California Stem Cell Agency Nixes ACT Grant Applications 15 Times

(Editor's note: The assertion in this item that 15 applications by ACT were rejected by the California stem cell agency is incorrect, according to the venture capitalist who made the statement. He retracted it on the afternoon of April 12. His explanation can be found here. )


IRVINE, Ca. --The only firm in the nation conducting an ongoing hESC clinical trial has been rejected 15 times for funding by California's $3 billion stem cell agency.

The figure was reported yesterday at a hearing by the blue-ribbon Institute of Medicine panel looking into the performance of the stem cell agency, which has been sharply criticized in recent years for its paucity of industry funding.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, a stem cell venture capital firm in Portola Valley, Ca., disclosed the grant attempts by Advanced Cell Technology, whose nominal headquarters are in Santa Monica, Ca. Bonfiglio indicated that it was a high profile example of how CIRM is not taking the necessary steps to fulfill its goal of developing therapies that actually reach the clinic.

He noted that ACT received national attention in January when it posted favorable findings for its clinical trial at UCLA dealing with blindness but that the firm was still unable to win a CIRM grant over the last several years.

ACT had moved much of its operations to California in the wake of passage of Proposition 71, the measure that created the state's stem cell research effort in 2004. It has since re-centered its operations in Massachusetts.

The California Stem Cell Report has queried ACT on its grant efforts and will carry its response verbatim when it is received.

Another firm, which cannot be identified, said privately yesterday that it was rejected 14 times.

According to our calculations based on figures this morning on the CIRM web site, businesses have received only $54.3 million in grants and loans during the last seven years, 4 percent of the $1.3 billion awarded. However, the CIRM list slightly understates the industry total. At least two other firms are sharing in two $20 million grants involving academic institutions, but are not noted on the list.

Yesterday's IOM meeting was the second and final California public session for the CIRM inquiry. Most of the day was occupied by a variety of critiques of the organization. The panel has already heard extensively from the agency itself and beneficiaries of its grants. The IOM report is expected in November.

Harold Shapiro, chairman of the panel and former president of Princeton University, described yesterday afternoon's panel involving stem cell business executives as "one of the more interesting" of the day.

One of the speakers was Michael West, CEO of Biotime in Alameda, which has received $4.7 million from CIRM. West, the founder of Geron, was also head of ACT when it moved it to California. He said CIRM had several "blind spots," including misconceptions about how products are made. For example, West said, CIRM's performance indicates that it does not fully understand that development leads directly to cures -- not research.

West said that if the high tech industry had to rely on CIRM-type funding years ago, laptops and iPads would still be in the lab instead of the marketplace.

The business industry representatives said that creation of CIRM has been beneficial for stem cell  research, but cited a number of deficiencies in connection with industry applications.

In some ways, their comments echoed past remarks by several CIRM board members, who have expressed concern about the lack of funding for industry, as well as those of the agency's own external review panel. One issue raised by those CIRM directors has been the lack of grant reviewers with product development and industry expertise.

At yesterday's hearing, Gabriel Nistor, vice president of research and development at California Stem Cell in Irvine, said, it is "exceedingly rare to find academics (grant reviewers) that understand the complexities" involving industry. Nistor said his firm has applied for a "few" CIRM grants. None have been awarded.

Also speaking was Allan Robins, CEO of Viacyte in San Diego, who said his firm has done well with CIRM funding. It has received $26.2 million, nearly all of it in the form of a loan. But he said companies develop products – not academia.

The Cartography of Stem Cell Science

The global reach and aspirations of the California stem cell agency are the subject of some legitimate debate and criticism.

On one hand, the agency has severe financial problems and will run out of money by next fall unless something changes in its cash position. It has approved nearly $700 million in grants including an ambitious lab construction program, which require attentive monitoring. And CIRM is continuing to hand out tens of millions of dollars in grants. All of this with less than 40 persons on its staff, and all of which leads some to say the agency needs to stick to its knitting.

But at the same time, stem cell science is hardly confined to the borders of the Golden State. Hot stuff is happening across the nation and globally. CIRM's leadership wants to leverage its position and build scientific and financial alliances throughout the world with the goal of pushing science along a bit faster.

Out in Minnesota, William Hoffman has captured the global stem cell picture in a way that words cannot. Co-author of "The Stem Cell Dilemma," he has been charting stem cell science since 2003 on a map of the world. The changes in that picture have been dramatic. He recapped them on Friday on the Bioethics Forum.

Hoffman wrote,

"To this layman, one of the most baffling things about the (the stem cell) debate here and the reaction to President Obama’s executive order is the near total inability of some leading critics to see the 'big picture' that the maps help to illustrate."

Some stories are best told in words. Some with numbers. Hoffman has demonstrated the the global spread of stem cell science may be best told with the tools of a cartographer.

Here is a link to the World Stem Cell Map website.

Stem Cell Research, Money and State Efforts

The United States is lagging behind other countries in terms of its global share of human embryonic stem cell research, but that could change as more states pump dollars into the effort.

That's the upshot of a report by Aaron Levine(pictured), assistant professor of public policy at Georgia Tech, in the online publication Cell Stem Cell.

He said supportive policies and public research dollars in the United Kingdom, Israel, China, Singapore and Australia are producing unusually large shares of published hESC research.

However, the Georgia Tech press release on Levine's work says,

"Venturing where the federal government fears to tread, states like California, New York, Connecticut and Maryland are becoming places researchers can turn to for human embryonic stem cell funding. But Levine thinks that development may complicate matters.

"'There are a variety of funding sources out there now, but it makes the field more complicated for scientists to follow the various rules set forth by the states and foundations,' said Levine. 'I think scientists would prefer clear oversight from a federal government that’s supportive of their research.'

"Levine plans to follow up this current work with a look at how collaboration is affected by these different state policies."

Monya Baker of Nature's Niche stem cell blog also wrote about the study.

She reported,

"'The study chips away at the question but doesn't necessarily take into account a number of other factors,' says Stanford University’s Jennifer McCormick, whose work has also found that the rate of the US publications in human ES cell research was lagging relative to other countries. For example, the study does not control for the fact that some countries invest more in commercial than academic research or that some countries recognize patents covering human ES cell research and others do not. "

Andrea Gawrylewski of The Scientist had this:

Brian Salter, professor of politics and biomedicine at King's College London, said the Levine study does not take into account the hierarchy of journals and journal impact factors. She quoted Salter as saying,

"Underperforming countries may have scientists who go for the higher status journals."

The Stem Cell Race: Underdogs, Singapore's Biopolis, China and the UK

The San Diego Union-Tribune Sunday began a three-part series on embryonic stem cell research globally, reporting that the United States is "getting a taste of being the underdog."

Reporter Terri Somers, who has followed the industry and the California stem cell agency from San Diego's biotech hotbed, also wrote a Sunday piece looking that the business side of the research.

Both Sunday articles are as comprehensive on their subjects as one is likely to see in the mainstream media. Included is a downloadable world map with country-by-country snapshots.

Here are some excerpts from the front page series called "The Stem Cell Race:"

"'For the first time, we have a lot of competition ... . I don't think we've had as much concern for another country besting us in science since the race to the moon,' said Dr. Evan Snyder, who runs the embryonic stem cell research program at the Burnham Institute in La Jolla.

"It is a competition with crucial consequences for San Diego County and California, home to leading stem cell researchers and 50 percent of the world's biotechnology research."

Somers continued:

"China reportedly is doubling its investment in stem cell research. But an air of mystery and skepticism surrounds China's work, because the country's regulatory guidelines differ from those in the West and because research from Chinese scientists has not been widely published.

"The United Kingdom already has invested about $198 million in stem cell research at 90 laboratories, of which 11 are licensed to conduct human embryonic stem cell research.

"Singapore, with just 4 million citizens, is investing $25 million to $29 million annually in research, excluding overhead costs and infrastructure.

"That investment may seem wimpy compared with the $609 million the United States government spent on stem cell research last year. But because of federal funding restrictions on human embryonic stem cell research, only $20 million to $40 million a year – about 6 percent at best – has been directed to that field.

"Money is not the sole catalyst of success. Scientists say supportive government policies that free them to concentrate on their work, national commitment and contagious scientific enthusiasm are just as important.

"'Here we are again, sitting on the beginning of another revolution, a possible way to provide cures rather than treatments," said Chris Mason, a stem cell researcher at University College London. 'The U.K., Singapore and other countries realize what might be within their grasp if they spend the money on the front end, and they don't want to miss it.'

"The United States, long the world leader in biomedical research and commercialization, is getting a taste of being the underdog."

Somers' piece on the business of stem cells said:

"Worldwide, only about a dozen companies are building a business based on human embryonic stem cells, and only three of those are publicly traded: Geron in Menlo Park, Advanced Cell Technology in Alameda and Stem Cell Sciences in Edinburgh, Scotland.

"Executives at several of the companies say the key to tapping funds at such an early stage is either finding someone with deep pockets and a personal passion for curing disease or possessing a unique technology to address a potentially huge market.

"Given the current business climate and the political and moral debate surrounding human embryonic stem cells in the United States, people in the business don't expect more competition to pop up soon."

On Monday, Somers will look at Singapore and its "Biopolis."