California Stem Cell Report
News, information and commentary on public policy and business issues involving California's new stem cell agency, the California Institute for Regenerative Medicine, created by Prop. 71. This Web page is published by David Jensen, whose background and email contact can be found on this page under oddly titled section, "About Me."
Friday, August 31, 2007
Fresh Comments
Comments have been posted on the Burger King item below from David Hamilton and David Jensen.
Labels: CSCR
Chris Scott: Rocky Road Ahead for CIRM
A onetime candidate for the presidency of the California stem cell agency today outlined his views of the challenges facing the agency in the next 12 months or so. They include the "K-factor," the politics of the CIRM Oversight Committee and micromanagement.
Christopher Scott, head of the Stem Cells in Society Program at Stanford, said, among other things, in an op-ed piece in The Sacramento Bee:
"The institute must quickly find a replacement for (its No. 1 scientist, Arlene) Chiu and double its staff; put in place efficient mechanisms for research and ethical oversight; generate new rounds of proposals, renewals and reviews."The Bee noted that Scott had been a candidate earlier for the permanent presidency of the institute but said he is not a candidate currently.
Scott wrote that Richard Murphy, the new interim presidency of CIRM "should demand more control over the institute's budget line items and governance decisions while listening to the strong personalities on the citizens committee and in Sacramento."
Scott said:
"The Red Cross collapsed under the weight of its hydra-headed board; the difficult issues centered on control and the dysfunction of consensus management. CIRM faces some of the same problems. Paying attention to the needs of the major players and being flexible to alternate views will help him balance control."Scott continued, hitting various topics:
"The K-Factor. Robert Klein(chairman of the Oversight Committee) is a blue-chip entrepreneur, passionate advocate and hero to many. His forceful personality and charisma made the institute what it is, but these qualities may not be suited for efficiently executing its mission. Though Klein has said he will step down in 2008, some founding entrepreneurs mistime their exit. Murphy will have to deftly manage Klein's freewheeling ways, leveraging his strengths while covering his weaknesses. Checking the ego at the door will help."Scott wrote,
"Secession. Any executive who has worked in a startup knows six months will pass in an instant. A permanent president must be found, one who can handle the political challenges while tending to the small stuff, the decidedly unsexy but essential routine of ramping up and running a large research granting agency."He concluded:
"CIRM's second phase is more important than the first. California voters put their money on the line for a vision of science and medicine. Now comes the hard part. The institute must execute the plan, bringing new knowledge, discoveries and therapies to California."
Labels: CIRM management, CIRM overview, presidential search, Prop. 71 difficulties
Thursday, August 30, 2007
Grueling Work, CIRM and Burger King
Is the $3 billion California stem cell agency a Rube Goldberg-like contraption deliberately designed to function on a shoestring?
Reporter David Hamilton of Venture Beat says yes. Hamilton, who once covered biotech for the Wall Street Journal, today wrote about the state of the CIRM in the wake of the departure of its No. 1 scientist.
??(I)t seems safe to say that the stem-cell agency is probably one of the most grueling places to work in all of biomedicine. Structually, CIRM is a Rube Goldberg-inspired contraption in which a panel of 26 appointed academic luminaries, business types and patient advocates oversees a professional staff of no more than 50. The powerful oversight committee chairman, Robert Klein II, essentially runs the show, which undoubtedly complicates the job of finding a prominent biologist ? not usually the shyest and most self-effacing people around ? willing to give up their laboratory in order to butt heads with Klein over the institute?s management and direction.We should add that as of a couple a weeks ago, CIRM had 26 employees, perhaps the equivalent of the staff needed for a 24-hour Burger King. CIRM´s board of directors numbers 29.
?What?s more, CIRM itself was deliberately designed to function on a shoestring. That hard cap of 50 staffers was initially intended to reassure California voters that the agency wouldn?t waste taxpayer money on a hiring binge, and in that sense, it?s clearly worked. On the other hand, add the fact that the agency hasn?t even come close to filling all 50 positions to the string of departures, and it begins to look a lot like the institute is paying the price by burning through its human resources at an accelerated rate.?
Labels: CIRM management, CIRM overview, media coverage, presidential search
Wednesday, August 29, 2007
CIRM Challenges Report on Chiu
The California stem cell agency has responded to our item on Monday dealing with the implications of the departure of its No. 1 scientist, Arlene Chiu. Dale Carlson, chief communications officer for the institute, cited the following sentence from the post:
"While it would be incorrect to say that all CIRM staff departures this
year are related to the presidential situation...
Carlson then said,
"In fact, it wouldn't be correct to say that ANY of the staff departures were related to the presidential situation, nor to each other. Each of these folks left or is leaving for individual reasons. The timing is coincidental and nothing more should be read into them.
"Contrary to Mr. Simpson's speculation, Dr. Chiu's desire to return to Southern California and pursue other interests is exactly as stated. She would not be staying longer if the presidential vacancy did not exist."
Labels: CIRM management, presidential search
Tuesday, August 28, 2007
Stem Cell Snippets: McGee, Lansing, Prinz
Pricing Stem Cell Cures ? The California stem cell agency is still wrestling with anticipated prices of stem cell therapies. Not directly, mind you. It comes under the topic of intellectual property. Glenn McGee, director of the Alden March Bioethics Institute, wrote recently about a drug pricing issue that could resonate in the future ? if not currently -- with CIRM. The issue involves Merck and its cervical cancer drug, Gardasil, which he said is priced out of the reach of millions of women. McGee cited a report that Merck has spent $48 million in the last 10 years on lobbying. He wrote:
"If the company can afford to spend huge amounts convincing legislators the vaccine is something every woman deserves, it can afford to take its own advice, and reduce the price."Variations of McGee's argument are certain to surface in the future involving stem cell cures. Plus they will be freighted with heated rhetoric about how those cures owe their very existence to funds provided by California taxpayers. Something for the good burghers on CIRM Oversight Committee to consider.
Another Presidential Search ? Sherry Lansing, a member of the Oversight Committee for the California stem cell agency, has added more to her plate. She will serve as vice chair of the search committee to find a new president for the University of California. As a CIRM director, she is already involved in the search for a new president for CIRM in addition to her other many philanthropic activities. Incidentally, the current UC president earns $405,000 annually, which is apparently not enough to attract a CIRM president. However, the UC position has other benefits, but may or may not involve less aggravation than the CIRM post.
Prisons vs. Stem Cell Research -- California attorney Kristie Prinz wants to know. Writing on her California Biotech Law Blog, she raises a fundamental question about the $3 billion California stem cell agency,
"One cannot help but wonder if the money couldn't have been better spent elsewhere, even if you are a supporter of the biotech industry and of the concept of the research generally. Our schools, health care, keeping drugs off the street, illegal immigration, crime, overcrowded prisons, and terrorism are just some of the many issues facing this state that could have also been better funded with the same money. Did we as taxpayers make a good decision when we voted to use the funds instead on stem cell research? It's a thought-provoking question that all Californians should consider."
Labels: IP, overview, presidential search, pricing, Prop. 71
Monday, August 27, 2007
More Analysis on the Chiu Resignation
The following came in today from Christopher Thomas Scott, head of the Stem Cells in Society Program at Stanford, concerning the departure of Arlene Chiu(see item below). He makes the very good point that, compared to the NIH, CIRM is working with quite lean staff resources.
Here are Scott's comments:
"The other shoe dropped at CIRM. Arlene Chiu, the top executive responsible for the nuts and bolts of the organization, resigned. Her manifold responsibilities included the tough work of writing and disseminating the agency's request for proposals, scheduling and running a time consuming and complicated scientific review process, overseeing the awards, managing staff, and most recently, filling a leadership vacuum left by the departure of former president Zach Hall. For those of us familiar with the research grants business, we know Dr. Chiu as a tireless and enthusiastic science professional, and understood how she kept CIRM on its feet. She did much of this working with less staff than stipulated by the operating budget. Even at full strength, the numbers of professionals in her group would be far fewer than a comparable agency of the NIH, where she and Hall had made their professional careers. There, the institutes have the benefit of massive federal support. Here, Hall and Chiu, along with a skeleton crew, had to manage the launch of an organization while fighting lawsuits, scrabbling for money, and dancing through political hoops. While the reasons for Dr. Chiu's departure are known only to her, its likely she's tired of the long hours, the pressures of running a research enterprise on thin margins and the purgatory caused by an unsuccessful presidential search.
"Interim president Richard Murphy, on the state rolls for only 180 days, has a doubly difficult task in front of him. He must find a replacement for his top scientist and one for himself. And, the award money must reach the California labs, which have begun to ramp up the experiments that will bring new knowledge and hopefully, new therapies to Californians. Any executive who has been in a start up knows that six months will pass in an instant. More importantly, it is just as hard, perhaps harder, to execute a vision as ambitious as this than to have it in the first place."
Labels: CIRM management, presidential search
Lab Grant RFA Now Available
The California stem cell agency has posted the request for applications for $227 million in lab construction grants, the largest round in its history. Letters of intent are required by Sept. 26. The news release can be found here. The RFA can be found here.
Labels: Lab grants
CIRM Loses its No. 1 Scientist
The top scientist at the California stem cell agency, Arlene Chiu, will soon depart in a move that reinforces the importance of maintaining the organization'
CIRM has been in a lame-duck mode since last December when former President Zach Hall announced that he planned to leave. John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said Chiu's resignation "underscores the importance" of finding a permanent president.
Simpson said the failure to have a new, permanent CEO in place represents "a substantial failure of leadership first and foremost on the part of board Chairman Bob Klein and to a lesser extent on the part of all board members."
Earlier this month, the CIRM Oversight Committee installed Richard Murphy, former president of the Salk Institute, as interim president for at least six months as it continues to seek a permanent replacement for Hall.
CIRM is still a young organization (less than three years old) with a small staff (26 persons)that has seen other significant departures relatively recently. They include Kirk Kleinschmidt, director of legislative relations; Mary Maxon, the lead staff person on intellectural property, Scott Tocher, associate general counsel; and scientific officer Ruth Globus. While it would be incorrect to say that all CIRM staff departures this year are related to the presidential situation, voids in permanent leadership create uncertainties and instability. Departures for unrelated reasons can take on a life of their own, triggering others to consider making job changes. Couple that with the regularly long hours that CIRM staffers put in, and you have the potential for more losses.
In several ways, the press release on Chiu's departure acknowledged those concerns. Indeed, the headline on the release did not even say she was resigning. Carefully crafted to stress continuity and stability, it noted that she will continue through the end of October on a fulltime basis and after that as a consultant on some of CIRM's important efforts. Chiu as well issued a statement emphasizing the progress at CIRM and the credentials of interim President Murphy.
On a personal note, Chiu is one of the first persons that we met at CIRM. Her diligence, integrity and dedication have always impressed us. And as one of the earliest regular staff members, she set a tone and example that was important in establishing a healthy organizational culture at the new enterprise.
She was recruited by Hall, who issued the following statement, which is not currently available on the CIRM Web site:
"Persuading Dr. Arlene Chiu to come to CIRM from NIH was one of the most important accomplishments of my presidency. As the senior CIRM scientist during its first three years - a time of constrained resources, Arlene recruited, mentored and led the scientific team responsible for awarding the first $200 M in grants for stem cell research in California - a remarkable legacy. She has a deep understanding of stem cell research, expert knowledge of grants administration, and extraordinary personal qualities of integrity, grace and a passion for the mission of CIRM. Arlene has left her mark on the DNA of CIRM. She will be hard to replace."Murphy and Klein also issued statements which can be found in the CIRM press release. Chiu's statement can also be found in the press release.
Here is the complete statement from Simpson:
"Dr. Chiu is one of the all-too-often unsung heroes of CIRM, regularly going beyond the call of duty to ensure scientific excellence in the agency's efforts. She has built an excellent scientific staff that should be able to carry on in her absence.News coverage of Chiu's resignation was light. Here are links to the stories we saw: Jim Downing of The Sacramento Bee, Kristen Philipkoski, Wired.com, Sacramento Business Journal (the same story appeared in other Business Journals), and the Associated Press.
"We agreed to disagree on some things, like the amount of transparency and openness that belongs in the peer review process; but I have tremendous respect for her and her contributions.
"I believe Dr. Chiu's departure underscores the importance of the oversight committee performing its single most important task: hiring a president and chief executive.
"Had the committee done so in a timely way, I believe Dr. Chiu would still be at CIRM. Given the situation, the selection of Richard Murphy as interim president is a necessary stopgap to hold the agency together.
"But the failure to hire a permanent president, given Zach Hall's announcement of his plans last December, is a substantial failure of leadership first and foremost on the part of board Chairman Bob Klein and too a lesser extent on the part of all board members."
Labels: CIRM management, CIRM PR, presidential search
Back in Mexico
For those of you unfamiliar with all the details of this blog, we produce it primarily from west coast of Mexico where we live on a sailboat. We have returned once again to Mexico after a stay in the Old Country minding grandchildren and providing low-skill labor for our children. But never fear. The items will continue to be posted on a reasonably regular basis. Later today, we will have an item on the departure of Arlene Chiu, the top scientist at the California stem cell agency.
Labels: CSCR
Thursday, August 23, 2007
Cash is Coming: Time for Stem Cell Firms To Show Up
Attention California stem cell firms: If you are looking for millions in grants from the state's stem cell agency and if you want to have an impact on how the money is given out, mark Sept. 7 on your calendar.
On that date, the California Institute for Regenerative Medicine has scheduled an "interested parties" meeting with teleconference locations in San Diego and San Francisco.
Here are some of the topics to be discussed.
"What unique situations might arise in for-profit organizations as opposed to academic or non-profit settings that would impact a current or previously-funded CIRM project (e.g., partnering, bankruptcy)? How should these changes be effectively managed?
"Given that the CIRM will require annual financial and programmatic reports, as well as reports of licensing activities, patent applications, and commercialization activities, what information can reasonably be provided to the CIRM by grantees or their successors? How can the CIRM best monitor the performance and commercial development activities of grantees and licensees of CIRM-funded patented inventions?
"In the context of the CIRM?s preference for California suppliers of goods and services, what proposals or concerns should be considered by the CIRM in managing potential pass-through costs to non-Californian entities?
"Given that there are various methods of accounting for grant-related activities in for-profit organizations, how well do the Proposition 71 definitions of 'direct research funding costs' and 'indirect costs' reflect these activities?"
A couple of things can said about the Sept. 7 session. One is that the CIRM staff has done a fine job of posting a public notice of this session well in advance. That allows time for interested parties to prepare and to come to the table with well-thought-
The other comment that can be made is that California's biotech community sometimes seems as if it doesn't know that regulations and grant procedures are being established that could have a major impact on their enterprises within the next year or so. While it is difficult to quantify, business turnout at some CIRM sessions seems limited to a handful of firms. CIRM has $3 billion to hand out. If biotech firms want a healthy chunk of that on good terms, now is the time to make their case. Otherwise, they can continue to wrestle with the usual financial alligators. And, as they know, that can be an unpleasant and fruitless experience.
Labels: CIRM management, for-profit research, openness
Wednesday, August 22, 2007
Fresh Comment
An anonymous comment has been posted on the Kessler item Aug. 10 concerning his professional aspirations.
Comments can be left on any item by clicking on the word "comments" below the item or they can be sent directly to me at djensen@californias
Labels: CSCR
Wisconsin and California: Dueling Views on Stem Cell IP
Cyberspace is sizzling between California and Wisconsin in a stem cell contrempts involving Tom Still, president of the Wisconsin Technology Council, and John M. Simpson, the stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca.
Well, sizzling might be a little strong. But these two former newspaper editors are whacking each other around a bit.
It all started Aug. 11 with an opinion piece that Simpson wrote for the web site of the Wisconsin Technology Network.
In it, he argued that a basic question is being left not entirely answered as states step up to the stem cell funding plate. He wrote:
"Who should control, profit, and otherwise benefit from discoveries made in state-funded laboratories across Wisconsin? How you settle such matters are known as intellectual property policy, and like most states, Wisconsin apparently doesn't have a coherent, across-the-board policy."On Aug. 20, Still responded, also on the Wisconsin Technlogy Network:
"Not only does Simpson think the historic Bayh-Dole Act has been a colossal waste of time and money, even though many experts believe it unchained the innovative potential of the nation's research universities, but he doesn't understand the basics about 'technology transfer' on those same campuses."Simpson responded in a comment filed Tuesday below Still's column:
"I never said the Bayh-Dole Act 'has been a colossal waste of time and money.' I said that it was 'flawed.' That means it has problems that need fixing. I also would assert that it ought not serve as the model for state funding programs without appropriate modification.Simpson's final paragraph in his response to Still:"
"Again, I do appreciate your thoughtful and carefully reasoned analysis of my first column. I'd ask you to ponder what I've just suggested and look forward to your comments."
Labels: interstate cooperation, IP
CSUS Responds on $31 Million Training Plan
Susan Baxter, executive director of the California State University Program for Education and Research in Biotechnology, sent the following comment on our item Aug. 13 on the $31 million training proposal her system presented to the Oversight Committee of the California stem cell agency.
You wrote, ?One could wonder why this proposal was not presented to the staff earlier.?
The CCC/CSU partnership presented its proposal to CIRM staff in August of 2006. Since then, conversations between CIRM staff and CSU and CCC faculty have taken place. Many of the concepts and ideas presented in the proposal were considered during the scientific strategic planning process at CIRM. The CIRM Scientific Strategic Plan, approved by the ICOC in December 2006, includes a five year goal to ?increase the workforce of stem cell researchers in California? and calls for CIRM to increase the number of scientists (basic, translational and clinical), as well as trained technical staff. CIRM will also strive to increase the diversity of the workforce at all levels. The CSU/CCC proposal clearly connects to the CIRM Scientific Strategic Plan and conversations about the proposal with CIRM staff are continuing.
Second, you wrote, ?The proposal keyed off the widespread belief that biotech firms in California have difficulty finding skilled workers.?
To clarify, we recognize that life science graduates are not often exposed to medical product development. Typically, a life science student?s first exposure to real-world research is in academic laboratory coursework or in faculty research laboratories. In contrast, the life sciences industry works within a highly regulated environment in order to develop safe, effective human therapies. Increased exposure and understanding of this business environment will better prepare California?s students for careers in the life science industry, including the emerging stem cell industry sector which faces unique challenges as it develops clinical best practices for new cell-based product testing, formulation, and delivery. Also, exposing life sciences students to issues and challenges around clinical research and product development may encourage more interest in this aspect of therapeutic, device and diagnostic development. Not only does the field need physicians interested in clinical research, but also project managers, statisticians, engineers, computer scientists, preclinical researchers and regulatory experts able to work in interdisciplinary teams. The CSU/CCC is uniquely positioned to deliver this high-level workforce to assist in ground-breaking research efforts and bring them to commercialization.
Labels: biotech workforce
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