Text of CIRM Response on the Weakening of Financial Disclosure Requirements

On April 24, the California Stem Cell Report asked the state stem cell agency about its proposed changes in its requirements for financial disclosures from its officials. Here are the key elements from that query with the stem cell agency's response following.

The agency was invited to respond to the following: "The new code appears to give discretion to the employee to determine what enterprise is 'the type to receive grants or other monies' from CIRM. Additionally, it would not appear to require disclosure of an investment with or income from, for example, Kleiner Perkins, which is a major investor in iPierian, which holds $7 million in CIRM grants and could well be a future applicant...(T)he weakening of the code comes at a time when the agency is moving to cozy up to industry and looking to raise funds to continue its existence, all of which raises even greater conflict of interest issues than earlier in CIRM's existence."

Here is the text of the response April 25 from Kevin McCormack, CIRM's new senior director for public communications and patient advocate outreach.

"In answer to your question, we are proposing changes to the Conflict of Interest Code based upon recommendations from the California Fair Political Practices Commission (FPPC). The Political Reform Act requires state agencies like CIRM to review their Conflict of Interest Codes every two years.  The FPPC, which is charged with enforcing the Political Reform Act, is responsible for reviewing and approving CIRM's Conflict of Interest Code.  In preparation for this review, CIRM's counsel met with the FPPC staff who suggested the proposed amendments which are the subject of the upcoming Governance Subcommittee meeting.  The proposed amendments to CIRM's Conflict of Interest Code are consistent with the FPPC's position that agencies should tailor their disclosure categories to type of work performed by the agency.  For example, CalPERS's conflict of interest code requires CalPERS officials to disclose investments in, and income from, entities that are of the type with which CalPERS contracts and entities in which funds administered by CalPERS could be invested.  Likewise, the State Board of Education requires its members to disclose investments, business positions, and income from a publisher, manufacturer, or vendor of instructional materials, or services offered to educational institutions in the State of California and investments, positions of management and income from any private school in the State of California.  Similar to these codes, the FPPC proposed that CIRM's Code be tailored to the nature of CIRM's work.  Thus, the FPPC proposed that CIRM require its board members and high-level employees to disclose investments in, and income from, entities that are of the type with which CIRM would contract or from which CIRM could procure goods or services as well as investments in, and income from, biotech and pharmaceutical companies.  Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate.  It is important to remember, however, that this is a preliminary proposal.  CIRM will seek input from the Governance Subcommittee, the Board, and members of the public before seeking approval of the amendments."

Former iPierian Exec Joins California Stem Cell Agency as CFO

A former executive at a California stem cell firm has been named as the first chief financial officer of the seven-year-old, $3 billion California stem cell agency, it was announced today.

Matthew Plunkett, CIRM CFO
CIRM Photo

Matthew Plunkett, former vice president and chief financial officer of iPierian Inc., has been at work at CIRM since late last month. The agency said in a news release today that Plunkett is overseeing "budgeting, forecasting, financial compliance and reporting, and implementation of the industry loan award program."

Plunkett will also "play a key role in securing opportunities to leverage CIRM funds with additional outside capital," said CIRM Chairman Jonathan Thomas.

Plunkett worked for iPierian from 2009 until last April. While he was at the firm, it received $7 million in grants from CIRM. The South San Francisco business has a unique connection to CIRM. Major investors in iPierian, including John Doerr of Kleiner Perkins Caulfield Byers of Menlo Park, pumped nearly $6 million into the 2004 ballot campaign that created CIRM. That amounted to 25 percent of the total contributed to the campaign, which was headed by Robert Klein, who later became the first chairman of the stem cell agency.

CIRM has said no connection exists between the contributions and subsequent awards to iPierian.

The agency has needed a chief financial officer for some time. It has sometimes struggled with routine budget matters, although that problem seems to have been largely solved even before Plunkett was hired. Plunkett will report to both the agency's chairman, Jonathan Thomas, and CIRM President Alan Trounson, in a continuation of the troublesome dual executive arrangement at the stem cell agency.

Prior to joining iPierian, Plunkett worked for Oppenheimer/CIBC World Markets from 2000 to 2009. In his last position there, he was managing director/head of West Coast biotechnology. He holds Ph.D. in organic chemistry from UC Berkeley.

Plunkett, who is earning $260,004 annually, began work on Nov. 28. Today's press release on his hiring came after the California Stem Cell Report inquired on Saturday about progress in filling the position.

Here is a link to a brief article in the San Francisco Business Times about the Plunkett announcement.
(An earlier version of this item incorrectly said Plunkett started work on Nov. 11 based on his resume which said "11/11.")

High Level Changes at iPierian, a Firm With Deep Roots in California Stem Cell Effort

The South San Francisco stem cell firm, iPierian, which has a special and early connection to the California stem cell agency, has been undergoing major changes in the past few months.

 The latest came last week when it announced it has hired a new CEO, Nancy Stagliano, who was replaced Aug. 11 as CEO at another South San Francisco firm, CytomX Therapeutics.

Luke Timmerman of the Xconomy website wrote on Sept. 7 that Stagliano was named to the iPierian post after the firm "prioritized the company’s efforts over the past several months toward using its (ips) stem cell technology to help discover drugs for neurodegenerative disorders like Alzheimer’s, amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy."

 Last May,  iPierian unloaded most of its executive team. A few weeks later, the board chairman, Corey Goodman, quit. With Stagliano's arrival, interim CEO Peter Van Vlasselaer will become executive chairman of the board.

Major investors in iPierian, including John Doerr of Kleiner Perkins Caufield & Byers of Menlo Park, contributed nearly $6 million to the 2004 campaign for Prop. 71. The figure was 25 percent of the total contributed to the campaign, which was run by former CIRM Chairman Robert Klein, a real estate investment banker. As far as we know, no other biotech firm can claim to have that sort of early linkage to the $3 billion California stem cell agency.

CIRM has awarded $7.2 million to iPierian. One grant amounted to about $1.5 million with Berta Strulovici as the principal investigator. The other was for about $5.7 million with Michael Venuti as the PI.

The firm has a cast of stem cell luminaries associated with it, including Shinya Yamanaka of Kyoto University and the Gladstone Institute, along with  George Daley of Harvard University. Daley is a co-founder of iPierian. He also was a member of the blue-ribbon review panel that analyzed CIRM's activities last fall and is a current member of the CIRM grants review group.

Deepak Srivastava of UC San Francisco and Gladstone is also a co-founder and scientific adviser to the firm. He holds $6.6 million in CIRM grants. Other scientific advisers include CIRM grant recipients Benoit Bruneau, UCSF-Gladstone, $2.8 million, and Bruce Conklin, UCSF-Gladstone, $1.7 million.

Kevin Eggan, Amy Wagers and Chad Cowan, all of Harvard, are scientific advisers to iPierian as well as members of the CIRM grant review group.

Members of the CIRM grant review group are barred from taking part in the discussions or voting on grants on which they have conflicts of interests. Reviews are conducted behind closed doors.

Yamanaka said in an iPierian news release earlier this year,

“Many of my colleagues at The Gladstone Institute, UCSF and Harvard are already actively involved with iPierian, and I am delighted to join them in guiding iPierian’s industrialization of iPSC technology for drug discovery and development.”

Here is a link to the iPierian press release on the new CEO and a related story in the San Francisco Business Times.

Yamanaka Wins Kyoto Award

The Japanese stem cell scientist who pioneered reprogramming of adult stem cells has won the prestigious Kyoto Award, a $550,000 prize from the Inamori Foundation for research in advanced technology.

Shinya Yamanaka, who also has a lab at UCSF's Gladstone Institutes and is working with a CIRM-connected firm, is in San Francisco for the International Society of Stem Cell Research's annual convention.

David Pearlman, science editor of the San Francisco Chronicle, wrote,

“Robert Lanza, chief scientific officer of Advanced Cell Technology and an adjunct professor at Wake Forest University's stem cell research center, said recently that Yamanaka's work 'is likely to be the most important stem cell breakthrough of all time.'”

Jef Akst of The Scientist reported,

“Yamanaka's 2007 Cell paper was one of the most-cited papers last year, according to ISI. Last year, the No. 1 spot in The Scientist's Top 10 Innovations of 2009 went to a group that induced pluripotency in mouse embryonic fibroblast cells using only proteins, including the protein form of Yamanaka's four transcription factors, avoiding genetic modification altogether.”

Yamanaka is director of the Kyoto Universityh's iPS research center, which has an agreement with iPierian, Inc., of South San Francisco, a company backed with $20 million from the Kleiner Perkins venture capital firm of Menlo Park, Ca.

The iPierian Web site says,

“iPierian is the first company to focus the power of iPS technology to revolutionize the drug discovery process by producing iPS cells derived from patients to create truly disease-relevant model systems. These systems can be used for the discovery of new drugs and ultimately for treating diseases more safely and effectively.”

Ipierian has a $1.5 million grant from the California stem cell agency seeking to identify small molecules that promote the reprogramming of human somatic cells to the pluripotent state. Berta Strulovici is the principal investigator on that grant. The firm says it plans to seek more during a clinical trial grant offering from CIRM in the next month or so.

Four principals in the Kleiner firm contributed nearly $6 million to Prop. 71, which created the California stem cell agency in 2004. The amount was 25 percent of all funds raised for the campaign.

Campaign Contributions, Kleiner Perkins, iPierian and CIRM Grant

A biotech company heavily backed by venture capitalists who contributed nearly $6 million to the election campaign that created the California stem cell agency was awarded a $1.5 million grant this spring from the very same agency.

The firm, iPierian, Inc., of South San Francisco, reportedly plans to seek many more millions from the California Institute for Regenerative Medicine in the near future.

The venture capitalists are principals in Kleiner Perkins Caufield & Byers of Menlo Park, Ca. They include John Doerr and his wife, Ann, who contributed nearly $4 million to the Prop. 71 ballot initiative, according to state records. Doerr is well-known in company start-up circles and was involved in the early funding of Google and Amazon.

Other Kleiner contributors to the campaign included Vinod Kholsa, $500,000; Joseph Lacob, $750,017, and Brooks Byers, $480,000.

The Kleiner-related contributions amounted to 25 percent of the $24 million contributed in 2004 to create the stem cell agency.

During the 2004 campaign, some critics said that Prop. 71 amounted to little more than seed money for the venture capital community. The state voter guide's argument against the proposition said, “...(P)harmaceutical company executives and venture capitalists contributed $2.6 million (to gather signatures) to put this measure on the ballot. By getting taxpayers to fund their corporate research, they stand to make billions with little risk.”

In 2008, Kleiner launched its investment into what is now iPierian with $20 million. Kleiner is its single largest financial backer. One of Kleiner's partners has a seat on the five-member iPierian board.

In response to a query, James Harrison, outside counsel to CIRM, strongly defended the agency. He said its conflict of interest code exceeds the requirements of state law. The full text of Harrison's comments can be read here, but he said in part,

“In order to advance CIRM's mission, it is critical that venture firms like KPC&B (Kleiner) invest in stem cell companies so that these start-up companies have the funds necessary to bring therapies to the market.”

Kleiner did not respond to a request yesterday for comment.

The grant to iPierian was approved with the vote of the man who was the head of the Prop. 71 campaign, Robert Klein, a real estate investment banker in Palo Alto, Ca. He is now also chairman of the $3 billion California stem cell agency. Klein sits on the grant review group that makes the de facto decisions on grants. He participated in the closed-door session during which the iPierian grant (see review summary here) was approved and the full board meeting at which the decision was ratified. Harrison said no conflict of interest existed for Klein.

Harrison said,

“California conflict of interest law does not require recusal under
these circumstances. Indeed, the connection is so attenuated, it is difficult even to understand how this could ever rise to the level of a conflict.”

Harrison said Klein had no knowledge of the involvement of the Kleiner campaign contributors with iPierian. Harrison also said that Klein has pledged to “refrain from holding any financial interests in biotech companies as long as he is chairman.”

Another member of the grant review group had a direct connection to iPierian and was recused. She is Amy Wagers, a Harvard scientist who sits on both the iPierian scientific board and the CIRM grant review group. Wagers did not respond to a request for comment.

The stem cell company has other ties to CIRM. George Daley of Harvard, co-chair of the iPierian's scientific advisory board, is on the blue-ribbon scientific panel that is slated to assess CIRM's progress next fall. In addition to Wagers, two other members (Kevin Eggan and Chad Cowan)of the iPierian advisory board serve on CIRM groups that make decisions on grants and recommend research policies to the CIRM board. John Walker, the president of iPierian, and Ted Love, a CIRM board member, both serve on the 9-member board of directors of Affymax, Inc., of Palo Alto, Ca.

Daley and iPierian did not respond to a request for comments.

Ipierian has said it is interested in applying for more cash from CIRM. According to Ron Leuty of the San Francisco Business Times, the firm plans to seek an award in CIRM's new, $50 million clinical trial round. It is expected to be one of only three companies applying in that round.

We will carry the full text of remarks from Kleiner, iPierian or individuals mentioned in this item if we receive them.

Text of CIRM Response on iPierian Grant and Campaign Contribution

Here is the text of an email June 15, 2010, from James Harrison, outside counsel to the California stem cell agency, concerning the iPierian grant.

David,

Thanks for speaking with me this morning. CIRM's Governing Board has
set conflict of interest standards that exceed the requirements of state
law, and Mr. Klein has exceeded even these standards by refraining from
holding any financial interest in biotech companies during his tenure.
I understand that your story will suggest that Bob Klein should have
recused himself from the Board's consideration of an application
submitted by iPierian for a Basic Biology II Award because iPierian is
backed by Kleiner Perkins Caufield & Byers, one of whose principals is
John Doerr who, along with his wife, contributed money to the Prop. 71
campaign. I strongly disagree with your suggestion that Mr. Klein's
participation in the Board's consideration of the iPierian application
creates a conflict. Here are the facts:

1. The Board awarded a Basic Biology II grant ($1.48 million) to
iPierian in April 2010.

2. KPC&B invested $20 million in iZumi in July 2008.

3. iZumi merged with Pierian to form iPierian in July 2009.

4. In 2003 and 2004, John and Ann Doerr contributed to the Prop. 71
campaign.

5. Chairman Klein had no knowledge that: (a) KPC&B had invested in
iZumi; (b) iZumi had merged with Pierian to form iPierian; (c) KPC&B
became an investor in the new company as a result of the merger; or (d)
that George Daley was associated with iPierian (although had he known,
it may have increased his respect for the company).

6. Chairman Klein has no financial interests in biotech companies and
has pledged to refrain from holding any financial interests in biotech
companies as long as he is Chairman.

7. California conflict of interest law does not require recusal under
these circumstances. Indeed, the connection is so attenuated, it is
difficult even to understand how this could ever rise to the level of a
conflict.

8. In order to advance CIRM's mission, it is critical that venture
firms like KPC&B invest in stem cell companies so that these start-up
companies have the funds necessary to bring therapies to the market.

Bob also asked me to relay to you that he has great respect for John and
Ann Doerr, who contributed to the Prop. 71 campaign and to other
research institutions to support their efforts to find a cure for cancer
and other major diseases.

Thanks for your consideration of these points.
__________________________
James C. Harrison
Remcho, Johansen & Purcell, LLP
201 Dolores Ave.
San Leandro, CA 94577