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California Stem Cell Research and Cures Act, California L-Occupancy, Kansas Bioscience Authority, New York State Foundation for Science, Technology and Innovation, High Performance Computation Consortium, California Institute for Regenerative Medicine Loa

Schwarzenegger Vetoes Calif. Stem Cell Agency Drug Access/Governance Bill; Little Hoover Commission to Examine CIRM, ICOC for Conflicts of Interest
Gov. Arnold Schwarzenegger has vetoed the California Stem Cell Research and Cures Act, a state Senate bill intended to address drug access and governance issues affecting the state’s stem cell funding agency.
Schwarzenegger sided with the California Institute for Regenerative Medicine and patient advocates, which objected to a provision that would lower, from two-thirds to a simple majority, the margin needed for an advisory panel to recommend funding for applications that present what lawmakers consider a “vital research opportunity.”
That provision was added to the original bill by state Sen. George Runner (R-Lancaster) — the state Senate’s second-most powerful Republican and an opponent of hESC research. CIRM and patient advocates contended the bill would torpedo California’s top-tier stem-cell effort by restricting future ICOC funding approvals to research based on adult stem cells, even if the federal prohibition on hESC funding is lifted by a new president in January [BRN, July 21].
“More than seven million voters were very clear when they passed Proposition 71 in 2004. They wanted to fund embryonic stem cell research that the federal government wouldn’t. They also wanted to make sure that California receives a return for its historic investment in medical research. Both of those important goals are already being accomplished,” Schwarzenegger stated in a veto message available here.
CIRM did not object to another provision of the bill that would have required drug makers, research centers, and other recipients of funding from the agency to ensure that the drugs they develop were accessible to uninsured state residents through Medi-Cal, California’s Medicaid program, and the state’s other publicly funded drug programs, at any of three benchmark prices in the California Discount Prescription Drug Program, unless waived from the rule by CIRM’s governing board, the Independent Citizens Oversight Committee.
The bill, known as Senate Bill 1565 and available here, was introduced last February by state Sen. Sheila Kuehl (D-Santa Monica). SB 1565 passed both the state Assembly and state Senate, and was among 890 bills stalled by the 81-day stalemate over a state budget for the fiscal year that began July 1 [BRN, Sept. 22].
Despite Schwarzenegger’s veto, another key provision of the bill will become reality. California’s Milton Marks, or “Little Hoover,” Commission on California State Government Organization and Economy last week said it would examine CIRM and ICOC, with an eye to determining what, if any, conflicts of interest are posed by the current governance of the state stem-cell agency.
Little Hoover’s first hearings on CIRM will be held Nov. 20 with another likely Jan. 22, Stuart Drown, the commission’s executive director, told California Stem Cell Report, a blog focused on public policy related to the stem cell agency. Drown also told the Report the commission may go beyond governance issues: “The commission has been asked to look at governance and transparency, but may look at other issues as well, including a discussion on ways to insure the most effective use of bond money.”
The Sept. 25 vote followed a request for an examination of CIRM and ICOC by Kuehl, Runner, and John Simpson, stem cell project director for the nonprofit advocacy group Consumer Watchdog, which has clashed with the stem-cell agency on a variety of governance and operations issues.
The Little Hoover commission’s action made moot the request for the examination contained in SB 1565. The bill initially required Little Hoover to conduct a study, until state lawmakers rewrote the legislation following an objection from the commission, on grounds that it alone can decide what to study under the state law that created it.
“When $6 billion in taxpayer money is at stake, the most efficient, responsive and transparent procedures are necessary. The commission will help ensure that happens," Simpson said.
Supporters of CIRM and patient advocates have objected to the study, expressing concerns it could lead to legislation that would hinder the agency, delaying cures for diseases, and lessening the agency’s value in helping research institutions leverage private donations.

California Building Standards Commission Approves L-Occupancy
California’s Building Standards Commission has approved a new L-Occupancy classification for the state’s building code, with the goal of promoting life sciences facilities growth, according to BayBio, the life sciences industry group for the San Francisco Bay Area and northern California.
The new L-Occupancy, which has already been used in some California communities, allows the construction of laboratory facilities above the third floor. The issue arose after California approved a revised building code last year; because the revised building code was based on a different source than the 2001 code, it restricted the use of laboratory chemicals above the first two above-ground levels of buildings.
The change followed two years of talks between BayBio representatives, architects, engineers, building officials and members of the Office of the State Fire Marshall.

Kansas Bioscience Authority Commits $52M to Labs and Biotech Companies
The Kansas Bioscience Authority has committed $52 million to research laboratories and biotechnology companies statewide during the coming year.
Some of the $52 million will maintain existing programs, such as an initiative to recruit more leading scientists to the state. Some funds will create new programs to assist entrepreneurs or boost cancer research. The authority also aims to invest in early-stage companies, and take steps toward creating Heartland BioVentures, a new venture capital fund in the Kansas City region.
“Our approach is to emphasize the research, look at commercialization with much greater focus and, of course, to focus on the expansion side,” Tom Thornton, president of the authority, told the Kansas City Star, adding: “It’s going to be a busy year.”
Last year, the authority made $29 million in spending commitments, part of an overall $67.6 million in approved spending since it began operating. State leaders created the authority in 2004 with the passage of the Kansas Economic Growth Act. The initiative is expected eventually to generate more than $580 million for the state.
The authority devotes most of its attention, and thus funds, to animal health, drug discovery and delivery, biomaterials, bioenergy and plant biology — life science segments where the state has already developed clusters of companies and academic researchers.
Among likely beneficiaries of this year’s spending: 
  • The Kansas Bioscience Centers of Innovation, which will receive $15 million toward commercializing technologies developed in academic institutions.
  • Kansas universities, which will be able to seek up to $6.75 million toward packages to recruit scientists.
  • The University of Kansas Cancer Center, which will receive $5 million toward its effort to win federal designation as a hub for cancer research and care. The alliance will work with the Midwest Cancer Alliance to step up collaborations and research into the disease.
  • Early-stage companies, and an effort to create an investment fund with a “high” commitment to investing in Kansas businesses, both of which will be funded through a $4 million share of this year’s spending.
The authority has also set three goals for the year 2019: 
  • Increase annual federal bioscience research and development investments to $650 million, compared with $219 million in the 2006 fiscal year.
  • Increase annual private venture capital investment to $200 million, compared with $61.6 million in 2007.
  • Increase bioscience companies from to 1,500 from the 981 recorded in 2004; and employment in the field to 23,000, from 14,889 as of 2004.

NYSTAR Awards $3M to Establish High Performance Computation Consortium
The New York State Foundation for Science, Technology and Innovation (NYSTAR) has awarded a $3 million, three-year grant from its Center for Advanced Technology Development Program to establish the High Performance Computation Consortium, or HPC2, that the agency has discussed for more than a year [BRN, June 9; June 4, 2007].


The consortium consists of Rensselaer Polytechnic Institute, Stony Brook University, the University at Buffalo, and the New York State Education and Research Network, or NYSERNet. Other institutions that will be working with the consortium include Cornell University, Columbia University, New York University, the University at Rochester, the Rochester Institute of Technology, the City University of New York, with other research institutions statewide expected to join as they undertake research based on high-performance computing.
The consortium will make available scientists and engineers to assist users of supercomputers at participating institutions, and guide the users in HPC. The grant will allow computational scientists based in one of three centers to be deployed to any location in the state to assist business and academic users needing HPC for projects involving NYSTAR’s Centers for Advanced Technology — one of which focuses on biotechnology.
Computational scientists deployed by HPC2 will help support existing software applications to run effectively on consortium computers, as well assist in developing new algorithms to facilitate the ability of the centers to use simulation-based engineering and science in their research. In addition, HPC2 will develop, maintain, and host a knowledgebase for HPC/SBES, which will contain application software, project specific information, tutorials and other training materials. 
HPC2 will also provide on-site workshops and training for CAT researchers.
Potential HPC users should contact Michael Ridley, director of high performance computing: [email protected].

California Stem Cell Institute Approves Outline of $500M Loan Program

As expected, the California Institute for Regenerative Medicine last week approved the outline of a plan to set aside $500 million for loans to companies and research institutes, with further detail expected to be added over the next several months [BRN, Aug. 18].
“The goal of the loan program is to find where there isn't any other funding along that pathway and make some available,” Duane Roth, a member of the Independent Citizens Oversight Commission, which oversees CIRM, and a leader of the loan policy effort, told the San Diego Union-Tribune.
The closer a drug is to market, the likelier its developer will pursue a larger loan. CIRM will award two types of loans: One will require the company to pay back the money no matter what happens, including failure of the product or company. The second does not require the company to pay the money back unless it has sufficient revenue. This type of loan would have a higher interest rate and give an equity stake to the state, which it would cash out if the product is successful.
The institute's loan program may offer a lifeline through the proverbial “valley of death” between angel and revenue-generating phases, according to a CEO quoted by the Union-Tribune: “It's a step in the right direction,” said Babak Esmaeli-Azad of the San Diego stem cell therapy company DNAmicroarray.
While CIRM has awarded $651 million in grants since its formation in 2005, following state voter approval the previous year of Proposition 71, all of that money has gone to nonprofit researchers working in basic research, or toward building lab space and training new stem cell scientists.
Companies have only recently become eligible to apply for institute grants, since CIRM approved a state policy for handling the rights to discoveries made with institute funds.
“We've been waiting for a turning point for (the institute) to become very friendly and accessible by the corporations,” Esmaeli-Azad told the newspaper. “This may be that turning point.”
Still unresolved: Who will evaluate loan applications, then administer and maintain the loans? The institute has said it plans to hire an outside underwriter.

Report: Outsourcing of Pharma Manufacturing, R&D to India Will Grow to $2.5B by 2012
Outsourcing of manufacturing and research and development operations by US and European Union pharmaceutical companies to India is projected to grow to $2.5 billion by 2012, according to a report released last week by Zinnov Management Consulting.
The report cited as a key factor increasing R&D costs, as well as growth in India’s pharma sector, which by 2010 is expected to move from being driven by domestic activity to export of products.
“Indian pharmaceutical companies need to penetrate further in [the] generics market in regulated countries and also increase their investment in R&D to move to gain expertise in higher value chain processes. Today, pharmaceutical is one of the most happening industries globally, and India has the potential to become one of the key global pharmaceutical players and also become the backbone of offshored services in pharmaceuticals”, Pari Natarajan, CEO of Zinnov Management Consulting, told the India Infoline News Service.

Southwest Michigan Life Science Venture Fund Seeks to Raise Another $50M
The Southwest Michigan Life Science Venture Fund has begun work within the past month to raise a second $50 million, according to the Western Michigan Business Review.
Founded by local investors who pooled $50 million, the venture fund provides capital for life sciences companies based in southwest Michigan or willing to move to the region. The fund has yet to record an exit, though its investors are seeking long-term gains from companies that grow in the Kalamazoo area following a series of cutbacks at the region’s longtime life-sci employer, Pfizer.
"We'd better get used to raising lots of money because of our success," Southwest Michigan First CEO Ron Kitchens told the newspaper.
Kitchens also said the fund will soon announce its 10th and largest investment since its formation three years ago. The new deal will involve a company that will relocate to Kalamazoo from the West Coast, Kitchens said.
The new round of fund raising for the venture fund began around the same time work started to expand the business incubator Southwest Michigan Innovation Center. The $3.4 million expansion will add 11,000 square feet to the 58,000-square-foot facility, located in Western Michigan University's Business Technology and Research Park, as well as reconfigure another 6,000 square feet of existing space.
Since it opened in July 2003, the Innovation Center has attracted 21 startup companies, nine of which have graduated to their own facilities.

Worcester Polytechnic Institute Wins $1M in Grants for Center for Neuroprosthetics
Researchers at Worcester (Mass.) Polytechnic Institute will receive $1 million in federal and state grants toward their development of new, permanent artificial limbs that could perform most of the movements and functions of natural limbs.
Most of the funding comes through a two-year, $860,000 grant awarded to WPI’s Bioengineering Institute by the US Army's Military Amputee Research Program of the Telemedicine and Advanced Technology Research Center. In addition, WPI will receive a $150,000 grant from the John Adams Innovation Institute, the economic development division of the Massachusetts Technology Collaborative, to undertake market evaluation, strategic planning, and business development activities supporting the growth of the center, and to help stage a national neuroprosthetics conference at WPI in 2009.
The TARTC grant, funded through appropriations supported by Massachusetts US senators Edward Kennedy (D) and John Kerry (D), as well as US Rep. James McGovern (D-Worcester), will cover three areas of prosthetics research at WPI: Control signal processing, nervous system integration, and the tissue-interface between device and body.

Pennsylvania’s Alleghany County OKs $500K Bridge Loan for Biotech Firm
Stemnion, a biotechnology firm that is developing a product to help heal burns and scars, has been approved for a bridge loan of up to $500,000 by the Redevelopment Authority of Allegheny County, Pa.
Stemnion will use the funding to begin clinical tests in January. While Stemnion was awarded a grant from the US Department of Defense in January to perform the tests on about 100 human volunteers, the money has not arrived, hence the need for the bridge loan, William Golden, Stemnion's executive chairman, told the Pittsburgh Tribune-Review.
"Tests now are being conducted on animals, and instead of conducting an initial test phase on about 10 humans, the government wants us to test a higher number starting in January," Golden told the newspaper.
He said Stemnion also needed the loan to hire new personnel and to relocate from a 2,500-square-foot office in the LifeScience Building at Pittsburgh Technology Park in South Oakland, into larger quarters at the Tech Park or elsewhere. The company has opened a clean lab at RiverPark Commons, on the South Side, and expects to double its work force to 24.
Golden co-founded the company with George Sing, who is chief executive officer.
Stemnion, formerly Kytaron Technologies, was formed in 2004 by University of Pittsburgh scientists to develop biomedical cell therapies. About half of the company is owned by Lancet Capital, which includes the University of Pittsburgh, Carnegie Mellon University, Highmark and the University of Pittsburgh Medical Center.

Marshall Institute for Interdisciplinary Research Receives First ‘Bucks for Brains’ Gift
Allied Realty, a third-generation family owned real estate business in Huntington, WV, has made the first donation — a $100,000 gift — to the Marshall Institute for Interdisciplinary Research.
The gift is the first Marshall has received for the institute since the state Legislature passed, and Gov. Joe Manchin signed into law, the West Virginia Research Trust Fund Program, commonly called either “Bucks for Brains” or “Bucks for Jobs,” earlier this year. The program allocates $15 million to Marshall and $35 million to West Virginia University, to be matched by contributions from each institution. [BRN, April 7, March 17].
Principal funds in each endowment would not be touched, but the interest income from each would fund research grants in biotechnology, biometrics, and other high-tech fields. The program’s goal is for the universities to commercialize new technologies developed in their laboratories.
Last month, Marshall announced that Eric Brian Kmiec, a biology professor who is a pioneer of gene repair, will join the faculty in January as the first director and the lead research scientist at Marshall's institute.

North Carolina Biotechnology Center Awards $347K to Raleigh, Charlotte Firms
The state-funded North Carolina Biotechnology Center has approved a combined $347,000 in loans to four state-based life-sci firms — Raleigh-based Arbovax and NanoVector, and Charlotte-based Countervail Corporation and EntoGenetics.
Arbovax won a Small Business Research Loan for $150,000 to help the company tweak a dengue fever virus it plans to use in developing a vaccine for the deadly disease. The company is seeking to produce a mutant virus incapable of reproducing in a mammalian cell while still producing a robust immune response to protect those who get the vaccine.
NanoVector received a $147,000 Small Business Research Loan to continue development of its nanovirus, developed by North Carolina State University scientists to fight cancer.
Countervail received a $25,000 Business Development Loan to help the firm commercialize a drug for use as an antidote for military nerve gas and pesticide poisoning. The company plans to use the funding to help it prepare a submission to the US Food and Drug Administration for clinical trial approval.
EntoGenetics won a $25,000 Business Development Loan to finalize patents and develop a faster process to produce spider silk for industrial and medical uses.
The awards add to the more than $16 million awarded by the center to more than 100 North Carolina biotechnology companies since 1989.

The Scan

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.

Study Reveals Potential Sex-Specific Role for Noncoding RNA in Depression

A long, noncoding RNA called FEDORA appears to be a sex-specific regulator of major depressive disorder, affecting more women, researchers report in Science Advances.

New mRNA Vaccines Offer Hope for Fighting Malaria

A George Washington University-led team has developed mRNA vaccines for malaria that appear to provide protection in mice, as they report in NPJ Vaccines.

Unique Germline Variants Found Among Black Prostate Cancer Patients

Through an exome sequencing study appearing in JCO Precision Oncology, researchers have found unique pathogenic or likely pathogenic variants within a cohort of Black prostate cancer patients.