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Fall is here and Montana is a happening place!
Please welcome our newest member:
Leslie Rosedahl
Pharmaceutical Research and Manufacturers of
America
950 F. Street N.W., Washington D.C. 2004
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Also, Don't forget to register for the Bio
International
Convention in Chicago, IL!
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Member News |
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Summit Corporate Services
Secures New Facility
to Accommodate Growth
BOZEMAN, MONTANA (August 13, 2009) - Summit
Corporate Services has secured a new facility to
accommodate its growing client base and expanding
service offerings. Summit successfully transitioned
its customer service center and business operations
into its new corporate headquarters at 2485 Manley
Road in Bozeman, MT on July 9th.
Summit's new facility boasts 6,200 square feet of
warehouse space, which is currently being remodeled
to ensure cGMP compliance and Summit expects to
launch its new inventory management and distribution
operation on-site by mid August. The facility also has
5,300 square feet of office and meeting space with
breathtaking views of the Bridger Mountain Range. As
a highlight to the recent move, Summit hosted Mederi
Therapeutics' annual meeting on August 7th and
shipped Mederi's first official order on the same day.
"It's a very exciting time for us here at Summit. This
new facility represents a significant investment in our
future and will enable us to accommodate additional
clients and broaden our services," stated Damon
Peary, Summit's founder and President. "In addition
to launching our new corporate headquarters, we've
also set our sights on attaining ISO 9001:2000 and
ISO 13485 Certification by year end." The facility is
just one of the many recent investments Peary has
made in Summit, demonstrating his commitment to
the company's future growth and success.
ISO9001 and ISO13485 are Quality Management
Systems (QMS) that aim to provide an internationally
recognized standard for a QMS. Although Summit is
already FDA cGMP compliant, becoming ISO certified
further demonstrates its commitment to quality and
continuous improvement.
Additional information about Summit is
available online at www.summit
corporate.com.
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Montana Molecular Awarded $100K
from the Montana Department of Commerce
Bozeman, Montana July 7, 2009 - Montana Molecular,
a leading developer of genetically encoded
fluorescent proteins, was awarded $100,000 by the
Montana Board of Research and Commercialization
Technology (MBRCT) to develop a new generation of
fluorescent molecules for detecting Cre recombinase.
Cre recombinase is widely used in genetic research
to manipulate genes and create genetic models of
human diseases. The project will be done in
collaboration with the Molecular Motion Laboratory at
Montana State University.
"Cre is a powerful tool for genetic research but it is
invisible." said Anne Marie Quinn, CEO of Montana
Molecular. "New funding from the MBRCT will enable
us to build the tools that will show which cells contain
Cre, and when Cre is active, making genetic
experiments more productive and cost effective." The
underlying fluorescence technology is based upon the
Green Fluorescent Protein (GFP) made famous by the
2008 Nobel Prize in Chemistry.
Montana Molecular plans to launch two new products
in 2010 resulting from this project. The Cre Stoplight
2.0TM will be a new generation of the very successful
Cre StoplightTM reporter that was originally developed
by Dr. Hughes and his colleague Yvonne Yang at Yale
Medical School in 2001. Cre Stoplight 2.0TM will be a
new and improved reporter that is sensitive enough to
detect the activity of a single Cre enzyme within a living
cell, and will produce a strong enough fluorescent
signal for cell purification and physiology. The new
product will also be updated with better fluorescent
proteins that are brighter and exhibit fluorescence
faster than those in the original Cre reporter. The
second product, Cre ShineTM will produce bright
fluorescence at the cell membrane of living cells
suitable for purification and physiological recordings.
Montana Molecular technologies are available for
license to partners with access to the underlying
fluorescent proteins and worldwide sales and
distribution channels.
Montana Molecular is a leading developer of
genetically encoded fluorescent proteins for cell-
based assays and live cell imaging. Montana
Molecular's scientific team is making breakthrough
innovations in fluorescent biosensors and read-outs
for cell activity. The management team is committed to
building a sustainable biotech industry in the state of
Montana, providing good jobs in a safe and healthy
environment. For more information about Montana
Molecular, please visit www.montanamolecular.com.
For more information about the Hughes laboratory at
Montana State University, go to
http://momotion.cns.montana.edu/
Congratulations to Anne Marie Quinn and Montana
Molecular.
Other successful projects can be viewed here
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AdvR and Photoacoustic Imaging
Photoacoustic imaging is an exciting new bio-optic
development that combines the superior selectivity
and resolution of lasers with cost effective ultrasound
imaging. This technique is expected to have a
significant impact on the diagnosis and treatment of
diabetic retinopathy (a major cause of blindness in the
US), as well in the treatment of burns, and a broad
range of other applications. Prof. H. Zhang at
University of Wisconsin-Milwaukee and Prof. S. Jiao at
the Doheny Vision Institute in Los Angeles are leaders
in developing this technique to image the vasculature
of the retina. AdvR, in Bozeman, has teamed up with
them to develop the next generation laser system
necessary for clinical usage. AdvR will address two
major barriers to practical usage by developing a dual
wavelength, 2 nanosecond pulse duration, kilohertz
repetition rate laser that delivers the laser pulses in
the alternating wavelengths.
A SBIR funding proposal
was submitted to the National Institute of Health in
August, 2009 to support the laser system
development. The specifications for the system are
well established by prior research that utilized
complex and slow lasers that were of value in a lab
environment, but are too slow for practical use with
patients. The alternating wavelengths at kilohertz
speeds proposed by AdvR will allow the retina to be
scanned in less than 2 seconds, which is critical due
to naturally occurring changes in the shape of the eye.
The two specific wavelengths allow separate images
to be created from hemoglobin with and without
oxygen attached. Thus, both blood flow in and out of
an area can be visualized, and the change in oxygen
level can be used to determine the metabolic rate of
the tissue. The performance viability of the system will
be verified in Dr. Zhang's Functional Optical Imaging
Lab. AdvR's system is based its broad range of in-
house capability in the design and fabrication of
engineered non linear crystals, and advanced
methods to generate unique and multiple
wavelengths. Past funding from MBRCT and Federal
plus-ups, as well as collaborative efforts with the
Montana Microfabrication Facility at MSU, have helped
to establish these capabilities.
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International Heart Institute
Pumping away: New technique
seals leaky heart without cutting into chest
By MICHAEL MOORE of the Missoulian
A couple of months ago, life looked pretty grim for Ken
Franklin.
His 63-year-old heart, weakened over decades by
Marfan syndrome, was at wit's end. It had been poked
and prodded, propped up and patched by doctors so
often that it couldn't take the strain of another surgery.
But it badly needed one.
"If we could have done surgery on him, we would
have," said Dr. Mark Sanz, a cardiologist at the
International Heart Institute of Montana, housed at St.
Patrick Hospital. "But his heart just couldn't take it. So
we had to look elsewhere."
That path led through a clinical trial for a new medical
device and the difficult-to-negotiate world of Medicare.
But the search paid off, and the fact that Franklin is
here to tell his story is proof of that.
The first step on the path was his heart's mitral valve.
As is often the case with Marfan, the valve had
weakened and begun to leak.
The process, called mitral regurgitation, sends blood
back into the heart's left atrium, a reverse flow that can
cause both the heart and lungs to swell.
In Franklin's case, if left alone, the leakage eventually
would have killed him.
"I would think he would have maybe had a year at the
outside," said Dr. Brad Berry, who was one of a half-
dozen doctors who eventually repaired Franklin's leaky
heart.
With an otherwise healthy heart, doctors would
surgically repair the problematic valve. But Franklin's
heart, already a mess of plastic, wiring, a defibrillator
and a pacemaker, couldn't handle another surgical
invasion.
"The risk for him was simply too high," Berry said.
During the months that Franklin's heart had been
growing progressively weaker, doctors at the Heart
Institute had been working on a clinical trial that
involved a new way to repair the mitral valve.
Valve repair or replacement has historically involved
cutting into the chest to reach the heart, and a
cardiopulmonary bypass. Hospital recovery time was
usually three to five days in the best cases.
But the trial involved something called the Evalve
Cardiovascular Repair System. Instead of cutting the
chest open, doctors guide a catheter through the
vascular system to the faulty valve.
Fluoroscopic and echocardiographic imaging guides
the cardiologist's efforts, which are focused on placing
a small clip attached to the catheter on the valve's
leaflets.
Ideally, the leak is sealed, the flow of blood back into
the left atrium is stanched and the patient recovers.
Two days later, the patient goes home.
Ken Franklin grew up in the shadow of the Anaconda
smelter. He later worked there for years, until it shut
down in the 1980s.
Franklin had bad eyes as a boy, but that wouldn't be
linked to Marfan syndrome for a long time. He didn't let
that slow him down, though, playing sports year round.
In fact, he didn't have a major health scare until 1986,
when he suffered an aortic aneurysm, a bulging
vessel that nearly took his breath away.
He was working on oil rigs in California then, and
when a company nurse asked when he might get
back to work, a doctor said he was "done already."
Franklin's heart began to break down in earnest in
2003, and he had surgery both that year and the year
after.
He didn't feel particularly wonderful for the next few
years, but he didn't have major trouble again until
November 2008.
That's when the wheels essentially fell off - heart
problems, collapsed lungs.
Soon enough, Berry and Sanz were trying to get
Franklin into an Evalve trial for high-risk patients, but
his risk proved too high even for the trial.
"At that point, we tried to get him into other clinics
around the country, but he was so high risk it just
didn't work out," said Berry.
Eventually, the options ran out. It was Missoula or
nothing.
The Food and Drug Administration, which regulates
clinical trials, had approved 120 high-risk Evalve
procedures, but the problem was cost.
"Just the device itself costs $18,000, and it looked like
Medicare wouldn't even pay that much for the entire
procedure," said Sanz.
And that's when St. Pat's got busy. Doctors spoke
directly with Medicare's chief medical officer for
Montana, Dr. Bernice Hecker.
Hecker initially declined to pay for the high-risk
procedure, but over time, her resolve weakened.
"We really owe a lot of this to Heidi Boehme," Sanz
said of the nurse who manages clinical trials at the
hospital. "She pretty much overwhelmed Medicare
with data."
The doctors provided Hecker with personal and
medical information about Ken Franklin, as well.
"We told her that as far as Ken was concerned, this
was really his only choice," Sanz said.
Hecker finally relented, authorizing the codes
necessary for Medicare to make the payments for high-
risk surgeries such as Franklin's.
"I think people have heard so many horror stories
about Medicare," said Sanz. "It's about time for a good
one, and this is certainly it."
Medicare's approval took Franklin's life out of the
capricious hands of fate and into the skilled hands of
doctors.
In this case, a handful of doctors who wound up
spending 10 hours repairing his heart.
"I don't think any of us expected to be there long, but it
turned into a very complex situation," said Berry.
Worse, by the time the docs finally clamped the leaky
valve, the procedure didn't really work. There was just
too much leakage.
"I had to go out and tell the family that the good news
was that we got the clamp in place but the bad news
was that it didn't seem to be working," Berry said.
The team then opted for a second clip. Sanz and Berry
said the hard work of the first eight hours paid off over
the last two.
"We definitely had learned from placing the first clamp,
and we moved much more quickly on the second
one," Sanz said. "We really had a great group of
people working on it, and it paid off for Ken."
Franklin will still need medical monitoring over time,
but he faces a much more optimistic future.
"I'd like to be feeling better a little more quickly," he
said, "but I really have to hand it to these guys and to
Heidi for getting me this far. Things could be much
worse for me."
For Sanz and Berry, Franklin's story is ongoing proof
that Missoula's medical community is world-class.
"This was something that wasn't going to get done,
but a lot of hard work here made it possible," said
Sanz. n little Missoula, Montana."
________________________
BioScience Laboratories Works
with Twenty-Five Companies to Test Their Products
for Effectiveness Against Swine Influenza
Following closely on heels of the Swine Influenza
outbreak, BioScience Laboratories received formal
approval from the USDA to acquire, house and work
with Swine Influenza A H1N1. With the World Health
Organization raising the worldwide pandemic alert
level to the highest level, phase 6, in response to the
human swine flu outbreak, antimicrobial product
manufacturers were concerned whether or not their
products are effective against this strain of influenza
and consumers were wondering about what products
they should be using to safeguard themselves and
their families from the spread of this virulent strain of
Influenza. Within a week, BioScience Laboratories
began conducting testing to measure product efficacy
against the problematic Swine Influenza strain. In
early June BioScience Laboratories received official
clearance from the CDC to receive and work with the
closely-guarded 2009 Clinical Isolate of the Swine
Influenza A H1N1 and immediately offered product
testing against this strain. Between May 1 and August
18, 2009, BioScience Laboratories has tested over
forty-five consumer, cleaning and healthcare products
from twenty-five different companies.
________________________
Cornell Scientist to Join MRI
MacLaughlin Research Institute is pleased to
announce that Dr. Teresa M. Gunn, currently the
Robert Hovey Udall Assistant Professor of Genetics at
Cornell University, will be joining the Institute's faculty
in July. Dr. Gunn's research on the molecular
mechanisms of degenerative brain disease in mice
will strengthen the Institute's focus on neurological
diseases, including Parkinson's, Alzheimer's, prion
diseases, and multiple sclerosis.
________________________
Deborah Cabin Awarded NIH Grant for
Parkinson's Research
McLaughlin Assistant Professor Dr. Deborah Cabin
has received a five-year grant from the National
Institute of Neurological Disorders and Stroke
(NINDS) to fund her Parkinson's disease research.
NINDS is one branch of the National Institutes of
Health (NIH), and its mission is "to reduce the burden
of neurological disease-a burden borne by every age
group, by every segment of society, by people all over
the world."
The grant totals more than $1.6 million over the five-
year period. This grant will fund salaries for Dr. Cabin
and her laboratory staff, as well as the cost of
research supplies and administration. During a
scientist's first couple of years at McLaughlin, the
Institute covers those expenses through fundraising,
giving the scientist time to establish her/his lab and
secure independent funding.
________________________
Scientist's Work Advances Understanding of
Memory
McLaughlin Research Institute's Dr. John Mercer and
his collaborators have advanced the understanding of
how memory works at the molecular level. The
research team indentified a key function of a protein
necessary for learning and memory. This was
published in the journal Cell in October 2008 and was
the subject of a commentary in the journal Nature.
According to Drs. Eran Perlson and Erika L.F.
Holzbauer, from the University of Pennsylvania School
of Medicine, writing in a commentary on the research
in Cell, "The insights gained from this work represent
an important step in our understanding of the
molecular mechanisms underlying memory and
learning."
Dr. Mercer and two members of his lab, Drs. Bill
Provance and Ryan Karcher, are coauthors of the Cell
paper, along with scientists from Duke University
Medical Center, Brown University, and the University of
Massachusetts Medical School.
________________________
Billings Clinic Research Center
By GAYLE WHITTENBERG
When Actos and Avandia (diabetic medications) were
presented in front of the FDA as cause for concern in
creating possible cardiovascular problems, we did a
study headed toward personalized medicine. We were
contacted first by a database firm who had permission
to enter our system-wide database of patients. What
they found resulted in them contacting a biotechnology
company in California who then approached us to see
if we wanted to do a study involving a simple DNA
blood test on prior patients who had taken Actos or
Avandia and who might have had complications as a
result.
We negotiated a contract and did business contacting
1,400 identified patients; 1,000 in control and 400 in
case. In all, we had over 300 patients contact us who
came in and either qualified or not. We drew their
blood and that was the end of the study. The California
company is looking for a blood marker in their DNA
that may help future diabetic patients either avoid or
take Actos or Avandia depending on what they find.
Montana is becoming quite a homogenous population
as you know in America and we are a hot "pool" in my
opinion of study patients.
Personalized medicine may be headed toward
someday when you walk into the ER and you are
diabetic, they could prick your finger and then tell you
what medications may or may not work for you. We
made some money on the study and gained quite a
lot of PR too. By the way, the FDA did not discontinue
these medications.
________________________
Dr. Leroy Hood in Bozeman
TechRanch, Montana BioScience Alliance and the
Institute for Systems Biology are very pleased to
present an afternoon with the World Famous BioTech
Pioneer and Montana Native Dr. Leroy Hood on
October 9, 2009 at the Rockin' TJ Ranch in Bozeman,
Montana. Dr. Hood will share his thoughts on the
future of biomedicine and how Montana can build its
life sciences and biotech community. Montana life
science entrepreneurs, research scientists and
investors will be attending the event to learn more
about collaborative opportunities with Dr. Hood's
Institute for Systems Biology and innovative ideas to
help Montana carve a niche in the life science
economy.
Please RSVP by October 2, 2009 to
plee@techranch.org or by calling 406-556-0272.
For more information click here.
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Universities |
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University of Montana Marketing Management
Class Offering Marketing Plan Development to
Montana Businesses
At the beginning of each semester, student teams in
the Marketing Management classes are assigned
marketing plan projects that have been requested
from businesses and nonprofit organizations in our
community. If you know of a business or organization
that needs to have a marketing plan developed this
semester, please have them contact me as soon as
possible. We try to have the marketing plan
assignments completed in the first week or two of the
semester. One caveat to remember is that the
students are given the option to pick which plan they
want to work on in their team. We have not had great
results when we assigned projects to student teams
that they did not want to work on.
http://matr.net/article-35700.html
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Montana News |
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Rocky Mountain Labs:
Genes Key to Staph Disease Severity, Drug
Resistance Found Hitchhiking Together
Genes Key to Staph Disease Severity, Drug
Resistance Found Hitchhiking Together Scientists
studying Staphylococcus bacteria, including
methicillin-resistant S. aureus (MRSA), have
discovered a potent staph toxin responsible for
disease severity. They also found the gene for the
toxin traveling with a genetic component of
Staphylococcus that controls resistance to antibiotics.
The study, now online in PLoS Pathogens, shows for
the first time that genetic factors that affect
Staphylococcus virulence and drug resistance can be
transferred from one strain to another in one
exchange event.
One of the ways Staphylococcus bacteria become
drug-resistant is through horizontal gene transfer,
whereby resistance genes move from one bacterium
to another. Staph bacteria also can exchange
virulence genes using the same mechanism, but this
was previously assumed to occur separately from the
transfer of antibiotic resistance.
Scientists from the National Institute of Allergy and
Infectious Diseases (NIAID), a component of the
National Institutes of Health, led the study. They
collaborated with researchers at the University of
Tubingen in Germany and the University of Medicine
and Dentistry of New Jersey.
"The discovery that bundled genes determine
virulence and antimicrobial resistance suggests a
new research focus for scientists trying to better
prevent and treat serious staph infections," says
Anthony S. Fauci, M.D., NIAID director.
The research involved more than 100 strains of S.
aureus and S. epidermidis, both bacteria found on the
skin of most people. In recent decades, these bacteria
have become increasingly virulent, often causing
severe disease that can be resistant to traditional
antibiotics such as methicillin.
The studies were directed by NIAID senior investigator
Michael Otto, Ph.D. In 2007, he and his colleagues
found that staphylococci secrete toxins of the phenol-
soluble modulin (PSM) family that are primarily
responsible for attracting and killing human white
blood cells called neutrophils. This process is critical
for the ability of S. aureus-including community-
acquired MRSA-to cause disease.
While screening S. aureus and S. epidermidis strains,
Dr. Otto's group noticed that some strains produced
one additional, previously unknown PSM toxin. The
researchers hypothesized that the toxin was
somehow connected to drug resistance. This idea
surfaced because the toxin appeared in 10 percent of
all MRSA strains and 68 percent of all methicillin-
resistant S. epidermidis strains analyzed-whereas the
researchers did not find it in strains of S. aureus or S.
epidermidis that are sensitive to methicillin.
The research group confirmed its theory by identifying
the specific location that encodes the toxin, which was
in gene clusters that control drug resistance, known
as SCCmec. The group named the new toxin PSM-
mec.
"This work represents a previously unknown example
of a toxin hitchhiking on staphylococcal mobile genetic
elements that are primarily in charge of transferring
antibiotic resistance," says Dr. Otto. He adds that the
finding "should alert the research community that
aggressive, drug-resistant staph can evolve more
quickly than we assumed."
The research group is continuing its study of PSM-
mec in S. epidermidis, where the toxin is more
prevalent. Ultimately, being able to neutralize PSM-
mec and other toxins that attack human defenses
could lead to new treatments for S. aureus and S.
epidermidis disease.
NIAID 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
www.niaid.nih.gov .
________________________
Shodair Children's Hospital Genetics Laboratory
Earns Re-Accreditation
HELENA - Shodair Children's Hospital is proud to
announce that its genetics laboratory once again
earned praises and the gold seal of approval for
quality health care-literally. Shodair's lab recently
passed a comprehensive inspection and was
awarded accreditation by the Joint Commission on
Accreditation of Healthcare Organizations. The Joint
Commission evaluated the laboratory's performance
in complying with nearly 300 standards related to
quality control, safety, infection control, leadership,
management of human resources, management of
information, ongoing performance improvement
activities and other issues.
Joint Commission accreditation confirms that
Shodair's lab has demonstrated a high level of quality
in care and services offered to patients and healthcare
providers. Accreditation is awarded for a two-year
period, and is indicated by a gold seal specifying
national quality approval.
"We're happy to have once again demonstrated our
commitment to quality lab services," said Shodair
Administrator Jack Casey. "Achieving Joint
Commission accreditation for our laboratory is an
important part of confirming the expectations of
healthcare providers across the country who count on
us for accurate and timely genetic testing results."
Shodair's lab performs genetic testing upon physician
referral or in conjunction with Shodair's genetic
outreach clinics across the state.
Last summer, the entire hospital passed an
exhaustive inspection and was awarded a three-year
re-accreditation by the Joint Commission following a
comprehensive survey of the hospital's psychiatric
facilities, care, and services.
The Joint Commission evaluates nearly 17,000 health
care organizations and programs in the United States.
Founded in 1951, it is an independent, not-for-profit
organization, and the nation's oldest and largest
standards-setting and accrediting body in health care.
About Shodair Children's Hospital-Shodair Children's
Hospital provides acute and residential psychiatric
care for Montana children and adolescents, and
clinical and laboratory medical genetic services to
residents of all ages. Shodair is a non-profit, non-
denominational facility and the state's only Children's
Miracle Network hospital. The medical genetics
department at Shodair is the state's medical genetics
program, and provides comprehensive services to
patients at the Helena campus and in communities
throughout the state, via outreach clinics.
________________________
Billings Clinic Opens New
Comprehensive Cancer Center
Billings, MT - Billings Clinic is proud to announce the
opening of its new, state-of-the-art, comprehensive
cancer center. On August 10, the doors (opened) to
the 50,000 square foot facility bringing clinical cancer
services together under one roof, including medical
oncology, radiation oncology, gynecologic oncology,
chemotherapy and support services. The $30.9
million Cancer Center was made possible in part
through a community wide campaign effort which
raised more than $10 million to fund construction of
this facility and the new inpatient cancer care unit that
opened in February 2009.
________________________
Clinical and Translational
Researchers
The Institute of Translational Health Sciences (ITHS)
is proud to announce the second annual program on
basic training in clinical and translational research
methods, the ITHS Clinical and Translational Boot
________________________
ITHS Technology and Resources Access
Grants
The "Institute of Translational Health Sciences" (ITHS)
was funded through the NIH Clinical and Translational
Science Award (CTSA). The ITHS brings together
scientists at the University of Washington, Fred
Hutchinson Cancer Research Center, Seattle
Children's, Group Health Research Institute, Benaroya
Research Institute and other partner institutions in the
Puget Sound region and in the WWAMI states to
advance and transform clinical and translational
research.
The ITHS is pleased to announce the opportunity to
apply for modest "technology and resources access"
grants. These grants will cover costs associated with
the provision of services to you through an ITHS-
approved facility core, shared resource, or cost center.
The aims of the Technology and Resources Access
grants are to:
- Support the incorporation of new technologies into
translational and clinical research.
- Foster collaborations between approved applicants
and technology service providers.
- Encourage the utilization of the latest technologies
and instrumentation into translational and clinical
research.
- Promote the career development of junior
faculty members in the ITHS.
Technology and Resources Access Grants
information:
- Up to $10,000 per accepted applicant will be directly
applied to the costs of the ITHS-approved facility core,
shared resource or cost center.
- Applications are due no later than Nov 2, 2009 11:59
PM.
- The ITHS will pay the service provider directly. Further
instructions can be found at:
http://www.iths.org/
node/31
For more information contact Kathy Long at 206-616-
9195 or ithsapps@u.washington.edu
________________________
Montana Department of Commerce to Provide
$2.5 Million for Bio-Medical Research
((HELENA) - The Montana Department of Commerce
has $2.5 million dollars in grant funding available for
Montana-based, private, non-profit research
institutions involved in bio-medical research that has
the potential to significantly and positively impact the
State of Montana. MDOC is requesting proposals from
private, non-profit research institutions involved in
innovative biomedical research. The grant funds can
be used to expand, renovate, and purchase
equipment for biomedical research and to expand
infrastructure that will enhance the scientific
collaborations between independent non-profit
researchers and researchers in the Montana
University System.
"Cutting edge bio-medical research is happening
every day here in Montana," said Governor Brian
Schweitzer. "Our bio-medical research industry is
advancing and new opportunities are on the horizon.
Through these bio-medical research grants, the State
of Montana is investing in the discoveries of
tomorrow."
"Encouraging growth in our already successful
research industry is good for our college graduates,
our job market and our economy," said Anthony Preite,
Director of the Montana Department of
Commerce. "These funds will foster continued
development in our growing technology sector and
allow Montana to remain competitive in the world of
bio-research."
The 2009 Legislature appropriated the $2.5 million in
funding for the Montana Department of Commerce to
contract with qualified independent non-profit
research organizations conducting bio-medical
research. Applicants are required to provide matching
funds to receive grant funds. Matching funding may
include grants, loans, and/or investments for proposal
related costs and activities. Applications are due by
October 16, 2009 and can be obtained by visiting
http://commerce.mt.gov/BioMedResearch.asp.
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 |
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The Technology Innovation Program
By MICHAEL WALSH
TIP is a new funding program that provides financial
assistance to small and medium size US companies,
universities, and other non-profit research institutions
engaged in high risk, high reward research that
addresses areas of critical national need (CNN). TIP
is currently in the process of identifying CNN areas
and has placed a call for white papers to help us in
shaping of topics of interest for future TIP
competitions. Information on TIP and the call for white
papers can be found on the TIP website:
http://www.nist.gov/tip.
One of the CNN areas where we have received
several white papers is healthcare, specifically
addressing the development of tools and
technologies to enable personalized medicine. I have
been tasked with gathering additional feedback on
current unmet high-risk/high-reward research needs
involving this and other potential CNNs. It would be
very helpful if I could get your thoughts on the
following:
1. Are there any specific technical areas (not specific
project (s) for funding) where you feel there is lack of
federal as well as private funding and where federal
funds need to be directed to solve critical national
problems?
2. If you had your choice where would you direct your
funding priorities keeping in mind critical national
needs in healthcare?
At this time, we are in an information gathering mode.
The information you provide will be incorporated along
with the visions of the administration, NIST, other
government agencies, technical communities and
other stakeholders, into the TIP selection process for
NIST to make a decision on an area of critical national
needs.
________________________
Montana BioScience On "Follow-on
Biologicals"
Biologic pharmaceuticals and the FDA approval
process of "follow-on biologics" are currently being
discussed in Congress as part of the national health
reform debate. Although a lesser-known issue, this
legislation will have a great impact on our industry.
While there is currently a FDA approval process for
biologics to treat and cure diseases and other
illnesses, there is no approval process for "follow-on
biologics" - also known as biosimilars - when the
innovator's data exclusivity expires. Currently, there is
legislation in the healthcare reform bills, approved by
the House and Senate committees, to give innovators
who develop biologics 12 years of data exclusivity.
This provision is supported by the Montana
BioScience Alliance, along with many biotech
companies, organizations, community, and voluntary
health organizations across the state and nation.
We argue this is an appropriate measure as biologics
are complex medicines that are manufactured using
living organisms, and are far more complex than most
small molecule chemical drugs, such as aspirin.
Biologics include many of the latest breakthrough
medical therapies for serious and life-threatening
illnesses, such as cancer, multiple sclerosis,
diabetes, and HIV/AIDS, as well as many serious rare
diseases. Due to their size and complexity, biologics
cannot yet be scientifically characterized to the same
degree as small molecule chemical drugs.
Follow-on biologics are not generic drugs. A generic
drug is a product that is shown to be the same as an
innovative drug, and is generally designated as
therapeutically interchangeable with the innovator
drug. Unlike generic drugs, a follow-on biologic is a
product that is similar to, but not the same as, the
innovator drug. Because of the complex science
involved, the Food and Drug Administration (FDA) and
foreign regulators have indicated that the generic drug
approval pathway is not appropriate for complex
biologics.
In order to ensure that new pioneer biotechnology
products continue to reach patients and physicians,
any statutory pathway for the approval of follow-on
biologics must protect patient safety and preserve
incentives to innovate.
The Energy and Commerce Committee passed the
Eshoo Amendment with overwhelming support 47-11
on July 31. This mirrors the support it has gained
throughout the House with 142 co-sponsors. The
Senate Health, Education, Labor and Pensions
(HELP) Committee also addressed the issue of
biosimilars in their health reform bill. On a 16-7
bipartisan vote, they agreed to the Enzi-Hatch-Hagen
Amendment which, like Eshoo, called for 12 years of
data exclusivity. Both House and Senate committees
establish incentives for innovation, protects patients'
safety, and allow competing biosimilars to be
approved so as to bring down the cost of medicine
over time.
The Montana BioScience Alliance strongly urges your
organization to learn more about this issue, as well as
advocate to and educate Montana decision makers,
like our three members of Congress so they will
support this issue when it arrives on the full House
and Senate floors.
If you have questions about this issue, or would like to
get involved and sign a letter of support, please
contact Leslie Rosedahl,
LRosedahl@pubaffairsco.com .
________________________
From Eli Lilly,
More than 60 instiutions across the United States are
currently
participating in a new drug discovery initiative recently
launched by
Eli Lilly and Company to discover and develop
potential new medicines to
treat
Alzheimer's disease, cancer, diabetes and
osteoporosis. Named the
Lilly
Phenotypic Drug Discovery Initiative, or PD2, the
program uses
disease-relevant assays developed by Lilly scientists
and a secure Web
portal to evaluate the therapeutic potential of
compounds designed and
synthesized in university and biotechnology
laboratories around the
globe.
"Each year, researchers throughout the world design
and synthesize
compounds in university and biotechnology
laboratories that are never
fully evaluated as potential drug candidates," says
Alan D. Palkowitz,
Ph.D., vice president of discovery chemistry research
and technologies
at Lilly.
"There's an untapped source of ideas and
compounds in the greater
scientific community that could ultimately impact
patients' lives
following further evaluation and development."
The PD2 initiative is designed to expand opportunities
for potential
innovation by providing global researchers a more
convenient point of
entry into Lilly's drug discovery and development
process. While
academia, biotech and pharma have been
collaborating for decades, those
collaborations typically involve specific researchers,
institutions or
companies. PD2 opens the door to global
researchers who may not have a
relationship with Lilly, or with any pharmaceutical
maker.
Through the PD2 portal, researchers may
confidentially submit a
structure of their compound for an initial
computational evaluation
using a set of proprietary Lilly algorithms focused on
drug-like
properties and structural novelty. If the compound
structure meets
certain specified criteria, Lilly will ask for a physical
sample, still
confidential, for biological testing across assay
modules in Alzheimer's
disease, cancer, diabetes and osteoporosis
(additional disease state
assays will likely be added).
Throughout the entire process of cheminformatics
analysis and biological
testing, the structure of the compound is not revealed
to Lilly
scientists.
In addition, all testing by Lilly is free, and all
intellectual property
rights remain with the submitting researcher and/or
institution
throughout the entire process.
In return for conducting the work and providing the
data -- data which
constitutes broader assessments of a compound's
biological profile than
what is generally available today in academic or
government laboratories
-- Lilly retains first rights to negotiate a collaboration or
licensing
agreement with the submitters. Importantly, if no such
agreement is
reached within a defined time period, the external
researcher is granted
no-strings-attached ownership of the data report and
can choose to use
it in publication or grant proposals, or to further refine
structural
hypotheses, all of which may advance scientific
discovery.
Lilly launched PD2 in mid-June and since that time,
more than 80
research institutions in 14 countries have signed on to
participate,
including, here in the United States, Harvard
University, Stanford
University, Princeton University, Memorial Sloan-
Kettering Cancer Center
and Indiana
University-Purdue University. Examples outside of
the United States
include the University of Syndey (Australia), National
University of
Singapore and the University of Postdam (Germany).
"We're incredibly pleased with the response thus far,"
said Palkowitz.
"PD
2 is a "win-win-win" in that external researchers gain
new insights into
their compounds, Lilly becomes connected to an
untapped global source of
ideas and compounds, and, patients may ultimately
be helped one day by
new medicines discovered and developed as part of
this
collaborative-based initiative."
For more information on PD2, please log onto pd2.lilly.com.
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What's Happening? |
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The Montana BioScience Alliance annual
meeting/conference took place on July 16th and 17th
at the beautiful GlaxoSmithKline Biologicals facility in
Hamilton, Montana with 60+ folks in attendance. At
the board meeting on July 16th, the following directors
were elected to 3 year terms: David Garloff, Carol
Beam, Howard Knapp and Ron Zook. Mark Jutila has
asked that we select a new representative for MSU
and that is pending. We thank Mark for his service as
a founding board member and we hope that he will
continue to stay involved. The following officers were
reelected: Rob Bargatze, Chair, Carol Beam,
Treasurer and Dave Crum, Secretary.
The theme of the one day conference was: Industry is
from Mars, Academia is from Venus. At the
conference, participants were welcomed by Michael
Covarrubias, site director, and given an overview of the
GSK Biologicals mission and purpose in Hamilton.
Chris Aageson of the Governor's office gave us a
quick update on the legislative session and recent
grant awards and Marshall Bloom provided an
interesting update of the work at Rocky Mountain
Labs. Industry and Academia panels brought forth a
very lively discussion and some insights into the
collaboration going on in the state. We were
pleased and honored to have Patrick Kelly from the
national Biotechnology Industry Association update us
on the issues that affect our industry. BIO also
provided the padfolios for the participants and we are
very grateful for the many ways they support the
Montana BioScience Alliance.
We would like to thank Michael Covarrubias and his
very efficient staff at GSK Biologicals for their fine
hospitality and we would like to thank all who
participated for making this a successful conference.
The new 2009-2010 Montana BioScience Alliance
directories were unveiled at the conference and were
well received. If you would like a copy either in print or
thumb-drive, please call of email Sharon Peterson:
sharonpeterson@bresnan.net or 406-896-5876.
________________________
Sharon Peterson attended the Midwest Council of
State Bioscience Association's meeting in Kansas
City on August 11. Attending were members from
Kansas, Missouri, North Dakota, Iowa, Ohio, Michigan,
Illinois, Indiana, Minnesota and Wisconsin. The focus
was on the Midwest presence at the BIO International
Conference in Chicago, May 3-6, 2010. The Montana
BioScience will participate with the Midwest in our
booth and receptions at the exposition. Be sure to
mark your calendars for those dates. The meeting
included a golf tournament, a session on Best
Practices and a tour of the The Stowers Institute for
Medical Research which aspires to be one of the
most innovative biomedical research organizations in
the world. The Institute conducts basic research on
genes and proteins that control fundamental
processes in living cells to unlock the mysteries of
disease and find the keys to their causes, treatment,
and prevention.
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Events Calendar |
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Western Region COBRE-INBRE Scientific
Conference
September 16-18, 2009
Big Sky Resort
All Investigators, Staff, and Students are welcome
First Annual Rocky Mountain Life
Science Investor Conference
September 17th, 2009
Ritz-Carlton Downtown
Denver, Colorado
Micro Nano Breakthrough Conference
September 21-23, 2009
Doulbetree Lloyd Center
Portland, Oregon
Oregon Nanoscience and Microtechnologies
Institute
and Washington Technology Center
Register Now
Angel Organization Seminar
Kauffman Foundation-sponsored and Angel Capital
Association-sponsored
September 24, 2009
8:00am-5:30pm
Museum of the Rockies
Bozeman, Montana
For more info click here.
8th Annual LifeScience Alley® Conference &
Expo
December 9, 2009
Minnesota Convention Center
Minneapolis, Minnesota
To register, visit Life
ScienceAlleyConference.org
2009 ITHS Clinical and Translational Research
Boot
Camp
September 21-25, 2009
University of Washington
Magnuson Health Sciences Building
Register Now
Dr. Leroy Hood
TechRanch and MontanaBSA
October 9, 2009
Rockin' TJ Ranch
Bozeman, MT
For more info click here.
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Classifieds |
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There is now a classifieds section on
the Montana Bio website, in the resources
section!
Please send information to Sharon at
sharonpeterson@bresnan.net .
HELP WANTED:
STUDY DIRECTORS
Enjoy the rewards of a challenging scientific position
and the outdoor lifestyle of Southwest Montana!
BioScience Laboratories, the leading independent
testing laboratory for topical antimicrobial testing, is
seeking experienced Study Directors for our Clinical
and In-Vitro Laboratories. The ideal candidate has a
Bachelor's degree, or higher, in Microbiology or
related sciences; possesses proven project
management skills; and has three plus years
experience in a GCP/GLP testing environment.
Visit
www.biosciencelabs.com/employment for a
complete job description.
________________________
CLINICAL PHARMACIST SPECIALIST
The University of Montana College of Health
Professions and Biomedical Sciences seeks a
Pharm.D. or B.S. pharmacist with equivalent Pharm.D.
experience to operate a community-based wellness
testing program. The individual chosen will conduct
clinics throughout Montana's rural and frontier
counties. Some over night stays will occur. The
individual chosen will be responsible for daily
operations, scheduling events, marketing and
advertising. Supervision of interdisciplinary teams of
health professions students during testing events is
required. Training will be provided on basic wellness
testing equipment used at events. The position is full-
time with a flexible schedule.
Salary is commensurate with experience and includes
benefits package. Review of applications will begin
July 27, 2009, and continue until the position is
filled.Please submit a letter of application, resume,
and three professional references with names and
phone numbers to:
Donna Beall, Pharm.D.
The University of Montana
Department of Pharmacy Practice
School of Pharmacy and Allied Health Sciences
32 Campus Drive
Missoula, MT 59812-1522
406-243-4624
AA/EOE/ADA/Veterans' preference employer
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The Montana BioScience Alliance is located
on the Downtown Campus of Montana State
University-Billings, through the generous support of
the University.
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