BioMatters - Spring 2013

BioMatters S P R I N G 2 013

A MichBio Publication Showcasing Michigan’s Biosciences Industry

Biosciences in Michigan:

A Rich Legacy of Discovery and Impact

Featured: Pushing the Frontiers of Science — and Providing Hope — Through the Biologics Pipeline Advancing Cell Engineering for Drug Discovery Biotechnology People Can Use Sophisticated Technologies Save Thousands of Lives Every Day

WHAT HAPPENS WHEN

START UP meets

launch pad Strapping a booster rocket onto a great idea.

When DeNovo Sciences entered the Accelerate Michigan Innovative Competition, they were a small company with a big dream. After winning the $500K grand prize, they’ve become a sought-after company on the verge of developing cutting-edge products for early cancer detection. Michigan offers them the right mix of experience and resources. And, with access to the expertise of two world-class cancer hospitals, DeNovo is ready for takeoff in Pure Michigan.

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GOVERNOR’S MESSAGE

Dear Friends,

This is an exciting time for high-tech visionaries and entrepreneurs to be in Michigan. Bold changes

to state government and improvements to our business climate are unleashing a new era of innovation.

Business taxes are lower than at any time in decades. We are getting rid of outdated and burdensome

regulations that hinder economic growth and job creation. New sources of capital are available along with a host of state and private resources to start new ventures and grow current ones.

These reforms, combined with our manufacturing leadership, outstanding talent, and world-class

educational institutions, are accelerating breakthrough bioscience discoveries and creating new technologies, products, businesses and jobs. Furthermore, they are providing an opportunity to carry forward a legacy of innovation that extends back more than a century.

Thomas Edison took us out of the darkness and into the light. Henry Ford connected us like never

before. These trailblazers moved our state forward with relentless positive action, something we are harnessing once again.

Thank you for your relentless positive action as we work to build a stronger state and a brighter

future together.

Sincerely,

Rick Snyder, Governor of Michigan

1

BioMatters | Spring 2013

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PRESIDENT’S MESSAGE

P R O F E S S I O N A L S TA F F

Michigan’s Biosciences Industry Welcomes You!

Welcome to MichBio’s (d/b/a Michigan Biosciences Industry Association) seventh

Stephen T. Rapundalo, Ph.D.

edition of BioMatters, the state’s only in-depth publication showcasing the breadth and

President & CEO

impact of our vibrant biosciences industry. BioMatters is a fundamental part of MichBio’s

srapundalo@michbio.org

mission to drive Michigan’s bio-industry growth through education, resources, business

734.527.9144

opportunities and advocacy. We’re proud of the fact that BioMatters has set a high standard as the voice for Michigan’s bio-industry around the globe.

In this issue of BioMatters, you’ll continue to discover the faces, organizations

Wendy Wendel Director,

and initiatives that represent just a tiny portion of Michigan’s outstanding biosciences

Marketing and Communications

community. We encourage you to explore what Michiganders already know – that

wendy@michbio.org

Michigan offers a business environment where bioscience companies can thrive and

734.527.9147

compete in today’s global economy.

Michigan has a rich pedigree in the bio-industry dating back to the 1860’s when

David McGuire

Parke-Davis & Company was formed in Detroit as the first pharmaceutical company in

Director,

the U.S., soon to be followed by the Upjohn Company in Kalamazoo, and the L. Perrigo

Operations and Membership

Company in Allegan. All went on to become great global bioscience brands, with notable

david@michbio.org

discoveries and products, and commercial success. That’s a proud heritage we’ve built

734.527.9150

upon with a lot of diligence, know-how, strong work ethic and commitment.

Michigan is now home to some of the world’s top research centers, more than 600

bioscience companies across multiple sectors, and about 125,000 individuals employed directly or secondarily in the bio-industry. We offer companies access to knowledge, talent, capital, infrastructure and resources. Not to be forgotten is our enviable low cost of doing business, and a superb quality of life that helps retain our highly-skilled

Nancy Marcotte Manager, Finance nancy@michbio.org 734.527.9145

bioscience workforce. In short, the biosciences are Pure Michigan®.

Whether you’re already here or looking from the outside, Michigan welcomes

you to learn more about its bio-industry. Contact MichBio, the statewide biosciences industry association, and we will serve as your gateway to our companies, services, assets, and markets.

Lastly, I invite you to visit the State of Michigan Pavilion (Booth #1805) at

the 2013 BIO International Conference at the McCormick Place in Chicago, IL from April 23-25, 2013. Especially don’t miss our Hospitality Reception from 5-6:30 pm on Tuesday, April 23rd.

C O N TA C T I N F O R M AT I O N Physical Address 3520 Green Court, Suite 150 Ann Arbor, Michigan 48105-1579 Mailing Address P.O. Box 130199 Ann Arbor, Michigan 48113-0199 Phone 734.527.9150

Stephen Rapundalo, Ph.D. President & CEO, MichBio

Fax 734.302.4933

Get Connected.

MICHBIO — YOUR GATEWAY TO MICHIGAN’S BIO-INDUSTRY

Website www.michbio.org Email info@michbio.org

www.michbio.org

3

BioMatters | Spring 2013

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C O R P O R AT E S P O N S O R S

O F F I C E R S , D I R E C TO R S A N D C O M M I T T E E S

Executive Officers

P L AT I N U M ÂŽ

GOLD

S I LV E R

Chairman Stephen Munk, Ph.D. Ash Stevens, Inc., President & CEO Vice Chairman David Zimmermann Kalexsyn, Inc., Chief Executive Officer

Paul Morris AlixPartners, LLP Finance Manager, National Enterprise Improvement Practice

President and CEO Stephen T. Rapundalo, Ph.D. MichBio, President & CEO

Brent Mulder, Ph.D., MBA Van Andel Research Institute Director, Office of Technology Transfer

Treasurer Matthew L. McColl Ernst & Young LLP, Partner

Stephen Munk, Ph.D. Ash Stevens President & CEO

Directors

Stephen T. Rapundalo, Ph.D. MichBio President & CEO

Arik Anderson Terumo Cardiovascular Systems Corp.

Vice President, Product Development David Felten, M.D., Ph.D. Beaumont Hospitals Vice President, Research, and Medical Director, Research Institute

BRONZE

Doug Gage, Ph.D. Michigan State University Director of the MSU BioEconomy Network, Office of the Vice President for Research and Graduate Studies Dale Grogan Michigan Accelerator Fund I Managing Director

MEDIA

Kevin McLeod Michigan Medical Device Accelerator Managing Director

Tim Mayleben Esperion Therapeutics Chief Operating Officer Kevin McCurren Grand Valley State University Executive Director, The Center for Entrepreneurship & Innovation and Grand Rapid’s Smart Zone

Tina Rogers, PhD, MBA, DABT MPI Research Executive Vice President, Director of Research and Interim Vice President, Bioanalytical and Analytical Services John J.H. Schwarz, M.D. Battle Creek Family Health Center Physician, Former U.S. Representative Ned Staebler Wayne State University Vice President, Economic Development Christopher J. Stein Ferndale Laboratories, Inc. Executive Vice President & Chief Operating Officer Karen Studer-Rabeler Coy Laboratory Products General Manager and Vice President of Business Development David Zimmermann Kalexsyn, Inc. Chief Executive Officer

PAT R O N Terumo Cardiovascular Systems/ Terumo Heart

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BioMatters | Spring 2013

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BioMatters TA B L E O F C O N T E N T S

8 11 12 15 17 19

Biosciences in Michigan: A Rich Legacy of Discovery and Impact Pushing the Frontiers of Science — and Providing Hope — Through the Biologics Pipeline SMIC at 10: New Ways of Seeing Innovation

24 26 29 30

Launch MI Lab Catalyzes Innovation Originus: Advancing Cell Engineering for Drug Discovery Biotechnology People Can Use

33 34

Michigan Biosciences

By The Numbers Sophisticated Technologies Save Thousands of Lives Every Day 3D Biomatrix Transforms Pharmaceutical Testing MichiganBased Diplomat Leads the Way in Specialty Pharmacy Industry Growth

36 37 38 39

Innovation and Expertise Puts Helix Biological Laboratory at the Forefront Algal Scientific Algae Startup Develops Lower-cost Manufacturing Platform for Valuable Immune Health Compound

40

polyElements: New Startup Creates Nanofiber Scaffolds for Tissue Engineering Ash Stevens Adds New Capacities and Capabilities

MPI Research: 3rd Largest Global CRO that Focuses on Improving the Odds Aastrom Biosciences of Ann Arbor Conducts Final Stage Development of Cell Therapy Ixmyelocel-T Pioneer Surgical Technology, Inc. Innovates With Its New Bone Graft

Subscribe to BioMatters: call 734.527.9150

ADVERTISERS Ash Stevens ........................... 16 Bank of Ann Arbor .................... 27 Doeren Mayhew ....................... 16 G2G Consulting.........................32 GLEQ.....................................28 Hylant ................................... 6 JB Ashtin ............................... 28 MedBio...................................28

MichBio ............................ 4, BC Michigan Economic Development Corp. ................. IFC Michigan State University ............32 MPI Research ......................... IBC Oakland University .................... 6 Originus..................................28 PhRMA .................................. 10

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Quest Research Institute ............ 18 Stryker .................................. 1 Terumo Cardiovascular Systems ... 18 University of Michigan ............... 18 VWR....................................... 2

BioMatters | Spring 2013

F E AT U R E S T O R Y

Biosciences in Michigan:

A Rich Legacy of Discovery and Impact

By Stephen Rapundalo, Ph.D., President & CEO, MichBio

Michigan has a long record of

The bioscience industry in Michigan

bioscience discovery triumphs and

continues to lead the way in creating

significant contributions to the health

solutions to some of the world’s most

and welfare of humankind. They stem

pressing medical, food, environmental

from a rich legacy of research, innovation

and energy problems. Some of the best

and manufacturing in various industry

global “bio” brands call Michigan home

sectors that have developed products for

for their facilities and are at the forefront

the betterment of lives around the world.

of developing innovative products...

Here are but a few of the key discoveries

Pfizer, Stryker, Dow Chemical, Kellogg,

and notable achievements that have

Amway, Dow Corning, Zoetis, Perrigo,

emanated from Michigan over the last

Mead Johnson, MPI Research, Nestlé Nutrition, Neogen, BD, Beckman Coulter,

150 years: • AZT, the first approved treatment for HIV/AIDS discovered at Wayne State University • Lipitor, the cholesterol-lowering agent and largest selling drug in history discovered at Parke-Davis Pharmaceuticals in Ann Arbor • Xanax, the first anti-anxiety medication, and Halcion, the first insomnia drug, both discovered and manufactured by the Upjohn Company • Oscillating electric bone saw invented by Dr. Horace Stryker • First U.S. pharmaceutical company — Parke-Davis & Company — and home to the first modern pharmaceutical laboratory and methods of performing clinical trials • Hybrid corn, created by genetic modification at Michigan State University, to enhance crop yields • Anthrax vaccine, first manufactured

by BioPort (now known as Emergent BioSolutions) in Lansing • Dilantin, the first marketed, and Neurontin, a current widely-used epilepsy treatment, both developed at Parke-Davis

Johnson & Johnson, Abbott Nutrition,

Stephen Rapundalo

• The Turning Frame, the first mobile hospital bed developed by Dr. Stryker • Homogenization of milk, first developed at Michigan State University

Cardinal Health, Ferndale Pharma, Diplomat Specialty Pharmacy, Bayer CropScience, DowAgra, and Emergent BioSolutions, to name a short list.

• Large scale production of the steroids, cortisone and prednisone developed at the Upjohn Company

The bioscience industry in Michigan continues to lead the way in creating solutions to some of the world’s most pressing medical, food, environmental and energy problems.

• Cisplatin, discovered at Michigan State University, a leading chemotherapy drug used as treatment in a wide range of malignancies

Michigan’s >600 bioscience

companies, academic research centers and clinical institutions reflect the breadth of pharma/biotech, medical devices/equipment, research products and diagnostics, informatics, ag-bio, bio-defense, industrial and environmental biotechnology, medical/laboratory testing and clinical research. It’s where research, development, life cycle management, manufacturing, converge with the delivery of healthcare and wellbeing.

In addition to world-class brands,

Michigan has a robust community of biotech and life science emerging companies. The state has witnessed an overall 7% increase in number of ventures over the last ten years with more than 134 companies (therapeutics, diagnostics, informatics, medical devices and CROs/ CMOs) launched during that period.

Consequently, a strong entrepreneurial culture has taken root that has established Michigan as a hotbed for

BioMatters | Spring 2013

8

bioscience technology commercialization

intellectual property necessary for

the state’s unparalleled bioscience

with a supporting CRO/CMO network

commercialization.

talent pool is broad as it is deep.

that’s second to none. In short, Michigan

Universities and technical colleges offer

offers a virtual product development

business and entrepreneurial support

a vast array of bioscience education

ecosystem to bioscience businesses from

resources, Michigan’s bio-industry is

opportunities, including specialty

ideas to profitable commercial outcomes.

well positioned for growth. The State

of Michigan provided approximately

Success breeds success...and

Buttressed by a full portfolio of

Companies looking for well-educated and seasoned professional bioscience workers need look no further than within Michigan.

Michigan’s emerging bioscience

$350 million in support to bioscience

companies have a remarkable track

companies during the last decade, as

record of investment, growth, and

well as an additional $50 million of

return. A number of them like Esperion

investment by the state’s fund-to-funds.

Therapeutics (acquired by Pfizer for

Coupled with other assets like our Pre-

$1.3 billion in 2003) HealthMedia (now

Seed Capital Fund and its Micro-Loan

J&J’s Wellness & Prevention Inc.), Accuri

Program, as well as the Venture Michigan

Cytometers and HandyLab (purchased

Fund and Pure Michigan Venture Match

applied training, to meet the needs

by BD), and Somanetics (acquired by

Fund, companies can access a portfolio

of employers. Michigan knows that

Covidien) are just a few examples of big

of capital and business resources across

advancing its bio-industry growth begins

commercial exits. Other companies like

their entire business life cycle.

with ensuring that top talent is available,

today and tomorrow.

Success breeds success... and Michigan’s emerging bioscience companies have a remarkable track record of investment, growth, and return.

An unrivalled statewide network

of SmartZonesSM provides business

acceleration and wet-lab incubator

are revolutionizing the way we think

services, allowing Michigan’s biosciences

about healthcare, consumer products,

companies to benefit from a strong

food, crops and energy consumption...

ecosystem that supports commercial

essentially the way we live. Michigan

growth from ideas to markets. And a

is ideally positioned for a continued

state-funded Emerging Biz Solutions

role in this rapidly evolving world of

Increasingly, bioscience advancements

biosciences, thanks to its diversity of sectors, research, technologies, CytoPherx ($36 million in 2012), Lycera

commercialization and manufacturing.

($47 million during 2009-10), and NanoBio

The biosciences are Pure Michigan®.

(>$90 million since 2006) have procured significant venture funding. And many others are on similar trajectories pointing to the fact that not only is there a thriving technology pipeline but also on-the-ground investment partners and capital efficient Michigan companies with reasonable valuations. All this makes for an attractive investment value.

Michigan’s world-renowned

universities, defined by its University Research Corridor, receive almost $1.2 billion alone in federal R&D funding for bioscience research — 4th among the major U.S. research clusters. Moreover, these institutions deliver high-tech, skilled bioscience graduates (>5,500/ year, 8th in the U.S.). In addition, over 1,800 bioscience patents were registered from Michigan institutions during 2004-2009, tenth in the nation. In so doing, our research centers offer unique

program, coordinated by MichBio, provides product development planning and ancillary business intelligence and partnering support services to qualified bioscience ventures.

Companies looking for

well-educated and seasoned professional bioscience workers need look no further than within Michigan. With its rich legacy in pharma and medical devices,

technology partnership opportunities to the private sector by providing the

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BioMatters | Spring 2013

A job engine for Michigan.

Life-saving medicines for the world.

From Alpena to Ypsilanti, scientists working at the nation’s biopharmaceutical companies are currently researching and developing life saving medicines.

In collaboration with the state’s university medical schools, science centers, local hospitals and contract research organizations, nearly 3,500 clinical trials have been conducted for new prescription drugs. These have led to remarkable discoveries inspiring hope and improving the quality of life for patients and their families.

R h P -

For the people of Michigan, biopharmaceutical research companies have also been an important source of jobs, tax revenue and research spending.

d A

A study found that in 2008 the industry supported nearly 95,000 jobs include life sciences researchers, management executives, office and administrative support workers, engineers, architects, computer and math experts and sales representatives.

We thank the people of Michigan and their communities for their collaboration, support and kindness. Right now, nearly 400 tests of new medicines for the six most debilitating chronic diseases in America is underway all over the state and they need patient volunteers.

BioMatters | Spring 2013

A M

Pushing the Frontiers of Science — and Providing Hope — Through the Biologics Pipeline

By John J. Castellani, President & CEO, Pharmaceutical Research and Manufacturers of America

John J. Castellani

The mapping of the human genome,

throughout the country, are building on the knowledge gained through

the development of amazing new biological

these and many more discoveries with the next generation of biologics.

technologies and a greater understanding

of how diseases work have allowed

areas (see chart below), the greatest amount of research is in a

Although biologics in development span a wide array of therapeutic

biopharmaceutical

category of medicines called monoclonal

researchers — working

antibodies (mAbs) and in vaccines, which

hand-in-hand with

together make up 65 percent of the biologics

Michigan’s thriving

in clinical trials or under review at the FDA.

medical research

MAbs have been instrumental in the treatment

community — to

of cancers by targeting unhealthy cells without

pursue new targets and personalize medicines to

harming healthy cells and are showing great

better treat specific subpopulations of patients.

promise in the treatment of asthma, psoriasis

Right now, scientists at America’s

and rheumatoid arthritis. Vaccines, typically

biopharmaceutical research companies are using revolutionary biological

considered a key tool for the prevention of infectious diseases, also are

processes to develop 907 new medicines and vaccines targeting more

evolving with the science and our understanding of disease. Today, they

than 100 diseases, providing hope where there was none for thousands

are being tested as therapies for cancer and other diseases.

of patients, according to a new report from the Pharmaceutical Research

and Manufacturers of America (PhRMA). Many of those treatments are

schools and research centers include:

being tested as part of the nearly 400 clinical trials currently underway companies assembled in Chicago for the 2013 BIO International

Convention.

diseases such as lung cancer and melanoma.

in Michigan — and are in development by many of the innovative

Before we discuss the excitement behind these potential medical

MAbs and therapeutic vaccines in clinical trials in Michigan medical

• A mAb for the treatment of cancer, • A mAb that targets lupus, and • A therapeutic vaccine to jump-start the immune system to fight With a robust pipeline which includes these potential new

breakthroughs, let’s take a look back at some of the key biologic medical

medicines, the U.S. continues to lead the world in biopharmaceutical

advancements that paved the way for the progress being made today.

research and development. That leadership is built on the foundation

In the last decade, the U.S. Food and Drug Administration (FDA) has

of a strong biomedical ecosystem that fosters collaboration between

approved the first genetically engineered antibody to deprive tumors

government, academia, and biopharmaceutical researchers — the kind

of oxygen and nutrients, the first new medicine for patients with lupus in

in place in the Great Lakes State. It is supported by public policies —

50 years and a vaccine for the prevention of human papillomavirus, which

both state and national — that encourage scientists to push boundaries

will dramatically reduce the number of women who will develop cervical

and take risks. And, it is fueled by the hope of patients around the

cancer. America’s biopharmaceutical researchers also have used biological

world that a medical breakthrough in a small lab in Kalamazoo can help them overcome disease

processes to bring a number of first-in-class medicines to patients that have made marked progress in the fights against certain cancers.

Our scientists, working in

partnership with university medical schools, science centers, local hospitals and contract research organizations in Michigan and

miles away.

Biologic Medicines in Development—by Therapeutic Category

Some medicines are listed in more than one category Autoimmune Disorders 43

Blood Disorders Cancer/Related Conditions

338

Cardiovascular Disease

58 28

Diabetes/Related Conditions Digestive Disorders

26

Eye Conditions

25 176 34

research/new-medicines.

38

Respiratory Disorders Skin Diseases Other

http://www.phrma.org/

39

Neurologic Disorders

Transplantation

report, “Biologic Medicines accompanying overview at

Infectious Diseases Musculoskeletal Disorders

new therapies in the new in Development” and the

30

Genetic Disorders

You can learn more

about these promising

71

30 13 58

11 9

BioMatters | Spring 2013

SMIC at 10: New Ways of Seeing Innovation

BioMatters | Spring 2013

12

“The roots of great innovation are never just in the technology itself. They are always in the wider historical context. They require new ways of seeing.”

David Brooks, New York Times columnist

By Robert DeWit, Ph.D.

enterprises and support, and more

Kalamazoo, Kalamazoo County and

a bioscience incubator/accelerator was

recently the Kalamazoo Promise,

private donors. Collectively, they posed

young but hardly new. Visionaries looked

providing full tuition to Kalamazoo

an intriguing option: local scientists

at the aging population, the emergence

Public Schools graduates attending

starting their own businesses in a new,

of biotechnology and the struggle of big

Michigan public colleges.

purpose-built lab facility equal to those

At the turn of this century, the idea of

in which they previously worked.

companies to generate breakthrough medical treatments, and they realized

that the next wave of innovation would

scientists aren’t entrepreneurs. While

This was no mean feat. Most

happen in the startup world. Before long,

those who lost their jobs at Pfizer had generous separation packages,

nearly every American state was jumping While the community seemed the

they faced enormous challenges. Lab

on the bio-bandwagon, each insisting

it would be the next Silicon Valley of

logical birthplace for a bioscience

space and equipment are frighteningly

life sciences.

incubator, a challenging coincidence

expensive, and many of the affected

gave SMIC its biggest push. In 2003, just

scientists knew very little about starting

Innovation Center (SMIC) opened its

weeks before SMIC opened its doors,

a business or seeking venture capital.

doors in Kalamazoo, Michigan. Buoyed

Pfizer announced a major reduction in

by a unique mix of expertise, history,

its research-and-development presence

for those aspiring entrepreneurs.

community support and circumstances,

in Kalamazoo. This left hundreds of

Located in WMU’s Business Technology

SMIC continues to thrive as a premier

researchers, many of whom had spent

and Research Park, the Innovation

incubator/accelerator, evolving with

decades in the community, unsure of

Center offers a comprehensive range

the times.

their next step.

of facilities and support to nurture

In 2003, the Southwest Michigan

SMIC provided a launching pad

Southwest Michigan Innovation Center

Timing is Everything

The center had been formed through

innovative life science businesses. SMIC

127-year legacy of life science

a partnership that included Southwest

provides subsidized rent at the time of

innovation, stretching back to the

Michigan First, the Michigan Economic

admission, which gradually increases

beginnings of The Upjohn Company

Development Corporation, Western

as the startup matures. SMIC also sits

(now Pfizer) and Stryker Corporation.

Michigan University, the City of

in a Michigan SmartZone, which offers

Southwest Michigan has a rich,

For SMIC, the timing was perfect.

Kalamazoo is home to four colleges/

the formation, survival and growth of

tax-related support. Further, there

universities, diverse entrepreneurial 13

BioMatters | Spring 2013

The most recent development at

establishing itself over the past two

is considerable expertise available,

from business consulting through the

the Innovation Center is Launch MI

years and was formally unveiled in

Michigan Small Business Technology

Lab, a staffed laboratory furnished

November 2012.

Development Center to counsel from

scientific, legal, accounting, venture

of SMIC’s success is found among its

capital and marketing experts. Many of those experts were former associates of the new entrepreneurs, with decades of experience in global biosciences.

Decade of Success

Over the past decade, SMIC has seen

a phenomenal success rate among its client companies. Of 26 “pure” startup companies — that is, business ventures born at the Innovation Center — 25 were

As it marks its 10th anniversary, the Southwest Michigan Innovation Center continues to evolve as a driver of innovation, economic growth and medical advancement ­— a jewel for the global life sciences community and a starting place for the bioscience innovators of the future.

still active as of late 2012. A total of

Perhaps the most important measure

client companies. All told, those firms have six Investigational New Drugs, 34 patents and 11 compounds in human clinical trials. Those wins hold far more than economic value; they bring hope to patients in need of new treatments and cures.

Beyond the Next Decade

The future of SMIC is bright. It’s also

changing. In the years ahead, growth at the Innovation Center will come in

35 firms have been incubated at SMIC,

different ways because there will be no

with 95 companies served. There are

with extensive scientific equipment

more displaced scientists to tap locally.

18 companies now operating at the

(See sidebar). With affordable short-

SMIC will need to take a global view

Innovation Center, employing 161

term leases available, entrepreneurs

for recruitment and attraction because

people. According to the W.E. Upjohn

can utilize bench and desk space and

the life sciences community is global in

Institute for Employment Research,

analytical services where early stage

nature. That means relationships and

SMIC’s presence generates 346 direct

entrepreneurs can test their ideas and

collaboration, both near and far, will

and indirect jobs in the region, totaling

apply for grants. The lab has been

be crucial.

$18.6 million in payrolls.

BioMatters | Spring 2013

14

Launch MI Lab Catalyzes Innovation

SMIC is already hard at work in

Even simple innovations require huge investments of time, testing and

that realm through recent interactions

money. Filling that need is the rationale behind Launch MI Lab, which

with Stanford and Startup America.

provides affordable wet-lab and bench space, state-of-the-art equipment,

Also, SMIC is being more intentional

professional analytical services, and scientific and business expertise for biosciences companies of all sizes, including entrepreneurs at the earliest

The future of SMIC is bright.

It’s also changing. In the years ahead, growth at the Innovation Center will come in different ways because there will be no more displaced scientists to tap locally.

stage. Housed in the Southwest Michigan Innovation Center in Kalamazoo, Launch MI Lab helps accelerate the work while reducing the costs of life sciences businesses.

Launch MI Lab

about building relationships with peers,

academia and corporate partners, as well

science startups: purpose-built space, business support services, and

as making itself more visible externally.

scientific expertise. Clients can lease bench space and work stations in

As it marks its 10th anniversary,

Launch MI Lab brings three critical elements to aid fledgling life

the 2,300-square-foot lab at a lower cost than in a traditional incubator.

the Southwest Michigan Innovation

Along with access to scientific equipment and services, each client has

Center continues to evolve as a driver

high-speed Internet and VOIP telephone service, use of conference and café

of innovation, economic growth and

facilities, and free parking. Available equipment includes mass spectrometry

medical advancement — a jewel for

systems, centrifuges, autoclaves, flow cytometers, a variety of microscopes,

the global life sciences community

incubators, lyophilizer, upright freezer, and standard lab supplies and tools.

and a starting place for the bioscience

innovators of the future.

helps entrepreneurs get access to affordable lab space and equipment as

Greg Cavey, lab manager for Launch MI Lab, points out that the facility

well as affordable, quality analytical services. Clients, advisors and staff Robert DeWit, Ph.D., is President

bring decades of bioscience and business experience that is made available

and CEO of the Southwest Michigan

to tenants. Among them is Cavey himself, a biochemist with more than

Innovation Center. Prior to joining

20 years’ experience in proteomics, mass spectrometry and laboratory

SMIC in 2009, Dr. DeWit spent more

management.

than 25 years in pharmaceutical

research and development, with

to creating the laboratory. Launch MI Lab was unveiled in November 2012.

science and leadership roles in the

For more on the operation, visit www.launchmilab.com.

Support from the Michigan Economic Development Corporation was key

U.S., Japan and United Kingdom.

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BioMatters | Spring 2013

SAVE THE DATE 9th Annual MichBio Expo & Conference

October 15-16, Radisson, Kalamazoo, MI

CONFERENCE HIGHLIGHTS:

• The Michigan Emerging Biosciences Showcase

• Concurrent track sessions in Pharma, Medical Device, Emerging Business and Bio-Based Technologies

• Industry Town Hall

• Tech Transfer Today

• CEOs Unplugged

• Poster Session

• Facility Tours and much more!

Over 70% of attendees are bio-executives.

www.michbio.org/expo

Experience makes a world of difference.

With more than 50 years of experience, Ash Stevens is a proven and trusted supplier of contract small molecule drug substance development and cGMP manufacturing services.

To see how Ash Stevens can help your drug substance program succeed, call or click today.

Insight, Oversight and Foresight to Foster Successful Innovation

734-282-3370 ashstevens.com

An internationally recognized, top 100 U.S. firm, Doeren Mayhew provides bioscience companies with insight into their businesses, oversight to ensure best practices and foresight for what’s ahead. From determining qualifying research expenses for R&D tax credits, to assisting with governmental audits, we invite you to see how we can help you capitalize on the opportunities and navigate the challenges specific to your industry.

248.244.3000

doeren.com

BioMatters | Spring 2013

Insight. Oversight. Foresight.

Visit Ash Stevens at BIO Booth #5243

SM

16 ASH-2410 BioMatters 1/4 Pg Ad.indd 1

3/13/13 10:57 AM

Originus:

Advancing Cell Engineering for Drug Discovery

Modern drug discovery is a highly industrialized process that begins

of multiple targets and readouts. This can be a boon to researchers

by testing a large number of chemical substances against biological

when trying to discover novel drug candidates.

targets which are hypothesized to be involved in diseases. Development

of functional assays for high throughput screening (HTS) of chemical

standards which confirm high reproducibility well-to-well, plate-

libraries is an integral part of this process and living cells are frequently

to plate, and batch-to batch, suitable for HTS and high content

Microplates are produced at Originus, Inc. under quality control

used as tools to understand the molecular pathways

screening (HCS) environments. In addition, STEP

involved in health and disease.

plates can be stored longer than a year without

Originus Inc. (www.originusinc.com), an

Ann Arbor-based company formed in 2001, has

Originus, Inc.

revolutionized the way functional assays can be

significant decrease of biological properties after transfection, resulting in great convenience for customers and partners who only need to add

applied in drug discovery. Their technology and products are based on

cells to the plates before testing. STEP is adaptable to a broad range

a robust technique called Surface Transfection and Expression Protocol

of cell types from commonly-used cultured cell lines to neurons or

(STEP) that was originally developed at the University of Michigan and

stem cells.

exclusively licensed to Originus. STEP allows for cell-based HTS with a

In short, Originus’ STEP technology offers a novel approach to

myriad of basic research and therapeutic

accelerating drug development and

discovery applications.

thereby reducing costs. It allows

STEP gets around many challenges

multiplexing, and offers flexibility in

faced by traditional functional assays.

cell selection and high reproducibility.

Novel cell-based screening assays

In addition, the “ready-to-use” plates

typically required establishing cell lines

are a great convenience and can be

that stably express the target(s) of

adapted by small academic labs to big

interest (stable cell transfection), a

pharmaceutical companies. The goal of

process that is laborious, expensive,

Originus’ team is to create robust and

time-consuming (3-9 months) and not

sophisticated functional assays that

without shortcomings. The alternative,

leverage the latest cellular engineering

transient cell transfection results in

techniques in the burgeoning field of

variable results and it is difficult

systems biology.

to control.

Originus has received several

Originus’ STEP technology

awards from the National Institutes

involves the formation of proprietary

of Health for the development of this

transfection complexes that are

highly innovative technology. STEP

applied directly to the growth surface

plates are being used successfully by

for the cells of interest and can be

pharmaceutical companies for HTS

used for functional experiments

of chemical libraries, not only in the

just by adding adherent cells. Assay

hunt for new drugs but also to test

engineering using STEP increases

for their safety and the way they are

efficiency and allows over-expression

metabolized by the body.

“Originus has revolutionized the way functional assays can be applied in drug discovery. Their technology and products are based on a robust technique called Surface Transfection and Expression Protocol (STEP) that was originally developed at the University of Michigan and exclusively licensed to Originus.”

17

BioMatters BioMatters || Spring Spring 2013 2013

ACCELERATE the Clinical Trial Process EXpEriEncE

Senior physicians and certified staff with no employee turnover

SPEED

Top in the industry in study start-up cycle time and patient enrollment

efficacy

Consistently exceeds enrollment targets with strong recruitment tactics and a 12,000 patient database

www.questri.com Terumo Cardiovascular Systems and Terumo Heart, Inc., are Proud Sponsors of MichBio and Michigan’s Growing Biosciences Industry

Early Phase, Multi-Specialty Unit 31000 Telegraph Rd, Suite 230 Bingham Farms, Michigan 48025 Neurology Clinic at MIND 28595 Orchard Lake Road, Suite 301 Farmington Hills, Michigan 48334 248-644-7770 www.questri.com

www.terumo-cvs.com | www.terumoheart.com Terumo® is a registered trademark of Terumo Corporation. ©2012 Terumo Cardiovascular Systems Corporation 829849

BioMatters | Spring 2013

18

Biotechnology People Can Use NECi is an environmental biotechnology company dedicated to the responsible application of novel products to help solve environmental problems. the Gempler’s Farm Supply catalog. A

protein catalysts that speed up the

production, and adoption of reagent grade

new nitrate Color Slider app to increase

myriad reactions that make life possible.

enzymes crafted for analytical chemistry

the quality of interpretation of test kit

Enzyme reactions happen in gentle

and application in the fields of agriculture,

results is now available — check it out at

conditions: no solvents, no high heat

food, water and biomedical science.

http://nitrate.com/nitratecolorslider.

or pressure, no heavy metals involved.

NECi is pioneering the development,

An Android app is due in April.

Enzyme-based analytical chemistry has

Michigan’s picturesque Upper Peninsula,

some real benefits:

near Michigan Technological University.

measurement is not a simple matter:

The company was founded in 1993 to

when the news announces that a harmful

commercialize the academic research of

compound has been detected in food or

its co-Founder, Dr. WH (Bill) Campbell,

water, people in a lab somewhere have

NECi is located in Lake Linden in

NECi understands that accurate

• Selectivity – Enzymes are able to find “targets” in complex mixtures (reduced sample prep time) • Sensitivity – Enzymes offer low detection limits in complex mixtures

after a publication in Nature resulted

• Specificity – Enzymes react ONLY with the target to be analyzed

in customers calling his lab asking for products. NECi’s first product, Nitrate

• Safety – Enzymes are accurate, reliable, and environmentally benign

Reductase, (NaR) replaces cadmium and hydrazine for nitrate analysis.

NECi’s YNaR reagent is used in

biomedical research for detection of

up for safe and lowest cost shipping,

nitric oxide (NO). YNaR and AtNaR

storage, export and disposal. And all

reagents are used by environmental,

one needs is standard lab equipment

food, industrial, and agricultural labs.

AtNaR is specified for nitrate analysis as a

painstakingly tested that food or water

Standard Method with the U.S. Geological

using standard, approved methods. Many

Survey. EPA and ASTM validation studies

of these methods were consecrated in the

are underway currently.

1960s, many of those methods were old at

NECi’s reagent grade products and

test kits are designed from the bottom

and a photometer, but reagent packs for microplate readers and discrete analyzers are available for high throughput labs.

that time — and most require hazardous

NECi’s on-site test kits target

agriculture and environmental/water

materials or expensive equipment.

quality monitoring. Test kit formats

developed for experienced users are

recombinant and native enzyme reagents

simplified by packaging reagents into

for analytical chemistry. Enzymes are

NECi sells its green nitrate detection

enzymes and test kits worldwide, including: consumers testing home wells; agricultural agents testing soil, plants,

NECi develops and produces

forage/feed and water/runoff; environmental citizen monitors testing fresh and salt water; and enzymes for

unit dose containers for true

labs in industry and university

ease of use. NECi’s Nitrate

research. Green chemistry

Test Kits for Agriculture (Ag-

involves biology... and NECi

NTKs) can test soil samples,

brings enzymes to a new level

runoff, nitrate levels in

in the 21st century... all the

flowering crops for maximum

way from the northern-most

yields, and nitrate toxicity of

tip of Michigan!

livestock feed. These semiquantitative kits, developed

NECi would like to

with support from the USDA’s

thank the SBIR program of

SBIR program, give a visible

NIH for funding the protein

pink color when nitrate is

expression work and the

present. The toxicity test kits

MEDC’s Emerging Technology

saw significant sales during

Fund for their monetary

the drought of summer and

gift that aided product

fall 2012. Ag-NTKs are sold

development.

via the company website and NECi’s

nitrate reductase

(NaR)

is a recombinant enzyme produced by fermentation

-

for optimal

quality control

19

BioMatters | Spring 2013

Innovate. Accelerate.

MichBio and the Michigan Economic Development Corporation will co-host the Michigan Pavilion at the BIO International Convention in Chicago April 22-25, 2013. The companies featured below are the exhibitors that will be showcased in the Michigan Pavilion.

Stop by. Visit. Booth #1805. BIO Convention 2013.

3D Biomatrix, Inc. 3D Biomatrix is a leader in three-dimensional (3D) cell culture products for stem cell research, drug discovery and testing, and cancer research. Its 96- and 384-well Perfecta3DÂŽ Hanging Drop well plates facilitate the formation, culture, and testing of 3D spheroids and embryoid bodies (EBs) without contact with surfaces or matrices. www.3DBiomatrix.com

City of Southfield Southfield is the premier business address in Michigan.

It is the center of a region with strong economic assets and opportunities in life sciences and technology based industries. We are an epicenter supported by St. John Hospital, Oakland Community College and Lawrence Technological University. www.cityofsouthfield.com

Algal Scientific Algal Scientific Corporation is pioneering a sterile fermentation process using specially selected algae to produce high purity beta-1,3 glucan for use as animal and human immune health and nutrition ingredients. A patented complementary technology uses algae to recycle water and recover valuable nutrients and co-products from food industry process streams. www.algalscientific.com

DeNovo Sciences, Inc. DeNovo’s proprietary CTC system provides the user effective and efficient methods to capture, enumerate and perform single cell molecular analysis on CTCs from whole blood. The DeNovo Microfludic System utilizes cutting edge consumables, resulting in unparalleled sensitivity and specificity without contamination. www.denovosciences.com

Ash Stevens Founded in 1962, Ash Stevens, Inc. (ASI) offers comprehensive small-molecule drug substance development and GMP manufacturing services spanning early-stage development through commercial API manufacturing. ASI supports all facets of chemistry and manufacturing controls (CMC) related to the development of small-molecule APIs including the development and manufacture of highly potent APIs (HPAPIs). www.ashstevens.com

Detroit Clinical Research Center, PC Detroit Clinical Research Center (DCRC) is a health research institution that supports clinical research studies across all hospitals and medical facilities in South, Mid and East Michigan. DCRC also collaborates with other health institutions in Michigan, North America and internationally to support leading health care research projects. www.dcrc.us

BioMatters | Spring 2013

20

Michigan.

Ferndale Pharma Group Ferndale Pharma Group’s business units offer health and wellness solutions to healthcare providers and consumers, with a special interest in skin care, GI/digestive health, and prevention of hospital acquired infections. Ferndale also provides contract manufacturing services with expertise in topical Rx, OTC, and cosmetic liquids and semi-solids. www.ferndalepharmagroup.com

Global Clinical Connections Global Clinical Connections offers consulting and project management solutions for small, medium, and large biotech and pharma companies in the preparation and distribution of investigational materials for Phase I-IV clinical trials to assist them in achieving their developmental milestones. www.globalclinicalconnections.com

LifeLine Ventures LifeLine Ventures is an investment company with a primary focus in the Life Science Industry targeting medical devices and diagnostics. Our distinctive approach blends significant financial investment with unique access to our ancillary services. Our ideal investment is mid to late stage development companies with an investment range from $2-10 million. www.lifeline-ventures.com

MichBio MichBio is the trade association committed to driving growth in Michigan’s biosciences industry and its many sectors, including agri-biotech, food and nutrition, biobased technologies and renewable chemicals, industrial and environmental biotech, medical devices and technologies, pharmaceuticals and consumer healthcare, diagnostics and research products, testing and research services, and clinical research. MichBio members include biosciences companies, academic and research institutions, biosciences service providers, and related organizations. www.michbio.org

Impact Analytical Impact Analytical is a contract testing laboratory working with more than 300 companies around the world and dedicated to providing top-notch analytical service in a variety of industries—pharmaceutical, plastics, consumer products, medical devices, packaging, automotive and specialty chemical. www.impactanalytical.com

21

BioMatters | Spring 2013

®

Michigan Economic Development Corporation The Michigan Economic Development Corporation (MEDC) is a public-private partnership serving as the state’s marketing arm and lead agency for business, talent and jobs, tourism, film and digital incentives, arts and cultural grants, and overall economic growth. MEDC offers a number of business assistance services and capital programs for business attraction and acceleration, economic gardening, entrepreneurship, strategic partnerships, talent enhancement and urban and community development.

MEDC, founded in 1999, also developed and manages the state’s popular Pure Michigan® brand. www.michiganadvantage.org

Michigan Business Incubator Association The Michigan Business Incubator Association aims to stimulate business growth and economic vitality by utilizing the state’s best business incubators, accelerators and economic partners to create jobs and develop Michigan’s local economies. www.michiganincubation.org

BioMatters | Spring 2013

2222

Michigan State University The nation’s pioneer land-grant university, MSU began as a bold experiment that democratized higher education and helped bring science and innovation into everyday life. Today, MSU is one of the top research universities in the world and is home to a diverse community of dedicated students and scholars, athletes and artists, scientists and leaders. www.msu.edu

MPI Research MPI Research is a preclinical and early clinical CRO that provides discovery, surgery, safety evaluation, bioanalytical, and analytical services. We exceed expectations through consistency and quality, with a commitment to communication and innovation, delivering benefits throughout all phases of development. Learn how we can go beyond for you at www.mpiresearch.com. www.mpiresearch.com

MYcroarray MYcroarray is a leading manufacturer of custom molecular probes for genomic applications, including capture baits libraries for targeted sequencing, fluorescent probes libraries, oligonucleotide libraries, oligonucleotide microarrays and building blocks for synthetic biology. Our unique, low-cost and flexible technology enables affordable yet fully customizable products to better serve your needs. www.mycroarray.com

Originus, Inc. Originus, Inc. Originus, Incorporated uses proprietary transfection technology to accelerate cell-based assay development and produce robust assays for GPCRs, drug transporters, ion channels, and other protein targets, as well as Cytochrome P450 metabolic enzyme induction. Assays are provided as ready-to-use kits or in large volume for high throughput screening. www.originusinc.com

polyElements, LLC polyElements, LLC is a new venture specializing in the production of electrospun nanofiber scaffolds for a variety of research applications. In addition to offering a standard array of fiber scaffolds and electrospinning equipment, polyElements also produces customized fibers, chemically and physically engineered to meet the specialized needs of our customers. www.polyelements.com

The Right Place, Inc. Serving West Michigan since 1985, The Right Place, Inc., is a regional non-profit economic development organization dedicated to spurring economic growth in West Michigan.

The Right Place serves both in-region and prospective West Michigan companies, providing one-stop assistance for business expansion, innovation and growth. www.rightplace.org

Velesco Velesco is a CMC contract research organization, founded by pharmaceutical scientists from Pfizer’s former Michigan R&D campus. As experts in pharmaceutical analytical chemistry, drug formulation and cGMP clinical supply manufacture, Velesco applies nimblocity to your early stage drug development projects, with our proven formulation of expertise, flexibility and velocity. www.velescopharma.com

Wayne State University Through our dedication and leadership, Wayne State University is a nationally recognized center of excellence in research. Our research activities provide new opportunities for commercialization, bringing university-based intellectual property into the marketplace and creating start-up companies based on WSU research that generate new jobs, products and service innovations. www.techtransfer.wayne.edu

Hosted by: ÂŽ

23 23

BioMatters | Spring 2013

Michigan Biosciences BY THE NUMBERS MI Bio-Industry Quick Facts # Bio Companies & Organizations:

618

# Bioscience Jobs:

39,282

Total Employment Impact:

124,657

Average Bioscience Salary:

$76,989 Total Payroll:

$2.5 billion Economic Impact:

$9.5 billion Total Bioscience Start-Ups Since 2002:

134

Academic Bio-Research University Research Corridor

21st Century Investment Fund:

$120 million fund-to-funds $46 million to biosciences

www.Michigan21stCenturyInvestmentFund.com

InvestMichigan! Fund:

$300 million

series of funds www.InvestMichiganFund.com Venture Michigan Fund:

$95 million fund-to-funds

www.VentureMichiganFund.com (2007-2009)

Accelerate MI Innovative Competition:

$1 million

in cash prizes; largest business plan competition in the world 2012 Winner – Algal Scientific 2011 Winner – DeNovo Sciences 2010 Winner – Armune Biosciences Angel Investment Group Seed Program:

$500 for each Angel group member; $25,000 for administrative fees

Total R&D:

for 50+ members

(#10 in the nation) Bioscience R&D:

EB-5 Investment & Visa Program: Permanent U.S. resident status based on EB-5 eligibility to

(#10 in the nation)

investors of new commercial enterprise

$2.01 billion $1.2 billion # of Bioscience Degrees:

5,548

(#8 in the nation) # of Bioscience-Related Patents:

1,871

(2004-2009)

$1 million in a

Emerging Technology Fund: Matching fund for SBIR/STTR awards;

25% of SBIR/STTR with maximum $25,000 for Phase I and up to $125,000 for Phase 2 up to of

Great Lakes Entrepreneurs Quest:

Bio-Industry Investment, Commercialization Resources & Incentives Life Sciences Corridor Fund – 21st Century Jobs Fund:

$323 million

$100,000 to prizes for

annual business plan competition MI Pre-Seed Fund:

≤ $250,000

Convertible note with 100% match; pre-seed loan is up to

$50,000

(1999-2009)

MI University Commercialization Initiative:

Total VC Investments:

$232 million

to commercialization projects at MI member universities;

(~45% life sciences) (2012) Total $ Raised:

requires companies/institutions

$107.1 million (2012)

Up to $50,000

50-100% match from

Pure Michigan Venture Match Fund:

$350,000-500,000 match on $700,000-$3 million investment

www.MichiganAdvantage.org

BioMatters | Spring 2013

24

Distribution of Michigan bio-companies by sector

a sample of Bioscience Companies in Michigan

Pharma & Therapeutics

21%

n Amway

n Kellogg

Medical Devices/Equipment

41%

n Ash Stevens

n Lycera

Research & Development

13%

n Asterland

n Medbio

Testing/Medical Labs

3%

n Atek Medical

n MPI Research

Information Technology

9%

n BD

n NanoBio

AgBio & Industrial Biotech

13%

n Beckman Coulter

n Neogen

AgBio & Industrial Biotech Pharma & Therapeutics Information Technology

Testing/ Medical Labs

Research & Development

Medical Devices/ Equipment

n Caraco Pharmaceuticals

n Orchid Orthopedic Solutions

n Dow Chemical

n Oxford Biomedical

n Dow Corning

n Perrigo

n Emergent BioSolutions

n Pfizer

n Enzo Life Sciences

n Pioneer Surgical

n Esperion Therapeutics

n Rockwell Medical

n Everist Genomics

n Stryker

n Ferndale Pharma Group

n Terumo Cardiovascular

n Housey Pharmaceuticals

n Terumo Heart

n Jasper Clinical R&D

n ThermoFisher

n JHP Pharmaceuticals

n Zoetis (formerly

n Kalexsyn

Pfizer Animal Health)

Biosciences is BIG Business in Michigan

25

BioMatters | Spring 2013

A perfusionist

uses a heart-lung machine and

blood parameter monitoring system (top monitor) to keep the patient’s blood flowing when the

heart stops beating during open-heart surgery.

Sophisticated Technologies

Save Thousands of Lives Every Day

Terumo Cardiovascular Systems

circuits, endoscopic vessel harvesting

Corporation (Terumo CVS) develops,

systems, and vascular grafts. Terumo

manufactures and distributes medical

CVS serves customers working primarily

devices for cardiac and vascular surgery

in cardiac and vascular operating rooms,

with an emphasis on perfusion products,

including cardiac and vascular surgeons

intraoperative monitoring and vascular

and perfusionists — the specialists

grafting. Terumo CVS produces the

who run heart-lung machines during

longest-running, commercially successful

cardiopulmonary bypass surgery.

line of heart-lung machines in the world

and is the only U.S. manufacturer of

perfusion products in the U.S. since

these life-saving medical devices.

the earliest days of open heart surgery.

Sarns™ branded heart-lung machines have

The company is headquartered in Ann

The company has been manufacturing

Arbor, Michigan, with manufacturing

been produced in Ann Arbor, Michigan,

operations in Ann Arbor; Elkton,

since 1963. Terumo acquired the Sarns

Maryland; and Ashland, Massachusetts.

and CDI™ brands in 1999, and since that

The company employs 1,300 Associates.

time, Terumo has become the leading

brand worldwide in perfusion products.

Key product categories include heart-

lung machines, intraoperative monitors,

Terumo CVS Associates are proud of the fact that their products are used in more than 1,000 life-saving procedures every day.

For example, sophisticated

technology is at the heart of the CDI™ 500 Blood Parameter Monitoring System, manufactured by Terumo Cardiovascular Systems in Ann Arbor. The CDI system uses optical fluorescence and a reflectance-based in-line system to

cannulae, oxygenators, perfusion

BioMatters | Spring 2013

‘Optical Fluorescence’ Technology is at the Heart of Terumo Cardiovascular Systems

26

continuously monitor 11 critical blood

gas parameters during cardiac surgery

Terumo is a leader in innovation and

with extracorporeal circulation.

was ranked number 14 out of the

top 100 global companies by Forbes

Fluorescence is a behavior that

Because of technologies like this,

occurs when molecules of certain dyes

magazine on its “World’s Most Innovative

are excited by exposure to light. When

Companies” list.

the molecules return to their less exited state, fluorescent light is emitted. The excitation light and the emitted light are of differing frequencies, allowing them to be measured independently.

The fluorescent dyes are housed

in the CDI 500 system shunt sensor, a disposable that is placed directly into the extracorporeal circuit.

Access to continuous information

is a key advantage to clinicians when providing optimum patient management because it enables clinicians to react without delay to changes in blood parameter values.

A perfusionist

adjusts the flow on the

Terumo® Advanced Perfusion System 1

heart-lung machine during open-heart surgery.

Reserve Your Ad Now! BioMatters will be published in October 2013.

Circulation

Print distribution to MichBio members and stakeholders, attendees at the MichBio Expo and BIO International Convention and numerous other state and national events.

Digital distribution to more than 7,000 addresses including biosciences companies and service providers, state and regional funding sources, economic development organizations, universities and research institutions.

Advertising Rates MichBio Inside Front Cover Back Cover Inside Back Cover Full page Half page Quarter page

Members Non-members $4,000 $4,400 $3,500 $3,850 $3,000 $3,300 $2,000 $2,200 $1,000 $1,100 $500 $550

Information/Reservations Contact Wendy Wendel 734.527.9147 wendy@michbio.org

27

BioMatters | Spring 2013

Originus, Inc.

Drive in the Fast Lane...

Innovative.

GLEQ moves Michigan’s life science and medical device companies into the fast lane with entrepreneurial education, one-to-one coaching, connections to resources, exposure to investors, and a statewide business plan competition.

Accelerate a new idea or an emerging company with GLEQ.

GLE

Trustworthy.

Product Design Project Management Injection Molding Micro Molding

Inspiring Success

Knowledgeable.

Over Molding Insert Molding Clean Room Molding Clean Room Assembly

Passionate.

Medical Device Biotech Diagnostic Microfluidics

ISO 13485:2003 Certified

Great Lakes Entrepreneur’s Quest

www.medbioinc.com

Learn more and register for the competition at: www.GLEQ.org

BioMatters | Spring 2013

Innovative Contract Manufacturing Solutions for the Life Sciences.

28 ad3x4.indd 1

2/27/13 8:47 PM

3D Biomatrix Transforms Pharmaceutical Testing

New drugs that fight disease are

high-throughput setting. Users simply pipet

often tested on laboratory-cultured cells.

a cell suspension into the top of a well, and

Traditionally, cells are grown on flat plastic

the plate design allows the suspension to hang

surfaces, such as flasks, dishes, or plates.

below the well surface (Figure 1, bottom).

Cells flatten on the two dimensional (2D)

The cells, which do not contact any surfaces or

plastic surface, but living tissues in animals and humans are

matrices, aggregate into a spheroid over one to several days.

three-dimensional (3D). As such, cells grown in 2D cultures often

fail to replicate those 3D tissues.

researchers in pharmaceutical companies and academia.

Recent publications have demonstrated that anticancer drugs

To bridge the gap between 2D cells and humans, Ann Arbor,

3D Biomatrix’s HDPs have been accepted readily by

MI-based 3D Biomatrix developed the Perfecta3D® Hanging Drop

with distinctly different mechanisms show much different

Plate (HDP) (Figure 1, top) to grow cells in 3D, so that they more

results when tested in 2D and 3D cultures. As well, researchers

closely mimic their tissue of origin. 3D Biomatrix has received

have shown that realistic tissue models can be made in HDPs

widespread recognition for their HDPs, including winning a

utilizing multiple cell types.

Wall Street Journal Technology Innovation Award and being

By introducing 3D cell culture early in the drug-screening

featured in Genetic Engineering

process, researchers can get

& Biotechnology News, The

more physiologically-relevant

Scientist, and Biocompare.

data earlier, and more drugs

The HDPs are designed for

that would be failures can

the formation, growth, and

be screened out before the

testing of micro-scale 3D tissues

animal-testing phase. This

called spheroids. Spheroids are

reduces the amount of animal

used as models of many types of

testing needed overall, and

avascular tissues, tumors, and

lowers the cost and time to

embryoid bodies. HDPs are easy

get a drug to market.

to use and, in 96- and 384-well

plate formats, work with existing

about Perfecta3D Hanging

lab instrumentation frequently

Drop Plates can be found at

employed to screen drugs in a

Figure 1 – Top: 96-

384-well Perfecta3D Hanging Drop Plates facilitate the culture of spheroids within a hanging drop. Bottom: The user pipets the cell suspension into each well and the spheroid self-assembles

Additional information

3dbiomatrix.com/products.

and

Get Connected.

RESOURCES. INTELLIGENCE. EDUCATION. ADVOCACY.

biolink

Career Center MichBio

Signature Series

Emerging Biz Solutions

BioMixers

CEO Leaders’ Club

EXPO

BioMatters 29

BioMatters | Spring 2013

Titled

mural depicting

Flint’s

rich history

created by hundreds of students with special needs from the

School District

Genesee Intermediate

Michigan-Based Diplomat Leads the Way in Specialty Pharmacy Industry Growth Biotechnology Drugs and the Patient Compliance Challenge

by Gary K. Rice, R.Ph., MS, MBA

Diplomat’s key therapy programs

Specialty pharmacy is a branch of the

General Motors’ Great Lakes Technology

pharmaceutical delivery system

Centre complex on Saginaw Street in

include Oncology, HIV/AIDS, Hepatitis C,

that focuses on comprehensive and

Flint, which now serves as Diplomat’s

Multiple Sclerosis, Rheumatoid Arthritis,

coordinated systems of pharmacological

headquarters. Also in 2010, Diplomat

Crohn’s, Hemophilia/IVIG, Growth

care for patients with serious and chronic

announced a plan to add over 1,000 new

Hormone and Psoriasis. Other specialty

illnesses and complex medical conditions.

jobs in five years, which the Company

areas include transplant, fertility and

Surprising to many Michiganders — even

remains on target to do. Concurrent

bio-identical hormone therapy. In addition

those in the biomedical field — is that

with its hiring efforts, Diplomat has

to working closely with “big pharma”

Michigan is home to the nation’s largest

taken a corporate leadership position in

and small biotech pharmacy companies,

privately held specialty pharmacy,

the revitalization of Flint, providing both

Diplomat’s business model creates unique

Diplomat Specialty Pharmacy in Flint.

money and manpower to develop several

partnerships with all industry stakeholders,

What started as a family-owned

community-based initiatives that result

including physicians, patients, group

business co-founded by current CEO Phil

in new job creation and improved quality

purchasing organizations, hospital systems,

Hagerman, R.Ph. and his pharmacist

of life for Flint area residents.

retail chains and managed markets — always focused on improving adherence

father, Dale Hagerman in 1975, is now a leading Genesee County employer with more than 800 employees. The company’s revenues in 2012 were $1.1 billion, up 50 percent from 2011, and Diplomat has made the Inc. 500 list of fastest growing private companies in America every year since 2009.

Diplomat Specialty Pharmacy’s goal is to optimally deliver high quality, patient-centric care in a growing industry, while promoting patient safety and convenience.

and the patient experience.

With its strong reputation in the

specialty pharmacy space, Diplomat has been able to recruit top talent to its executive ranks, including recent transplants from California and Texas who were eager to be part of the innovation and energy at Diplomat.

An important milestone in the

company’s history was the 2010 purchase

Another draw for executives and other

of the 340,000 square foot former

prospective employees is the training offered on-site to Diplomat staff

BioMatters | Spring 2013

30

and industry professionals at the new Diplomat Specialty Pharmacy University.

In addition to pharmacists, Diplomat employs nurses and patient advocates who interact with patients to answer

Diplomat

questions, offer support, and ensure

patient testimonial

featured in the hallways of

medication compliance. Diplomat refers

its

Flint

headquarters

to this as its high-tech, high-tough system, a robust patient management program that combines sophisticated software, personal outreach and call center support to optimize patient outcomes with often complicated treatment programs. Diplomat also helps find funding for those who cannot afford their prescriptions. In 2012, the company secured more than $19 million for patients through outreach to various non-profit funding sources.

The field of specialty pharmacy

is forecasted to grow at double-digit rates annually in the next few years, with recent information reflecting that

are non-adherent in one or more ways.

training, followed by compliance

Clinically the impact is realized in lower

packaging that keeps the drug

patient quality outcomes. Failures in

safe and secure yet is also easy

medication adherence lead to expensive

for the patient to open, prophylactic

and sometimes life-threatening

starter kits (a side effects management

complications. Economically, the impact

kit), nurse adherence calls to provide

of non-adherence is estimated to cost

clinical support and guidance, and

$100 billion annually.

technology, whether that be through smart phones, prescription bottles with

specialty products will be 50 percent

glow caps or packaging with alarms

of the drug spend by 2018. This will be

and reminders.

based on current specialty biotechnology

therapies gaining FDA approval for additional indication, newly FDAapproved biotechnology therapies and the introduction of biosimilars.

Much of the focus on the clinical

side of specialty pharmacy is patient compliance and medication persistence.

Medication compliance refers to whether patients take their medications as prescribed (e.g., twice daily) and persistence signifies whether they continue to do so. Together, treatment compliance and persistence contribute to overall medication effectiveness.

Indeed, the holy grail of specialty pharmacy is described as optimal compliance and persistence. The impact of non-compliance has both clinical and economic implications. Thirty-two

Diplomat Specialty Pharmacy’s goal

is to optimally deliver high quality, patient-centric care in a growing

These biotech specialty medications

industry, while promoting patient safety

tend to have greater side effects than

and convenience. At the same time,

traditional small-molecule medications

Diplomat’s core value of meaningful

and are more costly. Both of these

community commitment continues to

factors work against patient compliance,

direct the company’s actions beyond the

persistence and, ultimately, positive

world of specialty pharmacy.

patient outcomes. With Diplomat’s specialty patient satisfaction rates

Gary Rice is the Vice President

over the last three years ranging from

of Clinical Services for Diplomat

98 percent to 99 percent (the industry

Specialty Pharmacy.

average is 50 percent to 70 percent),

grice@diplomatpharmacy.com

there is additional competitive pressure to closely monitor adherence.

The key to patient compliance

and adherence begins with patient education and

million Americans use three or more medicines daily; 75 percent of adults

31

BioMatters | Spring 2013

Does your search for funding seem aimless, are you lost when it comes to developing relationships with Federal Agencies or don’t know how to use the ones you’ve got with elected officials to advocate for you?

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BioMatters_Ad_2010_FINAL.indd BioMatters | Spring 2013

1

32

8/19/10 9:39:14 PM

Innovation and Expertise Puts Helix Biological Laboratory at the Forefront

Helix Biological Laboratory LLC is a full service laboratory located

organizations within the state on water quality projects by providing

in southeast Michigan that is engaged in a wide variety of biological and

MST services that address fecal contamination in various waterways.

analytical testing, as well as consulting services.

Following EPA and NELAC guidelines for MST, the

laboratory identifies specific DNA markers of fecal

Established in 2009, Helix Biological Laboratory

specializes in the detection and identification of

bacteria that are found in specific host sources

microorganisms from a variety of sources such as water,

that include humans, cows, pigs, horses, dogs,

food and beverages products (including wine), soil,

and birds such as geese.

agricultural samples, biological samples, consumer

products, cosmetics items, pharmaceuticals and textile

of fecal contamination to be identified quickly

materials. In addition, Helix offers forensic, drug and

This methodology allows the sources

and accurately using an array of molecular

food micro testing, along with plant diagnostics.

genetic technologies that are very selective as well as sensitive.

The rapid identification of source fecal contamination assists health

Since its inception, Helix Biological Laboratory has distinguished

itself as a laboratory that has developed a high quality standard of

departments, municipalities and other agencies in quickly and

experimental expertise using a combination of leading edge molecular

efficiently identifying and taking measures to control the source or

biology and microbiological techniques for projects that require both

sources of fecal contamination in waterways. Helix is the industry

diverse and specialized proficiency. Helix Biological Laboratory’s diversity

leader in providing MST testing.

along with its ability to develop methods and custom design assays

provide a tremendous advantage to both current and potential clients.

analytical testing techniques for the detection and identification of

In addition to MST services, Helix provides the most advanced

a wide variety of bacterial, fungal and protozoan microorganisms that are sources of environmental health problems. The laboratory’s

Helix provides the most advanced analytical testing techniques for the detection and identification of a wide variety of bacterial, fungal and protozoan microorganisms that are sources of environmental health problems.

molecular technique capabilities also provide the means for performing metagenomics analysis. Metagenomics has emerged as a powerful tool that can be applied toward the analysis of microbial communities in environmental samples.

Michigan is fortunate to have an abundance of fresh water

resources like the Great Lakes, as well as many other waterways

Of the services that the lab provides, none stands out more than the

throughout the state. Water activities are an integral part of the

Microbial Source Tracking (MST) services and are unique in the industry.

culture in Michigan, so it is imperative that the health of waterways

MST involves a set of methods that are used to determine the host

be assured through the most advanced technologies available. Helix

source (human or animal) of fecal pollution in various waterways

Biological Laboratory sets a precedent for quality biological and

through the detection and identification of specific fecal indicator

analytical testing through innovative and industry-leading approaches

bacteria present in waterways.

and is helping insure the safety of Michigan’s water resources,

environment, agriculture and food.

Helix Biological Laboratory has been working with the Michigan

Department of Environmental Quality (MDEQ) as well as other

25 31 33

BioMatters || Spring Spring 2013 2011 BioMatters 2013

Geoff Horst, Chief Science Officer, selecting algal strains

Algal Scientific

Algae Startup Develops Lower-cost Manufacturing Platform for Valuable Immune Health Compound

Founded in 2009 by several graduate

students who won a University of

used with monoclonal antibodies in

lead to a heightened immune response,”

oncology therapies.

said LeBrun. “In one study we prevented

Michigan business plan competition,

Algal Scientific is commercializing a new

research to-date focus on beta glucans

as an antibiotic.”

type of low-cost manufacturing platform

that are extracted from yeast cell walls.

However, the majority of existing

for an immune health compound called

The company is entering the animal

feed market in the short term, with eyes

“beta-1,3-glucan”.

mortality from E. coli at the same level

“Over 20% of the poultry and swine grown in the U.S. does not use antibiotics as growth promoters.” (source: AgStats)

Jeff LeBrun, co-founder and product

manager for the beta glucan product, says that the company decided to develop a sterile fermentation process for making the product after learning

on the larger functional food ingredient market in the near future. In animal feed, beta glucans could be considered to be a pro-immune “alternative to antibiotics as a growth promoter — an industry practice that is facing increasing

about existing demand in the animal feed

scrutiny by governments, consumers

and nutraceutical industries.

and organizations such as the American

More than $200 million of basic

In contrast, Algal Scientific produces

Medical Association.”

research has already been invested

more bioavailable forms of beta glucans

into understanding the biology of

that are not bound to the cell wall,

up. Algal Scientific was told by the CEO

beta glucans. Several clinical trials

creating a cost advantage and the ability

of a public nutraceutical company that

have evaluated uses of beta glucans

to make more beta glucan extracts than

he believes beta glucans could be “the

applications ranging from prevention of

what is typically seen in the market today.

post-surgical infection to an adjuvant

“So far, we have performed several in

vivo studies that suggest our product can

BioMatters | Spring 2013

34

Recently, things have been heating

next Omega 3”.

The Omega 3 retail market is currently

estimated to be $30 billion annually.

Algamune™ AM – Beta Glucan

based algae

meal for animal immune health

The company reports to have made

Algal Scientific’s CEO Paul Horst is

Tests are currently underway at

a veteran entrepreneur who says he was

several major companies. Over the past

engaged with several multi-billion dollar

recruited “to bring some grey hair to

month, Algal Scientific has been receiving

companies that are evaluating their

the table.”

sample requests almost every week from

beta glucan product for uses including

various Fortune 500 companies who have

a functional food ingredient, an animal

can dramatically expand the current

seen their preliminary test results.

feed ingredient, and even as an adjuvant

market size by producing a more

for vaccine and monoclonal antibody

cost-effective product.”

“a couple early sales” while also being

Horst says, “We believe that we

therapies.

“Our regulatory consultants recently

confirmed that Algamune™ ZPC meets an approved animal feed ingredient definition allowing sales in the U.S.,” says Horst. “In addition to progress with customers, over the past six months we have made some key technical hires and we’ve demonstrated economical process metrics at a small commercial scale.”

The company says that although they

have benefited greatly from the facilities at the Michigan Life Science and Innovation Center, a former Pfizer R&D facility run by the Michigan Economic Development Corporation, they will soon need to expand into a larger commercial facility.

Based on the recent rate of progress,

Horst predicts that Algal Scientific will have over $50 million in product sales within a couple of years.

Craig Banotai, Senior Scientist, Algal Scientific, operating research fermenter

Not bad for a few graduate students

and some “grey hair”.

35

BioMatters | Spring 2013

polyElements:

New Startup Creates Nanofiber Scaffolds for Tissue Engineering

polyElements, LLC is a new biotechnology company founded

by three recent University of Michigan graduates. polyElements

Traditionally, cell culture is carried out on flat plastic or glass

surfaces coated with various polymers or proteins. However, this is

specializes in the creation of electrospun scaffolds for biological, medical, and tissue engineering research. Electrospun fibers can be

“Nanofibers offer a novel approach to cell and tissue research. We can consistently create a controlled environment, for cell growth and begin addressing specific questions about the relationship between cells and their environment.”

created from a variety of polymeric materials and can be designed to meet a number of specifications including diameter, alignment, elasticity, porosity, and hydrophobicity.

There is a diverse array of potential applications for

electrospun nanofibers. The fibers can be used as a scaffold to create semi-synthetic tissues, as a device-tissue interface for implantable biomedical devices, or as tools to study cellular biology. Currently well known in the field of biomedical engineering, biologists are beginning to realize the potential of

a far cry from the three dimensional environment cells occupy in

electrospun fibers to transform their own medical and basic science

vivo. New research continues to demonstrate the importance of

research methods.

cell-environment interactions to cell structure and function.

Recent studies have shown that cells can sense their physical

“Electrospinning is a difficult process with a high learning

curve, which has been a barrier to entry for scientists who may

surroundings and alter a number of cellular processes in response.

not have an engineering background,” says

For example, oligodendrocyte precursor cells

Sam Tuck, co-founder and lead technician

have been shown to wrap electrospun nanofibers

whose work has been featured in a number of

only when the nanofibers have diameters

scholarly publications including Nature Methods.

similar to the size of axons (Nature Methods,

“We have a combined 12 years of electrospinning

9:917-922, 2012). Expanding on these findings,

experience. We’ve mastered the curve and

researchers could create a neuron-free in vitro

can quickly customize scaffolds to address our clients’ specific

model of myelination which can be used to screen drug candidates

research questions.”

for demyelinating illnesses such as MS. Additionally, biological scientists could utilize the fibers to study alterations in cell signaling and gene expression caused by a specific nanotopography.

These are just two of many potential applications for our scaffolds.

“Nanofibers offer a novel approach to cell and tissue

research. We can consistently create a controlled environment, for cell growth and begin addressing specific questions about the relationship between cells and their environment,” says Michelle Leach, PhD, co-founder. polyElements currently offers a number of nanofiber products and an array of consultation services. The company is also working with a local manufacturer (MogulTech, Saline, MI) to produce an economical electrospinning rig for research groups.

For more information or to place an order, please visit www.polyElements.com.

Aligned

polymer microfibers for tissue scaffold research

BioMatters | Spring 2013

36 34

Ash Stevens Adds New Capacities and Capabilities with growing global demand from

approvals for FDA fast-tracked drugs

Southeast Michigan, is a provider of

biotech and pharmaceutical companies

developed under significantly accelerated

active pharmaceutical ingredient (API)

for these services. The additional capacity

timelines. Other FDA fast-tracked

development and manufacturing services

and services would also allow ASI to

manufacturing approvals for Ash Stevens

for clients in the Life Sciences industry

manufacture APIs for therapeutic

include the oncology drugs Velcade®

developing small-molecule innovator (New

indications requiring larger batch sizes

(Millennium /Takeda), Vidaza® (Celgene),

Chemical Entities or NCEs) drugs. The

while continuing in its leadership role

and Clolar® (Genzyme/Sanofi). Among

company was founded over fifty years ago

in the field of oncology chemistry.

ASI’s other manufacturing approvals is that

Ash Stevens Inc. (ASI), located in

by two chemists with deep ties to Wayne

The new large-scale reactor bay houses

State University (WSU) in Detroit: Dr. Art

2,000, 3,000 and 4,000-liter glass-lined

Ash, who received his doctorate degree in

vessels designed with appropriate

chemistry from WSU, and WSU chemistry

engineering controls for potent compound

Professor Dr. Cal Stevens. ASI initially

handling. The new, adjacent isolation bay

provided contract research services to

is equipped with a 1.5 m2 fixed filter dryer

the U.S. Government (Walter Reed Army

with glovebox technology for contained

Hospital, NIH, and NCI) and then over the

isolation, drying, and packaging of

years has provided contract chemistry

large-scale batches. This technology

support for many of the drugs developed

permits handling of potent compounds

through these government agencies.

and air sensitive materials at scale.

for Amotosalen used in the INTERCEPT Blood System for the Cerus Corporation.

In addition to the large-scale reactor and isolation bays, Ash Stevens has added many other upgrades to its Riverview manufacturing facility since beginning this expansion phase in 2006. These upgrades Ash Stevens still provides contract

include a new hydrogenation reactor

research services to the U.S. Government

bay, a new solid-state characterization

today. However, ASIs core business

laboratory, a new laboratory with

has since transitioned to providing

appropriate air handling systems for the

commercial drug development and cGMP

synthesis of highly potent compounds, a

manufacturing services to sponsor

new state-of-the-art materials storage and

companies in the life sciences industry

handling facility, new Rosenmund filter

developing small-molecule, innovator

dryers with glovebox technology, and a

drugs. The company’s clients range from

safety and hazard assessment laboratory.

virtual biotechs to some of the world’s

“With the completion of the

Ash Stevens’ new large-scale reactor bay housing 2,000, 3,000, and 4,000 liter reactors

Ash Stevens has excellent international

expansion, Ash Stevens will have the

regulatory compliance and safety. The

capability to meet the service and

company supports all facets of chemistry

construction, commissioning, and

capacity needs of our clients while still

and manufacturing controls (CMC) related

validation of a multi-year, multi-million

providing close interactive support and

to the development of small-molecule

dollar expansion to its cGMP manufacturing

project management demanded in today’s

APIs. The services offered by ASI include:

facility in Riverview, Michigan. Production

environment. We have come a long way

process development, cGMP manufacture

in the new bays begins in April 2013.

over the past fifty years and are very

of API for clinical trials, commercial API

excited to be completing this latest phase

manufacturing, comprehensive analytical,

and Chief Executive Officer, Dr. Stephen

of expansion at our state-of-the-art

and regulatory support, development and

Munk, recognized that the company’s

manufacturing facility,” says Dr. Munk.

manufacture of high potency APIs, and

largest pharmaceutical companies.

Ash Stevens recently completed

Ten years ago, Ash Stevens’ President

ability to function as a leader in the

Over the years, Ash Stevens has

preparation of documentation for

commercialization and manufacture of

achieved an impressive track record

submission (IND, NDA, DMF, CTD). For

chemically complex Active Pharmaceutical

with twelve FDA manufacturing approvals

more information on Ash Stevens, visit

Ingredients (APIs) would require an increase

for innovator APIs (NCEs) distributed

www.ashstevens.com.

in process capabilities simply to keep pace

world-wide. These include multiple API

37

BioMatters | Spring 2013

MPI Research:

3rd Largest Global CRO that Focuses on Improving the Odds

By Scott E. Boley, PhD, DAB, MPI Research, Senior Director, General Toxicology and Infusion

With the cost of bringing a new drug to

types of therapeutics (e.g., biopharmaceuticals, imaging agents,

market topping $1 billion, pharmaceutical

botanical products, and others). In these situations the “standard”

and biotechnology companies must make

approach was not appropriate to achieve approval for an Investigational

careful decisions about which candidates to

New Drug (IND) submission. This was the result of such factors as:

move forward along the drug development

• Selection criteria for the appropriate animal species to be used in testing

pathway. The primary challenge they face in developing their drugs and medical devices is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials.

Scott E. Boley

Nonclinical testing is required to establish both the efficacy of a new therapeutic as well as establishing a safe starting dose for the initial human clinical trials.

MPI Research, a full service preclinical Contract Research

Organization (CRO) located in Southwest Michigan, realizes that the development of novel therapeutics can be as diverse as the drugs developed within the industry. The company also understands how important it is to design a drug development program that is tailored specifically to the therapeutic that its sponsors are developing. There is not a “once size fits all” approach for therapeutics, and to design the right approach requires experience and regulatory knowledge of the various approaches that are critical to improve the odds of successfully moving into the clinical phase.

For many years, the majority of new therapeutics in development

involved small molecules designed to interact with cellular receptors.

The nonclinical studies conducted to support the progression of these products into Phase I became a “standard approach” for drug development and involved the following: in vitro genetic toxicology studies, safety pharmacology studies, general toxicology studies, and the associated analytical studies (formulation and bioanalytical). In recent years, however, there has been a dramatic increase in other

MPI Research

is known for its

surgical equipment and capabilities

• Immunogenicity concerns due to a lack of homology between the therapeutic and the animal species used for testing • The need to generate limited human data as part of the drug selection process • Therapies that are designed to be administered for limited lifetime use in humans • Therapies for life-threatening indications or serious diseases

where effective therapy is currently not available or of limited effectiveness • Physiochemical properties of therapeutics that justify the elimination/revision of specific studies

MPI Research has conducted thousands of efficacy and safety studies for small molecules and biopharmaceuticals (often referred to as large molecules or biologics), as well as medical devices. As a company, MPI works to maximize quality and efficiencies on behalf of its Sponsors’ regulatory applications. Partnering with pharmaceutical and biotechnology Sponsors in designing the studies required for the development of their

particular therapeutic, MPI can say with confidence that based on its amount of experience there isn’t much that the CRO hasn’t seen.

MPI’s goal is to improve the odds for sponsors, to select the right lead candidates, and to conduct the right studies in the right way, taking into consideration all factors to ensure their IND submission is successful. Contact info@mpiresearch.com to learn how MPI can help you achieve your drug and device research goals.

Aastrom Biosciences of Ann Arbor Conducts Final Stage Development of Cell Therapy Ixmyelocel-T Therapy to help patients with serious, untreatable cardiovascular diseases

One of Michigan’s oldest biotech companies, Aastrom

is exciting. However, rigorous clinical trials and a defined

Biosciences of Ann Arbor, has experienced a period of growth

regulatory strategy ensure that safe and effective products,

over the past few years, creating more jobs and expanding their

especially those with transformational potential, will reach

manufacturing infrastructure. The company is conducting the final

patients quickly.

stages of development of ixmyelocel-T, a cell therapy created

from a small sample of a patient’s own bone marrow that can

3 clinical trial in patients living with advanced peripheral

potentially treat multiple severe cardiovascular diseases.

arterial disease (PAD) who have limited treatment options.

Developing any therapy involving stem cells is

Ixmyelocel-T is currently being evaluated in a Phase

At this stage of the condition, patients can

challenging due to a number of reasons including

experience wounds that double in size,

strict regulations, a lengthy clinical trial process

gangrene, limb amputation and an increased

and the need for significant investment.

risk of mortality. In the completed Phase 2 trial,

Aastrom’s success in advancing ixmyelocel-T is

ixmyelocel-T was found to reduce the risk of a

the result of a number of key decisions and efforts

combined endpoint consisting of these negative

by the Aastrom team:

outcomes by 62% compared to placebo.

• The company uses only adult human stem cells from

Ixmyelocel-T is also being studied in patients living with

each patient’s own bone marrow. As a result, the

dilated cardiomyopathy (DCM), a condition that causes the

production process is not associated with the ethical

weakening and enlargement of the heart. A Phase 2 trial is

issues surrounding the use of embryonic stem cells.

underway in patients who have DCM as well as coronary artery

In addition, because Aastrom uses the patient’s own cells

disease or blockages in the arteries that lead to the heart.

to develop ixmyelocel-T, there is minimal risk of rejection.

high-risk surgeries for these patients, improve their quality

• The company uses a proprietary production process

“We have a unique opportunity to prevent invasive and

and a centralized manufacturing facility to ensure

of life and set new standards of care. Our team is working

that every patient receives a safe, consistent,

aggressively to accelerate the pace of development of

high-quality product derived from his or her own cells.

ixmyelocel-T to bring this treatment to patients in need,”

said Mr. Colangelo.

• Aastrom’s development team is following a clear

regulatory path established by other autologous

cellular therapies that have been approved by the

thus far and the company continues to explore new disease

FDA in recent years.

areas where patients can benefit from this therapy. The

ability to safely and effectively produce patient-specific

The positive attributes of ixmyelocel T, including its

Over 200 patients have been treated with ixmyelocel-T

autologous nature and multicellular composition, distinguish

therapies is a strong advantage for Aastrom as the company

it from other experimental cell therapies.

looks to grow its pipeline in Michigan.

“I have seen firsthand the tremendous potential of

Aastrom Biosciences is the leader in developing patient-

ixmyelocel-T to treat severe cardiovascular disease and

specific, expanded multicellular therapies for use in the

believe we have the potential to give new hope to people

treatment of patients with severe, chronic cardiovascular

with peripheral arterial disease

diseases. The company’s

and dilated cardiomyopathy who

proprietary cell-processing

have few or no other treatment

technology enables the

options available to them,”

manufacture of ixmyelocel-T

said Nick Colangelo, Aastrom’s

therapy expanded from a

president and CEO.

patient’s own bone marrow and

The prospect of new

delivered directly to damaged

regenerative treatments of

tissues. For more information,

diseases where current medicine

please visit Aastrom’s website

offers little hope for the patient

at www.aastrom.com.

Mary Ann Potok,

research associate, staining microscope slides to identify cell

types in bone marrow

39

BioMatters | Spring 2013

nanOss

Bioactive 3D

porosity (x30)

Pioneer® Surgical Technology, Inc.

Innovates With Its New Bone Graft

Pioneer Surgical, a medical technology

Executive Vice President — Biologics and

room times and patient outcomes. Today

company based in Marquette, Michigan,

Surgical Solutions for Pioneer stated,

they are considered national leaders in

recently added the innovative nanOss

“Three-dimensional shapes are popular

the design and manufacture of spinal and

Bioactive 3D to its flagship biologic bone

in spine surgery and with this addition,

orthopedic implants and instruments.

graft product line, nanOss Bioactive.

we now have one of the most extensive

The new nanOss Bioactive 3D is a bone

biologic portfolios on the market.” More

domestically and internationally,

Since then, Pioneer has expanded

void filler and bone graft extender in the

with several facilities throughout the

form of a three dimensional strip. nanOss

U.S. and in Houten, The Netherlands,

Bioactive 3D is comprised of a proprietary

employing nearly 300 people worldwide.

nanocrystalline hydroxyapatite as well as

The company’s vertically-integrated

a collagen-based biopolymer, that provide

manufacturing capabilities differentiate

a scaffold for the in-growth of new

information regarding Pioneer Surgical’s

it from others in the marketplace, greatly

bone in the posterolateral spine. nanOss

biologics product offerings, including

enhancing its ability to take an idea from

Bioactive 3D uses similar technology as

nanOss Bioactive 3D, can be found at

the drawing board to commercialization.

nanOss Bioactive, which was introduced

www.pioneersurgical.com.

Pioneer demonstrates a commitment

in a paste format in 2009. Pioneer Surgical

to surgical innovation by designing

offers several sizes of nanOss Bioactive

osteoconductive implant that provides an

and delivering products that provide

3D, including 5cc, 10cc and 20cc formats.

interconnected porosity similar to human

intraoperative efficiency for surgeons,

cancellous bone. Osteoconductive means

cost-effectiveness for the healthcare

market with two acquisitions in 2007.

that bone grows onto the surface or into

system and better outcomes for patients.

Pioneer’s biologics products have been

pores of the implant. nanOss Bioactive

For more information on Pioneer

the recipient of many prestigious

3D is used to fill bony voids or gaps

Surgical and its products visit

acknowledgements, including the 2005

created during surgery, traumatic

www.pioneersurgical.com.

Technology Award for nanocrystalline

injury, or for other bone voids not

hydroxyapatite in nanOss Bioactive, and

essential for stability. nanoss Bioactive

the 2009 Technology Award for engineered

3D is used in conjunction with the

collagen in nanOss Bioactive. Pioneer

patients’ own bone marrow aspirate

Surgical offers a full line of synthetic bone

and autograft bone, and is placed

grafts as well as human tissue products

into voids or gaps in the posterolateral

including machined lateral, traditional

spine. In time, nanOss Bioactive 3D is

lumbar and cervical allograft, human

resorbed and replaced by the growth

demineralized bone matrix (DBM) bone

of new bone during the healing process.

Pioneer Surgical entered the biologics

nanOss Bioactive 3D is an

grafts, as well as bone graft delivery

The company was started in

accessories.

Marquette, Michigan in 1992 by

orthopedic surgeon Dr. Matthew Songer

Regarding Pioneer’s latest biologics

product line extension, Mr. Shane Ray,

and his father, Robert. The pair sought innovative ways to improve operating

BioMatters | Spring 2013

40

ANALYTICAL/BIOANALYTICAL

DRUG SAFETY

GOING BEYOND CANDIDATE SELECTION

Beyond Expectations.

MPI Research is more than your typical CRO. We are leading the way in drug and device development, from discovery through early clinical testing.

Beyond Transactional.

At MPI Research, our broad scope of preclinical and early clinical services are supported by excellent scientific expertise. As the world’s largest preclinical research CRO in one location, our depth of experience enables us to offer a collaborative environment, the knowledge base to handle all types of studies, and the capability to smoothly transition from preclinical to clinical testing. Our Sponsors appreciate our ability to be their strategic partner in moving their drug or device along the development pathway.

LEAD OPTIMIZATION

Ready to Go Beyond?

DRUG EFFICACY

For more information, visit www.mpiresearch.com

TARGET ID & VALIDATION

Meet us at BIO International Convention booth #1473.

Fastforward WITH

Business Intelligence & Educational Resources

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Product Commercialization Planning Support

Introducing MichBio’s Emerging Biz Solutions, a new entrepreneurial support services pilot

Business Partnering & Development Support

program designed to provide highly specialized product development planning resources, business

Visit www.MichBio.org/EmergingBizSolutions

partnering connections

for more information and to apply.

and industry intelligence to bioscience companies.

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