The California stem cell agency next week will provide tips to scientists and others prospecting for some of the $3 billion in research funding that the state is handing out.
Two days of briefings are planned – one in San Francisco on Sept. 11 and the other in San Diego on Sept. 12.
The sessions are targeted at private businesses but are likely to be useful for academicians as well. CIRM says it will "discuss ways to increase chances of successfully submitting a grant to CIRM." It will also discuss the agency's intellectual property regulations and explain them for private sector attorneys, executives and scientists.
These are must-attend meetings if you want to be serious about securing a CIRM grant.
Tuesday, September 02, 2008
Monday, September 01, 2008
Hook Down
Well not exactly. The anchor is still in its roller, but we have come to rest in a rickety marina about midway up the Sea of Cortez in a community called Santa Rosalia. The town has some fame as the site of an iron church reportedly designed by Gustave Eiffel of Eiffel Tower fame. It was constructed for an exposition in France in the 1880s and then dismantled and ultimately shipped to Baja California, where a French company was conducting copper mining operations. Some skeptics contend that the church may not have been designed by Eiffel, but those folks dare not show their face here.
We will be posting some fresh stuff on California stem cell matters after we work our way through nearly 150 emails and other related news.
We will be posting some fresh stuff on California stem cell matters after we work our way through nearly 150 emails and other related news.
Wednesday, August 27, 2008
Hoisting Anchor
As many of you know, the California Stem Cell Report is produced from a sailboat that cruises the west coast of Mexico. Sometimes, such as today, we actually get to sail. We are departing Mazatlan for a multi-day passage north into the Sea of Cortez. Until we reach our next port, we will not have any further posts. Look for some fresh stuff in about a week or so. We would like to be more definite, but sailing is a pursuit that depends on many conditions totally out of our control.
Fallout From Disclosure of the CIRM 18
Alan Trounson, president of the California stem cell agency, has sent a letter concerning disclosure of the names of 18 companies who expressed an interest in applying for grants from the $3 billion research program.
Trounson wrote the letter to the companies after Consumer Watchdog revealed the names that CIRM had attempted to keep confidential as part of its pseudo policy of secrecy. Pseudo because CIRM chooses to keep some names secret and reveal others. And many of its public grant review summaries contain enough information that any reasonably well-informed person can determine the identity of the applicant should he or she want to make the effort.
In his letter, Trounson expressed regret about the disclosure and said that CIRM has issued a "reminder" concerning its confidentiality policies.
John M. Simpson, stem cell project director for Consumer Watchdog, published a copy of Trounson's letter on Tuesday. Simpson commented:
Trounson wrote the letter to the companies after Consumer Watchdog revealed the names that CIRM had attempted to keep confidential as part of its pseudo policy of secrecy. Pseudo because CIRM chooses to keep some names secret and reveal others. And many of its public grant review summaries contain enough information that any reasonably well-informed person can determine the identity of the applicant should he or she want to make the effort.
In his letter, Trounson expressed regret about the disclosure and said that CIRM has issued a "reminder" concerning its confidentiality policies.
John M. Simpson, stem cell project director for Consumer Watchdog, published a copy of Trounson's letter on Tuesday. Simpson commented:
"From what I've heard, representatives of companies on the list are talking with each other about why it was only one of the 18 companies, Novocell, received an award. They're comparing notes about the grant review process and how they feel it was biased against for-profit entities.
"There's a good chance they will work together as a group and take their concerns to the stem cell oversight committee, possibly as early as its September meeting.
"See what happens when a little light shines in?"
Tuesday, August 26, 2008
SB1565: CIRM Hopes Now Rest with Arnold
The California stem cell agency will be looking to Gov. Arnold Schwarzenegger to gallop to its rescue and veto legislation aimed at ensuring affordable access to state-financed stem cell therapies.
The bill cleared the Assembly on Monday, 64-7, and now is only one step away from hitting the governor's desk. It will only take Senate concurrence in Assembly amendments to send the measure, SB1565 by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, to the governor.
So far the governor has not taken a position on the legislation, although he has been a friend indeed to the stem cell research program. A couple of years ago when CIRM was in financial straits, he loaned it $150 million, which has since been repaid with the state bond funds that finance CIRM's efforts. On more than one occasion, he has cited CIRM as evidence of doing good, both economically and scientifically.
CIRM and industry groups object to Kuehl's bill because it would lock into state law requirements that the agency contends would hamstring it in connection with negotiations with biotech companies. CIRM also objects to a provision that would lower a barrier to the funding of non-embryonic stem cell research.
Reporter Ron Leuty of the San Francisco Business Times wrote about the provision last month, noting that it was inserted at the request of the conservative Runner, who opposes to human embryonic stem cell research.
Leuty quoted Jeff Sheehy, a member of the CIRM board of directors, as saying,
One could speculate that the CIRM legislation could get caught in that battle. Schwarzenegger needs some Republican votes for a budget. Perhaps he could generate a couple by signing the legislation, arguing that he is acting to support stem cell research that does not destroy human life.
The possibility may be remote but stranger things have been done under the dome. And lawmakers and the governor are desperate to find a solution to the budget crisis.
The bill cleared the Assembly on Monday, 64-7, and now is only one step away from hitting the governor's desk. It will only take Senate concurrence in Assembly amendments to send the measure, SB1565 by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, to the governor.
So far the governor has not taken a position on the legislation, although he has been a friend indeed to the stem cell research program. A couple of years ago when CIRM was in financial straits, he loaned it $150 million, which has since been repaid with the state bond funds that finance CIRM's efforts. On more than one occasion, he has cited CIRM as evidence of doing good, both economically and scientifically.
CIRM and industry groups object to Kuehl's bill because it would lock into state law requirements that the agency contends would hamstring it in connection with negotiations with biotech companies. CIRM also objects to a provision that would lower a barrier to the funding of non-embryonic stem cell research.
Reporter Ron Leuty of the San Francisco Business Times wrote about the provision last month, noting that it was inserted at the request of the conservative Runner, who opposes to human embryonic stem cell research.
Leuty quoted Jeff Sheehy, a member of the CIRM board of directors, as saying,
"We may be handing a political victory to people opposed to human embryonic stem cell research that hasn’t been earned and that isn’t supported by the science."The issue, however, is of little notice in the Capitol, where lawmakers and the governor are embroiled in a nearly two-month stalemate that has become the California budget crisis. The governor has ordered the layoff of 10,000 state employees and seeks to cut the pay of 200,000 state employees to the federal minimum hourly wage of $6.55 until a budget is passed. The spending measure is being blocked by Republicans, who can do so because it requires a two-thirds vote.
One could speculate that the CIRM legislation could get caught in that battle. Schwarzenegger needs some Republican votes for a budget. Perhaps he could generate a couple by signing the legislation, arguing that he is acting to support stem cell research that does not destroy human life.
The possibility may be remote but stranger things have been done under the dome. And lawmakers and the governor are desperate to find a solution to the budget crisis.
Saturday, August 23, 2008
Friday, August 22, 2008
Consumer Watchdog: Some CIRM Directors Missing Work and Should Resign
Five directors of the $3 billion California stem cell agency have missed 60 percent or more of its board meetings this year, the Consumer Watchdog group reported today, declaring that there is "no excuse for flagrant absenteeism."
John M. Simpson, stem cell project director for the Santa Monica, Ca., group, said directors who cannot attend meetings should resign.
Simpson disclosed the attendance performance in a news release after doing an analysis of meeting records since 2006 of the board of directors, which is known as the ICOC.
Here is key paragraph on this year's attendance, which includes names, affiliation and designated slot occupied on the board.
CIRM has been plagued since its inception by attendance and quorum problems, making it difficult to complete its official business. Part of the problem exists because of Prop. 71 language that requires a two-thirds quorum instead a simple majority of the 29-member board. Simpson said his analysis understates the attendance problem because a member is marked present if he or she attends only part of a session. On occasion, some directors seem to be fleeing for the exits in the waning hours of two-day meetings as they try catch planes, we have observed. Simpson wrote:
John M. Simpson, stem cell project director for the Santa Monica, Ca., group, said directors who cannot attend meetings should resign.
Simpson disclosed the attendance performance in a news release after doing an analysis of meeting records since 2006 of the board of directors, which is known as the ICOC.
Here is key paragraph on this year's attendance, which includes names, affiliation and designated slot occupied on the board.
"The worst attendance records for the five meetings this year, according to ICOC minutes, are: Marsha Chandler, executive vice president and chief operating officer, Salk Institute, an executive from a California Research Institute (20 percent); Jonathan Shestack, founder & vice president, Cure Autism Now, patient advocate mental health (20 percent); Tina S. Nova, president and CEO of Genoptix, executive officer of a commercial life science entity (40 percent) and Marcy Feit, president and CEO Valley Care Health Systems, patient advocate Type II Diabetes, (40 percent)."Also absent from 100 percent of meetings this year is John Reed of the Burnham Institute, who has recused himself during a state investigation into conflict of interest violations involving Reed's attempt to influence CIRM staff on a grant application.
CIRM has been plagued since its inception by attendance and quorum problems, making it difficult to complete its official business. Part of the problem exists because of Prop. 71 language that requires a two-thirds quorum instead a simple majority of the 29-member board. Simpson said his analysis understates the attendance problem because a member is marked present if he or she attends only part of a session. On occasion, some directors seem to be fleeing for the exits in the waning hours of two-day meetings as they try catch planes, we have observed. Simpson wrote:
"At this month’s ICOC meeting Chairman Bob Klein was urging members to act quickly because the board would lose a quorum in 25 minutes. That’s no way to make substantive decisions affecting a $6 billion (including interest) program."Simpson said,
"Patients hoping for stem cell cures rightly expect 100 percent commitment by board members. If they can’t do that, the fair thing for everyone is to step aside."Here is Simpson's complete attendance tally by member or alternate beginning in 2006:
"Ricardo Azziz — 14 of 14 — 100 percent
"David Baltimore — 10 of 10 — 100 percent
"Robert Birgeneau — 16 of 18 — 89 percent
"Keith L. Black — 2 of 2 — 100 percent
"Floyd Bloom — 6 of 6 — 100 percent
"David Brenner — 11 of 11 — 100 percent
"Susan Bryant — 17 of 18 — 94 percent
"Marsha Chandler — 3 of 7 — 43 percent
"Marcy Feit — 12 of 18 — 67 percent
"Michael Friedman — 15 of 18 — 83 percent
"Leeza Gibbons — 5 of 6 — 83 percent
"Michael Goldberg — 13 of 18 — 72 percent
"Brian E. Henderson — 14 of 15 — 93 percent
"Edward Holmes — 4 of 6 — 67 percent
"David Kessler — 10 of 13 — 77 percent
"Robert Klein — 18 of 18 — 100 percent
"Sherry Lansing — 16 of 18 — 89 percent
"Gerald Levey — 11 of 18 — 61 percent
"Ted Love — 15 of 18 — 83 percent
"Richard Murphy — 5 of 10 — 50 percent
"Tina Nova — 10 of 18 — 56 percent
"Ed Penhoet — 16 of 18 — 89 percent
"Philip Pizzo — 17 of 18 --- 94 percent
"Claire Pomeroy — 17 of 18 — 94 percent
"Francisco Prieto — 15 of 18 — 83 percent
"John Reed — 9 of 18 — 50 percent (Recused himself during ethics probe)
"Duane Roth — 16 of 16 — 100 percent
"Joan Samuelson — 12 of 18 — 67 percent
"David Serrano Sewell — 15 of 18 — 83 percent
"Jeff Sheehy — 15 of 18 — 83 percent
"Jonathan Shestack — 5 of 18 — 28 percent
"Oswald Steward — 16 of 18 — 89 percent
"Leon Thal — 6 of 6 — 100 percent
"Janet Wright — 15 of 15 — 100 percent."
Thursday, August 21, 2008
CIRM's Secret 18 Disclosed
The Consumer Watchdog group today pulled away a bit of the veil of pseudo-secrecy that surrounds much of the grant process at California's $3 billion stem cell agency.
CIRM – most of the time – refuses to disclose the names of enterprises or individuals seeking its taxpayer-financed largess, unless they have actually won some CIRM cash. However, the agency chooses to identify applicants when it is convenient for CIRM purposes, as was the case in the mammoth lab grant program earlier this year.
John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., has long contended that good government practices demand the release of the names of those who seek funding from the state of California.
Today on his blog, he disclosed the names of 18 companies that were looking for grants from CIRM. Only one, Novocell, eventually received a grant, despite oft-expressed desires by some CIRM directors that California companies should receive the benefit of state financing.
Simpson noted that some rejected business applicants have complained about CIRM's review process, contending that it "is skewed towards academic science." Some CIRM directors have also questioned the approach of its scientific reviewers, saying that they may overlook worthwhile efforts that are heavily focused on bringing cures into the hospital. Simpson suggested that the companies he identified might want to get together and talk.
Simpson said the names were drawn from a document "used for internal CIRM vetting processes" involving letters of intent, which are required in order to apply for a grant. Simpson wrote:
"Here's the list of firms which filed an LOI (letters of intent) to apply for the Disease Team Planning Grant: Advanced Cell Technology, Alameda; BioCardia Inc., South San Francisco; DNAmicroarray Inc., San Diego; Genomics Institue of Novartis Research Foundation, San Diego; International Stem Cell Corp., Oceanside, Novocell, San Diego; Panorama Research Inc., Mountain View; RegeneMed Inc., San Diego; StemCyte Inc., Covina; and Stemedica Cell Technologies, San Diego.
"Here are the companies that filed an LOI to apply for New Cell Lines Grant: Advanced Cell Technology, Alameda; BioTime, Inc., Emeryville; California Institute of Molecular Medicine, Ventura; Cascade Life Sciences Inc, San Diego; DNAmicroarray Inc., San Diego; Gene Security Network, Portola Valley; International Stem Cell Corp., Oceanside, Raven Biotechnologies Inc., South San Francisco; RegeneMed Inc., San Diego; Supercentenarian Research Foundation, Inglewood; VistaGen Therapeutics Inc., South San Francisco and WaferGen Biosystems, Fremont."
CIRM – most of the time – refuses to disclose the names of enterprises or individuals seeking its taxpayer-financed largess, unless they have actually won some CIRM cash. However, the agency chooses to identify applicants when it is convenient for CIRM purposes, as was the case in the mammoth lab grant program earlier this year.
John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., has long contended that good government practices demand the release of the names of those who seek funding from the state of California.
Today on his blog, he disclosed the names of 18 companies that were looking for grants from CIRM. Only one, Novocell, eventually received a grant, despite oft-expressed desires by some CIRM directors that California companies should receive the benefit of state financing.
Simpson noted that some rejected business applicants have complained about CIRM's review process, contending that it "is skewed towards academic science." Some CIRM directors have also questioned the approach of its scientific reviewers, saying that they may overlook worthwhile efforts that are heavily focused on bringing cures into the hospital. Simpson suggested that the companies he identified might want to get together and talk.
Simpson said the names were drawn from a document "used for internal CIRM vetting processes" involving letters of intent, which are required in order to apply for a grant. Simpson wrote:
"Here's the list of firms which filed an LOI (letters of intent) to apply for the Disease Team Planning Grant: Advanced Cell Technology, Alameda; BioCardia Inc., South San Francisco; DNAmicroarray Inc., San Diego; Genomics Institue of Novartis Research Foundation, San Diego; International Stem Cell Corp., Oceanside, Novocell, San Diego; Panorama Research Inc., Mountain View; RegeneMed Inc., San Diego; StemCyte Inc., Covina; and Stemedica Cell Technologies, San Diego.
"Here are the companies that filed an LOI to apply for New Cell Lines Grant: Advanced Cell Technology, Alameda; BioTime, Inc., Emeryville; California Institute of Molecular Medicine, Ventura; Cascade Life Sciences Inc, San Diego; DNAmicroarray Inc., San Diego; Gene Security Network, Portola Valley; International Stem Cell Corp., Oceanside, Raven Biotechnologies Inc., South San Francisco; RegeneMed Inc., San Diego; Supercentenarian Research Foundation, Inglewood; VistaGen Therapeutics Inc., South San Francisco and WaferGen Biosystems, Fremont."
A 'Booster Rocket' For Research in the 'Big Tomato'
The headline talks about the "dark side" of stem cells, but the piece was a bit of good news for the University of California, Davis, and particularly one man there who just won $2.2 million from the California stem cell agency. Reporter Carrie Peyton Dahlberg of The Sacramento Bee reported this week about Paul Knoepfler(pictured), a scientist who recently received a faculty award grant from CIRM that he calls a "booster rocket" that will nearly double the budget of his lab.
Dahlberg wrote:
"His target is a gene that causes tumors – and that can transform adult skin cells into versatile stem cells similar to those in embryos."She said his hope is to make potential stem cell therapies safer. Knoepfler was quoted as saying,
"I'm very optimistic. I don't think the hurdles we're facing are insurmountable."Dalhberg also quoted Meri Firpo of the University of Minnesota and Joseph Wu of Stanford, commenting favorable on Knoepfler's work.
The Bee piece triggered one reader remark on its website that expressed appreciation for an objective report. The anonymous commentator said it was one of the few articles that have addressed the cancer risk involved in stem cell therapies.
UC Davis has received $38 million from CIRM during the last three years. The dean of its medical school, Claire Pomeroy, is listed as one of the 100 most powerful persons in Sacramento (along with Gov. Schwarzenegger) by Sacramento magazine. Pomeroy is also one of the 29 directors of the state stem cell agency.
Interestingly, she is not quoted either in The Bee article or the press release from UC Davis on Knoepfler. We assume that is the result of her own choice. Probably a good position to take considering the conflict of interest issues surrounding all the many academic and research executives who sit on the CIRM board and whose employers have benefited to the tune of hundreds of millions of dollars handed out by CIRM.
(Editor's note: For those of you unfamiliar with California geography, Davis is just west of Sacramento, where the UC Davis medical school is actually located. Sacramento is sometimes known as the Big Tomato because of the vast amounts of tomatoes that are grown in the area. In years past, the Sacramento River would run red in the summer from tomato waste from processing plants.)
Monday, August 18, 2008
Stemcellbattles.com Is Offline; Webmaster Hospitalized
We received the following from patient advocate Don Reed of Hayward, Ca. "Karen Miner’s and my weblog, www.stemcellbattles.com, is down.
"Webmaster Karen(pictured) is in hospital, recovering from bladder augmentation surgery. The operation was done in hopes of freeing her from many problems of a personal nature, related to her spinal cord injury of fourteen years.
"We are in hopes she will recover fully, but for the foreseeable future, our small column, www.stemcellbattles.com, will not go forward. Karen was the webmaster; now her health will not permit her to carry on this unpaid chore.
"Selfishly, I am devastated.
"Not only did Karen’s webmastery give me a voice, but she and I have worked closely together for more than ten years. She is a part of everything I have done in research advocacy. Co-chair of Californians for Cures, Karen worked hard on the Roman Reed Spinal Cord Injury Research Act, Senator Deborah Ortiz’s stem cell laws, Bob Klein’s magnificent and unparalleled Proposition 71, and the four years continual defense of it afterward, in the unending attacks the California Institute for Regenerative Medicine has endured; always, Karen was there.
"Paralyzed in body but never in spirit, Karen Miner is a constant source of inspiration to me and all who have the blessing of knowing her.
"Anyone wishing to send Karen a get-well-soon email may send it me at: diverdonreed@pacbell.net. I will print them out and take them to her in the hospital.
"Don’t send anything electronically complicated or fancy, no e-cards, please. I don’t know how to work that stuff. Thanks.
"Don C. Reed
"Co-chair, Californians for Cures"
Sunday, August 17, 2008
Changes in the California Stem Cell Report
We have made a few changes on this page that we hope will be useful to readers. For those of you hunting for a site feed (formerly at the very bottom of this web page), it can now be found at the top just to the left. We have moved the "Links" listings to place them above the archives of recent headlines. And we have added a "related content" gizmo at the end of each item. It is a device that will take you automatically to content that its creators think is connected to the subject of the posting on this report. It seems moderately useful although like most automated search engines it turns up irrelevant information as well. Your comments are welcome along with suggestions for additional changes and improvements. You post them by clicking on "comments" or you can send them to me directly: djensen@californiastemcellreport.com.
Fresh Comment
"Jim" has posted a comment on the "blog ban comment" item. Jim's item links to a Vadlo cartoon involving stem cell research and "Science" magazine.
Thursday, August 14, 2008
Minimal News Coverage on CIRM Faculty Grants
News coverage of this week's $59 million in grants from the California stem cell agency was light today.
Most of the stories were heavily focused on the local impact of the grants. All appeared to have been written from the CIRM news release as opposed to actual coverage of the directors meeting.
Here is a listing of the stories we turned up.
Sacramento Bee
San Diego Union-Tribune, story by Terri Somers
San Francisco Chronicle, story by David Perlman
San Jose Business Journal
The Associated Press
Here is a listing of the news releases from recipient institutions.
Stanford
UC Irvine
University of California, statewide
UC San Diego
UC San Francisco
UCLA put out a news release that has not surfaced on its stem cell web site. You may be able to find it in the next day or two by going to the UCLA stem cell home home page.
Most of the stories were heavily focused on the local impact of the grants. All appeared to have been written from the CIRM news release as opposed to actual coverage of the directors meeting.
Here is a listing of the stories we turned up.
Sacramento Bee
San Diego Union-Tribune, story by Terri Somers
San Francisco Chronicle, story by David Perlman
San Jose Business Journal
The Associated Press
Here is a listing of the news releases from recipient institutions.
Stanford
UC Irvine
University of California, statewide
UC San Diego
UC San Francisco
UCLA put out a news release that has not surfaced on its stem cell web site. You may be able to find it in the next day or two by going to the UCLA stem cell home home page.
Correction
The correct number of applications for the most recent round of CIRM faculty award grants is 54. The initial CIRM news release on the subject incorrectly the number as 55, which is actually the number of letters of intent. CIRM has corrected the figure in its news release.
The Perils of Prop. 71: CIRM's Search for a Vote
Crafty. Ingenious. Resourceful. And dubious.
All of which describe the events Tuesday night at the meeting of the directors of the California stem cell agency.
As John M. Simpson of Consumer Watchdog of Santa Monica, Ca., put it, the board "essentially drafted a member from the audience" in order to achieve a quorum and to be able to act officially.
Simpson, a regular and longtime observer of CIRM, wrote on his organization's blog,
Simpson continued,
It is one more example of the pitfalls of Prop. 71 and the perils of writing laws by initiative. The board of directors of CIRM is too large to run efficiently and the quorum requirements too high. Other problems exist as well, including a dual executive situation and built-in conflicts of interest. All of which are virtually impossible to change. That's because Prop. 71 altered the California State Constitution to require a 70 percent vote of the Legislature and the signature of the governor to amend the measure. The super, super-majority vote requirement is unprecedented and unique. It makes CIRM nearly immune from tinkering by lawmakers. But it also prevents changes that would enhance CIRM's mission and fix problems that arise when laws are put together in private by special interests.
All of which describe the events Tuesday night at the meeting of the directors of the California stem cell agency.
As John M. Simpson of Consumer Watchdog of Santa Monica, Ca., put it, the board "essentially drafted a member from the audience" in order to achieve a quorum and to be able to act officially.
Simpson, a regular and longtime observer of CIRM, wrote on his organization's blog,
"Assembling a quorum for the 29-member ICOC is never easy. It's comprised largely of high-powered academic and industry representatives. Moreover, Prop. 71 requires a super-majority. A quorum is 19 members."Tuesday night, board officials had expected the necessary number but for a variety of reasons, the panel was short.
Simpson continued,
"Then as the board broke for dinner, Jacob E. Levin, Director of Research Development at UC Irvine, who was in the audience, asked Board Executive Director Melissa King what was necessary to serve as an alternate member.In years of covering hundreds, perhaps thousands, of California governmental hearings, I have never seen anything quite like this. State lawmakers have occasionally been locked in their legislative chambers until their leadership gets a desired vote. Some lawmakers have been dragooned from their homes to come in for a vote. But nothing quite like the CIRM maneuver on Tuesday.
"His boss, board member Dr. Susan Bryant, was one of those who was unable to attend. Under the ICOC's rules, board members from universities and research institutions may appoint alternates if they can't make it. The designate must be an executive of the university or institution.
"The lawyers determined Levin met the requirements, staff caught up with Dr. Bryant by phone, who agreed Levin could be her designate and after dinner the board got down to business. Chairman Bob Klein noted that Levin had been present for all the agenda items that had been discussed."
It is one more example of the pitfalls of Prop. 71 and the perils of writing laws by initiative. The board of directors of CIRM is too large to run efficiently and the quorum requirements too high. Other problems exist as well, including a dual executive situation and built-in conflicts of interest. All of which are virtually impossible to change. That's because Prop. 71 altered the California State Constitution to require a 70 percent vote of the Legislature and the signature of the governor to amend the measure. The super, super-majority vote requirement is unprecedented and unique. It makes CIRM nearly immune from tinkering by lawmakers. But it also prevents changes that would enhance CIRM's mission and fix problems that arise when laws are put together in private by special interests.
Wednesday, August 13, 2008
$59 Million Bonanza For California Stem Cell Researchers
Twenty-three California scientists hit it big today when the California stem cell agency awarded them grants that totaled as much as $3.2 million each.
In all, directors of the agency gave away $59 million in its second round of Faculty Awards, which are designed to support "young" researchers and develop more talent in the area of human embryonic stem cell research,.
The grants will support the recipients for as long as five years. They come at a time when competition for grants at the federal level is increasingly competitive. In a news release, CIRM Chairman Robert Klein noted that the average age of a researcher receiving his first grant from the National Institutes of Health is 43. Presumably, today's CIRM recipients are younger, but the agency did not specify their average age in its news release, which contains the names of the recipients and their institutions.
Grant reviewers decided 20 grants were unequivocally worth funding. Directors added three more from the second tier of applications, which reviewers say are worth approving if funds are available. Nine more grants remain in that category and will be considered at next month's directors meeting. A final vote will also be held then on the 22 applications not recommended for funding by reviewers. Fifty-four applications were received.
Today's grants come on top of a similar round approved last December. CIRM gave away $54 million then to 22 scientists. However, that round was tainted by conflict of interest violations by some CIRM directors, that caused the agency to reject 10 applications. Directors then decided to go ahead with another round of Faculty Award grants.
Initially CIRM budgeted $41 million for 14 recipients in the latest round of Faculty Awards. CIRM did not explain the rationale for increasing the program in its news release today.
(Editor's note: This item originally contained a sentence noting that CIRM's original press release said there were 55 applications although internally the numbers totalled 54. We queried CIRM about the matter. CIRM said that 55 was a mistake and that only 54 applications were received.)
In all, directors of the agency gave away $59 million in its second round of Faculty Awards, which are designed to support "young" researchers and develop more talent in the area of human embryonic stem cell research,.
The grants will support the recipients for as long as five years. They come at a time when competition for grants at the federal level is increasingly competitive. In a news release, CIRM Chairman Robert Klein noted that the average age of a researcher receiving his first grant from the National Institutes of Health is 43. Presumably, today's CIRM recipients are younger, but the agency did not specify their average age in its news release, which contains the names of the recipients and their institutions.
Grant reviewers decided 20 grants were unequivocally worth funding. Directors added three more from the second tier of applications, which reviewers say are worth approving if funds are available. Nine more grants remain in that category and will be considered at next month's directors meeting. A final vote will also be held then on the 22 applications not recommended for funding by reviewers. Fifty-four applications were received.
Today's grants come on top of a similar round approved last December. CIRM gave away $54 million then to 22 scientists. However, that round was tainted by conflict of interest violations by some CIRM directors, that caused the agency to reject 10 applications. Directors then decided to go ahead with another round of Faculty Award grants.
Initially CIRM budgeted $41 million for 14 recipients in the latest round of Faculty Awards. CIRM did not explain the rationale for increasing the program in its news release today.
(Editor's note: This item originally contained a sentence noting that CIRM's original press release said there were 55 applications although internally the numbers totalled 54. We queried CIRM about the matter. CIRM said that 55 was a mistake and that only 54 applications were received.)
Tuesday, August 12, 2008
A Tardy CIRM Posting on New Grant Reconsideration Policies
Only hours before its directors meet today, the California stem cell agency has posted its proposed policy for handling requests for reconsideration of negative recommendations from reviewers on grant applications.
The proposal is an attempt to deal with a problem that has dogged CIRM since last January when an unhappy applicant asked the board to approve its grant despite a negative decision by reviewers.
The board was clearly uncomfortable with the attempt, both in terms of fairness to other applicants and because of the disruption of its normal procedures. The issue surfaced once again in June, leading to more extended public discussion of the appeal or reconsideration process. CIRM allows "appeals" only in the case of conflicts of interest on the part of reviewers. However, reviewers do not have to publicly disclose their economic or professional interests.
The proposed procedure requires the applicant to file a request for reconsideration five days prior to a directors meeting. CIRM's president will then evaluate it and make a finding on whether it has merit. The proposal is unclear on whether it means calendar days or business days.
The reconsideration requests, which CIRM calls "extraordinary petitions," will be posted on the CIRM website. Presumably the president's findings will be as well, although that is not specified.
The policy does not appear to eliminate an applicant's ability to appear publicly before the board to seek reconsideration. However, with a negative decision from reviewers and a "no merit" finding from the president, a disgruntled applicant is not likely to find a receptive audience.
It is unfortunate, to say the least, that this important proposal, which affects hundreds of scientists in California, has been posted at the very last minute. It deals with an issue that affects CIRM's credibility and the credibility of its reviewers. It is virtually impossible for those affected by this plan to comment intelligently to the board in a timely fashion.
Presumably, they could send an email with their comments at this late hour – if they are aware of the details of the proposal. It is our sense, however, that few scientists spend much time scouring the depths of the CIRM website, which does not even put a notice of its directors meetings on its home page.
For a look at previous items on this issue, search on the label "reconsideration" or "grant appeals."
The proposal is an attempt to deal with a problem that has dogged CIRM since last January when an unhappy applicant asked the board to approve its grant despite a negative decision by reviewers.
The board was clearly uncomfortable with the attempt, both in terms of fairness to other applicants and because of the disruption of its normal procedures. The issue surfaced once again in June, leading to more extended public discussion of the appeal or reconsideration process. CIRM allows "appeals" only in the case of conflicts of interest on the part of reviewers. However, reviewers do not have to publicly disclose their economic or professional interests.
The proposed procedure requires the applicant to file a request for reconsideration five days prior to a directors meeting. CIRM's president will then evaluate it and make a finding on whether it has merit. The proposal is unclear on whether it means calendar days or business days.
The reconsideration requests, which CIRM calls "extraordinary petitions," will be posted on the CIRM website. Presumably the president's findings will be as well, although that is not specified.
The policy does not appear to eliminate an applicant's ability to appear publicly before the board to seek reconsideration. However, with a negative decision from reviewers and a "no merit" finding from the president, a disgruntled applicant is not likely to find a receptive audience.
It is unfortunate, to say the least, that this important proposal, which affects hundreds of scientists in California, has been posted at the very last minute. It deals with an issue that affects CIRM's credibility and the credibility of its reviewers. It is virtually impossible for those affected by this plan to comment intelligently to the board in a timely fashion.
Presumably, they could send an email with their comments at this late hour – if they are aware of the details of the proposal. It is our sense, however, that few scientists spend much time scouring the depths of the CIRM website, which does not even put a notice of its directors meetings on its home page.
For a look at previous items on this issue, search on the label "reconsideration" or "grant appeals."
Monday, August 11, 2008
CIRM Should Say No to Mullin Tresspass Bill
Directors of the California stem cell agency this week are scheduled to discuss legislation aimed at dealing somewhat with the recent upsurge in attacks on California researchers, including at least one of its grantees.
On the agenda for either tomorrow or Wednesday is AB2296 by Assemblyman Gene Mullin, D-San Mateo. It has already passed the Assembly and is now in the Senate Public Safety Committee in a heavily amended form.
It now states in part:
While we are adamantly opposed to the domestic terrorism that has targeted researchers in this country, we cannot support the Mullin bill. Nor should CIRM.
The legislation is vague and raises major constitutional issues regarding freedom of speech. Existing law already provides a wide array of tools dealing with trespass, as the legislative analysis points out. The measure is certain to be challenged by such enterprises as the ACLU. Who knows what "chilling" a researcher's academic freedom means? And one wonders exactly why persons engaged in labor union activities are specifically exempted from the terms of the proposed law.
Instead of endorsing the bill, CIRM directors should add $50,000 to the reward in the firebombing case at UC Santa Cruz, which occurred at the home of CIRM-funded research David Feldheim. That would bring the total to $100,000. CIRM should also issue a strong condemnation of the terrorist actions and make it clear that there is no tolerance for those misguided souls who think they protect mice by endangering children and adults.
On the agenda for either tomorrow or Wednesday is AB2296 by Assemblyman Gene Mullin, D-San Mateo. It has already passed the Assembly and is now in the Senate Public Safety Committee in a heavily amended form.
It now states in part:
"Any person who enters the residential real property of an academic researcher for the purpose of chilling or interfering with the researcher's academic freedom is guilty of trespass, a misdemeanor."The bill totals about 600 words. The legislative staff analysis is about 5,600 words, reflecting the complexities of the issues involved. (CIRM has linked on its agenda to an earlier analysis.)
While we are adamantly opposed to the domestic terrorism that has targeted researchers in this country, we cannot support the Mullin bill. Nor should CIRM.
The legislation is vague and raises major constitutional issues regarding freedom of speech. Existing law already provides a wide array of tools dealing with trespass, as the legislative analysis points out. The measure is certain to be challenged by such enterprises as the ACLU. Who knows what "chilling" a researcher's academic freedom means? And one wonders exactly why persons engaged in labor union activities are specifically exempted from the terms of the proposed law.
Instead of endorsing the bill, CIRM directors should add $50,000 to the reward in the firebombing case at UC Santa Cruz, which occurred at the home of CIRM-funded research David Feldheim. That would bring the total to $100,000. CIRM should also issue a strong condemnation of the terrorist actions and make it clear that there is no tolerance for those misguided souls who think they protect mice by endangering children and adults.
CIRM To Define PI and Their Grant Time Commitments
If you are interested in winning a grant from the California stem cell agency, you may want to pay special attention to proposed policies that define the eligibility of a principal investigator and spell out the amount of time he or she must commit.
The proposal, which also deals with limits on the number of applications, will come before the directors of the agency tomorrow or Wednesday. The actual text of the recommendations was not available on the CIRM website until today.
The document does not make it explicitly clear what the purpose of the plan is. However, CIRM has sometimes been flooded with grant applications, creating an extraordinary burden on its staff and reviewers. The document also attempts to deal with the question of co-principal investigators, which seems to be an issue involving a grant that includes multiple institutions. You can find a discussion of this in the transcripts from the June directors meeting (v. 1) and their March session.
Two important paragraphs from the PI document read:
The proposal, which also deals with limits on the number of applications, will come before the directors of the agency tomorrow or Wednesday. The actual text of the recommendations was not available on the CIRM website until today.
The document does not make it explicitly clear what the purpose of the plan is. However, CIRM has sometimes been flooded with grant applications, creating an extraordinary burden on its staff and reviewers. The document also attempts to deal with the question of co-principal investigators, which seems to be an issue involving a grant that includes multiple institutions. You can find a discussion of this in the transcripts from the June directors meeting (v. 1) and their March session.
Two important paragraphs from the PI document read:
"CIRM, in contrast to the NIH, has a limited lifespan in which to accomplish its mission. Funding is commensurate with a sense of urgency to accomplish the mission that should be matched by a commensurate effort by key personnel, especially the PI and Co-PIs.The recommendations were developed without public hearings by an "ICOC RFA Task Force" that appears to consist of Stanford Medical School Dean Philip Pizzo, who is also a CIRM director, and one other person. It is not clear whether other institutions that are likely to submit grant applications were consulted in the process.
"Therefore CIRM, mindful of the urgency of its mission, will require a minimum percent effort of the PI (and Co-PIs), typically 10%, where it deems such minimum effort is necessary to ensure PI (Co-PI) oversight and timely accomplishment of the proposed research. Extraordinary circumstances may be applied by CIRM, at the discretion of the President, to allow senior research scientists to have reduced percent effort commitment in the interests of obtaining the best outcomes for a research project. CIRM and the Task Force agree that no changes will be made to the GAP in order to maintain flexibility."
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