CIRM Website Improves; More Info on Where The Money Goes

The California stem cell agency is slowly beefing up and improving its web site, posting additional information that is helpful to folks seeking to know more about how $3 billion in taxpayer funds are being spent.

One of the features added to the site recently is a list of all 206 grants (worth $554 million), their subject areas, institutions and the names of the principal investigators with links to the summary of the proposal by reviewers.

CIRM has also posted a ranking of institutions by the dollar value of CIRM grants that they have received. That list includes the type of grants awarded to each institution and the total dollars in each grant round.

Much, if not all, of this information was previously available on the CIRM website. But it took a lot of digging to ferret it out. The material is basic information, but it takes considerable work and care to compile it in a readily accessible format, not to mention updating it as warranted. And as we mentioned earlier, CIRM has also begun an "alert" service that provides automatic email notification to interested persons about a variety of events and information.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., recently singled out the list of all 206 grants for praise, calling the summary "user friendly and handy."

Don Gibbons is the chief communications officer for CIRM and oversees the content on the website. He is to be commended for pulling all this together. It is a valuable resource for the public and interested parties. We look forward to other features that he may add to the web site.

You can sign up for the CIRM alerts by going to its home page and clicking on the sign-up button. Sphere: Related Content

The Associated Press Digs Into Eggs, Money and Stem Cell Research

The Human Egg Debate just racheted up a notch.

Generally confined to scientific journals and websites like the California Stem Cell Report, the issue of scientists paying for eggs for human embryonic stem cell research today clattered onto a broader stage in a thorough-going piece by The Associated Press. The international news service distributes its stories to virtually every newspaper, radio and television station in the country.

Marcus Wohlsen wrote the article out of San Francisco. It began,

"Facing a human egg shortage they say is preventing medical breakthroughs, scientists and biotech entrepreneurs are pushing the country's top funders of stem cell research to rethink rules that prohibit paying women for eggs."

The California stem cell agency was mentioned in the second paragraph. Stemagen, a San Diego stem cell firm, was mentioned in the sixth. Alan Trounson, CIRM's president, Harvard's Kevin Eggan, Cascade LifeSciences, also of San Diego, and the Center for Genetics and Society of Oakland, Ca., were all included.

Sam Wood(pictured), chief executive of Stemagen, said that bans on payments for eggs have kept researchers from making advances that could save lives.

He was quoted as saying,

"You need to have enough eggs to make this thing work, and when you have enough eggs it does work."

"If these guidelines weren't in place, we'd already have many (stem cell) lines and be much closer to a treatment for devastating illnesses for which these are so well suited."

The AP story continued:

"As the country's largest funder of stem cell research by far, California's policy sets the pace for biotech firms and academic researchers nationwide. National guidelines advising against egg payments were developed to ensure any innovations would remain eligible for California funds; any changes to the state's policy would likely have an immediate ripple effect.

"California could also face increasing competition for business and scientific talent as New York prepares guidelines for its own $600 million stem cell research program. A draft report released by the New York program's planning committee said the state may allow payment for eggs."

But Wohlsen quoted Marcy Darnvosky of the Center for Genetics and Society as saying,

"Do we really want to put women at risk to provide raw materials for research a lot of scientists say really isn't the way to go?"

The references to Cascade, Trounson and Eggan all were to events chronicled earlier on the California Stem Cell Report, including the June meeting of CIRM's directors and the February meeting of the CIRM Standards Working Group.

The AP story pulled all of it together for general readers across the nation and perhaps abroad. Wohlsen's article will also attract the attention of editors around the country who may well commission locally written pieces and possibly editorials. It might even trigger a television news story or two. Sphere: Related Content

Fresh Comment

Don Thornton has filed a comment on the correction item below. Sphere: Related Content

Correction

The "Klein Confirms Resignation" item incorrectly identified John M. Simpson as Robert Simpson.

This is not the first time I have had made that mistake. The reasons go back to the early 1970s when I covered the California State Capitol for United Press International. Ronald Reagan was then governor. But he was not the only fixture under the dome. An elderly gentleman by the name of Robert Simpson also prowled the hallowed halls of state government. He was upset about some quite legitimate issue involving him personally, and the state system that did it to him. Unfortunately, the details are lost to memory. Even Google can't turn them up.

Robert Simpson meandered about the Capitol with his walker on nearly a daily basis, carrying hand-lettered signs with red characters proclaiming his grievances. His most memorable slogan was: "Reagan is a bastard!" It came at a time when such a public denunciation was still shocking. From time to time, Simpson was arrested by state police or Reagan's security forces and carted off to the local hoosegow. Undeterred he would pop up the next day invigorated by the experience.

I interviewed Robert Simpson on several occasions. His dentures did not fit well, and his enunciation was poor. Sometimes, spittle would fly and land on those nearby. The stories I wrote about him did little to solve his problems with the state of California. He was banging futilely against the state's bureaucracy. However, he relished the fight and the attention.

A couple of years later, a new reporter arrived in the Sacramento UPI bureau. (I taught him everything he knows.) Appropriately, he re-discovered Simpson and wrote about him again, pushing those stories into national prominence. Mr. Simpson, as we called him, delighted once more in the attention but his disputes were never settled to his satisfaction.

My recollection is that Mr. Simpson's health, never the best, declined. Members of his family came from out of town to assist. His obituaries were fulsome and replete with fond references to Mr. Simpson's good humor, despite his belief that he was never treated fairly by the state of California and the governor who portrayed so many amiable characters on the silver screen.

And that is why my fingers – to this day -- sometimes type in Robert Simpson's name instead that of John M. Simpson. Sphere: Related Content

CIRM Revising Rules on Pre-2006 Cell Lines

The CIRM Standards Working Group had a plateful last week, dealing with the question of whether it can finance human embryonic stem cell research involving cell lines that were derived prior to CIRM regulations.

The short answer is provided by John M. Simpson, stem cell project director of the Consumer Watchdog group, who attended the meeting. He wrote on his group's blog:

"A stem cell line may be deemed acceptably derived before November 2006 if the following criteria are met:

"Informed consent from woman or couple in IVF (and no indication that original donor would not consent for research).

"Approval of the donation protocol by an Institutional Review Board.

"Compliance with prevailing ethical and legal standards in place at the time of derivation in the jurisdiction where the derivation was carried out.

"The process to determine if the criteria had been met would begin with a request to CIRM. The staff would review the request and make a recommendation to the oversight board, the Independent Citizens Oversight Committee.  The review would have to include consideration of the scientific significance of the stem cell line.  The ICOC would consider the request in a public meeting after publicly posting it."

The Standards Working Group did not have a quorum so its "plan" will go to directors, presumably at their August meeting, as representing the "sense of the group" but without a formal recommendation. Such a practice is commonplace with CIRM since it has perennial problems with securing quorums at meetings.

If you see problems with the CIRM proposal or support it, now is the time to send something along to the agency. Sphere: Related Content

Klein Confirms Resignation, Lobbying Connections Remain

The chairman of the California stem cell agency has personally confirmed that he has resigned as head of his personal stem cell lobbying group, Americans for Cures, which has been nearly silent on the subject since July 14.

Robert Klein's exit as president of the group came after it excoriated an influential California lawmaker on a widely read political blog, the Daily Kos.

Second-hand reports surfaced (the first on July 14) that he was resigning as president of the group, which shares the same address as his real estate investment firm as well as the same fax number.

Since then, Americans for Cures has not responded to repeated requests asking for confirmation of Klein's departure. Nor did Klein tell state Sen. Sheila Kuehl, object of the attack, that he was resigning, as he had said he would.

But Robert M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., encountered Klein last week at the meeting of the CIRM Standards Working Group. Simpson said,

"I asked Klein what his status with the group was when I saw him on Friday. He said that he had resigned the night he learned about the Kos article and came back from vacation.

"I told him that his name was still on the website. He said he'd call them to have it removed."

Since then, the reference to Klein as president has been removed from the website by Americans for Cures, along with a list of all its directors.

On July 24, we wrote about Klein's failure to announce his resignation, commenting that the initial, second-hand reports may have amounted to some sort of trial balloon that Klein hoped would trigger calls for him to remain as head of Americans for Cures.

Don Gibbons, chief communications officer for CIRM, today volunteered the following reaction to our trial balloon comment,

"The Americans for Cures web site has been corrected regarding the president. That theory you put forth on the issue goes beyond speculative paranoia."

With his resignation, Klein has recognized that his connections with Americans for Cures are not compatible with his role as a public servant and chairman of an agency that is giving away $3 billion of California taxpayer's money.

Klein's resignation, however, is less than a half-measure and does not even well serve his own best interests. If it is an attempt to distance himself from the organization, it falls far short. If he continues to serve on the board of directors of the lobbying group, if the group continues to share Klein's office fax number and address, if he continues to control hiring and policy and generate financing for the group, Klein remains accountable for whatever the group does. Particularly for any actions that do not coincide with the best interests of the people of California or CIRM.

Klein volunteered for his role at CIRM and has not been paid for his work for nearly three years, which is all to his credit. Would that more California businessmen and women donate their time and energy to help solve some of society's difficult problems.

But when Klein accepted his job as a public servant, other activities became incompatible. One of those is directing a lobbying group that operates in the same area as CIRM.

As we reported earlier, Klein's dual roles represent an inherent conflict of interest. It is as if a high level executive with the California Medical Association also served on the state Medical Board. It is impossible to know whether their official actions represent their own views or the views of the special interest group. Sphere: Related Content

CIRM Confirms Departure of General Counsel

The California stem cell agency today confirmed that Tamar Pachter is leaving her post (see item below) as general counsel of the $3 billion enterprise.

Her Aug. 15 departure pretty much finishes off the senior management team assembled by former President Zach Hall, who retired in the spring of 2007. The top senior executives now in place were brought in after Hall left and after Chairman Robert Klein recruited Alan Trounson as president.

Under Klein's leadership, CIRM has also been reorganized to shift more staff and responsibility to the chairman's office, undoing directors' changes in 2007 that stripped Klein's office of six positions.

Klein and Hall butted heads more than once, mostly in private, but in public put the best face on their relationship. Conflicts emerged partly because of the overlapping roles provided for president and chairman in Prop. 71. Under normal state and business practices those roles could be clarified by an organization's board of directors, but Prop. 71 locks them into state law, making them virtually impossible to change. The differences between the men, however, went beyond the CIRM structure, reflecting their divergent personalities, professional background and philosophies.

In response to a query from the California Stem Cell Report, Don Gibbons, chief communications officer for CIRM, confirmed Pachter's resignation. He said she would return to the state Department of Justice, where she served as a deputy attorney general. It was in that position that she argued and won the case that threatened to put CIRM out of business. Sphere: Related Content

CIRM's Chief Counsel Quits

The attorney who successfully defended the California stem cell agency against challenges to its existence has resigned as CIRM general counsel after only 16 months on the job, according to a well-informed source.

One longtime observer of CIRM affairs characterized the reported resignation of Tamar Pachter(pictured) as a "troubling development" that reflects poorly on CIRM Chairman Robert Klein.

Pachter could not be reached for comment on her decision to leave her $225,000-a-year post. CIRM has not responded to our queries on her resignation.

Pachter is at least the 17th employee to leave CIRM since it began work in 2005. The agency has only slightly more than 30 employees with plans to reach 39 by the end of this fiscal year.

Only last December Pachter received a 41 percent pay increase, up from the $160,000 that she was hired at in March 2007.

Rumblings have surfaced, however, that Pachter was not happy. One likely issue is the fragmented legal approach at CIRM. Typically a general counsel oversees all the legal operations of a state agency or business. However, that was clearly not the case at CIRM.

The agency has retained outside counsel, Remcho, Johansen & Purcell of San Leandro, Ca., since 2005 at a cost exceeding $1 million. CIRM has at least three other attorneys, not including Pachter and Chairman Klein, who wrote much of Prop. 71, the ballot measure that created the agency. None of those attorneys reported to Pachter, according to CIRM's organizational chart. Instead they come under Klein.

CIRM plans to hire two more attorneys this year. Neither of them is linked directly to the general counsel's office. CIRM also has received legal assistance from the state Department of Justice.

Frequently Pachter and James Harrison, Remcho's main CIRM representative, would attend the same CIRM public meetings. Often, Klein deferred to Harrison at those sessions. The Harrison/Remcho contract is due to be renewed on Wednesday for $450,000 for 2008-09 at rates up to $350 an hour.

We asked John M. Simpson, stem cell project director for the Consumer Watchdog group of Santa Monica, Ca., for his thoughts on Pachter's departure. Simpson recently commented on how CIRM's top management seems to be an "old boys' club."

Simpson said,

"If Tamar Pachter has resigned, it is a troubling development. CIRM has been plagued with high turnover and much of the blame for this rests with the management style of Chairman Bob Klein. The agency has lurched too frequently in different directions; what's needed is a steady hand at the helm that allows the routine to become routine."

When Pachter was hired out of a pool of nearly 100 applicants, CIRM hailed her "impeccable legal credentials" and described her as a "superb litigator." Sphere: Related Content

Bee 'Flabbergasted' by Klein's Actions

The Sacramento Bee has not been pleased with Robert Klein virtually since he became chairman of the $3 billion California stem cell agency more than three years ago.

Earlier this week, the newspaper fired off another editorial lambasting Klein, this time accusing of him of misusing his office.

The case in point involves Klein's personal stem cell lobbying group, Americans for Cures, which recently publicly excoriated an offending state legislator in a posting on a widely read, national political blog.

The Bee wrote,

"Through his connections with the governor and other state leaders, Klein effectively directs who is appointed to the institute's 29-member oversight board, which includes university deans dependent on research funds that Klein controls.

"That should be enough power for any one public official. But not for Klein.

"Up until last week, Klein also served as president of Americans for Cures, an advocacy group that works out of offices he owns in Palo Alto. That linkage provides Klein with a nongovernmental agent with which to go after his opponents and further his institutional power."

The Bee continued:

"Government officials shouldn't be affiliated with special interest groups that lobby on issues that affect their agencies. After three years, it remains flabbergasting that Klein doesn't recognize that conflict and the injury it causes to the state's stem cell program. Even more curious is why the institute's 'oversight' board continues to condone it."

The Bee's editorial was written before the disclosure that Klein plans to spend 88 days traveling out of state this fiscal year at taxpayer expense. We are certain that the newspaper would have been even more exercised if that had been known at the time the editorial was written.

As far as Klein's reported resignation as president of Americans for Cures, so far no official announcement has been forthcoming. One report had it that the resignation would be announced after he told Sen. Sheila Kuehl, the object of his group's ire, about it. But her office said that Klein did not mention resigning in their conversation following the offending Internet post.

The delay in announcing his resignation may indicate that the earlier resignation reports amounted to something of a trial balloon effort by Klein in which Klein expected supporters to rally around him. Meanwhile, he is still listed as president on the Americans for Cures website. Sphere: Related Content

Lockyer Names Quint to CIRM Directorate

The California stem cell agency has a new member on its board of directors, a cardiologist from San Jose who once treated former state lawmaker John Vasconcellos.

The new member of the CIRM Oversight Committee is Robert Quint, who was appointed to the post by state Treasurer Bill Lockyer.

A spokesman for Lockyer said Vasconcellos had recommended Quint. "We were highly impressed with Quint's resume, and the man himself, and Lockyer decided he was the person for the job." the spokesman said. Lockyer and Vasconcellos, both Democrats, served in the state legislature together.

Quint replaces Janet Wright, also a cardiologist, on the 29-member board. Wright left earlier this year to take a job in Washington, D.C., with the American College of Cardiology.

Quint has operated his own cardiology practice in San Jose since 1980. Lockyer's office said,

"He has helped develop pioneering diagnostic and treatment techniques for arteriosclerotic heart disease, including coronary angiography and angioplasty."

We asked Lockyer's office whether Quint had been recommended by CIRM Chairman Robert Klein. Spokesman Tom Dresslar replied,

"Former state legislator John Vasconcellos did.  He and Lockyer go way back."

One vacancy remains on the CIRM board of directors. Sphere: Related Content

CIRM Mulls Kuehl Legislation Once Again, Supplier Proposal Also on Table

A directors subcommittee of the California stem cell agency will discuss on Thursday their opposition to legislation aimed at ensuring affordable access to state-financed stem cell therapies.

The bill is only two steps away from being sent to the governor's desk. No lawmaker has voted against the measure, SB 1565 by state Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. It is now on the the Assembly floor. If it wins approval as expected, it will go to the Senate for concurrence in Assembly amendments and then to the governor.

CIRM has officially opposed the measure, and it is not clear what its Legislative Subcommittee might do at the Thursday afternoon meeting, short of renewing the agency's opposition. Interested parties can participate or listen in on the meeting at public teleconference locations throughout the state, including San Francisco, Elk Grove, Irvine, Healdsburg, Sacramento and Palo Alto.

The meeting comes as BioRegion News is carrying a lengthy look at the bill, its support and opposition. Written by Alex Philippidis, the piece quotes Kuehl as saying regarding CIRM,

"They don’t intend to remove their opposition. They simply want more, and more, and more amendments, because they want the bill to go away. But the bill is not going away."

Also up for discussion at the Thursday meeting is the California supplier bill, AB 2381 by Assemblyman Gene Mullin, D-San Mateo. That bill would define California supplier for the purposes of providing a preference to such businesses as required by Prop. 71.

Currently the bill is in the Senate Appropriations Committee and is scheduled for a hearing Aug. 4. CIRM is also proceeding with its own regulatory definition of California supplier. The legislation has been the subject of considerable negotiation. Movement by CIRM may well come at the Thursday meeting. Here is a link to the latest amended version of the bill, although it may not reflect more current drafts that are not available on the Internet. Sphere: Related Content

Fresh Comments

Larry Ebert has posted a comment on the "group-think" item. "Anonymous" has filed a comment on the "WARF whacked" item. Sphere: Related Content

The Perils of Group-Think at CIRM

Is the California stem cell agency dominated by an Old Boys Club that is shy on experience in running a grant program totalling a half-billion dollars?

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., thinks so.

Simpson, who describes himself as a "fat, old white guy," says he doesn't have anything against such persons. But he warns about the perils of group-think when the top execs are cut from the same general mold.

Only one woman and no minorities hold top management positions at CIRM, which Simpson lists as chairman, vice chairman, president, vice president, chief scientific officer and chief communications officer.

Writing on his organization's blog, Simpson sees the hiring of John A. Robson of McGill as part of the influence of CIRM's old boys. Simpson cites the role of Richard Murphy, former CIRM director, former interim president and ongoing consultant, in recruiting Robson. Murphy also once worked at McGill.

Simpson also notes that former CIRM acting president Lori Hoffman had a falling out with Chairman Robert Klein last year and was "pushed out."

Simpson writes that with Zach Hall as president and Arlene Chiu as chief scientific officer, CIRM "had extensive experience on the grant-making and management side of the equation by virtue of their time at the National Institutes of Health. They knew something about holding grantees accountable."

Simpson continues,

"The Old Boys Club members' experience has been on the grant-receiving side -- and most of that in academia.  Certainly some of the top executives at an agency charged with handing out $3 billion in scientific grants should have experience on the grant-making side. It's almost as if the henhouse is being taken over by the foxes."

Simpson concludes:

"I fear the Old Boys Club is letting visions of playing on the international stage distract them from what is really CIRM's charge: Funding vital research and finding cures in California.  The real danger of a having a management team that looks alike is that team members will think alike. Nobody will stand up and say, 'Wait a minute; just what are we doing here and why?'"

Sphere: Related Content

Fresh Comment

Marcy Darnovsky of the Center for Genetics and Society in Oakland, Ca., has filed a comment on the "no egg shortage" item. Sphere: Related Content

Fresh Comments

Larry Ebert has posted a comment on "WARF Whacked Again."

Angsuman Chakraborty has posted a comment on "Stem Cell Globe-Trotting." Sphere: Related Content

A Re-Look at Friday's Egg Meeting

The California stem cell agency has taken issue with the way we have framed this coming Friday's meeting dealing with human eggs.

It is not really about availability, cost and prices, says CIRM. But rather about stem cell lines and embryos created through IVF treatments and their possible use in CIRM-financed research.

Geoff Lomax, senior officer for the Standards Working Group, said,

"You have got this one completely wrong and framed the meeting in a sensational and inflammatory way which does a disservice to thoughtful policy deliberations."

Lomax prepared the briefing paper – called "Use of Embryos Created for Reproductive Purposes with Paid Gametes" – for use at the Standards meeting later this week.

When we read it, we took a broader perspective, one that concerned the general availability of eggs for research and the economics behind their apparent scarcity.

But first CIRM must deal with the information Lomax presents in his background material as well that which will be brought to the table by others.

He wrote:

"Nationally, the CIRM policy deviates from other jurisdictions that have developed policies to advance stem cell research. This deviation has raised concerns over the ability of CIRM researchers to utilize materials derived under other jurisdictional policies or the National Academies Guidelines."

The issue of the use of human eggs is freighted with emotional and political baggage, plenty of which will surface eventually. But meantime, Lomax is trying to lay the groundwork for a straightforward consideration of practical issues that need attention sooner rather than later. Sphere: Related Content

San Diego Researchers Say No Shortage of Human Eggs

Jeff Sheehy, a member of the board of directors of the California stem cell agency, has brought to the human egg debate a new entry that appears to fly in the face of assertions that scientists cannot get enough eggs for their human embryonic stem cell research.

His comments and information come as the CIRM Standards Working Group plans to dig into the topic again this Friday during a public hearing in Los Angeles. The issue of egg availability, however, goes well beyond California, reaching out to such places as the United Kingdom, where discounted IVF services are being offered to generate eggs for research.

Sheehy, also a member of the Standards Working Group, pointed to work being done by Cascade LifeSciences in San Diego and others to show that the egg shortage concerns of CIRM President Alan Trounson and Harvard's Kevin Eggan may be overstated.

Sheehy's starting point is a letter for reconsideration of Cascade's rejected application for a CIRM grant. Cascade's letter, which can be found here on the California Stem Cell Report, stated that the firm was collaborating with David Smotrich of the La Jolla IVF clinic to obtain eggs. Cascade said that the clinic had a "list of young and healthy volunteers who desire to donate oocytes specifically for this SCNT project. All these donors were pre-tested and demonstrated a high oocyte production (20-25 oocytes per cycle) in response to homornal stimulation."

Last week Sheehy queried Ken Woolcott, who wrote the reconsideration request, about the availability of eggs, which Sheehy recalled as being 100 a year. Sheehy also asked whether they were obtained under circumstances that would make them available for use by CIRM grantees i.e. proper consent, no payment outside of CIRM policy, etc.

In response, Woolcott, Cascade's chief business officer, emailed Sheehy that he checked with Cascade's primary investigator, Dr. Sophia Khaldoyanidi, as well as Smotrich, head of the collaborating La Jolla IVF clinic. Woolcott replied,

"Dr. Smotrich confirmed that the oocyte donors are only reimbursed for their time and medical care expenses.   These donors are not IVF patients that receive discounts or are paid for their eggs.  They tend to be donors that desire to enhance medical research in the Stem Cell  area, are younger and have a track record of high oocyte quality and productivity. 

"I believe that this is consistent with the draft guidelines prepared by CIRM and is consistent with the law in California.    More importantly, any work in this area would be subject to IRB approval."

Sheehy said that Woolcott's information is "very important" if it "confirms that at least one investigator in California is able to obtain sufficient oocytes to conduct research within the confines of CIRM's ethical standards and the provisions of Prop. 71 and SB 1260(the law that deals with non-CIRM funded hESC research)."

But the devil may well be in the details. In this case, does the La Jolla clinic's definition of reimbursement for "time and medical care expenses" match that of CIRM's? Sphere: Related Content

A Critical Look at CIRM's Stem Cell Globe-Trotting

The Consumer Watchdog group is taking a dim view of the travel plans of the top executives of the California stem cell agency, describing as "bafflegab" the justification for spending much of the $558,000 in what CIRM describes as its "other travel" budget.

John M. Simpson, stem cell project director for the non-profit advocacy group, made his comments on his organization's blog. They were based on previously undisclosed documents that he requested from CIRM.

Among other things, the CIRM documents showed that its chairman, Bob Klein(pictured), is scheduled to be outside of California for 88 days at state expense in 2008-09. That does not include his travel within California, such as his trip today to Santa Barbara.

Chief Science Office Marie Csete will be out of California 75 days, CIRM President Alan Trounson 68 days, Chief Communications Officer Don Gibbons 32 days. All of which amounts to a 287 percent increase (in terms of dollars) in "other travel" by CIRM officials.

China, Japan, the United Arab Emirates, Israel, the United Kingdom, Sweden, The Netherlands, France, Korea, Australia, Italy, South Africa and Canada are among the destinations.

To a CIRM travel justification that said in part that some of the trips were necessary "in order to have an integrated picture of state of the art and forward-looking research agendas," Simpson retorted, "bafflegab."

He continued,

"After crunching the numbers I checked with some scientists.  All agreed there is a need for the hard-working science staff to attend some conferences to stay abreast of the latest developments. Perhaps one or two a year, suggested one.

"Another scientist reported traveling 4-5 days a month to to give seminars, attend meetings and review grants and then said about CIRM's travel plans:

"'Is the travel necessary? No.  Useful for CIRM? Probably not very much.  Good for Bob and Alan?  Absolutely.'

"Voters passed Proposition 71 because they wanted to pay for vital stem cell research in California that the federal government would not fund.  They did not intend to send Bob Klein around the world as a stem cell research advocate."

Still undisclosed, as far as we can tell, are travel expenses that are not classified as "other travel."

Simpson has posted the documents in question on his website. Links to them are contained in his blog. Sphere: Related Content

CIRM Reviews the Business of Human Eggs

One week from today, the California stem cell agency is going to dig into the hot topic of human eggs – how many can scientists can get and their cost.

To its credit, the agency has posted background material on the subject well in advance of the July 25 meeting of its Standards Working Group in Los Angeles. Providing the material early is a refreshing change from CIRM's recent dilatory practices. The agency is to be commended.

The egg meeting comes in the wake of complaints earlier this year by researchers and CIRM President Alan Trounson that human eggs were not to be had in sufficient quantities for research. Kevin Eggan(pictured) of Harvard, a member of the Standards group, said that he and his colleagues had spent $100,000 advertising for human egg donors with little success.

The problem is that California and other states bar compensation for eggs for research. But handsome payments -- $15,000 and even more -- are made by IVF clinics for the same egg donation process. So most women take the cash.

Eggan made his comments last February. The ensuing discussion set in motion a review of CIRM policies dealing with compensation of donors. The issue also came up briefly last month at the meeting of the CIRM board of directors.

Trounson said scientists are having a "terrible time" securing eggs. He declared,

"It's all because there's no partnershipping arrangements or because they're using very few oocyte material. They're now trying to use cattle eggs, other species. They're floundering."

CIRM has prepared a draft briefing paper dealing with the egg issue. The agency has not completed all of its work on the subject, but it is surveying funding institutions, interviewing scientists and others and determining whether specific cell lines are not being used by CIRM grantees.

The briefing paper lists the following policy questions.

"Should CIRM funded researchers be able to use 'outside' hESC lines if they are derived from IVF-embryos created with paid gametes?

"Should CIRM funded researchers be able to utilize hESC lines derived from IVF-embryos created with paid gametes under an 'authorized authority'?

"Should CIRM funded researchers be be able to utilize IVF-embryos created with
paid gametes to derive new lines?"

Also prepared for next week's meeting is a briefing paper on uses of cell lines derived prior to CIRM regulations. Sphere: Related Content

WARF Whacked Again

The latest chapter in the WARF stem cell patent saga opened today with the filing of an appeal by two consumer groups and a statement from California researcher Jeanne Loring of the Scripps Institute. She said,

"It's not just scientists that are affected by the patents. Patients and their families know that WARF’s iron-fisted control of stem cells is slowing life-saving research."

Consumer Watchdog of Santa Monica, Ca., and the Public Patent Foundation in New York City announced the filing of the appeal. The issue is not likely to be resolved for years, although John M. Simpson of Consumer Watchdog said WARF has already relaxed its licensing requirements in the wake of the patent challenge.

Simpson said,

"WARF executives were acting like arrogant bullies blinded by dollar signs. Our challenge has engendered a more co-operative stance towards the stem cell research community on their part."

Sphere: Related Content

Kindling the Flame in Goleta: Thomson, Klein Part of Gaucho Show

California's Robert Klein will share the stage with Wisconsin's Jamie Thomson Friday at the University of California, Santa Barbara, which has lured the renown researcher to its seaside campus with a $1 million package, including a new lab.

Klein, of course, is both the chairman of California's $3 billion stem cell agency and still officially president of his own private stem cell lobbying group, Americans for Cures. (No announcement has been forthcoming from the group confirming his reported resignation in the wake of its vitriolic attack on an influential state legislator.)

Klein and Thomson (pictured) will appear as part of a town hall event to discuss the state of stem cell research. The roundtable will also feature Congresswoman Lois Capps, a former nursing instructor, Gaucho (as UCSB denizens are known) alum and Wisconsin native.

CIRM has had a huge impact in California stem cell circles in the last 3 ½ years, but UC Santa Barbara might well be a poster child for what the agency has achieved.

Human embryonic stem cell research hardly existed on the campus (pictured) prior to 2005, the first full year for the California's research effort. But with a strong push from professor Dennis Clegg, now co-director of the UCSB Center for Stem Cell Biology and Engineering, the school scored in the first round of grants approved by CIRM. Today it has $6.7 million in stem cell research and lab construction funds from the California stem cell agency and another $3 million from one of the founders of Amgen. And it succeeded in drawing Thomson into the state on a part-time basis.

Thomson, whose lab is located in the UCSB California NanoSystems Institute, says,

"I am attracted by UCSB's strengths in materials science, instrumentation, and by the availability of marine model organisms for comparative studies."

Of course, UCSB's $6.7 million in CIRM funding is eclipsed by the $91 million given by CIRM to Stanford and the $69 million to UC San Francisco. But those campuses can generate buckets of money even without the state cash.

The Santa Barbara university has this to say about its fledgling stem cell effort:

"UCSB is well positioned to make unique, significant contributions in stem cell research, with extraordinary enabling technologies in biomaterials, systems biology, nanotechnology, micro-processing and bioengineering, all of which are synergistic with fundamental biomedical research efforts. Our approaches are uniquely distinct from those at California medical schools, with our emphasis on basic biological questions and engineering challenges related to stem cell research."

What CIRM has done is kindle a flame in Goleta (the actual location of UCSB). The hope is that the UCSB effort will grow and prosper, bringing new initiatives and insights into development of possible stem therapies. Sphere: Related Content

Stem Cell Affordability Bill Marches Towards Schwarzenegger

Legislation aimed at ensuring affordable access to any therapies developed as the result of California's $3 billion stem cell research program today easily cleared its final committee hurdle and appears likely to wind up on the desk of Gov. Arnold Schwarzenegger.

The measure (SB 1565) by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, was sent to the Assembly floor by the Assembly Appropriations Committee. Presuming it wins Assembly approval, it will go back to the Senate for concurrence in Assembly amendments. No lawmaker has voted against the bill, nor did any today although the final official vote is not yet available.

The bill has faced sometimes vitriolic opposition, particularly from the private lobbying group of the chairman of the state's stem cell research effort, Robert Klein. Americans for Cures lambasted Kuehl as "ignorant" and "craven" in a posting on the Daily Kos, a political blog with about 1 million page views a day.

Americans for Cures, which operates out of the same address as Klein's real estate investment banking firm, later apologized and asked that the offending item be removed. Klein said he did not know about the item. He is reportedly resigning as president of Americans for Cures, but it is not clear whether he will sever all ties or whether the organization will move from his offices.

Klein's connection to the lobbying group, which is an offshoot of the Prop. 71 campaign organization, has long triggered criticism because of concerns about conflicting interests.

One commentator, who must remain anonymous, told the California Stem Cell Report today:

"I would say it's an inherent conflict to be an officer of any kind of 'Cures,' while being on the ICOC (the board of directors of the stem cell agency). It would be like a physician who is a high level officer in the California Medical Association being on the (state) Medical Board. One would never know whether their official actions represented their own views or the views of the CMA."

Americans for Cures has not yet confirmed that Klein is resigning. (Shortly after this item was posted, we saw a report on the Niche stem cell blog of Nature magazine saying that Americans said Klein has resigned but will remain on the lobbying group's board, which probably means that it will continue to be housed at Klein's offices.)

The next lobbying target for CIRM and the stem cell activists is the governor, who can veto the legislation and who has been more than receptive towards the stem cell agency's efforts.

Here is a link to the latest legislative staff analysis of the bill. Sphere: Related Content

CGS Says CIRM Legislation is 'Gentle'

The Center for Genetics and Society says the stem cell measure now before the California legislature would only "gently alter" affairs at the state's $3 billion stem cell research effort.

The group's comments came as as more activity surfaced concerning the measure, SB 1565, which comes before the Assembly Appropriations Committee today. It has sailed through the legislature without a dissenting vote despite fierce – sometimes scathing – opposition from stem cell advocates.

Commenting on the center's blog, Biopolitical Times, Jesse Reynolds said that CIRM's board of directors is engaging in "histrionics" and opposes the measure even though it would give them more flexibility.

Reynolds, who wrote presciently nearly four years ago about some of the problems that have surfaced at CIRM, commented Tuesday that the agency

"... can fund any biomedical research if a two-thirds supermajority of its grants review working group approves. The current Senate bill would lower that bar to a simple majority.

"This would not restrict the CIRM in any way. If anything, the bill simply gives the CIRM more flexibility. Considering that the grants working group generally operates by consensus, that the governing board must approve all grants, and that the CIRM currently generously supports non-embryonic stem cell research, the amendment would have zero practical impact.

"Nevertheless, the board worked itself into histrionics over any concession to the development of alternatives."

Reynolds' "gently alter" remark appeared in a related posting that said that Klein's apparent resignation as president of his lobbying group, Americans for Cures, was long overdue. A CIRM spokesman said on Monday that Klein had resigned, but deferred any further comment to Americans for Cures. That group has not responded to repeated requests for confirmation of the Klein resignation.

Reynolds' postings came as patient advocate Don Reed, vice president of Americans for Cures (the private lobbying group of CIRM Chairman Robert Klein), wrote on the influential Daily Kos political blog about the measure. He urged readers to lobby against the bill and send "hard copy" letters to the governor, asking him to veto the proposal.

Also, James Kovach, president of the Buck Institute in Novato, Ca., sent a letter to a member of the Assembly Appropriations Committee, declaring the organization's opposition to the Kuehl bill. He said it would disrupt embryonic stem cell research. The full text of the letter follows in a separate item below. Sphere: Related Content

Text of Buck Institute Letter on SB 1565

Here is the text of a July 15 letter to Assemblyman Jared Huffman, a member of the Assembly Appropriations Committee, from the Buck Institute, opposing legislation aimed at ensuring affordable access to state-financed stem cell therapies.

Dear Assemblyman Huffman,
 
Thank you for the opportunity to comment on SB 1565.  We understand that SB 1565 will be heard before the Appropriations Committee on Wednesday, July 16th, at the Sacramento Capitol. As this will be the last full committee hearing on SB 1565, before it goes to the Assembly floor, on behalf of the Buck Institute I would like to provide you with our view of this proposed bill.
 
We strongly oppose SB 1565.  Our reading of the proposed changes led us to conclude that the changes are unnecessary and, if adopted, would likely have several negative consequences.  Our primary objections are set forth below:
 
The scientific review committees are represented by specialists in stem cell research.   They are already tasked with reviewing many excellent applications for funding of research in the stem cell arena.  It is important work done on often grueling schedules and any requests to evaluate “vitally important research” not associated with stem cell and/or stem cell related work will distract their attention from the work they were specifically chosen to perform.  We believe the purpose of Proposition 71 will be altered by the amendment and moreover, alter the mission of the scientific review committees.
 We believe the proposed amendment will disrupt the conduct of human embryonic stem cell research as set forth in Proposition 71, the Constitution of the State of California and the will of a majority of the voters in California.  If passed, the proposed amendment would alter the will of the people without their consent. 
The potential change in the direction of stem cell research funding would come at a crucial juncture in the development of the CIRM.  The development of the CIRM has been guided by the principles embodied in Proposition 71 and is just beginning to apply its full attention to stem cell research funding rather than the startup activities and infrastructure development of the largest and singularly unique enterprise of its kind.
The CIRM has been under virtually constant scrutiny from its inception.  Our experiences with the CIRM and its staff have not always turned out as we had hoped but we have never had reason to question the CIRM’s dedication to fulfillment of the intentions of Proposition 71.  We see no benefit in adding more layers of scrutiny to an already transparent organization. 
The fair pricing sections proposed by SB 1565 are redundant to administrative procedures that we have seen first hand to be working to ensure that all Californians benefit from therapies developed by Proposition 71.
 
With the above in our thoughts, we ask that you oppose the passage of SB 1565.
 
For the sake of completeness, I have attached a cogent editorial written by a colleague, Don Reed.   http://www.dailykos.com/story/2008/7/15/111757/794?new=true
 
Please feel free to contact me with any questions or desire any clarification of our position on SB1565.
 
Jim
 
Jim Kovach, M.D., J.D.
President & COO
Buck Institute for Age Research

Sphere: Related Content

The Media Mustard and Meaning of Klein-Kuehl Flap

The Klein-Kos-Kuehl Affair has drawn no attention in the mainstream media and almost none on the Internet – surprising to some deeply involved in the California stem cell scene.

Especially given the history of high profile verbal snafus that have publicly plagued scores and scores of public figures. In a totally different context than stem cell research, the Klein flap recalls presidential aspirants who have been given serious media fits as the result of misguided rhetoric, either from themselves or associates. One only has to look at the Obama-Clinton race to see major political figures wrestling with verbal gaffes.

But the reality is that the comments from Robert Klein's lobbying group, Americans for Cures, concerning an influential state lawmaker's intelligence, knowledge and political fortitude are not even close to making the front page of any newspaper. They may be outrageous, an incredible display of bad judgment and reflect poorly on California's $3 billion stem cell research program, but they do not cut the media mustard.

We cannot find even a single story on the comments in any newspaper in California, much less a current story dealing with the underlying conflicts of interest posed by Klein's dual roles as head of a stem cell lobbying organization and chairman of the leading source worldwide of funding for human embryonic stem cell research. Only two Internet sites that we know of have picked up on the matter, The Niche stem cell blog of Nature magazine and Larry Ebert's IPBiz blog. Monya Baker of Niche largely provided a neutral summary of the events. Ebert made reference to what he called ongoing bungling at CIRM.

We asked one mainstream media reporter about the reasons for the lack of coverage, promising anonymity to guarantee candor. The response:

"It was an easy call that it was not as important as the many other stories on my plate. You know how it goes: Mainstream media has to deal with many more topics than most blogs, including the California Stem Cell Report. For instance, Dave Jensen doesn't have to worry about sharing space on his blog with stories on the price of oil, or failing banks, or city council meetings and murder trials. Blogs also are not expected to meet the same journalistic standards as newspapers, which means they can run items with one source and lots of opinion. And they can touch on the same topic in many different posts, giving incremental developments.

"Meanwhile, newspapers try get several sources and views into one story. We are also dealing with budgetary, staffing and news hole cuts. That means reporters in mainstream media are covering much, much more than just CIRM and stem cells. (CIRM is just one small piece of my very broad and complicated beat.) All that means that I must be much more selective in what I write about."

We also asked John M. Simpson, stem cell project director of Consumer Watchdog, for his views on the media coverage. Simpson had a long career as a newspaper editor prior to holding his current position. He said,

"The news business is in a terrible state. Newsroom staffs have been slashed. Every news organization is trying to do more with less and that's simply impossible.

"Complex ongoing stories, like CIRM and its governance structure, get short shrift in the face of the current crisis in journalism.

"Until somebody figures out a new viable financial model to support quality journalism, we going to see less and less coverage of issues like this. I don't want to sound hysterical, but I think good democratic government is seriously threatened by the sorry state of the mainstream media."

With 30 years experience in journalism, we do not disagree with either our anonymous reporter or Simpson. But we can also add that coverage of state agencies has traditionally been given short shrift in California. It is easier to cover the governor, political activities and only the highest profile legislative issues.

CIRM is off the current agenda for the mainstream media. Does that mean that the issues or specifics involved in the Klein-Kos-Kuehl affair are not important? Far from it. The posting by Americans for Cures was destructive of CIRM's goals. Ironically, the action increased the likelihood that the bill will pass. The vitriol demonstrated indirectly that CIRM is not to be trusted in sensitive dealings. It showcased once again flaws in Klein's leadership that surfaced as long ago as 2005. And it highlighted one of the conflicts that pervade CIRM's board of directors.

The California stem cell experiment is a remarkable endeavor. It has achieved much. But much more remains to be done. CIRM directors should look to finding ways to foster cooperation – not only with the international stem cell community – but here in California, where the home fires are now in need of some renewed and careful tending. Sphere: Related Content

Fresh Comments

Jesse Reynolds of the Center for Genetics and Society, who has followed California stem cell affairs since prior to the passage of Prop. 71, has posted comments on the "Klein Resigns" and "CIRM Letter" items. Sphere: Related Content

Latest Version of SB 1565

Here is a link to the full text of the latest, amended version of legislation, SB 1565, which is aimed at ensuring affordable access to therapies financed by California's $3 billion stem cell agency.

It is the measure that triggered flap that has led to the resignation of Robert Klein, chairman of the agency, as president of his own stem cell lobbying group.

The bill comes before the Assembly Appropriations Committee Wednesday. Sphere: Related Content

Klein Resigns as Head of Stem Cell Lobbying Group

In the wake of a flap over a personal attack on a leading California lawmaker, Robert Klein, chairman of the California stem cell agency, has resigned as president of the stem cell lobbying group that posted the offending item on the Internet.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., today reported Klein's resignation on the Watchdog group's blog. Klein's action came after Simpson called for Klein (see photo) to resign either as president of Americans for Cures, Klein's lobbying group, or as chairman of the $3 billion state agency.

Simpson wrote,

"Don Gibbons, communications director for the California Institute for Regenerative Medicine, called this afternoon to tell me that Klein had stepped down from Americans for Cures. His phone call came after my posting the view today that holding both the state position and the advocacy position was untenable and the situation was a train wreck waiting to happen.

"In fact, Gibbons said, Klein quit the presidency on Friday, but didn't issue any public statement about it until he personally told Sen. Kuehl what he had done."

Sen. Sheila Kuehl, D-Santa Monica, is the lead author of legislation aimed at ensuring affordable access to any therapies developed as the result of CIRM-financed research.

Kuehl's office told the California Stem Cell Report that the senator and Klein were scheduled to talk on Tuesday. Americans for Cures has not responded to inquiries concerning Klein's resignation. Sphere: Related Content

Coming Stem Cell Train Wreck?

The combination of Robert Klein as head of a state agency giving away $3 billion for stem cell research and presiding as well over a personal, stem cell lobbying group is a "train wreck waiting to happen," according to the Consumer Watchdog group.

John M. Simpson, stem cell project director for the Santa Monica, Ca., organization, said he welcomed Klein's apology for the "unseemly" attack on state Sen. Sheila Kuehl, lead author of legislation opposed by both the stem cell agency and Klein's group.

Simpson wrote on his organization's blog:

"The apologies are welcome.  However, so long as Klein remains chairman of the state stem cell agency, the California Institute for Regenerative Medicine, and president of the advocacy group, Americans for Cures, the situation remains a train wreck waiting to happen."

Simpson continued:

"Insisting on wearing both hats in untenable.  It damages the credibility of both CIRM and Americans for Cures. Klein needs to realize his dual roles seriously undermine the dedicated staff of both organizations."

Sphere: Related Content

Patient Advocate Reed Praises Kuehl, Says Sometimes People Go Too Far

Patient advocate Don Reed, who has probably attended more meetings of the California stem cell agency than any of its directors or even its staffers, reacted this weekend to the blistering attack on the author of legislation he fervently opposes.

Reed (see photo) is vice president of Americans for Cures, which fired off the personal comments on the national and influential political blog, Daily Kos. While Reed said that he is proud of the group, he added:

"Sometimes in the heat of battle, people go too far with hurtful words."

Here is the text of what he sent the California Stem Cell Report.

"A negatively slanted editorial on Senate Bill 1565 (Kuehl, Runner) was recently printed in the weblog Daily Kos. It was written by some of the staff at Americans for Cures, a group with which I am proud to be associated. They are my friends and co-workers.

"But I want it clearly understood I had no part in the writing of that particular article.

"I have not yet been able to read the entire piece, just bits and pieces of it. But as the co-directors of our group have publicly apologized for it, apparently it went over the edge. Sometimes in the heat of battle, people go too far with hurtful words. I have stuck my own foot in my mouth too many times to criticize anyone.

"I do strongly oppose SB 1565. Anyone wanting my opinions need only go to my website, www.stemcellbattles.com, or just Google me. My writing is signed, either with my name, Don C. Reed, or as Diverdonreed, for blogs which require a pseudonym.

"But my differences with Senator Sheila Kuehl are professional, not personal. She has earned the right to be treated with affection and respect.

"Ironically, last week I had a very positive conversation with Senator Sheila Kuehl’s legislative aides, Lark Park and Peter Hansel. We argued about the bill, of course. To me the bill is a serious mistake: a threat to the California stem cell program.

"I had two reasons for the visit.

"One reason was of course to see if there were any loopholes possible, especially in the price-control part of the bill. Ms. Park and Peter Hansel said the Senator had offered to make a change. The stem cell board may or may not agree that the answer is enough to gain their support, but it was a genuine attempt, a serious proposal. (Other serious objections remain, and I am still in opposition to the bill.)

"But there was a second reason for the visit, a personal one, something I had hoped to tell the Senator herself, but that was a long shot at budget crisis time.The Senator is “termed out”, that California mistake of a law that says lobbyists may remain in Sacramento forever, but the people’s representatives can only stay a while.

"But her efforts on behalf of all Californians will live on after her term in office. It is to be hoped she will continue her work to bring decent and affordable healthcare to everyone, perhaps on a national or international level. I would love to see her be U.N. Ambassador for international health programs, or a similar position.

"Sheila Kuehl is an exemplary human being. She makes the world a brighter place."

(After Reed sent us this item, we sent him a copy of the piece on Daily Kos, which has removed the item. If you would like to receive a copy of it, please email a request to us at djensen@californiastemcellreport.com) Sphere: Related Content

Stem Cell Affordability Legislation Changed to Meet CIRM Objections

The California lawmakers behind legislation to ensure affordable access to taxpayer-financed stem cell therapies moved last week to ease the concerns of the state's $3 billion stem cell research agency.

The changes were made prior to a scathing, national Internet attack on the bill's lead author by the private lobbying group run by Robert Klein, who also serves as chairman of the state stem cell agency. One consumer advocate has called for Klein's resignation in the wake of the assault by Americans for Cures, the Klein organization. The group used such terms as "ignorant," "dumb" and "craven" in connection with Sen. Sheila Kuehl, D-Santa Monica.

Late Friday, Klein's group apologized. Klein told the California Stem Cell Report he was unaware of the Internet attack by his group and said he had "great personal respect" for Kuehl. Our understanding is that he intends to personally apologize to Kuehl.

CIRM last month officially opposed Kuehl's bill, SB 1565, on the grounds that it would discourage biotech firms from developing therapies and limit the agency's flexibility to negotiate affordability issues, among other things.

In response, Sens. Kuehl and George Runner, R-Antelope Valley, made changes that appear to go a long ways in dealing with the objections. But in a letter Thursday to Kuehl, Klein expressed the agency's continued opposition. The letter, dated the same day as the Internet attack on Kuehl, was also signed by CIRM President Alan Trounson and Ed Penhoet, vice chairman of the CIRM board of directors.

Below are key sections of the latest amendments to the measure, as provided by Kuehl's office. The actual bill, however, will not be available online via the Legislature’s website until Tuesday. The measure comes up for a hearing in the Assembly Appropriations Committee on Wednesday. The full text of CIRM's letter to Kuehl follows in a separate item.

Here are the amendments in SB 1565.

"Any plan subject to subdivision (a) shall include a requirement that each grantee and any licensee of the grantee that sells drugs that are, in whole or in part, the result of research funded by CIRM shall provide those drugs to publicly funded programs in California at one of the three benchmark prices in the California Discount Prescription Drug Program."

"Notwithstanding subdivision (c), the ICOC may waive the requirement that grantees and licensees of the grantee provide drugs that are, in whole or in part, the result of research funded by CIRM at one of the three benchmark prices in the California Discount Prescription Drug Program (Division 112 (commencing with Section 130500)), as it exists on January 1, 2008, only when the following conditions are met:
"(1) Either of the following conditions is met:
"(A) The drug shall be used for the diagnosis, cure, mitigation, or prevention of a rare disease or condition, as recognized by the federal Food and Drug Administration under Section 360bb of Title 21 of the United States Code, by individuals who would not otherwise have access to the drug through private insurance or public programs, the number of individuals who will have increased access to the drug represent a significant proportion of the individuals in California who have that rare disease or condition, and the ICOC has made a determination that, in the absence of the waiver, development of the drug will be impeded.
"(B) The grantee commits, in writing, to provide expanded access to a drug under its access plan to a class of patients who would not otherwise receive access to the drug, including working uninsured individuals who do not qualify for any public program or private health plan or policy that provides coverage of the drug, and the ICOC has made a determination, before granting a waiver and based on the number of individuals who will have access to the drug and the likely costs of the drug, that the waiver will provide significant benefits that equal or exceed the benefits that would otherwise accrue to the state through the pricing requirements set forth in subdivision (c).
"(2) The ICOC has conducted a public hearing prior to adopting any waiver pursuant to this subdivision. The ICOC shall provide findings and declarations and documentation to the Legislature substantiating the need for, and benefits of, a waiver adopted pursuant to this subdivision at least 30 days prior to the public hearing and shall post these documents on its Internet Web site at the time of submission to the Legislature and provide notice to the public that these documents have been posted."

Sphere: Related Content

CIRM Letter Opposing Kuehl Legislation

Here is the text of the CIRM letter stating the agency's continued opposition to SB 1565.


SB 1565: OPPOSE UNLESS AMENDED

July 10, 2008

Dear Senator Kuehl:

Thank you for the opportunity to comment upon the potential amendments to Senate Bill No. 1565. While the Independent Citizens’ Oversight Committee (the “ICOC”), the governing board of the California Institute for Regenerative Medicine (“CIRM”), has taken a position in opposition to the bill on the grounds that is it premature and unnecessary, we appreciate your willingness to engage in a dialogue regarding the potential amendments.

Section 1 of the bill, which would remove the two-thirds vote requirement for funding “vital research opportunities” was added in early June and it has caused a powerful reaction of unanimous opposition from CIRM’s governing board. Proposed subparagraph (E) makes clear that the goal of Section 1 is to eliminate the priority that Proposition 71 places on human embryonic stem cell research. As long as Section 1 remains in the bill, we must strongly oppose SB 1565.

At a time when opponents of stem cell research are arguing that recent developments obviate the need for human embryonic stem cell research, a position we believe to be incorrect, the proposed amendment to Proposition 71 would send the wrong message to Californians and to the nation at large. It would also thwart the will of the more than seven million Californians who voted for Proposition 71 in order to address the federal funding gap for human embryonic stem cell research, a gap that continues to exist to this day. By removing the two-thirds vote requirement, the amendment would undermine the very purpose of Proposition 71 – to provide a priority for funding human embryonic stem cell research. Finally, eliminating the two-thirds vote requirement would be inconsistent with the requirement that Proposition 71 may only be amended to further its purposes. For all of these reasons, which are discussed in greater detail in the attached addendum, we are strongly opposed to the removal of the two-thirds vote requirement.

With respect to Section 2 of SB 1565, we share your view that California state and local government purchasers should have access, at the lowest possible price, to the therapies and drugs derived from CIRM-funded research. Indeed, our regulations include provisions very similar to those set forth in SB1565. Given the complexities of our healthcare system and the uncertainty regarding the types of therapies and drugs that will be developed as a result of CIRM-funded research, we must retain the flexibility to address issues specific to particular diseases and particular therapies. We appreciate your offer of alternative language, including a waiver process. However, we offer our suggestions below in an effort to reduce the risk of unintended consequences. If you are willing to remove the amendment to the two-thirds vote requirement and to accept our proposed amendments, we would be willing to consider taking a “neutral” position on the bill.

Proposed Addition of Subdivision (e)

We believe it would be preferable to give CIRM greater discretion to establish a waiver mechanism pursuant to the Administrative Procedure Act. The addendum to this letter addresses this issue in more depth. This would permit CIRM to assess changes in medical technology and in the health care sector prior to defining the scope and contours of the waiver and it would provide an opportunity for the Legislature and the public to comment upon the proposed waiver mechanism before it is adopted. Therefore, rather than trying to anticipate the circumstances pursuant to which a waiver may be justified, we recommend replacing subdivision (e) with the following language:

(e) Notwithstanding subdivision (c), CIRM may waive the requirement for grantees, and licensees of the grantee, to sell drugs that are, in whole or in part, the result of research funded by CIRM, at one of the three benchmark prices in CalRx, based on a finding that a waiver is necessary to protect the health of Californians whose lives or quality of life is at risk. CIRM shall adopt a regulation or regulations pursuant to the Administrative Procedure Act to implement the waiver provided in this subdivision after notifying the Legislature and conducting a public hearing.

Proposed Amendments to Subdivision (c)(1)

Your proposed amendments to subdivision (c)(1) clarify what we understand to be the original intent of SB 1565. We believe that further refinements, however, may sharpen the expression of the Legislature’s intent. For example, we understand that you intend SB 1565 to apply only to therapies or drugs purchased in California by California state or local government funded programs. The current language, however, would appear also to apply to federally funded programs, including programs funded and administered entirely by the federal government without regard to need. Similarly, we are concerned by the provision that specifies that CalRx, as it exists on January 1, 2008, shall apply regardless of any subsequent changes in the law. While we share your concern about the unintended consequences that could flow from designating a successor program, we believe these concerns could be addressed by incorporating a successor program only if it covers CIRM stem cell-derived therapies or drugs. We therefore propose the following changes to subdivision (c)(1):

(c)(1) Any plan subject to subdivision (a) shall include a requirement that each grantee and any licensee of the grantee that sells drugs that are, in whole or in part, the result of research funded by CIRM shall sell those drugs in California to publicly California state and local government funded programs in California at one of the three benchmark prices in the California Discount Prescription Drug Program (Division 112 (commencing with Section 130500)), as it exists on January 1, 2008, or a successor program to the extent that the program applies to California Institute for Regenerative stem cellderived therapies and drugs.

Conclusion
CIRM is committed to working with the Legislature to address the important issues raised by SB 1565 and to ensure that Californians have access to therapies and drugs derived from CIRM-funded research. Placing these provisions in statute, however, may hinder our efforts rather than help, because we cannot anticipate all of the challenges we will face in the future.

We recognize that the Legislature could amend the law in the future through urgency legislation, but we are concerned about the potential political opposition to changes that may be required to ensure that Californians have access to a therapy derived from human embryonic stem cells. Given the 70 percent vote requirement in Proposition 71, such opposition could prevent the Legislature from passing an amendment that is essential to ensure access. CIRM’s ability to amend its regulations pursuant to the Administrative Procedure Act, on an emergency basis if necessary, does not pose the same risk.

While well-intentioned, SB 1565 is premature and unnecessary. Nonetheless, if you are willing to amend the bill to remove Section 1 and provide for a waiver directive regarding the public pricing policy as described above, we are prepared to recommend a neutral position to the ICOC.

We appreciate your support of CIRM and your willingness to work with us to address these critical issues.

Sincerely,
Robert N. Klein, Chairman, ICOC
Alan O. Trounson, President
Edward E. Penhoet
Vice –Chairman, ICOC
Sphere: Related Content

California Stem Cell Chief Says He Was Unaware of Personal Attack on Lawmaker

Robert Klein, chairman of the $3 billion California stem cell agency, today said he was "completely unaware" of the personal attack on a California state lawmaker by his lobbying group, Americans for Cures.

Klein, who is president of Americans for Cures, said he had "great personal respect" for Sen. Sheila Kuehl, D-Santa Monica, the object of the attack. Kuehl, a respected California lawmaker and chair of the state Senate Health Committee, drew the ire of Americans for Cures because of her legislation aimed at ensuring affordable access to taxpayer-financed stem cell therapies.

In a statement to the California Stem Cell Report, Klein praised Kuehl's "intellectual strength" and leadership. Here is the text of what Klein sent the California Stem Cell Report:

"Dear David,

"Theoretically, I have been on vacation since Tuesday morning, July 8th, but I gave up my vacation last night and came back to CIRM to deal with misinformation regarding my personal position on SB 1565. As I stated at the Controller’s financial oversight committee meeting on Monday, July 7th, I have great personal respect for Senator Kuehl, including most recently her leadership on the effort to create universal healthcare coverage. On Monday, I made it clear that I have deep respect for her intellectual strength in the healthcare area, and that the ICOC’s position is a substantive policy disagreement. The ICOC has taken the position that the complexity of the stem cell therapy area may not permit simple pricing formulas and the agency needs discretion in adapting to the 70 areas of possible stem cell therapies for chronic disease and injury. I also emphasized on Monday that the ICOC is committed to the same goals as Senator Kuehl in obtaining the lowest possible price for state and local government public providers in California.

"The language in the bill addressing embryonic stem cell research, I think, is being interpreted very differently by the ICOC and Senator Kuehl. We are very concerned about the message this type of an amendment would send within California and nationally, and we do not believe that the message would be consistent with the best scientific and medical knowledge at this time.

"As always, I am happy to discuss this with you further. I wanted to make sure you knew right away that I was completely unaware of the blog entry. I have requested that the Daily Kos entry associated with Americans for Cures be deleted from the site because it did not receive clearance from senior members of the organization, and it did not properly reflect the organization’s views on Senator Kuehl.

"Bob Klein"

Sphere: Related Content

Consumer Watchdog: Despite Apology, Klein Still Should Still Resign

The Consumer Watchdog group today said it is not withdrawing its call for the resignation of Robert Klein as chairman of California's $3 billion stem cell agency, despite an apology from his lobbying group for its personal attack on a Democratic state legislator.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., said the co-executive directors of Klein's lobbying organization, Americans for Cures, "are taking the blame" for the posting on an influential national political blog, Daily Kos. Simpson said on his group's blog,

"What this incident underscores is how inappropriate it is for Klein to hold  positions as chairman of the California stem cell agency and president of a stem cell advocacy group simultaneously.  If he wants to be an advocate -- and he can indeed be effective as the passage of Proposition 71 demonstrates -- he must step down from his position as chairman of the stem cell board.

"The welcomed staff apology does not change the fundamental confict Klein faces by insisting on holding both positions."

Sphere: Related Content

Stalled

Our promised items on changes to SB 1565 have been stalled because of events related to Americans for Cures and their posting on Sheila Kuehl. We will carry the amendments and the CIRM opposition letter during the weekend. Sphere: Related Content

Klein's Lobbying Group Apologizes for Blistering Attack on Kuehl

The lobbying group controlled by Robert Klein, chairman of the California stem cell agency, today apologized to state Sen. Sheila Kuehl for the personal attack on her that it published on the influential national political blog, the Daily Kos.

The co-executive directors of Americans for Cures, Amy Daly and Constance McKee, said the language in the item, which included such terms as "dumb," "craven" and "ignorant," was inappropriate. Daly said the item had been removed from the Daily Kos.

Here is the text of their apology, which they asked the California Stem Cell Report to run.

"To all who have read the Americans for Cures diary posted on DailyKos regarding SB 1565:

"We write to offer a formal apology to Senator Kuehl and her supporters. This posting did not go through our normal review clearances. The choice of language was inappropriate and did not reflect the respect that senior members of the organization have for Senator Kuehl.

"We have always appreciated her efforts and were disappointed that her single payer plan was not implemented. She has historically been a great health care advocate for the people of California. This is why it has been so frustrating to us that she is working with Senator Runner – who is strongly anti-embryonic stem cell research – to implement a bill that could frustrate efforts to get stem cell therapies to patients.

"We were wrong in our characterization of her. We have been working hard to educate everyone about the perils of this bill. No one is questioning it precisely because Senator Kuehl has been such an effective advocate. Our frustrations prevented us from using good judgment in our post, and we apologize profusely for our insensitive and unwarranted remarks.

"It should be noted that Bob Klein was completely unaware of our actions on this. We have not spoken to him or met with him in well over two weeks. I’m certain that he is as disappointed in our judgment as you, and we, are.

"Please forgive us and please put the blame for this where it belongs – on Americans for Cures Foundation staff involved in this individual posting – not on Bob Klein. Americans for Cures Foundation has learned from this experience and will re-institute the tight control it has historically had over its postings.

"Sincerely,

"Amy Daly & Constance McKee"

Sphere: Related Content

Consumer Watchdog Says Klein Should Resign Because of Personal Attack on Lawmaker

The Consumer Watchdog organization today called for the resignation of Robert Klein as chairman of the $3 billion California stem cell agency after his private lobbying group called a respected state senator "dumb" and "craven."

John M. Simpson, stem cell project director for Consumer Watchdog, a nonprofit Santa Monica, Ca., organization, said the attack was an inappropriate "over-the-top, hysterical call to battle."

Writing on the group's blog, Simpson referred to the Internet posting Thursday by Americans for Cures, Klein's stem cell lobbying group, on the Daily Kos, a widely read and influential political blog.

Americans for Cures targeted Sen. Sheila Kuehl, D-Santa Monica, and her legislation – SB 1565 – which is designed to ensure affordable access to any therapies that result from taxpayer-financed stem therapies. Simpson wrote:

"One can oppose the bill without launching personal attacks and suggesting the sky is falling. For the most part, the board members and agency's staff have followed that policy. But Klein insists on wearing two hats: ICOC(CIRM's board of directors) chairman and president of his advocacy group.

"The positions are incompatible. Since Klein refuses to give up the advocacy role, he must step down from his public position as head of a state agency. Failure to do so undermines the stem cell agency's credibility and ability to do its vital work."

Simpson summarized the legislation:

"It puts in statute regulations CIRM itself developed governing access to drugs by the uninsured; it lowers the vote of the scientific working group necessary to recommend funding non-embryonic stem cell research from a two-thirds majority to a simple majority; and it asks the state's non-partisan Little Hoover Commission to study the governance structure of the agency."

Kuehl's aides have been working with CIRM staffers to deal with the agency's official objections. Earlier this week, Kuehl amended her measure to deal with CIRM concerns. But Klein's lobbying group says the bill is unacceptable in "any form."

We have asked CIRM and Kuehl's office if they have any comment on the posting by the Klein group. We have not received a response, but will carry their comments should they make any. Sphere: Related Content

Coming Up

Later today we will have the text of changes made earlier this week to legislation aimed at ensuring affordable access to CIRM-financed therapies along with the text of a letter from the agency saying that it still opposes the legislation. Sphere: Related Content

Fresh Comment

"Anonymous" has posted a comment/question on the item below. Sphere: Related Content

Coming Up

Early this afternoon, we plan to carry a follow-up story concerning the Daily Kos item (see the item directly below) in which a lobbying group controlled by the chairman of the state stem cell agency personally attacked a California lawmaker. We have asked the state stem cell agency, the lawmaker and others for comment, which we will include if we receive it in a timely fashion. Otherwise, we will carry the comments when we receive them. Sphere: Related Content

Klein's Group Says Kuehl is Ignorant or Mindless or Craven and Dumb

Using the influential national political blog, the "Daily Kos," the private lobbying group of the chairman of California's $3 billion stem cell agency today filed a sharp, personal attack on a Democratic state legislator who is seeking to ensure the affordability of stem cell therapies financed by taxpayers.

Americans for Cures, whose president is Robert Klein and who also serves as chairman of CIRM, wrote an item for Daily Kos which took on highly respected California state Sen. Sheila Kuehl(see photo), D-Santa Monica, co-author of SB 1565, the affordability legislation in question. The Daily Kos is one of the more widely read political blogs in the nation. According to its web counter, it had 899,000 page views today.

The Daily Kos piece, which did not identify the specific author of the article but only attributed it to Klein's group, said,

"Either Kuehl is ignorant on the science, or mindlessly buying into Republican and anti-cures messaging from the Catholic Church, or playing dumb in a craven attempt to get Republican votes to back her legacy as defender of the poor."

Kuehl heads the Senate Health Committee and has been a leader on a variety of issues, including universal health care. A graduate of the Harvard Law School, she has been cited by Capitol insiders as one of the more intelligent lawmakers in Sacramento.

Late last month, at a meeting chaired by Klein, CIRM directors formally opposed SB 1565 but indicated that they wanted to continue to work with Kuehl to resolve differences. Klein's lobbying group, however, was unbending. It referred to "legislative dirty tricks." It called Kuehl's legislation "a thinly veiled ploy to stop embryonic stem cell research in California." Klein's group said,

"California is an example of what we’re seeing all across America.  Anti-cures forces are stepping up state-based legislative dirty tricks to pass 'personhood' laws that would discourage or criminalize stem-cell research.  If this sounds like the pro-life strategy that successfully undercut federal support for reproductive rights, you’re connecting the dots.  Anti-cures legislation is popping up all over America right now, in anticipation of a loosening of restrictions on hESC in January 2009."

Klein's group said,

"We speak for advocates whom Kuehl claims to represent. Our focus is on cures, not legacy.  We understand that private capital will lead science to the marketplace."

Klein's group declared,

"SB 1565 should not be passed in any form."

Sphere: Related Content

Fresh Comment and Correction

The Klein lobbying group item indicated that Wesley J. Smith's opposition to hESC research was religion based. He says, "I don't argue from religion, nor get into it." Smith has also filed a comment on the item. Sphere: Related Content

Fresh Comment

John M. Simpson of the Consumer Watchdog group has posted a laudatory comment on the "Sheehy Proposes Changes" involving the grant appeal process. Sphere: Related Content

Klein's Lobbying Group Waging Cyberspace, Patient-Advocate Battle Against SB 1565

The private stem cell lobbying group controlled by Robert Klein, who is also chairman of the state of California's $3 billion stem cell agency, has launched a major campaign to kill legislation aimed at ensuring affordable access to therapies financed by the agency.

The group is Americans for Cures, which denies that it engages in lobbying. Klein (see photo) is its president, a very unusual position for a top government official. Americans for Cures shares the same address as Klein's real estate investment banking firm in Palo Alto, Ca.

Via the Internet, the group is marshalling patient advocates and stem cell research backers to write, phone, email and personally appear in Sacramento to defeat the legislation. Sample scripts are provided along with names, phone numbers and email addresses of lawmakers.

Its email message to supporters says:

"We need you to take a few minutes to help save the California Institute for Regenerative Medicine and embryonic stem cell research in California.  This is under siege right now in the state legislature."

Americans for Cures is targeting SB 1565 by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. It sailed easily through the Senate and comes before the Assembly Appropriations Committee on July 16. No state lawmaker has voted against it.

Assuming the bill clears the committee next week, it then faces Assembly floor action and would return to the Senate for concurrence in Assembly amendments before going to the governor for his signature, which is by no means assured.

Also linked to the Americans for Cures effort is patient advocate Don Reed of Hayward, Ca., who is vice president of the group. Reed has appeared personally in the Capitol to oppose the bill, but says he is doing so as a private individual. Reed is also one of the most regular attendees at CIRM's public meetings, testifying on almost every occasion.

Reed wrote recently on his blog, stemcellbattles.com, that passage of the bill is a retirement "gift" by lawmakers to Kuehl, who is barred from running again for legislative office because of term limits. Reed said that personally he regards passage of the measure as akin to "getting an arm chopped off in a sword battle."

Klein's private political activities and lobbying efforts fouled relations with the legislature as early as 2005. At one point, CIRM directors moved the agency's legislative unit out from under Klein's control. Relationships improved, but Klein now has a firm grasp on the agency's dealings with lawmakers.

Activities of Klein's group have also lead to public confusion about its relationship to the official state agency. At one point in 2007, Americans for Cures (then operating with a different name) called a news conference for CIRM. The agency staff did not learn about the news conference until it was disclosed on the California Stem Cell Report. This week, Wesley J. Smith, a lawyer, author and foe of hESC research, incorrectly attributed language from Americans for Cures to CIRM. He said CIRM is "is wailing and gnashing its teeth that the very existence of the CIRM is threatened." His error has been picked up by at least one other web site(a religiously oriented foe) and probably more.

CIRM has never officially commented substantively on Klein's lobbying group, and Klein does not see the activity as a conflict with his government duties. Nonetheless, the priorities of Americans for Cures are not necessarily the same as those of a government agency, whose first responsibility is to the public – not industry, not patient advocates and not researchers.

(The item below contains the text of the email being sent out to drum up opposition to Kuehl's bill. The copy was sent to us by an interested party who must remain anonymous.)

(Editor's note: An earlier version of this item indicated that Smith's opposition to hESC research is religiously based. He says he "does not argue from religion or get into it." Sphere: Related Content

Text of Americans for Cures Email and Links to Its Position

Here is a partial text of the email message from the Americans for Cures campaign against SB 1565, minus much of its html coding.

Here also are links to Cures' one-page analysis of the bill and its full analysis, its home page pitch on SB 1565 and other material.

Subject: Action Alert: Last Chance to Stop Restrictions on Research

We need you to take a few minutes to help save the California Institute for Regenerative Medicine and embryonic stem cell research in California.  This is under siege right now in the state legislature.  A few weeks ago, we failed to stop Senate Bill 1565 (Kuehl-Runner).  The bill was passed by the Senate, and has now also passed through two Assembly Committees: Health and Judiciary. The final step before a floor vote is a hearing in the Assembly Appropriations Committee (contact information below). We need you to act now and ask for a NO vote on SB 1565. Here's how:
1.Please call the Appropriations Committee at (916) 319-2081 and fax the Committee at (916) 319-2181.
2.Please email us to add your name to our listof those who oppose SB 1565.
3.Please call/fax/write as many of the Committee Members as you can.
4.Please call/fax/write your own Assembly Member. (To find your Assembly Member or State Senator, please click here and enter your address.)
5.Please see below for a script/sample email.

The Appropriations Committee will hear the bill on July 16, and so we need your help right now. If you live near Sacramento, please consider joining us in person to stand up for this research. (Let us know if you can be there we'll keep you updated on time and place.)

Over seven million voters expressed a desire to fund embryonic stem cell research when they passed Proposition 71. SB 1565 would remove the built-in preference for embryonic stem cell research - directly contradicting the will of Californians.

We passionately support the goal of healthcare that is accessible and affordable to all Californians. However, this bill will discourage private industry from developing therapies and cures. Currently, the law allows the California Institute of Regenerative Medicine (CIRM) to provide companies with additional incentives to develop therapies for "orphan" diseases such as cystic fibrosis and Lou Gehrig's disease. SB 1565 will eliminate these incentives, making it financially unfeasible for companies to pursue therapies for rare diseases. SB 1565 abandons these patients and their families.  
  
If SB 1565 passes, entrepreneurs and private capital will likely remain on the sidelines in the fight for cures. That means a delay in developing cures and therapies; even worse, therapies for some conditions may never be developed.  
  
Opposing SB 1565 keeps therapy development on the fastest track for cures.  
Opposing SB 1565 is the best vote for taxpayers because new therapies can reduce direct and indirect economic costs.  
Opposing SB 1565 is the best vote for families and patients who suffer every day from devastating chronic conditions.  

We must accelerate investment in CIRM technologies for the benefit of everyone. And that is why we need you to call now.
 
1.Please call the Appropriations Committee at (916) 319-2081 and fax the Committee at (916) 319-2181.
2.Please email us to add your name to our list of those who oppose SB 1565.
3.Please call/fax/write as many of the Committee Members as you can.
4.Please call/fax/write your own Assembly Member. (To find your Assembly Member or State Senator,  please click here and enter your address.)
5.Ask your friends and family to do the same.
6.After you have done your best to stop SB1565, please let us know what you were able to accomplish. (inform@americansforcures.org)

Thank you for being on the frontlines in the fight for cures.
  

Warm regards,
Amy & Constance
  

For a full analysis of the bill and its negative impacts, please click here .
  

Sample Script/Email:
 

Hello, my name is ______________, and I live in ____, CA.  I am calling/writing to urge Assembly Member __________ to oppose Senate Bill 1565 in the Appropriations Committee and on the floor.  SB 1565 will remove CIRM's funding preference for embryonic stem cell research and will delay the development of emerging medical treatments that have the potential to help millions of Californians and people around the globe.  SB 1565 will price-fix technologies not yet in existence. It will discourage investment in vital stem cell research and cures.  We must stay on track to develop these lifesaving treatments, and for that, I am asking for your NO vote on SB 1565.  Thank you.  
  


Assembly Committee on Appropriations
      
  Committee Members   District   Phone   Fax   E-mail   
  
  Mark Leno - Chair     Dem-13   (916) 319-2013   (916) 319-2113     Assemblymember.leno@assembly.ca.gov   
  
  Mimi Walters - Vice Chair     Rep-73   916) 319-2073   (916) 319-2173     Assemblymember.walters@assembly.ca.gov   
  
  Anna M. Caballero     Dem-28   (916) 319-2028   (916) 319-2128     Assemblymember.Caballero@assembly.ca.gov   
  
  Mike Davis     Dem-48   (916) 319-2048   (916) 319-2148     Assemblymember.Davis@assembly.ca.gov    
  
  Mark DeSaulnier     Dem-11   (916) 319-2011   (916) 319-2111     Assemblymember.DeSaulnier@assembly.ca.gov   
  
  Bill Emmerson     Rep-63   (916) 319-2063   (916)319-2163   Assemblymember.emmerson@assembly.ca.gov   
  
  Warren T. Furutani     Dem-55   (916) 319-2055   (916) 319-2155     Assemblymember.Furutani@assembly.ca.gov   
  
  Jared Huffman     Dem-6   (916) 319-2006   (916) 319-2106     Assemblymember.Huffman@assembly.ca.gov   
  
  Betty Karnette     Dem-54   (916) 319-2054   (916) 319-2154   Assemblymember.Karnette@assembly.ca.gov   
  
  Paul Krekorian     Dem-43   (916) 319-2043   (916) 319-2143   Assemblymember.Krekorian@assembly.ca.gov   
  
  Doug La Malfa     Rep-2   (916) 319-2002   (916) 319-2102     Assemblymember.lamalfa@assembly.ca.gov   
  
  Ted W. Lieu     Dem-53   (916) 319-2053   (916) 319-2153     Assemblymember.Lieu@assembly.ca.gov   
  
  Fiona Ma     Dem-12   (916) 319-2012   (916) 319-2112   Assemblymember.Ma@assembly.ca.gov   
  
  Alan Nakanishi     Rep-10   (916) 319-2010   (916) 319-2110   Assemblymember.nakanishi@assembly.ca.gov   
  
  Pedro Nava     Dem-35   (916) 319-2035   (916) 319-2135     Assemblymember.nava@assembly.ca.gov   
  
  Sharon Runner     Rep-36   (916) 319-2036   (916) 319-2136     Assemblywoman.Runner@assembly.ca.gov   
  
  Jose Solorio     Dem-69   (916) 319-2069   (916) 319-2169   Assemblymember.solorio@assembly.ca.gov     


 
       
  Authors   District   Phone   Fax   E-mail   
  Senator Sheila Kuehl     Dem-23   (916) 651-4023   (916) 324-4823   senator.kuehl@sen.ca.gov   
  Senator George Runner     Rep-17   (916) 651-4017   (916) 445-4662   Via website: http://cssrc.us/web/17/contact_us.aspxhttp://cssrc.us/web/17/contact_us.aspx
Sphere: Related Content

CIRM Director Sheehy Proposes Changes in Grant Appeals

Jeff Sheehy, a member of the board of directors of the California stem cell agency, offers the following thoughtful perspective on the problems with appeals/reconsideration of grant applications. His comments include suggestions for changes that could ease concerns of some applicants and what he describes as a "muddle."

Sheehy is a member of the Grants Working Group and has participated in the reviews of hundreds of grant applications at CIRM. He has served as its acting vice chairman on a number of occasions. Here is the text of his comments.

"I think we have gotten into a muddle over the question of appeals by applicants to CIRM and the ICOC(CIRM's board of directors). First, as Don Gibbons has reiterated in this item, objective process complaints such as one involving potential undisclosed conflicts of interest by reviewers are allowed by CIRM and given appropriate consideration with appropriate action if needed.

"However, appeals/comments concerning the content of reviews cannot be considered by CIRM staff. To do so would make CIRM staff effectively reviewers. In addition, CIRM staff could be placed in the position of making decisions regarding the funding of grant applications. Prop. 71 clearly gives the Grants Working Group (GWG) responsibility for reviewing grants and the ICOC takes those reviews as advice and then is solely empowered to make decisions to approve or not approve a grant application.

"CIRM and the ICOC could decide to implement a resubmission process allowing applications with disputed reviews to be re-reviewed by the GWG. I personally am undecided on this approach but think it is unlikely to be adopted.

"What is confusing is that appeals/comments about any item under consideration by the ICOC are expressly allowed. California public meeting laws govern a state agency with a decision-making board that meets in public. That means public comments/appeals are expressly allowed, as the ICOC has already experienced. In addition, letters to the ICOC regarding applications or any matter under consideration are also allowed and we have received them on an application and other matters.

"Instead of obfuscating and stonewalling, CIRM should be direct and forthright about this existing appeal process. In that context, the process could then be properly organized. Those who wish to use public comment can be informed of our current 3-minute limit and advised that the limit could be shortened to 2 or even 1 minute if we get a significant number of individuals who wish to comment. In addition, we could suggest length (hopefully a couple of pages) and format for written appeals (i.e., formats easy to post on CIRM¹s website). We could also inform applicants who wish to use this process that their letters will be made public and the application score and identity will be revealed upon receipt/posting of letters or after public comment.

"From my perspective, written comments/appeals from applicants would be preferable and I would hope to receive them early enough to consider thoughtfully as I review materials prior to ICOC meetings.

"Part of the rationale for the composition of the ICOC is to have on hand scientific expertise to inform decisions around grant applications. I have confidence that my colleagues can digest any additional input from applicants and make appropriate decisions. After all, the ICOC has already considered and made decisions regarding applications appealed to it."

Sphere: Related Content

CIRM Responds to Cascade Complaints

The California stem cell agency today defended its grant review process in the wake of complaints by an applicant, Cascade LifeSystems of San Diego, concerning the fairness of CIRM's procedures.

We asked CIRM if it had any comments concerning the item we wrote dealing with Cascade's concerns. We also specifically asked CIRM the following question: How can an applicant appeal on the basis of a conflict of interest if it does not know the names of the specific reviewers who evaluated their application?

Here is the text of the response from Don Gibbons, chief communications officer for CIRM.

"The company would note anyone on the review panel whom it believes has a potential conflict, then staff would see if that person was a primary or secondary reviewer, or if not, whether they made substantive comments during the review that could have influenced scores.

"You should know that CIRM does not believe that the reviewer citing 0.3 percent instead of 0.66 percent is a substantive error. The latter would still require 150 eggs to get one cell line, and that was a significant weakness in the application. The three percent or one-in-30 number cited elsewhere in the application by the firm is noted to come from preliminary data, something that we felt was not peer reviewed and not substantiated, and therefore outside of the realm of consideration for review. There were several other weaknesses in the application cited by the reviewers.

"CIRM’s success rate for grant applications is already considerably higher than for NIH applicants."

Our comment on the conflict of interest question raised by Cascade: The names of all the scientists on the review panel are public. Only in cases of the names of individuals assigned specifically to a specific application are the names secret, as we understand the process. An applicant can see the names of all reviewers in advance, do some research on the individuals and ask CIRM ahead of the review to bar particular reviewers from evaluating its application.

We suspect that no applicant has performed that sort of due diligence, but we could be wrong. In fact, raising such an issue ahead of a review could have a negative impact on consideration of an application. Few reviewers are likely to be fond of having their integrity questioned. And an accusation of a conflict of interest cannot be fully investigated without informing the reviewer involved. Sphere: Related Content

French, Stemagen, Trounson and Egg Shortages

Biopolitical Times, the blog of the Center for Genetics and Society of Oakland, Ca., took a look recently at ongoing events in the human egg debate, including some developments at the California stem cell agency.

Jesse Reynolds, who has followed the California stem cell movement for years, also commented about research involving Stemagen of San Diego, which has created the first human clonal embryos.

Among other things, Reynolds wrote,

"The medical staff treating the egg providers share the same address, supervisor, and authorship credits as the Stemagen researchers, in violation of requirements that medical personnel not have conflicts of interest with researchers, so that doctors’ duty of care toward women providing egg isn’t compromised."

Reynolds also pointed out a relationship between Stemagen and CIRM President Alan Trounson.

Reynolds wrote:

"He helped recruit his old friend Andrew French from their common homeland of Australia to serve as Stemagen's Chief Scientific Officer. And Trounson, French, and Stemagen CEO Samuel Wood authored a 2006 paper advocating cloning-based stem cell research. So it wasn't surprising when Trounson took his first opportunity... at CIRM Standards Working Group to call for undermining California's prohibition on paying women (beyond their expenses) to provide eggs for research, even though this policy is enshrined in Proposition 71, the statewide initiative that created CIRM, the California Institute for Regenerative Medicine."

Reynold said that Susan Berke Fogel of Pro-Choice Alliance for Responsible Research reported that Trounson and CIRM Chairman Robert Klein "tag-teamed a renewed effort to find a tortured interpretation of Proposition 71 that would allow paying women for eggs" at the CIRM directors' meeting last month. Reynolds said Klein "tried to force a discussion" that would have changed policy and circumvented the Standards Working Group.

We were present during the discussion that Fogel heard. However, we did not have the same impression. There was a discussion of the shortage of human eggs, basically a brief recap of what Trounson told the Standards Working Group last February. Our take is that Klein brought up the subject before the full CIRM board perhaps with intention of setting the stage for some sort of action later this year. That would be the politic thing to do if he wants changes in CIRM's current policies on eggs and cash.

Later this year, the Standards Working Group is expected to conduct a review of CIRM egg policies, probably sometime this fall.

However, Klein and Trounson have a high hurdle to clear. Prop. 71, which Klein says he authored, requires CIRM directors to set standards "prohibiting compensation to research donors or participants, while permitting reimbursement of expenses."

While Reynolds pointed out links between Trounson and French, he also reported that the relationship apparently did not benefit Stemagen recently. Its application for a new cell lines grant was "raked over the coals" by reviewers, according to Reynolds, who quotes them at some length.

We are asking CIRM and Stemagen if they have any comment on Reynolds' posting. We will carry it when we receive it. Sphere: Related Content

Multimillion Dollar Hooha Over CIRM Grant Reviews

As part of a burgeoning flap over grant reviews at the $3 billion California stem cell agency, one rejected applicant has formally asked for reconsideration of its request for funds, citing errors in fact by reviewers, among other things.

Such a request might seem routine, but for CIRM it is novel and fraught with pitfalls. At stake is the reputation for fairness and credibility of the still young California Institute for Regenerative Medicine.

Created only in 2004 with its first grants approved in 2005, CIRM has struggled with its processes. It has been helped, but also hamstrung by the ballot initiative that created it. The measure, which bypassed the legislature and the governor, also locked in a host of restrictive procedures. One of those involves the grant review process, which is also governed by policies approved by the CIRM board of directors.

The rejected applicant, Cascade LifeSciences of San Diego, was routinely denied funding last month by the CIRM board of directors, based on the decisions of scientific reviewers. The board has almost universally ratified the $500-million-plus decisions of its scientific reviewers, who conduct their sessions in private and whose economic or professional interests are not publicly known.

Rejected applicants do not have the right of appeal except in the case of a conflict of interest. But Cascade says it does not know the identity of reviewers of its grant so it is impossible to know whether a conflict of interest exists. However, the board itself is filled with conflicts of interest -- all legal -- that even Nature magazine has warned about.

Ken Woolcott, chief business officer for Cascade, appeared before the CIRM directors last month to express concern about the grant review process. At the time, he did not seek an appeal or reconsideration of the firm's application. He had been told by CIRM that no appeal was possible. After he left the meeting, another rejected grant, albeit in a slightly higher category, won funding after a CIRM director read a letter from the applicant.

On July 3, Woolcott wrote a letter to CIRM Chairman Robert Klein and CIRM President Alan Trounson that includes a request for reconsideration of his firm's grant. Woolcott's letter does not seek an appeal.

Much of the information in it is contained in an earlier posting on the California Stem Cell Report. But Woolcott has fine-tuned the letter and added important significant details. The entire letter follows as a separate posting. Here is a sample.

"The information on the 0.3% efficiency presented to the Study Section by the Reviewer #2 is factually incorrect. Even if the reviewer was mistakenly relying on our Nov. 2007 Nature publication, that efficiency was reported as 0.66%. More importantly, on pages 5 and 8 of this grant application we provided information that the efficiency of SCNT in primates was 3.3% (1 ESC line per 30 oocytes)."

We have asked CIRM if it has any comment on the situation. We will carry its response when it provides one. Here is the link to the public summary of the CIRM scientific review of the Cascade application. Sphere: Related Content

Text of Reconsideration Letter From Cascade

Here is the text of the reconsideration letter from Cascade concerning its application for a grant from the California stem cell agency.

July 3, 2008
Mr. Robert Klein, J.D.
Chairman, ICOC Committee
210 King Street
San Francisco, CA 94107
Re: Request for Reconsideration - New Cell Line Development RFA 07-05 Review Process

Dear Committee Member:
Last Thursday evening, 26 June 2008, I had the pleasure of appearing before your Committee, officially on behalf of Cascade LifeSciences (See Exhibit A) and perhaps unofficially as a voice for industry, regarding our expectations and experience with the RFA and Grant Review noted above. To quote Mark Twain, “I apologize for the length of my letter; I did not have time to write a shorter one.” Three minutes to comment on a $1MM decision is remarkably challenging. For the benefit of the Committee and with the luxury of a written response, let me see if I can more clearly articulate our expectations, experience and suggestions going forward.

First, I would like to start at the beginning. Prop. 71 is a very innovative and groundbreaking paradigm shift in the funding of research. We applaud the CIRM mission and the stewardship of the Committee. The mission statement of Prop. 71 makes very clear that although science is a laudable goal it is not the end game. Products that treat, cure, or enhance our lives are the end game. Fast forward 10 to 15 years and I would like to be so bold as to suggest that the ultimate arbiter of the success of CIRM or Prop. 71 will be PRODUCTS. Not research achievements, not publications, not patents, not even Nobel Prizes. All of these are important milestones that will advance our efforts and may even contribute to the economy of California. But “John Q. Public” will only benefit directly by the development of innovative stem cell related PRODUCTS that I believe will change medical approaches to disease in fundamental ways.

In the interest of full disclosure, I prefer to admit my biases up front. I have a bias toward products. I am also a lawyer, the Chief Business Officer of Cascade LifeSciences, and a taxpayer. My product bias has been cultivated over 20 years with two of the San Diego biotech pioneers, Hybritech and IDEC. (See Exhibit B, Background). What I know about Stem Cells I have learned, but what I know about product development, I have lived.

I believe that industry and CIRM share the same goal of enhancing product development. Although funding cutting edge research and academic inquiry are part of the larger goal, I believe that industry will be the ultimate conduit through which products must run the clinical, regulatory and marketplace gauntlet.

RFA 07-05 and Cascade’s Expectations

Upon understanding that CIRM was opening up funding under the RFA process to for-profit entities, we were quite pleased and encouraged. Funding critically important translational research that can neither be funded by the NIH nor is of interest to all but a very few private investors seems prudent and product focused.

The specific language in the Objective of RFA 07-05 perhaps set our expectation too high:

Page 1 -- Somatic cell nuclear transfer (SCNT) , a method for reprogramming that is well-established in several mammalian species, has not yet been achieved with human cells, but recent success has been reported in non-human primates. " [This is Dr. Mitalipov's work published in Nature and exclusively licensed by Cascade]

Page 2. "The needs may in the future be met by derivation of hESC following SCNT..."

Page 2. "CIRM proposes a new program to address the need for new types and sources of human pluripotent stem cell lines and for the optimization of existing methods for their derivation." To be candid, we believed that the translation of our SCNT primate work into the SCNT generation of hESC was right in the "strike zone" of the RFA as written. The alternate non-embryo sourced approach, iPS is a very important scientific avenue of research and should be funded as well. That said, SCNT is a very compelling opportunity to develop genetically matched cell lines that may lead to human therapeutic products.

Cascade’s Grant Review Experience

Our responses to the Reviewers’ comments are beyond the scope of this letter but are attached as Exhibit C for independent review. For the record, we filed a formal request with Dr. Trounson to rebut the conclusions and comments of the reviews but were told by Staff that there was no such process. We were told that the only avenue for rebuttal would be based on conflict of interest. As the reviewers are anonymous, it is unclear how this would ever be realistic. Two additional points are striking in this regard. First, we now understand that after our departure on Thursday evening, Rusty Gage, one of our esteemed colleagues here in San Diego was allowed to rebut reviewer comments and, hence, did receive funding. We are unclear on how this rebuttal process works and why we were denied any opportunity to dialogue on the merits of our grant application. Second, I understand second-hand that an ICOC member believed my discussion at CIRM was flawed, for example, because I did not address the mistake regarding efficiency of our SCNT. This is unfortunate, as we were told our request for rebuttal was rejected and that we were not allowed to discuss the merit or lack of merit of the specific review of our application but our three minutes was limited to expressing our concerns about the process and our suggestions for improvement from an industry perspective.

By way of example, we would like you to better understand the disconnect between our expectations and our experience with this Grant Review. As you will note in Exhibit C, most of the review comments we received on our Grant Application were factually incorrect. We are unable to reconcile the review committees’ comments with the stated objectives of the RFA, the articulated criteria for review and our actual grant submission.

For example, Reviewer #1 comment was:
"Lack of Novelty, pure translation of the non-human primate work into humans."
This seems to defy logic and the mission of human therapeutics. Moreover, this does not seem to be consistent with the objectives published by CIRM in its RFA, which specifically calls out the "hurdle" of human SCNT as a fundable goal. I would venture to suggest that successful application of SCNT to humans will be a scientific achievement and will be an “above the fold” kind of worldwide news story. Finally, at the CIRM ICOC meeting, Dr. Uta Grieshammer, presented the review committees grant criteria and noted specifically that the review team was advised that "novelty" was NOT a priority for these types of grants.

Also at the meeting, Dr. Trounson announced that no SCNT grants had been funded due to some sort of vague policy concern about access to human oocytes and the challenges this had created in other countries. (We are aware of Grant#R31-00404 related to SCNT that was previously funded).

First, this was "moving the goal posts" after we had submitted our grant application. Second, we appreciate the challenge of securing oocytes but we at Cascade had been fortunate enough to secure a collaboration with La Jolla IVF clinic to supply all the oocytes we need to proceed with our cell line development effort. Moreover, if this was truly the reason for flagging our grant application as non-fundable, CIRM should have just told us that in writing and explained how they were going to proceed, if at all, in the area of SCNT.

A factually incorrect assumption about our “efficiency” may have been the fundamental error that doomed our application. The CIRM reviewer commented:
The ability to generate individualized human embryonic stem cell lines using somatic cell nuclear transfer from either healthy individuals or patients with specific disease states is an exciting and yet technically demanding prospect. To date, no one has successfully cloned human embryonic stem cells, although recently, a group at University of Oregon Heath Sciences Center has successfully derived primate embryonic stem cells, with an efficiency of approximately 0.3%
This is factually incorrect at two levels. First, we are unclear where the reviewer got the 0.3% efficiency rate. This is not a number we have used. Our November 2007 Nature paper calls out 0.66% efficiency at page 497. Our grant application (filed Jan 2008) describes in detail at page 8, "These results represent a significant reduction in the number of oocytes required to produce a single ESC line over previously reported efficiency (from 152 to 30) providing the important foundation to conduct the proposed studies in humans." 1 ESC cell line out of 30 oocytes is actually 3.3%.

I am unclear how this fundamental oversight occurred. Mistake? Miscommunication? Pre-existing bias? Misunderstanding? Suffice it to say, we believe that the incorrect information about efficiency was the driving force behind the reviewers’ comments and failure to fund.

Suggestions and Action Items for Consideration.

Our hope is that thru expressing our concerns and our experience we will be able to make industry (For-Profit) a viable partner in the mission of Prop 71. With that in mind, we would like to suggest the following ideas for review and consideration by the ICOC:

Industry representation on CIRM grant review teams

Formal appeal process or ability to respond in writing to reviewer comments. See, for example, SBIR, STTR, NIH funding for models of review cycles.

Holding the review team to the published review criteria--e.g., novelty is not a priority criteria.

One of the review criteria should always be the impact of the research on the advancement of human product development. If the Rusty Gage review reconsideration is as I understand it, it seems that there is one set of rules for a deservingly prominent scientist and a different set of rules for Cascade LifeSciences/Industry. We also filed a letter with CIRM asking for the opportunity to comment on our grant review and were denied. This seems, without more complete information, to be unfair.

Perhaps separate academic/not-for-profit grant application review from for-profit review. Comparing not for profit grants (institutions that are Grant Writing Machines) with the grant applications of fledgling biotech companies is fundamentally unbalanced.

Although I believe that Industry is a key element of Product development and we desire to work with CIRM to advance the cause, if CIRM’s funding criteria or standards are inconsistent with industry participation or pragmatic product development, we need to know that earlier rather than later.

I am personally and professionally committed to assist CIRM in making industry an equal partner in achieving the mission of Prop 71. I would look for guidance from the ICOC on how we can work through some of these administrative and structural challenges.

Although we are disappointed by the CIRM review and admittedly discouraged by the process, I trust that the agency and the applicants will evolve favorably with time and experience.
As our distinguished Governor would say.............."We'll be Back."
Sincerely,

Kenneth J. Woolcott
Chief Business Officer
Cascade LifeSciences Inc
10398 Pacific Center Ct.
San Diego, CA 92121
kjwoolcott@aol.com
858-945-4667

KJW/rrc
cc: Alan Trounson, President CIRM
Howard Birndorf
Sophia Khaldoyanidi


Exhibit A

Cascade LifeSciences

Founded 2004
San Diego, CA
Howard Birndorf, Chairman
Kenneth Woolcott, Chief Business Officer
Sophia Khaldoyanidi, Ph.D, MD, Chief Scientific Officer
Larry Respess, General Counsel
Exclusive Licensee of Novel SCNT technology developed at Oregon Health Sciences University (OHSU) and published in Nature, Nov 2007. (First successfully SCNT in Primates)
Dr. S. Mitalipov, inventor of SCNT patents and consultant on human SCNT effort.
Exhibit B



KENNETH J. WOOLCOTT


6100 La Jolla Scenic Drive South
2000 First Avenue
La Jolla, CA 92037
Suite 2304
858-454-8496 phone/fax
Seattle, WA 98121
kjwoolcott@aol.com
206-795-4667 phone


GENERAL COUNSEL & LICENSING EXECUTIVE
Strategic Advisor . . . Entrepreneurial Counsel . . . Transactional Architect


Summary: Executive with over 20 years of experience and outstanding accomplishment in the Biopharmaceutical Industry, including 12 plus years of key legal and management responsibilities at IDEC Pharmaceuticals Corporation (now Biogen IDEC) through its growth from a market cap of $50M to a company with a valuation of over $10B. Provided counsel and craftsmanship on over $1B in global corporate alliances and public financings. Contributed legal leadership and team influence in the development and FDA approval of two oncology drugs, RITUXAN (first antibody approved for cancer) and ZEVALIN (first radioimmunotherapy approved for cancer), currently generating annual U.S. sales of over $1.9B. Provided leadership in diverse and challenging roles based on the growth and needs of the organization, for example:

Strategic advisor with entrepreneurial zeal and global biopharma perspective.
Counsel with intra-disciplinary experience, scientific background and a proven track-record of incisive legal analysis and problem-solving.
Executive officer with achievement in operational management, strategic planning, business development, team building, and change agent in development of company’s core values as it grew from 70 to over 800 employees.
General Counsel and Corporate Secretary with broad experience in public company matters, corporate governance, SEC compliance, FDA issues, intellectual property strategy, transactional negotiation and crafting, corporate partner management, litigation management, and government relations.
PROFESSIONAL EXPERIENCE AND KEY METRICS

Woolcott Bioscience Strategies 2002-present
Transactional and Business Development Consulting Services

Chief Business Officer, Cascade Lifesciences Inc 2007 to present

Strategic Advisor 2005 to 2007
Nativis, Inc. San Diego, CA

Acting Vice President, Business Development & General Counsel 2004-2005
Imagine Pharmaceuticals, San Diego, CA




IDEC Pharmaceuticals Corp., San Diego, CA 1989-2002

VP, General Counsel, Licensing Executive and Secretary 1994-2002
General Counsel, Licensing Executive and Secretary 1992-1994
Deputy General Counsel and Secretary 1991-1992
Intellectual Property Counsel 1989-1991

Counsel to approximately $700M in IDEC Public Equity & Debt Financings:

Initial public offering (IPO): (1991--$52 M)
Follow-on equity offerings: (1994 – $8M; 1996 -- $50M; 2000 -- $473M)
“LYONS” convertible debt offering: (1999 -- $113M)

Counsel and negotiator for approximately $300M in corporate alliances from 1991-00, including:

Zenyaku/Rituxan – 1991, $10M SmithKline/CD4 – 1992, $60M
Mitsubishi/B7 – 1994, $12M Seikagaku/CD23 – 1995, $26M
Genentech/Rituxan – 1995, $57M Eisai/gp39/CD40L – 1995, $38M
Kirin, BI, and Chugai/ Upjohn/9AC – 1997, $12M
Expression System – 1995-7, $15M
Schering AG/Zevalin –1999, $47M Nordion /Yttrium – 2000, $20M
Member of core team of executives that led turnaround from $50M valuation and six months of cash in 1994 to pivotal Genentech partnership/cash infusion and over 800% increase in stock valuation in 1995.
Managed key patent litigation (IDEC v. Corixa et al), including selection process for lead counsel and development of declaratory judgment strategy over a multi-year period. Strategically, IDEC prevailed in securing venue in San Diego Federal District Court, while actions in Delaware and Northern District of California were dismissed. In October 2003, summary judgment was granted in favor of IDEC declaring invalid and unenforceable all of Corixa’s subject patents. The case was ultimately settled on favorable terms
Executive Committee level advisor on IND, clinical strategy, Advisory Committee meeting, manufacturing subcontracting and inspection, approval and launch of RITUXAN and ZEVALIN.
Early advocate and adopter of Rule 10b-5 executive stock selling plans, including successful initiation of amendment to California State Securities Laws to conform with provisions of new Federal law
Managed preparation and filing of SEC corporate disclosure documents including crafting of numerous sensitive and challenging press releases.
Managed legal aspects of “Poison Pill” adoption and revision
Lead legal analysis and selection of RITUXAN and ZEVALIN trademarks
Coordinated legal and peer analysis for stock splits 2:1 21 Dec ’99 and 3:1 18 Jan ‘01
Built and managed a high-performance Legal Team of thirteen professionals
Managed Corporate Policy on Insider Trading and Stock Trading Windows
Member of Executive Committee, Corporate Secretary and liaison with Board of Directors
Strong presentation skills and recognized public speaker

Christensen, O’Connor, et al., Seattle WA 1987-1989
Associate


Hybritech, Inc., San Diego, CA 1985-1987

Intellectual Property and Licensing Counsel 1986-1987
Patent Counsel 1985-1986

EDUCATION
George Washington University, Washington, D.C.
Juris Doctorate, 1985
Leader, Save the Night Law School Campaign, 1984
President—Evening Division, Student Bar Association, 1984

University of Maryland, College Park, MD
MS candidate/Chemical Engineering, 1980-81

Pacific Lutheran University, Tacoma, WA
B.S,. Biochemistry, Cum Laude, 1980

PROFESSIONAL ORGANIZATIONS

California State Bar Association
Washington State Bar Association
District of Columbia Bar Association
United States Patent Office
Registered Patent Attorney (#30,824)
American Corporate Counsel Association
Founding Director of San Diego Chapter, 1994
American Association of Corporate Secretaries
Biotechnology Industry Organization
Founder of General Counsel Committee, 2001

COMMUNITY AFFILIATIONS

Burnham Institute for Medical Research, La Jolla, CA
Trustee and Chairman of Technology Transfer Committee., 2004 to present
Basketball Club of Seattle, L.L.P.
Partner, 2002 to 2006
The Jimmy V Foundation for Cancer Research
Friends of V Member
The Starlight Foundation for Children
Freshstart , Inc.




Exhibit C

Rebuttal letter & REQUEST FOR rECONSIDERATION
sophia Khaldoyanidi, ph.d., m.d.,
chief scientific officer
cascade lifesciences, inc.

RL1-00656-1: Generation of human ESC lines using SCNT
Executive Summary Comments
Comment #1: The proposal lacks a detailed description of how the resultant cell lines will be assessed and characterized for pluripotency.

Response #1: This concern was raised by the Reviewer #2. However, the description of the pluripotency tests is described on page 5 of the grant application (Step 4 of our protocol). We proposed to evaluate pluripotency of SCNT-ESC lines based on stemness marker expression and both in vivo and in vitro differentiation using standard state-of-the art methods. These methods include immunocytochemistry, flow cytometry, quantitative RT-PCR, embryoid body formation and teratoma assay. All these assays are standard in stem cells biology field and are routinely used by the members of our scientific team (see list of publications provided in Part C of this grant application).

Comment #2: No data is presented suggesting that these assays [for pluripotency] are routinely available in the applicant’s laboratory.

Response #2: Due to the space constrains of the Preliminary Results and Feasibility section (2 pages), we have chosen to present the results supporting the novel and scientifically-challenging aspects of the SCNT technology. The concern regarding our ability to run the pluripotency tests was raised by the Reviewer #2 and the rationale for this concern is not clear to us: the assays for pluripotency are standard techniques used in every stem cell laboratory including laboratories leaded by the members of our scientific team. The fact that we are familiar with the standard techniques used in our field is supported by our publications (Part C of this grant application).

Comment #3: The collaborator with the primate cloning expertise proposes to spend 25% of his/her time in the applicant’s laboratory in California. However, reviewers expressed serious concern that it will be logistically difficult for the out-of-state collaborator to be available at the time when the oocytes are donated.

Response #3: Anyone with experience with IVF understands that the day of oocyte harvesting is predicted in advance based on the rigid hormone treatment schedule for each donor. Based on this well known schedule, the travel for Dr. Mitalipov from Portland to San Diego (2.5 hour duration) can be easily planned in advance.

Comment #4: Regarding the source of the oocytes, which will be obtained from an in vitro fertilization (IVF) clinic, one reviewer felt that the procurement of 100 oocytes per year seems reasonably achievable. However, others felt that not enough information is presented in the application to firmly support that the applicant can obtain the high quality eggs.

Response #4: Due to the space constrains, we did not have an opportunity to explain in the body of the grant as to how human oocytes will be obtained. This information is provided very clearly in the letter of collaboration from Dr. Smotrich of La Jolla IVF Clinic (Part C). Dr. Smotrich established a list of young and healthy volunteers who desire to donate oocytes specifically for this SCNT project. All these donors were pre-tested and demonstrated a high oocyte production (20-25 oocytes per cycle) in response to hormonal stimulation. We do not intent to use oocytes that have been obtained for the purpose of IVF treatment and were not used due to poor quality.

Comment #5: If they [Cascade LifeSciences team] have access to 100 eggs, some reviewers argued that it would not be enough to make a cell line in 1 year, given the primate success rates (0.3%).

Response #5: The information on the 0.3% efficiency presented to the Study Section by the Reviewer #2 is factually incorrect. Even if the reviewer was mistakenly relying on our Nov. 2007 Nature publication, that efficiency was reported as 0.66%. More importantly, on pages 5 and 8 of this grant application we provided information that the efficiency of SCNT in primates was 3.3% (1 ESC line per 30 oocytes)

Comment #6: Reviewers mentioned that there is no consideration of how the resultant cell lines, if any, will be distributed to other research groups and under what conditions as requested in the application.

Response #6: This is factually incorrect. This concern was raised by the Reviewer #2. However, this information has been provided on page 10 of the application (last paragraph).
In summary: Our response demonstrates that the Reviewer #2 provided factually incorrect information to the Study Section. In particular, the efficiency (which is an important parameter) was erroneously reported. Moreover, despite the challenges others may legitimately face in securing oocyte donors, we were able to secure reliable and excellent source of oocytes to advance our work in humans. Finally, to suggest our proposal is not novel is a flawed conclusion as Human SCNT is a stated goal of the RFA and the stated RFA review criteria specifically noted that “novelty” was NOT a measure for funding. As a result of these factual errors and an unknown change in SCNT funding philosophy in mid-review, our project received a non-fundable score. We requested an opportunity to rebut. We were denied.
REQUESTED ACTION: We respectfully request that the ICOC reconsider our grant application for funding.

Sphere: Related Content

CIRM's Grant Review Process: Complaints About Errors and Appeals

California's stem cell agency has pumped out more than $554 million in awards for stem cell research, but this year grumbling has emerged about its secretive awards process, which officially does not permit rebuttal in the case of errors and allows appeals only in the case of conflicts of interest.

On Sunday, reporter Terri Somers of the San Diego Union-Tribune became the first mainstream media writer to examine the issue in some detail.

Somers used June's meeting of the CIRM board of directors to discuss the subject, including additional interviews with researchers.

Somers wrote that CIRM is

"...basing its funding decisions on recommendations from panels of scientists who sometimes make significant factual errors in their reviews of grant requests, some applicants say.

"Yet there is no way for applicants to point out or rebut the errors – at least not through a formal appeals process, such as the one used by the National Institutes of Health.

"'I cannot tell you how frustrating it is to get turned down for a grant and have no recourse other than to shred it and all the time you spent doing it,' said Jeanne Loring(see photo), a researcher at the Scripps Research Institute in La Jolla.

Somers said CIRM has no plans to change its policies concerning appeals or error. She quoted CIRM Chairman Robert Klein as saying the NIH appeal process is too slow for CIRM. He said an NIH appeal can take as long as two years.

Somers did not raise the closed-door nature of the grant reviews as an issue, but applicants do not have access to the proceedings. Nor do apparently many of them know that they can appear publicly before CIRM directors and ask them to change the recommendations of scientific reviewers or even write a letter to that effect.

Directors have final authority on grant approval but generally ratify decisions of the scientific reviewers, without even officially knowing the identities of the research applicants. Their identities are withheld but in many cases can be discerned through the public summary of reviewers' comments.

Somers quoted one CIRM director, Jeff Sheehy of the University of California, San Francisco, about the review process. Sheehy is also a patient advocate member of the CIRM grant review group and played a role last month in airing concerns by one scientist, Fred Gage of the Salk Institute.

Sheehy told Somers:

"We may have missed some good science, but I don't think we have funded (bad science)."

While CIRM does not plan changes in its review process, Klein did tell Somers about one option for disgruntled applicants. She wrote:

"If a scientist wants to rebut an error of fact of great scientific importance, he or she should point it out to institute President Alan Trounson or Chief Scientific Officer Marie Csete, Klein said.

"Those scientists could then sort out the issue with the reviewers and decide whether it needs to be brought to the board's attention, he said."

Our take: If that is CIRM policy, all applicants should be informed about that possibility as they apply. Fairness and the appearance of fairness are critical to CIRM's credibility.

Here is a link to a detailed critique by one applicant and our report from the June meeting of CIRM directors. Sphere: Related Content

Klein's Possible Salary: Comments From CIRM

The question of a salary, possibly exceeding more than $500,000, for the chairman of the California stem cell agency is a "non-issue" and a "non-reality," according to the agency's chief communications officer.

In an interview with the Marc Strassman of the Etopia News Channel, Don Gibbons explained that Robert Klein has not yet decided whether to ask CIRM board of directors whether they want to pay him for his work at the state agency. Klein, a multimillionaire real estate investment banker, refused to take a salary when he was elected to his post by directors in 2004.

More recently, however, Klein has more than once indicated that the question of a salary for both him and the vice chairman, Ed Penhoet, is something that the board is likely to have to deal with.

Last month, we asked Penhoet, who is a California venture capitalist and one of the co-founders of Chiron, about his position on taking a salary. He replied:

"I don't think it's appropriate for me to comment on personnel matters ( including my own)."

In the Etopia interview, Gibbons additionally discussed CIRM's opposition to legislation designed to ensure affordable access to CIRM-financed therapies. He also noted that 56 research papers have been published so far by CIRM grantees.

You can hear the 10-minute Gibbons interview here.
Sphere: Related Content

Nosing Around for Stem Cell Millions

More camels are trying to crawl into the hundred-million-dollar, California stem cell supplier tent.

But just how many and which camels ultimately will end up enjoying the bounty of the Golden State is very much up in the air.

Both the state's $3 billion stem cell agency and the California Legislature have different approaches to defining California supplier for the purposes of research funded by CIRM. Prop. 71 requires CIRM grant recipients to give purchasing preference to California businesses. However, the measure failed to define exactly what a California supplier is.

So nearly four years after passage of Prop. 71, the state is trying to deal with the issue. The question drew a small platoon of business representatives to the two-day meeting last week of the board of directors of the agency. The meeting ran long and no resolution appeared imminent, so there was little public testimony but plenty of private discussions.

CIRM, the various interested parties and a representative from the office of Assemblyman Gene Mullin, D-San Mateo, basically said they need more time to negotiate the issue and talk with each other.

Mullin's supplier definition bill, AB 2381, is now before the Senate Appropriations Committee after easily winning Assembly approval. The measure was originally supported by Invitrogen, which has now backed away. Instead, it is supported by Becton, Dickinson and Co., ThermoFisher Scientific and the Advanced Medical Technology Association.

Here is the key wordage in the July 2 version of the measure. Following that language is the last available public language from CIRM. Be aware that these definitions could change with rapidity. If you want to have a hand in the debate, contact Mullin's office and CIRM soon.

"'California supplier' means any sole proprietorship, partnership, joint venture, corporation, or other business entity that meets any of the following criteria:
"(A) The owners or policymaking officers are domiciled in California and the permanent, principal office or place of business from which the supplier's trade is directed or managed is located in California.
"(B) A business or corporation, including those owned by, or under common control of, a corporation, that meets all of the following criteria:
"(i) Has owned and operated a manufacturing facility or research facility located in California that researches, develops, builds, or manufactures products for life sciences research, continuously during the five years prior to submitting a bid or proposal to provide supplies to a California Institute of Regenerative Medicine (CIRM) grantee.
"(ii) Has been licensed by the state on a continuous basis to conduct business within the state during the five years prior to submitting a bid or proposal to provide supplies to a CIRM grantee.
"(iii) Has continuously employed California residents for work within the state during the five years prior to submitting a bid or proposal to provide supplies to a CIRM grantee.
"(C) The entity produces, builds, or manufactures a product or products in California and for the specific product or products that are used by CIRM facilities grantees.
"(2) For purposes of qualifying as a California supplier, a distribution or sales management office or facility does not qualify as a manufacturing or research facility."

Here is the CIRM language from last week:

"'California supplier' means any sole proprietorship, partnership, joint venture, corporation, or other business entity:
"(1) whose permanent, principal office or place of business from which the supplier’s trade is directed or managed is located in California; or
"(2) that includes a business unit, division or subsidiary whose permanent principal office or place of business from which the unit, division or subsidiary’s trade is directed or managed is located in California, for the specific product or products that are sold by the unit, division or subsidiary to CIRM grantees; or
"(3) that employs at least one-third of its total employees in California; or
"(4) that produces, builds, or manufactures a product or products in California for the specific product or products that are sold to CIRM grantees; or
"(5) that sells a product or products in California, for the specific product or products that are sold to CIRM grantees, so long as the supplier certifies that at least 50% of the cost of the product is attributable to activity undertaken in California."

Sphere: Related Content

Kuehl on Klein Salary and CIRM Legislation Prospects

California state Sen. Sheila Kuehl says she doesn't mind if the chairman of the $3 billion California stem cell agency solicits private funds to pay his own salary, although she says the agency should be barred from accepting cash from applicants.

However, the question of private solicitation for salaries is probably moot. CIRM Chairman Robert Klein has told John M. Simpson, stem cell project director for the Consumer Watchdog group, that he has backed away from the solicitation plan. Simpson told the Etopia News Channel Wednesday that Klein now thinks his proposal is not a good idea.

Kuehl, D-Santa Monica, heads the state Senate Health Committee and is co-author of legislation, SB 1565, aimed at ensuring affordable access to CIRM-financed therapies. CIRM directors officially opposed the legislation last week.

She made her comments regarding Klein in an interview with Etopia News. She also said she is "very satisfied with the progress" of CIRM. On the federal level, she said that changing federal restrictions on funding for human embryonic stem cell research may not even be in the top 10 priorities of Barack Obama.

Kuehl said he has heard "no negatives" from the governor's office on her CIRM bill, which is now in the Assembly Appropriations Committee and close to final passage. Unless Big Pharma bends the governor's ear, she expects the measure to be signed into law.

The bill has had easy going in the legislature. No lawmaker has voted against it.

You can hear Kuehl's 19 minute interview here.
Sphere: Related Content

Fresh Comment

Larry Ebert has posted a comment on the "salary freeze" item. Sphere: Related Content

Video Overview of CIRM: From Bob Klein to Stem Cell Beneficiaries

John M. Simpson, stem cell project director for the Consumer Watchdog group, and yours truly participated in a video teleconference interview earlier today with Marc Strassman of the Etopia News Channel concerning the California stem cell agency.

The nearly 44-minute session includes a discussion of CIRM's accomplishments, some of its problems, intellectual property issues, Prop. 71 campaign promises, the possible salary for CIRM Chairman Robert Klein and much more.

You can see it all right here.

Sphere: Related Content

CIRM Salary Freeze: Sharing the Pain

The California stem cell agency's budget contained a little surprise last week – one that was not contained in the proposed spending plan presented to its Finance Subcommittee.

The proposal for the fiscal year that began today imposes a salary freeze through December. It is not a move that is financially necessary at the $3 billion agency, but one designed to show CIRM's fiscal responsiveness.

John M. Simpson, stem cell project director for the Consumer Watchdog group, commented on the freeze, which CIRM executives said the staff had agreed to. Simpson wrote on his group's blog:

"This is a sensible PR gesture by an agency who's leadership too frequently in the past has not seemed to understand that it is part of state government. Kudos for the step."

Simpson continued:

"It's difficult to know the exact financial impact. The proposed fiscal 2008-09 budget includes $250,000 for merit and cost-of-living increases. How much of that falls in this calendar year and how much comes in 2009 is not clear.

"Nonetheless -- as with many things in life -- it's the thought that counts . And this was a good one."

The reason for freeze? To show "solidarity" with the rest of the state and share the pain of the fiscal extremis in which California finds itself.

Simpson said that CIRM could go a little farther, demonstrating true fiscal leadership and cut by 10 percent the salary of any CIRM staffer making more than $190,000 a year.

Our take? With 10 years experience as business editor of a large daily newspaper and roughly that many years also as labor union representative, I am skeptical of salary freezes. They disproportionately affect employees at the lower pay scales, who have more difficult economic times, particularly with today's rising energy and food costs.

In the case of CIRM, the staff really has no choice concerning the freeze. Management wants it. Drag your feet, and you are not a team player or worse.

CIRM staffers are relatively well-paid by state standards so a case can be made that a freeze is reasonable. Symbols are powerful. An even more powerful symbol – a 10 percent pay cut for CIRM execs -- is suggested by Simpson, but we suspect that will remain a suggestion – not a reality. Sphere: Related Content