BioMatters - Spring 2013

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

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access to the expertise of two world-class cancer hospitals,

DeNovo is ready for takeoff in Pure Michigan.

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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 We are getting rid of outdated and burdensome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

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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

[email protected]

734.527.9144

Wendy Wendel

Director,

Marketing and Communications

[email protected]

734.527.9147

David McGuire

Director,

Operations and Membership

[email protected]

734.527.9150

Nancy Marcotte

Manager, Finance

[email protected]

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

Email

[email protected]

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

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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


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

with Insurance and Risk Management

Medical Devices | Clinical Research | Clinical Trials | Pharmaceuticals

Biotechnology | Product and Technology Development

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P 734-741-0044


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


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


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.


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.


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


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


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.


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


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.”


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


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


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


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


®

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


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


Michigan Biosciences BY THE NUMBERS

Testing/ Medical Labs


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


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


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.


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

Great Lakes Entrepreneur’s Quest

GLE Inspiring Success

Innovative. Trustworthy. Knowledgeable. Passionate.

Innovative Contract Manufacturing Solutions for the Life Sciences.

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Originus, Inc.


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

Get Connected.RESOURCES. INTELLIGENCE. EDUCATION. ADVOCACY.

biolinkMichBio Signature Series

ExPO

BioMixers CEO Leaders’ Club

BioMattersEmerging Biz Solutions

Career Center


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.


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.

[email protected]

diploMat patient teStiMonial featuRed in the hallwayS of itS flint headquaRteRS


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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


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


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


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


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


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


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


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

FastforwardWITH EMERGING BIZ SOLUTIONSIntroducing MichBio’s

Emerging Biz Solutions,

a new entrepreneurial

support services pilot

program designed to

provide highly specialized

product development

planning resources, business

partnering connections

and industry intelligence to

bioscience companies.

Business Intelligence &

Educational Resources

Product Commercialization Planning Support

Business Partnering & Development

Support

Visit www.MichBio.org/EmergingBizSolutions

for more information and to apply.

This program is sponsored by the Michigan Economic Development Corporation (MEDC) as part of a comprehensive entrepreneurial resource ecosystem that ensures emerging companies have access to the necessary tools, funding and business support essential for commercialization success.

®

Documents

BioMatters - Spring 2013