Thursday, January 30, 2014

Moderate Media Coverage of Stem Cell Agency and Genomics Award

The California stem cell agency's $40 million stem cell genomics effort is receiving a moderate amount of attention in California media outlets and on some national online sites.

Some in the world of academic science might say, “So what.” The simple answer is that if the agency's work is unnoticed or unappreciated by the public, raising the cash to continue its awards beyond 2017 is unlikely. Funds will run out then for new grants, and the agency is looking for ways to stave off its demise. Its needs public recognition – particularly among well-endowed circles, be they private, industry or governmental.

The agency could be reasonably satisfied with its media play. This week's coverage represents an increase in media attention compared to the  usual meager stories about the agency's board meetings.

(After this item was posted, we caught up with an item by Kevin McCormack on the agency's blog. McCormack, the top communications person at CIRM, said,
("Reporters from newspapers, radio, TV and online news outlets around the state seemed to...appreciate the significance of the award.
("The story was carried in outlets from the Sacramento Bee and San Francisco Chronicle to the San Diego Union TribuneABC7 TV in San Francisco covered the meeting and NPR stations around the state also aired pieces about it. It even caught the interest of the sometimes-jaded scientific business press.
("The money we use to fund this research comes from the people of California, thanks to Proposition 71, so it’s important that they know how we are spending their money. This round of stories showed them it’s being used in ways that could one day help change the face of medicine.")
In California, stories appeared in the San Francisco Chronicle (Erin Allday writing), the San Diego U-T(Bradley Fikes), the San Francisco Business Times (Ron Leuty), the Sacramento Bee (David Jensen),  Palo Alto Online and San Diego Metro. Nationally, Xconomy (Bruce Bigelow)and Genetic Engineering News carried pieces.

The Associated Press did not carry a story, although the news service had one last Sunday, which was a rewrite of The Bee story that day. Duplicates of today's Bee story are likely to appear in California via the McClatchy-Tribune News Service, which distributes Bee articles to other outlets.

Most of the stories yesterday and today made little or no mention of the controversial aspects of the award process.

(Shortly after this item was posted, Nick Paul Taylor of FierceBiotech posted a piece that began,
Illumina ($ILMN) is a company that has become used to success. Over the past year its share price has soared 180% as it has established a dominant position in what is potentially a $20 billion market. Yet this week it tasted defeat when Stanford University beat it to a $40 million grant to set up a stem cell genomics center in California.”
(GenomeWeb also filed a late story.)

The Chronicle story by Allday noted that the award was the board's “first formal foray” into genomics. Fikes' story in the San Diego U-T carried brief remarks from Jeanne Loring of Scripps, whose genomics proposal was rejected by CIRM, and Joe Panetta, president of the San Diego life sciences industry group, Biocom.

Panetta was attending his first meeting as a member of the agency's governing board. At the session, Panetta pressed for broader geographic representation, which would have favored Scripps' proposal. He told Fikes that he intends to become “a lot more engaged” in the grant review process.

Loring said the value of Illumina, Inc., as her partner was undervalued in the CIRM grant review process.

Here is Stanford's press release by Krista Conger, which carries the names of other researchers involved in addition to ones previously identified.

Correction

In the item yesterday “Stanford Consortium Wins....,” the vote on the genomics award was incorrectly stated as 6-2. The vote was actually 6-1.



Wednesday, January 29, 2014

Stanford Consortium Wins $40 Million to Create Stem Cell Genomics Center

Directors of the California stem cell agency today approved a $40 million proposal ultimately targeted at creating medical treatments tailored to a patient's genetic makeup and making the state a world leader in stem cell genomics.

The proposal by a seven-member consortium led by Stanford University was approved on a 6-1 vote of the 29-member board. Most of those not voting were disqualified because of conflicts of interest.

The action came despite charges by Stanford's competitors that the grant review process was tainted by unfairness, apparent preferential treatment and manipulation of scientific scores.

The award is the largest research grant that the agency has made in its nine-year history although the cash is being divided among the seven participants over five years.

The board added $7 million to the Stanford award to help possibly fund proposals from institutions that lost out in the round. They would have to apply to the consortium, which might have their own proposals in the same areas already underway.

The stem cell agency has high hopes for the genomics project, which is supposed to provide resources for all researchers in California. CIRM President Alan Trounson has predicted that the effort will build “an effective stem-cell genomics infrastructure that will be unique in the world, thus positioning California as a leader in this critical area of basic and translational research while genomic technologies build steam in the next five years.”

In addition to Stanford, the other enterprises involved its proposal include UC Santa Cruz, the Venter and the Salk institutes and Illumina, Inc., all in San Diego,  A complete list was not immediately available this afternoon because the stem cell agency withholds their names until after the board votes. They are expected to be disclosed shortly in an official press release.

(Here is a link to the CIRM press release.)

The top competitors against Stanford were groups led by UCLA, UC San Francisco and the Scripps Research Institute in La Jolla. UC San Francisco and Scripps both sent letters to the agency's board protesting the grant review process.

In a letter last week to the board, Pui-Yan Kwok of UC San Francisco, criticized the manipulation of the Stanford's grant application in such a way that its scientific score was improved. Kwok, leader of the bid that also involved UC Berkeley, called the situation “appalling.” The stem cell agency said, however, the changes were permitted under the terms that the agency had laid out in advance.

Jeanne Loring of Scripps, leader of an effort also involving the genomics firm, Illumina, Inc., of San Diego, said in a letter that the agency had failed to disclose in its request for applications that one of the key criteria for the “scientific merit” of the grants would be matching funds. Stanford was praised by reviewers for its “substantial” matching funds. Scripps' application was cited for a “serious” deficiency in that area.

Loring said that Illumina, a world leader in genomics, added major value to their proposal. The firm was also involved in the Stanford proposal in a lesser manner.

Michael Snyder, leader of the winning consortium, told the board that his group promised $7 million in matching funds. 

During the meeting, Trounson said he had told all applicants, with the exception of Stanford, that financial matching would be considered during the review. However, that was not included in the RFA.

Several board members earlier raised questions about the problem with the RFA and said it could create confusion and lead to perceptions of unfairness.

The RFA called for creation of one or two centers. Trounson recommended funding only the Stanford effort.

Michael Yaffe, associate director of CIRM's research activities, said the Stanford proposal would fulfill all goals of the RFA. He said the staff did not see a "compelling need" for a second center nor would it fit within the budgeted $40 million.

The California Stem Cell Report first reported on Friday that Stanford was set to win the award. 

(Editor's note: An earlier version of this article incorrectly stated the vote was 6-2. The correct vote is 6-1 with board member Steve Juelsgaard voting no.) 

Genomics Center Discussion Begins

Deliberations in the $40 million genomics round at the California stem cell agency have begun.

California's Stem Cell Directors Back at Work

Directors of the California stem cell agency have resumed their meeting and expect to take up the $40 million genomics round after dealing with three brief items.

California Stem Cell Directors Working Through Lunch

Directors of the California stem cell agency are fetching their meals for a working lunch as they continue with their agenda at their meeting in Berkeley. Still to be heard are applications in the $40 million genomics round.

Just prior to lunch, the directors paid tribute to Michael Goldberg, who is leaving the board after serving since its inception in 2004. In his remarks after hearing his colleagues and noting the arduous history of the agency, he said,
"They tried to kill us. They failed. Let's eat."

$27 Million Approved for Basic Stem Cell Research in California

Directors of the California stem cell today approved, 11-0, about $27 million for basic research into workings of stem cells.

The round was originally budgeted for $40 million, but grant reviewers did not approve grants that would have required that level of funding.

Reviewers recommended 21 grants for approval for a total of $21 million. CIRM staff recommended another five costing $4.8 million. The 29-member board added another two grants totaling $1.1 million.

The board rejected other pitches by reviewer-rejected applicants for reconsideration. The stem cell agency later today is expected to release the names of all the winners. It never releases the names of rejected applicants.
 (Here is a link to the CIRM press release with the names of the winners.)

Stem Cell Ethics to be Examined in March

In its $700,000 study of the California stem cell agency, the Institute of Medicine recommended that it finance more work dealing with ethical issues in stem cell research. 

Today, CIRM President Alan Trounson announced that the agency was participating in a workshop in Berkeley in March. The above chart was presented at the meeting of governing board of the agency this morning. 

For more information, email the agency at info@cirm.ca.gov

$21 Million of Basic Research Being Discussed by Stem Cell Agency

Directors of the California stem cell agency have begun discussion of applications in its grant round involving basic biology research. The board is expected to award at least $21 million in this round. 

Conflicts Listed in Upcoming Voting in California's $40 Million Genomics Round

Here is a list of members of the governing board of the California stem cell and the conflicts of interest that exist on each application in the $40 million genomics round.

The list was provided by the stem cell agency at the request of the California Stem Cell Report.

The members listed in each row are are barred from voting on the grant listed in the far left column. (Following the first posting of this list, the agency said, "Steve Juelsgaard is erroneously listed as being in conflict with genomics application 6683 under the Data and Coordination Management category." Later in the day, the agency also reported another error.  "Jacob Levin is included for application 6708, but does not have a conflict.")

A Reading List for California's $40 Million Stem Cell Genomics Round

Here are links to recent stories dealing with the California stem cell agency's $40 million stem cell genomics round -- a plan to make the state the world leader in the new field.

Thursday Jan. 23, 2014
California's Stem Cell Genomics Awards: An Untidy Affair
The California stem cell agency's $40 million genomics round seems to be turning into a bit of a muddle.

Friday Jan. 24, 2014
Stanford Genomics Consortium Likely Winner in $33 Million Stem Cell Agency Project
A seven-member consortium led by Stanford University's Center for Genomics and Personalized Medicine is expected next week to win a $33 million award from the California stem cell agency to create a stem cell genomics center.

Saturday Jan. 25, 2014
California's $40 Million Genomics Round: Charges of Unfairness, Factual Error and More
Scientists at two major California research institutions have leveled charges that the state stem cell agency's $40 million genomics round is tainted with unfair and non-scientific considerations along with factual errors, manipulation of scores and apparent preferential treatment.

Sunday Jan. 26, 2014
Sacramento Bee: California Stem Cell Agency Betting Big on Genomics
The Sacramento Bee today published an article by the publisher of the California Stem Cell Report on this week's $40 million genomics round and its significance. The Associated Press picked up the story and distributed it nationally.

Sunday Jan. 26, 2014
Alan Trounson's Opaque Messages, Genomics and $40 Million
Cryptic is probably a good word for the messages delivered last week by the president of the California stem cell agency, Alan Trounson, in his recommendations in the agency's $40 million genomics round. Odd might be another.

Monday Jan. 27, 2014
California's $40 Million Genomics Round and Conflicts of Interest
Concerns about conflicts of interest have dogged the California stem cell agency since its earliest days, and they continue into this week's $40 million genomics round.

Monday Jan. 27, 2014
California's $40 Million Genomics Awards: Stem Cell Agency Defends its Review Practices
The California stem cell agency today defended itself against charges that scoring on grant applications was manipulated in its $40 million genomics grant round to the benefit of a consortium headed by Stanford University researchers.

Wednesday Jan. 29, 2014
California Stem Cell Agency Withholds Key Information in $40 Million Genomics Proposals
The California stem cell agency has declined to disclose publicly a critical criteria – the amount of matching funds offered by each applicant -- in its ambitious $40 million genomics round scheduled to be acted on later today.

New CEO for California Stem Cell Agency in May

The California stem cell agency expects to make a decision on a candidate for a new president by May, the chairman of its governing board said this morning.

J.T. Thomas opened this morning's meeting by addressing the search for a new president to replace Alan Trounson, who has resigned but is serving temporarily.

Warren Roth, a representative of the Korn Ferry search firm, said that it expects to present candidates in late March. He said the board would be able to interview candidates in April.

The board has a regular meeting scheduled for May 29.

California Stem Cell Agency Opens Meeting to Discuss $40 Million Genomics Proposals

Directors of the California stem cell agency began their meeting today in Berkeley at 9:11 a.m. It is not yet clear at what time they will take up the proposals in the $40 million stem cell genomics round.

Stem Cell Agency Yet to Begin

Today's meeting of the governing board of the California stem cell agency appears to be a bit late in starting. We are checking on the situation.

California Stem Cell Agency Withholds Key Information in $40 Million Genomics Proposals

The California stem cell agency has declined to disclose publicly a critical criteria – the amount of matching funds offered by each applicant -- in its ambitious $40 million genomics round scheduled to be acted on later today.

A spokesman for the $3 billion state agency yesterday said the figures were not a public record. However, the agency has public revealed such figures in the past.

The matching funds played a major role in the top ranking of a $33 million genomics proposal by a Stanford-led consortium. Lack of matching funds also was deemed a serious problem by the agency's grant reviewers, who operate behind closed doors, in an application led by the Scripps Research Institute.

When asked for the figures, Kevin McCormack, senior director for public communications, said,
 “That is proprietary information, and so it's not available.”
He has not yet responded a follow-up question about the rationale for cloaking such figures in secrecy that goes beyond the simple assertion that they are proprietary. Generally, proprietary information is considered to be trade secrets or involve intellectual property or unique business methods.

Financing is commonly disclosed by businesses and is even required by federal law when a company is publicly traded.  

Tracking the Evolution of the Stem Cell Genomics Applicants

The plan to create one or two stem cell genomics centers in California at a cost of $40 million began in 2012. Since then there have been some changes, some of which resulted from the failure of reviewers to recommend any proposals in 2013.

Last week, the California Stem Cell Report (CSCR) asked the California stem cell agency(CIRM), which is scheduled to make a decision today on an at least one application, about several of the changes. Here are the texts of the questions and answers from the agency.

CSCR: Has the cast of applicants changed since the initial review in early 2013? Have some dropped out or been added? Have the applications been recast significantly for the most recent review?

CIRM: Applicants to the first round of review were eligible to participate in the second round.  Although review criteria remained the same as those stated in the RFA, applicants were allowed to change proposal components, establish new collaborations and/or combine efforts.  

CSCR: How many letters of intent (LOI) were received with a breakdown on the number from academic and business enterprises?  How many applications were received, also with a breakdown on academic and business?


CIRM: For the first round, there were 9 LOI's; 7 of these submitted applications.  No LOI was required for the second round.  All first round applicants participated in the second round of competition, but several have combined efforts, so there were 5 applications in the second round.  Three of these applications were collaborative proposals combining both for-profit and not-for-profit organizations, while the other two were from not-for-profit institutions.

Tuesday, January 28, 2014

Upcoming: Live and Complete Coverage of Tomorrow's $80 Million Stem Cell Meeting

Check in tomorrow on the California Stem Cell Report for gavel-to-gavel coverage of the meeting of the governing board of the $3 billion California stem cell agency. As much as $80 million is at stake, including a $33 million plan by a Stanford consortium to create a world-leading stem cell genomics center.

The meeting is scheduled to begin at 9 a.m. PST. Coverage will begin at that time with stories filed as developments warrant.

For those who want to attend the event, it will be in Berkeley. Teleconference locations are in La Jolla and Los Angeles. The meeting will be audiocast on the Internet with a WebEx transmission of documents that are displayed for the board. Full instructions are on the meeting agenda along with the addresses of the teleconference locations and the actual meeting.

Goldberg Departs from California Stem Cell Board; Panetta and Miller Join

The California stem cell agency is losing another of the original members of its governing board but two new ones with markedly different backgrounds will be joining the 29-member panel tomorrow.

Departing is Michael Goldberg, a venture capitalist from the San Francisco Bay area. He has served as head of the board's finance subcommittee. Along with Marcy Feit, another longtime board member, he has cleaned up the accounting
Michael Goldberg
Mobihealth News photo
mess that once made the $3 billion agency's operational budget nearly incomprehensible.

In response to a question from the California Stem Cell Report, Goldberg said,
"John Thomas's leadership (as agency board chairman) has long been firmly established and it is now time for me to step aside to allow for a new appointee to contribute to taking CIRM to the next level.
"I will be forever indebted to have had the privilege to serve my fellow Californians as a member of the ICOC(the agency governing board). As a patient advocate and member of industry I am extraordinarily proud of what CIRM has accomplished to date and enormously enthusiastic about our future prospects for improving patient care and bettering the health care economics of our state."
Joe Panetta
Biocom photo
Joining the board in Berkeley tomorrow are expected to be Joe Panetta, head of Biocom, and Hollywood actress and writer Lauren Miller. Both were appointed by California Gov. Jerry Brown, who sometimes is noted for his unusual choices in personnel.

Panetta, however, does not fit that category. He is a longtime figure in the biotech community in California. He has been head of Biocom, the life sciences industry association in the San Diego area, since 1999. He fills the vacancy left by the death of Duane Roth, who was also came from the San Diego business community.

Lauren Miller
Ivan Nikolov/WENN photo
Brown's other appointment, Lauren Miller, comes from a far different perspective. She wrote the script for the movie "For a Good Time, Call..." Last spring, she and her husband, actor and director Seth Rogen, staged a fundraiser last year called “Hilarity for Charity” on behalf of Alzheimer's, generating more than $500,000 in donations.

CIRM quoted Miller in a press release as saying,
“To have the opportunity to learn about, and support the research for so many important diseases is such a great honor and responsibility and I look forward to starting.”
The agency also said,
“Miller’s commitment to raising awareness about Alzheimer’s comes from her family’s battle against the disease. Her grandfather died of Alzheimer’s and her mother was diagnosed with it when she was just 55 years old.”
Miller replaces Leeza Gibbons, another celebrity who is a patient advocate for Alzheimer's.

$21 Million Likely for California's Basic Stem Cell Research

Directors of the California stem cell agency tomorrow are expected to approve at least $21 million for basic research into “significant, unresolved issues in human stem cell biology.”

The round was originally slated for $40 million but grant reviewers decided to fund only 20 applications out of 62. The round began with 341 scientists filing pre-applications.

(Here is a link to reviewers' summaries and rankings as well as a link to the CIRM staff's Power Pointpresentation.)

CIRM President Alan Trounson and his staff recommended approval of five additional applications totaling$4.8 million. The rationale in their recommendations could be considered fulsome compared to what Trounson offered on the $40 million genomics round also to be considered tomorrow.

Five additional researchers filed letters with the CIRM governing board seeking its approval. Those letters can be found on the agenda for tomorrow's meeting. Seven researchers filed formal appeals with the CIRM, which are now dealt with behind closed doors by the agency's staff.

The 20 applicants given the nod by reviewers were placed in a tier one category that is virtually certain to be approved by the board with no debate. Others were ranked in a wobbler category called tier two, meaning it could go either way for the scientists. The remainder fell into tier three – not recommended for funding by reviewers.

The board is increasingly turning to proposals that will turn more advanced research into clinical treatments. If directors do not go for spending the entire $40 million budgeted, they would save money that could be used for clinical trials. However, aside from the general arguments for doing basic research, those grants provide large sums to recipient institutions to pay for their overhead. And many of the agency's board members come from institutions that could benefit from payments for those overhead costs. Those board members will not be allowed to vote on applications involving their institutions.

(Editor's note: The number of researchers filing formal appeals was not contained in an earlier version of this article.)

California's Stem Cell CEO Search: Dangling a 16-page Lure

The California stem cell agency yesterday posted what could be called a recruiting brochure for the effort to hire a new president to replace Alan Trounson.

The document, which was prepared by the search firm Korn Ferry, is couched in language designed to stimulate interest in those seeking a challenge and opportunity.
  • “Few technologies have captured the imagination of the public quite like human stem cells,” the brochure begins.
  • “Transformative public funding,” it says at one point.
  • “One of the most influential agencies in the universe of stem cell research,” it says at another.
The 16-page brochure deals directly with less pleasant aspects of the job such as the likelihood that the agency could wind up in hospice care in three years when the money for new grants runs out.

It is also surprisingly forthright about the longstanding and controversial problem of the dual executive arrangement decreed by law. It may be the first time that the agency has so directly admitted publicly and formally that the overlapping responsibilities of the president and chairman have caused serious difficulties. 

The document says,
“This unique partnership has amply demonstrated its value when the president and chair have worked well together, but the organization has suffered when this has not been the case. An ability to adapt to this model of governance and management will be a critical attribute for the next president.”
The CIRM/Korn Ferry brochure is explicit about the direction of the agency towards pushing therapies into the marketplace and clinic. That is significant because of continuing pressures to well fund basic research, which means less money for efforts that are closer to clinical use. The document says,
"With the remaining resources of the state’s commitment, it is CIRM’s intention to focus its funding decisions increasingly on a host of projects with particular clinical promise, bringing the science it has strategically cultivated to the fruition of human therapy.  Both the governing board and the staff of CIRM are committed to this pivot in organizational priorities, driven to fulfill the dream of the people of the State...."
It is unclear when a new president will be on the scene. There is talk about a hire being made by April or May, but having the new person actually in the office five or more days a week could be a different matter. Trounson said last November he would stay on for awhile. But his family remains in Australia, where he is seeking to return.

The directors' Presidential Search Subcommittee meets tonight in Berkeley to discuss the brochure, which the agency labels a "candidate position statement." Korn Ferry has a $160,000 contract with the agency. The agency has previously used search firms in its presidential recruitment. None of them have come up with the person that was ultimately hired.  

Teleconference locations where the public can comment are available in Costa Mesa, La Jolla and San Francisco. Specific addresses can be found on the agenda.

(Editor's note: The three sentences on the size of the Korn Ferry contract and the success of previous search firms were not contained in an earlier version of this story.)

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