California Stem Cell Agency Seeking More Help on Push for Cures

The California stem cell agency has decided to put more manpower behind its push to drive therapies into the clinic.

The agency this week posted an opening for a senior development officer, who would be paid up to $226,108 annually.

The new hire would have a strong background in industry and an advanced degree. The job posting calls for a minimum of 10 years experience and expertise in "in developing, designing and assessing preclinical and early clinical safety and efficacy, within regulatory framework."

The position reports directly to Ellen Feigal, CIRM's VP for research and development. The job description says the person would "directly interact with investigators on CIRM’s clinically applicable research programs to help provide product development guidance from preclinical, manufacturing, and first in human to early phase clinical regulatory perspectives."

The $3 billion agency, which has yet to produce the cures promised to voters in 2004, is re-examining its strategies, particularly with an eye to backing a product that would actually be used on patients.

Changes Upcoming in $500 Million State Biotech Loan Program?

California biotech firms looking to dip into a new $500 million source of capital would be well-advised to sit in on a meeting next week of the state's stem cell agency.

A group of its directors – the Loan Task Force – meets next Wednesday at noon on the Stanford University campus to discuss the state of the unprecedented lending program and, more specifically, the loan terms. The session offers a golden opportunity to learn about the program, influence its direction and chat with key figures at the $3 billion funding agency.

The loan program is clearly in its formative stages. CIRM only approved its first loan --- $20 million loan to Novocell, Inc., of San Diego – a little more than a month ago.

Curiously, while CIRM has embarked on an effort to become more friendly to the biotech industry, it has provided little public information about the specifics to be discussed next week. That's the sort of stuff, however, that is needed to draw busy executives to the task force meeting to provide valuable input on the program and to encourage them to seek funding.

With three business days left before the task force meeting, the agenda states only that the panel will hear a presentation and discuss loan terms.

In order to provide more information to businesses, the public and other interested parties, the California Stem Cell Report yesterday queried Duane Roth, chairman of the task force and vice chairman of the stem cell agency, about next week's meeting.

Roth, a San Diego businessman, told us that the meeting will include a review of the initial loan policy and terms in light of feedback from potential applicants. He indicated that the session will focus on items that need further review or adjustment. Those specifics and any others identified at the meeting would come back to the task force and then the full CIRM board for action on later dates. It is fair to say that significant changes could be in the works.

The biotech loan program is significantly different than ordinary commercial lending. It specifically targets firms that otherwise could not raise cash or secure conventional financing. The idea is provide help to firms that are in what is known as the financial “valley of death.”

For more on the biotech loan program, click on the label “biotech loans” at the end of this article. You can find a list of members of loan task force here.

Scripps' Loring Teams with International Stem Cell Corp.

The Scripps Research Institute and scientist Jeanne Loring are collaborating with International Stem Cell Corp. of Oceanside, Ca., to study parthenogenic stem cells and their potential therapeutic use, it was announced today.

In a news release from the company, Loring, director of the Center for Regenerative Medicine at Scripps, said,

“"Parthenogenetic cell lines are uniquely valuable for our quest to understand the genetic and epigenetic processes that control stem cells. We are excited about the opportunity to collaborate with scientists at ISCO."

International Stem Cell said its scientists have derived a type of cell found in the human eye from parthenogenetic stem cells that may have application in treatment of macular degeneration. The company said it and Loring and will study these cells as part of the collaboration.

Kenneth Aldrich, chairman of International Stem Cell said,

“Our intent is to begin to provide these parthenogenetic stem cell lines to advance the field of regenerative medicine, as well as to commercialize our cells for cell transplant therapies.”

The firm has applied for grants from the California stem cell agency, but so far has not been successful. CIRM, however, is currently trying to link more closely with industry.

CIRM Directors Wrestle with Strategy and Ties to Business

The Chinese calendar calls this the year of the ox. At the California stem cell agency, however, this is the year of cozier relationships with the biotech industry.

At a two-day San Francisco meeting that begins tomorrow, the $3 billion state enterprise will re-examine its strategic plan with an eye to strengthening its ties to industry. CIRM's intent is to push taxpayer-financed stem cell therapies into the marketplace and actually treat people – but not necessarily right away. That probably won't happen for 10 to 14 years, according to its plan. Science and regulators are slow.

The plan (here and here) covers a lot of ground, ranging from CIRM's goal of a creating a “stem cell culture” in California to beefing up the management of its burgeoning portfolio of grants, which is expected to hit $1 billion this year.

But the overriding theme is closer ties to industry. A new and highly paid vice president will be handling them. CIRM will lobby increasingly on behalf of industry. The agency will implement an unprecedented, $500 million lending program for the riskiest biotech firms. And it will recruit scientific grant reviewers who understand “what is necessary for commercial success.”

Nothing is wrong with this, in principle. In fact, we think CIRM early on was not aggressive enough in engaging business. Only tiny numbers of industry representatives have appeared at CIRM meetings. Few companies have been successful in winning CIRM grants. And rejected business applicants have complained bitterly about the process.

Business must be firmly engaged with CIRM in order to develop therapies. But the marriage of business and government is fraught with peril. The best of intentions can go awry. They seemed to have done so with proposed creation this week of “a tremendous loophole” in the agency's earlier regulations to ensure affordable access to taxpayer-financed therapies.

John M. Simpson has observed CIRM for several years as the stem cell project director of Consumer Watchdog of Santa Monica, Ca. He and others we talked to have expressed concern about the vagueness of the strategic plan's proposals about industry. In response to a query, he said,

“The strategic plan envisions greater ties with the business community without providing enough specifics of how it all will work. Implicit in the plan seems to be the idea that if businesses are not taking CIRM's money it is a failure on CIRM's part and CIRM needs to loosen its rules.

“This loses sight of the fact that CIRM plays a regulatory role. In fact, if businesses want taxpayer dollars, businesses need to abide by CIRM's well-crafted regulations.

“CIRM seems to be saying we'll keep changing the rules, until you come and play with us. CIRM needs to understand if you go too far down a path of accommodation, the game isn't worth it.”

As part of the plan, another observer says that it would be useful for CIRM to survey activity in California's private sector concerning stem cell research. And, he said, more details are needed on CIRM's role in clinical trials and just exactly how it will help industry in connection with the FDA.

Earlier this year, CIRM's apparent move away from basic research triggered concerns among some scientists. They argued that it is too early to push most research into clinical trials. For example, the agency this year will approve a $210 million disease team grant round, its largest ever single research grant round. CIRM's plan reaffirms a commitment to basic science, but whether that allays fears of critics remains to be seen.

One matter that may trouble many scientists is what may be a reluctance to share information outside of the CIRM research community. The strategic plan discusses sharing “instructive negative research” results within its own community. And it says,

“To manage the flow of information, CIRM is developing and implementing a categorization system and database to store information according to disease relevance, cell types and technologies employed, research results, questions raised and answered and possible next steps.”

In neither of those two examples does CIRM specifically say the information will be shared outside the CIRM community or with the public. That may be an oversight, but it would useful to have some assurance that the information will be publicly accessible.

The latest revision to the strategic plan also presents scientifically justified movement away from its original charter – funding work related almost entirely to hESC research. In fact, the word “embryonic” only appears 20 times in the plan's 37 pages. That may be disappointing to some patient advocates, who may also not be pleased with the 10 to 14 year timetable for therapies.

Simpson additionally identified one objective in the report that he took issue found dubious. He said,

“As a scientific goal CIRM pledges to 'encourage the development of a 'stem cell culture' in California...'

“That makes about as much sense as if NASA said it planned to encourage a rocket science culture in the United States.

“The notion of a 'stem cell culture' becomes even more troublesome when you consider the hype that has been all too common in the field.”

(The strategic plan will be taken up at a two-day meeting of the CIRM board that begins Wednesday in San Francisco. The public can participate in Southern California at a location at the City of Hope in Duarte. A Web audiocast is also available without the possibility of participation. See the agenda for details.)

Salk CEO Brody Named to CIRM Board

The latest addition to the board that controls California's $3 billion stem cell agency is an electrical engineer and a physician. He was once ranked as the highest paid university president in the United States (Johns Hopkins, 2007, $1.49 million). And in pinch he could fly you – as a pilot – to the headquarters of Novartis in Basel, Switzerland, where he sits on the board of directors of that $53 billion pharmaceutical enterprise.

William R. Brody (see photo) is the man who is coming aboard at CIRM. Last fall he took over as head of the Salk Institute in La Jolla, Ca. And last week, California Lt. Gov. John Garamendi named him to replace Martha Chandler, the executive vice president at Salk, on the CIRM board. Chandler presumably resigned in favor of her boss.

In a news release on Friday, CIRM quoted Garamendi as saying that Brody is one of the nation's leading thinkers in biomedical engineering and healthcare policy. CIRM said he has authored more than 100 medical journal articles and co-founded three medical device companies.

Brody's pedigree also includes stints on the board of directors of a number of companies. In addition to Novartis, he currently sits on the IBM board, including its executive compensation committee, and the board of the Commonweath Fund, a foundation working toward a “high performance health system.”

Brody has spoken out and written on subjects of wider interest than those in scientific journals. In 2005, he deplored “the hodgepodge of local legislation, control and restriction (that) does not recognize the fundamentally porous nature of modern research science.” And he raised the specter of a human embryonic stem cell scientist being arrested in an unfriendly state during a layover there.

Also in 2005, he made a comment which seems to have application to CIRM, which refuses to disclose the financial interests of scientists who make the de facto decisions on hundred of millions of dollars in grants. Brody wrote,

“...(C)onflict-of-interest situations should always require disclosure. Disclosure is a necessary—but not sufficient—condition for supervising conflicts of interest. Additional checks, balances or prohibitions may be required to reach an appropriate risk profile for the behavior, but full disclosure is always the vital first step.”

He had this to say on another occasion.

“In my mind, conflict of interest begins the day a scientist has an idea. Even receiving NIH grant support drives a certain mode of behavior that could conflict the objectivity of that scientist. And licensing the idea to outside interests adds additional conflicts. A surgeon who develops a new clinical procedure will want to pursue the development of that procedure—which means conflict, hopefully positive—even without the involvement of an outside company. If she invents a surgical device that enables the operation and licenses that technology to an outside company, the conflict becomes more apparent, even though the conflict was no less real before any agreement was signed. But it is probably impossible to erect a firewall between the scientist and the supposed source of conflict. I know of few surgeons who would use a device invented by someone else if that colleague, even for reasons of conflict of interest, did not use that device herself. As a venture capitalist once told me, 'No conflict, no interest.'”

The July issue of the Salk Institute's house organ carried a profile on its new CEO in which he said, “The best institutions have to have a ruthless commitment to excellence."

That effort includes, he said, “assembling the money for hefty research start-up packages for new faculty.” That could mean a vote – depending on his view of conflicts of interest – for the $40 million research recruitment plan being offered up later this week at the CIRM board meeting.

The Salk profile also has other interesting tidbits, but does not mention that Brody holds ratings as an airline transport pilot and flight instructor, which in theory could make it possible for him to wing his own way to Basel.

Brody's career is indeed impressive. However, he seems careful to soft-pedal it. As he told then San Diego Union-Tribune reporter Terri Somers in an article last fall,

“I grew up in Stockton. Someone from Stockton can't put on airs.”