Showing posts with label cirm culture. Show all posts
Showing posts with label cirm culture. Show all posts

Tuesday, July 22, 2014

California Stem Cell CEO Randy Mills on Focus and Four-Part Tests

It was a case of CEOs interviewing CEOs.

More specifically, it was Robin Smith, head of Neostem, Inc., “grilling” Randy Mills, the new CEO of the $3 billion California stem cell agency. The venue was the Huffington Post.

It wasn’t exactly hard ball stuff, as one might expect. Nonetheless it was the lengthiest such exchange with Mills, the former president of Osiris Therapeutics of Maryland, since he was named president of the stem cell agency in April.

Neostem, by the way, does not hold any awards from the agency, although it does have operations in Mountain View and Irvine. The Southern California location is the site of the former California Stem Cell, Inc., which was purchased by Neostem for $126 million earlier this year, obviously making Neostem a potential applicant for CIRM funds.

Here are some excerpts from Smith’s interview with Mills.

On leaving Osiris and coming to California, Mills,
“I started discussing with my family what might be next, including taking a break to spend more time with them. However, fate had other plans.
“In February I received a call from CIRM asking if I was interested in the President and CEO position. Having spent the past five years as a grant reviewer for CIRM, I was already quite familiar with the stem cell agency. If you believe in the potential of regenerative medicine and cell therapy as I do, there is no place in the world you could go to have a bigger impact. No company, no other state, not even a country can have the impact California can have in bringing these treatments to patients. And so with that, I accepted the challenge.”
Mills’ four-part test for CIRM projects:
“First, will what we are doing speed up the development of stem cell treatments for patients? Second, will it increase the likelihood of a successful treatment reaching patients? Third, is it for an unmet medical need? And lastly is it efficient?”
Mills’ focus on “focus,” something he mentioned in slicing $15 million from the $70 million Alpha stem cell clinic plan.
“For CIRM to achieve its full potential, I firmly believe we need to remain focused on bringing treatments to patients, fast. Everyone loves that word, ‘focus.’ However, what they may not love is living with its reciprocal, which is everything else we don't do. Without focus, you never have to have the hard conversation. You never have to say ‘no.’ However, without focus, you also tend to not get things done. I came to CIRM to get stem cell treatments to patients in need, and that means focus.”
Mills on funding projects that “otherwise will get done.”
“CIRM exists under the principle of ‘If not for us....’ California stepped up when, and most importantly because, others would not. Funding something here-and-now that will otherwise get done without CIRM is not consistent with what the people of California wanted to accomplish with Proposition 71(which created the agency). It also violates my third rule, because it wouldn't really be an unmet need if it were going to happen in any event.
“We are here to help get stem cell treatments that, if not for us, would take longer to reach patients or might not happen at all. If you look at the projects we support that are now heading into clinical trials, many would never have even gotten off the ground if it hadn't been for us.”­­­­
Mills did not mention this, but funding such projects is also high risk. That’s why they haven’t been funded. So the reasonable expectation is to see a few failures – perhaps more than a few – among the CIRM efforts.

Tuesday, February 24, 2009

Honesty, Science and Politics

Part of the justification for the existence of the California stem cell agency lies in the argument that scientific research should be above politics and government and apart from it.

However, science has rarely been apart from politics – at least in the last 50 or 60 years in this country.

New York Times
columnist John Tierney dealt with the intersection of the two in a Monday piece – headlined "Politics in the Guise of Pure Science" -- in which he raised questions about whether some of President Obama's scientific advisers can be "honest brokers."

He quoted Roger Pielke(see photo) of the University of Colorado on the matter, whose book, not so coincidentally, is entitled "The Honest Broker." Tierney said Pielke argues that "most scientists are fundamentally mistaken about their role in political debates. As a result, he says, they’re jeopardizing their credibility while impeding solutions to problems like global warming."

Tierney wrote,
"...(T)oo often, Dr. Pielke says, they pose as impartial experts pointing politicians to the only option that makes scientific sense. To bolster their case, they’re prone to exaggerate their expertise (like enumerating the catastrophes that would occur if their policies aren’t adopted), while denigrating their political opponents as 'unqualified'or 'unscientific.'"
Tierney cited recent statements by John Holdren and Steven Chu as examples. Tierney did not discuss human embryonic stem cell research in his piece, but he could have.

The case for hESC research is often imbued with messianic zeal and rhetoric about "missions" that seems more appropriate to an ideology rather than cold, hard scientific research. Hyperbole does not necessarily serve the public or scientists well over the long term, perhaps not even in the short. Instead, it can become a justification for spending on ill-considered, dubious efforts advanced to attain some sort visionary goal. Pielke's and Tierney's cautions are something for the overseers of California's $3 billion stem cell research program to keep in mind as they evaluate the agency's efforts in the next few months.

(Editor's note -- Tierney's column drew 156 comments at the time of this writing. You can read them here).

Thursday, April 24, 2008

Fresh Comment

Marcy Darnovsky of the Center for Genetics and Society has left a new comment on the Flamm item below. Among other things, she says there were a number of concerns with the Cha grant that were not mentioned in the item about Flamm. She is absolutely correct. We also did not mention that CIRM's scientific reviewers had no idea of the controversy surrounding Cha when they approved the grant. The scientific reviewers knew the name of the applying organization at the time of the review but it was kept secret from CIRM directors when they later ratified the reviewers' decision in public session. That secrecy is part of the official CIRM process. One CIRM official told us later that the Cha grant would not have been approved by the scientific panel if they had been informed of the controversy.

Monday, June 25, 2007

A Retrospective on CIRM: The View from Wyoming

The former president of the California stem cell agency – Zach Hall -- reflects on his two years in the job, CIRM's accomplishments and the challenges facing in the $3 billion program in a piece in the San Diego Union-Tribune.

Reporter Terri Somers wrote the Sunday story on the eve of this evening's and tomorrow's meetings dealing with the appointment of a new president. Hall had planned to leave the agency this month, but accelerated his departure following an acrimonious session of CIRM's Facilities group.

Hall was circumspect on some topics, including the longstanding structural problems at CIRM with its dual executive arrangement that is locked into state law by Prop. 71.

Nonetheless, Somers' story offered some insights. She wrote that the president has no clear voice in grant funding. Hall noted that the CIRM president has no seat on CIRM's controlling body, the Oversight Committee, as contrasted to the NIH. Hall said:
"Proposition 71 poses an administrative challenge in that it gives significant leadership responsibility to both the chairman and president. In a small organization, which at the time I was president it was, two strong leaders often posed a challenge. Both of us had (previously) been in leadership positions and had strong views about how things should be done.

"This sometimes led to conflict. In the end, results can best be judged by the record of accomplishment of the institute."
Hall on relations with Oversight Committee members:
"'In retrospect, I think I could have probably worked harder to improve my relations with some of the board members. I think it wasn't clear to me as early as it might have been how important that was,' Hall said. 'I mostly confined my interactions to official occasions, and I think it would have helped if I did some things to meet with people individually.'"
Somers continued:
"There are a number of internal problems at CIRM that need to be worked out, he said.

For example, there needs to be a unified vision among the groups represented on the board and the staff, he said.

"'I hope that out of that process would come a strong sense of mutual trust, which I think was one of the issues at the facilities working group meeting.'"
Hall on relations between CIRM staff and the 29-member Oversight Committee, which sometimes engages in micromanagement (our word, not Hall's):
"The institute has a tremendously talented staff and I think it is important the board trust the staff to do its work, and work in the direction that is congenial with where the board wants to go. There needs to be a sense that the board doesn't need to participate in every decision, or be involved in all details of the administration."
Hall on the private sector and the future:
"The institute's next president, he said, could really make an impact by developing a strategy for working with private industry. So far, the institute has developed plans only for dealing with nonprofit research institutions and universities. Ultimately, the institute wants to partner with companies by helping with clinical trials and getting therapies to patients.

"'This is a whole new territory, and we don't have good models,' Hall said.

"'Because of the way the field has developed, a lot of important discoveries have been made on the private side, and we don't always know what they are. We need to know who it's worth putting money into, while not violating their need for confidentiality, which will be a challenge.'"
Hall's plans? Enjoy the summer at his place in Wyoming and serve on the scientific advisory board of the New York Stem Cell Institute.

Sunday, April 22, 2007

CIRM's Facilities Meeting: 'Not So Terrible'

The contentious Friday the 13th session of the Facilities Working Group of the California stem cell agency triggers different reactions from different folks. We queried John M. Simpson, stem cell project director of the California Foundation for Taxpayer and Consumers Rights, about his impressions. Here is his reply.
"I've finally read the transcript of the FWG meeting. I actually didn't think it was so terrible.

"Yes, there were 'full,fair,frank exchanges of views' as the diplomats would say, but I thought the meeting got to what is a fundamental split on the question of how to award facilities grants-- or indeed if any should be awarded.

"I think all too often the academics and research institution representatives on the ICOC have exhibited almost a sense of entitlement to CIRM money.

"I am delighted to see members of the Facilities Working Group voicing their sense of responsibility to California taxpayers to be good stewards of CIRM funds. They are taking their responsibility seriously and should be commended for that.

"I'd also add that on the issue of making facilities grants, the academics are clearly conflicted.

"Deliberate speed is appropriate, but the emphasis must be on deliberate – not on speed for speed's sake."

Thursday, April 19, 2007

CIRM Facilities Rancor: Delay and Dollars

Contentious, personal, confrontational, sarcastic – all could accurately describe last Friday's session of a key group of the California stem cell agency.

But, based on the transcript, the descriptions miss what was fundamentally important about the meeting and also what was hardly said. And that is: The agency is not required to spend $300 million on bricks and mortar – the major labs so desired by California research institutions. It is merely authorized to do so. And delaying them could mean more money for other endeavors.

The meeting of the Facilities Working Group was cited by CIRM President Zach Hall in his letter announcing that he was stepping down early. (See "Edifice" below.) The nominal topic of the meeting involved the laying more of the groundwork for $222 million in grants for major research facilities at California universities and nonprofit institutions.

But by the end of the acrimonious session, the Facilities Group, dominated by patient advocates, had set the stage for a major debate within the CIRM Oversight Committee. Three days prior to the Facilities meeting, patient advocates had lost a straw vote within the 29-member Oversight Committee for a more modest proposal for a written survey instead of the public hearings approved by the Facilities group. A seeming routine matter that was freighted with major baggage, including who is in charge – the Oversight Committee or its advisory groups?

Other issues emerged as well. The Facilities meeting highlighted the difficulties that any organization faces when it tries to operate without a "permanent" CEO. Hall was already a lame duck at the time of the meeting, having announced his departure last December. The session also demonstrated persistent divergence about the role of the CIRM president. Oversight Committee Chairman Robert Klein insisted that Hall execute the wishes of the Facilities Group even though Hall believed they conflicted with the Oversight Committee.

Finally, there were questions of the balance between making grants with great speed and exercizing due diligence.

Prop. 71
, which altered the California Constitution and created CIRM, provided for spending as much as $300 million on laboratory facilities. If the agency does not spend all of the sum, the remainder could go for more direct development of cures and therapies, a high priority for patient advocates who sit on the board. At the same time, top executives from California universities sit on the Oversight Committee. Their view is that they do not have enough room for existing researchers, much less the ones that are being recruited to come to the Golden State to perform embryonic stem cell research financed by CIRM. Construction costs are spiraling upward, and any grants will buy less in 12 months than they do today.

Prolonging the grant process could, however, mean that more funds would be ultimately available for patient advocate-backed research. Unwilling to wait, institutions will find other funding sources. Needs will change. Grant criteria could become more strict, ruling out some institution's plan. Some projects may become prohibitively expensive because of rising construction and equipment costs.

No one on the Oversight Committee is talking publicly about such a delaying strategy but it is clearly viable. And it is one that is not likely to be regarded kindly by institutions represented on the panel.

At last Friday's meeting, Hall said that the Oversight Committee had indicated a need for speed in moving grants forward and that he was receiving the opposite instructions from the Facilities Group. He said his first responsibility was to the full Oversight Committee. Hall said,
"I feel it is very important that it be worked out at the highest governance level for this whole organization, which is the board. I think that is the key. This is a really important issue here, and there's a, I would even say, a cultural difference between those involved in the scientific culture who see the need, who understand the urgency, and who are trying to move this forward in order to get the whole project going, and those here whose point of view I have heard(at this meeting)."
Oversight Committee member Marcy Feit, CEO of Valley Healthcare Systems, said she did not detect the same urgency as Hall. She said,
"This is a public agency with taxpayer dollars. And we are foolhardy if we don't pay attention to our responsibility. But nowhere on that (April 10) board meeting did I hear any board member not encourage us to do our job. So I would beg to differ with you that there is a cultural difference. There is not a cultural difference. I think if there were the rest of the board members here today, they would agree with us."
James Harrison, CIRM's private counsel, said,
"Zach is correct, that the ICOC expressed its intent that gathering information through a survey or through some prenoticed letter was not necessary or desirable in light of the sense of urgency that was expressed."
Oversight Committee member David Serrano-Sewell, vice chair of the Facilities Group and author of the public hearings motion, said it would not mean a delay in approving grants. In response to a query, he said in an email,
"Will undertaking a deliberative approach cause a delay? No, it will not. The Facilities Working Group can do its thing and meet the deadline, but it will need the support of the president to make it happen. That's where things got a little tense (see item below)."
To resolve the $222 million worth of edifice issues plus the question of who will be in charge of CIRM beginning in May, the institute is attempting to set up a special meeting of the Oversight Committee as soon as possible. The meeting is likely to be in the form of a conference call.

The committee will be operating in an atmosphere damaged by the rancor of last Friday's Facilities meeting. For a closer look at the acrimony, see the item below.

A Friday Filled with Acrimony

"Time out. Time out," said Rusty Doms, chairman of CIRM's Facilities Working Group, at one point as the discussion threatened to wheel out of control.

It was a conference call meeting last Friday that CIRM President Zach Hall later cited as one reason for his early departure as head of the $3 billion institute. Dom also resigned, submitting a terse letter with no explanation.

On the agenda was the topic of how to give away $222 million for embryonic stem research facilities.

The contentious discussion went on for some length. Questions of responsibility, due diligence, consideration of the public interest, loss of purchasing power, conflicts of interest and more surfaced.

At one point, Oversight Committee member David Serrano-Sewell, vice chair of the Facilities Group, repeatedly demanded that Hall answer a question with a yes or no. It related to a motion, authored by Serrano-Sewell, for public hearings on research lab needs. The motion had just been unanimously approved by the group.

Hall said that the vote contradicted the position of the Oversight Committee three days earlier. This exchange followed, according to the transcript of the meeting:
Hall: "Now, given the unanimous vote of this working group, there is no – I think there's no point in us doing that(preparing an outline for a major facilities RFA for the June Oversight Committee meeting). It's very clear, but it's also very clear to me that there are two different points of view represented on the ICOC(Oversight Committee)."

Serrano-Sewell: "Zach, it's a simple question. yes or no? Before the June meeting, will you aid this working group in a hearing?"

Hall: "I will."

Serrano-Sewell: "Yes or no? Will you assist this working group?"

Hall: "I want direction from the ICOC about how we should proceed on this."

Serrano-Sewell: "I'll take that as a no. If you're not helping us before the June meeting by committing resources, saying, yes, working group, I will commit resources, I will commit time in aiding you setting up these hearings which you unanimously passed."

Hall: "I'm sorry."

Serrano-Sewell: "It's either a yes or a no."
At this point, Hall said it was a matter that needed to be worked out by the full Oversight Committee and reflected a cultural difference within that group.

More sharp exchanges can be found in the transcript. But care should be taken in the reading. It was a conference call situation. Tone of voice, facial expressions (where the participants were together) are all missing. And there may transcribing errors, which can occur because of the difficulty in hearing all participants.

One such error seems to involve a quote for Serrano-Sewell. In the transript, he is quoted as saying, "I wanted to create a constitutional crisis." We queried him about the remark. He said he recalled saying that he did NOT want to create a crisis.

Wednesday, April 18, 2007

Wright: 'Not The Best Day'

More details emerged today on the heated, Friday the 13th session concerning the California stem cell agency's plans to give away $220 million for major research labs and buildings.

The meeting involved CIRM's Facilities Working Group, which is laying the groundwork for dispensing the funds (see the item below). At issue seemed to be questions of how much time and information was needed by members of the group before the grant applications went out. CIRM President Zach Hall characterized the meeting as "exceedingly contentious and personal" in a letter announcing his early resignation.

The session was not covered by the media, and a transcript is not yet available. So reporters prepared stories that were published today based on what some of the participants recalled in the wake of the resignation letter by Hall. That reconstruction process is common in the news business but always carries a certain amount of risk.

Reporter Terri Somers of the San Diego Union Tribune wrote:
"Dr. Janet Wright, a cardiologist who is a member of the (CIRM) board, said she couldn't believe the tone of contention, sarcasm and aggression toward Hall at the meeting.

"'I still don't know the gist of the attitude or tone, or where it was coming from,' Wright said. "I was so surprised by the tone, I couldn't seem to recover enough to call attention to it and try to set things right."

"Working group members David Serrano-Sewell and Jeff Sheehy acknowledged that they 'passionately' disagreed with Hall's stance at the meeting, but did not mean to be contentious or disrespectful.

"'I have nothing but the utmost respect for him. We couldn't have done all we've done without him,' said Serrano-Sewell, the working group's vice-chairman.
Somers continued:
"(A)t a meeting three days earlier, the full institute board had rejected a request by working group members, including (CIRM Chairman Robert) Klein, to survey possible grant recipients and others about their facilities proposals.

"As a result, Hall on Friday tried to push the working group to skip the information gathering and move directly to details of the grant applications....

"But the working group members voted unanimously for more information gathering, similar to the public hearing process that was used in developing the institute's standards and ethics policies and its strategic plan."
Carl Hall of the San Francisco Chronicle quoted Sheehy as saying:
"Zach identified a cultural divide that existed between the scientist members and the patient advocates, and he didn't want to straddle it anymore."
The stories also included the resignation of the chairman of the Facilities Working Group in the wake of the session. Rusty Doms, a Southern California developer, turned in a brief letter that did not cite any reasons for his departure. The letter was dated Sunday April 15, just prior to the announcement of Hall's resignation.

Jim Downing of The Sacramento Bee wrote:
"Bob Klein, the chair of the governing board, said Doms told him he was resigning principally because he did not have time to attend the series of meetings that Wright and others proposed. Doms is also on the board overseeing the construction of a major new hospital in Los Angeles, Klein said."
Somers said that one member of the public was uncomfortable with what occurred at the meeting, She wrote:
"'You can choose to agree or disagree, but the tone with which Zach Hall was treated was not the way you want to treat a president that accomplished so much for the (California Institute for Regenerative Medicine),' said Dan Oshiro, vice president of administrative affairs at the Gladstone Institute in San Francisco. The working group meeting was the first Oshiro had attended."
Downing of The Bee quoted Oversight Committee member Wright as saying,
"It was not our best day."

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