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Want to submit an article for the next newsletter? Simply email the article or article link to
Sharon Peterson. |
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Catch-up with all the latest news in Montana's
bioscience industry by visiting
Montanabio.org. | |
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Dear Sharon,
Happy Holidays from the
Montana BioScience Alliance!
Please Welcome our newest member:
Megan Harrington
Montana World Trade Center
Missoula, Mt.
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 MEMBER NEWS
BioScience Laboratories, Inc. and Synomics Pharmaceutical Services Announce Their Partnership to Provide Phase 1 Clinical Study Services
Bozeman, Montana, October 8, 2009 - BioScience Laboratories, Inc. and Synomics Pharmaceutical Services announced today their formal partnership to provide a fully integrated phase 1 clinical study capability for trials in healthy human subjects to provide drug manufacturers with a single source for outsourcing clinical trials. The combination of BioScience Laboratories' 18 years of experience conducting clinical trials and Synomics Pharmaceutical Services' strong reputation for providing pre-clinical and clinical bioanalysis and analytical chemistry services provides drug manufacturers with an outsourcing solution to conduct all aspects of phase 1 clinical trials in a GCP and GLP compliant environment. In recent years, drug manufacturers have experienced an increased demand on the quality of data from clinical trials. Combined with the drive to decrease the drug development timeline, the industry trend is back towards using contract research organizations located in the United States. To assure FDA acceptance drug manufacturers are requiring, more than ever, clinical trials that are conducted strictly in compliance with the FDA, GCP and GLP guidelines. For drug manufacturers wanting to realize the revenue of bringing a product to market, it is critical to select a contract research organization that conducts the clinical trial on time, on budget, and with resulting data that is suitable for FDA submission. The partnership between BioScience Laboratories and Synomics Pharmaceutical Services allows a single point of project management with the full array of bioanalytical and clinical trials capabilities.
To read full article, click here. __________________________________________________ |
FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine
GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Cervarix® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).
"The approval of Cervarix will bring an important new cervical cancer vaccine to girls and young women," said Deirdre Connelly, President, North American Pharmaceuticals, GlaxoSmithKline. "Immunisation with a vaccine such as Cervarix - along with annual doctor visits and Pap tests - will help protect women from cervical cancer, the second leading cause of cancer death in women in their twenties and thirties."
Cervarix was shown to be 93 percent efficacious in the prevention of cervical pre-cancers (cervical intraepithelial neoplasia 2+/ CIN 2+ or adenocarcinoma in situ) associated with HPV 16 or 18, in women without evidence of current infection with, or prior exposure to, the same HPV type at the time of vaccination. The majority (approximately 75 percent) of cervical cancers in North America are caused by HPV types 16 and 18.
The impact of Cervarix against the overall burden of HPV-related cervical disease results from a combination of efficacy against, and disease contribution of, HPV-16, HPV-18, and oncogenic HPV types not included in the vaccine. In a subgroup of clinical trial participants without oncogenic HPV infection at the time of the first vaccination and without evidence of prior exposure to HPV 16 and 18, the vaccine showed an overall efficacy of 70 percent against pre-cancerous lesions, regardless of HPV type. In an additional analysis that assessed the impact of Cervarix against specific HPV types not included in the vaccine, in women without oncogenic HPV infection with a specific type at the time of vaccination, approximately 89 percent efficacy was observed in the prevention of precancerous lesions associated with HPV type 31, the third most common cancer-causing virus type in North America.
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MONTANA NEWS/ UNIVERSITIES
Montana State University wins $98.4 million in research dollars for fiscal year
BOZEMAN - Research funding won by Montana State University rose $2.2 million in the past year, totaling $98.4 million for the fiscal year that ended June 30.
"The competition for research dollars is fierce," said Tom McCoy, MSU vice president for research. "Nationally, only one in five proposals for federal research dollars is funded on average. In some cases it is only one in 100. That our faculty continue to compete so well speaks well of their excellence and ambition."
 Federal stimulus money had no effect on this year's figures, but its influence will likely appear in next year's report, McCoy added. The university's largest college, Letters and Science, received $24.5 million in Fiscal Year 2009, making it MSU's top grant-getting college again. The College of Engineering followed with $19.9 million, a $2.5 million increase over FY 2008.
"Whatever the college, our students benefit from these research dollars by having hands-on opportunities to work on some of the most complex problems of our day with the most sophisticated equipment available," McCoy said. "That kind of experience prepares them for success in a way the classroom alone cannot."
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MSU to Figure Out Tricky Viruses, Adapt for Gene Therapy
BOZEMAN -- Viruses have an uncanny ability to trick cells into letting them inside. Once inside, they take over, says Brian Bothner, a faculty member in Montana State University's Center for Bio-Inspired Nanomaterials and the Department of Chemistry and Biochemistry.
Now -- with the assistance of an MSU senior who helped renovate the campus duck pond -- Bothner has a $1.2 million grant to tap into that talent.
The National Institutes of Health recently awarded Bothner a four-year grant to understand how viruses assemble themselves, enter cells and seize control. He and his collaborators will use that knowledge to build viruses that can carry genes to specific targets. A doctor might want to send a healthy gene to a heart muscle, for example, or an optic nerve.
"We study viruses from lots of different angles," Bothner said. "This is from a biophysical standpoint."
Working with researchers Mavis Agbandje-McKenna and Robert McKenna from the University of Florida, Bothner will study four types of the Adeno-associated Virus (AAV) to learn more about their structures and tricks for getting inside cells. Nick Muzyczka, a molecular biologist, also at the UF, will use those findings to build specialized AAVs.
"This could dramatically expand their uses as a delivery vehicle," Bothner said.
AAVs are unique human viruses that are popular in gene therapy, partly because they don't cause any diseases in humans or animals.
"If you mess up, you won't get someone sick with this virus," Bothner commented.
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MSU joins national consortium for biomedical scientists
BOZEMAN -- Montana State University has joined a national consortium that will help biomedical scientists accelerate their research by sharing resources.
Called eagle-i, the consortium so far involves nine institutions across the country, said Sara Young, principal investigator at MSU. Besides MSU, those schools include Harvard Medical School, Dartmouth College, Oregon Health and Science University, the University of Alaska Fairbanks, the University of Hawaii Manoa, the University of Puerto Rico, Jackson State University and the Morehouse School of Medicine.
The eagle-i team received a grant amounting to almost $15 million over two years to create a huge database for biomedical scientists around the United States, Young said. The scientists will be able to search the database for resource inventories at the nine participating institutions and request access to data that will assist in their work.
The grant -- awarded through the American Recovery and Reinvestment Act -- came from the National Center for Research Resources, part of the National Institutes of Health.
More than four dozen jobs are expected to be created across the consortium, Young said. Team members will start by collecting information about all the biomedical resources available at each of the nine participating institutions. Then they'll catalog that information and build databases, a search portal and necessary links.
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University of Montana News
University of Montana researchers secured over $62 million in external grants and contracts for fiscal year 2008. The top five recipients were Andrij Holian , Center for Environmental Health Sciences, $3 million; Jerry Bromenshenk, Division of Biological Sciences, $2.9 million; Jack Stanford, Flathead Lake Biological Station, $2.8 million; Rick Hauer, Flathead Lake Biological Station, $2.4 million; and Mike Kavanaugh, Center for Structural and Functional Neuroscience, $1.9 million.
In his 2008 State of the University address, President Dennison said, "In my view, the record of achievement during the last few years, combined with a renewed commitment to respond to emerging needs in Montana, warrant a positive response, echoing Merriam's closing words: 'The University of Montana - It Shall Prosper!'"
Joe Fanguy, Director of Technology Transfer in the Office of the Vice President for Research and Development will join the University of Montana in September from Mississippi State University where he served as the Assistant Director for the Office of Technology Commercialization. Joe has a doctorate in Biophysical Chemistry and seven years of experience in technology transfer in higher education.
From Dr. Fanguy:
Welcome to the University of Montana's Office of Technology Transfer, where we're pursuing commercial applications for technology generated by the university's research enterprise.
As a primary support arm of the Office of Research & Development, the Office of Technology Transfer serves as a resource for University of Montana faculty and staff regarding intellectual property and commercialization opportunities. The office also manages the university's intellectual property portfolio, creates business relationships with external organizations through marketing and licensing efforts, and plays an active role in the formation of start-up companies launched to commercialize University of Montana technology.
If you'd like to learn more about the ongoing technology transfer activities at The University of Montana, feel free to email me at joe.fanguy@umontana.edu or give me a call at 406-243-2148. Dr. Joe Fanguy Director of Technology Transfer |
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Montana Department of Commerce Awards $2.5 Million for Biomedical Research to Montana Research Institutions
(HELENA) - The Montana Department of Commerce has awarded a total of $2.5 million dollars in grants for the expansion of biomedical research to the McLaughlin Research Institute and the International Heart Institute of Montana Foundation (IHIMF). McLaughlin will receive $2,033,369 for the continued expansion of its facility in Great Falls, employee recruitment and specialized equipment. IHIMF will receive a total $466,631 for biomedical research activities in Missoula.
"Groundbreaking scientific research is happening every day across Montana," said Anthony Preite, Director of the Montana Department of Commerce. "These grant awards will help expand Montana's growing research and technology sector, create cutting-edge jobs, and allow Montana to remain competitive in the exciting fields of bioresearch. These awards are long term-investments in the discoveries of tomorrow."
The 2009 Legislature appropriated $2.5 million to the Montana Department of Commerce for Montana-based, private, non-profit research institutions involved in biomedical research that has the potential to significantly and positively impact the state of Montana. The Department of Commerce accepted proposals from institutions involved in research that could: improve the health of Montana citizens and/or livestock, create educational opportunities for Montanans in research activities, or provide economic benefit to the state through expanded research infrastructure and increased employment.
To receive the grants, the research institutes must provide matching funds totaling each individual award amount. Matching funding may include grants, loans, and/or investments for proposal related costs and activities.
For more information contact: Andy Poole, Deputy Director, Montana Department of Commerce, (406) 841-2707, apoole@mt.gov.
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| INDUSTRY NEWS/
OPPORTUNITIES
Influenza Research Expert to Discuss Past and Future Threats
Dr. Taubenberger discussed his influenza research and past and future threats on Friday, Oct. 23, at 7 p.m. in the Performing Arts Center of Hamilton High School, 327 Fairgrounds Rd. A question-and-answer session followed. Rocky Mountain Laboratories (RML) is sponsoring the free presentation, which is intended for a general audience.
"We are extremely fortunate that Dr. Taubenberger will be able to present this talk in Hamilton," says Marshall Bloom, M.D., RML's Associate Director for Scientific Management. "The ground-breaking work that he and his colleagues have done on the 1918 virus has led to many unexpected insights about influenza. He is recognized as one of the world's leading experts on these viruses."
Dr. Taubenberger is Chief of the Viral Pathogenesis and Evolution Section in the Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID). He leads a group of scientists studying respiratory viruses, focusing on influenza. Before coming to NIAID in 2006, he served as chair of the Department of Molecular Pathology at the Armed Forces Institute of Pathology in Washington, D.C., a position he had held since 1994.
He has published more than 130 papers in journals such as Science, Nature and the New England Journal of Medicine. In 2006 Dr. Taubenberger received an outstanding alumnus award from the School of Medicine, Medical College of Virginia, where he received his M.D. and Ph.D. In 2008 he received an award of the same name from George Mason University, where he received his undergraduate degree. RML is a component of NIAID, which conducts and supports research-at NIH, throughout the United States, and worldwide-to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov. The National Institutes of Health (NIH)-The Nation's Medical Research Agency-includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
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GlaxoSmithKline and SuperGen Inc Enter Multi-year Collaboration
Oct 26 (Reuters) - Cancer drug developer SuperGen Inc (SUPG.O: Quote, Profile, Research, Stock Buzz) said it entered into a multi-year collaboration with GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research, Stock Buzz) to discover and develop cancer therapeutics for an upfront payment of $5 million.
The upfront payment includes a $3 million common stock investment, SuperGen said and added that total potential development and commercialization milestones payable to it could exceed $375 million.
Shares of SuperGen soared 28 percent to $3.05 in pre-market trade. They had closed at $2.38 Friday on Nasdaq.
According to the deal, SuperGen will progress drug candidates through to early clinical development, and Glaxo will have the right to exercise an option to develop them further and market the drugs globally.
The companies would develop cancer therapeutics based on epigenetic targets, which refer to the regulation of genes with mechanisms other than changes to the underlying DNA sequence.
Epigenetic processes are widely believed to play a central role in the development and progression of almost all cancers, the company said.
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Drug Makers Face Tougher Measures
By ALICIA MUNDY WASHINGTON -- The House health-care bill presents more problems for drug makers than legislation in the Senate, but it gives the medical-device industry better breaks. The variations in the bills underscore why health-care companies have been lobbying vigorously on Capitol Hill. Billions of dollars are at stake, depending on which version is adopted. The Senate Finance Committee in October approved a bill that would place a $40 billion tax over 10 years on medical-device makers. That figure is halved to roughly $20 billion in the House version. Senate leaders are also preparing to reduce the tax to around that level, according to industry officials and congressional aides. Comparing the Plans Public Option House: Creates government-run health-insurance plan that would negotiate rates with doctors and hospitals. Senate: Same except states would have right to opt out. Winners/Losers: Doctors likely to get higher payments than they would if public plan rates were tied to Medicare. Insurers could lose because they'll face a new competitor. Employer Mandate House: Employers must provide health-insurance coverage or pay fine of 8% of payroll (for those with payroll greater than $750,000). Senate: Penalty for employers who don't provide coverage is up to $750 per employee, if employees get government subsidies. Winners/Losers: Employers generally fare better under Senate plan. Taxes House: Surtax of 5.4% on married couples earning more than $1 million a year or individuals making more than $500,000 a year. Senate: No surtax on the wealthy. Tax on certain high-value health-insurance plans. Winners/Losers: Unions prefer the House bill because some union members have high-value or "Cadillac" health plans. Individual Mandate House: Those who go without insurance would pay fine of up to 2.5% of adjusted gross income. Senate: Finance Committee bill would levy fines of up to $1,500 per family if people refuse to purchase health insurance. Winners/Losers: Lower-income people get subsidies to buy coverage. Those who feel they still can't afford health insurance would lose, because they have to pay a fine.
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Federal Circuit Rewrites Standard for Patentability of Processes
(Republished with permission of Antoinette M. Tease, P.L.L.C.)
On October 30, 2008, the U.S. Court of Appeals for the Federal Circuit handed down a decision that purports to clarify the standard for determining whether a "process" is patentable. Section 101 of the Patent Act provides that whoever invents any new and useful "process, machine, manufacture or composition of matter" may obtain a patent therefor, assuming all other requirements for patentability (such as the requirement that the patent application fully teach the invention) are met. The words "machine, manufacture and composition of matter" have been included in the Patent Act since it was first enacted in 1793. The word "process," however, was substituted for the word "art" in 1952. Thus, the question before the court in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008)--and the question with respect to the patentability of any so-called "business method patent"--is: What is meant by the word "process"?
The court in Bilski held that the word "process" means something that is (1) tied to a particular machine or apparatus or (ii) transforms a particular article into a different state or thing. The court referred to this test as the "machine-or-transformation test" and argued that it is consistent with U.S. Supreme Court precedent. The Federal Circuit acknowledged, however, that future developments in science and technology may "present difficult challenges" and that the U.S. Supreme Court may ultimately decide to come up with a new test. This author had the sense in reading the Bilski opinion that the Federal Circuit was doing its best to find consistency in past U.S. Supreme Court opinions where such consistency may not exist and that the court itself did not necessarily believe that the test it was espousing was one that would stand the test of time.
In this author's view, the "machine-or-transformation test" will prove extremely difficult to implement. With one exception (noted below), the court did not answer the question as to whether, and under what circumstances, data or an electronic signal is transformed into a "different state or thing." Similarly, the court expressly declined to answer the question whether or when including reference to a "computer" in a claim will satisfy the requirement of tying the invention to a machine or apparatus. Thus, in this author's view, inventors seeking to protect their software or business method inventions have no further guidance today than they did prior to the Bilski decision.
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NCI Grant Funding Available for Small Business Innovation in Cancer Technologies
The National Cancer Institute Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs has announced grant funding opportunities to eligible small business and research institutions.
These funding opportunities are intended for U.S. small businesses that have the research capabilities and technological expertise to contribute to the development and commercialization of novel technologies and products to prevent, diagnose, and treat cancer. The deadline to apply for these grant opportunities is December 5, 2009.
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WHAT'S HAPPENING
Rocky Mountain Life Science Investor Conference Report:
Liz Marchi
September 2009
Wednesday, September 16, 2009, While representing the Montana BioScience Alliance at the Rocky Mountatin Life Science Investor Conference, Liz Marchi attended a reception at the Colorado's Governor's Mansion hosted by The Colorado BioScience Alliance, Dorsey Whitney and Johnson & Johnson' Business Development unit. She had the opportunity to speak with a number of members who work in business development for J & J. They discussed their virtual incubator, RedScript, how they are working with tech transfer and how they find new technologies. She also had conversations with Bob Eaton, with the Arizona BioIndustry Organization and Jim Linfield, Partner at Cooley Godward, who is a native of Bozeman. They were both very interested in what is developing in Montana in the Life Science area. The common themes from the speakers and industry experts regarding how work gets done these days is collaboration, building relationships and getting out of the silos of the corporate office. Liz had the chance to meet a number of company CEO's as well as investors from small to very large funds. Many of the life science fund managers have both domain and finance expertise. The head of Frazier Healthcare Ventures is a MD, PhD, MBA who can actually communicate. Thursday's conference started at 7:00am. The keynote speaker, Roy Davis, President of J & J Corporate Development talked about the "white space" in the life science industry referring to the vast opportunity for new products, diagnostics, therapies, devices, and procedures that are yet to be discovered. He spoke of the pressure on the corporate P & L and how J & J is looking for new science, new ideas and developing companies through the virtual incubator. He noted the importance of securing intellectual property and how often this is not done well. He repeatedly talked about the imperative to work across disciplines in the development process for life science.  Liz attended presentations from Applied Microarrays, Inc, Biodesix, Beacon BioTechnology and Axial BioTech and High Throughput Genomics, all diagnostic companies. She attended presentations for Kinetic Muscles, Inc., Leap Frogg, LLC, Medipacs and Medivance all device companies. The lunch speakers were Governor Bill Ritter who has committed $26 million to support life science discovery even in a tough recession. Governor Ritter stated that the cure for cancer may well be found in Colorado. He was very enthusiastic about the future of life science on the Rocky Mountain Front. Governor Ritter spoke of the desirable outdoor lifestyle in Colorado as a huge attraction for people and companies but he stressed that the ability to grow the life science industry is to have the talent such as Dr. Tom Cech, the 1998 Nobel Prize winner in chemistry. Dr. Cech followed Governor Ritter and shared his work in building the Howard Hughes Medical Research Campus near DC. Next to the NIH, the Howard Hughes Foundation invests more in life science research than any other entity. Dr. Cech focused mainly on the cross discipline, inter discipline research campus being built at CU where biology, chemistry, engineering, computer science and chemists will work side by side collaboratively on projects. The new center broke ground at September 11th in Boulder. In the afternoon, Liz attended pitches from MicroImaging Solutions, LigoCyte Pharmaceuticals. ( Don Beeman did a very good presentation.) Allogenisis, Valve Exchange and Vital Access. Liz did a private one on one with Vale Exchange, at their request. They have a very interesting business model which allows them a lower valuation than many device companies. Liz encouraged them to apply to Frontier Fund. Liz had the opportunity to distribute a directory to the head of the Eli Lilly Venture Fund. He and his wife have bought property in Thompson Falls. He said he would be happy to come to Montana to speak about how Eli Lilly works with companies. The venture capital panelists predicted that there will be half as many vc firms in 5 years as there are today. They also noted the importance of local angel groups as the best business development teams in communities with life science entrepreneurs. All said that Tech Transfer operations should not be in the business of building companies. Tech Transfer should be about relationship building across curriculums and across the globe. Again, relationships and collaborations. The conference attendees were most welcoming and very much appreciated having Montana as a sponsor and having a Montana company present.
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Update from Sharon:
On October 22, Anne Marie Quinn and Sharon Peterson appeared before the Governor's Economic Development Advisory Council meeting regarding the Small Business Innovative Research opportunities. We emphasized the strong support the legislation had and the number of organizations in Montana receiving SBIR/STTR grants. There was a discussion regarding the matching funds needed and possible sources for matching funds. Members of the committee are: Evan Barrett, Chief Business Officer, Governor's office of Economic Development , Tony Preite, Director, Montana Department of Commerce, Richard Sangrey, Chippewa Cree Business, Committee, Senator Joe Balyeat, Senator Kim Gillan, Representative John Fleming, Representative Tom McGillvray, Jim Atchison, Colstrip, Kathie Bailey, Lewistown, Sheila Hogan, Helena, Liz March, Polson, Corlene Martin, Choteau, Joe Menicucci, Belgrade, Joe Reber, Missoula, Wade Sikorski, Baker, Jim Smitham, Butte, Curt Starr, Billings, Paul Tuss, Havre, Linda Twitchell, Wolf Point. On Nov. 10 Sharon Peterson attended BioWest in Denver. The Montana BioScience Alliance exhibited at the conference and many visitors stopped by our table. Featured speakers at the BioWest conference were: Peter Sims who is a bestselling coauthor and strategic advisor specializing in leadership and innovation. He is the coauthor (with Bill George, DEO Medtronic) of True North, the bestselling book that the NewYork Times called "one of the most important books on leadership to come along in years. For more information on Peter Sims go to www.petersims.com, Ginger Graham, Former President and CEO, Amylin Pharmaceuticals Inc, a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines to treat diabetes, obesity and other metabolic disorders. She is currently the President and CEO of Two Trees Consulting and spoke about the future of the Biotech Industry. Sessions were held on Investor Relations For Lifescience Companies; the Rocky Mountain Life Science Investor Conference and the Keynote presentation at the Annual Awards Dinner was Eric Alexander. Eric is a skier, climber and mountaineer who is achieving his goals while playing an instrumental role in helping others to achieve their own. On May 25th 2001, Eric defied the odds and scaled Mt. Everest guiding his blind friend Erick Weihenmayor to its lofty 29,035' summit. Congratulations to the Colorado Bioscience Association for a very successful conference and thank you to all the Montana folks who sent materials for the booth. |
EVENTS CALENDAR
2009 Recognition & Holiday Event
December 3, 2009
TechRanch
Bozeman, MT
and to register.
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8th Annual LifeScience
Alley® Conference & Expo
December 9, 2009 Minnesota Convention Center Minneapolis, MN Click here for more info and to register.
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2009-2010 KEYSTONE SYMPOSIA CONFERENCES
Triglycerides and Triglyceride
-Rich Particles in Health and Disease
January 9-14, 2010
Big Sky Resort
Big Sky, MT
Dynamics of Eukaryotic Transcription
During Development
April 7-12, 2010
Big Sky Resort
Big Sky, MT
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Life Science Innovation Northwest 2010
March 16-17
Washington Biotechnology and Biomedical Association
Seattle Washington
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Bio International ConventionMay 3-6, 2010 McCormick Place Chicago, IL Click here for more info
and to register.
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| About Montana BioScience Alliance
The Montana Bioscience Alliance serves as a hub for Montana's biotechnology companies, entrepreneurs, laboratories, hospitals, clinics and universities to commercialize, grow and sustain globally competitive bioscience companies -- ultimately to create high-quality jobs and economic opportunity in Montana.
Montana BioScience Alliance
P.O. Box 1773
Billings, Montana 59103
406-8965876
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