Showing posts with label biotech industry. Show all posts
Showing posts with label biotech industry. Show all posts

Monday, July 09, 2018

Stanford's Weissman Lauds California Stem Cell Agency For Innovation, Critical Financing

The California stem cell agency has chalked up hearty praise from an internationally known Stanford researcher for its 13-year, $3-billion search for stem cell therapies and cures.

Irv Weissman, Stanford photo
The scientist is Irv Weissman, director of the Institute of Stem Cell Biology and Regenerative Medicine at the Stanford University School of Medicine.  His laudatory reflections on the California Institute for Regenerative Medicine (CIRM), as the stem cell agency formally known, recently found their way to the Oakland-based enterprise. And last Monday the agency posted an item on Weissman's remarks on its blog, The Stem Cellar.  The article began,
"When you get praise from someone who has been elected to the National Academy of Sciences and has been named California Scientist of the Year you know you must be doing something right."
Weissman said the agency has provided the financial support that allows research to bypass "the valley of death," short hand for the stage in which promising research can often die. Plus, he said, CIRM allows the discoverers to guide early stage development rather than diverting it into commercial arena.

Weissman's comments spoke to what the agency calls its "value proposition," a term that is becoming increasingly important as the agency faces its possible demise. The agency expects to run out of cash for new awards by the end of next year. It is trying to raise more than $200 million privately to continue operations until November 2020, when it hopes voters will approve $5 billion more for stem cell research.

CIRM's blog item was authored by Kevin McCormack, CIRM's senior director of communications,  in the context of a $115 million initial public stock offering by Forty Seven, Inc., of Menlo Park, Ca., a company founded on the basis of Weissman's work. Weissman is currently a member of the company's board.

Forty Seven has received $15.2 million from CIRM. Weissman has received $32.4 million.

Weissman said in the statement that CIRM carried,
"The major support (for Forty Seven) came from the California Institute of Regenerative Medicine (CIRM), funded by Proposition 71, as well as the Ludwig Cancer Research Foundation at the Ludwig Center for Cancer Stem Cell Research at Stanford. CIRM will share in downstream royalties coming to Stanford as part of the agreement for funding this development.
"This part of the state initiative, Proposition 71, is highly innovative and allows the discoverers of a field to guide its early phases rather than licensing it to a biotech or a pharmaceutical company before the value and safety of the discovery are sufficiently mature to be known. Most therapies at early-stage biotechs are lost in what is called the ‘valley of death’, wherein funding is very difficult to raise; many times the failure can be attributed to losing the expertise of the discoverers of the field.”
In response to a question from the California Stem Cell Report, McCormack said Weissman's statement came "unbidden" by the agency.  We asked Weissman about what led him to issue the remarks. Weissman said he said he had not seen the CIRM piece, but responded after reading it.
He said in an email, 
"Now that I’ve seen the quote, it is close to what I sent to colleagues at Stanford. I did it so that my colleagues understood the nature of the CIRM experiment in funding research and its translation. One of these colleagues sent it on to CIRM, and I didn’t object.
"I think its very important to know how the original Prop 71 was designed not only to fund stem cell related research, but also to take selected projects competitively reviewed by expert referees to and through phase 1 trials if warranted. The therapy that was developed at Stanford by the team led to the discovery team forming a disease team of experts usually only found in biotechs and pharma, but here led by the discoverers of the leukemia stem cell overexpressed molecule, CD47, which by its ‘don’t eat me’ actions protects the leukemia from removal by scavenger macrophages. The CIRM oversight team helped guide selection of outside advisors, and met frequently with us to monitor our progress, and most importantly, give us advice that led to Stanford filing two INDs on time in the US [FDA] and the UK[MHRA]. The importance of doing high level preclinical testing and toxicity etc without a profit motive allowed the team to keep going when surprising events came up. Many biotechs fail at that point, as the risk starts to worry investors and shareholders. But this went through, and in addition to getting into important phase 1 trials that broadened the potential cancer targets to cancers beyond myelogenous leukemia, the group could see how the therapy needs to be administered to avoid toxicity in patients. By the time Stanford informed us it was time for them to license the ip, many independent companies had formed around the concept discovered by the team, a validation that this could become the second type of checkpoint inhibitor therapy for human cancers, this time for macrophages instead of inhibited T cells. 
"I felt it was equally important to try to get the agency that funded these stem cell related efforts to share royalties with the academic institution that held and licenses the intellectual property; I first raised this issue in 1994 when I was President of the American Association of Immunologists; my article is attached here.
"Most of us hope the discoveries we make can have the potential to help patients with diseases that are only incompletely treated by current medical practice. Very early results of clinical trials reported in the ASCO meeting in early June are consistent with that possibility. 
"I need to make clear that the statement in the blog was written by me, and was not an official document of Stanford University, of Forty Seven, Inc, or from others from the discovery team. If you decide to publish this answer to your question, please either publish it in full, unedited, or don’t publish it at all. I didn’t write this for you to publish, but for you to understand from your question the reason I wrote the original document to colleagues at Stanford."

Monday, May 09, 2016

Rise and Fall of California's Onetime Biotech Guru Steve Burrill

Two years ago, the investment empire of California biotech maven Steve Burrill was crumbling amidst allegations of fraud and mismanagement.

Steve Burrill
Today Burrill has all but vanished from the San Francisco scene that he once dominated. He has agreed to repay nearly $5 million and pay a $1 million penalty. He has been barred by the Securities and Exchange Commission from the securities industry.

All that and more was covered by Thomas Lee of the San Francisco Chronicle in a piece Sunday about Burrill, named in 2002 as one of the world's top visionaries by Scientific American. Lee's article  ran on the front page of the California newspaper's business section.

According to the SEC, Burrill misused company funds for such things as charitable contributions, gifts for his wife and girlfriend, trips to Europe, jewelry and private jets.

Andrew Ceresney, director of the SEC’s Enforcement Division. said in a March 30 press release,
“Burrill spent his fund’s capital on whatever he pleased, and elevated his own interests above those of investors.”
Burrill was once a sought-after speaker at such events as the national BIO conference, which draws upwards of 16,000 attendees. In 2006, wearing his trademark pink ties, he presided over an international stem cell conference in San Francisco that was a bit of a celebration of California's new stem cell agency.

Lee brought to his story a fresh perspective from Minnesota, where Burrill promoted a $1 billion biotech park in a rural elk farm that involved a Woodland, Ca., real estate firm, Tower Investments.

Lee, who wrote about the proposal as a reporter in Minnesota, said that Burrill "personified the idea that (Minnesotans), too, could create an economic miracle out of nothing." Lee continued,
"Burrill did not respond to a request for comment left through his attorney or messages sent to him through LinkedIn. Public records do not list a current address or phone number. The office in the Presidio of San Francisco listed on his website is vacant, with his name off the building directory and the space up for lease. No one seems to know his current whereabouts."

Wednesday, July 15, 2015

Lawsuit Alleges Biotech Guru Steve Burrill Embezzled $17 Million

Steve Burrill, wn.com photo
California biotech maven Steve Burrill, once a keynote speaker at such events as the annual BIO industry conference, has been charged with embezzling more than $17 million from an investment fund bearing his name.

The lawsuit surfaced in a spate of articles this month beginning with a piece July 10 by Dawn Lim of the Wall Street Journal. She wrote,
“The lawsuit, filed on July 6 with the Superior Court of California in San Francisco, alleges that Mr. Burrill, as well as corporate entities and individuals tied to him, embezzled more than $17 million from Burrill Life Sciences Capital Fund III L.P. between late 2007 and 2013.
 “The lawsuit also claims that the improper use of the fund’s money drained it of capital to support further investments in companies it backed, causing 'more than $30 million in investment losses.'
 “Earlier this year, investors in Burrill Life Sciences Capital Fund III L.P. installed executives from San Francisco-based Kearny Venture Partners to manage the fund. A corporate entity affiliated with Kearny authorized the lawsuit."
John Carroll of Fiercebiotech wrote,
“'Burrill was also a fraudster,’ the suit goes on. ‘Shortly after his company assumed the helm of the Fund as its General Partner, he started looting the Fund's cash and diverting it to entities he wholly owned or controlled.’” 
Reports of financial irregularities surfaced a little more than a year ago when Burrill was removed from control of his fund.

Over the years, Burrill raised more than $1 billion for life sciences financing via his investment banking firm. He produced an annual state-of-the-industry study that was something of a bible.

In 2006, his firm organized an international stem cell conference that was partly a celebration of the California stem cell agency. 

None of the stories published about the latest lawsuit reported comments from Burrill or his representatives.

Here are links to other stories on the matter: San Francisco Business Times, Biospace, Biocentury and Giacor Consulting.

Thursday, June 19, 2014

California Biotech Guru Steven Burrill in 'Deep Yogurt'

Steve Burrill is perhaps the leading maven on biotech in California as well as nationally. 

He has raised more than $1 billion for life sciences financing via his investment banking firm. He publishes an annual state-of-the-industry study that is something of a bible.

He is an omnipresent speaker at major biotech conferences. In 2006, his firm organized a stem cell conference that was partly a celebration of the California stem cell agency. Next week he is scheduled to be a keynote speaker at the huge BIO2014 industry conference in San Diego, which is expected to be attended by 16,000 persons.

Today, however, the Web site for his investment firm is shut down. The headlines about him on the Internet are less than pleasant. To use an expression that Burrill sometimes utters, he is in “deep yogurt.”
Nathan Vardi broke the story yesterday on Forbes. The piece was headlined 
"Steven Burrill Removed From Control Of Venture Fund For Unauthorized Payments”
Other stories used terms like “disbelief,” “fraud allegations,” “ousted” and "dumped."
Vardi’s snynopsis of the allegations said,
"G. Steven Burrill, the CEO and founder of Burrill & Co., a San Francisco financial firm specializing in biotechnology and life sciences investing, was ousted from control of a $283 million venture capital fund earlier this year by big institutional investors that cited willful or reckless misconduct related to unauthorized payments, according to documents recently filed in California State court in San Francisco." 
Alex Nash at Xconomy wrote,
“Burrill, known for his natty suits and pink shirts, is being sued for fraud by a former colleague for allegedly taking cash meant for investment and diverting it to his own 'designees and affiliates.'”
Burrill has not yet responded to requests for comments from the media covering the situation. And it is not clear whether he will still appear for his scheduled 90-minute talk next Tuesday in San Diego.

All of this involves allegations and contentions in lawsuits. But the perception is not good. Burrill himself knows the importance of perceptions. A few years back he spoke to a group at Stanford about making money in biotech and said,
 “Perceived value is more important than real value.”
 (See embedded video at the top of this article.)
And in February in comments to the Tampa Bay Business Journal about California’s success in life sciences, he said,
“Culture is a big part of it. People want to be part of a culture that tolerates failure.”

Friday, May 16, 2014

Trounson Calls for Closer Ties Between Biotech Industry and Academic Research

Alan Trounson, the departing president of the California stem cell agency, was in Australia earlier this month beating the drum for tighter links between science and industry.

Trounson, a native Australian, said researchers are “starving” in Australia and did not have much good to say either about the amount of the federal research funding in the United States.

According to an account on probonoaustralia, Trounson, who is now working as a senior adviser to the California agency, declared,
"What is hampering our smartness in converting high quality science discoveries to community benefit? Is Australian science research sustainable without the ability to expand beyond the publicly funded institutional base of universities, medical centers and (the national science agency)? Where is our biotech industry? Who spans the (funding) valley of death? There is a distinct scarcity of industry connecting with the Australian medical research community and a lack of venture investment in the biosciences."

He continued, 
“We need to really encourage the very smart academics to become interested in applying their discoveries for the community benefit – universities have to change how they recognize and reward scientists who enter this pathway – not penalize them. 
“It isn’t about number of publications or grants... – these are not the measure for making the innovative contributions needed. They probably handicap the conversion to a more effective system that the community will recognize and endorse. 
“The current federal grant system is broken in the USA...and would not be any better here. Money is trickling down an unsustainable pipeline that fails to encourage developments of use to the community. 
“The system must be fixed despite the inertia that exists even among the majority of scientists. We will have no viable research environment soon if we continue to look away from the problems that are evident and are turning away the smart young scientists.”

Trounson spoke during the 10th anniversary symposium of veski, an Australian group he helped to found. It is designed to foster an “innovation economy.”

Trounson's portrayal of Australian science was not all bleak. He cited major achievements scored by researchers down under. He said,
“We might have cause to be optimistic about the next 20 years! Maybe even expect Australia to have a minister of science driving high tech developments and a strong biotechnology industry employing scientists and medical graduates maturing in universities and research centers.”

Trounson's last day at CIRM is June 30. He is returning to his family in Australia.

Wednesday, June 26, 2013

Bluebird and Banking: Media Pluses for California Stem Cell Agency

The California stem cell agency scored a couple of favorable publicity points last week as the result of a successful stock offering by an award recipient and another piece about creation of a stem cell bank in Northern California.

The IPO by bluebird bio (the company's preferred spelling) of Massachusetts was a big winner for the company, raising millions of dollars more than anticipated.

The Boston Globe wrote,
“Shares of the Cambridge life sciences company bluebird bio Inc. soared almost 60 percent on their first day of trading (last) Wednesday, an impressive debut for a business that endured years of stagnation and another encouraging sign for the biotechnology industry.
“The local gene therapy company raised $101 million in an initial public offering priced at $17 per share, higher than the $14 to $16 estimated by investment bankers. Bluebird shares closed at $26.91 per share on Wednesday.”
The stock continues to trade around $25 a share at the time of this writing, which is good news generally for the biotech industry.

The company received a $9.4 million award last fall from the $3 billion stem cell agency. The company has yet to receive any actual cash from the agency as both parties work out final details of an agreement, a spokesman for the agency said last week.

The stem cell agency touted the successful IPO in a blog item by  that said,
“Bluebird Bio, one of the oldest companies in the struggling gene therapy field, is having an outstanding first day in the stock market today, and largely by marrying its gene therapy technology with stem cell science. The company’s financial milestone brings hope and excitement to both fields.”
However, the news stories about the IPO failed to mention the stem cell agency's involvement, which would have been nice for the agency but was to be expected given the way news is covered.

The story about the stem cell bank appeared on Xconomy, an Internet news service dealing with technology. Written by Bernadette Tansey, a former San Francisco Chronicle reporter, the piece dealt with the both business and science of stem cell banking. She wrote,
“One of the main goals of California’s $3 billion stem cell research agency is to draw companies into the state so they can vie for a share of the funding.
"With a recently funded $32 million initiative, the California Institute for Regenerative Medicine(CIRM) has attracted two of the biggest US players in stem cell banking to Novato, CA, to form one of the largest biobanks of induced pluripotent stem cells (iPS cells) in the world.”
The stem cell bank effort has become a minor staple in recent news coverage of CIRM, surfacing in a number of articles since the awards were approved. One of the reasons for that is that the project has a relatively straight-forward story line compared to many research efforts and the concept of "banking" is familiar to editors, writers and readers. 

Friday, May 31, 2013

Bluebird bio of Massachusetts Still Waiting for California Stem Cell Money

Seven months after the California stem cell agency awarded $9.4 million to bluebird bio of Cambridge, Mass., the company has yet to receive any of the cash from the Golden State.

Kevin McCormack, a spokesman for the $3 billion agency, this week said negotiations are still underway with the bluebird, which is planning to go public,  but did not elaborate. Post-award negotiations are common at the agency, but generally take much less time.

The cash from CIRM is scheduled to assist in clinical trials for a stem cell-gene therapy to correct a genetic disease in young patients with B-thalassemia, a rare blood disorder that can cause widespread organ damage and premature death.

Earlier this month, bluebird bio, which prefers the lower case lettering for its name, announced that it intends to take the company public in an $86 million offering. In March, it announced a collaboration with Celgene that provided for an upfront payment of $75 million and promised up to $225 million per product in potential option fees and clinical and regulatory milestones. The CIRM grant is conditioned on a matching commitment from bluebird.

Cash from the stem cell agency can only be spent on operations within California. According to the CIRM summary of the review of the bluebird application, which was scored at 73, the company said,
“We will have at least two clinical sites in California, and more likely up to 4 sites, 2) our viral vector manufacturing will occur in California, 3) our cell processing will occur in California, 4) we will hire several consultants and full-time employees within California to support the program. Overall, several million dollars will be spent employing the services of people, academic institutions, and other companies within the state of California.”
The company has said that it is working with Donald Kohn at UCLA and Elliot Vichinsky at Oakland's Children's Hospital.

The bluebird web site lists a California location for bluebird at 1001 Bayhill Dr, Suite 200, in San Bruno, which is south of San Francisco. An Internet search indicates that is a generic address for a number of business including a realty firm, a roof repair business and a family law attorney. The California Stem Cell Report has asked bluebird to clarify the nature of the address.

In an interview last October with Ron Leuty of the San Francisco Business Times, David Davidson, the lead scientist on the project, said,
“We began the process (with CIRM) early in (2012) but discussions have been going on for over a year about potentially pursuing this.
“The interaction with CIRM has been extraordinarily collaborative. We had contact with the coordinators at CIRM that helped us manage the process. It took a lot of effort on our part to put together a dossier providing support for our program. It was really like a mini-regulatory filing — on the science, the preclinical toxicology work that we’ve done, a detailed plan for the trial, a detailed plan for the budgets, a detailed plan on how we intended to spend the CIRM money in California. That was an important part of it. They wanted a clear plan on how this investment would be spent."

Sunday, June 17, 2012

Parsing Geron's Stem Cell Foray: A Nature Journal Commentary

Why did Geron "fail" in its much ballyhooed pursuit of the first-ever human embryonic stem cell therapy?

Christopher Scott, senior research scholar at Stanford, and Brady Huggett, business editor of the journal Nature, took a crack at answering that question in a commentary in the June edition of Nature.

Following the sudden abandonment last fall by Geron of its hESC business and the first-ever clinical trial of an hESC therapy, Scott and Huggett scrutinized the history of the company. The financial numbers were impressive. They wrote,
"How did Geron’s R&D program meet such a demise? After all, the company raised more than $583 million through 23 financings, including two venture rounds, and plowed more than half a billion dollars into R&D (about half of that into hESC work) through 2010. 
"There are problems with being at the forefront of unknown territory. Of Geron’s development efforts, the hESC trial was the most prominent, and fraught. Therapies based on hESCs were new territory for the US Food and Drug Administration (FDA), and it eyed Geron warily. The investigational new drug application (IND), filed in 2008, was twice put on clinical hold while more animal data were collected among fears that nonmalignant tumors would result from stray hESCs that escaped the purification process. Geron says it spent $45 million on the application, and at 22,000 pages, it was reportedly the largest the agency had ever received."
The California stem cell agency also bet $25 million on the company just a few months before it pulled the plug. Geron repaid all the CIRM money that it had used up to that point.

Geron suffered from a lack of revenue despite its vaunted stem cell patent portfolio. Scott and Huggett reported that Geron received only $69 million from 1992 to 2010 from collaborations, license and royalties. At the same time losses were huge – $111 million in 2010.

The Nature article noted all of that was occurring while other biotech companies – such as Isis and Alnylam – found ample financial support, revenue and success.

Scott's and Huggett's directed their final comment to Advanced Cell Technology, now the only company in the United States with a clinical trial involving a human embryonic stem cell therapy.
"Your technology may be revolutionary, your team may be dedicated and you may believe. But it does not matter if no one else will stand at your side."
Our take: The California stem cell agency obviously has learned something from its dealings with Geron. The company's hESC announcement was an unpleasant surprise, to put it mildly, coming only about three months after CIRM signed the Geron loan agreement. Today, however, the agency has embarked on more, equally risky ventures with other biotech enterprises. Indeed, CIRM is forging into areas that conventional investment shuns. It is all part of mission approved by California voters in 2004.

The dream of cures from human embryonic stem cells or even adult stem cells is alluring. And CIRM is feeling much justifiable pressure to engage industry more closely. All the more reason for CIRM's executives and directors to maintain a steely determination to terminate research programs that are spinning their wheels and instead pursue efforts that are making significant progress in commercializing research and attracting other investors.  

Friday, May 11, 2012

StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency


StemCells, Inc., said today it has applied for as much as $40 million in funding from the California stem cell agency for two projects dealing with Alzheimer's disease and cervical spinal cord injury.

The announcement came in a news release dealing with the publicly traded firm's quarterly earnings. The applications are part of a $240 million round expected to be acted on in late July by the board of the $3 billion California stem cell agency. Funding for businesses in the disease team round is expected to come through a loan.

StemCells, Inc., of Newark, Ca., said,
"In January 2012, we submitted two applications to the California Institute of Regenerative Medicine (CIRM) for 'Disease Team Therapy Development Research Awards,' one for Alzheimer's disease and one for cervical spinal cord injury. A research award may be up to $20 million, payable over four years, to fund preclinical and IND-enabling activities with the aim of starting human clinical trials within a four-year window."
Applications in the round were reviewed behind closed doors in April. CIRM also has a policy of not releasing the names of applicants until its board acts and then only if an applicant is approved. CIRM says it does not want to embarrass firms that do not win approval. That includes individual researcher names as well as the names of such institutions as the University of California.

During discussion of grant applications by the CIRM board, directors are not told the names of the applicants, just the number of the application. If board members have conflicts of interest on specific applications, they are barred from voting on and discussing the application. The names of applicants have occassionally slipped out. Sometimes their identities can also be discerned by information contained in the summaries of the reviews of the applications, which become available on the CIRM web site shortly before the directors act. The summaries normally carry scientific scores and recommendations for funding.

Most companies seeking funding from CIRM do not identify themselves in advance, although they do if they appeal a negative decision by reviewers. The board has ultimate authority for approval of grants but has almost never rejected a recommendation for funding by reviewers.

StemCells Inc. was founded by Irv Weissman of Stanford, who sits on its board of directors. Weissman is also on its scientific advisory board along with Fred Gage of Salk and David Anderson of Caltech. Weissman and Gage have won substantial grants from CIRM. 

StemCells Inc.'s stock price closed at 92 cents yesterday. Its 52-week high was $8.20, and its 52 week low was 70 cents.

Here is a link to an analyst's report on the company.

(Editor's note: An earlier version of this item incorrectly stated that the disease team round will be acted on later this month.)

Thursday, December 08, 2011

California Stem Cell Agency Approves $27 Million To Hasten Stem Cell Therapies

Efforts to speed development of stem cell therapies received a $27 million boost today from directors of the $3 billion California stem cell agency.

They approved two initiatives that grew out of recommendations from a blue-ribbon panel that CIRM organized last year to review its operations.

One element in the plan is a $12 million "bridging fund" that would apply only to current CIRM-funded projects in three areas: disease team grants, some early translational projects and clinical development projects. The bridging fund would provide up to $3 million for up to one year for each recipient.

As originally proposed by CIRM staff, CIRM President Alan Trounson would have been authorized to approve each project. However, the board altered that process to require board approval with "peer review input."

Director Shlomo Melmed, a senior vice president at Cedars-Sinai in Los Angeles, argued that leaving the decision to Trounson and staff could place Trounson in an "untenable" position and lead to second-guessing. Melmed and others also said that process could open the agency to public criticism.

Trounson and other staff members said that biotech firms often need speedier action than can be provided by a more extended process. Director Jonathan Shestack, a Hollywood producer, agreed, but he was the lone vote to oppose removing the authority from Trounson.

No biotech companies spoke out at the meeting concerning the proposal (see here for an earlier version of the plan).

The second part of the response to the review panel's finding is a $15 million "external innovation initiative" to support collaborative efforts of CIRM grantees to work with teams that CIRM said are "making extraordinary progress outside California."

The $15 million program would provide awards as often as two times a year. The maximum amount on each award was not specified. The program was approved on a unanimous voice vote.

Ellen Feigal, CIRM's vice president of research and development, said in a memo to directors that examples of potential projects included collaborative efforts with the NIH and work with the Harvard Stem Cell Institute and its disease-focused programs. CIRM is planning to spend $300,000 over two years in work with the NIH.

Some of the latest CIRM initiatives are open to biotech businesses. Others are open only to non-profit or academic researchers.

Tuesday, August 30, 2011

Biotech Industry Scores in Stem Cell Agency Grant Round: Beginning of a Trend?

Proposal by Tim Hoey
of OncoMed outscored
leading research institutions. 
In what is a first for the $3 billion California stem cell agency, biotech firms have snagged 20 percent of the cash in a grant round offered by the state's research enterprise.

The industry has long been unhappy with its picayune share of the $1.3 billion that CIRM has given away so far. The agency has talked about moving towards a more business-friendly position, but last week's awards were the first hard-cash demonstration – albeit a tiny one – of CIRM's commitment.

The round totalled only $1.8 million. Four biotech businesses were awarded $368,519. However, the awards are for planning for applications for a whopping $240 million disease team round next year. It is all part of a CIRM's aggressive push for clinical therapies.

The success rate for the business applicants was also high – 50 percent. Eight firms applied, CIRM told the California Stem Cell Report. In all, 36 applications were received and 19 approved.

Since CIRM began approving awards in late 2005, only 7 percent of all grants have gone to businesses -- that in a state that is one of the hotbeds globally of the biotech industry.

Scoring the highest in last week's round with an 87 was the application , for $65,120 from Tim Hoey, a senior vice president at OncoMed Pharmaceuticals, Inc., of Redwood City, Ca.  The score topped applicants from Stanford, UCLA and other vaunted stem cell research institutions. OncoMed is looking at developing a new anti-cancer drug.

The winning businesses included two publicly traded firms, Geron Corp. of Menlo Park, Ca., and Stem Cells Inc., of Newark, Ca. It was the second CIRM award for Geron, which won a $25 million loan last May for help with its spinal injury clinical trial.

Geron's $106,239 planning grant (scored at 79) involves an hESC treatment for heart failure. Jane Lebkowski, senior vice president and chief scientific officer, is the principal investigator on the project. Stem Cells Inc. received $98,050 for a look at an Alzheimer's treatment. Its proposal also scored 79. Alexandra Capela is taking the lead on the project.

The fourth winning business was Wintherix, LLC, San Diego, Ca., which scored 69 on its $99,110 application. John Hood, chief scientific officer and a co-founder of the firm will lead the research into a therapy for osteoporosis-related fractures.

Only one of the applications – the one from Geron – appears to involve research using human embryonic stem cells,  the raison d'etre for voter approval of the California stem cell agency in 2004. The ballot measure that created CIRM was justified by backers because former President Bush had restricted federal funding of hESC research, a ban that has since been lifted by President Obama.

Wednesday, August 24, 2011

Biotech Industry Alert: California Stem Cell Agency Moves Ahead with Industry-Friendly Efforts

The newly elected chairman of the $3 billion California stem cell agency is pushing forward with efforts to engage industry more deeply in state efforts to develop commercial stem cell therapies.

Industry has long been unhappy with its meager share of CIRM grants – 7 percent of $1.25 billion. A blue-ribbon panel commissioned by CIRM last year recommended major improvements.

Duane Roth
The latest action by Jonathan Thomas, the Los Angeles bond financier who was elected in June to head the agency, comes in the form of a thrust to be led by CIRM co-Vice Chair Duane Roth, a San Diego businessman.

Thomas' plan for engagement of industry will be discussed this evening at Stanford at the first meeting of the board's new eight-member Intellectual Property Subcommittee.

Thomas' proposal, posted only early today on the CIRM web site, would expand the panel's current jurisdiction. The document said,
Stephen Juelsgaard
"In light of CIRM’s desire to engage industry in its mission to deliver therapies and cures to patients who suffer from chronic disease and injury and the overlap between industry-related issues and the current jurisdiction of the subcommittee, Chairman Thomas, with the concurrence of Subcommittee Chair (Stephen) Juelsgaard, proposes to expand the jurisdiction of the subcommittee to include industry-related issues, such as: (1) participation by representatives of industry as members of the Grants Working Group; (2) the development and refinement of programs to incorporate industry into CIRM’s research programs; (3) financing issues relating to industry involvement with CIRM; (4) evaluation of barriers to industry engagement in CIRM-related or funded activities; (5) addressing means of encouraging industry interaction and involvement, especially in the areas of development, regulatory compliance, manufacturing and commercialization, with CIRM-funded research organizations that have identified potential promising therapies and (6) consideration and refinement of CIRM’s loan program."
Juelsgaard, former executive vice president of Genentech and currently a lecturer at Stanford Law School, was appointed to the board last May by Lt. Gov. Gavin Newsom. Juelsgaard once was reported as being considered as a possible candidate for chair of the agency.

Thomas said Roth would be named co-chair of the IP Subcommittee with responsibility for industry relations. Juelsgaard will deal more generally with IP issues, including "developing a program to assist CIRM grantees in protecting intellectual property generated from CIRM-funded research and to ensure that the state has an opportunity to share in the revenues arising out of CIRM-funded research." That topic is on the agenda of this evening's meeting.

Also to be discussed is another industry-friendly effort: A $30 million "Opportunity Fund" to "enhance the likelihood that CIRM funded projects will obtain funding for Phase III clinical trials (e.g. follow-on financing), (ii) provide a potential source of co-funding in the earlier stages of clinical development, and (iii) provide CIRM funded projects with access to pharma and large biotech partners that can provide valuable expertise in the areas of regulatory, clinical trial design and manufacturing process development."

Monday, March 14, 2011

CIRM Schedules Action on New Directions for May

Directors of the California stem cell agency last week curtailed discussion of recommendations for changes in the agency's direction, including stronger ties with the biotech industry, putting off the matters until their May meeting.

At last Thursday's meeting, CIRM President Alan Trounson quickly ran through his agency's response to the proposals last fall from a blue-ribbon panel commissioned by the agency. But other matters, including selection of a new chair, occupied the board's time.

CIRM's staff response to the commission did not contain specific implementation plans and was vague on some of the matters.

Art Torres, co-vice chair of the CIRM board, told directors that he would like to see directors vote specifically on the staff proposals regarding CIRM's international leadership role, improvement of communications and PR and movement away from traditional funding models (responses 3, 5 and 7 in the CIRM memo).

Director Jeff Sheehy, a communications manager at UC San Francisco, asked the CIRM staff to provide in May a "clear implementation path" for its proposals, including specific actions that the staff would like the board to take.

The recommendations will affect how CIRM allocates its remaining cash, including support for basic research versus grants and loans for efforts more focused on producing clinical therapies. The proposals could mean putting more cash behind research before the results have been "written up," in Trounson's words. The staff recommendations also could mean more cash for biotech firms, including grant rounds that would be limited to business applicants.

Commenting on involvement of biotech companies with CIRM, Trounson said,
"Companies sometimes don't know we are in this space. They all don't read our web site avidly."
He added,
"Clearly we're not meeting their needs."

Friday, February 18, 2011

Geron's Golden Parachute for Okarma

Tom Okarma may be out as Geron's CEO but he has a nifty cushion to ease the pain.

Reporter Ron Leuty of the San Francisco Business Times has reported that the onetime head of the Menlo Park stem cell firm could receive up to $1.3 million, including $802,500 in severance pay, as part of an agreement with the firm.

The package consists of consulting fees, reimbursement of legal fees, health care coverage plus an additional $24,000 for benefits not covered by Medicare. He also has stock options that Leuty reported would have been worth more than $3.9 million if cashed out at Wednesday's closing price.

Geron, we should point out, has reported negative profit margins during the last 10 years. One web site reports that its current profit margin is MINUS 3,359.71 percent. Of course, making money is exception rather than the rule for biotech companies. Geron additionally could be in line for a $25 million loan from the California stem cell agency.

Friday, July 02, 2010

$250,000, Six-Month Contract for CIRM's Lewis

The new interim vice president for research and development at the California stem cell agency holds a $250,000, six-month contract that calls for him to push hard to develop clinical applications that CIRM hopes will demonstrate the success of its $3 billion effort.

The hiring -- as a consultant -- of Alan Lewis (at right), onetime head of ViaCyte, Inc. of San Diego (formerly Novocell) and the Juvenile Diabetes Research Foundation,  brings at least a temporary halt to the search to fill the new VP post that was created after Marie Csete resigned suddenly as chief scientific officer. The CIRM Web site no longer lists the VP position as available.

CIRM President Alan Trounson sought unsuccessfully for a nearly a year to fill the job. This spring he appeared to have run afoul of resistance to his plans for compensation for the post, which would normally top out at $332,000 annually if the position were filled by a regular CIRM employee.

Under the terms of Lewis' contract, he is expected to work about 24 hours a week and meet with CIRM officials at least once a week at the agency's San Francisco headquarters. (CIRM provided an unsigned copy of the contract, which is a public document, at the request of the California Stem Cell Report.)

Lewis is the third top executive of CIRM to be working on a part-time, paid basis. The others are CIRM Chairman Robert Klein, who receives $150,000 for half-time work, and co-Vice Chairman Art Torres, who is paid $225,000 for four days a week. By way of contrast, CIRM President Alan Trounson receives $490,008 annually for fulltime work.

Lewis' agreement runs from June 21 through the end of this year at a rate of $2,500 a day, “with pro-ration (sic) for less than four hours.” The contract is capped at $250,000 not including travel expenses.

On June 23, Trounson told the CIRM governing board that Lewis would be serving as a consultant two or three days a week "to help us with the clinical, preclinical programs." Trounson did not mention that Lewis would carry the title of interim vice president for research and development nor did he mention the size of the contract. If it had been above $250,000, it would have required director approval.   

Lewis is expected to travel widely and possibly internationally. Trips from his home in Solana Beach near San Diego in Southern California to CIRM's headquarters will be paid for by CIRM.

Lewis has had a long business career, which raises questions about possible conflicts of interest. In addition to Novocell, he worked for Signal Pharmaceuticals and Celgene in the San Diego area. He left Novocell in 2008 to work for the diabetes group. The CIRM contract said Lewis affirmed that “there exists no actual or potential conflict between the consultant's family, business or financial interest and the services provided under this agreement.”

ViaCyte is the recipient of more than $26 million in awards from CIRM.

Lewis must file a statement of economic interests that is required of most state officials. We have asked CIRM for a copy of that document.

Here is how the contract describes Lewis' responsibilities:
“• Consult Senior Management on biotechnology, pharmaceutical and investment sectors to enable and enhance the development of clinical applications in CIRM’s scientific portfolio.
“• Consult on the preclinical and clinical development phases of CIRM’s programs and projects involving not-for-profit and for-profit teams, including assembling and working closely with CIRM advisory committees to provide oversight of these programs and make go/no go recommendations to the President for continuation of CIRM support.
“• Work in close collaboration with the Executive Director of Scientific Activities.
“• Integrate basic discoveries where possible into the translational and preclinical pipeline and identifies gaps in CIRM’s scientific program for delivery of cell therapies and related products.
“• Develop and implements strategies to aid clinical applications such as in the critical areas of manufacturing, drug and cell product safety and efficacy.
“• Consult Senior Management regarding interface approaches with national and international regulatory organizations”
The contract differs somewhat from the CIRM news release on Lewis. It said that he would “take direction” from the executive director of scientific affairs – not work in collaboration. This is of significance because their duties overlap and could be a source of friction if not carefully managed.

(Photo from San Diego Union-Tribune)

(Editor's note: An earlier version of this item incorrectly said that Lewis' contract was not mentioned by Trounson at the June CIRM board meeting.)

Wednesday, June 23, 2010

'Troubling' Trend: Is CIRM Playing Field Level for Business?

A longtime observer of California stem cell matters today said he is troubled by a trend at CIRM that appears to give short shrift to research at biotech businesses in the Golden State.

John M. Simpson has been watching the California stem cell agency since late 2005, along with participating in its affairs, most notably development of its IP policies.

Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., prepared this statement to be read at today's CIRM board meeting in San Diego. Simpson is on the East Coast on other business and may not be able to reach the Washington, D.C., teleconference location to deliver his remarks personally. Here is the full text.
“I apologize that that I was unable to attend today's ICOC meeting. I
appreciate this statement being read into the record on my behalf.

“When Consumer Watchdog began its Stem Cell Project almost five years ago, I
naïvely expressed concerns that the program would be hijacked by the biotech
industry. That has -- at least so far -- not happened; rather, it has been
dominated by academic research institutions, whose representatives hold the
largest number of seats on the board.

“I believe the trend is troubling enough to ask whether the playing field is
level for all applicants. I believe there are grounds for concern.

“Here are some suggestions to improve the situation:

“-- A task force should be convened to consider why companies have fared so
poorly and what should be done. All sessions must be public.

“-- A workshop should be scheduled with interested companies to discuss ways
to improve their applications. It must be opened to the public.

“-- An effort should be made to recruit scientific reviewers with substantial
experience in research programs conducted by businesses.

“-- CIRM meetings that currently include only grantees should be expanded to
include all legitimately interested parties. Currently you have an annual
conference for all grantees. This must be opened to include all grant and
loan applicants, even if they were unsuccessful. If there is a concern
about expenses, unsuccessful applicants could be charged a modest fee. What
better venue to learn what makes a successful application than a conference
that includes CIRM's awardees? It would also create opportunities for
developing collaborations. Currently CIRM continues to suffer from the image
that it is a closed club. Opening conferences to all applicants -- and even
other interested parties -- would help correct that.

“Thank you for your consideration.

“John M. Simpson”

Monday, May 03, 2010

WARF Loses Latest Round on Challenge to hESC Patents

Two watchdog groups said today they have scored a “major victory for unfettered scientific research” in a case involving a WARF patent on human embryonic stem cells.

Consumer Watchdog
of Santa Monica, Ca., and the Public Patent Foundation of New York City filed the challenges to the WARF patents on work by Jamie Thomson of the University of Wisconsin.

The groups said in a news release that federal patent regulators have “agreed with the groups that the creation of human embryonic stem cell lines was obvious in the light of work that had been done in other species. In order to obtain a patent, work must be both new and non-obvious.”

WARF, which can appeal the decision, released the following statement.
“WARF has been invited by the Board of Patent Appeals to continue prosecution of this application and plans to do so and vigorously pursue these claims with the patent office. This decision regarding ‘913 does not affect the patent office’s 2008 decision to reaffirm WARF’s two most important base stem cell patents for primate and human embryonic stem cells, ‘780 and ‘806. These reaffirmed patents are not eligible for further appeal in this reexamination process.”
Geron Corp., of Menlo Park, Ca., which holds a license on the patent, said the decision will not “impact” the firm's “dominant human embryonic stem cell patent position.”

The 2006 challenge to the WARF patents was supported by Alan Trounson, then connected to Monash University but now president of the California stem cell agency, Douglas Melton and Chad Cowan of Harvard and Jeanne Loring, director of the Center for Regenerative Medicine at Scripps.

Loring said,
“This is great news for medical research. Human embryonic stem cells hold great promise for advancing human health, and no one has the ethical right to own them.”
The challenge involved three patents. Federal officials originally ruled unfavorably.

The Consumer Watchdog news release said,
“Under current patent law only one of the three (earfier) patent rulings could be appealed by the two groups.  That was the patent rejected by the Board of Appeals and Interferences. However, said the groups, the latest ruling by the Board of Appeals is a strong decision that could set a precedent leading to the revocation of the other two patents as well.

“The two public interest groups noted that the original three patent challenges  had already improved the situation for stem cell researchers; shortly after the PTO launched its initial re-examinations in 2006 at the groups’ request,  WARF announced a substantial easing of its licensing requirements.

“'WARF executives were acting like arrogant bullies blinded by dollar signs,' said (John M.)  Simpson (of Consumer Watchdog). 'Our challenges prompted a more co-operative stance towards the stem cell research community on their part.'”

“Both Consumer Watchdog and the Public Patent Foundation stressed that while University of Wisconsin researcher James Thomson deserved acclaim for his research that isolated human stem cells, important scientific accomplishments are not necessarily patentable.  They said one of the main reasons he was able to derive a human stem cell line was because he had access to human embryos and financial support that other researchers did not have.”
Geron issued a news release on the decision. The company said,
"'This is not a final rejection of the patent claims,' noted David J. Earp, J.D., Ph.D., Geron's chief patent counsel and senior vice president of business development. 'We are confident that WARF will make a strong case in support of the patentability of these claims in continued examination.'"

Monday, April 05, 2010

Ipierian to Seek Multimillion Clinical Trial Loan from CIRM

One of the handful of companies likely to be eligible for CIRM's ambitious clinical trial loan program has identified itself – iPierian, Inc., of South San Francisco.

According to Ron Leuty of the San Francisco Business Times, the firm will seek funding for possible therapies for Lou Gehrig's disease and spinal muscular atrophy.

Last month, CIRM directors approved the $50 million program, its first venture into clinical trials. The one or two winning applicants could see cash by the end of this year. Directors were told that perhaps only three firms might be eligible to apply. They were not identified at the meeting because that would raise conflict of interest questions. CIRM also does not identify applicants for grants or loans for fear of embarrassing them if they lose their bids for cash.

Leuty wrote about the CIRM clinical trial program on Friday. He quoted John Walker(at left), president of iPierian, as saying that CIRM's assistance fits “very nicely” with the company's plans to generate a therapy candidate within three years.

Ipieran is backed by Kleiner Perkins Caufield and Byers, Highland Capital Partners, FinTech Capital Partners and MPM Capital, which have provided $31.5 million to the firm.

Ipierian came into being last July when iZumiBio and Pierian merged. The company's Web site said it was collaborating with Gladstone Institutes and Kyoto University's Center for iPS Cell Research and Application with Shinya Yamanaka, whose lab first succeeded in creating iPS cells in mice.

Friday, February 26, 2010

Stem Cell Agency Launches High School Education Effort

The California stem cell agency this week announced its online high school study program, which is aimed at helping to provide workers for the biotech industry.

Art Torres, co vice chairman of the stem cell agency, said that California is "a fertile ground for stem cell science," but added that to "realize the full potential of this burgeoning field" requires development of "an educated workforce."

In a news release, CIRM said the high school science program provides “a robust source of educational materials with a wide variety of teaching formats and levels of presentation.” Four units were provided on the CIRM Web site. The agency said the program can be taught in a day or fill a week. Another component is in development.

The program is tied to legislation that requires the state Department of Education to post on its Web site the model curriculum launched by CIRM.

In response to a question, Don Gibbons, chief communications officer for CIRM, said the program cost $45,500 to produce, including the component under development.

We also asked about CIRM's outreach to promote use of the program and whether the agency had an email list for all high school science teachers in the state.

Gibbons replied,
“We previewed it (the program) at the Nat. Bio Teachers Assoc. last November in Denver. The California chapter of that group is just forming and we will ship materials to their organizing meeting in two weeks in Roseville. We developed a list of county science coordinators around our school outreach for Stem Cell Awareness Day and will be reaching out to them, as well as the 50+ teachers who asked for a CIRM researcher guest lecture that day. The state has a master site for high-speed access to on-line resources and we will be posted there. We will be seeking to present at the Cal Sci Educ Conf this October. Etc.”
The CIRM announcement was covered Thursday by the San Francisco Business Times in a brief article by Ron Leuty.

Friday, December 11, 2009

Inside Biotech in San Diego: A Multibillion Dollar Matter

If you want to understand a little more about the biotech biz in San Diego, the Voice of San Diego Web site has a couple of pieces that deal with the industry that employs 40,000 people in that balmy corner of California.

Both are by David Washburn, who wrote last month about the impact in San Diego of the Pfizer cutbacks. He said:
“Pfizer's research facility in La Jolla...was not only spared in the downsizing, but is now one of five main R&D centers in the newly restructured operation. That's good news for the roughly 1,000 employees at the La Jolla facility, and perhaps for other San Diego scientists who could get hired by Pfizer as it moves more of its work here.

“And, on another level, the new Pfizer — as well as other Big Pharma restructurings — might be good news for the all the little fish that make up the San Diego biotech industry.”
In October, he explored reasons for the tiny voice that the tech and biotech industry has in local government, a phenomenon not unique to San Diego. Washburn said,
"San Diego is home to hundreds of high-technology and biotechnology companies that collectively employ close to 150,000 people, and have an overall economic impact on the region of more than $10 billion.

“Despite these big numbers the tech industry does very little to push the agenda at San Diego City Hall. In fact, among the hundreds of lobbyists registered with the city, only about a half-dozen organizations represent the tech and biotech industry. Scores of lobbyists, on the other hand, represent the tourism and building industries.

“Consider that San Diego Bike & Kayak is represented by a lobbyist, but Connect, the tech industry's most high-profile industry organization, is not.

"'That is telling,' said Duane Roth, the CEO of Connect(and co vice chairman of the California stem cell agency). 'It shows how little cause we've had to be down there.'

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