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Around the Regions: Jan 26, 2009


Norwegian Government Unveils Package to Aid Life-Sci Industry, Including Oslo Cancer Cluster

The government of Norway has developed a package of measures intended to aid the nation's life sciences industry, particularly its Oslo Cancer Cluster. One key provision calls for Innovation Norway, the country's main industrial development agency, to nearly triple its funding of "Innovation" loans from $44.8 million to $133 million. The loans may be used as working capital for biotech companies.

Other highlights of the package:

• R&D Funding — $9.8 million will be set aside to stimulate increased cooperation within industry on research and development, as well as to promote industry development in the health sector and internationalization.
• Tax breaks — Small- and medium-sized enterprises may deduct $810,133 in tax breaks, up from the previous $586,722.
• Argentum – The government-owned investment company will receive increased equity capital of $279.4 million, and will be allowed to increase its investments in private VC funds focusing in life sciences in Norway and abroad.

The package is Norway's response to calls from the cancer cluster and the country's life-sci industry for assistance. They have argued that more than half of the 25 Norwegian oncology companies that are in the cancer cluster are in danger of running out of cash in the next 12 to 18 months [BRN, Dec. 22, 2008]

"This is the most active political move in Europe so far regarding support to the biotech industry. At this point, these seem to be the necessary measures to bring the Norwegian biotech companies through the financial crisis," Bjarte Reve, the CEO of Oslo Cancer Cluster, said in a statement.

Georgia Announces Legislation to Protect Life Sciences Employers from Product Liability Claims

Georgia Gov. Sonny Perdue has proposed legislation intended to protect Georgia-based biotech companies from product liability claims.

"With this proposed legislation, we will cement our position as a leader in the biotech industry by enacting laws that respect the role of the federal Food and Drug Administration as the regulator of the safety of drugs and medical devices," Perdue said, in remarks to the Georgia Chamber of Commerce. "The legislation will make Georgia an even more attractive environment for biotechnology companies."

Perdue said the legislation is intended to entice biotech companies to locate in Georgia and support the companies that are currently located in the state. In order to qualify for the protection, companies would have to:

• Manufacture devices or sell pharmaceuticals,
• Base their corporate headquarters in Georgia — either by employing more than 200 workers in manufacturing or research and development; or by having their principal place of research and development in Georgia.

The proposed legislation will state that FDA approval is sufficient to protect against "design defect" lawsuits based on the premise that a drug or device is faulty and caused injury, as well as "failure to warn" lawsuits that maintain that health risks were not sufficiently communicated to doctors and patients.

The legislation would not apply to biotech companies found to have defrauded the FDA, or to have used a drug or device in an off-label manner.

CIRM Chairman Eyes $10B for Agency-Funded Research, Programs from Obama Stimulus Bill

The chairman of the governing board for California's state stem cell research agency, Robert Klein, has circulated a five-page letter to members of his Independent Citizens Oversight Committee with details of a proposal to request $12.7 billion from the Obama Administration's economic stimulus bill, and add to it $6.15 billion in state funds, toward programs supporting regenerative medicine and broader biomedical research nationwide. Klein said he intends to discuss the letter, first reported by the California Stem Cell Report, at ICOC's next meeting Jan. 29-30.

In the letter, available here, Klein proposed five "federal initiatives." They include $6 billion for increased NIH funding of biomedical research; a $3 billion loan guarantee program somewhat similar to the $500 million loan program discussed by the committee for more than a year; $2.1 billion for assistance to state government research programs; a $1.5 billion biomedical lab construction effort, and the sale of R&D tax credits by some smaller life sci companies to fund research efforts; no projected cost was furnished for the credits.

Accompanying the letter was a chart concluding that the nearly $18.9 billion in proposals would generate 159,832 "job years" of employment.

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Economic Upheaval Stymies Marshall U. Fundraising for West Virginia's 'Bucks for Brains' Program

Marshall University has raised about $2 million, and received another $1.1 million in verbal pledges, toward the $15 million it must amass to match the state's share of funds under West Virginia's 'Bucks for Brains' researcher recruitment program, Marshall U. President Stephen Kopp told MetroNews.

Gov. Joe Manchin signed Bucks for Brains into law last year [BRN, March 17, 2008], under which the state committed $35 million to West Virginia University as well as the $15 million envisioned for Marshall. By next month, WVU should be ready to publicly release a list of donors who have already signed on to research programs in energy, biometrics, nanotechnology, and biotechnology, WVU Vice President for Research and Economic Development Curt Peterson told MetroNews.

Battelle Revises Metrics in Six-Year Update of Arizona's Bioscience Roadmap

Arizona is growing faster than the national average in its volume of federal research grant dollars, and its growth of bioscience jobs and firms — but early-stage life-sci companies continue to need capital for future growth, according to Turning the Corner: 2008 Progress on Arizona's Bioscience Roadmap, an update of the 2002 Arizona's Bioscience Roadmap released by Battelle Memorial Foundation.

These findings are from new data released by Battelle, the Ohio-based nonprofit contract research firm that developed Arizona's life-sci effort in 2002, and has tracked its progress in the years since. The Roadmap project, commissioned by the Flinn Foundation, has been guided by a statewide collaboration of more than 350 officials from business, science, academia, government, finance, law, and other areas.

"Arizona has one of the nation's fastest-growing bioscience industries. It's not a major bioscience destination yet — that will require several more years — but Arizona has gained a national reputation as an emerging bioscience center," Walter Plosila, senior advisor to the Battelle Technology Partnership Practice, said in a statement.

Among the updated metrics from Battelle's annual tracking:

Federal Grants: Research grants from the National Institutes of Health grew 24 percent from 2002 through 2007 — double the growth of the nation's top-10 states.

R&D Expenditures: Bioscience-related academic research and development expenditures at the state universities reached $415 million in 2007, a 48 percent gain since 2002. This exceeds the 42 percent mark of the nation's top-10 states.

Bioscience Jobs: During 2002-07, Arizona bioscience jobs grew by 23 percent, compared to the US average of 8 percent. Job growth occurred across all five subsectors that comprise the state biosciences industry — drugs and pharmaceuticals; research, testing, and labs; medical devices and equipment; hospitals; and agriculture feedstock and chemicals.

Bioscience Firms: The number of bioscience establishments in Arizona grew by 22 percent during 2002-07, outpacing the national average of 11 percent.

Venture Capital: At $86 million, Arizona recorded its best year in 2007 since the banner year of 2002, though fell short of the Roadmap goal of $100 million for the year. Reflecting a national trend, venture capital investments fell in 2008 at $65 million. The state continues to account for less than 1 percent of national venture capital investments.

University licensing income: While the state's universities have been showing continued gains in spinning out new companies, securing more patents, and other measures of technology transfer, 2008 saw a substantial drop-off in licensing income. At $1.5 million, the mark fell 50 percent from 2007.

In addition, Battelle has determined that 17 of the 19 Roadmap actions recommended in 2002 have recorded progress; of the 17, 10 recorded "substantial" progress. Grants from Science Foundation Arizona moved three actions from "progress" to "substantial progress" in 2008.

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Report Pegs Impact of Ohio's Bioscience and Healthcare Industries at $148B

Ohio's bioscience and healthcare industries generated $148.2 billion in economic activity in 2007, representing 15.7 percent of Ohio's total economic output, according to a report released earlier this month by BioOhio, the state's life-sci industry group.

The report, produced for BioOhio by Tripp Umbach, found bioscience accounted for 1.4 million jobs in 2007, using a definition that included hospitals, healthcare providers, and medical colleges, as well as commercial bioscience. Commercial bioscience alone accounted for a $33.8 billion overall economic impact and 50,100 direct jobs in 2007, up from $27.3 billion and 48,485 direct jobs in 2006. When indirect and induced jobs are factored, the commercial bioscience employment impact jumps to 135,136.

Analysis of commercial bioscience industry segments revealed research and development as the top employment sector (12,415 jobs), while agricultural biotechnology contributed the largest direct economic impact ($10.7 billion) in 2007. Medical device and equipment manufacturers directly employed 9,757 Ohioans.

Bioscience, medical technology, and research organizations continue to thrive in Ohio. As of December 2008, 1,141 bioscience-related entities were operating in the state. While company launches and relocations explain some of the 39.5 percent increase since last year's count of 818 entities, the report said the expansion was mostly attributable to a more thorough census of organizations.

The report counted 636 Ohio companies as certified by the US Food and Drug Administration to manufacture medical devices, and counted 88 facilities in the state as being FDA-certified to manufacture pharmaceuticals.

Half of Ohio's bioscience entities (574) are located in northeast Ohio, which includes the Cleveland area, Akron, Canton, and Youngstown. Southwest Ohio, anchored by Cincinnati, and central Ohio, which includes the capital Columbus, are each home to about 200 of the state's bioscience-related entities, the study found.

Also in 2007, Ohio welcomed 60 bioscience organizations by way of new company launches or companies establishing their first facility in the state, including AcelleRX Therapeutics (Cleveland), Akebia Therapeutics (Cincinnati), Freedom Meditech (Cleveland/Toledo), and Traycer Diagnostic Systems (Columbus).

The complete report and appendix are available here.

Study: Biotech Generated $3.5B in Direct Economic Activity, 13,600+ Jobs for Oregon in 2007

Oregon's bioscience industry generated $3.5 billion in direct economic activity in 2007, accounting for 2 percent of the state's gross domestic product, as well as 13,630 jobs with a combined personal income of $800 million, and about $250.5 million in state and local tax revenues, a study released last week concluded.

Dimensions and Contributions of the Bioscience Industry in Oregon, commissioned by the Oregon Bioscience Association and conducted by ECONorthwest, also calculated overall economic activity — which includes indirect factors such as purchased goods and services, and support of other business sectors — of $6.2 billion, 37,040 jobs and $1.7 billion in personal income to Oregon.

"With its continued and anticipated growth curve in Oregon, the data show that biotech is likely to beat the current recessionary trends," Nathan Gibson, vice president of business development for Skanska and chair of the board for the Oregon Bioscience Association, said in a statement.

Other findings of the study:

• Oregon has 615 bioscience-related companies, labs and institutions, about three times more than the number previously counted.
• National Institutes of Health funding for Oregon's biosciences increased 18.7 percent since 2001 and totaled $277 million in fiscal year 2007.

A 2007 report commissioned by the bioscience association, Oregon Bioscience Industry Segmentation and Cluster Analysis, offered the approximate percent of companies in each biosci subcluster: Medical devices (39%); followed by pharmaceuticals and diagnostics (23%); reagents, services and equipment (20%); software (8%), health care (5%); and agriculture (4%).

The complete economic analysis can be read here.

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UK's BioIndustry Association Recommends More Tax Incentives, Biopharma Regulation Vision

The UK must step up tax incentives for pharmaceutical development, work with international agencies to develop a vision for future global biopharmaceutical regulation, and convene an independent inquiry to study the long-term impact of the National Institute for Health and Clinical Excellence on the cost of, access to, and use of medicines, a report released last week recommended.

The BioIndustry Association's Bioscience 2015 Review and Refresh report — an update of a 2003 life sciences industry report — is designed to track progress against the original recommendations of the 2003 study, and issue new recommendations reflecting changes in the industry over the past six years. The report was crafted by a panel chaired by Sir David Cooksey, and including representatives from industry, the finance community, patient groups, research councils, academia and various government departments.

BIA, a group with more than 300 members, credits the publication of the original Bioscience 2015 report with raising government funding of medical research, especially translational research; introducing legislation against animal rights activism, and helping establish bioProcessUK which has sought to strengthen links between business and academia in bioprocessing.

Sir David Cooksey, Chairman of the Bioscience 2015 Review and Refresh Steering Group, commented:

"The UK bioscience sector should be one of the UK's high achieving, knowledge based industries, yet despite excellent progress in certain areas, its future is at risk if we do not act now. In particular, it is vital that the problem that the sector is currently facing from inadequate financing is addressed, otherwise the future of early-stage bioscience companies is in doubt," Cooksey said in a statement.

The full Bioscience Innovation and Growth Team review and Refresh report is available here while the Bioscience 2015 report is available here.

BIO Releases Guide to State Legislative 'Best Practices' in Growing Bioscience Industry

The Biotechnology Industry Organization has released its guide to policies and legislation adopted by several states to grow their life sciences industries. The report, entitled State Legislative Best Practices in Support of Bioscience Industry Development, chronicles several types of state programs deemed helpful in forming and sustaining bioscience industry development.

The guide cites numerous state efforts to invest in the fundamental components of early stage research and efforts to encourage capital investment, exploring the rationale behind current legislative efforts as well as serving as a practical reference guide to various state measures.

The report can be accessed here.

Pennsylvania Reaches First Milestone Under State Law — 2 Percent Biofuel Required for Diesel

Pennsylvania Gov. Governor Rendell has announced that within one year, every gallon of on-road diesel fuel sold in his state will contain at least 2 percent biodiesel. He made the announcement last week during a visit to the renewable energy exhibit of the 93rd Pennsylvania Farm Show, saying the mandate was possible because the state's biodiesel producers can now manufacture 40 million gallons of the alt fuel a year within the state.

Act 78 of 2008, available here, establishes biofuel percentage thresholds for all diesel fuel sold at retail — 2 percent biodiesel, once in-state production reaches 40 million gallons; 5 percent biodiesel, once in-state production reaches 100 million gallons; 10 percent biodiesel, once in-state production reaches 200 million gallons; and 20 percent biodiesel, once in-state production reaches 400 million gallons.

And once in-state cellulosic ethanol production reaches 350 million gallons, all gasoline sold at retail must contain10 percent ethanol.

"Last year, Pennsylvania motorists spent approximately $30 billion on fuels produced beyond our borders. Rather than sending that money overseas, we can put it to work in Pennsylvania to support industries that are developing and transporting home-grown biofuels," Rendell said in a statement

The state said its first biodiesel threshold — 40 million gallons produced in-state annually — was achieved in September, following production of 3.9 million gallons in June, 2.9 million gallons in July, and nearly 3.2 million gallons in August. The state multiplies the total gallons produced over a three-month period by four.

Act 78 is expected to add up to 1 billion gallons of biofuels to the state's fuel supply.

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Devens, Mass., Community College Launches Biotech Job Training Program

Mount Wachusett Community College in Devens, Mass., has launched a 15-week program designed to train people for jobs in biomanufacturing, the Worcester Telegram & Gazette reported. The program — funded through a $1.6 million US Department of Labor grant — combines classroom instruction and practical laboratory sessions to give students skills and knowledge for manufacturing and quality-control positions in biotech.

"The economy is going to turn around and when it does, the region of the country that has the best educated work force will come out of this recession sooner than other parts of the country," MWCC president Daniel M. Asquino told the newspaper.

Recruitment will begin March 15 for the second work force training program session, scheduled to begin in August. Recent high school graduates, as well as career-changers with a strong background in mathematics, biology and chemistry are eligible to apply for the program. Classes will be three days a week, seven hours a day, at the Devens campus.

The program will be repeated the next three years for six 15-week sessions. The grant covers student tuition, fees, equipment and supplies — but students must buy their own textbook, which they can retain as reference.

GCCC-ACRP Launches Training Programs for Clinical Research Professionals in Dubai

The Gulf Cooperation Council Chapter of the Association of Clinical Research Professionals has launched a series of training programs for clinical research professionals in the Middle East, aimed at promoting clinical research in the region. The training programs are being held in association with the clinical research organization Clinart International.

The GCP Refresher Workshop for investigators, and a project management program will take place March 4-5, while the Fundamentals of Clinical Research and Independent Ethics Committee programs will meet from March 6-7.

MichBio Will Publish 2009 Michigan Biosciences Directory and Resource Guide

MichBio, Michigan's biosciences industry group, said last week it was updating and compiling its 2009 Michigan Biosciences Directory and Resource Guide. The directory will be included in the May issue of BioMatters Magazine, MichBio's new, bi-annual publication spotlighting Michigan biosciences news and trends.

MichBio said the directory will be distributed to MichBio's targeted database of biosciences companies and service providers, state and regional funding sources, economic development organizations, universities and research institutions. In addition, it will be made available to economic development, investment, site selection and other groups essential to industry expansion at the 2009 BIO International Convention, to be held in Atlanta from May 18-21. The magazine and directory will be published in both print and CD versions.

Companies eligible to be included in the directory are entities engaged in:

• Research, development, manufacturing and/or marketing of therapeutic, diagnostic, medical device equipment, reagents and research tools;
• Nutriceutical products;
• Informatics and information technology services and products (bio- and/or healthcare);
• Bio-agricultural and other bio-based technologies;
• Academic, biomedical and clinical research organizations (including universities, institutes and hospitals); and
• Biosciences and biomedical non-profit associations and organizations.

The form is available here.

The Scan

Expanded Genetic Testing Uncovers Hereditary Cancer Risk in Significant Subset of Cancer Patients

In Genome Medicine, researchers found pathogenic or likely pathogenic hereditary cancer risk variants in close to 17 percent of the 17,523 patients profiled with expanded germline genetic testing.

Mitochondrial Replacement Therapy Embryos Appear Largely Normal in Single-Cell 'Omics Analyses

Embryos produced with spindle transfer-based mitochondrial replacement had delayed demethylation, but typical aneuploidy and transcriptome features in a PLOS Biology study.

Cancer Patients Report Quality of Life Benefits for Immune Checkpoint Inhibitors

Immune checkpoint inhibitor immunotherapy was linked in JAMA Network Open to enhanced quality of life compared to other treatment types in cancer patients.

Researchers Compare WGS, Exome Sequencing-Based Mendelian Disease Diagnosis

Investigators find a diagnostic edge for whole-genome sequencing, while highlighting the cost advantages and improving diagnostic rate of exome sequencing in EJHG.