-based stem cell company in California.
Reporter Steve Johnson of the San Jose Mercury News prepared a piece on the business of ACT late last week. He quoted on William Caldwell, CEO of ACT, as being "very optimistic" on his enterprise. Johnson wrote:
Reporter Steve Johnson of the San Jose Mercury News prepared a piece on the business of ACT late last week. He quoted on William Caldwell, CEO of ACT, as being "very optimistic" on his enterprise. Johnson wrote:
"Advanced Cell Technology disclosed that it expects to get $13.5 million in funding from investors. Moreover, the company next year plans to seek federal approval to begin studies in people of its proposed stem-cell treatment for macular degeneration, an eye disease."Johnson continued:
"The firm has consistently lost money since its inception and last year reported a net loss of $9.4 million. Its revenue from licensing fees and royalties totaled $395,007.(As for that island business in the first paragraph of this item, it is not widely known that the city of Alameda is on an island in San Francisco Bay. We report that as part of our effort to educate the public about important geographic issues. We are also fond of interesting minutia.)
"Consequently, it has resorted to unusual tactics to save
cash.
"When it public last year, for example, it didn't use the usual method of doing an initial public offering. Instead, it chose the cheaper route of taking over an existing public company, acquiring Two Moons Kachinas, which sold kachina dolls used in American Indian ceremonies. Advanced Cell Technology then changed Kachina's stock symbol and is traded on the over-the-counter bulletin board as ACTC.OB.
"Despite a huge jump in its stock price after Wednesday's announcement, the company's stock has fallen from a high of $2.95 a share on Oct. 17 last year to 96 cents at the close of trading Friday. Its future remains murky."
Vatican to ACT: No Way
How often does the Vatican take on a humble business based on a tiny island in California?
Maybe once.
And that one time came on Saturday when Monsignor Elio Sgreccia, No. 1 in the Vatican on bioethical questions, gave a thumbs down to Advanced Cell Technology's latest development on extraction of embryonic stem cells.
ACT should capture the good monsignor's pronouncement and emblazon it on the walls of their headquarters in Alameda, Ca., which is a city on an island in San Francisco Bay.
Maybe once.
And that one time came on Saturday when Monsignor Elio Sgreccia, No. 1 in the Vatican on bioethical questions, gave a thumbs down to Advanced Cell Technology's latest development on extraction of embryonic stem cells.
ACT should capture the good monsignor's pronouncement and emblazon it on the walls of their headquarters in Alameda, Ca., which is a city on an island in San Francisco Bay.
Friday, August 25, 2006
Stem Cell Snippets: Interviews to IP
News, press releases and other interesting items related to stem cells in California.
Salary—Earlier, we indicated we would bring you the salary of the new chief communications officer at CIRM. The range for the position is $130,000 to $195,000. He is receiving $180,000.
Strategic Plan – Interviews conducted during the stem cell plan process now stand at 69 and appear to be nearly complete. Here is the list. Here is a rundown on the events and number of persons involved.
IP – The Wellcome Trust, a nearly $20 billion charity in Great Britain funding biomedical research, will be on the agenda next Tuesday at CIRM's latest IP meeting, including its revenue sharing and funding agreements. Also added to the agenda is consideration of "pertinent public comment" on nonprofit IP policy.
Conflicts – Jesse Reynolds of the Center for Genetics and Society criticizes the Connecticut stem cell effort for conflicts of interest, pointing to California as an example not to be emulated.
Salary—Earlier, we indicated we would bring you the salary of the new chief communications officer at CIRM. The range for the position is $130,000 to $195,000. He is receiving $180,000.
Strategic Plan – Interviews conducted during the stem cell plan process now stand at 69 and appear to be nearly complete. Here is the list. Here is a rundown on the events and number of persons involved.
IP – The Wellcome Trust, a nearly $20 billion charity in Great Britain funding biomedical research, will be on the agenda next Tuesday at CIRM's latest IP meeting, including its revenue sharing and funding agreements. Also added to the agenda is consideration of "pertinent public comment" on nonprofit IP policy.
Conflicts – Jesse Reynolds of the Center for Genetics and Society criticizes the Connecticut stem cell effort for conflicts of interest, pointing to California as an example not to be emulated.
What About WARF?
The announcement that Advanced Cell Technology has developed a new method for extracting embryonic stem cells has raised questions about its impact on WARF – the Wisconsin Alumni Research Foundation.
Reporter Jim Downing of The Sacramento Bee quoted Stanford law professor Hank Greely as saying:
Reporter Jim Downing of The Sacramento Bee quoted Stanford law professor Hank Greely as saying:
"The mere fact … of having a new way to make embryonic stem cells weakens the WARF patents, which I think is a good thing."Downing continued:
"Greely said that the main complaint with the Wisconsin patents is how the foundation has chosen to enforce them.Downing reported that WARF did not respond to two requests for comment. However, the Wisconsin Technology Network did have a general reaction from WARF in a piece by Joe Vanden Plas.
"'Stanford and UCSF have the seminal genetic engineering patent, and they … quite cleverly, had very lenient license terms for non-universities -- a relatively small cash amount and a small royalty,' Greely said. 'And the result was, the technology went everywhere and those two universities made a lot of money.'
"By contrast, he said, 'WARF is making enemies.'"
"Andrew Cohn, a spokesman for WARF, said the new method of deriving stem cells should not hurt Wisconsin's standing as a leader in stem-cell research. He also said WiCell, the nation's first stem-cell bank and a subsidiary of WARF, would be interested in helping distribute stem cell lines derived from this method.
"He also said it's too early to tell how the new method would impact WARF's stem cell patents. 'We don't even know what they claim in their patents, but that's the last thing we're concerned about,' Cohn said. 'We need time to dissect and digest its full impact.'"
After the Lights Go Out at CIRM
What happens when the California stem cell party is over? That's one of the questions posed to the agency as it maps a strategy to give away $3 billion. The question is not insignificant. CIRM has only about eight more years left on its clock. The measure that created CIRM gave it a 10-year life, nearly 20 percent of which has expired.
Martin McGlynn, president of StemCells, Inc., of Palo Alto, gave this response:
Here are a few more excerpts.
Bruce Cohen, president and chief executive officer, Cellerant Therapeutics of San Carlos, Ca., on CIRM's goals:
Martin McGlynn, president of StemCells, Inc., of Palo Alto, gave this response:
"I would ask CIRM to clearly define success. Publish a road map to achieve those successes. I would offer two thoughts as to what you might deem success. I look to the notion of what happens when the party is over....:McGlynn was among a number of private sector folks who discussed strategic planning issues last month with CIRM. Their comments are summarized in a 40-page document now available on the Web. The summary adds considerable meat to the skimpy bones of their Power Point presentations.
"There would be Centers of Excellence in the state with a critical mass of world-class talent and a proven track record or diversity at each center in its chosen field of endeavor.
"You would have created a vibrant, sustainable for-profit sector that focuses on applied research and the translation of discoveries into use for the benefit of mankind. Those entities by then should be fundable by more traditional sources of funds.
"The cycle time for the work that needs to be done is twice what VCs wants to see, so get out of blocks quickly, leverage your dollars, and make sure you are the first money to accomplish your mission."
Here are a few more excerpts.
Bruce Cohen, president and chief executive officer, Cellerant Therapeutics of San Carlos, Ca., on CIRM's goals:
"The taxpayer needs to see a return on this investment. You need to find a way for them to see company and job creation, which will come sooner than cures for some of the debilitating disease we are trying to address. So we need to encourage capital to come in to accelerate new businesses and let existing businesses get bigger.Sumit K. Chanda, group leader,, Division of Cellular Genomics, Genomics Institute of the Novartis Research Foundation, on core facilities:
"You also need to get therapies into the clinic so voters will see a potential change in their lives. You need to accelerate the process by which adult and embryonic stem cells therapies find their way to people. Even if it's an inconclusive Phase I trial, you'll be happy someone with state funding is trying to accelerate the process.
"It's those two things that will make people who voted for this appreciate what’s been done on their behalf."
"We have started to get into a little bit of stem cell screening. These are the major challenges and possibilities that we have seen using high-throughput screens using stem cells:Chanda continued on the subject of cultural roadblocks.
"One of the possible solutions that I am proposing is a core facility for screening where everyone in California who is interested in running high-throughput stem cell screens can go. This would be parallel to the NIH roadmap project where they had the MLSCN [Molecular Libraries Screening Centers Network] centers located in different areas in the States.
"The only exception I would make to this is that the NIH had the centers run by academic groups. It is really the private sector that has been making advances in screening in the last 20 years or so, so it might make more sense to have the private sector spearhead a screening facility."
"We have found that there are culture roadblocks between the academic and biotech sectors, even though we have pretty good relationships with various academic groups. We find that the collaborations are very fruitful, but most of our knowledge of what is going on from academic groups comes from publications, which usually do not give you enough information and often occur a couple of years later than the initial discovery."Ann F. Hanham, managing director, Burrill & Company of San Francisco on "concerns:"
"How much more basic research is going to need to be done? Many of the companies that pitch to our firm are not ready for VC funding yet. They have not worked up their business metrics or their technology or their idea or how much time/resources they need to get to a final product.Thomas B. Okarma, president and chief executive officer, Geron Corp. of Menlo Park, Ca.
"Patents are a huge issue for VCs. We need to protect our investment. If we are going to put capital in, we need to ensure protection of that asset. The University of Wisconsin patents have raised issues about whether we can invest in this field.
"We also need to see a commercialization strategy. Right now, stem cell science is much more on the research side than the development side of the R&D process.
"There are issues to be addressed around manufacturing and the scalability and reproducibility of manufacturing.
"There are questions to be answered such as: Can you pool stem cells? What is the right commercialization strategy? Wow do you become a company and earn back that money that was put in?"
"My message is going to be straight forward. Because of the depths of your pockets and lack of competition at the state and federal level, we have an opportunity to shape the way the field is developed.
"My take home message to you today is the 'D' word - development. My advice to you is to subordinate research to support development. Don't eliminate the research in R&D, but do the research as necessary to support the 'D.'"
Thursday, August 24, 2006
CIRM Replies Re Public Disclosure by Grant Reviewers
Dale A. Carlson, the new chief communications officer for the California stem cell agency, is differing with an earlier item "CIRM, disclosure and conflicts" on the California Stem Cell Report.
Here are his comments verbatim:
We do believe that CIRM's disclosure rules go beyond the usual requirements elsewhere in the nation, as do a number of its other policies. Indeed, CIRM has become a benchmark for other states as well as other nations on stem cell policies.
Here are his comments verbatim:
"On Tuesday, August 22, you wrote: 'Putting the public universities aside, we suspect that nearly all California agencies require public disclosure of financial interests as opposed to 'secret' disclosure, which is what CIRM does with its reviewers. We base on that on several decades of experience watching California public agencies, but we could be wrong.'Carlson raises a number of interesting issues, but he does not convince us that CIRM's disclosure rules for grant reviewers "go beyond the rules of other state agencies." Much more can and will be said concerning CIRM and disclosure, but CIRM and the California Stem Cell Report differ fundamentally on one central issue. We consider the grant reviewers de facto decision makers. Yes, legally they are advisors and make only "recommendations." But given the nature of such governmental agencies as CIRM, it is unlikely that reviewer recommendations will be overturned by the Oversight Committee in any significant number of cases. If only because the Oversight Committee will soon have no reviewers if it consistently rejects their recommendations.
"You are wrong. California public officials are indeed required to disclose their financial interests – only their financial interests – and to make those disclosures public, as specified by the Political Reform Act (PRA). CIRM staff and members of the ICOC are subject to and complying with those requirements.
"Members of CIRM’s working groups are not public officials. They are advisors, not decision-makers. The distinction is clear and well-defined by the PRA, by the Fair Political Practices Commission and by the courts. Like members of advisory bodies and committees at other state agencies, they are therefore not subject to the requirements of the Political Reform Act. Indeed, as a matter of law, advisors to state agencies – including CIRM – are not required to disclose any information about their personal, professional, or financial interests, to the agency or to the public.
"CIRM working group members are, however, subject to disclosure requirements adopted by the ICOC, pursuant to the mandate of Proposition 71.
"The ICOC requires CIRM advisors to disclose financial interests as well as personal and professional ties to grant applicants. We have a more complete picture of the potential conflicts of interests facing our advisors than the public has of any California official subject to the PRA.
"Our advisors’ disclosure statements are available to state auditors. If we find violations of our policies, the discovery will be reported to the legislature, along with corrective actions to ensure they are not repeated.
"Our conflict of interest policies, including our disclosure requirements for advisors, go beyond the requirements of the law, and beyond the practices of other state agencies, including the universities. If there are stronger policies in force, they’ve yet to be identified.
"The success of the CIRM research program and its ability to maintain the confidence of the people of California depends critically upon the agency’s ability to fund the highest quality research proposals, chosen without bias. We want to attract the best people we can find to help evaluate research proposals, and to ensure that the ICOC has sufficient information to make the best decisions possible.
"Our conflict of interest policies strike an appropriate balance, between the public’s confidence in the integrity of our decision-making and the public value of having the country’s best experts involved in the review of grant proposals."
We do believe that CIRM's disclosure rules go beyond the usual requirements elsewhere in the nation, as do a number of its other policies. Indeed, CIRM has become a benchmark for other states as well as other nations on stem cell policies.
Stem Cell Stocks Jump on ACT News
This is the kind of news that really captures the attention of those timid souls known as venture capitalists, who have shied away from stem cell enterprises.
On the day Advanced Cell Technology of Alameda, Ca., announced its new method of extracting stem cells from embryos, its stock more than quadrupled. Of course, it did not have far to go. The stock climbed from 42 cents to 1.83. Today the stock closed at $1.60.
The Wall Street Journal reported this afternoon that the ACT news also "pushed up shares of the four largest publicly-traded stem-cell researchers. StemCells advanced six cents, or 2.7%, to 2.31; Aastrom Biosciences added one cent to 1.20; Geron rose 31 cents, or 4.9%, to 6.67; and ViaCell jumped 19 cents, or 5%, to 4."
The 52-week low for ACT's stock price is 26 cents and its 52-week high is $2.95.
Earlier today, reporter David Hamilton wrote in the WSJ:
On the day Advanced Cell Technology of Alameda, Ca., announced its new method of extracting stem cells from embryos, its stock more than quadrupled. Of course, it did not have far to go. The stock climbed from 42 cents to 1.83. Today the stock closed at $1.60.
The Wall Street Journal reported this afternoon that the ACT news also "pushed up shares of the four largest publicly-traded stem-cell researchers. StemCells advanced six cents, or 2.7%, to 2.31; Aastrom Biosciences added one cent to 1.20; Geron rose 31 cents, or 4.9%, to 6.67; and ViaCell jumped 19 cents, or 5%, to 4."
The 52-week low for ACT's stock price is 26 cents and its 52-week high is $2.95.
Earlier today, reporter David Hamilton wrote in the WSJ:
"Larger pharmaceutical and biotechnology companies have mostly steered clear of the field, in part because of the ethical controversy and the lack of federal research support. Advanced Cell Chief Executive William Caldwell, however, said he believes an embryo-safe method of deriving stem cells may help spark large-company interest in the area.At mid-afternoon Thursday, the story on ACT in the WSJ did not make the paper's top 10 lists in either the most viewed or most e-mailed categories. But among Web readers of the New York Times, the story was the No. 5 most blogged and No. 6 most e-mailed. At the Los Angeles Times, it was the No. 8 most e-mailed stories but not in the top 10 of most viewed. At the Washington Post, it was the No. 12 most e-mailed story.
"'I think this is going to help address the problem and the issues they have' with stem-cell derivation, Mr. Caldwell said. Advanced Cell, which is currently raising new funds in a private offering to bolster its meager cash reserves, hopes to sign a development partnership with a larger company by the end of the year."
Wednesday, August 23, 2006
Rules for the $100 Million Stem Cell Giveaway
The river of money is beginning to flow, so it is time for some of you to dip your scoop in.
The California stem cell agency has posted detailed information on how to snag a chunk of more than $100 million for research involving embryonic stem cells. The deadlines are coming up quickly.
For those of you who do not work in the Golden State, you are mostly out of luck unless you can finesse the rules that limit the grants to academic and non-profit research institutions in California.
While this round does not include grants to businesses, it would behoove them to examine the current process, which is likely to set a pattern for future grants. CIRM said grants for businesses will not be awarded until intellectual property policies are developed (a hearing on that is scheduled for next Tuesday).
The agency is looking for innovation. One two-year, 30-grant program is called SEED, short for Scientific Excellence through Exploration and Development, and is funded at $24 million. The other program contains more cash -- $80 million over four years –for "comprehensive research grants." That 25-grant program will support "mature, ongoing studies" by scientists with a "record of accomplishment."
The deadline for letters of intent to apply for both programs is Sept. 15 with applications due Oct. 13 for SEED and Nov. 13 for the other grants. In addition to the usual scientific information, applicants are asked to provide a "public abstract" intended to explain the research to the lay public. A statement concerning how the research will benefit California is also required. The letters of intent for both SEED and comprehensive grants ask about sources of stem cells and the names of researchers, collaborators and subcontractors.
The application for comprehensive grants seeks "strong preliminary data." "Particular emphasis will be placed on impact and significance and quality of the research plan," the application says.
The lucky winners are expected to be determined at the CIRM Oversight Committee meetings either in February (SEED) or April (comprehensive grants).
Here are links on the grant program: CIRM press release, SEED letter of intent, SEED application information, comprehensive letter of intent, comprehensive application, discussion of the grant program by the Oversight Committee earlier this month (starts on page 149 of the transcript).
The California stem cell agency has posted detailed information on how to snag a chunk of more than $100 million for research involving embryonic stem cells. The deadlines are coming up quickly.
For those of you who do not work in the Golden State, you are mostly out of luck unless you can finesse the rules that limit the grants to academic and non-profit research institutions in California.
While this round does not include grants to businesses, it would behoove them to examine the current process, which is likely to set a pattern for future grants. CIRM said grants for businesses will not be awarded until intellectual property policies are developed (a hearing on that is scheduled for next Tuesday).
The agency is looking for innovation. One two-year, 30-grant program is called SEED, short for Scientific Excellence through Exploration and Development, and is funded at $24 million. The other program contains more cash -- $80 million over four years –for "comprehensive research grants." That 25-grant program will support "mature, ongoing studies" by scientists with a "record of accomplishment."
The deadline for letters of intent to apply for both programs is Sept. 15 with applications due Oct. 13 for SEED and Nov. 13 for the other grants. In addition to the usual scientific information, applicants are asked to provide a "public abstract" intended to explain the research to the lay public. A statement concerning how the research will benefit California is also required. The letters of intent for both SEED and comprehensive grants ask about sources of stem cells and the names of researchers, collaborators and subcontractors.
The application for comprehensive grants seeks "strong preliminary data." "Particular emphasis will be placed on impact and significance and quality of the research plan," the application says.
The lucky winners are expected to be determined at the CIRM Oversight Committee meetings either in February (SEED) or April (comprehensive grants).
Here are links on the grant program: CIRM press release, SEED letter of intent, SEED application information, comprehensive letter of intent, comprehensive application, discussion of the grant program by the Oversight Committee earlier this month (starts on page 149 of the transcript).
Tuesday, August 22, 2006
The Scientist Magazine: CIRM, Disclosure and Conflicts
The topic of conflicts of interests and stem cell research is surfacing again in the scientific media. The latest article can be found in The Scientist magazine.
Writer Andrew Holtz reported on the hooha out here in California – although hooha is probably too strong a word, given that the issue is nearly totally ignored by the mainstream media.
Holtz quoted Zach Hall, president of CIRM, as saying its disclosure rules for grant reviewers "go beyond the rules of other state agencies in California and in fact they go beyond the national standards." While we don't like to quibble with the good doctor, we are not sure he is really on target concerning California disclosure rules. Putting the public universities aside, we suspect that nearly all California agencies require public disclosure of financial interests as opposed to "secret" disclosure, which is what CIRM does with its reviewers. We base on that on several decades of experience watching California public agencies, but we could be wrong.
In the case of CIRM, it requires grant reviewers to disclose basically only to the agency itself.
The article quoted John M. Simpson of the Foundation for Taxpayer and Consumer Rights as calling for more disclosure because of the multimillion dollar impact of actions by the reviewers.
Holtz also interviewed some of the reviewers concerning their sentiments on public disclosure of their financial information.
Writer Andrew Holtz reported on the hooha out here in California – although hooha is probably too strong a word, given that the issue is nearly totally ignored by the mainstream media.
Holtz quoted Zach Hall, president of CIRM, as saying its disclosure rules for grant reviewers "go beyond the rules of other state agencies in California and in fact they go beyond the national standards." While we don't like to quibble with the good doctor, we are not sure he is really on target concerning California disclosure rules. Putting the public universities aside, we suspect that nearly all California agencies require public disclosure of financial interests as opposed to "secret" disclosure, which is what CIRM does with its reviewers. We base on that on several decades of experience watching California public agencies, but we could be wrong.
In the case of CIRM, it requires grant reviewers to disclose basically only to the agency itself.
The article quoted John M. Simpson of the Foundation for Taxpayer and Consumer Rights as calling for more disclosure because of the multimillion dollar impact of actions by the reviewers.
Holtz also interviewed some of the reviewers concerning their sentiments on public disclosure of their financial information.
"One reviewer, Rainer Storb, from the Fred Hutchinson Cancer Research Center in Seattle, Washington, told The Scientist he isn't bothered by the idea of public disclosure of his financial statements. 'The burden is that you have to fill out these forms all the time. That's a bit of a nuisance. But I'm perfectly fine with things being made public,' Storb said.For more on this subject, see "immune feelings" and "second tier."
"Other members of the Grants Review Working Group were either unavailable or said they didn't know enough about the debate to comment. Arlene Chiu,director of scientific activities at CIRM, said many reviewers she had spoken with oppose public disclosure.
"The Director of the Oregon Stem Cell Center, Markus Grompe, who said he was contacted about becoming a reviewer, said his financial ties are already public. 'If they bar you from being involved with biotech to be a reviewer, then that will scare off a majority actually; but if it's just about disclosing it, we disclose all the time,' Grompe said.
"Lisa A. Bero, from the Institute for Health Policy Studies at University of California San Francisco, who has studied conflict of interest issues in medical research, said people have difficulty judging their conflicts of interest. She said the specific CIRM disclosure rules improve upon policies that ask general questions about 'relevant' financial ties, but public
disclosure would still help detect cases where disclosure is less than complete."
FTCR: CIRM May be Moving Too Hastily
While the California stem cell agency is moving quickly forward with plans for its first research grants, a watchdog group continues to raise questions about whether the results will be affordable and available to Californians.
The Foundation for Taxpayer and Consumer Rights said today that it is "concerned that the pressure to show results from a program that was approved by voters in 2004 and stalled by legal challenges could lead to hastily made and poorly considered grants that waste public money."
The news release continued:
Here is a link to the foundation's full statement.
The Foundation for Taxpayer and Consumer Rights said today that it is "concerned that the pressure to show results from a program that was approved by voters in 2004 and stalled by legal challenges could lead to hastily made and poorly considered grants that waste public money."
The news release continued:
"FTCR also said that the stem cell institute must have policies in place that ensure any treatments and cures developed with taxpayer money are accessible and affordable for all Californians."The trigger for the foundation's comments is posting of the timelines for application for the research grants. The foundation said that "the letters of intent to apply for CIRM SEED Grants and CIRM Comprehensive Grants will be due Sept. 15. Full applications are due Oct. 13 and Nov. 13 respectively. CIRM envisions awarding the SEED grants in March 2007. The Comprehensive Grants would be awarded in March or April."
Here is a link to the foundation's full statement.
IP Principles for Business Coming Up Next Week
Dividing up the stem cell spoils comes up again next Tuesday as the CIRM Task Force on Intellectual Property looks at "principles" for IP involving for-profit enterprises.
No details have been posted yet for the session, which will also consider comments from the Oversight Committee on IP for non-profits.
The actual meeting will take place at the San Francisco International Airport, but remote sites are available at UC Irvine, Los Angeles and Stanford. Here is a link to the full agenda.
No details have been posted yet for the session, which will also consider comments from the Oversight Committee on IP for non-profits.
The actual meeting will take place at the San Francisco International Airport, but remote sites are available at UC Irvine, Los Angeles and Stanford. Here is a link to the full agenda.
More State Oversight of CIRM Not Likely
Events last week in Sacramento re-arranged the stem cell stage in California.
The California stem cell agency skated past the latest attempt to bring more stringent oversight to its unique, $6 billion effort to turn stem cells into cures. That means that critics of the agency are not likely to be successful at bringing CIRM under more state direction for the foreseeable future.
A hefty scandal is about all that would create a climate conducive to major changes at the agency. At the same time, the door has opened for a state politician or two to seize the stem cell issue.
The quiet demise of the stem cell oversight bill by state Sen. Deborah Ortiz, D-Sacramento, signalled the new arrangements. Ortiz is chair of the Senate Health Committee and a pioneer on California stem cell issues. But term limits are forcing her from office at the end of the year and have reduced her legislative clout.
Assemblywoman Judy Chu, D-Monterey Park, chair of the Assembly Appropriations Committee, Thursday dispatched Ortiz' measure (SB401) to legislative oblivion. No vote was taken as Chu ordered the bill held in committee. Chu indicated, among other reasons, that she did not want to move forward with another stem cell ballot measure, which Ortiz' bill would have been.
Ortiz had a different view. She said the bill would have improved the performance of the agency and ensured access to affordable cures.
Nonetheless, political hay can be made involving embryonic stem cell research – on all sides of the issue. Gov. Schwarzenegger, who is facing a re-election challenge, made that clear a few weeks ago when he ponied up $150 million to ease the financial strains at CIRM. The impending departure of Ortiz leaves a void in the legislature on stem cell issues. Just who may fill it is unclear. Assemblyman Dave Jones, D-Sacramento, has been mentioned as one possibility. Ortiz was a friendly critic of the agency, although some at the agency did not regard her in that fashion. An unfriendly legislative critic can create considerable mischief, even if he or she cannot effectively make changes legislatively.
If the concept of political hay mixing with stem cell research is troubling, consider the host of continuing public policy issues involving CIRM and the nature of the research, ranging from treatment of egg donors to conflicts of interest. The fact is that politics and stem cell research are inextricably linked. It behooves the agency to keep a close eye on the state Capitol.
California newspapers paid scant attention to the demise of Ortiz bill. Most, if they carried any article at all, relied on a brief from The Associated Press. Reporter Judy Lin of The Sacramento Bee had a somewhat longer piece.
The California stem cell agency skated past the latest attempt to bring more stringent oversight to its unique, $6 billion effort to turn stem cells into cures. That means that critics of the agency are not likely to be successful at bringing CIRM under more state direction for the foreseeable future.
A hefty scandal is about all that would create a climate conducive to major changes at the agency. At the same time, the door has opened for a state politician or two to seize the stem cell issue.
The quiet demise of the stem cell oversight bill by state Sen. Deborah Ortiz, D-Sacramento, signalled the new arrangements. Ortiz is chair of the Senate Health Committee and a pioneer on California stem cell issues. But term limits are forcing her from office at the end of the year and have reduced her legislative clout.
Assemblywoman Judy Chu, D-Monterey Park, chair of the Assembly Appropriations Committee, Thursday dispatched Ortiz' measure (SB401) to legislative oblivion. No vote was taken as Chu ordered the bill held in committee. Chu indicated, among other reasons, that she did not want to move forward with another stem cell ballot measure, which Ortiz' bill would have been.
Ortiz had a different view. She said the bill would have improved the performance of the agency and ensured access to affordable cures.
"The measure was extensively debated and refined during two years of public informational and legislative committee hearings. It had bipartisan support in both houses of the Legislature, and was supported by public interest groups.Normally state departments, of which CIRM is one, are subject to regulation by the state legislature, which approves their budgets and can change their scope or eliminate them entirely. CIRM is radically different. It is a creature of the ballot. Voters altered the state constitution and state law to create the agency. Changes in the agency can only be made by another ballot initiative or by approval of 70 percent both houses of the state legislature and the governor. And that legislative action can only happen three full years after adoption of Prop. 71, which would be in November 2007. The extraordinary, "super-super" vote requirement makes it virtually impossible to tinker with CIRM. It would only 13 state senators to block any changes affecting the agency.
"The bill was steadfastly opposed by the CIRM and the ICOC, the two entities the bill would have opened to increased public scrutiny. This is nothing but an example of a special interest group killing legislation to avoid being held accountable to those it serves."
Nonetheless, political hay can be made involving embryonic stem cell research – on all sides of the issue. Gov. Schwarzenegger, who is facing a re-election challenge, made that clear a few weeks ago when he ponied up $150 million to ease the financial strains at CIRM. The impending departure of Ortiz leaves a void in the legislature on stem cell issues. Just who may fill it is unclear. Assemblyman Dave Jones, D-Sacramento, has been mentioned as one possibility. Ortiz was a friendly critic of the agency, although some at the agency did not regard her in that fashion. An unfriendly legislative critic can create considerable mischief, even if he or she cannot effectively make changes legislatively.
If the concept of political hay mixing with stem cell research is troubling, consider the host of continuing public policy issues involving CIRM and the nature of the research, ranging from treatment of egg donors to conflicts of interest. The fact is that politics and stem cell research are inextricably linked. It behooves the agency to keep a close eye on the state Capitol.
California newspapers paid scant attention to the demise of Ortiz bill. Most, if they carried any article at all, relied on a brief from The Associated Press. Reporter Judy Lin of The Sacramento Bee had a somewhat longer piece.
Wednesday, August 16, 2006
On to the Deadly Vizcaino Plain
We are going to have one of those periodic pauses in postings on the California Stem Cell Report. This time because of air and land – as opposed to sea – travel. On Thursday Aug. 17, we will wing our way from Guaymas on the Mexican mainland to Loreto in Baja California in one of Aero Guerrero's finest tiny planes. (Guaymas is, by the way, where Charlie Chaplin married his first child bride. En route to the US by train from Mexico City with the prospective mother-in-law also in tow, he decided to do the honorable thing. They honeymooned in the port city for several days.)
From Loreto, we will leap into a 1986 VW Vanagon and forge north into the deadly heat of the Vizcaino Plain, average annual rainfall less than two inches a year. With luck, we will arrive in the Old Country (the U.S.) in a few days and resume postings as we re-enter the dirt life(life on land) for a short while.
From Loreto, we will leap into a 1986 VW Vanagon and forge north into the deadly heat of the Vizcaino Plain, average annual rainfall less than two inches a year. With luck, we will arrive in the Old Country (the U.S.) in a few days and resume postings as we re-enter the dirt life(life on land) for a short while.
CIRM Hires Senior Communications Executive
The California stem cell agency has found a communications director, a man with considerable business experience who has also wrestled in the public policy arena in the San Francisco Bay Area and elsewhere.
Dale Carlson officially begins work next Monday. As communications director, his responsibilities will include developing a "clear and consistent message about the new frontier of stem cell research in California" and promoting "a deeper and more sophisticated public awareness of stem cell research and therapy." His duties go beyond dealing with the ink-stained wretches of the fourth estate and include developing communications programs with the public, the patient advocacy community, the legislature and the scientific community.
Carlson was vice president for corporate affairs with the Pacific (stock) Exchange in San Francisco from 1987 to 2005. He dealt with the media, business, public and handled a wide range of responsibilities, including dealing with Web content. Carlson also served in a variety of volunteer positions with civic and nonprofit agencies in the Bay Area, including tours of duty as chair of the San Francisco library foundation and the Treasure Island Development Authority.
Carlson, who has a masters degree in health services administration from the University of Michigan, surfaced in February of this year as an "interim senior communications officer" at CIRM, working on a parttime, volunteer basis.
CIRM has had difficulties since its inception with its communications/PR programs, resorting to hiring Edelman PR for $378,000 for a 16-month contract that expires at the end of this month. One problem was the lack of a senior CIRM official with specific PR responsibilities, which Carlson's appointment seems to solve.
In the interests of full transparency, we must disclose that Carlson is a sailor, as are we. He describes himself as a "competitive" sailor. We are just your average sea dog.
The salary range for Carlson's position is from $130,000 to $195,000. We expect to have the specific figure soon.
Dale Carlson officially begins work next Monday. As communications director, his responsibilities will include developing a "clear and consistent message about the new frontier of stem cell research in California" and promoting "a deeper and more sophisticated public awareness of stem cell research and therapy." His duties go beyond dealing with the ink-stained wretches of the fourth estate and include developing communications programs with the public, the patient advocacy community, the legislature and the scientific community.
Carlson was vice president for corporate affairs with the Pacific (stock) Exchange in San Francisco from 1987 to 2005. He dealt with the media, business, public and handled a wide range of responsibilities, including dealing with Web content. Carlson also served in a variety of volunteer positions with civic and nonprofit agencies in the Bay Area, including tours of duty as chair of the San Francisco library foundation and the Treasure Island Development Authority.
Carlson, who has a masters degree in health services administration from the University of Michigan, surfaced in February of this year as an "interim senior communications officer" at CIRM, working on a parttime, volunteer basis.
CIRM has had difficulties since its inception with its communications/PR programs, resorting to hiring Edelman PR for $378,000 for a 16-month contract that expires at the end of this month. One problem was the lack of a senior CIRM official with specific PR responsibilities, which Carlson's appointment seems to solve.
In the interests of full transparency, we must disclose that Carlson is a sailor, as are we. He describes himself as a "competitive" sailor. We are just your average sea dog.
The salary range for Carlson's position is from $130,000 to $195,000. We expect to have the specific figure soon.
Forbes on Private Stem Cell Giving
For more on private stem cell philanthropy and the California stem cell agency, see this Forbes piece. It popped up today after the Wall Street Journal carried its page one story. The timing has all the earmarks of a publication being a tad pressured to push its story into public view after a competitor got the jump on it. Of course, we could be wrong.
CIRM to Examine 'Outline' of $3 Billion Giveaway
The Strategic Planning Advisory Committee of the California stem cell agency has a meeting planned for Aug. 24 to discuss the outline of a plan to give away $3 billion.
Details of the outline are not yet available and may not be available by the time of the meeting, given the way the agency works. Nonetheless the San Francisco meeting is open to the public. See the agenda here but don't expect illumination.
Details of the outline are not yet available and may not be available by the time of the meeting, given the way the agency works. Nonetheless the San Francisco meeting is open to the public. See the agenda here but don't expect illumination.
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