biomatters - spring 2013
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BioMattersA MichBio Publication Showcasing Michigan’s Biosciences Industry
S P R I N G 2 013
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
Biosciences in Michigan: A Rich Legacy of
Discovery and Impact
START UPlaunch pad
WHAT HAPPENS WHEN
meets
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.
1.888.565.0052michiganadvantage.org/BM
BioMatters | Spring 20131
G O V E R N O R ’ S M E S S A G E
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 We are getting rid of outdated and burdensome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
GLOBAL REACH, LOCAL SUPPORT. SINCE 1852.
VWR Accelerating Life Science Solutions in Michigan
VWR is a global leader in the distribution of laboratory products, supplies and services, offering the best product choices, including the Exclusive VWR Collection, from premier manufacturers to customers around the globe. We are committed to providing efficient, effective solutions for all your Life Science needs by offering products, service and support that make your work faster, easier and more accurate.
Bio_Ad_8.5x11.indd 1 10/16/2012 1:38:39 PM
BioMatters | Spring 2013
3
Michigan’s Biosciences Industry Welcomes You! Welcome to MichBio’s (d/b/a Michigan Biosciences Industry Association) seventh
edition of BioMatters, the state’s only in-depth publication showcasing the breadth and
impact of our vibrant biosciences industry. BioMatters is a fundamental part of MichBio’s
mission to drive Michigan’s bio-industry growth through education, resources, business
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
and initiatives that represent just a tiny portion of Michigan’s outstanding biosciences
community. We encourage you to explore what Michiganders already know – that
Michigan offers a business environment where bioscience companies can thrive and
compete in today’s global economy.
Michigan has a rich pedigree in the bio-industry dating back to the 1860’s when
Parke-Davis & Company was formed in Detroit as the first pharmaceutical company in
the U.S., soon to be followed by the Upjohn Company in Kalamazoo, and the L. Perrigo
Company in Allegan. All went on to become great global bioscience brands, with notable
discoveries and products, and commercial success. That’s a proud heritage we’ve built
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
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.
Stephen Rapundalo, Ph.D.
President & CEO, MichBio
P R E S I D E N T ’ S M E S S A G E
P R O F E S S I O N A L S TA F F
C O N TA C T I N F O R M AT I O N
Stephen T. Rapundalo, Ph.D.
President & CEO
734.527.9144
Wendy Wendel
Director,
Marketing and Communications
734.527.9147
David McGuire
Director,
Operations and Membership
734.527.9150
Nancy Marcotte
Manager, Finance
734.527.9145
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
Fax
734.302.4933
Website
www.michbio.org
Get Connected.MICHBIO — YOUR GATEWAY
TO MICHIGAN’S BIO-INDUSTRY
www.michbio.org
www.michbio.org
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.
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
Membership Has Its Rewards
BIO BuSIneSS SOlutIOnS®
“
”
5
CORPORATE SPONSORS
P L AT I N U M
G O L D
S I LV E R
B R O N Z E
®
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
Terumo Cardiovascular Systems/Terumo Heart
M E D I A
ExECUTIVE OFFICERSChairmanStephen Munk, Ph.D.Ash Stevens, Inc., President & CEO
Vice ChairmanDavid ZimmermannKalexsyn, Inc., Chief Executive Officer
President and CEOStephen T. Rapundalo, Ph.D.MichBio, President & CEO
Treasurer Matthew L. McCollErnst & Young LLP, Partner
DIRECTORSArik AndersonTerumo Cardiovascular Systems Corp.Vice President, Product Development
David Felten, M.D., Ph.D.Beaumont HospitalsVice President, Research, and Medical Director, Research Institute
Doug Gage, Ph.D.Michigan State UniversityDirector of the MSU BioEconomy Network, Office of the Vice President for Research and Graduate Studies
Dale GroganMichigan Accelerator Fund IManaging Director
Tim MaylebenEsperion TherapeuticsChief Operating Officer
Kevin McCurrenGrand Valley State UniversityExecutive Director, The Center for Entrepreneurship & Innovation and Grand Rapid’s Smart Zone
Kevin McLeodMichigan Medical Device AcceleratorManaging Director
Paul MorrisAlixPartners, LLP Finance Manager, National Enterprise Improvement Practice
Brent Mulder, Ph.D., MBAVan Andel Research Institute Director, Office of Technology Transfer
Stephen Munk, Ph.D.Ash Stevens President & CEO
Stephen T. Rapundalo, Ph.D.MichBio President & CEO
Tina Rogers, PhD, MBA, DABTMPI 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 CenterPhysician, Former U.S. Representative
Ned StaeblerWayne State University Vice President, Economic Development
Christopher J. SteinFerndale Laboratories, Inc. Executive Vice President & Chief Operating Officer
Karen Studer-RabelerCoy Laboratory ProductsGeneral Manager andVice President of Business Development
David ZimmermannKalexsyn, Inc.Chief Executive Officer
BioMatters | Spring 2013
PAT R O N
BioMatters | Spring 2013 6
As a client-focused, partnership-driven organization, our talented and
proven professionals have the Life Science risk experience and expertise
you need. With our depth of resources, we provide innovative risk
strategies to protect and enhance the value of your life science organization.
Balancing your Life Science Objectives
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Medical Devices | Clinical Research | Clinical Trials | Pharmaceuticals
Biotechnology | Product and Technology Development
hylant.com
Ann Arbor Office24 Frank Lloyd Wright DriveSuite J4100Ann Arbor, MI 48106
P 734-741-0044
BioMatters | Spring 20137
BioMattersT A B L E O F C O N T E N T S
A D V E R T I S E R S
Ash Stevens .......................... 16Bank of Ann Arbor ................... 27 Doeren Mayhew ...................... 16G2G Consulting ........................32GLEQ ....................................28Hylant .................................. 6JB Ashtin .............................. 28 MedBio ..................................28
Quest Research Institute ........... 18Stryker ................................. 1Terumo Cardiovascular Systems ... 18University of Michigan .............. 18VWR ...................................... 2
MichBio ........................... 4, BCMichigan Economic Development Corp. ................ IFCMichigan State University ...........32 MPI Research ........................ IBCOakland University ................... 6Originus .................................28PhRMA ................................. 10
Subscribe to BioMatters:call 734.527.9150
11 Pushing the Frontiers of Science — and Providing Hope — Through the Biologics Pipeline
Biosciences in Michigan: A Rich Legacy of Discovery and Impact
19 Biotechnology People Can Use
12 SMIC at 10: New Ways of Seeing Innovation 38 MPI Research:
3rd Largest Global CRO that Focuses on Improving the Odds
34 Algal Scientific Algae Startup Develops Lower-cost Manufacturing Platform for Valuable Immune Health Compound
3D Biomatrix Transforms Pharmaceutical Testing
8
37 Ash Stevens Adds New Capacities and Capabilities
30 Michigan- Based Diplomat Leads the Way in Specialty Pharmacy Industry Growth
Aastrom Biosciences of Ann Arbor Conducts Final Stage Development of Cell Therapy Ixmyelocel-T
29
15 Launch MI Lab Catalyzes Innovation
Sophisticated TechnologiesSave Thousands of Lives Every Day
26
polyElements: New Startup Creates Nanofiber Scaffolds for Tissue Engineering
36
Innovation and Expertise Puts Helix Biological Laboratory at the Forefront33
Originus: Advancing Cell Engineering for Drug Discovery
17Pioneer Surgical Technology, Inc. Innovates With Its New Bone Graft
39
40
Michigan Biosciences By The Numbers24
BioMatters | Spring 2013
F E AT U R E S TO RY
By Stephen Rapundalo, Ph.D., President & CEO, MichBio
Michigan has a long record of
bioscience discovery triumphs and
significant contributions to the health
and welfare of humankind. They stem
from a rich legacy of research, innovation
and manufacturing in various industry
sectors that have developed products for
the betterment of lives around the world.
Here are but a few of the key discoveries
and notable achievements that have
emanated from Michigan over the last
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
• The Turning Frame, the first mobile hospital bed developed by Dr. Stryker
• Homogenization of milk, first developed at Michigan State University
• Large scale production of the steroids, cortisone and prednisone developed at the Upjohn Company
• 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.
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. Some of the best
global “bio” brands call Michigan home
for their facilities and are at the forefront
of developing innovative products...
Pfizer, Stryker, Dow Chemical, Kellogg,
Amway, Dow Corning, Zoetis, Perrigo,
Mead Johnson, MPI Research, Nestlé
Nutrition, Neogen, BD, Beckman Coulter,
Johnson & Johnson, Abbott Nutrition,
Cardinal Health, Ferndale Pharma,
Diplomat Specialty Pharmacy, Bayer
CropScience, DowAgra, and Emergent
BioSolutions, to name a short list.
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
Biosciences in Michigan:
A Rich Legacy of Discovery and Impact
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.
Stephen Rapundalo
8
BioMatters | Spring 20139
bioscience technology commercialization
with a supporting CRO/CMO network
that’s second to none. In short, Michigan
offers a virtual product development
ecosystem to bioscience businesses from
ideas to profitable commercial outcomes.
Success breeds success...and
Michigan’s emerging bioscience
companies have a remarkable track
record of investment, growth, and
return. A number of them like Esperion
Therapeutics (acquired by Pfizer for
$1.3 billion in 2003) HealthMedia (now
J&J’s Wellness & Prevention Inc.), Accuri
Cytometers and HandyLab (purchased
by BD), and Somanetics (acquired by
Covidien) are just a few examples of big
commercial exits. Other companies like
CytoPherx ($36 million in 2012), Lycera
($47 million during 2009-10), and NanoBio
(>$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
technology partnership opportunities
to the private sector by providing the
intellectual property necessary for
commercialization.
Buttressed by a full portfolio of
business and entrepreneurial support
resources, Michigan’s bio-industry is
well positioned for growth. The State
of Michigan provided approximately
$350 million in support to bioscience
companies during the last decade, as
well as an additional $50 million of
investment by the state’s fund-to-funds.
Coupled with other assets like our Pre-
Seed Capital Fund and its Micro-Loan
Program, as well as the Venture Michigan
Fund and Pure Michigan Venture Match
Fund, companies can access a portfolio
of capital and business resources across
their entire business life cycle.
An unrivalled statewide network
of SmartZonesSM provides business
acceleration and wet-lab incubator
services, allowing Michigan’s biosciences
companies to benefit from a strong
ecosystem that supports commercial
growth from ideas to markets. And a
state-funded Emerging Biz Solutions
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,
Success breeds success... and Michigan’s emerging bioscience companies have a remarkable track record of investment, growth, and return.
the state’s unparalleled bioscience
talent pool is broad as it is deep.
Universities and technical colleges offer
a vast array of bioscience education
opportunities, including specialty
applied training, to meet the needs
of employers. Michigan knows that
advancing its bio-industry growth begins
with ensuring that top talent is available,
today and tomorrow.
Increasingly, bioscience advancements
are revolutionizing the way we think
about healthcare, consumer products,
food, crops and energy consumption...
essentially the way we live. Michigan
is ideally positioned for a continued
role in this rapidly evolving world of
biosciences, thanks to its diversity
of sectors, research, technologies,
commercialization and manufacturing.
The biosciences are Pure Michigan®.
Companies looking for well-educated and seasoned professional bioscience workers need look no further than within Michigan.
BioMatters | Spring 2013
Ad - PhRMA
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.
For the people of Michigan, biopharmaceutical research
companies have also been an important source of jobs,
tax revenue and research spending.
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.
A job engine for Michigan.Life-saving medicines for the world.
9
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.
For the people of Michigan, biopharmaceutical research
companies have also been an important source of jobs,
tax revenue and research spending.
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.
A job engine for Michigan.Life-saving medicines for the world.
BioMatters | Spring 201311
The mapping of the human genome,
the development of amazing new biological
technologies and a greater understanding
of how diseases work have allowed
biopharmaceutical
researchers — working
hand-in-hand with
Michigan’s thriving
medical research
community — to
pursue new targets and personalize medicines to
better treat specific subpopulations of patients.
Right now, scientists at America’s
biopharmaceutical research companies are using revolutionary biological
processes to develop 907 new medicines and vaccines targeting more
than 100 diseases, providing hope where there was none for thousands
of patients, according to a new report from the Pharmaceutical Research
and Manufacturers of America (PhRMA). Many of those treatments are
being tested as part of the nearly 400 clinical trials currently underway
in Michigan — and are in development by many of the innovative
companies assembled in Chicago for the 2013 BIO International
Convention.
Before we discuss the excitement behind these potential medical
breakthroughs, let’s take a look back at some of the key biologic medical
advancements that paved the way for the progress being made today.
In the last decade, the U.S. Food and Drug Administration (FDA) has
approved the first genetically engineered antibody to deprive tumors
of oxygen and nutrients, the first new medicine for patients with lupus in
50 years and a vaccine for the prevention of human papillomavirus, which
will dramatically reduce the number of women who will develop cervical
cancer. America’s biopharmaceutical researchers also have used biological
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
Pushing the Frontiers of Science — and Providing Hope —
Through the Biologics Pipeline
throughout the country, are building on the knowledge gained through
these and many more discoveries with the next generation of biologics.
Although biologics in development span a wide array of therapeutic
areas (see chart below), the greatest amount of research is in a
category of medicines called monoclonal
antibodies (mAbs) and in vaccines, which
together make up 65 percent of the biologics
in clinical trials or under review at the FDA.
MAbs have been instrumental in the treatment
of cancers by targeting unhealthy cells without
harming healthy cells and are showing great
promise in the treatment of asthma, psoriasis
and rheumatoid arthritis. Vaccines, typically
considered a key tool for the prevention of infectious diseases, also are
evolving with the science and our understanding of disease. Today, they
are being tested as therapies for cancer and other diseases.
MAbs and therapeutic vaccines in clinical trials in Michigan medical
schools and research centers include:
• A mAb for the treatment of cancer,
• A mAb that targets lupus, and
• A therapeutic vaccine to jump-start the immune system to fight diseases such as lung cancer and melanoma.
With a robust pipeline which includes these potential new
medicines, the U.S. continues to lead the world in biopharmaceutical
research and development. That leadership is built on the foundation
of a strong biomedical ecosystem that fosters collaboration between
government, academia, and biopharmaceutical researchers — the kind
in place in the Great Lakes State. It is supported by public policies —
both state and national — that encourage scientists to push boundaries
and take risks. And, it is fueled by the hope of patients around the
world that a medical breakthrough in a small lab in Kalamazoo can help
them overcome disease
miles away.
You can learn more
about these promising
new therapies in the new
report, “Biologic Medicines
in Development” and the
accompanying overview at
http://www.phrma.org/
research/new-medicines.
John J. CaStellani
By John J. Castellani, President & CEO, Pharmaceutical Research and Manufacturers of America
Biologic Medicines in Development—by Therapeutic CategorySome medicines are listed in more than one category
Autoimmune Disorders
Blood Disorders
Cancer/Related Conditions
Cardiovascular Disease
Diabetes/Related Conditions
Digestive Disorders
Eye Conditions
Genetic Disorders
Infectious Diseases
Musculoskeletal Disorders
Neurologic Disorders
Respiratory Disorders
Skin Diseases
Transplantation
Other
71
43
58
28
26
25
34
39
176
30
338
38
30
13
58
12BioMatters | Spring 2013
SMIC at 10: New Ways of Seeing Innovation
BioMatters | Spring 201313
By Robert DeWit, Ph.D.
At the turn of this century, the idea of
a bioscience incubator/accelerator was
young but hardly new. Visionaries looked
at the aging population, the emergence
of biotechnology and the struggle of big
companies to generate breakthrough
medical treatments, and they realized
that the next wave of innovation would
happen in the startup world. Before long,
nearly every American state was jumping
on the bio-bandwagon, each insisting
it would be the next Silicon Valley of
life sciences.
In 2003, the Southwest Michigan
Innovation Center (SMIC) opened its
doors in Kalamazoo, Michigan. Buoyed
by a unique mix of expertise, history,
community support and circumstances,
SMIC continues to thrive as a premier
incubator/accelerator, evolving with
the times.
TIMING IS EVERYTHING Southwest Michigan has a rich,
127-year legacy of life science
innovation, stretching back to the
beginnings of The Upjohn Company
(now Pfizer) and Stryker Corporation.
Kalamazoo is home to four colleges/
universities, diverse entrepreneurial
enterprises and support, and more
recently the Kalamazoo Promise,
providing full tuition to Kalamazoo
Public Schools graduates attending
Michigan public colleges.
While the community seemed the
logical birthplace for a bioscience
incubator, a challenging coincidence
gave SMIC its biggest push. In 2003, just
weeks before SMIC opened its doors,
Pfizer announced a major reduction in
its research-and-development presence
in Kalamazoo. This left hundreds of
researchers, many of whom had spent
decades in the community, unsure of
their next step.
For SMIC, the timing was perfect.
The center had been formed through
a partnership that included Southwest
Michigan First, the Michigan Economic
Development Corporation, Western
Michigan University, the City of
Kalamazoo, Kalamazoo County and
private donors. Collectively, they posed
an intriguing option: local scientists
starting their own businesses in a new,
purpose-built lab facility equal to those
in which they previously worked.
This was no mean feat. Most
scientists aren’t entrepreneurs. While
those who lost their jobs at Pfizer
had generous separation packages,
they faced enormous challenges. Lab
space and equipment are frighteningly
expensive, and many of the affected
scientists knew very little about starting
a business or seeking venture capital.
SMIC provided a launching pad
for those aspiring entrepreneurs.
Located in WMU’s Business Technology
and Research Park, the Innovation
Center offers a comprehensive range
of facilities and support to nurture
the formation, survival and growth of
innovative life science businesses. SMIC
provides subsidized rent at the time of
admission, which gradually increases
as the startup matures. SMIC also sits
in a Michigan SmartZone, which offers
tax-related support. Further, there
SouthweSt MiChigan innovation CenteR
“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
BioMatters | Spring 2013 14
is considerable expertise available,
from business consulting through the
Michigan Small Business Technology
Development Center to counsel from
scientific, legal, accounting, venture
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
still active as of late 2012. A total of
35 firms have been incubated at SMIC,
with 95 companies served. There are
18 companies now operating at the
Innovation Center, employing 161
people. According to the W.E. Upjohn
Institute for Employment Research,
SMIC’s presence generates 346 direct
and indirect jobs in the region, totaling
$18.6 million in payrolls.
The most recent development at
the Innovation Center is Launch MI
Lab, a staffed laboratory furnished
with extensive scientific equipment
(See sidebar). With affordable short-
term leases available, entrepreneurs
can utilize bench and desk space and
analytical services where early stage
entrepreneurs can test their ideas and
apply for grants. The lab has been
establishing itself over the past two
years and was formally unveiled in
November 2012.
Perhaps the most important measure
of SMIC’s success is found among its
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
different ways because there will be no
more displaced scientists to tap locally.
SMIC will need to take a global view
for recruitment and attraction because
the life sciences community is global in
nature. That means relationships and
collaboration, both near and far, will
be crucial.
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.
BioMatters | Spring 201315
SMIC is already hard at work in
that realm through recent interactions
with Stanford and Startup America.
Also, SMIC is being more intentional
about building relationships with peers,
academia and corporate partners, as well
as making itself more visible externally.
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.
Robert DeWit, Ph.D., is President
and CEO of the Southwest Michigan
Innovation Center. Prior to joining
SMIC in 2009, Dr. DeWit spent more
than 25 years in pharmaceutical
research and development, with
science and leadership roles in the
U.S., Japan and United Kingdom.
Launch MI Lab Catalyzes Innovation Even simple innovations require huge investments of time, testing and
money. Filling that need is the rationale behind Launch MI Lab, which
provides affordable wet-lab and bench space, state-of-the-art equipment,
professional analytical services, and scientific and business expertise for
biosciences companies of all sizes, including entrepreneurs at the earliest
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 brings three critical elements to aid fledgling life
science startups: purpose-built space, business support services, and
scientific expertise. Clients can lease bench space and work stations in
the 2,300-square-foot lab at a lower cost than in a traditional incubator.
Along with access to scientific equipment and services, each client has
high-speed Internet and VOIP telephone service, use of conference and café
facilities, and free parking. Available equipment includes mass spectrometry
systems, centrifuges, autoclaves, flow cytometers, a variety of microscopes,
incubators, lyophilizer, upright freezer, and standard lab supplies and tools.
Greg Cavey, lab manager for Launch MI Lab, points out that the facility
helps entrepreneurs get access to affordable lab space and equipment as
well as affordable, quality analytical services. Clients, advisors and staff
bring decades of bioscience and business experience that is made available
to tenants. Among them is Cavey himself, a biochemist with more than
20 years’ experience in proteomics, mass spectrometry and laboratory
management.
Support from the Michigan Economic Development Corporation was key
to creating the laboratory. Launch MI Lab was unveiled in November 2012.
For more on the operation, visit www.launchmilab.com.
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.
launCh Mi lab
SAVE THE DATE
16BioMatters | Spring 2013
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
9th Annual MichBio Expo & Conference October 15-16, Radisson, Kalamazoo, MI
An internationally recognized, top 100 U.S. firm, DoerenMayhew provides bioscience companies with insight intotheir businesses, oversight to ensure best practices andforesight for what’s ahead. From determining qualifyingresearch expenses for R&D tax credits, to assisting withgovernmental audits, we invite you to see how we canhelp you capitalize on the opportunities and navigate thechallenges specific to your industry.
Insight. Oversight. Foresight. SM
Insight, Oversight and Foresightto Foster Successful Innovation
248.244.3000 doeren.com
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.
734-282-3370 ashstevens.com
Visit Ash Stevens at BIO Booth #5243
ASH-2410 BioMatters 1/4 Pg Ad.indd 1 3/13/13 10:57 AM
BioMatters | Spring 201317 BioMatters | Spring 201317
Modern drug discovery is a highly industrialized process that begins
by testing a large number of chemical substances against biological
targets which are hypothesized to be involved in diseases. Development
of functional assays for high throughput screening (HTS) of chemical
libraries is an integral part of this process and living cells are frequently
used as tools to understand the molecular pathways
involved in health and disease.
Originus Inc. (www.originusinc.com), an
Ann Arbor-based company formed in 2001, 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. STEP allows for cell-based HTS with a
myriad of basic research and therapeutic
discovery applications.
STEP gets around many challenges
faced by traditional functional assays.
Novel cell-based screening assays
typically required establishing cell lines
that stably express the target(s) of
interest (stable cell transfection), a
process that is laborious, expensive,
time-consuming (3-9 months) and not
without shortcomings. The alternative,
transient cell transfection results in
variable results and it is difficult
to control.
Originus’ STEP technology
involves the formation of proprietary
transfection complexes that are
applied directly to the growth surface
for the cells of interest and can be
used for functional experiments
just by adding adherent cells. Assay
engineering using STEP increases
efficiency and allows over-expression
of multiple targets and readouts. This can be a boon to researchers
when trying to discover novel drug candidates.
Microplates are produced at Originus, Inc. under quality control
standards which confirm high reproducibility well-to-well, plate-
to plate, and batch-to batch, suitable for HTS and high content
screening (HCS) environments. In addition, STEP
plates can be stored longer than a year without
significant decrease of biological properties after
transfection, resulting in great convenience for
customers and partners who only need to add
cells to the plates before testing. STEP is adaptable to a broad range
of cell types from commonly-used cultured cell lines to neurons or
stem cells.
In short, Originus’ STEP technology offers a novel approach to
accelerating drug development and
thereby reducing costs. It allows
multiplexing, and offers flexibility in
cell selection and high reproducibility.
In addition, the “ready-to-use” plates
are a great convenience and can be
adapted by small academic labs to big
pharmaceutical companies. The goal of
Originus’ team is to create robust and
sophisticated functional assays that
leverage the latest cellular engineering
techniques in the burgeoning field of
systems biology.
Originus has received several
awards from the National Institutes
of Health for the development of this
highly innovative technology. STEP
plates are being used successfully by
pharmaceutical companies for HTS
of chemical libraries, not only in the
hunt for new drugs but also to test
for their safety and the way they are
metabolized by the body.
Originus:Advancing Cell Engineering for Drug Discovery
Originus, Inc.
“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.”
BioMatters | Spring 2013 18
Terumo® is a registered trademark of Terumo Corporation. ©2012 Terumo Cardiovascular Systems Corporation 829849
Terumo Cardiovascular Systems and Terumo Heart, Inc., are Proud Sponsors of MichBio and Michigan’s
Growing Biosciences Industry
www.terumo-cvs.com | www.terumoheart.com
Early Phase, Multi-Specialty Unit 31000 Telegraph Rd, Suite 230 Bingham Farms, Michigan 48025 Neurology Clinic at MIND28595 Orchard Lake Road, Suite 301Farmington Hills, Michigan 48334
248-644-7770 www.questri.com
ACCELERATEEXpEriEncE
SPEED
efficacy
the Clinical Trial Process
Senior physicians and certified staff with no employee turnover
Top in the industry in study start-up cycle time and patient enrollment
Consistently exceeds enrollment targets with strong recruitment tactics and a 12,000 patient database
www.questri.com
BioMatters | Spring 201319
Biotechnology People Can UseNECi is an environmental biotechnology company
dedicated to the responsible application of novel products to help solve environmental problems.
NECi is pioneering the development,
production, and adoption of reagent grade
enzymes crafted for analytical chemistry
and application in the fields of agriculture,
food, water and biomedical science.
NECi is located in Lake Linden in
Michigan’s picturesque Upper Peninsula,
near Michigan Technological University.
The company was founded in 1993 to
commercialize the academic research of
its co-Founder, Dr. WH (Bill) Campbell,
after a publication in Nature resulted
in customers calling his lab asking for
products. NECi’s first product, Nitrate
Reductase, (NaR) replaces cadmium and
hydrazine for nitrate analysis.
NECi’s YNaR reagent is used in
biomedical research for detection of
nitric oxide (NO). YNaR and AtNaR
reagents are used by environmental,
food, industrial, and agricultural labs.
AtNaR is specified for nitrate analysis as a
Standard Method with the U.S. Geological
Survey. EPA and ASTM validation studies
are underway currently.
NECi’s on-site test kits target
agriculture and environmental/water
quality monitoring. Test kit formats
developed for experienced users are
simplified by packaging reagents into
unit dose containers for true
ease of use. NECi’s Nitrate
Test Kits for Agriculture (Ag-
NTKs) can test soil samples,
runoff, nitrate levels in
flowering crops for maximum
yields, and nitrate toxicity of
livestock feed. These semi-
quantitative kits, developed
with support from the USDA’s
SBIR program, give a visible
pink color when nitrate is
present. The toxicity test kits
saw significant sales during
the drought of summer and
fall 2012. Ag-NTKs are sold
via the company website and
the Gempler’s Farm Supply catalog. A
new nitrate Color Slider app to increase
the quality of interpretation of test kit
results is now available — check it out at
http://nitrate.com/nitratecolorslider.
An Android app is due in April.
NECi understands that accurate
measurement is not a simple matter:
when the news announces that a harmful
compound has been detected in food or
water, people in a lab somewhere have
painstakingly tested that food or water
using standard, approved methods. Many
of these methods were consecrated in the
1960s, many of those methods were old at
that time — and most require hazardous
materials or expensive equipment.
NECi develops and produces
recombinant and native enzyme reagents
for analytical chemistry. Enzymes are
protein catalysts that speed up the
myriad reactions that make life possible.
Enzyme reactions happen in gentle
conditions: no solvents, no high heat
or pressure, no heavy metals involved.
Enzyme-based analytical chemistry has
some real benefits:
• Selectivity – Enzymes are able to find “targets” in complex mixtures (reduced sample prep time)
• Sensitivity – Enzymes offer low detection limits in complex mixtures
• Specificity – Enzymes react ONLY with the target to be analyzed
• Safety – Enzymes are accurate, reliable, and environmentally benign
NECi’s reagent grade products and
test kits are designed from the bottom
up for safe and lowest cost shipping,
storage, export and disposal. And all
one needs is standard lab equipment
and a photometer, but reagent packs for
microplate readers and discrete analyzers
are available for high throughput labs.
NECi sells its green nitrate detection
enzymes and test kits worldwide,
including: consumers testing home wells;
agricultural agents testing soil, plants,
forage/feed and water/runoff;
environmental citizen monitors testing
fresh and salt water; and enzymes for
labs in industry and university
research. Green chemistry
involves biology... and NECi
brings enzymes to a new level
in the 21st century... all the
way from the northern-most
tip of Michigan!
NECi would like to
thank the SBIR program of
NIH for funding the protein
expression work and the
MEDC’s Emerging Technology
Fund for their monetary
gift that aided product
development.
neCi’S nitRate ReduCtaSe (naR) iS a ReCoMbinant enzyMe pRoduCed by feRMentation - foR optiMal quality ContRol
BioMatters | Spring 2013
Innovate. Accelerate. Michigan.
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 Perfecta3D® 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
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
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
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
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
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
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.
20
BioMatters | Spring 2013
Innovate. Accelerate. 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
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
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, bio-based 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
21
BioMatters | Spring 2013 22
®
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
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
22
BioMatters | Spring 201323
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:
®
23
MI BIO-INDUSTRY QUICK FACTS# Bio Companies & Organizations:
618# Bioscience Jobs:
39,282Total Employment Impact:
124,657Average Bioscience Salary:
$76,989Total Payroll:
$2.5 billionEconomic Impact:
$9.5 billionTotal Bioscience Start-Ups Since 2002:
134
ACADEMIC BIO-RESEARCH UNIVERSITY RESEARCH CORRIDORTotal R&D:
$2.01 billion (#10 in the nation)
Bioscience R&D:
$1.2 billion (#10 in the nation)
# of Bioscience Degrees:
5,548 (#8 in the nation)
# of Bioscience-Related Patents:
1,871(2004-2009)
BIO-INDUSTRY INVESTMENT, COMMERCIALIZATION RESOURCES & INCENTIVESLife Sciences Corridor Fund – 21st Century Jobs Fund:
$323 million(1999-2009)
Total VC Investments:
$232 million(~45% life sciences) (2012)
Total $ Raised:
$107.1 million (2012)
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 world2012 Winner – Algal Scientific2011 Winner – DeNovo Sciences2010 Winner – Armune Biosciences
Angel Investment Group Seed Program:
$500 for each Angel group member;
$25,000 for administrative fees for 50+ members
EB-5 Investment & Visa Program: Permanent U.S. resident status based on EB-5 eligibility to
investors of $1 million in a new commercial enterprise
Emerging Technology Fund: Matching fund for SBIR/STTR awards;
up to 25% of SBIR/STTR with maximum
of $25,000 for Phase I and up to
$125,000 for Phase 2
Great Lakes Entrepreneurs Quest:
$100,000 to prizes for annual business plan competition
MI Pre-Seed Fund:
Convertible note ≤ $250,000 with 100% match; pre-seed loan is
up to $50,000MI University Commercialization Initiative:
Up to $50,000 to commercialization projects at MI member universities;
requires 50-100% match from companies/institutions
Pure Michigan Venture Match Fund:
$350,000-500,000 match on
$700,000-$3 million investmentwww.MichiganAdvantage.org
BioMatters | Spring 2013 2424
Michigan Biosciences BY THE NUMBERS
Testing/ Medical Labs
BioMatters | Spring 201325
DISTRIBUTION OF MICHIGAN BIO-COMPANIES BY SECTORPharma & Therapeutics 21%
Medical Devices/Equipment 41%
Research & Development 13%
Testing/Medical Labs 3%
Information Technology 9%
AgBio & Industrial Biotech 13%
n Amway
n Ash Stevens
n Asterland
n Atek Medical
n BD
n Beckman Coulter
n Caraco Pharmaceuticals
n Dow Chemical
n Dow Corning
n Emergent BioSolutions
n Enzo Life Sciences
n Esperion Therapeutics
n Everist Genomics
n Ferndale Pharma Group
n Housey Pharmaceuticals
n Jasper Clinical R&D
n JHP Pharmaceuticals
n Kalexsyn
n Kellogg
n Lycera
n Medbio
n MPI Research
n NanoBio
n Neogen
n Orchid Orthopedic Solutions
n Oxford Biomedical
n Perrigo
n Pfizer
n Pioneer Surgical
n Rockwell Medical
n Stryker
n Terumo Cardiovascular
n Terumo Heart
n ThermoFisher
n Zoetis (formerly
Pfizer Animal Health)
A SAMPLE OF BIOSCIENCE COMPANIES IN MICHIGAN
Biosciences is BIG Business in Michigan
Pharma & Therapeutics
Medical Devices/Equipment
Research & Development
Testing/ Medical Labs
AgBio & Industrial Biotech
Information Technology
BioMatters | Spring 2013 26
Terumo Cardiovascular Systems
Corporation (Terumo CVS) develops,
manufactures and distributes medical
devices for cardiac and vascular surgery
with an emphasis on perfusion products,
intraoperative monitoring and vascular
grafting. Terumo CVS produces the
longest-running, commercially successful
line of heart-lung machines in the world
and is the only U.S. manufacturer of
these life-saving medical devices.
The company is headquartered in Ann
Arbor, Michigan, with manufacturing
operations in Ann Arbor; Elkton,
Maryland; and Ashland, Massachusetts.
The company employs 1,300 Associates.
Key product categories include heart-
lung machines, intraoperative monitors,
cannulae, oxygenators, perfusion
circuits, endoscopic vessel harvesting
systems, and vascular grafts. Terumo
CVS serves customers working primarily
in cardiac and vascular operating rooms,
including cardiac and vascular surgeons
and perfusionists — the specialists
who run heart-lung machines during
cardiopulmonary bypass surgery.
The company has been manufacturing
perfusion products in the U.S. since
the earliest days of open heart surgery.
Sarns™ branded heart-lung machines have
been produced in Ann Arbor, Michigan,
since 1963. Terumo acquired the Sarns
and CDI™ brands in 1999, and since that
time, Terumo has become the leading
brand worldwide in perfusion products.
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
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
‘Optical Fluorescence’ Technology is at the Heart of Terumo Cardiovascular Systems
BioMatters | Spring 201327
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 Members Non-members Inside Front Cover $4,000 $4,400 Back Cover $3,500 $3,850 Inside Back Cover $3,000 $3,300 Full page $2,000 $2,200 Half page $1,000 $1,100 Quarter page $500 $550
INFORMATION/RESERVATIONSContact Wendy Wendel 734.527.9147 [email protected]
continuously monitor 11 critical blood
gas parameters during cardiac surgery
with extracorporeal circulation.
Fluorescence is a behavior that
occurs when molecules of certain dyes
are excited by exposure to light. When
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.
Because of technologies like this,
Terumo is a leader in innovation and
was ranked number 14 out of the
top 100 global companies by Forbes
magazine on its “World’s Most Innovative
Companies” list.
BioMatters | Spring 2013 28
Drive in the Fast Lane...
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.
Learn more and register for the competition at: www.GLEQ.org
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GLE Inspiring Success
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BioMatters | Spring 201329
high-throughput setting. Users simply pipet
a cell suspension into the top of a well, and
the plate design allows the suspension to hang
below the well surface (Figure 1, bottom).
The cells, which do not contact any surfaces or
matrices, aggregate into a spheroid over one to several days.
3D Biomatrix’s HDPs have been accepted readily by
researchers in pharmaceutical companies and academia.
Recent publications have demonstrated that anticancer drugs
with distinctly different mechanisms show much different
results when tested in 2D and 3D cultures. As well, researchers
have shown that realistic tissue models can be made in HDPs
utilizing multiple cell types.
By introducing 3D cell culture early in the drug-screening
process, researchers can get
more physiologically-relevant
data earlier, and more drugs
that would be failures can
be screened out before the
animal-testing phase. This
reduces the amount of animal
testing needed overall, and
lowers the cost and time to
get a drug to market.
Additional information
about Perfecta3D Hanging
Drop Plates can be found at
3dbiomatrix.com/products.
3D Biomatrix Transforms Pharmaceutical Testing
New drugs that fight disease are
often tested on laboratory-cultured cells.
Traditionally, cells are grown on flat plastic
surfaces, such as flasks, dishes, or plates.
Cells flatten on the two dimensional (2D)
plastic surface, but living tissues in animals and humans are
three-dimensional (3D). As such, cells grown in 2D cultures often
fail to replicate those 3D tissues.
To bridge the gap between 2D cells and humans, Ann Arbor,
MI-based 3D Biomatrix developed the Perfecta3D® Hanging Drop
Plate (HDP) (Figure 1, top) to grow cells in 3D, so that they more
closely mimic their tissue of origin. 3D Biomatrix has received
widespread recognition for their HDPs, including winning a
Wall Street Journal Technology Innovation Award and being
featured in Genetic Engineering
& Biotechnology News, The
Scientist, and Biocompare.
The HDPs are designed for
the formation, growth, and
testing of micro-scale 3D tissues
called spheroids. Spheroids are
used as models of many types of
avascular tissues, tumors, and
embryoid bodies. HDPs are easy
to use and, in 96- and 384-well
plate formats, work with existing
lab instrumentation frequently
employed to screen drugs in a figuRe 1 – top: 96- and 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
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BioMatters | Spring 2013 30
Specialty pharmacy is a branch of the
pharmaceutical delivery system
that focuses on comprehensive and
coordinated systems of pharmacological
care for patients with serious and chronic
illnesses and complex medical conditions.
Surprising to many Michiganders — even
those in the biomedical field — is that
Michigan is home to the nation’s largest
privately held specialty pharmacy,
Diplomat Specialty Pharmacy in Flint.
What started as a family-owned
business co-founded by current CEO Phil
Hagerman, R.Ph. and his pharmacist
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.
An important milestone in the
company’s history was the 2010 purchase
of the 340,000 square foot former
by Gary K. Rice, R.Ph., MS, MBA
Michigan-Based Diplomat Leads the Way in
Specialty Pharmacy Industry Growth Biotechnology Drugs and the Patient Compliance Challenge
General Motors’ Great Lakes Technology
Centre complex on Saginaw Street in
Flint, which now serves as Diplomat’s
headquarters. Also in 2010, Diplomat
announced a plan to add over 1,000 new
jobs in five years, which the Company
remains on target to do. Concurrent
with its hiring efforts, Diplomat has
taken a corporate leadership position in
the revitalization of Flint, providing both
money and manpower to develop several
community-based initiatives that result
in new job creation and improved quality
of life for Flint area residents.
Diplomat’s key therapy programs
include Oncology, HIV/AIDS, Hepatitis C,
Multiple Sclerosis, Rheumatoid Arthritis,
Crohn’s, Hemophilia/IVIG, Growth
Hormone and Psoriasis. Other specialty
areas include transplant, fertility and
bio-identical hormone therapy. In addition
to working closely with “big pharma”
and small biotech pharmacy companies,
Diplomat’s business model creates unique
partnerships with all industry stakeholders,
including physicians, patients, group
purchasing organizations, hospital systems,
retail chains and managed markets —
always focused on improving adherence
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.
Another draw for executives and other
prospective employees is the training
offered on-site to Diplomat staff
titled MuRal depiCting flint’S RiCh hiStoRy CReated by hundRedS of StudentS with SpeCial needS fRoM the geneSee inteRMediate SChool diStRiCt
Diplomat Specialty Pharmacy’s goal is to optimally deliver high quality, patient-centric care in a growing industry, while promoting patient safety and convenience.
BioMatters | Spring 201331
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
questions, offer support, and ensure
medication compliance. Diplomat refers
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
specialty products will be 50 percent
of the drug spend by 2018. This will be
based on current specialty biotechnology
therapies gaining FDA approval for
additional indication, newly FDA-
approved 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
million Americans use three or more
medicines daily; 75 percent of adults
are non-adherent in one or more ways.
Clinically the impact is realized in lower
patient quality outcomes. Failures in
medication adherence lead to expensive
and sometimes life-threatening
complications. Economically, the impact
of non-adherence is estimated to cost
$100 billion annually.
These biotech specialty medications
tend to have greater side effects than
traditional small-molecule medications
and are more costly. Both of these
factors work against patient compliance,
persistence and, ultimately, positive
patient outcomes. With Diplomat’s
specialty patient satisfaction rates
over the last three years ranging from
98 percent to 99 percent (the industry
average is 50 percent to 70 percent),
there is additional competitive pressure
to closely monitor adherence.
The key to patient compliance
and adherence begins with
patient education and
training, followed by compliance
packaging that keeps the drug
safe and secure yet is also easy
for the patient to open, prophylactic
starter kits (a side effects management
kit), nurse adherence calls to provide
clinical support and guidance, and
technology, whether that be through
smart phones, prescription bottles with
glow caps or packaging with alarms
and reminders.
Diplomat Specialty Pharmacy’s goal
is to optimally deliver high quality,
patient-centric care in a growing
industry, while promoting patient safety
and convenience. At the same time,
Diplomat’s core value of meaningful
community commitment continues to
direct the company’s actions beyond the
world of specialty pharmacy.
Gary Rice is the Vice President
of Clinical Services for Diplomat
Specialty Pharmacy.
diploMat patient teStiMonial featuRed in the hallwayS of itS flint headquaRteRS
BioMatters | Spring 2013
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BioMatters_Ad_2010_FINAL.indd 1 8/19/10 9:39:14 PM32
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BioMatters | Spring 201331 BioMatters | Spring 201125 BioMatters | Spring 201333
Helix Biological Laboratory LLC is a full service laboratory located
in southeast Michigan that is engaged in a wide variety of biological and
analytical testing, as well as consulting services.
Established in 2009, Helix Biological Laboratory
specializes in the detection and identification of
microorganisms from a variety of sources such as water,
food and beverages products (including wine), soil,
agricultural samples, biological samples, consumer
products, cosmetics items, pharmaceuticals and textile
materials. In addition, Helix offers forensic, drug and
food micro testing, along with plant diagnostics.
Since its inception, Helix Biological Laboratory has distinguished
itself as a laboratory that has developed a high quality standard of
experimental expertise using a combination of leading edge molecular
biology and microbiological techniques for projects that require both
diverse and specialized proficiency. Helix Biological Laboratory’s diversity
along with its ability to develop methods and custom design assays
provide a tremendous advantage to both current and potential clients.
Of the services that the lab provides, none stands out more than the
Microbial Source Tracking (MST) services and are unique in the industry.
MST involves a set of methods that are used to determine the host
source (human or animal) of fecal pollution in various waterways
through the detection and identification of specific fecal indicator
bacteria present in waterways.
Helix Biological Laboratory has been working with the Michigan
Department of Environmental Quality (MDEQ) as well as other
organizations within the state on water quality projects by providing
MST services that address fecal contamination in various waterways.
Following EPA and NELAC guidelines for MST, the
laboratory identifies specific DNA markers of fecal
bacteria that are found in specific host sources
that include humans, cows, pigs, horses, dogs,
and birds such as geese.
This methodology allows the sources
of fecal contamination to be identified quickly
and accurately using an array of molecular
genetic technologies that are very selective as well as sensitive.
The rapid identification of source fecal contamination assists health
departments, municipalities and other agencies in quickly and
efficiently identifying and taking measures to control the source or
sources of fecal contamination in waterways. Helix is the industry
leader in providing MST testing.
In addition to MST services, 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. The laboratory’s
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
throughout the state. Water activities are an integral part of the
culture in Michigan, so it is imperative that the health of waterways
be assured through the most advanced technologies available. Helix
Biological Laboratory sets a precedent for quality biological and
analytical testing through innovative and industry-leading approaches
and is helping insure the safety of Michigan’s water resources,
environment, agriculture and food.
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.
Innovation and Expertise Puts Helix Biological Laboratory at the Forefront
BioMatters | Spring 2013 34
Algal ScientificAlgae Startup Develops Lower-cost Manufacturing Platform
for Valuable Immune Health Compound Founded in 2009 by several graduate
students who won a University of
Michigan business plan competition,
Algal Scientific is commercializing a new
type of low-cost manufacturing platform
for an immune health compound called
“beta-1,3-glucan”.
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
about existing demand in the animal feed
and nutraceutical industries.
More than $200 million of basic
research has already been invested
into understanding the biology of
beta glucans. Several clinical trials
have evaluated uses of beta glucans
applications ranging from prevention of
post-surgical infection to an adjuvant
used with monoclonal antibodies in
oncology therapies.
However, the majority of existing
research to-date focus on beta glucans
that are extracted from yeast cell walls.
In contrast, Algal Scientific produces
more bioavailable forms of beta glucans
that are not bound to the cell wall,
creating a cost advantage and the ability
to make more beta glucan extracts than
what is typically seen in the market today.
“So far, we have performed several in
vivo studies that suggest our product can
lead to a heightened immune response,”
said LeBrun. “In one study we prevented
mortality from E. coli at the same level
as an antibiotic.”
The company is entering the animal
feed market in the short term, with eyes
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
scrutiny by governments, consumers
and organizations such as the American
Medical Association.”
Recently, things have been heating
up. Algal Scientific was told by the CEO
of a public nutraceutical company that
he believes beta glucans could be “the
next Omega 3”.
The Omega 3 retail market is currently
estimated to be $30 billion annually.
“Over 20% of the poultry and swine grown in the U.S. does not use antibiotics as growth promoters.”(source: AgStats)
geoff hoRSt, Chief SCienCe
offiCeR, SeleCting algal StRainS
BioMatters | Spring 201335
The company reports to have made
“a couple early sales” while also being
engaged with several multi-billion dollar
companies that are evaluating their
beta glucan product for uses including
a functional food ingredient, an animal
feed ingredient, and even as an adjuvant
for vaccine and monoclonal antibody
therapies.
Algal Scientific’s CEO Paul Horst is
a veteran entrepreneur who says he was
recruited “to bring some grey hair to
the table.”
Horst says, “We believe that we
can dramatically expand the current
market size by producing a more
cost-effective product.”
Tests are currently underway at
several major companies. Over the past
month, Algal Scientific has been receiving
sample requests almost every week from
various Fortune 500 companies who have
seen their preliminary test results.
“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.
Not bad for a few graduate students
and some “grey hair”.
algaMune™ aM – beta gluCan baSed algae Meal foR aniMal iMMune health
CRaig banotai, SenioR SCientiSt, algal SCientifiC, opeRating ReSeaRCh feRMenteR
34BioMatters | Spring 2013
polyElements, LLC is a new biotechnology company founded
by three recent University of Michigan graduates. polyElements
specializes in the creation of electrospun scaffolds for biological,
medical, and tissue engineering research. Electrospun fibers can be
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
electrospun fibers to transform their own medical and basic science
research methods.
“Electrospinning is a difficult process with a high learning
curve, which has been a barrier to entry for scientists who may
not have an engineering background,” says
Sam Tuck, co-founder and lead technician
whose work has been featured in a number of
scholarly publications including Nature Methods.
“We have a combined 12 years of electrospinning
experience. We’ve mastered the curve and
can quickly customize scaffolds to address our clients’ specific
research questions.”
Traditionally, cell culture is carried out on flat plastic or glass
surfaces coated with various polymers or proteins. However, this is
a far cry from the three dimensional environment cells occupy in
vivo. New research continues to demonstrate the importance of
cell-environment interactions to cell structure and function.
Recent studies have shown that cells can sense their physical
surroundings and alter a number of cellular processes in response.
For example, oligodendrocyte precursor cells
have been shown to wrap electrospun nanofibers
only when the nanofibers have diameters
similar to the size of axons (Nature Methods,
9:917-922, 2012). Expanding on these findings,
researchers could create a neuron-free in vitro
model of myelination which can be used to screen drug candidates
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.
“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.”
36
aligned polyMeR MiCRofibeRS foR tiSSue SCaffold ReSeaRCh
polyElements: New Startup Creates Nanofiber Scaffolds for Tissue Engineering
BioMatters | Spring 2013BioMatters | Spring 2013 37
Ash Stevens Adds New Capacities and Capabilities
Ash Stevens Inc. (ASI), located in
Southeast Michigan, is a provider of
active pharmaceutical ingredient (API)
development and manufacturing services
for clients in the Life Sciences industry
developing small-molecule innovator (New
Chemical Entities or NCEs) drugs. The
company was founded over fifty years ago
by two chemists with deep ties to Wayne
State University (WSU) in Detroit: Dr. Art
Ash, who received his doctorate degree in
chemistry from WSU, and WSU chemistry
Professor Dr. Cal Stevens. ASI initially
provided contract research services to
the U.S. Government (Walter Reed Army
Hospital, NIH, and NCI) and then over the
years has provided contract chemistry
support for many of the drugs developed
through these government agencies.
Ash Stevens still provides contract
research services to the U.S. Government
today. However, ASIs core business
has since transitioned to providing
commercial drug development and cGMP
manufacturing services to sponsor
companies in the life sciences industry
developing small-molecule, innovator
drugs. The company’s clients range from
virtual biotechs to some of the world’s
largest pharmaceutical companies.
Ash Stevens recently completed
construction, commissioning, and
validation of a multi-year, multi-million
dollar expansion to its cGMP manufacturing
facility in Riverview, Michigan. Production
in the new bays begins in April 2013.
Ten years ago, Ash Stevens’ President
and Chief Executive Officer, Dr. Stephen
Munk, recognized that the company’s
ability to function as a leader in the
commercialization and manufacture of
chemically complex Active Pharmaceutical
Ingredients (APIs) would require an increase
in process capabilities simply to keep pace
with growing global demand from
biotech and pharmaceutical companies
for these services. The additional capacity
and services would also allow ASI to
manufacture APIs for therapeutic
indications requiring larger batch sizes
while continuing in its leadership role
in the field of oncology chemistry.
The new large-scale reactor bay houses
2,000, 3,000 and 4,000-liter glass-lined
vessels designed with appropriate
engineering controls for potent compound
handling. The new, adjacent isolation bay
is equipped with a 1.5 m2 fixed filter dryer
with glovebox technology for contained
isolation, drying, and packaging of
large-scale batches. This technology
permits handling of potent compounds
and air sensitive materials at scale.
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
include a new hydrogenation reactor
bay, a new solid-state characterization
laboratory, a new laboratory with
appropriate air handling systems for the
synthesis of highly potent compounds, a
new state-of-the-art materials storage and
handling facility, new Rosenmund filter
dryers with glovebox technology, and a
safety and hazard assessment laboratory.
“With the completion of the
expansion, Ash Stevens will have the
capability to meet the service and
capacity needs of our clients while still
providing close interactive support and
project management demanded in today’s
environment. We have come a long way
over the past fifty years and are very
excited to be completing this latest phase
of expansion at our state-of-the-art
manufacturing facility,” says Dr. Munk.
Over the years, Ash Stevens has
achieved an impressive track record
with twelve FDA manufacturing approvals
for innovator APIs (NCEs) distributed
world-wide. These include multiple API
approvals for FDA fast-tracked drugs
developed under significantly accelerated
timelines. Other FDA fast-tracked
manufacturing approvals for Ash Stevens
include the oncology drugs Velcade®
(Millennium /Takeda), Vidaza® (Celgene),
and Clolar® (Genzyme/Sanofi). Among
ASI’s other manufacturing approvals is that
for Amotosalen used in the INTERCEPT
Blood System for the Cerus Corporation.
Ash Stevens has excellent international
regulatory compliance and safety. The
company supports all facets of chemistry
and manufacturing controls (CMC) related
to the development of small-molecule
APIs. The services offered by ASI include:
process development, cGMP manufacture
of API for clinical trials, commercial API
manufacturing, comprehensive analytical,
and regulatory support, development and
manufacture of high potency APIs, and
preparation of documentation for
submission (IND, NDA, DMF, CTD). For
more information on Ash Stevens, visit
www.ashstevens.com.
aSh StevenS’ new laRge-SCale ReaCtoR bay houSing 2,000, 3,000, and 4,000 liteR ReaCtoRS
polyElements: New Startup Creates Nanofiber Scaffolds for Tissue Engineering
With the cost of bringing a new drug to
market topping $1 billion, pharmaceutical
and biotechnology companies must make
careful decisions about which candidates to
move forward along the drug development
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.
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
types of therapeutics (e.g., biopharmaceuticals, imaging agents,
botanical products, and others). In these situations the “standard”
approach was not appropriate to achieve approval for an Investigational
New Drug (IND) submission. This was the result of such factors as:
• Selection criteria for the appropriate animal species to be used in testing
• 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 [email protected] to learn how MPI can help
you achieve your drug and device research goals.
By Scott E. Boley, PhD, DAB, MPI Research, Senior Director, General Toxicology and Infusion
SCott e. boley
Mpi ReSeaRCh iS known foR itS SuRgiCal equipMent and CapabilitieS
MPI Research: 3rd Largest Global CRO that Focuses on Improving the Odds
BioMatters | Spring 201339
is exciting. However, rigorous clinical trials and a defined
regulatory strategy ensure that safe and effective products,
especially those with transformational potential, will reach
patients quickly.
Ixmyelocel-T is currently being evaluated in a Phase
3 clinical trial in patients living with advanced peripheral
arterial disease (PAD) who have limited treatment options.
At this stage of the condition, patients can
experience wounds that double in size,
gangrene, limb amputation and an increased
risk of mortality. In the completed Phase 2 trial,
ixmyelocel-T was found to reduce the risk of a
combined endpoint consisting of these negative
outcomes by 62% compared to placebo.
Ixmyelocel-T is also being studied in patients living with
dilated cardiomyopathy (DCM), a condition that causes the
weakening and enlargement of the heart. A Phase 2 trial is
underway in patients who have DCM as well as coronary artery
disease or blockages in the arteries that lead to the heart.
“We have a unique opportunity to prevent invasive and
high-risk surgeries for these patients, improve their quality
of life and set new standards of care. Our team is working
aggressively to accelerate the pace of development of
ixmyelocel-T to bring this treatment to patients in need,”
said Mr. Colangelo.
Over 200 patients have been treated with ixmyelocel-T
thus far and the company continues to explore new disease
areas where patients can benefit from this therapy. The
ability to safely and effectively produce patient-specific
therapies is a strong advantage for Aastrom as the company
looks to grow its pipeline in Michigan.
Aastrom Biosciences is the leader in developing patient-
specific, expanded multicellular therapies for use in the
treatment of patients with severe, chronic cardiovascular
diseases. The company’s
proprietary cell-processing
technology enables the
manufacture of ixmyelocel-T
therapy expanded from a
patient’s own bone marrow and
delivered directly to damaged
tissues. For more information,
please visit Aastrom’s website
at www.aastrom.com.
Aastrom Biosciences of Ann Arbor Conducts Final Stage Development of
Cell Therapy Ixmyelocel-TTherapy to help patients with serious, untreatable cardiovascular diseases
One of Michigan’s oldest biotech companies, Aastrom
Biosciences of Ann Arbor, has experienced a period of growth
over the past few years, creating more jobs and expanding their
manufacturing infrastructure. The company is conducting the final
stages of development of ixmyelocel-T, a cell therapy created
from a small sample of a patient’s own bone marrow that can
potentially treat multiple severe cardiovascular diseases.
Developing any therapy involving stem cells is
challenging due to a number of reasons including
strict regulations, a lengthy clinical trial process
and the need for significant investment.
Aastrom’s success in advancing ixmyelocel-T is
the result of a number of key decisions and efforts
by the Aastrom team:
• The company uses only adult human stem cells from
each patient’s own bone marrow. As a result, the
production process is not associated with the ethical
issues surrounding the use of embryonic stem cells.
In addition, because Aastrom uses the patient’s own cells
to develop ixmyelocel-T, there is minimal risk of rejection.
• The company uses a proprietary production process
and a centralized manufacturing facility to ensure
that every patient receives a safe, consistent,
high-quality product derived from his or her own cells.
• Aastrom’s development team is following a clear
regulatory path established by other autologous
cellular therapies that have been approved by the
FDA in recent years.
The positive attributes of ixmyelocel T, including its
autologous nature and multicellular composition, distinguish
it from other experimental cell therapies.
“I have seen firsthand the tremendous potential of
ixmyelocel-T to treat severe cardiovascular disease and
believe we have the potential to give new hope to people
with peripheral arterial disease
and dilated cardiomyopathy who
have few or no other treatment
options available to them,”
said Nick Colangelo, Aastrom’s
president and CEO.
The prospect of new
regenerative treatments of
diseases where current medicine
offers little hope for the patient
MaRy ann potok, ReSeaRCh aSSoCiate, Staining MiCRoSCope SlideS to identify Cell typeS in bone MaRRow
BioMatters | Spring 2013 40
Pioneer® Surgical Technology, Inc. Innovates With Its New Bone Graft
Pioneer Surgical, a medical technology
company based in Marquette, Michigan,
recently added the innovative nanOss
Bioactive 3D to its flagship biologic bone
graft product line, nanOss Bioactive.
The new nanOss Bioactive 3D is a bone
void filler and bone graft extender in the
form of a three dimensional strip. nanOss
Bioactive 3D is comprised of a proprietary
nanocrystalline hydroxyapatite as well as
a collagen-based biopolymer, that provide
a scaffold for the in-growth of new
bone in the posterolateral spine. nanOss
Bioactive 3D uses similar technology as
nanOss Bioactive, which was introduced
in a paste format in 2009. Pioneer Surgical
offers several sizes of nanOss Bioactive
3D, including 5cc, 10cc and 20cc formats.
Pioneer Surgical entered the biologics
market with two acquisitions in 2007.
Pioneer’s biologics products have been
the recipient of many prestigious
acknowledgements, including the 2005
Technology Award for nanocrystalline
hydroxyapatite in nanOss Bioactive, and
the 2009 Technology Award for engineered
collagen in nanOss Bioactive. Pioneer
Surgical offers a full line of synthetic bone
grafts as well as human tissue products
including machined lateral, traditional
lumbar and cervical allograft, human
demineralized bone matrix (DBM) bone
grafts, as well as bone graft delivery
accessories.
Regarding Pioneer’s latest biologics
product line extension, Mr. Shane Ray,
Executive Vice President — Biologics and
Surgical Solutions for Pioneer stated,
“Three-dimensional shapes are popular
in spine surgery and with this addition,
we now have one of the most extensive
biologic portfolios on the market.” More
information regarding Pioneer Surgical’s
biologics product offerings, including
nanOss Bioactive 3D, can be found at
www.pioneersurgical.com.
nanOss Bioactive 3D is an
osteoconductive implant that provides an
interconnected porosity similar to human
cancellous bone. Osteoconductive means
that bone grows onto the surface or into
pores of the implant. nanOss Bioactive
3D is used to fill bony voids or gaps
created during surgery, traumatic
injury, or for other bone voids not
essential for stability. nanoss Bioactive
3D is used in conjunction with the
patients’ own bone marrow aspirate
and autograft bone, and is placed
into voids or gaps in the posterolateral
spine. In time, nanOss Bioactive 3D is
resorbed and replaced by the growth
of new bone during the healing process.
The company was started in
Marquette, Michigan in 1992 by
orthopedic surgeon Dr. Matthew Songer
and his father, Robert. The pair sought
innovative ways to improve operating
room times and patient outcomes. Today
they are considered national leaders in
the design and manufacture of spinal and
orthopedic implants and instruments.
Since then, Pioneer has expanded
domestically and internationally,
with several facilities throughout the
U.S. and in Houten, The Netherlands,
employing nearly 300 people worldwide.
The company’s vertically-integrated
manufacturing capabilities differentiate
it from others in the marketplace, greatly
enhancing its ability to take an idea from
the drawing board to commercialization.
Pioneer demonstrates a commitment
to surgical innovation by designing
and delivering products that provide
intraoperative efficiency for surgeons,
cost-effectiveness for the healthcare
system and better outcomes for patients.
For more information on Pioneer
Surgical and its products visit
www.pioneersurgical.com.
nanoSS bioaCtive 3d poRoSity (x30)
CANDIDATE SELECTION
LEAD OPTIMIZATION
DRUG EFFICACY
TARGET ID & VALIDATION
DRUG SAFETY
ANALYTICAL/BIOANALYTICAL
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 scienti� c expertise. As the world’s largest preclinical research CRO in one location, our depth of experience enables us to o� er 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.
Ready to Go Beyond?
GOING BEYOND
For more information, visit www.mpiresearch.com
Meet us at BIO International Convention booth #1473.
8.5x11 MPIdna_BioMttrs-BIO.indd 1 3/5/13 8:23 PM
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