BioMatters S P R I N G 2 013
A MichBio Publication Showcasing Michigan’s Biosciences Industry
Biosciences in Michigan:
A Rich Legacy of Discovery and Impact
Featured: Pushing the Frontiers of Science — and Providing Hope — Through the Biologics Pipeline Advancing Cell Engineering for Drug Discovery Biotechnology People Can Use Sophisticated Technologies Save Thousands of Lives Every Day
WHAT HAPPENS WHEN
START UP meets
launch pad Strapping a booster rocket onto a great idea. When DeNovo Sciences entered the Accelerate Michigan Innovative Competition, they were a small company with a big dream. After winning the $500K grand prize, they’ve become a sought-after company on the verge of developing cutting-edge products for early cancer detection. Michigan offers them the right mix of experience and resources. And, with access to the expertise of two world-class cancer hospitals, DeNovo is ready for takeoff in Pure Michigan.
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GOVERNOR’S MESSAGE
Dear Friends,
This is an exciting time for high-tech visionaries and entrepreneurs to be in Michigan. Bold changes
to state government and improvements to our business climate are unleashing a new era of innovation.
Business taxes are lower than at any time in decades. We are getting rid of outdated and burdensome
regulations that hinder economic growth and job creation. New sources of capital are available along with a host of state and private resources to start new ventures and grow current ones.
These reforms, combined with our manufacturing leadership, outstanding talent, and world-class
educational institutions, are accelerating breakthrough bioscience discoveries and creating new technologies, products, businesses and jobs. Furthermore, they are providing an opportunity to carry forward a legacy of innovation that extends back more than a century.
Thomas Edison took us out of the darkness and into the light. Henry Ford connected us like never
before. These trailblazers moved our state forward with relentless positive action, something we are harnessing once again.
Thank you for your relentless positive action as we work to build a stronger state and a brighter
future together. Sincerely,
Rick Snyder, Governor of Michigan
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BioMatters | Spring 2013
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PRESIDENT’S MESSAGE
P R O F E S S I O N A L S TA F F
Michigan’s Biosciences Industry Welcomes You!
Welcome to MichBio’s (d/b/a Michigan Biosciences Industry Association) seventh
Stephen T. Rapundalo, Ph.D.
edition of BioMatters, the state’s only in-depth publication showcasing the breadth and
President & CEO
impact of our vibrant biosciences industry. BioMatters is a fundamental part of MichBio’s
srapundalo@michbio.org
mission to drive Michigan’s bio-industry growth through education, resources, business
734.527.9144
opportunities and advocacy. We’re proud of the fact that BioMatters has set a high standard as the voice for Michigan’s bio-industry around the globe.
In this issue of BioMatters, you’ll continue to discover the faces, organizations
Wendy Wendel Director,
and initiatives that represent just a tiny portion of Michigan’s outstanding biosciences
Marketing and Communications
community. We encourage you to explore what Michiganders already know – that
wendy@michbio.org
Michigan offers a business environment where bioscience companies can thrive and
734.527.9147
compete in today’s global economy.
Michigan has a rich pedigree in the bio-industry dating back to the 1860’s when
David McGuire
Parke-Davis & Company was formed in Detroit as the first pharmaceutical company in
Director,
the U.S., soon to be followed by the Upjohn Company in Kalamazoo, and the L. Perrigo
Operations and Membership
Company in Allegan. All went on to become great global bioscience brands, with notable
david@michbio.org
discoveries and products, and commercial success. That’s a proud heritage we’ve built
734.527.9150
upon with a lot of diligence, know-how, strong work ethic and commitment.
Michigan is now home to some of the world’s top research centers, more than 600
bioscience companies across multiple sectors, and about 125,000 individuals employed directly or secondarily in the bio-industry. We offer companies access to knowledge, talent, capital, infrastructure and resources. Not to be forgotten is our enviable low cost of doing business, and a superb quality of life that helps retain our highly-skilled
Nancy Marcotte Manager, Finance nancy@michbio.org 734.527.9145
bioscience workforce. In short, the biosciences are Pure Michigan®.
Whether you’re already here or looking from the outside, Michigan welcomes
you to learn more about its bio-industry. Contact MichBio, the statewide biosciences industry association, and we will serve as your gateway to our companies, services, assets, and markets.
Lastly, I invite you to visit the State of Michigan Pavilion (Booth #1805) at
the 2013 BIO International Conference at the McCormick Place in Chicago, IL from April 23-25, 2013. Especially don’t miss our Hospitality Reception from 5-6:30 pm on Tuesday, April 23rd.
C O N TA C T I N F O R M AT I O N Physical Address 3520 Green Court, Suite 150 Ann Arbor, Michigan 48105-1579 Mailing Address P.O. Box 130199 Ann Arbor, Michigan 48113-0199 Phone 734.527.9150
Stephen Rapundalo, Ph.D. President & CEO, MichBio
Fax 734.302.4933
Get Connected.
MICHBIO — YOUR GATEWAY TO MICHIGAN’S BIO-INDUSTRY
Website www.michbio.org Email info@michbio.org
www.michbio.org
3
BioMatters | Spring 2013
Membership Has Its Rewards MichBio’s Preferred Providers Save You Money — Guaranteed! Maximize your ROI on a MichBio membership with MichBio’s Preferred Providers. Receive discounted prices on products and services you need and use every day.
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We try to get the best value for every product we buy and service we contract. That means… seeking the best pricing and delivery terms. The MichBio program has been a blessing. We are saving double digit percentage off what we were paying previously! — Brian McMullen, MPI Research
BIO BuSIneSS SOlutIOnS®
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C O R P O R AT E S P O N S O R S
O F F I C E R S , D I R E C TO R S A N D C O M M I T T E E S
Executive Officers
P L AT I N U M ÂŽ
GOLD
S I LV E R
Chairman Stephen Munk, Ph.D. Ash Stevens, Inc., President & CEO Vice Chairman David Zimmermann Kalexsyn, Inc., Chief Executive Officer
Paul Morris AlixPartners, LLP Finance Manager, National Enterprise Improvement Practice
President and CEO Stephen T. Rapundalo, Ph.D. MichBio, President & CEO
Brent Mulder, Ph.D., MBA Van Andel Research Institute Director, Office of Technology Transfer
Treasurer Matthew L. McColl Ernst & Young LLP, Partner
Stephen Munk, Ph.D. Ash Stevens President & CEO
Directors
Stephen T. Rapundalo, Ph.D. MichBio President & CEO
Arik Anderson Terumo Cardiovascular Systems Corp. Vice President, Product Development David Felten, M.D., Ph.D. Beaumont Hospitals Vice President, Research, and Medical Director, Research Institute
BRONZE
Doug Gage, Ph.D. Michigan State University Director of the MSU BioEconomy Network, Office of the Vice President for Research and Graduate Studies Dale Grogan Michigan Accelerator Fund I Managing Director
MEDIA
Kevin McLeod Michigan Medical Device Accelerator Managing Director
Tim Mayleben Esperion Therapeutics Chief Operating Officer Kevin McCurren Grand Valley State University Executive Director, The Center for Entrepreneurship & Innovation and Grand Rapid’s Smart Zone
Tina Rogers, PhD, MBA, DABT MPI Research Executive Vice President, Director of Research and Interim Vice President, Bioanalytical and Analytical Services John J.H. Schwarz, M.D. Battle Creek Family Health Center Physician, Former U.S. Representative Ned Staebler Wayne State University Vice President, Economic Development Christopher J. Stein Ferndale Laboratories, Inc. Executive Vice President & Chief Operating Officer Karen Studer-Rabeler Coy Laboratory Products General Manager and Vice President of Business Development David Zimmermann Kalexsyn, Inc. Chief Executive Officer
PAT R O N Terumo Cardiovascular Systems/ Terumo Heart
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BioMatters | Spring 2013
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P 734-741-0044
Medical Devices | Clinical Research | Clinical Trials | Pharmaceuticals Biotechnology | Product and Technology Development
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BioMatters TA B L E O F C O N T E N T S
8 11 12 15 17 19
Biosciences in Michigan: A Rich Legacy of Discovery and Impact Pushing the Frontiers of Science — and Providing Hope — Through the Biologics Pipeline SMIC at 10: New Ways of Seeing Innovation
24 26 29 30
Launch MI Lab Catalyzes Innovation Originus: Advancing Cell Engineering for Drug Discovery Biotechnology People Can Use
33 34
Michigan Biosciences By The Numbers Sophisticated Technologies Save Thousands of Lives Every Day 3D Biomatrix Transforms Pharmaceutical Testing MichiganBased Diplomat Leads the Way in Specialty Pharmacy Industry Growth
36 37 38 39
Innovation and Expertise Puts Helix Biological Laboratory at the Forefront Algal Scientific Algae Startup Develops Lower-cost Manufacturing Platform for Valuable Immune Health Compound
40
polyElements: New Startup Creates Nanofiber Scaffolds for Tissue Engineering Ash Stevens Adds New Capacities and Capabilities
MPI Research: 3rd Largest Global CRO that Focuses on Improving the Odds Aastrom Biosciences of Ann Arbor Conducts Final Stage Development of Cell Therapy Ixmyelocel-T Pioneer Surgical Technology, Inc. Innovates With Its New Bone Graft
Subscribe to BioMatters: call 734.527.9150
ADVERTISERS Ash Stevens ........................... 16 Bank of Ann Arbor .................... 27 Doeren Mayhew ....................... 16 G2G Consulting.........................32 GLEQ.....................................28 Hylant ................................... 6 JB Ashtin ............................... 28 MedBio...................................28
MichBio ............................ 4, BC Michigan Economic Development Corp. ................. IFC Michigan State University ............32 MPI Research ......................... IBC Oakland University .................... 6 Originus..................................28 PhRMA .................................. 10
7
Quest Research Institute ............ 18 Stryker .................................. 1 Terumo Cardiovascular Systems ... 18 University of Michigan ............... 18 VWR....................................... 2
BioMatters | Spring 2013
F E AT U R E S T O R Y
Biosciences in Michigan:
A Rich Legacy of Discovery and Impact By Stephen Rapundalo, Ph.D., President & CEO, MichBio
Michigan has a long record of
The bioscience industry in Michigan
bioscience discovery triumphs and
continues to lead the way in creating
significant contributions to the health
solutions to some of the world’s most
and welfare of humankind. They stem
pressing medical, food, environmental
from a rich legacy of research, innovation
and energy problems. Some of the best
and manufacturing in various industry
global “bio” brands call Michigan home
sectors that have developed products for
for their facilities and are at the forefront
the betterment of lives around the world.
of developing innovative products...
Here are but a few of the key discoveries
Pfizer, Stryker, Dow Chemical, Kellogg,
and notable achievements that have
Amway, Dow Corning, Zoetis, Perrigo,
emanated from Michigan over the last
Mead Johnson, MPI Research, Nestlé Nutrition, Neogen, BD, Beckman Coulter,
150 years: • AZT, the first approved treatment for HIV/AIDS discovered at Wayne State University • Lipitor, the cholesterol-lowering agent and largest selling drug in history discovered at Parke-Davis Pharmaceuticals in Ann Arbor • Xanax, the first anti-anxiety medication, and Halcion, the first insomnia drug, both discovered and manufactured by the Upjohn Company • Oscillating electric bone saw invented by Dr. Horace Stryker • First U.S. pharmaceutical company — Parke-Davis & Company — and home to the first modern pharmaceutical laboratory and methods of performing clinical trials • Hybrid corn, created by genetic modification at Michigan State University, to enhance crop yields • Anthrax vaccine, first manufactured by BioPort (now known as Emergent BioSolutions) in Lansing • Dilantin, the first marketed, and Neurontin, a current widely-used epilepsy treatment, both developed at Parke-Davis
Johnson & Johnson, Abbott Nutrition,
Stephen Rapundalo
• The Turning Frame, the first mobile hospital bed developed by Dr. Stryker • Homogenization of milk, first developed at Michigan State University
Cardinal Health, Ferndale Pharma, Diplomat Specialty Pharmacy, Bayer CropScience, DowAgra, and Emergent BioSolutions, to name a short list.
• Large scale production of the steroids, cortisone and prednisone developed at the Upjohn Company
The bioscience industry in Michigan continues to lead the way in creating solutions to some of the world’s most pressing medical, food, environmental and energy problems.
• Cisplatin, discovered at Michigan State University, a leading chemotherapy drug used as treatment in a wide range of malignancies
Michigan’s >600 bioscience
companies, academic research centers and clinical institutions reflect the breadth of pharma/biotech, medical devices/equipment, research products and diagnostics, informatics, ag-bio, bio-defense, industrial and environmental biotechnology, medical/laboratory testing and clinical research. It’s where research, development, life cycle management, manufacturing, converge with the delivery of healthcare and wellbeing.
In addition to world-class brands,
Michigan has a robust community of biotech and life science emerging companies. The state has witnessed an overall 7% increase in number of ventures over the last ten years with more than 134 companies (therapeutics, diagnostics, informatics, medical devices and CROs/ CMOs) launched during that period. Consequently, a strong entrepreneurial culture has taken root that has established Michigan as a hotbed for
BioMatters | Spring 2013
8
bioscience technology commercialization
intellectual property necessary for
the state’s unparalleled bioscience
with a supporting CRO/CMO network
commercialization.
talent pool is broad as it is deep.
that’s second to none. In short, Michigan
Universities and technical colleges offer
offers a virtual product development
business and entrepreneurial support
a vast array of bioscience education
ecosystem to bioscience businesses from
resources, Michigan’s bio-industry is
opportunities, including specialty
ideas to profitable commercial outcomes.
well positioned for growth. The State
of Michigan provided approximately
Success breeds success...and
Buttressed by a full portfolio of
Companies looking for well-educated and seasoned professional bioscience workers need look no further than within Michigan.
Michigan’s emerging bioscience
$350 million in support to bioscience
companies have a remarkable track
companies during the last decade, as
record of investment, growth, and
well as an additional $50 million of
return. A number of them like Esperion
investment by the state’s fund-to-funds.
Therapeutics (acquired by Pfizer for
Coupled with other assets like our Pre-
$1.3 billion in 2003) HealthMedia (now
Seed Capital Fund and its Micro-Loan
J&J’s Wellness & Prevention Inc.), Accuri
Program, as well as the Venture Michigan
Cytometers and HandyLab (purchased
Fund and Pure Michigan Venture Match
applied training, to meet the needs
by BD), and Somanetics (acquired by
Fund, companies can access a portfolio
of employers. Michigan knows that
Covidien) are just a few examples of big
of capital and business resources across
advancing its bio-industry growth begins
commercial exits. Other companies like
their entire business life cycle.
with ensuring that top talent is available,
today and tomorrow.
Success breeds success... and Michigan’s emerging bioscience companies have a remarkable track record of investment, growth, and return.
An unrivalled statewide network
of SmartZonesSM provides business
acceleration and wet-lab incubator
are revolutionizing the way we think
services, allowing Michigan’s biosciences
about healthcare, consumer products,
companies to benefit from a strong
food, crops and energy consumption...
ecosystem that supports commercial
essentially the way we live. Michigan
growth from ideas to markets. And a
is ideally positioned for a continued
state-funded Emerging Biz Solutions
role in this rapidly evolving world of
Increasingly, bioscience advancements
biosciences, thanks to its diversity of sectors, research, technologies, CytoPherx ($36 million in 2012), Lycera
commercialization and manufacturing.
($47 million during 2009-10), and NanoBio
The biosciences are Pure Michigan®.
(>$90 million since 2006) have procured significant venture funding. And many others are on similar trajectories pointing to the fact that not only is there a thriving technology pipeline but also on-the-ground investment partners and capital efficient Michigan companies with reasonable valuations. All this makes for an attractive investment value.
Michigan’s world-renowned
universities, defined by its University Research Corridor, receive almost $1.2 billion alone in federal R&D funding for bioscience research — 4th among the major U.S. research clusters. Moreover, these institutions deliver high-tech, skilled bioscience graduates (>5,500/ year, 8th in the U.S.). In addition, over 1,800 bioscience patents were registered from Michigan institutions during 2004-2009, tenth in the nation. In so doing, our research centers offer unique
program, coordinated by MichBio, provides product development planning and ancillary business intelligence and partnering support services to qualified bioscience ventures.
Companies looking for
well-educated and seasoned professional bioscience workers need look no further than within Michigan. With its rich legacy in pharma and medical devices,
technology partnership opportunities to the private sector by providing the
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BioMatters | Spring 2013
A job engine for Michigan. Life-saving medicines for the world. From Alpena to Ypsilanti, scientists working at the nation’s biopharmaceutical companies are currently researching and developing life saving medicines. In collaboration with the state’s university medical schools, science centers, local hospitals and contract research organizations, nearly 3,500 clinical trials have been conducted for new prescription drugs. These have led to remarkable discoveries inspiring hope and improving the quality of life for patients and their families.
R h P -
For the people of Michigan, biopharmaceutical research companies have also been an important source of jobs, tax revenue and research spending.
d A
A study found that in 2008 the industry supported nearly 95,000 jobs include life sciences researchers, management executives, office and administrative support workers, engineers, architects, computer and math experts and sales representatives.
We thank the people of Michigan and their communities for their collaboration, support and kindness. Right now, nearly 400 tests of new medicines for the six most debilitating chronic diseases in America is underway all over the state and they need patient volunteers.
BioMatters | Spring 2013
A M
Pushing the Frontiers of Science — and Providing Hope — Through the Biologics Pipeline
By John J. Castellani, President & CEO, Pharmaceutical Research and Manufacturers of America
John J. Castellani
The mapping of the human genome,
throughout the country, are building on the knowledge gained through
the development of amazing new biological
these and many more discoveries with the next generation of biologics.
technologies and a greater understanding
of how diseases work have allowed
areas (see chart below), the greatest amount of research is in a
Although biologics in development span a wide array of therapeutic
biopharmaceutical
category of medicines called monoclonal
researchers — working
antibodies (mAbs) and in vaccines, which
hand-in-hand with
together make up 65 percent of the biologics
Michigan’s thriving
in clinical trials or under review at the FDA.
medical research
MAbs have been instrumental in the treatment
community — to
of cancers by targeting unhealthy cells without
pursue new targets and personalize medicines to
harming healthy cells and are showing great
better treat specific subpopulations of patients.
promise in the treatment of asthma, psoriasis
Right now, scientists at America’s
and rheumatoid arthritis. Vaccines, typically
biopharmaceutical research companies are using revolutionary biological
considered a key tool for the prevention of infectious diseases, also are
processes to develop 907 new medicines and vaccines targeting more
evolving with the science and our understanding of disease. Today, they
than 100 diseases, providing hope where there was none for thousands
are being tested as therapies for cancer and other diseases.
of patients, according to a new report from the Pharmaceutical Research
and Manufacturers of America (PhRMA). Many of those treatments are
schools and research centers include:
being tested as part of the nearly 400 clinical trials currently underway companies assembled in Chicago for the 2013 BIO International
Convention.
diseases such as lung cancer and melanoma.
in Michigan — and are in development by many of the innovative
Before we discuss the excitement behind these potential medical
MAbs and therapeutic vaccines in clinical trials in Michigan medical
• A mAb for the treatment of cancer, • A mAb that targets lupus, and • A therapeutic vaccine to jump-start the immune system to fight With a robust pipeline which includes these potential new
breakthroughs, let’s take a look back at some of the key biologic medical
medicines, the U.S. continues to lead the world in biopharmaceutical
advancements that paved the way for the progress being made today.
research and development. That leadership is built on the foundation
In the last decade, the U.S. Food and Drug Administration (FDA) has
of a strong biomedical ecosystem that fosters collaboration between
approved the first genetically engineered antibody to deprive tumors
government, academia, and biopharmaceutical researchers — the kind
of oxygen and nutrients, the first new medicine for patients with lupus in
in place in the Great Lakes State. It is supported by public policies —
50 years and a vaccine for the prevention of human papillomavirus, which
both state and national — that encourage scientists to push boundaries
will dramatically reduce the number of women who will develop cervical
and take risks. And, it is fueled by the hope of patients around the
cancer. America’s biopharmaceutical researchers also have used biological
world that a medical breakthrough in a small lab in Kalamazoo can help them overcome disease
processes to bring a number of first-in-class medicines to patients that have made marked progress in the fights against certain cancers.
Our scientists, working in
partnership with university medical schools, science centers, local hospitals and contract research organizations in Michigan and
miles away.
Biologic Medicines in Development—by Therapeutic Category
Some medicines are listed in more than one category Autoimmune Disorders 43
Blood Disorders Cancer/Related Conditions
338
Cardiovascular Disease
58 28
Diabetes/Related Conditions Digestive Disorders
26
Eye Conditions
25 176 34
research/new-medicines.
38
Respiratory Disorders Skin Diseases Other
http://www.phrma.org/
39
Neurologic Disorders
Transplantation
report, “Biologic Medicines accompanying overview at
Infectious Diseases Musculoskeletal Disorders
new therapies in the new in Development” and the
30
Genetic Disorders
You can learn more
about these promising
71
30 13 58
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BioMatters | Spring 2013
SMIC at 10: New Ways of Seeing Innovation
BioMatters | Spring 2013
12
“The roots of great innovation are never just in the technology itself. They are always in the wider historical context. They require new ways of seeing.” David Brooks, New York Times columnist By Robert DeWit, Ph.D.
enterprises and support, and more
Kalamazoo, Kalamazoo County and
a bioscience incubator/accelerator was
recently the Kalamazoo Promise,
private donors. Collectively, they posed
young but hardly new. Visionaries looked
providing full tuition to Kalamazoo
an intriguing option: local scientists
at the aging population, the emergence
Public Schools graduates attending
starting their own businesses in a new,
of biotechnology and the struggle of big
Michigan public colleges.
purpose-built lab facility equal to those
At the turn of this century, the idea of
in which they previously worked.
companies to generate breakthrough medical treatments, and they realized
that the next wave of innovation would
scientists aren’t entrepreneurs. While
This was no mean feat. Most
happen in the startup world. Before long,
those who lost their jobs at Pfizer had generous separation packages,
nearly every American state was jumping While the community seemed the
they faced enormous challenges. Lab
on the bio-bandwagon, each insisting
it would be the next Silicon Valley of
logical birthplace for a bioscience
space and equipment are frighteningly
life sciences.
incubator, a challenging coincidence
expensive, and many of the affected
gave SMIC its biggest push. In 2003, just
scientists knew very little about starting
Innovation Center (SMIC) opened its
weeks before SMIC opened its doors,
a business or seeking venture capital.
doors in Kalamazoo, Michigan. Buoyed
Pfizer announced a major reduction in
by a unique mix of expertise, history,
its research-and-development presence
for those aspiring entrepreneurs.
community support and circumstances,
in Kalamazoo. This left hundreds of
Located in WMU’s Business Technology
SMIC continues to thrive as a premier
researchers, many of whom had spent
and Research Park, the Innovation
incubator/accelerator, evolving with
decades in the community, unsure of
Center offers a comprehensive range
the times.
their next step.
of facilities and support to nurture
In 2003, the Southwest Michigan
SMIC provided a launching pad
Southwest Michigan Innovation Center
Timing is Everything
The center had been formed through
innovative life science businesses. SMIC
127-year legacy of life science
a partnership that included Southwest
provides subsidized rent at the time of
innovation, stretching back to the
Michigan First, the Michigan Economic
admission, which gradually increases
beginnings of The Upjohn Company
Development Corporation, Western
as the startup matures. SMIC also sits
(now Pfizer) and Stryker Corporation.
Michigan University, the City of
in a Michigan SmartZone, which offers
Southwest Michigan has a rich,
For SMIC, the timing was perfect.
Kalamazoo is home to four colleges/
the formation, survival and growth of
tax-related support. Further, there
universities, diverse entrepreneurial 13
BioMatters | Spring 2013
The most recent development at
establishing itself over the past two
is considerable expertise available,
from business consulting through the
the Innovation Center is Launch MI
years and was formally unveiled in
Michigan Small Business Technology
Lab, a staffed laboratory furnished
November 2012.
Development Center to counsel from
scientific, legal, accounting, venture
of SMIC’s success is found among its
capital and marketing experts. Many of those experts were former associates of the new entrepreneurs, with decades of experience in global biosciences.
Decade of Success
Over the past decade, SMIC has seen
a phenomenal success rate among its client companies. Of 26 “pure” startup companies — that is, business ventures born at the Innovation Center — 25 were
As it marks its 10th anniversary, the Southwest Michigan Innovation Center continues to evolve as a driver of innovation, economic growth and medical advancement — a jewel for the global life sciences community and a starting place for the bioscience innovators of the future.
still active as of late 2012. A total of
Perhaps the most important measure
client companies. All told, those firms have six Investigational New Drugs, 34 patents and 11 compounds in human clinical trials. Those wins hold far more than economic value; they bring hope to patients in need of new treatments and cures.
Beyond the Next Decade
The future of SMIC is bright. It’s also
changing. In the years ahead, growth at the Innovation Center will come in
35 firms have been incubated at SMIC,
different ways because there will be no
with 95 companies served. There are
with extensive scientific equipment
more displaced scientists to tap locally.
18 companies now operating at the
(See sidebar). With affordable short-
SMIC will need to take a global view
Innovation Center, employing 161
term leases available, entrepreneurs
for recruitment and attraction because
people. According to the W.E. Upjohn
can utilize bench and desk space and
the life sciences community is global in
Institute for Employment Research,
analytical services where early stage
nature. That means relationships and
SMIC’s presence generates 346 direct
entrepreneurs can test their ideas and
collaboration, both near and far, will
and indirect jobs in the region, totaling
apply for grants. The lab has been
be crucial.
$18.6 million in payrolls.
BioMatters | Spring 2013
14
Launch MI Lab Catalyzes Innovation
SMIC is already hard at work in
Even simple innovations require huge investments of time, testing and
that realm through recent interactions
money. Filling that need is the rationale behind Launch MI Lab, which
with Stanford and Startup America.
provides affordable wet-lab and bench space, state-of-the-art equipment,
Also, SMIC is being more intentional
professional analytical services, and scientific and business expertise for biosciences companies of all sizes, including entrepreneurs at the earliest
The future of SMIC is bright. It’s also changing. In the years ahead, growth at the Innovation Center will come in different ways because there will be no more displaced scientists to tap locally.
stage. Housed in the Southwest Michigan Innovation Center in Kalamazoo, Launch MI Lab helps accelerate the work while reducing the costs of life sciences businesses. Launch MI Lab
about building relationships with peers,
academia and corporate partners, as well
science startups: purpose-built space, business support services, and
as making itself more visible externally.
scientific expertise. Clients can lease bench space and work stations in
As it marks its 10th anniversary,
Launch MI Lab brings three critical elements to aid fledgling life
the 2,300-square-foot lab at a lower cost than in a traditional incubator.
the Southwest Michigan Innovation
Along with access to scientific equipment and services, each client has
Center continues to evolve as a driver
high-speed Internet and VOIP telephone service, use of conference and café
of innovation, economic growth and
facilities, and free parking. Available equipment includes mass spectrometry
medical advancement — a jewel for
systems, centrifuges, autoclaves, flow cytometers, a variety of microscopes,
the global life sciences community
incubators, lyophilizer, upright freezer, and standard lab supplies and tools.
and a starting place for the bioscience
innovators of the future.
helps entrepreneurs get access to affordable lab space and equipment as
Greg Cavey, lab manager for Launch MI Lab, points out that the facility
well as affordable, quality analytical services. Clients, advisors and staff Robert DeWit, Ph.D., is President
bring decades of bioscience and business experience that is made available
and CEO of the Southwest Michigan
to tenants. Among them is Cavey himself, a biochemist with more than
Innovation Center. Prior to joining
20 years’ experience in proteomics, mass spectrometry and laboratory
SMIC in 2009, Dr. DeWit spent more
management.
than 25 years in pharmaceutical
research and development, with
to creating the laboratory. Launch MI Lab was unveiled in November 2012.
science and leadership roles in the
For more on the operation, visit www.launchmilab.com.
Support from the Michigan Economic Development Corporation was key
U.S., Japan and United Kingdom.
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BioMatters | Spring 2013
SAVE THE DATE 9th Annual MichBio Expo & Conference
October 15-16, Radisson, Kalamazoo, MI
CONFERENCE HIGHLIGHTS:
• The Michigan Emerging Biosciences Showcase
• Concurrent track sessions in Pharma, Medical Device, Emerging Business and Bio-Based Technologies
• Industry Town Hall
• Tech Transfer Today
• CEOs Unplugged
• Poster Session
• Facility Tours and much more!
Over 70% of attendees are bio-executives. www.michbio.org/expo
Experience makes a world of difference. With more than 50 years of experience, Ash Stevens is a proven and trusted supplier of contract small molecule drug substance development and cGMP manufacturing services. To see how Ash Stevens can help your drug substance program succeed, call or click today.
Insight, Oversight and Foresight to Foster Successful Innovation
734-282-3370 ashstevens.com
An internationally recognized, top 100 U.S. firm, Doeren Mayhew provides bioscience companies with insight into their businesses, oversight to ensure best practices and foresight for what’s ahead. From determining qualifying research expenses for R&D tax credits, to assisting with governmental audits, we invite you to see how we can help you capitalize on the opportunities and navigate the challenges specific to your industry.
248.244.3000
doeren.com
BioMatters | Spring 2013
Insight. Oversight. Foresight.
Visit Ash Stevens at BIO Booth #5243
SM
16 ASH-2410 BioMatters 1/4 Pg Ad.indd 1
3/13/13 10:57 AM
Originus:
Advancing Cell Engineering for Drug Discovery
Modern drug discovery is a highly industrialized process that begins
of multiple targets and readouts. This can be a boon to researchers
by testing a large number of chemical substances against biological
when trying to discover novel drug candidates.
targets which are hypothesized to be involved in diseases. Development
of functional assays for high throughput screening (HTS) of chemical
standards which confirm high reproducibility well-to-well, plate-
libraries is an integral part of this process and living cells are frequently
to plate, and batch-to batch, suitable for HTS and high content
Microplates are produced at Originus, Inc. under quality control
used as tools to understand the molecular pathways
screening (HCS) environments. In addition, STEP
involved in health and disease.
plates can be stored longer than a year without
Originus Inc. (www.originusinc.com), an
Ann Arbor-based company formed in 2001, has
Originus, Inc.
revolutionized the way functional assays can be
significant decrease of biological properties after transfection, resulting in great convenience for customers and partners who only need to add
applied in drug discovery. Their technology and products are based on
cells to the plates before testing. STEP is adaptable to a broad range
a robust technique called Surface Transfection and Expression Protocol
of cell types from commonly-used cultured cell lines to neurons or
(STEP) that was originally developed at the University of Michigan and
stem cells.
exclusively licensed to Originus. STEP allows for cell-based HTS with a
In short, Originus’ STEP technology offers a novel approach to
myriad of basic research and therapeutic
accelerating drug development and
discovery applications.
thereby reducing costs. It allows
STEP gets around many challenges
multiplexing, and offers flexibility in
faced by traditional functional assays.
cell selection and high reproducibility.
Novel cell-based screening assays
In addition, the “ready-to-use” plates
typically required establishing cell lines
are a great convenience and can be
that stably express the target(s) of
adapted by small academic labs to big
interest (stable cell transfection), a
pharmaceutical companies. The goal of
process that is laborious, expensive,
Originus’ team is to create robust and
time-consuming (3-9 months) and not
sophisticated functional assays that
without shortcomings. The alternative,
leverage the latest cellular engineering
transient cell transfection results in
techniques in the burgeoning field of
variable results and it is difficult
systems biology.
to control.
Originus has received several
Originus’ STEP technology
awards from the National Institutes
involves the formation of proprietary
of Health for the development of this
transfection complexes that are
highly innovative technology. STEP
applied directly to the growth surface
plates are being used successfully by
for the cells of interest and can be
pharmaceutical companies for HTS
used for functional experiments
of chemical libraries, not only in the
just by adding adherent cells. Assay
hunt for new drugs but also to test
engineering using STEP increases
for their safety and the way they are
efficiency and allows over-expression
metabolized by the body.
“Originus has revolutionized the way functional assays can be applied in drug discovery. Their technology and products are based on a robust technique called Surface Transfection and Expression Protocol (STEP) that was originally developed at the University of Michigan and exclusively licensed to Originus.” 17
BioMatters BioMatters || Spring Spring 2013 2013
ACCELERATE the Clinical Trial Process EXpEriEncE
Senior physicians and certified staff with no employee turnover
SPEED
Top in the industry in study start-up cycle time and patient enrollment
efficacy
Consistently exceeds enrollment targets with strong recruitment tactics and a 12,000 patient database
www.questri.com Terumo Cardiovascular Systems and Terumo Heart, Inc., are Proud Sponsors of MichBio and Michigan’s Growing Biosciences Industry
Early Phase, Multi-Specialty Unit 31000 Telegraph Rd, Suite 230 Bingham Farms, Michigan 48025 Neurology Clinic at MIND 28595 Orchard Lake Road, Suite 301 Farmington Hills, Michigan 48334 248-644-7770 www.questri.com
www.terumo-cvs.com | www.terumoheart.com Terumo® is a registered trademark of Terumo Corporation. ©2012 Terumo Cardiovascular Systems Corporation 829849
BioMatters | Spring 2013
18
Biotechnology People Can Use NECi is an environmental biotechnology company dedicated to the responsible application of novel products to help solve environmental problems. the Gempler’s Farm Supply catalog. A
protein catalysts that speed up the
production, and adoption of reagent grade
new nitrate Color Slider app to increase
myriad reactions that make life possible.
enzymes crafted for analytical chemistry
the quality of interpretation of test kit
Enzyme reactions happen in gentle
and application in the fields of agriculture,
results is now available — check it out at
conditions: no solvents, no high heat
food, water and biomedical science.
http://nitrate.com/nitratecolorslider.
or pressure, no heavy metals involved.
NECi is pioneering the development,
An Android app is due in April.
Enzyme-based analytical chemistry has
Michigan’s picturesque Upper Peninsula,
some real benefits:
near Michigan Technological University.
measurement is not a simple matter:
The company was founded in 1993 to
when the news announces that a harmful
commercialize the academic research of
compound has been detected in food or
its co-Founder, Dr. WH (Bill) Campbell,
water, people in a lab somewhere have
NECi is located in Lake Linden in
NECi understands that accurate
• Selectivity – Enzymes are able to find “targets” in complex mixtures (reduced sample prep time) • Sensitivity – Enzymes offer low detection limits in complex mixtures
after a publication in Nature resulted
• Specificity – Enzymes react ONLY with the target to be analyzed
in customers calling his lab asking for products. NECi’s first product, Nitrate
• Safety – Enzymes are accurate, reliable, and environmentally benign
Reductase, (NaR) replaces cadmium and hydrazine for nitrate analysis.
NECi’s YNaR reagent is used in
biomedical research for detection of
up for safe and lowest cost shipping,
nitric oxide (NO). YNaR and AtNaR
storage, export and disposal. And all
reagents are used by environmental,
one needs is standard lab equipment
food, industrial, and agricultural labs. AtNaR is specified for nitrate analysis as a
painstakingly tested that food or water
Standard Method with the U.S. Geological
using standard, approved methods. Many
Survey. EPA and ASTM validation studies
of these methods were consecrated in the
are underway currently.
1960s, many of those methods were old at
NECi’s reagent grade products and
test kits are designed from the bottom
and a photometer, but reagent packs for microplate readers and discrete analyzers are available for high throughput labs.
that time — and most require hazardous
NECi’s on-site test kits target
agriculture and environmental/water
materials or expensive equipment.
quality monitoring. Test kit formats
developed for experienced users are
recombinant and native enzyme reagents
simplified by packaging reagents into
for analytical chemistry. Enzymes are
NECi sells its green nitrate detection
enzymes and test kits worldwide, including: consumers testing home wells; agricultural agents testing soil, plants,
NECi develops and produces
forage/feed and water/runoff; environmental citizen monitors testing fresh and salt water; and enzymes for
unit dose containers for true
labs in industry and university
ease of use. NECi’s Nitrate
research. Green chemistry
Test Kits for Agriculture (Ag-
involves biology... and NECi
NTKs) can test soil samples,
brings enzymes to a new level
runoff, nitrate levels in
in the 21st century... all the
flowering crops for maximum
way from the northern-most
yields, and nitrate toxicity of
tip of Michigan!
livestock feed. These semiquantitative kits, developed
NECi would like to
with support from the USDA’s
thank the SBIR program of
SBIR program, give a visible
NIH for funding the protein
pink color when nitrate is
expression work and the
present. The toxicity test kits
MEDC’s Emerging Technology
saw significant sales during
Fund for their monetary
the drought of summer and
gift that aided product
fall 2012. Ag-NTKs are sold
development.
via the company website and NECi’s
nitrate reductase
(NaR)
is a recombinant enzyme produced by fermentation
-
for optimal
quality control
19
BioMatters | Spring 2013
Innovate. Accelerate. MichBio and the Michigan Economic Development Corporation will co-host the Michigan Pavilion at the BIO International Convention in Chicago April 22-25, 2013. The companies featured below are the exhibitors that will be showcased in the Michigan Pavilion.
Stop by. Visit. Booth #1805. BIO Convention 2013.
3D Biomatrix, Inc. 3D Biomatrix is a leader in three-dimensional (3D) cell culture products for stem cell research, drug discovery and testing, and cancer research. Its 96- and 384-well Perfecta3DÂŽ Hanging Drop well plates facilitate the formation, culture, and testing of 3D spheroids and embryoid bodies (EBs) without contact with surfaces or matrices. www.3DBiomatrix.com
City of Southfield Southfield is the premier business address in Michigan. It is the center of a region with strong economic assets and opportunities in life sciences and technology based industries. We are an epicenter supported by St. John Hospital, Oakland Community College and Lawrence Technological University. www.cityofsouthfield.com
Algal Scientific Algal Scientific Corporation is pioneering a sterile fermentation process using specially selected algae to produce high purity beta-1,3 glucan for use as animal and human immune health and nutrition ingredients. A patented complementary technology uses algae to recycle water and recover valuable nutrients and co-products from food industry process streams. www.algalscientific.com
DeNovo Sciences, Inc. DeNovo’s proprietary CTC system provides the user effective and efficient methods to capture, enumerate and perform single cell molecular analysis on CTCs from whole blood. The DeNovo Microfludic System utilizes cutting edge consumables, resulting in unparalleled sensitivity and specificity without contamination. www.denovosciences.com
Ash Stevens Founded in 1962, Ash Stevens, Inc. (ASI) offers comprehensive small-molecule drug substance development and GMP manufacturing services spanning early-stage development through commercial API manufacturing. ASI supports all facets of chemistry and manufacturing controls (CMC) related to the development of small-molecule APIs including the development and manufacture of highly potent APIs (HPAPIs). www.ashstevens.com
Detroit Clinical Research Center, PC Detroit Clinical Research Center (DCRC) is a health research institution that supports clinical research studies across all hospitals and medical facilities in South, Mid and East Michigan. DCRC also collaborates with other health institutions in Michigan, North America and internationally to support leading health care research projects. www.dcrc.us
BioMatters | Spring 2013
20
Michigan.
Ferndale Pharma Group Ferndale Pharma Group’s business units offer health and wellness solutions to healthcare providers and consumers, with a special interest in skin care, GI/digestive health, and prevention of hospital acquired infections. Ferndale also provides contract manufacturing services with expertise in topical Rx, OTC, and cosmetic liquids and semi-solids. www.ferndalepharmagroup.com
Global Clinical Connections Global Clinical Connections offers consulting and project management solutions for small, medium, and large biotech and pharma companies in the preparation and distribution of investigational materials for Phase I-IV clinical trials to assist them in achieving their developmental milestones. www.globalclinicalconnections.com
LifeLine Ventures LifeLine Ventures is an investment company with a primary focus in the Life Science Industry targeting medical devices and diagnostics. Our distinctive approach blends significant financial investment with unique access to our ancillary services. Our ideal investment is mid to late stage development companies with an investment range from $2-10 million. www.lifeline-ventures.com
MichBio MichBio is the trade association committed to driving growth in Michigan’s biosciences industry and its many sectors, including agri-biotech, food and nutrition, biobased technologies and renewable chemicals, industrial and environmental biotech, medical devices and technologies, pharmaceuticals and consumer healthcare, diagnostics and research products, testing and research services, and clinical research. MichBio members include biosciences companies, academic and research institutions, biosciences service providers, and related organizations. www.michbio.org
Impact Analytical Impact Analytical is a contract testing laboratory working with more than 300 companies around the world and dedicated to providing top-notch analytical service in a variety of industries—pharmaceutical, plastics, consumer products, medical devices, packaging, automotive and specialty chemical. www.impactanalytical.com
21
BioMatters | Spring 2013
®
Michigan Economic Development Corporation The Michigan Economic Development Corporation (MEDC) is a public-private partnership serving as the state’s marketing arm and lead agency for business, talent and jobs, tourism, film and digital incentives, arts and cultural grants, and overall economic growth. MEDC offers a number of business assistance services and capital programs for business attraction and acceleration, economic gardening, entrepreneurship, strategic partnerships, talent enhancement and urban and community development. MEDC, founded in 1999, also developed and manages the state’s popular Pure Michigan® brand. www.michiganadvantage.org
Michigan Business Incubator Association The Michigan Business Incubator Association aims to stimulate business growth and economic vitality by utilizing the state’s best business incubators, accelerators and economic partners to create jobs and develop Michigan’s local economies. www.michiganincubation.org
BioMatters | Spring 2013
2222
Michigan State University The nation’s pioneer land-grant university, MSU began as a bold experiment that democratized higher education and helped bring science and innovation into everyday life. Today, MSU is one of the top research universities in the world and is home to a diverse community of dedicated students and scholars, athletes and artists, scientists and leaders. www.msu.edu
MPI Research MPI Research is a preclinical and early clinical CRO that provides discovery, surgery, safety evaluation, bioanalytical, and analytical services. We exceed expectations through consistency and quality, with a commitment to communication and innovation, delivering benefits throughout all phases of development. Learn how we can go beyond for you at www.mpiresearch.com. www.mpiresearch.com
MYcroarray MYcroarray is a leading manufacturer of custom molecular probes for genomic applications, including capture baits libraries for targeted sequencing, fluorescent probes libraries, oligonucleotide libraries, oligonucleotide microarrays and building blocks for synthetic biology. Our unique, low-cost and flexible technology enables affordable yet fully customizable products to better serve your needs. www.mycroarray.com
Originus, Inc. Originus, Inc. Originus, Incorporated uses proprietary transfection technology to accelerate cell-based assay development and produce robust assays for GPCRs, drug transporters, ion channels, and other protein targets, as well as Cytochrome P450 metabolic enzyme induction. Assays are provided as ready-to-use kits or in large volume for high throughput screening. www.originusinc.com
polyElements, LLC polyElements, LLC is a new venture specializing in the production of electrospun nanofiber scaffolds for a variety of research applications. In addition to offering a standard array of fiber scaffolds and electrospinning equipment, polyElements also produces customized fibers, chemically and physically engineered to meet the specialized needs of our customers. www.polyelements.com
The Right Place, Inc. Serving West Michigan since 1985, The Right Place, Inc., is a regional non-profit economic development organization dedicated to spurring economic growth in West Michigan. The Right Place serves both in-region and prospective West Michigan companies, providing one-stop assistance for business expansion, innovation and growth. www.rightplace.org
Velesco Velesco is a CMC contract research organization, founded by pharmaceutical scientists from Pfizer’s former Michigan R&D campus. As experts in pharmaceutical analytical chemistry, drug formulation and cGMP clinical supply manufacture, Velesco applies nimblocity to your early stage drug development projects, with our proven formulation of expertise, flexibility and velocity. www.velescopharma.com
Wayne State University Through our dedication and leadership, Wayne State University is a nationally recognized center of excellence in research. Our research activities provide new opportunities for commercialization, bringing university-based intellectual property into the marketplace and creating start-up companies based on WSU research that generate new jobs, products and service innovations. www.techtransfer.wayne.edu
Hosted by: ÂŽ
23 23
BioMatters | Spring 2013
Michigan Biosciences BY THE NUMBERS MI Bio-Industry Quick Facts # Bio Companies & Organizations:
618
# Bioscience Jobs:
39,282
Total Employment Impact:
124,657
Average Bioscience Salary:
$76,989 Total Payroll:
$2.5 billion Economic Impact:
$9.5 billion Total Bioscience Start-Ups Since 2002:
134
Academic Bio-Research University Research Corridor
21st Century Investment Fund:
$120 million fund-to-funds $46 million to biosciences
www.Michigan21stCenturyInvestmentFund.com
InvestMichigan! Fund:
$300 million
series of funds www.InvestMichiganFund.com Venture Michigan Fund:
$95 million fund-to-funds
www.VentureMichiganFund.com (2007-2009)
Accelerate MI Innovative Competition:
$1 million
in cash prizes; largest business plan competition in the world 2012 Winner – Algal Scientific 2011 Winner – DeNovo Sciences 2010 Winner – Armune Biosciences Angel Investment Group Seed Program:
$500 for each Angel group member; $25,000 for administrative fees
Total R&D:
for 50+ members
(#10 in the nation) Bioscience R&D:
EB-5 Investment & Visa Program: Permanent U.S. resident status based on EB-5 eligibility to
(#10 in the nation)
investors of new commercial enterprise
$2.01 billion $1.2 billion # of Bioscience Degrees:
5,548
(#8 in the nation) # of Bioscience-Related Patents:
1,871
(2004-2009)
$1 million in a
Emerging Technology Fund: Matching fund for SBIR/STTR awards;
25% of SBIR/STTR with maximum $25,000 for Phase I and up to $125,000 for Phase 2 up to of
Great Lakes Entrepreneurs Quest:
Bio-Industry Investment, Commercialization Resources & Incentives Life Sciences Corridor Fund – 21st Century Jobs Fund:
$323 million
$100,000 to prizes for
annual business plan competition MI Pre-Seed Fund:
≤ $250,000
Convertible note with 100% match; pre-seed loan is up to
$50,000
(1999-2009)
MI University Commercialization Initiative:
Total VC Investments:
$232 million
to commercialization projects at MI member universities;
(~45% life sciences) (2012) Total $ Raised:
requires companies/institutions
$107.1 million (2012)
Up to $50,000
50-100% match from
Pure Michigan Venture Match Fund:
$350,000-500,000 match on $700,000-$3 million investment
www.MichiganAdvantage.org
BioMatters | Spring 2013
24
Distribution of Michigan bio-companies by sector
a sample of Bioscience Companies in Michigan
Pharma & Therapeutics
21%
n Amway
n Kellogg
Medical Devices/Equipment
41%
n Ash Stevens
n Lycera
Research & Development
13%
n Asterland
n Medbio
Testing/Medical Labs
3%
n Atek Medical
n MPI Research
Information Technology
9%
n BD
n NanoBio
AgBio & Industrial Biotech
13%
n Beckman Coulter
n Neogen
AgBio & Industrial Biotech Pharma & Therapeutics Information Technology
Testing/ Medical Labs
Research & Development
Medical Devices/ Equipment
n Caraco Pharmaceuticals
n Orchid Orthopedic Solutions
n Dow Chemical
n Oxford Biomedical
n Dow Corning
n Perrigo
n Emergent BioSolutions
n Pfizer
n Enzo Life Sciences
n Pioneer Surgical
n Esperion Therapeutics
n Rockwell Medical
n Everist Genomics
n Stryker
n Ferndale Pharma Group
n Terumo Cardiovascular
n Housey Pharmaceuticals
n Terumo Heart
n Jasper Clinical R&D
n ThermoFisher
n JHP Pharmaceuticals
n Zoetis (formerly
n Kalexsyn
Pfizer Animal Health)
Biosciences is BIG Business in Michigan
25
BioMatters | Spring 2013
A perfusionist
uses a heart-lung machine and
blood parameter monitoring system (top monitor) to keep the patient’s blood flowing when the
heart stops beating during open-heart surgery.
Sophisticated Technologies
Save Thousands of Lives Every Day
Terumo Cardiovascular Systems
circuits, endoscopic vessel harvesting
Corporation (Terumo CVS) develops,
systems, and vascular grafts. Terumo
manufactures and distributes medical
CVS serves customers working primarily
devices for cardiac and vascular surgery
in cardiac and vascular operating rooms,
with an emphasis on perfusion products,
including cardiac and vascular surgeons
intraoperative monitoring and vascular
and perfusionists — the specialists
grafting. Terumo CVS produces the
who run heart-lung machines during
longest-running, commercially successful
cardiopulmonary bypass surgery.
line of heart-lung machines in the world
and is the only U.S. manufacturer of
perfusion products in the U.S. since
these life-saving medical devices.
the earliest days of open heart surgery.
Sarns™ branded heart-lung machines have
The company is headquartered in Ann
The company has been manufacturing
Arbor, Michigan, with manufacturing
been produced in Ann Arbor, Michigan,
operations in Ann Arbor; Elkton,
since 1963. Terumo acquired the Sarns
Maryland; and Ashland, Massachusetts.
and CDI™ brands in 1999, and since that
The company employs 1,300 Associates.
time, Terumo has become the leading
brand worldwide in perfusion products.
Key product categories include heart-
lung machines, intraoperative monitors,
Terumo CVS Associates are proud of the fact that their products are used in more than 1,000 life-saving procedures every day.
For example, sophisticated
technology is at the heart of the CDI™ 500 Blood Parameter Monitoring System, manufactured by Terumo Cardiovascular Systems in Ann Arbor. The CDI system uses optical fluorescence and a reflectance-based in-line system to
cannulae, oxygenators, perfusion
BioMatters | Spring 2013
‘Optical Fluorescence’ Technology is at the Heart of Terumo Cardiovascular Systems
26
continuously monitor 11 critical blood
gas parameters during cardiac surgery
Terumo is a leader in innovation and
with extracorporeal circulation.
was ranked number 14 out of the
top 100 global companies by Forbes
Fluorescence is a behavior that
Because of technologies like this,
occurs when molecules of certain dyes
magazine on its “World’s Most Innovative
are excited by exposure to light. When
Companies” list.
the molecules return to their less exited state, fluorescent light is emitted. The excitation light and the emitted light are of differing frequencies, allowing them to be measured independently.
The fluorescent dyes are housed
in the CDI 500 system shunt sensor, a disposable that is placed directly into the extracorporeal circuit.
Access to continuous information
is a key advantage to clinicians when providing optimum patient management because it enables clinicians to react without delay to changes in blood parameter values.
A perfusionist
adjusts the flow on the
Terumo® Advanced Perfusion System 1
heart-lung machine during open-heart surgery.
Reserve Your Ad Now! BioMatters will be published in October 2013.
Circulation
Print distribution to MichBio members and stakeholders, attendees at the MichBio Expo and BIO International Convention and numerous other state and national events. Digital distribution to more than 7,000 addresses including biosciences companies and service providers, state and regional funding sources, economic development organizations, universities and research institutions.
Advertising Rates MichBio Inside Front Cover Back Cover Inside Back Cover Full page Half page Quarter page
Members Non-members $4,000 $4,400 $3,500 $3,850 $3,000 $3,300 $2,000 $2,200 $1,000 $1,100 $500 $550
Information/Reservations Contact Wendy Wendel 734.527.9147 wendy@michbio.org
27
BioMatters | Spring 2013
Originus, Inc.
Drive in the Fast Lane...
Innovative.
GLEQ moves Michigan’s life science and medical device companies into the fast lane with entrepreneurial education, one-to-one coaching, connections to resources, exposure to investors, and a statewide business plan competition. Accelerate a new idea or an emerging company with GLEQ.
GLE
Trustworthy.
Product Design Project Management Injection Molding Micro Molding
Inspiring Success
Knowledgeable.
Over Molding Insert Molding Clean Room Molding Clean Room Assembly
Passionate.
Medical Device Biotech Diagnostic Microfluidics
ISO 13485:2003 Certified
Great Lakes Entrepreneur’s Quest
www.medbioinc.com
Learn more and register for the competition at: www.GLEQ.org
BioMatters | Spring 2013
Innovative Contract Manufacturing Solutions for the Life Sciences.
28 ad3x4.indd 1
2/27/13 8:47 PM
3D Biomatrix Transforms Pharmaceutical Testing
New drugs that fight disease are
high-throughput setting. Users simply pipet
often tested on laboratory-cultured cells.
a cell suspension into the top of a well, and
Traditionally, cells are grown on flat plastic
the plate design allows the suspension to hang
surfaces, such as flasks, dishes, or plates.
below the well surface (Figure 1, bottom).
Cells flatten on the two dimensional (2D)
The cells, which do not contact any surfaces or
plastic surface, but living tissues in animals and humans are
matrices, aggregate into a spheroid over one to several days.
three-dimensional (3D). As such, cells grown in 2D cultures often
fail to replicate those 3D tissues.
researchers in pharmaceutical companies and academia.
Recent publications have demonstrated that anticancer drugs
To bridge the gap between 2D cells and humans, Ann Arbor,
3D Biomatrix’s HDPs have been accepted readily by
MI-based 3D Biomatrix developed the Perfecta3D® Hanging Drop
with distinctly different mechanisms show much different
Plate (HDP) (Figure 1, top) to grow cells in 3D, so that they more
results when tested in 2D and 3D cultures. As well, researchers
closely mimic their tissue of origin. 3D Biomatrix has received
have shown that realistic tissue models can be made in HDPs
widespread recognition for their HDPs, including winning a
utilizing multiple cell types.
Wall Street Journal Technology Innovation Award and being
By introducing 3D cell culture early in the drug-screening
featured in Genetic Engineering
process, researchers can get
& Biotechnology News, The
more physiologically-relevant
Scientist, and Biocompare.
data earlier, and more drugs
The HDPs are designed for
that would be failures can
the formation, growth, and
be screened out before the
testing of micro-scale 3D tissues
animal-testing phase. This
called spheroids. Spheroids are
reduces the amount of animal
used as models of many types of
testing needed overall, and
avascular tissues, tumors, and
lowers the cost and time to
embryoid bodies. HDPs are easy
get a drug to market.
to use and, in 96- and 384-well
plate formats, work with existing
about Perfecta3D Hanging
lab instrumentation frequently
Drop Plates can be found at
employed to screen drugs in a
Figure 1 – Top: 96-
384-well Perfecta3D Hanging Drop Plates facilitate the culture of spheroids within a hanging drop. Bottom: The user pipets the cell suspension into each well and the spheroid self-assembles
Additional information
3dbiomatrix.com/products.
and
Get Connected.
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EXPO
BioMatters 29
BioMatters | Spring 2013
Titled
mural depicting
Flint’s
rich history
created by hundreds of students with special needs from the
School District
Genesee Intermediate
Michigan-Based Diplomat Leads the Way in Specialty Pharmacy Industry Growth Biotechnology Drugs and the Patient Compliance Challenge
by Gary K. Rice, R.Ph., MS, MBA
Diplomat’s key therapy programs
Specialty pharmacy is a branch of the
General Motors’ Great Lakes Technology
pharmaceutical delivery system
Centre complex on Saginaw Street in
include Oncology, HIV/AIDS, Hepatitis C,
that focuses on comprehensive and
Flint, which now serves as Diplomat’s
Multiple Sclerosis, Rheumatoid Arthritis,
coordinated systems of pharmacological
headquarters. Also in 2010, Diplomat
Crohn’s, Hemophilia/IVIG, Growth
care for patients with serious and chronic
announced a plan to add over 1,000 new
Hormone and Psoriasis. Other specialty
illnesses and complex medical conditions.
jobs in five years, which the Company
areas include transplant, fertility and
Surprising to many Michiganders — even
remains on target to do. Concurrent
bio-identical hormone therapy. In addition
those in the biomedical field — is that
with its hiring efforts, Diplomat has
to working closely with “big pharma”
Michigan is home to the nation’s largest
taken a corporate leadership position in
and small biotech pharmacy companies,
privately held specialty pharmacy,
the revitalization of Flint, providing both
Diplomat’s business model creates unique
Diplomat Specialty Pharmacy in Flint.
money and manpower to develop several
partnerships with all industry stakeholders,
What started as a family-owned
community-based initiatives that result
including physicians, patients, group
business co-founded by current CEO Phil
in new job creation and improved quality
purchasing organizations, hospital systems,
Hagerman, R.Ph. and his pharmacist
of life for Flint area residents.
retail chains and managed markets — always focused on improving adherence
father, Dale Hagerman in 1975, is now a leading Genesee County employer with more than 800 employees. The company’s revenues in 2012 were $1.1 billion, up 50 percent from 2011, and Diplomat has made the Inc. 500 list of fastest growing private companies in America every year since 2009.
Diplomat Specialty Pharmacy’s goal is to optimally deliver high quality, patient-centric care in a growing industry, while promoting patient safety and convenience.
and the patient experience.
With its strong reputation in the
specialty pharmacy space, Diplomat has been able to recruit top talent to its executive ranks, including recent transplants from California and Texas who were eager to be part of the innovation and energy at Diplomat.
An important milestone in the
company’s history was the 2010 purchase
Another draw for executives and other
of the 340,000 square foot former
prospective employees is the training offered on-site to Diplomat staff
BioMatters | Spring 2013
30
and industry professionals at the new Diplomat Specialty Pharmacy University. In addition to pharmacists, Diplomat employs nurses and patient advocates who interact with patients to answer
Diplomat
questions, offer support, and ensure
patient testimonial
featured in the hallways of
medication compliance. Diplomat refers
its
Flint
headquarters
to this as its high-tech, high-tough system, a robust patient management program that combines sophisticated software, personal outreach and call center support to optimize patient outcomes with often complicated treatment programs. Diplomat also helps find funding for those who cannot afford their prescriptions. In 2012, the company secured more than $19 million for patients through outreach to various non-profit funding sources.
The field of specialty pharmacy
is forecasted to grow at double-digit rates annually in the next few years, with recent information reflecting that
are non-adherent in one or more ways.
training, followed by compliance
Clinically the impact is realized in lower
packaging that keeps the drug
patient quality outcomes. Failures in
safe and secure yet is also easy
medication adherence lead to expensive
for the patient to open, prophylactic
and sometimes life-threatening
starter kits (a side effects management
complications. Economically, the impact
kit), nurse adherence calls to provide
of non-adherence is estimated to cost
clinical support and guidance, and
$100 billion annually.
technology, whether that be through smart phones, prescription bottles with
specialty products will be 50 percent
glow caps or packaging with alarms
of the drug spend by 2018. This will be
and reminders.
based on current specialty biotechnology
therapies gaining FDA approval for additional indication, newly FDAapproved biotechnology therapies and the introduction of biosimilars.
Much of the focus on the clinical
side of specialty pharmacy is patient compliance and medication persistence. Medication compliance refers to whether patients take their medications as prescribed (e.g., twice daily) and persistence signifies whether they continue to do so. Together, treatment compliance and persistence contribute to overall medication effectiveness. Indeed, the holy grail of specialty pharmacy is described as optimal compliance and persistence. The impact of non-compliance has both clinical and economic implications. Thirty-two
Diplomat Specialty Pharmacy’s goal
is to optimally deliver high quality, patient-centric care in a growing
These biotech specialty medications
industry, while promoting patient safety
tend to have greater side effects than
and convenience. At the same time,
traditional small-molecule medications
Diplomat’s core value of meaningful
and are more costly. Both of these
community commitment continues to
factors work against patient compliance,
direct the company’s actions beyond the
persistence and, ultimately, positive
world of specialty pharmacy.
patient outcomes. With Diplomat’s specialty patient satisfaction rates
Gary Rice is the Vice President
over the last three years ranging from
of Clinical Services for Diplomat
98 percent to 99 percent (the industry
Specialty Pharmacy.
average is 50 percent to 70 percent),
grice@diplomatpharmacy.com
there is additional competitive pressure to closely monitor adherence.
The key to patient compliance
and adherence begins with patient education and
million Americans use three or more medicines daily; 75 percent of adults
31
BioMatters | Spring 2013
Does your search for funding seem aimless, are you lost when it comes to developing relationships with Federal Agencies or don’t know how to use the ones you’ve got with elected officials to advocate for you? Whether it is money, policy changes, federal contracts or representation in Washington, D.C., trying to navigate the maze of government opportunities can be daunting. Now you’ve got help.
The G2G team includes individuals with senior positions in government, Capitol Hill and the Pentagon.
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Contact Liz Powell at 202-445-4242 or lpowell@G2Gconsulting.com
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BioMatters_Ad_2010_FINAL.indd BioMatters | Spring 2013
1
32
8/19/10 9:39:14 PM
Innovation and Expertise Puts Helix Biological Laboratory at the Forefront
Helix Biological Laboratory LLC is a full service laboratory located
organizations within the state on water quality projects by providing
in southeast Michigan that is engaged in a wide variety of biological and
MST services that address fecal contamination in various waterways.
analytical testing, as well as consulting services.
Following EPA and NELAC guidelines for MST, the
laboratory identifies specific DNA markers of fecal
Established in 2009, Helix Biological Laboratory
specializes in the detection and identification of
bacteria that are found in specific host sources
microorganisms from a variety of sources such as water,
that include humans, cows, pigs, horses, dogs,
food and beverages products (including wine), soil,
and birds such as geese.
agricultural samples, biological samples, consumer
products, cosmetics items, pharmaceuticals and textile
of fecal contamination to be identified quickly
materials. In addition, Helix offers forensic, drug and
This methodology allows the sources
and accurately using an array of molecular
food micro testing, along with plant diagnostics.
genetic technologies that are very selective as well as sensitive.
The rapid identification of source fecal contamination assists health
Since its inception, Helix Biological Laboratory has distinguished
itself as a laboratory that has developed a high quality standard of
departments, municipalities and other agencies in quickly and
experimental expertise using a combination of leading edge molecular
efficiently identifying and taking measures to control the source or
biology and microbiological techniques for projects that require both
sources of fecal contamination in waterways. Helix is the industry
diverse and specialized proficiency. Helix Biological Laboratory’s diversity
leader in providing MST testing.
along with its ability to develop methods and custom design assays
provide a tremendous advantage to both current and potential clients.
analytical testing techniques for the detection and identification of
In addition to MST services, Helix provides the most advanced
a wide variety of bacterial, fungal and protozoan microorganisms that are sources of environmental health problems. The laboratory’s
Helix provides the most advanced analytical testing techniques for the detection and identification of a wide variety of bacterial, fungal and protozoan microorganisms that are sources of environmental health problems.
molecular technique capabilities also provide the means for performing metagenomics analysis. Metagenomics has emerged as a powerful tool that can be applied toward the analysis of microbial communities in environmental samples.
Michigan is fortunate to have an abundance of fresh water
resources like the Great Lakes, as well as many other waterways
Of the services that the lab provides, none stands out more than the
throughout the state. Water activities are an integral part of the
Microbial Source Tracking (MST) services and are unique in the industry.
culture in Michigan, so it is imperative that the health of waterways
MST involves a set of methods that are used to determine the host
be assured through the most advanced technologies available. Helix
source (human or animal) of fecal pollution in various waterways
Biological Laboratory sets a precedent for quality biological and
through the detection and identification of specific fecal indicator
analytical testing through innovative and industry-leading approaches
bacteria present in waterways.
and is helping insure the safety of Michigan’s water resources,
environment, agriculture and food.
Helix Biological Laboratory has been working with the Michigan
Department of Environmental Quality (MDEQ) as well as other
25 31 33
BioMatters || Spring Spring 2013 2011 BioMatters 2013
Geoff Horst, Chief Science Officer, selecting algal strains
Algal Scientific
Algae Startup Develops Lower-cost Manufacturing Platform for Valuable Immune Health Compound
Founded in 2009 by several graduate
students who won a University of
used with monoclonal antibodies in
lead to a heightened immune response,”
oncology therapies.
said LeBrun. “In one study we prevented
Michigan business plan competition,
Algal Scientific is commercializing a new
research to-date focus on beta glucans
as an antibiotic.”
type of low-cost manufacturing platform
that are extracted from yeast cell walls.
However, the majority of existing
for an immune health compound called
The company is entering the animal
feed market in the short term, with eyes
“beta-1,3-glucan”.
mortality from E. coli at the same level
“Over 20% of the poultry and swine grown in the U.S. does not use antibiotics as growth promoters.” (source: AgStats)
Jeff LeBrun, co-founder and product
manager for the beta glucan product, says that the company decided to develop a sterile fermentation process for making the product after learning
on the larger functional food ingredient market in the near future. In animal feed, beta glucans could be considered to be a pro-immune “alternative to antibiotics as a growth promoter — an industry practice that is facing increasing
about existing demand in the animal feed
scrutiny by governments, consumers
and nutraceutical industries.
and organizations such as the American
More than $200 million of basic
In contrast, Algal Scientific produces
Medical Association.”
research has already been invested
more bioavailable forms of beta glucans
into understanding the biology of
that are not bound to the cell wall,
up. Algal Scientific was told by the CEO
beta glucans. Several clinical trials
creating a cost advantage and the ability
of a public nutraceutical company that
have evaluated uses of beta glucans
to make more beta glucan extracts than
he believes beta glucans could be “the
applications ranging from prevention of
what is typically seen in the market today.
post-surgical infection to an adjuvant
“So far, we have performed several in
vivo studies that suggest our product can
BioMatters | Spring 2013
34
Recently, things have been heating
next Omega 3”.
The Omega 3 retail market is currently
estimated to be $30 billion annually.
Algamune™ AM – Beta Glucan
based algae
meal for animal immune health
The company reports to have made
Algal Scientific’s CEO Paul Horst is
Tests are currently underway at
a veteran entrepreneur who says he was
several major companies. Over the past
engaged with several multi-billion dollar
recruited “to bring some grey hair to
month, Algal Scientific has been receiving
companies that are evaluating their
the table.”
sample requests almost every week from
beta glucan product for uses including
various Fortune 500 companies who have
a functional food ingredient, an animal
can dramatically expand the current
seen their preliminary test results.
feed ingredient, and even as an adjuvant
market size by producing a more
for vaccine and monoclonal antibody
cost-effective product.”
“a couple early sales” while also being
Horst says, “We believe that we
therapies.
“Our regulatory consultants recently
confirmed that Algamune™ ZPC meets an approved animal feed ingredient definition allowing sales in the U.S.,” says Horst. “In addition to progress with customers, over the past six months we have made some key technical hires and we’ve demonstrated economical process metrics at a small commercial scale.”
The company says that although they
have benefited greatly from the facilities at the Michigan Life Science and Innovation Center, a former Pfizer R&D facility run by the Michigan Economic Development Corporation, they will soon need to expand into a larger commercial facility.
Based on the recent rate of progress,
Horst predicts that Algal Scientific will have over $50 million in product sales within a couple of years.
Craig Banotai, Senior Scientist, Algal Scientific, operating research fermenter
Not bad for a few graduate students
and some “grey hair”.
35
BioMatters | Spring 2013
polyElements:
New Startup Creates Nanofiber Scaffolds for Tissue Engineering
polyElements, LLC is a new biotechnology company founded
by three recent University of Michigan graduates. polyElements
Traditionally, cell culture is carried out on flat plastic or glass
surfaces coated with various polymers or proteins. However, this is
specializes in the creation of electrospun scaffolds for biological, medical, and tissue engineering research. Electrospun fibers can be
“Nanofibers offer a novel approach to cell and tissue research. We can consistently create a controlled environment, for cell growth and begin addressing specific questions about the relationship between cells and their environment.”
created from a variety of polymeric materials and can be designed to meet a number of specifications including diameter, alignment, elasticity, porosity, and hydrophobicity.
There is a diverse array of potential applications for
electrospun nanofibers. The fibers can be used as a scaffold to create semi-synthetic tissues, as a device-tissue interface for implantable biomedical devices, or as tools to study cellular biology. Currently well known in the field of biomedical engineering, biologists are beginning to realize the potential of
a far cry from the three dimensional environment cells occupy in
electrospun fibers to transform their own medical and basic science
vivo. New research continues to demonstrate the importance of
research methods.
cell-environment interactions to cell structure and function.
Recent studies have shown that cells can sense their physical
“Electrospinning is a difficult process with a high learning
curve, which has been a barrier to entry for scientists who may
surroundings and alter a number of cellular processes in response.
not have an engineering background,” says
For example, oligodendrocyte precursor cells
Sam Tuck, co-founder and lead technician
have been shown to wrap electrospun nanofibers
whose work has been featured in a number of
only when the nanofibers have diameters
scholarly publications including Nature Methods.
similar to the size of axons (Nature Methods,
“We have a combined 12 years of electrospinning
9:917-922, 2012). Expanding on these findings,
experience. We’ve mastered the curve and
researchers could create a neuron-free in vitro
can quickly customize scaffolds to address our clients’ specific
model of myelination which can be used to screen drug candidates
research questions.”
for demyelinating illnesses such as MS. Additionally, biological scientists could utilize the fibers to study alterations in cell signaling and gene expression caused by a specific nanotopography. These are just two of many potential applications for our scaffolds.
“Nanofibers offer a novel approach to cell and tissue
research. We can consistently create a controlled environment, for cell growth and begin addressing specific questions about the relationship between cells and their environment,” says Michelle Leach, PhD, co-founder. polyElements currently offers a number of nanofiber products and an array of consultation services. The company is also working with a local manufacturer (MogulTech, Saline, MI) to produce an economical electrospinning rig for research groups. For more information or to place an order, please visit www.polyElements.com.
Aligned
polymer microfibers for tissue scaffold research
BioMatters | Spring 2013
36 34
Ash Stevens Adds New Capacities and Capabilities with growing global demand from
approvals for FDA fast-tracked drugs
Southeast Michigan, is a provider of
biotech and pharmaceutical companies
developed under significantly accelerated
active pharmaceutical ingredient (API)
for these services. The additional capacity
timelines. Other FDA fast-tracked
development and manufacturing services
and services would also allow ASI to
manufacturing approvals for Ash Stevens
for clients in the Life Sciences industry
manufacture APIs for therapeutic
include the oncology drugs Velcade®
developing small-molecule innovator (New
indications requiring larger batch sizes
(Millennium /Takeda), Vidaza® (Celgene),
Chemical Entities or NCEs) drugs. The
while continuing in its leadership role
and Clolar® (Genzyme/Sanofi). Among
company was founded over fifty years ago
in the field of oncology chemistry.
ASI’s other manufacturing approvals is that
Ash Stevens Inc. (ASI), located in
by two chemists with deep ties to Wayne
The new large-scale reactor bay houses
State University (WSU) in Detroit: Dr. Art
2,000, 3,000 and 4,000-liter glass-lined
Ash, who received his doctorate degree in
vessels designed with appropriate
chemistry from WSU, and WSU chemistry
engineering controls for potent compound
Professor Dr. Cal Stevens. ASI initially
handling. The new, adjacent isolation bay
provided contract research services to
is equipped with a 1.5 m2 fixed filter dryer
the U.S. Government (Walter Reed Army
with glovebox technology for contained
Hospital, NIH, and NCI) and then over the
isolation, drying, and packaging of
years has provided contract chemistry
large-scale batches. This technology
support for many of the drugs developed
permits handling of potent compounds
through these government agencies.
and air sensitive materials at scale.
for Amotosalen used in the INTERCEPT Blood System for the Cerus Corporation.
In addition to the large-scale reactor and isolation bays, Ash Stevens has added many other upgrades to its Riverview manufacturing facility since beginning this expansion phase in 2006. These upgrades Ash Stevens still provides contract
include a new hydrogenation reactor
research services to the U.S. Government
bay, a new solid-state characterization
today. However, ASIs core business
laboratory, a new laboratory with
has since transitioned to providing
appropriate air handling systems for the
commercial drug development and cGMP
synthesis of highly potent compounds, a
manufacturing services to sponsor
new state-of-the-art materials storage and
companies in the life sciences industry
handling facility, new Rosenmund filter
developing small-molecule, innovator
dryers with glovebox technology, and a
drugs. The company’s clients range from
safety and hazard assessment laboratory.
virtual biotechs to some of the world’s
“With the completion of the
Ash Stevens’ new large-scale reactor bay housing 2,000, 3,000, and 4,000 liter reactors
Ash Stevens has excellent international
expansion, Ash Stevens will have the
regulatory compliance and safety. The
capability to meet the service and
company supports all facets of chemistry
construction, commissioning, and
capacity needs of our clients while still
and manufacturing controls (CMC) related
validation of a multi-year, multi-million
providing close interactive support and
to the development of small-molecule
dollar expansion to its cGMP manufacturing
project management demanded in today’s
APIs. The services offered by ASI include:
facility in Riverview, Michigan. Production
environment. We have come a long way
process development, cGMP manufacture
in the new bays begins in April 2013.
over the past fifty years and are very
of API for clinical trials, commercial API
excited to be completing this latest phase
manufacturing, comprehensive analytical,
and Chief Executive Officer, Dr. Stephen
of expansion at our state-of-the-art
and regulatory support, development and
Munk, recognized that the company’s
manufacturing facility,” says Dr. Munk.
manufacture of high potency APIs, and
largest pharmaceutical companies. Ash Stevens recently completed
Ten years ago, Ash Stevens’ President
ability to function as a leader in the
Over the years, Ash Stevens has
preparation of documentation for
commercialization and manufacture of
achieved an impressive track record
submission (IND, NDA, DMF, CTD). For
chemically complex Active Pharmaceutical
with twelve FDA manufacturing approvals
more information on Ash Stevens, visit
Ingredients (APIs) would require an increase
for innovator APIs (NCEs) distributed
www.ashstevens.com.
in process capabilities simply to keep pace
world-wide. These include multiple API
37
BioMatters | Spring 2013
MPI Research:
3rd Largest Global CRO that Focuses on Improving the Odds By Scott E. Boley, PhD, DAB, MPI Research, Senior Director, General Toxicology and Infusion
With the cost of bringing a new drug to
types of therapeutics (e.g., biopharmaceuticals, imaging agents,
market topping $1 billion, pharmaceutical
botanical products, and others). In these situations the “standard”
and biotechnology companies must make
approach was not appropriate to achieve approval for an Investigational
careful decisions about which candidates to
New Drug (IND) submission. This was the result of such factors as:
move forward along the drug development
• Selection criteria for the appropriate animal species to be used in testing
pathway. The primary challenge they face in developing their drugs and medical devices is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials.
Scott E. Boley
Nonclinical testing is required to establish both the efficacy of a new therapeutic as well as establishing a safe starting dose for the initial human clinical trials.
MPI Research, a full service preclinical Contract Research
Organization (CRO) located in Southwest Michigan, realizes that the development of novel therapeutics can be as diverse as the drugs developed within the industry. The company also understands how important it is to design a drug development program that is tailored specifically to the therapeutic that its sponsors are developing. There is not a “once size fits all” approach for therapeutics, and to design the right approach requires experience and regulatory knowledge of the various approaches that are critical to improve the odds of successfully moving into the clinical phase.
For many years, the majority of new therapeutics in development
involved small molecules designed to interact with cellular receptors. The nonclinical studies conducted to support the progression of these products into Phase I became a “standard approach” for drug development and involved the following: in vitro genetic toxicology studies, safety pharmacology studies, general toxicology studies, and the associated analytical studies (formulation and bioanalytical). In recent years, however, there has been a dramatic increase in other
MPI Research
is known for its
surgical equipment and capabilities
• Immunogenicity concerns due to a lack of homology between the therapeutic and the animal species used for testing • The need to generate limited human data as part of the drug selection process • Therapies that are designed to be administered for limited lifetime use in humans • Therapies for life-threatening indications or serious diseases where effective therapy is currently not available or of limited effectiveness • Physiochemical properties of therapeutics that justify the elimination/revision of specific studies
MPI Research has conducted thousands of efficacy and safety studies for small molecules and biopharmaceuticals (often referred to as large molecules or biologics), as well as medical devices. As a company, MPI works to maximize quality and efficiencies on behalf of its Sponsors’ regulatory applications. Partnering with pharmaceutical and biotechnology Sponsors in designing the studies required for the development of their
particular therapeutic, MPI can say with confidence that based on its amount of experience there isn’t much that the CRO hasn’t seen. MPI’s goal is to improve the odds for sponsors, to select the right lead candidates, and to conduct the right studies in the right way, taking into consideration all factors to ensure their IND submission is successful. Contact info@mpiresearch.com to learn how MPI can help you achieve your drug and device research goals.
Aastrom Biosciences of Ann Arbor Conducts Final Stage Development of Cell Therapy Ixmyelocel-T Therapy to help patients with serious, untreatable cardiovascular diseases
One of Michigan’s oldest biotech companies, Aastrom
is exciting. However, rigorous clinical trials and a defined
Biosciences of Ann Arbor, has experienced a period of growth
regulatory strategy ensure that safe and effective products,
over the past few years, creating more jobs and expanding their
especially those with transformational potential, will reach
manufacturing infrastructure. The company is conducting the final
patients quickly.
stages of development of ixmyelocel-T, a cell therapy created
from a small sample of a patient’s own bone marrow that can
3 clinical trial in patients living with advanced peripheral
potentially treat multiple severe cardiovascular diseases.
arterial disease (PAD) who have limited treatment options.
Developing any therapy involving stem cells is
Ixmyelocel-T is currently being evaluated in a Phase
At this stage of the condition, patients can
challenging due to a number of reasons including
experience wounds that double in size,
strict regulations, a lengthy clinical trial process
gangrene, limb amputation and an increased
and the need for significant investment.
risk of mortality. In the completed Phase 2 trial,
Aastrom’s success in advancing ixmyelocel-T is
ixmyelocel-T was found to reduce the risk of a
the result of a number of key decisions and efforts
combined endpoint consisting of these negative
by the Aastrom team:
outcomes by 62% compared to placebo.
• The company uses only adult human stem cells from
Ixmyelocel-T is also being studied in patients living with
each patient’s own bone marrow. As a result, the
dilated cardiomyopathy (DCM), a condition that causes the
production process is not associated with the ethical
weakening and enlargement of the heart. A Phase 2 trial is
issues surrounding the use of embryonic stem cells.
underway in patients who have DCM as well as coronary artery
In addition, because Aastrom uses the patient’s own cells
disease or blockages in the arteries that lead to the heart.
to develop ixmyelocel-T, there is minimal risk of rejection.
high-risk surgeries for these patients, improve their quality
• The company uses a proprietary production process
“We have a unique opportunity to prevent invasive and
and a centralized manufacturing facility to ensure
of life and set new standards of care. Our team is working
that every patient receives a safe, consistent,
aggressively to accelerate the pace of development of
high-quality product derived from his or her own cells.
ixmyelocel-T to bring this treatment to patients in need,”
said Mr. Colangelo.
• Aastrom’s development team is following a clear
regulatory path established by other autologous
cellular therapies that have been approved by the
thus far and the company continues to explore new disease
FDA in recent years.
areas where patients can benefit from this therapy. The
ability to safely and effectively produce patient-specific
The positive attributes of ixmyelocel T, including its
Over 200 patients have been treated with ixmyelocel-T
autologous nature and multicellular composition, distinguish
therapies is a strong advantage for Aastrom as the company
it from other experimental cell therapies.
looks to grow its pipeline in Michigan.
“I have seen firsthand the tremendous potential of
Aastrom Biosciences is the leader in developing patient-
ixmyelocel-T to treat severe cardiovascular disease and
specific, expanded multicellular therapies for use in the
believe we have the potential to give new hope to people
treatment of patients with severe, chronic cardiovascular
with peripheral arterial disease
diseases. The company’s
and dilated cardiomyopathy who
proprietary cell-processing
have few or no other treatment
technology enables the
options available to them,”
manufacture of ixmyelocel-T
said Nick Colangelo, Aastrom’s
therapy expanded from a
president and CEO.
patient’s own bone marrow and
The prospect of new
delivered directly to damaged
regenerative treatments of
tissues. For more information,
diseases where current medicine
please visit Aastrom’s website
offers little hope for the patient
at www.aastrom.com. Mary Ann Potok,
research associate, staining microscope slides to identify cell
types in bone marrow
39
BioMatters | Spring 2013
nanOss
Bioactive 3D
porosity (x30)
Pioneer® Surgical Technology, Inc.
Innovates With Its New Bone Graft
Pioneer Surgical, a medical technology
Executive Vice President — Biologics and
room times and patient outcomes. Today
company based in Marquette, Michigan,
Surgical Solutions for Pioneer stated,
they are considered national leaders in
recently added the innovative nanOss
“Three-dimensional shapes are popular
the design and manufacture of spinal and
Bioactive 3D to its flagship biologic bone
in spine surgery and with this addition,
orthopedic implants and instruments.
graft product line, nanOss Bioactive.
we now have one of the most extensive
The new nanOss Bioactive 3D is a bone
biologic portfolios on the market.” More
domestically and internationally,
Since then, Pioneer has expanded
void filler and bone graft extender in the
with several facilities throughout the
form of a three dimensional strip. nanOss
U.S. and in Houten, The Netherlands,
Bioactive 3D is comprised of a proprietary
employing nearly 300 people worldwide.
nanocrystalline hydroxyapatite as well as
The company’s vertically-integrated
a collagen-based biopolymer, that provide
manufacturing capabilities differentiate
a scaffold for the in-growth of new
information regarding Pioneer Surgical’s
it from others in the marketplace, greatly
bone in the posterolateral spine. nanOss
biologics product offerings, including
enhancing its ability to take an idea from
Bioactive 3D uses similar technology as
nanOss Bioactive 3D, can be found at
the drawing board to commercialization.
nanOss Bioactive, which was introduced
www.pioneersurgical.com.
Pioneer demonstrates a commitment
in a paste format in 2009. Pioneer Surgical
to surgical innovation by designing
offers several sizes of nanOss Bioactive
osteoconductive implant that provides an
and delivering products that provide
3D, including 5cc, 10cc and 20cc formats.
interconnected porosity similar to human
intraoperative efficiency for surgeons,
cancellous bone. Osteoconductive means
cost-effectiveness for the healthcare
market with two acquisitions in 2007.
that bone grows onto the surface or into
system and better outcomes for patients.
Pioneer’s biologics products have been
pores of the implant. nanOss Bioactive
For more information on Pioneer
the recipient of many prestigious
3D is used to fill bony voids or gaps
Surgical and its products visit
acknowledgements, including the 2005
created during surgery, traumatic
www.pioneersurgical.com.
Technology Award for nanocrystalline
injury, or for other bone voids not
hydroxyapatite in nanOss Bioactive, and
essential for stability. nanoss Bioactive
the 2009 Technology Award for engineered
3D is used in conjunction with the
collagen in nanOss Bioactive. Pioneer
patients’ own bone marrow aspirate
Surgical offers a full line of synthetic bone
and autograft bone, and is placed
grafts as well as human tissue products
into voids or gaps in the posterolateral
including machined lateral, traditional
spine. In time, nanOss Bioactive 3D is
lumbar and cervical allograft, human
resorbed and replaced by the growth
demineralized bone matrix (DBM) bone
of new bone during the healing process.
Pioneer Surgical entered the biologics
nanOss Bioactive 3D is an
grafts, as well as bone graft delivery
The company was started in
accessories.
Marquette, Michigan in 1992 by
orthopedic surgeon Dr. Matthew Songer
Regarding Pioneer’s latest biologics
product line extension, Mr. Shane Ray,
and his father, Robert. The pair sought innovative ways to improve operating
BioMatters | Spring 2013
40
ANALYTICAL/BIOANALYTICAL
DRUG SAFETY
GOING BEYOND CANDIDATE SELECTION
Beyond Expectations. MPI Research is more than your typical CRO. We are leading the way in drug and device development, from discovery through early clinical testing.
Beyond Transactional. At MPI Research, our broad scope of preclinical and early clinical services are supported by excellent scientific expertise. As the world’s largest preclinical research CRO in one location, our depth of experience enables us to offer a collaborative environment, the knowledge base to handle all types of studies, and the capability to smoothly transition from preclinical to clinical testing. Our Sponsors appreciate our ability to be their strategic partner in moving their drug or device along the development pathway.
LEAD OPTIMIZATION
Ready to Go Beyond? DRUG EFFICACY
For more information, visit www.mpiresearch.com
TARGET ID & VALIDATION
Meet us at BIO International Convention booth #1473.
Fastforward WITH
Business Intelligence & Educational Resources
EMERGING BIZ SOLUTIONS
Product Commercialization Planning Support
Introducing MichBio’s Emerging Biz Solutions, a new entrepreneurial support services pilot
Business Partnering & Development Support
program designed to provide highly specialized product development planning resources, business
Visit www.MichBio.org/EmergingBizSolutions
partnering connections
for more information and to apply.
and industry intelligence to bioscience companies.
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This program is sponsored by the Michigan Economic Development Corporation (MEDC) as part of a comprehensive entrepreneurial resource ecosystem that ensures emerging companies have access to the necessary tools, funding and business support essential for commercialization success.