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BioMatters FA L L 2 0 1 0

A MichBio Publication Showcasing Michigan’s Biosciences Industry

From Molecule to Market:

Michigan’s CROs Go Faster, Farther… for Less

Also Featured: “Rust Belt” Takes on New Shine as Bio Activity Booms New Oakland University Wm. Beaumont School of Medicine Takes Non-Traditional Approach Specialty Centers Add Fuel to University Research Powerhouses


get connected.

Find the people and careers driving innovation in the biosciences industry. Visit the new MichBio Career Center, where we’re bringing professionals and employers together in Michigan’s biosciences community. Recruit top talent, find biotech jobs and get connected.

Visit the MichBio Career Center today!

www.michbio.org


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 BioMatters, the bi-annual publication of MichBio (Michigan Biosciences

Industry Association). Despite recent economic challenges and uncertainty, Michigan has witnessed some remarkable achievements within its biosciences industry. This fifth issue provides an opportunity for us to showcase our significant biosciences community and raise awareness of its many strengths and dynamic growth.

Michigan has seen its bioscience employment grow by 5.6% and its number of

bioscience establishments increase by 13.2% from 2001 to 2008 (according to the Battelle/BIO State Bioscience Initiatives 2010 Report). This growth was faster than the national average, especially in the R&D/Testing and Ag/Chemicals sub-sectors.

Venture capital investment rose steadily during that period to a peak of $138

million in 2008 (with a six-year cumulative of $440 million). Our research universities, especially those of the University Research Corridor (Michigan State, University of Michigan and Wayne State) continue to be leaders in the amount of bioscience R&D expenditures (>$950 million) and patents issued (1,871 from 2004 to 2009). In addition, the state’s biosciences industry has witnessed a surge in entrepreneurial ventures, largely due to the retention and redirection of a high-quality bio-workforce following contractions in the pharmaceutical sector. A number of those enterprises are on upward trajectories with notable investment or have had tremendously successful market exits already.

One of the primary functions of an industry association such as ours is to promote

Michigan’s diverse strengths in biosciences. In this issue, you will find information about

Stephen T. Rapundalo, Ph.D. President and CEO srapundalo@michbio.org 734.527.9144 Jayne Berkaw Director, Marketing and Communications jayne@michbio.org 734.527.9147 Heather Kusiak Manager, Operations and Membership heather@michbio.org 734.527.9150 Nancy Marcotte Manager, Finance nancy@michbio.org 734.527.9145

our drug development CRO network, unparalleled anywhere in the country, new entrepreneurial ventures on the path to commercialization, specialty research centers within our great academic institutions, growth in medical education, and regional economic development efforts to further develop the bio-industry throughout the state.

We are extremely excited about sharing the news of recent developments in

C O N TA C T I N F O R M AT I O N Physical Address

Michigan’s biosciences community. We look forward to your continued interest and

3520 Green Court, Suite 450

support as MichBio strives to foster the growth of the biosciences industry in Michigan.

Ann Arbor, Michigan 48105-1579

Whether your company is well established here, just emerging or considering its development, Michigan offers a broad array of resources and partnering groups that

Mailing Address

stand ready to help evolve your vision into success. Please join us!

P.O. Box 130199 Ann Arbor, Michigan 48113-0199 Phone 734.527.9150

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

Fax 734.302.4933 Website www.michbio.org Email info@michbio.org

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BioMatters | Fall 2010


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

P L AT I N U M

GOLD

S I LV E R

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 Chairman Stephen Munk, Ph.D. Ash Stevens, President and CEO Vice Chairman Davis 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 and CEO

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

Secretary Christina DeHayes Asterand plc, General Counsel

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

Treasurer Matthew L. McColl Ernst & Young LLP, Partner

Jennifer Rice Neogen Corporation Senior Scientific Officer

ssistant Treasurer A Ryan Noel Division of Metabolism, Endocrinology and Diabetes, University of Michigan Administrator

John J.H. Schwarz, M.D. Family Health Center Physician, Former U.S. Representative

Directors Linda Chamberlain, Ph.D. Center for Entrepreneurship & Innovation Grand Valley State University Executive Director

BRONZE

J. Patrick Elliott Terumo Cardiovascular Systems Corp. Vice President, Business Development David Felten, M.D., Ph.D. Beaumont Hospitals, Research Institute Vice President, Research and Medical Director

MEDIA

PATRON

Ash Stevens, Asterand, Lumigen, Terumo, Varnum

FRIEND

Kalexsyn, Phadia US, Inc., Wayne State University

SUPPORTER

Biotechnology Business Consultants, Caraco, sanofi-aventis U.S., West Michigan Science & Technology Initiative

BioMatters | Fall 2010

Barry Klein GlaxoSmithKline Regional Marketing Manager

James Freeman, Ph.D. Pfizer Animal Health Vice President, Laboratory Sciences Teri Grieb U of M Medical School, Office of Research Director of Administration for Research Office of Research and Graduate Studies Mark Kielb Altarum Institute Chief Financial Officer

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Eric Stief Wayne State University — Technology Commercialization Licensing Manager Director of Venture Development Karen Studer-Rabeler Coy Manufacturing/ Coy Laboratory Products General Manager Vice President, Business Development Bill Worzel Genetics Squared, Inc. President and CEO David Zimmermann Kalexsyn, Inc. Chief Executive Officer

Committees Clinical Trials Financial Services and Risk Management Intellectual Property and Legal Membership and Marketing Programs Public Policy


Karsten Gamble ‘12 Mechanical Engineering/Bio-engineering Biomet Sports Medicine

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

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MichBio Corporate Sponsors, Officers, Directors and Committees

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Feature Story: Ideas to Markets: Michigan’s Unrivalled Drug Development CRO Network Metabolic Solutions Finds Collaboration is the Path to Success

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ECONOMIC DEVELOPMENT: Michigan’s “Rust Belt” Takes on New Shine as Bio Activity Grows

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RX for Traverse City: Supplement Tourism with Healthcare, Medical Devices

Growing and Sustaining a Vibrant Michigan Biosciences Community

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22

EDUCATION: Non-Traditional Education and Early Clinical Practice are Key Priorities at New Medical School Center Serves as Foundation for Growth of Oakland University Wm. Beaumont Hospital Medical School

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PROFILE: “Entrepreneurs of the Year” Guide Kalexsyn to Success

Research: Specialty Research Centers Raise Profile of Michigan Universities

31

Karmanos Keeps Its Eye on the Prize: A Cure for Cancer

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ENTREPRENEURS: Entrepreneurship Drives the Next Wave of Michigan Biotech Innovation

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Guest Opinion: Biotech Workforce Development: A Partnership between Industry and Academia

The following MichBio members are featured in this issue of BioMatters: AAPharmaSyn LLC, Ann Arbor SPARK, Apjohn Group LLC, Armune BioScience, Inc., Ash Stevens, Barbara Ann Karmanos Cancer Institute, Beaumont Hospitals, Center for Clinical Research Solutions, Inc., Dow Chemical Co., Draths Corporation, Ferris State University, HistoSonics LLC, Innovative Analytics, Inc., Jasper Clinical Research & Development, Inc., Kalexsyn, Inc., Metabolic Solutions Development Co., Michigan State University, Michigan Technology & Research Institute, MPI Research, Inc., Oakland University, Pfizer, PharmOptima LLC, Phrixus Pharmaceuticals, Southwest Michigan First, Tolera Therapeutics, University of Michigan, Wayne State University, and Western Michigan University.

Subscribe to BioMatters:

Visit www.michbio.org and click “Register Now” or call 734.527.9150.

ADVERTISERS Ash Stevens .............................................................. 26 Asterand .................................................................. 26 Calibrate................................................................... 34 DBA Analytical......................................................... 26 Doeren Mayhew....................................................... 34 Dykema.................................................................... 24 Grand Valley State University.................................. 35 Great Lakes Entrepreneur’s Quest .......................... 35 Healthmark Industries............................................ 20 Kalexsyn, Inc. ........................................................... 20

Kettering University .................................................. 3 MichBio .................................................................. BC MichBio Career Center .......................................... IFC Michigan Economic Development Corporation.... IBC Michigan State University ....................................... 39 MPI Research .......................................................... 27 Oakland University.................................................. 20 Pfizer........................................................................... 4 PhRMA..................................................................... 21 Radar Fishman & Grauer ....................................... 35

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The Brooks Industrial Park..................................... 10 The Timberland Group ........................................... 21 Varnum Law............................................................. 34 West Michigan Science & Technology Initiative ....13 Western Michigan University.................................. 27

BioMatters | Fall 2010


F E AT U R E S TO RY

Ideas to Markets:

Michigan’s Unrivalled Drug

Michigan’s pharmaceutical industry has a different face today. Where large companies like Upjohn and Pfizer once ruled the landscape, contract research organizations have now largely absorbed their intellectual capital. Some 200 CRO’s operate in the Kalamazoo-Grand Rapids area alone. By Tom Beaman

Target and Model Validation:

“Big Pharma is coming to the realization that a small group of gifted and talented researchers can go faster and produce better results at a lower cost,” says Ron Kitchens, CEO of Southwest Michigan First. Here’s a look at five CRO’s that specialize in various stages along the drug development pathway.

BioMatters | Fall 2010

“Big Pharma is coming to the realization that a small group of gifted and talented researchers can go faster and produce better results at a lower cost”

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Michigan State University In Vivo Pharmacology Facility, East Lansing Michigan State University’s In Vivo Pharmacology Facility is bringing customer service to the world of biotechnology research,


MSU’s In Vivo Pharmacology

service facility is led

by pharma industry veterans and contracts with both private sector and academia to facilitate research.

providing not only the university’s expertise to academic and private sector scientists, but also a respect for their unique requirements. “In the past, universities and the private sector always worked together on a one-off basis, but universities were never really focused on that,” says Marc Bailie, DVM, PhD, a former Pfizer

chemists in the labs of

AAPharmaSyn

Photo courtesy of AA PharmaSyn

Medicinal

focus on

synthesizing organic compounds and providing support for drug discovery research.

Photo courtesy of Michigan State University

Development CRO Network

director of safety pharmacology who heads the four-person staff. He says academic researchers in less-structured relationships with clients can often

“Michigan State has now institutionalized the concept of outreach and customer support.”

be distracted by other professional pressures and fail to meet clients’ specific needs. With the In Vivo Pharmacology Facility, Bailie says, “Michigan State has now institutionalized the concept of outreach and customer support.”

7

The Facility has worked with over 20 clients since 2008 on studies ranging from pharmacokinetic characterization in rodents to chronic heart failure in large animals, and it conducts research to their exact specifications. If a Michigan State faculty member leads a project, Bailie’s team helps them understand the client’s needs and assures that they stay on task and follow the scope of the project. “We partner not just with Michigan State’s pharmacology and toxicology departments, but with pathology, physiology, and the veterinary school,” Bailie says. “We have reached out across the sciences.”

BioMatters | Fall 2010


F E AT U R E S TO RY

A scientist

at

MPI Research

handles cryo-banked

cell samples located in their dedicated, discovery services area.

Chemistry Selection/ Characterization: AAPharmaSyn, LLC, Ann Arbor Dr. Helen T. Lee, can list many accomplishments during her career, including being inventor or co-inventor of 55 patents. But as president of business development for Ann Arbor-based AAPharmaSyn LLC, she is most proud that her CRO exists at all. “Most people think this is a big achievement — a whole bunch of chemists who don’t know anything about business,” she says. “Our doors are open and we are busier than ever.” Founded in 2006 with lab equipment donated by Pfizer Inc. — via the Michigan Innovation Equipment Depot program — AAPharmaSyn specializes in synthesizing organic compounds and medicinal chemistry research support. Since then, its client list has grown to nearly three-dozen universities and life science, pharmaceutical, and biotech companies. Lee says AAPharmaSyn serves the needs of large firms whose chemists cannot take on more work and small biotech companies that lack in-house resources. “CRO’s are getting busier because many companies are downsizing and laying off chemists,” she adds. Indeed, AAPharmaSyn’s 12 employees had worked at Pfizer’s now-shuttered Ann Arbor campus. While the privately held company does not release financial information, Lee says AAPharmaSyn continues to grow and is building an enviable reputation. “We deliver, and we deliver on time,” she says. “Clients have gone overseas to try to get a better deal and save money, but a year later they come back to us.”

“We’re in a growth mode,” Laveglia says. “It makes you feel good about working in Michigan.”

Photo courtesy of MPI Research

Pre-Clinical Pharmacology/ Toxicology:

BioMatters | Fall 2010

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MPI Research, Kalamazoo Mattawan-based MPI Research Inc., with 1,250 employees and hundreds of clients, is the third largest pre-clinical CRO in the world. The company has carved a niche for itself serving smaller continued on page

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F E AT U R E S TO RY

Metabolic Solutions Finds Collaboration is the Path to Success

“We had a lot of friends who’d stayed in Kalamazoo [after Pfizer

closed its human health discovery operation] and had set up contract research organizations that were doing pretty well,” Colca says. “Kalexsyn had a lot of the medicinal chemists I had worked with, so all we had to do was show them how to make the compound.”

Photo courtesy of Metabolic Solutions Development Company.

“There’s expertise in the development of small molecules that exists in Michigan that doesn’t exist anywhere else, not just on the science level, but on every level of the business that you can imagine— marketing and sales expertise exists right here.”

and

Jerry Colca (left)

rewards.

Metabolic Solutions Development

The partners also worked with Innovative Analytics Inc. to manage

for phase I clinical trials; MPI Research for pre-clinical toxicology; PharmOptima LLC for pharmacology and initial toxicology work related to animal testing; and AvTech Laboratories to conduct analytical chemistry to support pre-clinical and clinical studies. Ash Stevens, Inc. in Detroit supplied current Good Manufacturing Practice materials for clinical trials.

“Michigan has a really unique collection of talent,” says Colca. “For

years, Upjohn recruited people to Kalamazoo, and you had Parke-Davis in Ann Arbor. Both of those companies are gone, but a lot of the people that they recruited and trained are still here. There’s expertise in the development of small molecules that exists in Michigan that doesn’t exist anywhere else, not just on the science level, but on every level of the business that

is reaping

you can imagine - marketing and sales expertise exists right here.”

clinical trial data; Jasper Clinical Research and Development, Inc.

sought a better approach to diabetes research, and

the collaborative business model they implemented at

Rolf Kietzien (right)

In the meantime, the company continues its research into the treat-

After more than 30 years experience in diabetes research and

ment of type 2 diabetes. In a recently completed phase IIa study, MSDC’s

scientific positions at Upjohn, Pharmacia, and Pfizer, Jerry Colca,

lead candidate, MSDC-0160, successfully achieved effective glucose con-

Ph.D., retired in 2005 to follow a different drummer. Impatient with

trol without the side effects of weight gain or plasma volume expansion.

the approach to diabetes research being taken by the pharmaceutical

“We think it’ll be a better drug,” says Colca.

industry, Colca and partner Rolf Kletzien formed Metabolic Solutions Development Co. in Kalamazoo in 2006.

Metabolic Solutions’ Approach: Modular Organization of Contract “Departments”

They also leveraged their network of former colleagues in the region, and in the process, created a new model for pharmacological research that’s lean and flexible.

With an office in a spare bedroom, a rented lab bench at Western

Michigan University, and $250,000 of their own money, Colca and Kletzien went to work on their first project–investigating an isomer of one of the metabolites of the diabetes drug Actos (pioglitazone) that they believed could lead to a breakthrough in the treatment of type 2 diabetes. They also leveraged their network of former colleagues in the

Medicinal Chemistry

Kalexsyn (Kalamazoo)

Pharmacology/Metabolism

PharmOptima (Kalamazoo)

API production [GMP]

Ash Stevens (Detroit/Riverside)

Analytical/Kinetics

AvTech/Eurofins (Kalamazoo)

Preclinical Toxicology

MPI Research (Mattawan)

Clinical Trials

Jasper Clinical (Kalamazoo)

Clinical Trial Design/Statistics

Innovative Analytics (Kalamazoo)

Regulatory Affairs

Ken King Associates (Ann Arbor)

Clinical Supplies

TEAM Pharmaceutical (Martin)

Legal/Intellectual Property

Honigman (Kalamazoo)

Cell biology, Proteomics, etc.

Van Andel Institute (Grand Rapids)

Discovery Research

SWM Innovation Center (Kalamazoo)

Using existing infrastructure allows for growth of “IP” companies: • Creates expanding value (feeder system for development) • New companies with product line and sustained growth

region, and in the process, created a new model for pharmacological research that’s lean and flexible.

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BioMatters | Fall 2010


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Photos courtesy of MPI Research

F E AT U R E S TO RY

MPI

helps clients ensure the safety and efficacy of compounds before their use in clinical trials.

pharmaceutical and biotech firms, says James Laveglia, Ph.D., executive vice president, drug safety evaluation. MPI Research helps clients ensure the safety and efficacy of compounds before they use them in human clinical trials. It collaborated with Cordis Corp. on research that resulted in Cordis being the first company to receive FDA approval for the drug eluting Cypher coronary stent. Laveglia is especially gratified by the work MPI Research did for a client that was developing stem cell therapy for severed spinal cords. “We injected stem cells into rats with injured spinal cords and in a matter of days the rats were walking on their own,” he says. “I’m very proud to say that we worked with this company to get them their first IND (Investigational New Drug) for stem cells with the FDA. That’s really huge.” Since it’s founding, in 1995, through 2008, MPI Research’s revenue has grown an average of 34 percent per year. “We’re in a growth mode,” Laveglia says. “It makes you feel good about working in Michigan.”

“The majority of our clients are early stage biotechnology or pharmaceutical companies,” says Michael R. Bleavins, president of the laboratory center at MITRI and a former Pfizer and Warner-Lambert scientist. “They’re normally at the stage where they have a promising molecule, but they’ve not had a lot of interactions with the FDA. We help clients design the studies that are required to meet federal regulations and to put together a scientifically valid approach.” A scientist

at the

MPI Research

labs.

Development Pharmacology/Safety: Michigan Technology and Research Institute (MITRI), Ann Arbor The U.S. bioscience industry comprises thousands of creative minds, but not all of them are as skilled at navigating the labyrinth of regulation and documentation relating to drug safety as they are at building a molecular compound. That’s where the Michigan Technology & Research Institute in Ann Arbor comes into play.

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“The idea is to get a decision as quickly as possible, either to advance a good compound or eliminate a bad one.” MITRI, whose clients extend from San Francisco to Europe, also helps to determine the efficacy of pharmacological compounds and whether further investment in them is warranted. “We help manage the risk,” Bleavins says. “One of the things that is really important in the drug development

BioMatters | Fall 2010


Photo courtesy of Michigan Technology & Research Institute

F E AT U R E S TO RY

The Michigan Technology and Research Institute provides tools, ideas and laboratory support session with Mike Bleavins (right), MTRI president, and other members of the MTRI team.

process is [to arrive at] either ‘yes, we want to go forward’ or ‘no, we want to kill the compound.’ If you fall in the middle you can be there for a long time and spend a lot of money. The idea is to get a decision as quickly as possible, either to advance a good compound or eliminate a bad one.”

“We are a clinical research consulting firm,” says Michele Sciamanna, Ph.D., who founded C2RS in 2008. “We can assist with investigative site personnel training and education, on-site coordinator services, recruitment of the study, and pre-site visits

“We’d hate to see something that could have changed millions of lives not make it to market because of failed clinical trials.”

Clinical Development/ Medical Affairs: Center for Clinical Research Solutions, Inc., Kalamazoo As the regulations and technologies faced by today’s clinical researchers get more complicated, the Center for Clinical Research Solutions Inc. (C2RS) in Kalamazoo offers training and assistance that results in a win-win for sponsors and investigators alike.

BioMatters | Fall 2010

to assist clients in selecting the most promising new drug candidates.

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Above,

a planning

with the sponsor.” C2RS also helps sponsors develop clinical research programs, from early laboratory bench work to helping identify pre-clinical study resources and facilities.


Michigan CRO Companies Cross All Phases of the Pharmaceutical R&D Life Cycle Target and Model Validation

Chemistry Selection and Characterization

Preclinical Pharmacology and Toxicology

Development Pharmacology and Safety

Clinical Development and Medical Affairs

Patient Use and Post-Market Activities

that means making sure that they’re safe and that these clinical trials are conducted with the [highest] clinical practices,” Sciamanna says. “We’d hate to see something that could have changed millions of lives not make it to market because of failed clinical trials.”

Sciamanna sees growth opportunities for her young company in consulting with community hospitals that want to become more active in clinical research. “It allows non-academic physicians to participate, and certainly with medical devices, that’s very important,” she says. Sciamanna says she formed C2RS to improve patients’ quality of life. “We want to make sure that patients are number one, and

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BioMatters | Fall 2010


economic D evelopment

Michigan’s “Rust Belt” Takes on New Shine as Bio Activity Grows Ask people what comes to mind when they think of cities such as Flint, Lansing and Saginaw, and their response is likely to be “rust belt.” But these cities and others located far from the biosciences hotspots in southern Michigan are shaking off that label. By Rick Haglund They’re nurturing new businesses in such areas as medical devices, alternative energy and other bio-based industries. Economic development agencies in mid- and northern Michigan say they are turning to the biosciences as one way to try to revitalize their regions, which have been hard hit by the recession and the near collapse of the domestic auto industry. “You’re talking about a talent industry,” said Ray DeWinkle, senior vice president of global business development at

the Lansing Economic Area Partnership, about biosciences. “The intersection of economic development and talent development is coming closer together.” Lansing’s Draths Corporation uses microbiological methods to transform sugars, often from corn, into high value chemical intermediates. The company is focused on manufacturing biobased materials used in everyday products.

Draths Corp. Cultivates Success in Lansing Area One of Lansing’s promising companies is Draths Corporation, a chemical company startup that takes corn and other bio-based feedstocks, and converts them into nylons and other polymers.

Economic development agencies in mid- and northern Michigan say they are turning to the biosciences as one way to try to revitalize their region. “We wouldn’t be anyplace else,” said Roger Cook, operations manager at Draths, which expanded in September into a new 30,000 square-foot building and hopes to employ 200 workers by 2014.

BioMatters | Fall 2010

14


Photos courtesy of The Standing Co.

One

of

Saginaw’s

success stories,

The Standing Company,

physiological as well as psychological benefits.

The company now employs 30 biologists, chemists and other workers and plans to hire 10 more people in the next six months. Draths was founded in 2005 by Michigan State University professors John and Karen Frost, who spun off their work in bacterial organisms into a private company.

Draths benefits from a variety of bioscience resources at MSU and has been able to attract quality talent. Cook said the poor image of Michigan’s economy by outsiders is unsettling, but the benefits of growing a new business in the Lansing area are numerous. “If you’re just listening to what’s on the news, you’d say ‘I’m not considering (Michigan),’” he said. Draths benefits from a variety of bioscience resources at MSU and has been able to attract quality talent. “It’s quite surprising who’s around in this area,” Cook said.

Saginaw Attracts Medical Device Companies with Incentives, Lifestyle Further north, the Saginaw area has become a regional center for health sciences and medical device manufacturers.

makes precision-built wheelchairs that allow chair-bound users to stand with ease and safety, a motion that has numerous

That’s in no small measure due to the presence of two large medical centers in the city, St. Mary’s of Michigan and Covenant HealthCare, the two biggest employers in Saginaw County. Together, they employ about 6,300 workers. JoAnn Crary, president of Saginaw Future, a local economic development agency, said her organization targeted the medical device industry for new business investment about five years ago. In addition to the typical tax incentives used to lure companies, Crary said Saginaw Future have been promoting the region’s manufacturing work force, displaced from the auto industry, as a selling point to prospective employers.

JoAnn Crary, president of Saginaw Future, a local economic development agency, said her organization targeted the medical device industry for new business investment about five years ago. “We have generations of precision manufacturing expertise,” she said. “You can find the employees you’re looking for here.” Among the medical-related companies in the area are Orchid Unique Orthopedic Solutions, which makes precision surgical cutting tools, and Filtrona Porous Technologies, which manufactures high-tech filtering

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systems for medical and other uses, and the Standing Company, whose products enable those confined to a wheelchair to stand up and stretch with ease and safety. Filtrona recently invested $2 million in its Saginaw-area operations, Crary said. Saginaw also is attractive for its location as the gateway to recreational and vacation opportunities in northern Michigan, she said. “We’re the last big city going north,” Crary said. “It’s part of our quality-of-life appeal.”

Dow Powers Midland/Mt. Pleasant Region with Resources, Support Dow Corning Corp. has long been an economic mainstay in mid-Michigan. The company is moving past its reputation for its role in the silicon breast implant controversy years ago with new products in the health field. Dow Corning’s Healthcare Industries Materials site in Hemlock employs 150 people developing products for the healthcare industry. Those products include pacemaker leads, nicotine patches, home diagnostic kits for renal patients and other pharmaceutical products. In the Midland/Mt. Pleasant region, the MidMichigan Innovation Center provides space and business services at its Midland incubator for 21 startup companies that employ 149 people.

BioMatters | Fall 2010


economic D evelopment

RX for Traverse City: Supplement Tourism with Healthcare, Medical Devices

Traverse City long has been known as a prime vacation

Munson is at the center of a growing

destination and the center of the nation’s tart cherry industry.

medical industry in the region that includes

such companies as Thompson Surgical Instru-

But spend some time driving around the post-card-pretty

Grand Traverse region and what you’ll see is a surprising

ments, which manufactures bone retractor tools

number of new buildings dedicated to healthcare, medical

used in surgeries, and Teeter Orthotics, which makes

device manufacturing and bio-related alternative energy.

devices used in the treatment of back and neck pain.

“There are a lot of profession-

Traverse City also has seen an expansion

als between the ages of 30 and 39

of orthopaedic clinics in recent years. That’s not surprising,

who vacationed here when they

considering the active lifestyles of its residents and the growth

were younger,” said Tino Breithaupt,

of the retiree population.

senior vice president of economic development at the Traverse City

“We don’t have a lot of Petri dish research in the Traverse City area,” Breithaupt said. What it does have is Munson Healthcare, a seven-hospital, regional health system that employs 6,500 people.

Area Chamber of Commerce.

“They want to raise their families

here and make a living. You can do Tino Breithaupt, vice president of economic development for

that now,” said Breithaupt, who was born and raised in Traverse City.

Traverse City Chamber of Commerce, is bullish on the area’s bio-business potential, and its

in such biosciences hotspots as Ann

robust and desirable quality of

Arbor and Grand Rapids, but the old

across the street from Munson Medical Center,” Breithaupt

saying, “a view of the bay is half

said. “We’re really seeing a lot of growth here.”

the

life is the topping on the cake.

Salaries may not be as high as “It really is an amazing cluster of medical activity right

your pay,” doesn’t ring nearly as true as it did years ago.

Power, the local electric utility, has been working on plans

Breithaupt said his agency, which covers Benzie, Grand

In the alternative energy sector, Traverse City Light &

Traverse, Kalkaska and Leelanau counties, uses the traditional

for a biomass plant.

tools of tax breaks and other financial incentives to attract

companies in the life sciences and bio-related sectors.

converting a defunct auto parts plant in Traverse City into

And American Waste, a Kalkaska-based company, is

a facility that converts solid waste into products used to produce energy.

But spend some time driving around the post-card-pretty Grand Traverse region and what you’ll see is a surprising number of new buildings dedicated to healthcare, medical device manufacturing and bio-related alternative energy.

Traverse City lacks a four-year university that often is at

the center of biosciences activity. But the local community college, Northwestern Michigan College, has partnered with 10 four-year universities that offer bachelor’s, master’s and doctorate degrees in such areas as education, business, nursing and social work.

But the region also realizes that it isn’t going to challenge

The college also features the Water Studies Institute,

southern Michigan as a center for biosciences research.

which offers an associate’s degree in water studies that

focuses on global freshwater policy, sustainability and

“We don’t have a lot of Petri dish research in the Traverse

City area,” Breithaupt said.

stewardship of the Great Lakes.

What it does have is Munson Healthcare, a seven-hospital,

Breithaupt said the NMC University Center could someday

regional health system that employs 6,500 people as well as

lend itself to the establishment of small research labs in the

the Northern Michigan Regional Health System that serves 22

areas of healthcare, food sciences, water studies or alterna-

countries.

tive energy.

BioMatters | Fall 2010

16

“We think that makes a lot of sense for this area,” he said.


Dow Corning® Pharma fabricated tubing assemblies used for fluid transport applications in pharmaceutical processing.

They include Gantec, Inc., a maker of sprays, plant supplements and soil additives from natural substances for home and

“Our region has an extensive network of business experts thanks to our rich history with the chemical, automotive and related industries.” commercial use, and Caltech Industries, whose EPA-registered, fast-acting surface disinfectants protect healthcare workers and patients from environmental surface contamination by dangerous pathogens. The privately funded, nonprofit Innovation Center receives “significant” financial support from Dow Chemical Co. “Our region has an extensive network of business experts thanks to our rich history with the chemical, automotive and related industries,” said Bill Moneypenny, chief executive officer of the Innovation Center, in a recent newspaper op-ed column. “One of our key responsibilities as an incubation center is to tap into that expertise to assist entrepreneurs in growing their new businesses and help put many people back to work,” he said.

Flint Rebuilds with Bio Focus, Support of Universities and Active Chamber Flint, the birthplace of General Motors Co., has seen massive disinvestment by the company over the past several decades and the loss of tens of thousands of auto jobs.

The city is rebuilding its hard-hit economy, in part, by seeking new opportunities in healthcare and alternative energy. Its highest-profile project is a multimillion-dollar biogas plant being built by a Swedish company that was recruited to Flint by local officials and Gov. Jennifer Granholm. Swedish Biogas International is building a “green” electricity plant there, slated to cost as much as $5 million. It announced in August that it would spend another $2 million to $3 million to build a co-digester used to process human and food waste to create biogas. “I don’t think the current administration could be more helpful,” said Tom Guise, an Ann Arbor native who is the CEO of Swedish Biogas. “My feeling is they want to move forward and look to a new future.” The project has created only about 20 jobs so far, but the potential could be much larger, said Janice Karcher, vice president of economic development at the Genesee County Regional Chamber of Commerce. “It’s becoming a national headquarters for what is fast developing into a consulting and franchising approach to help other communities adopt a biogas system,” Karcher said. Guise said the plant will begin producing biogas energy early next year. In the biomedical area, the Insight Institute for Neurosurgery and Neuroscience is developing new therapies for pain management. Its president is Dr. Jawad Shah, a Canadian-born neurosurgeon, whose lofty goal for the institute is to become a “world class” biomedical campus.

17

His center in Flint features 600,000 square feet of available incubator space for health, business and software-related startups and clinical services provided by physicians. One of Flint’s advantages in developing new bio-related industries is its network of colleges that include Kettering University, the University of Michigan and Mott Community College. And like in Saginaw, economic developers in Flint see the region’s skilled manufacturing work force as a draw for medical device companies and others needing design, engineering and production expertise.

Photo courtesy of Swediish Biogas

Photo courtesy of Dow Corning

economic development

Swedish Biogas

is just one of the companies helping to

shape the future of

Flint. The

company is building a

new biogas plant next to an existing sludge plant to process waste and create biogas.

The real opportunity we see is in leveraging the supply base for the commercialization of new products,” Karsher said. Those products and the jobs they bring could create new life for Flint and other cities that are in transition from an industrial to a knowledge-based economy.

BioMatters | Fall 2010


D ATA

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BioMatters | Fall 2010

18


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BioMatters | Fall 2010


Beaumont Hospital’s 5,500 sq. ft. Surgical Learning Center, one of the most advanced medical simulation facilities in the nation, gives teams an opportunity to practice their skills using computerized, state-of-theart equipment in a safe environment.

Photos courtesy of Oakland University

education

Non-Traditional Education and Early Clinical Practice are Key Priorities at New Medical School Like other new medical schools being started around the country, the Oakland University William Beaumont School of Medicine was formed to address an expected future shortage of physicians. But that’s just part of the story. by Rick Haglund Founders of the OU Beaumont school say they are creating an educational model that will train physicians for profound changes in the medical field over the next decade. “We don’t know what primary care will look like in the next 10 years,” said Dr. Robert Folberg, founding dean of the school. “What society needs are medical schools that are flexible and adaptable to changing environments.”

BioMatters | Fall 2010

“Founders of the OU Beaumont school say they are creating an educational model that will train physicians for profound changes in the medical field over the next decade.” Experts say an aging population, changes in the healthcare delivery system and the impending retirements of perhaps a third of

22

the nation’s physicians are resulting in a spate of new medical schools. Federal healthcare reform, passed earlier this year, will give more people access to the healthcare system and require more physicians to meet the demand for services, some say. OU Beaumont, which received approval from the Liaison Committee for Medical Education in February, is among 15 new U.S. medical schools that have recently garnered preliminary accreditation.


Central Michigan University and Western Michigan University also are planning new medical schools. Michigan has four medical schools, one each at the University of Michigan and Wayne State University, and two at Michigan State University. Formed as a private school that will not receive state funding, OU Beaumont will open to its first class of 50 students in August 2011. “This is a tremendous development for the state, the region and the medical profession at large,” said Oakland University President Gary Russi. Unlike traditional medical schools— Folberg calls them “legacy” schools—OU Beaumont students won’t be spending the majority of their first two years learning basic medical science in lecture halls. They’ll be expected to engage in team-based collaborative learning. And they will have more patient contact in their first two years of medical school than in some legacy programs. Fifty percent of students’ time in the early stages of their education will be spent outside traditional classrooms. But students will cover all the same material as taught in legacy medical schools.

Early

Dr. Robert Folberg, Founding Dean, Oakland University Wm. Beaumont School of Medicine.

“Medicine is becoming more of a team sport.” Folberg said. “What we are doing is training physicians from the first day of medical school on how to be part of a team, how to lead a team and how to communicate with patients.” “Medicine is becoming more of a team sport.” Folberg said. “What we are doing is training physicians from the first day of medical school on how to be part of a team, how to lead a team and how to communicate with patients.” But as students move into their clinical rotations in their final two years of school, their basic science education will continue, he said. The school will be housed in the renovated O’Dowd Hall on Oakland University’s Rochester campus. Students will do their clinical work at Beaumont’s three hospitals in Royal Oak, Troy and Grosse Pointe.

And in another twist in their training, the school will require students to pick a research project they want to work on during their first three years with a report written on it in the fourth year. It’s called the Capstone Project. For instance, a student could work with a local school district on an obesity reduction project and measure the results in his or her final year of medical school. “I think that’s a terrific idea,” said. Dr. Daniel Michael, a Detroit neurosurgeon who also serves as president of the Michigan State Medical Society. OU Beaumont has to have something to attract the best and brightest.” Michael said he thinks the Capstone Project will help students become better physicians because it will teach them to assemble and interpret data about their patients. “So much of what we do is involved with gathering and synthesizing information,” he said. “People don’t see that. It’s the 75 percent of the iceberg that’s underwater.” Students with outstanding projects can win additional scholarship money for their fourth year of school, Folberg said. That’s likely to appeal to many of OU Beaumont’s

lessons on being part of and leading a team, as well as communicating with patients, will be fundamental to medical students at the new school.

23

BioMatters | Fall 2010


education

students because the cost of its tuition will be well above that charged by public universities in the state. OU Beaumont will charge $42,760 a year, nearly $16,000 a year more than Michigan State University College of Human Medicine’s in-state tuition of $26,954. The medical school already has raised $26.1 million for operations, some of which will go to financial aid. “At a minimum, 15 percent of the aggregate amount of tuition will be awarded in scholarships,” said Tracy Utech, the medical school’s assistant dean for development and director of philanthropy. The school also is taking a nontraditional approach to recruiting students. Unlike many others, it does not require minimum undergraduate grade-point averages or a minimum score on the Medical College Admission Test. “We do a holistic review of our applicants,” Folberg said. “We’re looking at critical thinking skills, intellectual curiosity and a commitment to life-long learning.”

Getting accepted to the school won’t be easy. There already are 2,500 applicants for the school’s 50 slots. The application deadline is Nov. 15. The school also is taking a nontraditional approach to

recruiting students. Unlike many others, it does not require minimum undergraduate gradepoint averages or a minimum score on the Medical College Admission Test.

The school is focusing on students who want to practice medicine and conduct research in Michigan, including areas underserved by physicians. It will have a tight link with Oakland University’s Center for Biomedical Research (see sidebar story), which uses a multidisciplinary approach to searching for the causes of a variety of diseases.

“Society may not need another person injecting botox. But it may need another general orthopaedics physician,” he said. A 2008 study by Public Sector Consultants in Lansing found that Michigan could face a shortage of nearly 4,500 physicians, or 12 percent of the current number of physicians, by 2020. Areas with the largest projected shortages are family physicians, general surgeons, cardiologists, orthopaedic surgeons, psychiatrists, internists and radiologists. Medical education must change to help Michigan and other states meet the demand for physicians and better serve patients, Folberg said. That’s a major reason why new medical schools, such as OU Beaumont are emerging. “What it’s really about is a lot of innovation in medical education,” he said.

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24


education

Center Serves as Foundation for Growth of Oakland University- Wm. Beaumont Hospital Medical School center also will teach at the medical school, further aiding in melding academic research with clinical practice.

“Already we are making great strides in diverse areas, including

researching stem cells for spinal cord injuries, developing blood tests to identify Alzheimer’s disease and using magnetic resonance imaging to study epilepsy,” said Virinder Moudgil, Oakland’s senior vice president for academic affairs.

Oakland invests more than $25 million a year in medical research.

The Center for Biomedical Research works to supplement

university funds by seeking outside private and federal research grants. It also recruits new biomedical scientists to the university.

Brad Roth

Oakland University’s Center

Oakland invests more than $25 million a year in medical research.

Biomedical Research, whose mission is to promote and support biomedical research and education at the University and allied institutions, including the new Oakland University Wm. Beaumont School of Medicine. is director of

for

Oakland University and Beaumont Hospitals may be new to the

In the past two years, Oakland has received $4.9 million from the

business of creating a medical school, but a key resource for educat-

National Institutes of Health, the National Science Foundation, the

ing its students has been in place for 13 years.

American Heart Association and others.

sciences throughout the university.

The center, which supports biomedical research throughout the campus, already collaborates with Beaumont and Henry Ford Hospitals to advance biomedical knowledge in those organizations.

In addition to the medical school, work is progressing on a

157,000 square-foot, $61 million Human Health Building that will house the School of Health Sciences and the School of Nursing.

In the past two years, Oakland has received $4.9 million from the National Institutes of Health, the National Science Foundation, the American Heart Association and others.

It’s Oakland University’s Center for Biomedical Research, founded

in 1997 as a way of bringing together researchers from departments throughout the university in a collaborative effort to unlock the mysteries of various diseases.

The center’s work is getting a boost from the expansion of health

The center is expected to work closely with the medical school,

which will require students to conduct research during their four

years of medical training.

be fully linked with the new medical school.

“It really is a platform on which the medical school can grow,”

But Roth said it likely will take several years for his center to “The medical school initially will be very focused on its

said Dr. Robert Folberg, founding dean of the Oakland University

curriculum and educational foundation,” he said. “But we’re already

William Beaumont Medical School, which will begin educating its first

collaborating.”

class of medical students in August 2011.

The center, which supports biomedical research throughout the

campus, already collaborates with Beaumont and Henry Ford Hospitals to advance biomedical knowledge in those organizations.

Having a medical school connected to the center should result in

more research being transferred into clinical applications, said center

Photos courtesy of Oakland University

director Brad Roth. “It increases our chances of translating research from the bench

to the bedside,” Roth said.

For example, Oakland researchers are working to understand why

proteins sometimes misfold into clumps, causing diseases such as Alzheimer’s. Learning the answer could lead to blood tests allowing for more effective treatment of these diseases, Roth said. University professors from various departments connected to the

25

BioMatters | Fall 2010


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BioMatters | Fall 2010


profile

The two scientists-turned-entrepreneurs identified key

areas where they could deliver solutions that other CROs had so far neglected to offer their pharma partners. But competitive pricing was difficult as so many pharma companies were outsourcing their chemistry to India and China for cost savings. Accordingly, Zimmermann and Gadwood chose to make innovation the cornerstone of their new business.

The strategy worked. In seven years, Kalexsyn—a con-

traction that stands for “Kalamazoo Experts in Synthesis”— has experienced a remarkable average 20 percent annual growth. In 2007, the company outgrew its original space and moved into a new, custom-designed 20,000 sq. ft. lab where it currently employs 36 full-time people who

Michigan Governor, Jennifer Granholm, is flanked by David Zimmermann (left), CEO of Kalexsyn, Robert Gadwood (right), Kalexsyn’s president and CSO, and others at the grand opening of the company’s new facility in June 2009.

provide chemistry research services for over 90 drugmakers

“Entrepreneurs of the Year” Guide Kalexsyn to Success by David Bardallis

from North America, Europe, and Japan. Annual revenues now exceed $5 million.

The keys to this success, say Zimmermann and

Gadwood, have been an “excellent scientific staff,” consistently delivering of results for customers, and a strong partnership with clearly defined roles.

At a gala event in Dearborn, MI, last June, professional ser-

“David and I have separate areas of responsibility,”

vices giant Ernst & Young named the two founders of Kalamazoo’s

says Gadwood. “After the first few months of working

Kalexsyn, Inc., 2010 Entrepreneurs of the Year for the Michigan/

together, we learned to align our responsibilities with our

Northwest Ohio region. The award is given annually to business

talents and interests. Mine are the science and all opera-

innovators who achieve outstanding financial success as well as

tions, including financials, HR, and project management.”

demonstrate strong personal commitment to their communities.

what our passions and drivers were,” agrees Zimmermann.

The two scientists-turned-entrepreneurs identified key areas where they could deliver solutions that other CROs had so far neglected to offer their pharma partners.

“My passion is in creating or finding new business opportunities and executing on them. My responsibility as CEO is to keep abreast or ahead of the industry in terms of vision and direction.”

“The stimulus for our evolution was each of us finding

Kalexsyn CEO, David Zimmermann, and President and Chief

Despite challenges including a weak economy, the

future direction of Kalexsyn seems to be upward.

Scientific Officer, Robert Gadwood, both fit the bill perfectly.

The pair started the company as a medicinal chemistry contract

Gadwood. “My hope is for Kalexsyn to continue to grow

research organization (CRO) in 2003 in the wake of Pfizer’s

at a steady and modest rate.” Despite a great 2009, he

decision to close its recently acquired Pharmacia research site

predicts a flat 2010, but the company still hopes to add

in Kalamazoo, where they had both worked for decades.

several new scientists to its team this year.

“I learned about the site closure a couple weeks before

The keys to this success, say Zimmermann and Gadwood, have been an “excellent scientific staff,” consistently delivering results for customers, and a strong partnership with clearly defined roles.

the general announcement, and it occurred to me there would be an opportunity to form a company around all the experienced and talented chemists who were losing their jobs,” says Gadwood. “I also expected there would be lab equipment and space available for the new company to use.”

“Ours is a dynamic and unpredictable market,” says

Gadwood approached the colleague he knew had similarly

extensive experience in life sciences — and who also shared

his desire to continue living and working in Kalamazoo.

executing on our mission,” says Zimmermann. “We need to

constantly stay in tune with the continued change in the

“The afternoon of the site closure announcement, Bob

“Our challenge, as with any business, is to continue

met with me and laid out his plan,” says Zimmermann. “It

pharmaceutical industry. I believe the pharma industry will

was clear he had given it serious thought, and after deliberat-

continue to increase external collaborations to drive early

ing for several weeks I decided to team with him to carry out

drug discovery. This will provide new and sustained business

our vision of Kalexsyn, realizing that this unique opportunity

opportunities to fuel Kalexsyn’s future growth.”

would not likely come about again.”

BioMatters | Fall 2010

28


research

James Humpula

operates

the high throughput screening robot at the

Michigan State University Bruce Dale lab. The lab, part of MSU’s Great Lakes Bioenergy Research Center, is focused on developing improved pretreatment and deconstruction methods to release biomass sugars

Photo courtesy of: Kurt Stepnitz, Michigan State University Office of Biobased Technologies.

for biofuel production.

Specialty Research Centers Raise Profile of Michigan Universities Michigan is counted among the country’s top research centers, thanks to the University Research Corridor, which stretches from Detroit to East Lansing and encompasses Wayne State University, the University of Michigan, and Michigan State University. The URC was established in 2006 to amp up the natural collaboration and innovation that existed among the institutions and to help diversify Michigan’s ailing economy. Collectively, the schools spend over $1.4 billion annually on research, over $950 million of which was devoted to the biosciences in 2008. by Tom Beaman “These three institutions are a powerhouse in terms of generating basic and applied research ideas in the life sciences area,” says Jeff Mason, executive director of Michigan’s University Research Corridor. “It really becomes the fuel for the life sciences industry.” A 2010 report by the Battelle/Biotechnology Industry Organization says the state’s bio-

sciences industry “grew faster than the national average.” More than 37,000 Michigan residents work directly in the sector, with a total employment impact of 139,789 and an average salary of $76,394 in 2008, according to the report. Among seven leading regional “innovation clusters,” the URC is topped by only California’s Silicon Valley and

29

Research Triangle Park in North Carolina in terms of the percentage of spending (64%) devoted to life sciences. Though they barely scratch the surface, here are some specialty examples of the scope of biosciences research going on throughout Michigan’s University Research Corridor.

BioMatters | Fall 2010


Photos courtesy of WSU Perintology Research Branch

research

Scientists

at

Wayne State University’s Perinatology Research Branch “have PRB’s Center for Advanced Obstetrical Care & Research.

uncovered a multitude of factors that cause or are associated with prematurity,” says

Dr. Sonia Hassan,

director of the

“Through research from bench to bedside, the scientists at the PRB hope to make a significant impact on the causes and treatments of the major complications during pregnancy.” The Perinatology Research Branch, which is affiliated with Wayne State University and Hutzel Women’s Hospital in Detroit, is recognized worldwide for its breakthroughs in prematurity, congenital birth defects, and other complications of pregnancy. It received the March of Dimes award for “Best Research in Prematurity” at the 2010 annual meeting of the Society for Maternal-Fetal Medicine. The PRB was established by Congress in 1993 and is a division of the National Institute of Child Health and Human Development.

BioMatters | Fall 2010

30

Center for neural communications, university of michigan In the 1966 film “Fantastic Voyage,” a miniature Raquel Welch traveled through an injured scientist’s brain in a submarine. Today, life imitates art at the University of Michigan’s Center for Neural Communications Technology, where researchers are developing microscale brain implants in their quest to understand how the complex organ works. “That’s one of the fundamental questions of humanity,” says Center Director Daryl R. Kipke, Ph.D.

Photo courtesy of the University of Michigan

Despite its sophisticated healthcare system, the United States ranks 30th in infant mortality among industrialized countries, according to the Centers for Disease Control and Prevention. Prematurity is the leading cause of many complications of pregnancy, including infant mortality. Twenty-five percent of all infant deaths are the results of premature birth, and premature babies are also at much greater risk of respiratory, neurological, and cardiovascular problems.

“The PRB’s mission is to comprehensively approach pregnancy both with respect to the fetus and the mother,” says Sonia S. Hassan, M.D., director of the PRB’s Center for Advanced Obstetrical Care & Research. “Through research from bench to bedside, the scientists at the PRB hope to make a significant impact on the causes and treatments of the major complications during pregnancy. “To date, about 15,000 pregnant women have enrolled in research protocols of the PRB. Of these, over 4,000, many of whom are from uninsured households, have visited the Center for Advanced Obstetrical Care & Research. These patients have benefited from access to knowledge, technology, and diagnostic procedures developed at the PRB that would otherwise be unavailable.” Among the discoveries that have emerged from the PRB are the discovery of the molecular processes that cause the onset of premature birth in women who have an amniotic fluid infection and the identification of DNA variants in the Hispanic population that predispose it to a higher rate of prematurity. “There is no silver bullet in preventing or treating prematurity,” says Dr. Hassan. “Instead, scientists at the PRB have uncovered a multitude of factors that cause or are associated with prematurity. Current work evaluating the use of natural progesterone could lead to a new treatment for Ob-Gyn’s to both prevent and treat prematurity.”

Perinatology research branch, Wayne State University

Led by Daryl Kipke, director, researchers at U-M’s Center for Neural Communications Technology are developing tiny brain implants that can both decode brain signals and stimulate the brain.

The surgically implanted, hair-like devices serve as a two-way street, allowing scientists to detect, amplify, process, and decode brain signals that can help unlock the secrets of neural processing; alternatively, the implants can electrically stimulate the brain with encoded information from outside the body.


R esearch

Karmanos Keeps Its Eye on the Prize: A Cure for Cancer

If Dr. Ann Schwartz could be defined by

one word, it would be “hope.” Schwartz,

“Our basic science group asks, ‘What molecular pathways are altered in the development and progression of cancer?’,”

deputy center director and executive vice president for research and academic affairs at the Barbara Ann Karmanos Cancer Institute (KCI) in Detroit, believes strongly that

Dr. Ann Schwartz

the work underway at her facility holds the

Institute. 130 new drugs, KCI’s population studies group investigates

key to unlocking the mysteries of cancer—

racial disparities in the incidence of cancer while behavioral specialists

and someday finding a cure.

look at more effective ways to better communicate the benefits of

clinical trials to patients.

“The best treatment comes out of a strong

research foundation,” she says, pointing to KCI’s 300 physicians and re-

searchers, 700-plus cancer-specific investigations and clinical trials, and

independent cancer hospital, sees nearly 6,000 patients each year

the $60 million per year the Institute receives in research grant funding.

and is one of only two NCI-designated comprehensive cancer centers

in Michigan. “This designation speaks to the Institute’s commitment

Among the discoveries to emerge from KCI since its founding in 1943

The Barbara Ann Karmanos Cancer Institute, Michigan’s only

as the Detroit Institute for Cancer Research is the development of the

to cure cancer and reduce suffering,” says Schwartz. “Here you have

MCF-7 breast cancer cell line that’s used worldwide to study mutations

an opportunity to get cutting edge treatments that aren’t offered

that are associated with breast cancer. Other work has focused on the

elsewhere, and that wouldn’t be available if we didn’t have the

role that proteases play in the progression of prostate cancer.

research base that we have.

“Our basic science group asks, ‘What molecular pathways are

“I think there will be cures—plural—for cancers. Our most likely

altered in the development and progression of cancer?’,” explains

path to success will be to fully appreciate what’s happening within

Schwartz. “If you can target these altered pathways, you can

a particular cancer. Each individual’s cancer is defined by a set of

theoretically stop the progression of the disease.”

mutations to which directed therapy can be targeted. We may come

to a day when a cure is a combination of drugs that specifically

The developmental therapeutics group at Karmanos, which treats

targets your cancer versus someone else’s.”

400 patients each year on Phase I clinical trials, is one of the largest

Photo courtesy of Karmanos Cancer Center

Phase I clinical trial programs in the country funded by National Cancer

31

BioMatters | Fall 2010


research

making new discoveries from what would otherwise be an avalanche of data that would be very hard to assimilate,” says Omenn.

The surgically implanted, hairlike devices serve as a twoway street, allowing scientists to detect, amplify, process, and decode brain signals that can help unlock the secrets of neural processing;

father’s laboratory, look no further than the University of Michigan’s Center for Computational Medicine and Bioinformatics. The CCMB is a national leader in this emerging field, where scientists use advanced computer technology to conduct biological research. “We generate so much data that it must be organized and manipulated with computers so you can pull out important information, visualize the relationships between sets of genes and proteins, and how that influences a person’s behavior, response to infection, response to a cancer, and response to treatment,” says Dr. Gil Omenn, director of the University’s Center for Computational Medicine and Bioinformatics. Using this technology, Omenn and his colleagues recently crunched data from over 1,100 metabolites in 262 clinical samples related to prostate cancer. In the end, they identified a compound - sarcosine - that can indicate whether a prostate cancer tumor will be aggressive or innocuous.

BioMatters | Fall 2010

to assimilate huge data sets and make sense of new research discoveries.

“We generate so much data that it must be organized and manipulated with computers The five-year-old Center draws on expertise from the Medical School; Colleges of Engineering, Pharmacy, and Literature, Arts, and Sciences; and the Schools of Information and Public Health. Resources range from laptops to cloud computing, using supercomputing centers at other universities if the problem is sufficiently complex. “At the basic science and technology level, this is very much about making sense and The Pilot Plant

at the

MSU Bioeconomy Institute;

The Institute complements Michigan State’s research into alternatives to petroleumbased products.

featured are some of the chemical reactors in the facility used for

conducting commercial-level pilot or manufacturing runs.

Photo courtesy of Michigan State University

Center for computational medicine and bioinformatics, university of michigan If you need proof that it’s no longer your

Under the direction of Dr. Gil Omenn, scientists U-M’s Center for Computational Medicine and Bioinformatics use advanced computer technology

at

The Michigan State University Bioeconomy Institute in Holland opened in 2009 in a 138,000 sq. ft. facility that was donated to the university by Pfizer, Inc. The facility boasts modern laboratories and a fully equipped pilot plant with 37,000 liters of chemical reactor capacity that is open to both university and private sector researchers. The Institute complements Michigan State’s research into alternatives to petroleumbased products. Based on faculty expertise and the needs of the furniture and automotive interiors industries, the current focus is on bio-based specialty chemicals and materials, says Paul Hunt, Ph.D., Michigan State’s senior associate vice president of research and graduate studies. “We think that novel feed sources can lead the way to novel products,” he says.

“This class of device has been used in animal research to develop brain-computer interfaces, neuro-prosthetic systems in which some external system is controlled directly through brain signals that are acquired through these implantable neural probes,” says Kipke.“At the end of the day, we’re working toward developing devices that can be implanted in the brain to treat paralysis, to help stimulate damaged circuits, or to enable targeted, ondemand delivery of drugs to treat diseases like brain cancer or degenerative conditions like Parkinson’s disease.”

Bioeconomy institute michigan state university

32


Photos courtesy of Michigan State University

Michigan State’s Great Lakes Bioeconomy Research Center researchers are evaluating the performance of quality, impacts on microbial-plant interactions, biogeochemical and biodiversity responses and water use.

a variety of novel bioenergy crop production systems for crop yield and

says Doug Gage, Ph.D., director of the Michigan State University Bioeconomy Network. “To make this a viable process there are many technical bottlenecks to overcome.”

Private sector tenants include EcoComposites LLC, which is studying bio-based composites and BoroPharm, Inc., which develops “green” pharmaceutical intermediates.

great lakes bioenergy research center, michigan state university As of July 2009, only 1,928 out of 164,000 U.S. filling stations offered E85 (85 percent ethanol and 15 percent gasoline) to more than 8 million flexible fuel vehicles on U.S. roadways, according to the U.S. Department of Energy. As manufacturers build more vehicles than run on alternative fuels, their availability has lagged. Ethanol suffers in part because it contains 27 percent less energy per gallon than gasoline. Recognizing these challenges, the Department of Energy-funded Great Lakes Bioenergy Research Center (GLBRC), led by the University of Wisconsin-Madison with Michigan State University as the major partner, is exploring new ways to convert agricultural residues, wood chips, and nonfood grasses into liquid transportation fuels. “As we move into renewable fuels, it’s recognized that…the next generation of bio fuels will very likely be derived from nonfood crops like biomass and waste products,”

“As we move into renewable fuels, it’s recognized that…the next generation of bio fuels will very likely will be derived from non-food crops like biomass and waste products,”

and maximize

Eva Ziegelhoffer, harvests cultures GLBRC understand hydrogen production.

Dr. Sanjaya

at

MSU

researcher,

for analyses in an effort to help

MSU’s GLBRC,

has developed the

transformation procedure, where

Rutabaga

plants

are engineered to convert carbohydrates into oil in their beet-like storage organ.

33

Questions being asked by GLBRC researchers include how to develop biofuel crops for particular environments and produce them in an ecologically and economically sustainable manner. GLBRC is also developing methods to more efficiently break down cellulosic biomass (woody waste products and grasses) into fermentable sugars and to convert these sugars into alternative fuels. “The Center is very much a basic research-driven effort, so it won’t be building factories or producing the next generation bio fuels,” says Gage. “We hope to provide the breakthroughs that will allow those technologies to be developed in a sustainable way.”

BioMatters | Fall 2010


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35

BioMatters | Fall 2010


E ntrepreneurs

Entrepreneurship Drives the Next Wave of Michigan Biotech Innovation

Arising from the ashes of Big Pharma mergers, site closures, and mass layoffs is a cadre of small but innovative startups that not only prove entrepreneurship is alive and well in Michigan, they have the potential to generate billions of dollars in revenues and revolutionize everything from treatment of the most common sexually transmitted virus to the early detection and treatment of various forms of cancer.

BioMatters | Fall 2010

36


by David Bardallis

Michigan is a great place for business

Here are just five of the Michigan startups driving the next wave of biosciences innovation.

Big Pharma was not addressing the problem In 2003, biochemist Jim Bashkin and developmental biologist Chris Fisher started NanoVir in Kalamazoo to develop therapeutic alternatives for individuals infected with human papillomavirus (HPV), a sexually transmitted virus so common that roughly half of the sexually active population acquire it sometime in their lives.

NanoVir’s approach has shown enough promise that the company now employs 10 people in Kalamazoo and St. Louis. “We recognized Big Pharma was not addressing the HPV problem,” says Fisher. “It was viewed as too difficult a virus to target, plus it was thought the coming HPV vaccines would eliminate the need. That proved totally off the mark.” Although many HPV-infected people never develop symptoms, the virus can lead to genital warts and various forms of cancer, especially cervical cancer. And despite the prevalence of HPV, no real treatment options exist. “Currently there is no therapy other than surgery for women who test HPV-positive,” says Fisher. “They are simply told to return in six months to see if they have progressed to a more serious condition. We hope to provide an option for treatment.” NanoVir’s approach has shown enough promise that the company now employs 10 people in Kalamazoo and St. Louis, where Bashkin is a University of Missouri researcher. Fisher believes NanoVir’s potential market is large. “When you consider the first blockbuster drug treated herpes and HPV is the most prevalent sexually transmitted virus in the

Scientists

at

NanoVir

have made significant inroads in

HPV DNA-Targeted therapies. Above, co-founder Chris Fisher works with researcher, Michael Helmus, at the company. human papillomavirus developing treatments for using

world, I would say we could achieve blockbuster status – over $1 billion per year,” says Fisher. “This is only a possibility. But if we’re successful, we can be a game changer and help a lot of people.”

The large biotech model is dead Ann Arbor’s Phrixus Pharmaceuticals is working to commercialize another potentially game-changing drug for patients suffering heart failure, particularly the kind associated with muscular dystrophy. The four-employee startup was born in 2006 out of University of Michigan researcher Joseph Metzger’s work with a compound that heals small tears in damaged or degenerating heart muscle – and a serendipitous meeting with Bruce Markham, a longtime Pfizer scientist who was looking for a startup opportunity.

“The large biotech model of raising tons of money to ‘do everything themselves’ is dead.” Markham has extended Metzger’s research with the goal of shepherding the therapy through clinical trials then selling the results to a large company with the resources to take advantage of the potentially $1 billion market for the drug. “The large biotech model of raising tons of money to ‘do everything themselves’ is dead,” says President and CEO, Thomas Collet. “This is all about developing products, not infrastructure.” Phase 2 clinical studies of the drug are now set to begin, with an anticipated commercialization date of 2013 or 2014.

37

Spun off from the Cleveland Clinic in 2007, Tolera Therapeutics moved to Kalamazoo one year later to develop therapies for organ transplant patients and those who suffer from autoimmune diseases, where the body attacks its own tissues.

Earlier this year, the Edward Lowe Foundation named Tolera one of its 2010 “Michigan 50 Companies to Watch.

“Tolera offers a safer, more effective approach to down-regulate the immune system than current drugs, which can be very toxic and trigger adverse reactions,” says co-founder and COO James Herrmann. “Our lead compound, TOL101, has the potential to prevent organ transplant rejection and stop certain autoimmune diseases such as Type 1 diabetes and multiple sclerosis in their tracks.” To date, the company has raised over $14 million from Midwestern private and government investment funds and earlier this year, it began Phase 2 clinical testing in kidney transplant patients. Also, earlier this year, the Edward Lowe Foundation named Tolera one of its 2010 “Michigan 50 Companies to Watch.” “Michigan is a great place for business, with deep roots in pharmaceuticals,” says Herrmann. “Here we found investors who understood the unique challenges of drug development and had the experience to guide us as we’ve grown.” However, Herrmann cautions that most biotech investment still comes from the east and west coasts – a concern echoed by many Michigan life science startups – and acknowledges the difficulties ahead in raising the $30 million needed to complete the development of TOL101, which could achieve over $1 billion in revenues in its three targeted markets.

BioMatters | Fall 2010


E ntrepreneurs

as well as suggesting more personalized treatment options. The U.S. market for present prostate cancer diagnostics is roughly $250 million, but Thomssen believes an improved test could go over $1 billion. “One reason more men don’t get tested is because the current test isn’t very good,” he explains. Once the test is brought to market in early 2011, the team will focus on adapting it for lung and breast cancers as well. “This technology will not only save the health care system money, it will change how doctors diagnose and treat cancer,” says Thomssen.

Photo courtesy of Armune BioScience

Michigan’s challenges translated into opportunities

At Armune,

scientists are targeting the development and commercialization of high value, protein signature-based

diagnostic tests for prostate, lung and breast cancers that will allow physicians and patients to make better treatment decisions.

“The challenge will be to attract significant new dollars from out of state,” he says. “But the resources available locally in terms of scientific, drug development, analytical, and clinical experience are tremendous.”

It will change how doctors diagnose and treat cancer Headquartered in Kalamazoo with a lab in Ann Arbor, Armune BioScience Inc. began in mid-2008 with a $1.1 million initial investment

The U.S. market for present prostate cancer diagnostics is roughly $250 million, but Thomssen believes an improved test could go over $1 billion.

BioMatters | Fall 2010

through the efforts of the Kalamazoo-based Apjohn Group LLC, a business accelerator that works with innovators to launch biotech companies. “We like to align with researchers who have patented, innovative technology but no experience starting a company, raising capital, or taking a product through development,” says Eli Thomssen, president and CEO of Armune and a founding partner of Apjohn. “Apjohn is made up of people who have that experience.” Based on technology licensed from University of Michigan researchers, Armune is developing a test to more accurately detect prostate cancer – the second-most prevalent cancer affecting men – at an earlier stage, thereby improving the prognoses of patients

38

Prostate health is also the focus of Ann Arbor-based HistoSonics, LLC. Launched late last year with three employees and $11 million in capital, the company is working to develop and commercialize histotripsy, an ultrasound system that can non-invasively shrink swollen prostates and destroy cancerous cells. As with Armune, the technology behind histotripsy was developed at and licensed from the University of Michigan.

Beyond the numbers, however, Gibbons says the promise of offering a new non-surgical option for treating these conditions has great human potential.

“The university research team had a tremendous body of data showing the effectiveness of this technology,” says startup specialist Christine Gibbons, HistoSonics’s president and COO. “And while Michigan’s economy faces numerous challenges, those challenges have translated into opportunities for us – to access the resources, such as lab space and product development expertise, necessary to advance our efforts nimbly and cost effectively.”


Images courtesy of HistoSonics

Images

“A letter from a 93-year man asked me when our product will be ready. He was pleading for a non-invasive effective treatment, given the failure of his drug therapy and the significant risks associated with surgery,” says Gibbons. “This tells me our technology has the ability to transform patient care.”

show the precision of histotripsy, a non-invasive, image guided and robotic tissue ablation technology that

was licensed from the

University

of

Michigan

by

HistoSonics.

Gibbons, who has helped raise $70 million to launch 14 new ventures, estimates the potential U.S. market for histotripsy’s initial application, treatment of benign prostatic hyperplasia, is over $300 million. Once the technology is adapted for other

conditions including various cancers, she says, the market potential rises to over $2 billion. Beyond the numbers, however, Gibbons says the promise of offering a new nonsurgical option for treating these conditions has great human potential.

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39

8/19/10 9:39:14 BioMatters | Fall PM 2010


G uest O pinion

My Opinion

Biotech Workforce Development: A Partnership between Industry and Academia By Charles W. Jacobs, Ph.D. Growing a successful biotechnology industry in Michigan requires a supportive economic environment, strong academic base, and a well-trained workforce. The state has encouraged venture capital and favorable tax laws, its universities and research institutes provide a stimulating environment for new innovation, and its higher education system trains scientists and technicians from the associate through the doctoral levels. At less than the graduate level, Ferris State University offers a Bachelor’s degree in biotechnology, Kalamazoo Valley Community College offers a postgraduate program in biotech skills, Lansing Community College and Henry Ford Community College offer Associate degrees and certificates in molecular biotechnology, and Schoolcraft College offers a program in repair of biotech equipment. Much of the day-to-day work in research laboratories and production facilities can be done by technicians with high-quality training at the Associate degree level. And that’s where the state’s community colleges make the greatest contribution. Community colleges, far from being, in comedian Chris Rock’s words, “a disco with books,” are a phenomenal resource for workforce development. Community colleges excel in intensive workforce training and skill updates, and provide students with basic academic education to contribute to our biotechnology industry. Community colleges are also nimble and can adapt quickly to changing workforce needs. The strongest biotechnology workforce training programs connect local industries with the community colleges and universities that provide the training. When Henry Ford Community College began planning its Biotechnology Technician Program, we met with local industries and academic research facilities in Southeast Michigan. We developed our curriculum directly from the skills and competencies that those scientists, human resources directors, and CEOs told us they wanted. Our students learn lab skills, but are also literate, mathematically inclined, skilled in workplace etiquette, and know scientific ethics. Laboratory skills are taught under the tutelage of Ph.D. scientists in a real-world setting, using state-of-the-art equipment. Students work in small groups on extended projects. They are responsible for preparing all the materials they need to work with nucleic acids or isolate proteins. And they regularly present to their group an update of their coursework. The capstone of our program is an internship in a biotech laboratory. In addition to offering Associate degrees, the programs at Henry Ford Community College and Lansing Community College provide updated training for workers with degrees. These students can either take individual courses or complete a certificate program consisting of several courses. Last year, we at HFCC had students with Bachelors’ and Masters degrees, and one M.D., complete our courses in nucleic acid and protein techniques. A well-trained, flexible and adaptable workforce is essential to the success of Michigan’s biotechnology industry. The state’s community colleges and universities are prepared to meet the demand by partnering with industry and developing curricula that meet the specific needs of the local market. Together we can build on the foundation that makes Michigan an attractive area for the biotech industry, and support a strong, vibrant, and diverse biotech sector in the state. Charles Jacobs is the Associate Dean of Science at Henry Ford Community College.

BioMatters | Fall 2010

40


In Michigan, new businesses and jobs are growing out of labs and incubators every day. Researchers and innovators in the life sciences are leading the transition to the 21st Century economy. Working alongside MichBio, the Michigan Economic Development Corporation connects high-tech innovators with services, incentives, networking opportunities and public and private venture capital to help them grow and prosper.

Visit MichiganAdvantage.org and learn how Michigan can give innovators the Upper Hand.

Economic Development C o r p o r a t i o n

41


Get Connected. Nurturing an idea into a marketable product and growing it into a dynamic, self-sustaining bioscience company is a process. How do Michigan companies connect with the right people, learn what they need to know, find the resources to keep the pipeline flowing?

MichBio brings the total continuum together. We know the players, the market; and what it takes. We give you access to a valuable network of people representing all facets of the biosciences community. We are your matchmaker, your guru and your standard bearer.

In a state boasting the world’s longest freshwater coastline, with oceans of lakes, where water is a way of life and life is good; in an industry that studies life at its core, MichBio is there to propel Michigan’s bioscience people, products and prospects.

Join us.

Ann Arbor, MichigAn

42

734.527.9150

www.Michbio.org

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