BioMatters - Spring 2015

IN THIS ISSUE:

15 IT TAKES A VILLAGE: ENTREPRENEURS TAP STATE RESOURCES SISU GLOBAL HEALTH

18 MICHIGAN BIOSCIENCES:

BY THE NUMBERS MICHBIO

24 ANTHRAX VACCINE ROOTED IN MICHIGAN EMERGENT BIOSOLUTIONS

28 CMO TAKES PRIDE IN QUALITY GRAND RIVER ASEPTIC MANUFACTURING

SP R I N G 2015

A magazine showcasing Michigan’s biosciences industry

– 10 –

MICHIGAN:

A POWERHOUSE IN CLINICAL TRIALS

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PRESIDENT’S MESSAGE Welcome to our first BioMatters of 2015.

With it comes a fresh design that embraces a new collection of informative stories from Michigan’s bio-industry.

Since our inaugural issue in Fall 2008, MichBio has championed our member organizations and Michigan’s thriving bioscience industry that includes 1,760 companies with an economic impact of over $15 billion.

The articles you’ll find on the following pages were written by those who know the industry best – our members. We applaud their efforts and look forward to highlighting more of their achievements in future issues. Let us know what you think of the new design and how we can keep BioMatters engaging (email comments to our editor Katie Trevathan at katie@michbio.org).

As I write this letter, 2015 is shaping up to be an exciting year. We’ve embarked on several new undertakings in programming, services, and strategic planning.

MichBio’s 2015 event line-up was changed to offer a series of signature events with more focused topics – the approach is meant to replace this year’s annual conference and expo.

“2015 is shaping up to be an exciting year. We’ve embarked on several new undertakings in programming, services, and strategic planning.”

Our first event is the inaugural Women Building Success in Biosciences program on June 9. The goal is to bring together women from various bioscience backgrounds and career stages to inspire professional and personal success.

Next is the first ever Michigan Drug Discovery Symposium, which we’ll co-host with the University Research Corridor and Michigan State University in early September. The event will facilitate interactions between faculty, postdocs/ students, and bio-industry professionals who are interested in all aspects of therapeutic science and advancing academic drug discovery to clinical outcomes.

In the services space, MichBio added new vendors to its Preferred Purchasing Program – including biohazard waste management (Clean Harbors), executive and organizational liability insurance (Aon), and energy management procurement/ consulting (APPI). The Purchasing Program has been a bottom-line boon to large and small member companies who saved over $6.7 million collectively in 2013.

Lastly, and perhaps most importantly, MichBio is leading a statewide, strategic planning initiative – Michigan Bio-Industry Roadmap 2015 – in partnership with the Business Leaders for Michigan and University Research Corridor. The final product will be a tactical and performance-based growth plan that will guide industry growth through 2020. Findings and recommendations will be shared at a Michigan Bio-Industry Growth Summit in late fall (more on p. 8).

Please join us in our various activities as MichBio continues to be the only statewide voice and resource for the biosciences community in Michigan.

Sincerely,

STEPHEN RAPUNDALO, PHD President & CEO, MichBio

BIOMATTERS | SPRING 2015

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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.

1.888.565.0052 michiganadvantage.org/BM

MichBio is the biosciences trade association for the state of Michigan. Our goal is to drive the growth of the state’s bio-industry through advocacy, education, and supportive resources.

PREMIUM MEMBERS full c olor

GOLD b l ack

Stephen Rapundalo, PhD President and CEO Katie Trevathan, MS Editor Director, Marketing & Communications

MichBio 3520 Green Court, Suite 175 Ann Arbor, MI 48105-1175 734-527-9150 info@michbio.org michbio.org

white

David McGuire, II Director, Membership & Operations

Designer: Daina Fuson Designs Printer: Progressive Printing

Nancy Marcotte Manager, Finance

© Copyright Michigan Biosciences Industry Association DBA MichBio

SILVER MICHBIO BOARD OFFICERS

BRONZE

CHAIRMAN Michael Hagen Ash Stevens, Inc. Director, Business Development

PRESIDENT AND CEO Stephen Rapundalo, PhD MichBio President and CEO

VICE CHAIRMAN Kevin McCurren Grand Valley State University Executive Director, Center for Entrepreneurship and Innovation

SECRETARY Vacant TREASURER Vacant

MICHBIO BOARD DIRECTORS Arik Anderson Terumo Cardiovascular Systems Vice President, Global R&D and Marketing Dale Grogan Michigan Accelerator Fund I, LP Managing Director Charles Hasemann, PhD Michigan State University Assistant Vice President, Innovation & Economic Development Tim Mayleben Esperion Therapeutics President and CEO Kevin McLeod Michigan Medical Device Accelerator Managing Director Paul Morris AlixPartners, LLP Finance Director, Enterprise Improvement

John J.H. Schwarz, MD Battle Creek Family Health Center, Physician Former U.S. Representative David Serota, PhD, DABT MPI Research Senior Vice President, Drug Safety Director of Research Ned Staebler Wayne State University Vice President, Economic Development President and CEO, TechTown Christopher J. Stein Ferndale Pharma Group, Inc. Executive Vice President Chief Operating Officer George Wilson Beaumont Health System Chief of Radiation Biology Scientific Director, Beaumont Biobank

PATRON BioMatters is published twice per year to showcase Michigan’s bioscience industry. Much of the content is submitted by MichBio member companies. Interested in submitting an article or advertising in a future issue? CONTACT KATIE TREVATHAN AT KATIE@MICHBIO.ORG.

BIOMATTERS | SPRING 2015

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HOPELESS Rhys’ diagnosis isn’t his destiny. such as type 1 diabetes. Their bravery inspires countless Michigan researchers and scientists across the country in their quest for new medicines. Today, more than 7,000 medicines are in development around the world. Each step brings us closer to a cure.

fromhopetocures.org

TABLE OF CONTENTS a successful path for 08 | Creating bio-industry growth Feature Story

10 | Michigan: A powerhouse in clinical trials

10

Cover Story

Research, Jasper Clinic go further 13 | MPI with Phase I testing MPI Research

a village: Determined entrepreneurs 15 | Ittaptakes Michigan startup resources to develop first product and its path to market Sisu Global Health and in2being

18 | Michigan biosciences: By the numbers MichBio

health organization launches 21 | Public quality manufacturing standard NSF Health Sciences

pharmaceutical reach with 23 | Global Michigan roots

15

Pfizer CentreSource

24 | Anthrax vaccine rooted in Michigan Emergent Biosolutions

life science training: A high-value 26 | Specialized for Michigan bioscience companies Center for Professional Innovation and Education, Inc.

CMO takes pride in 28 | Growing commitment to quality

Grand River Aseptic Manufacturing, Inc.

the power of imaging 30 | Leveraging in drug development Molecular Imaging, Inc.

30 WANT TO RECEIVE BIOMATTERS?

32 | Protecting the next generation of science Brownrigg Companies LTD

Visit michbio.org/subscribe

BIOMATTERS | SPRING 2015

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CREATING A SUCCESSFUL PATH FOR BIO-INDUSTRY GROWTH THE MICHIGAN BIO-INDUSTRY ROADMAP 2015 STRATEGIC PLANNING INITIATIVE An exciting five-year strategic planning effort — the Michigan Bio-Industry Roadmap 2015 — launched earlier this year to develop a bold, yet realistic approach to growing the state’s biosciences industry.

Why? Because many inside and external to the bioindustry recognize the field as a large and fast-growing economic sector able to produce high-wage jobs in manufacturing, service, and R&D activities. While Michigan has a strong foundation and robust bioindustry, it must do more if it’s to be a truly recognized leader in the diverse global biosciences marketplace.

Competition is stiff, as nearly every U.S. state and many countries are targeting bioscience industry sectors — from therapeutics to medical devices and diagnostics

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MICHBIO | michbio.org

to agriculture/industrial biotech and bio-energy — as a growth driver for their economies.

MichBio is leading the Roadmap effort in partnership with Business Leaders for Michigan and the University Research Corridor. The planning effort is overseen by an executive steering committee of bio-industry experts from around the state with Detroit-based Data Consulting Group serving as project manager and facilitator.

What and where are Michigan’s greatest strengths in the biosciences? In which industry segments will Michigan have the best opportunities to compete globally for talent, investment, and economic development success?

Are there near-term opportunities for state resources that could enhance Michigan’s competitiveness and yield strong outcomes for the state’s economy? These are just some of the questions asked of stakeholders.

FEATURE STORY

During the first three months of 2015, approximately 175 individuals from industry, academia, and government volunteered hundreds of man-hours in a comprehensive data and best practices gathering exercise. The compiled opinions will be analyzed to validate key strategic themes and areas, identify new unmet needs and growth opportunities, and help develop proposals for legislative or policy action.

The final report, to be issued at the Michigan Bio-Industry Growth Summit in late fall 2015, will feature recommendations to help Michigan compete in the national and international biosciences arena. The report will include performance measures and identify the parties most responsible for delivering outcomes. Annual assessments on progress and impact are also planned.

Michigan is fortunate to have a strong biosciences industry that contributes over $15 billion to the state’s economy. A shared and executable vision with performance measures will be critical to the future success of biosciences research, development, and manufacturing enterprises. ■

Thus far, the Roadmap efforts have revealed that Michigan has the necessary ingredients to spur prosperous biosciences-related growth in several industry sectors or market areas: • Medical devices and technologies • Pharmaceuticals and drug discovery • Clinical trials research • Contract research/ manufacturing services • Biobanking

TO LEARN MORE ABOUT THE ROADMAP: michbio.org/roadmap2015 BIOMATTERS | SPRING 2015

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MICHIGAN: A POWERHOUSE IN CLINICAL TRIALS

BY RICK HAGLUND

Economic development in Michigan is often thought about in terms of new jobs in manufacturing, agriculture, and tourism — traditionally the state’s largest industries.

But many don’t realize Michigan is a powerhouse in clinical trials that bring hundreds of millions of dollars to the state, support high-paying medical jobs and, most importantly, save lives.

Clinical trials of potential new drugs and device therapies are performed throughout the state in the labs and treatment centers of its research universities, major medical centers, such as the Henry Ford Health System, and smaller private, for-profit organizations including the Michigan Center of Medical Research in Farmington Hills.

Those overseeing clinical trials say they provide a variety of benefits, including access to potentially life-saving drugs and treatments, as well as a higher level of care through common care practices for all patients, whether or not they are involved in clinical trials.

“It raises the bar on how you’re performing medical care,” said Kimberly Barber, PhD, director of the Genesys Health System Office of Research in Grand Blanc.

Michigan consistently ranks among the top states in the number of clinical trials conducted. More than 5,999 industry-sponsored trials have been performed in Michigan since 2000, in addition to several thousand institutional/investigator research programs.1 Almost half of those trials – 2,864 – have targeted the nation’s six most debilitating chronic diseases: cancer, diabetes, heart disease, stroke, mental illness, and asthma. Some 1,815 trials in Michigan are still actively recruiting patients.1 Michigan captured nearly $1 billion in federal health research dollars in 2013, ranking it ninth among the states, according to Research!America, which advocates for more federal health care research funding.

Clinical trials benefit the state’s economy because they are conducted, in part, for biopharmaceutical research companies by Michigan’s academic and clinical research centers, hospitals, and related organizations.

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MICHBIO | michbio.org

COVER STORY

HENRY FORD HEALTH SYSTEM A PIONEER IN CLINICAL RESEARCH

MICHMER FOCUS ON UNDERSERVED POPULATIONS

One of Michigan’s oldest and largest health care organizations that conducts clinical trials is the Detroitbased Henry Ford Health System, which is celebrating is 100th anniversary this year.

A number of small private-sector organizations also do important clinic trials work. One of them is the Michigan Center of Medical Research, based in Farmington Hills.

Researchers at Henry Ford are involved in about 1,700 research studies, with about one-third of those involving active clinical trials, said Tiffany Pearce, practice manager of the health system’s clinical trials office.

The center, known as MICHMER, was formed from research organizations and medical practices and serves as the research arm of more than 300 physicians and 20-plus hospitals. It has partnerships with several universities in the state.

Henry Ford was awarded $60.2 million in research funding last year from the state and federal government, pharmaceutical and other health care companies, and foundations.

MICHMER has more than 100 ongoing clinical trials covering a variety of therapeutic areas, including cancer, cardiology, pulmonology, and metabolic and behavioral disorders.

Its research is concentrated in the areas of orthopaedics, cancer, heart, immunology, neuroscience, vascular and kidney, and population health.

Henry Ford has 80 full-time researchers involved in translating research from the lab to the bedside, while many of its 1,000 physicians lead or participate in clinical trials.

“We are focused on community outreach, rural, and underserved locations,” said Karen Basha, RN, director of clinical operations. “Our niche is really strong access to patients.”

MICHMER has 11 facilities, mostly in southeast Michigan. It plans on opening new centers in Kalamazoo and the Upper Peninsula this year.

Dr. Ding Wang, medical director of Henry Ford’s clinical trials office, said some cutting-edge areas of research there involve using viruses and the body’s immune system to treat various type of cancer.

Henry Ford conducts its own clinic trials in this area and participates in a national group conducting trials on immunotherapy.

“This is a very exciting area and has shown a lot of interest by patients,” Wang said.

As many as 100 early-stage Phase I through late-state Phase IV oncology clinical trials are available to Henry Ford cancer patients at any given time.

BIOMATTERS | SPRING 2015

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MICHIGAN: A POWERHOUSE IN CLINICAL TRIALS

GENESYS SPECIALIZES IN CARDIOLOGY TRIALS Genesys Regional Medical Center, a 410-bed community teaching hospital in Grand Blanc has been conducting Phase II through Phase IV clinical trials on drugs and devices on patients for more than 10 years.

Phase IV studies are conducted after a drug or treatment has gone on the market to gather information on the effects on various populations and any side effects through long-term use. Patients typically are followed for five to 10 years in such trials.

Genesys conducts and participates in about 100 trials a year, including cancer trials through the Genesys Hurley Cancer Institute. It also specializes in the area of cardiology.

Barber said the clinical trials Genesys participate in gives patients access to the newest technology and drugs, and attracts companies “on the leading edge of future treatments” to the region.

Formed in 2006 as a partnership between several research organizations from a $1.5 million Michigan Economic Development Corporation’s 21st Century Jobs Fund grant, ClinXus became a unit of Mercy Health in Grand Rapids in 2013.

Now known as Mercy Health Research and Innovation, the program conducts Phase I through Phase III drug and other treatment trials, some in a new 6,000 square-foot, eight-bed unit.

“I think the real opportunity we have is to serve the unmet needs of the patient population here,” said William Baer, MD, medical director of research and innovation at Mercy Health.

“The community and state benefit from bringing these advances to our area,” she said.

“We offer novel agents so that people don’t have to leave West Michigan,” he said. “Our clinicians and scientists have significant research experience to offer patients.”

One national trial Genesys participates in involves a device that warns patients who are at a high risk of having heart attack that an attack is imminent. Several local patients are involved in the trial.

Mercy Health Research and Innovation is involved in about 120 clinical trials, said Susan Hoppough, executive director of research and innovation at Mercy Health. It specializes in research in oncology, neuroscience, population health, and endocrinology.

The device is implanted under the skin in the chest area and has leads connected to the heart muscle. It sends a message to the patient through a page if it senses he or she is about to have a heart attack.

“What’s unique here is that unlike most community-based hospitals, we interface in clinical research with industry and universities,” she said.

Genesys also has been picked as a possible site for a study based in Europe on heart stents that bioabsorb in the body, possibly preventing clotting and other problems associated with metal stents.

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MERCY HEALTH RESEARCH AND INNOVATION SERVES WEST MICHIGAN PATIENTS

MICHBIO | michbio.org

COVER STORY

MICHIGAN STATE UNIVERSITY EMPHASIZES TRANSLATIONAL RESEARCH A lot of health care research takes place in the research labs, two medical schools, and nursing school at Michigan State University, which has hundreds of ongoing clinical trials.

Translational research can mean different things to different people. To Amalfitano, it’s simply “the movement of knowledge from one venue to another.”

It’s the job of the university’s Clinical and Translational Sciences Institute to keep track of it all.

Among the best examples of that is MSU’s development of Cisplatin, one of the most widely prescribed cancer drugs in the world.

“The institute provides the infrastructure, administrative support, and expertise to navigate the hurdles one must navigate to be involved in clinical trials,” said institute director Dr. Andrea Amalfitano.

In addition to providing support to MSU researchers, the institute links drug companies and other treatment developers with the appropriate campus researchers to conduct research and clinical trials.

It also helps MSU researchers find funding for research projects and connects individuals and groups seeking to sponsor research with the appropriate experts.

Cisplatin was developed at MSU by chemistry professor Barnett Rosenberg in the 1960s. The university also was involved in some of the early clinical trials.

“Cisplatin is one of the best examples in the world of translational medicine being achieved by a university,” Amalfitano said. “It has saved countless lives.”

And the institute also facilitates research linkages between MSU and 51 hospitals in the state.

integrating pharmacogenetics and biomarkers into studies.

The three-story, 25,000-square-foot facility is located on the downtown Kalamazoo campus of Bronson Hospital, and is physically connected to Bronson’s Level I trauma center.

MPI Research, Jasper Clinic go further with Phase I testing

BY MPI RESEARCH

MPI Research is renowned in early-stage development, for its deep scientific expertise and state-of-the-art technology, as the world’s largest preclinical research facility. In October of 2014, MPI Research acquired the assets of Kalamazoo-based Jasper Clinical Research & Development, Inc., a well-respected, and well-known, CRO that provides early-stage human clinical testing of promising new drugs.

The original clinical facility, known today as Jasper Clinic, was constructed in 1984 when it operated as the internal Phase I testing unit of The Upjohn Company. It became Jasper Clinic in 2003, an independent operation that was formed when Pfizer, Inc. and Pharmacia Corporation merged in April 2003.

This acquisition continues the momentum MPI Research is making to become the leading integrated resource for early development.

Jasper Clinic, a 50-bed clinic, provides a wide range of early-stage services, including pharmacokinetic and pharmacodynamics, drug interaction and methodology studies, as well as expertise in

Primary competencies are Phase I to IIa (through clinical proof of concept) adaptive design studies. Simple, traditional studies (e.g., BA/BE, pilot, and pivotal) are also readily supported. Studies are conducted in healthy volunteers and patients in therapeutic areas, including CNS, diabetes, infectious diseases, inflammation, ophthalmology, obesity, cardiovascular, oncology, and select rare diseases.

JASPER CLINIC OFFERS: •

Early clinical development, first-in-human

•

Clinical Pharmacology (cardiac, ophthalmology, diabetes, and CNS)

•

PK/PD and pharmacogenetics

•

Methodology/translational medicine

The acquisition marks the second major service expansion by MPI Research in the past year. In May of 2014, the company, along with partners inviCRO and 3D Imaging, opened its doors to the world’s only Translational Imaging Center, which includes a cyclotron and specialized services. The Translational Imaging Center is connected to the world-class vivarium at the MPI Research headquarters, in Mattawan, Michigan. ■

WWW.MPIRESEARCH.COM/JASPERCLINIC BIOMATTERS | SPRING 2015

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MICHIGAN: A POWERHOUSE IN CLINICAL TRIALS

The other MichBio member organizations conducting Phase I clinical trials in Michigan

SRI: THE NEW KID ON THE BLOCK

include Quest Research Institute in Bingham

SRI International, a California-based research institute, is planning to start clinical trials within a few months in its new biosciences facility at the Michigan Life Science and Innovation Center in Plymouth.

Farms, the University of Michigan Institute

Developed with the assistance of a $5 million grant from the Michigan Strategic Fund, SRI’s aim is to help small biotech companies through the process of drug discovery and commercialization.

“I would regard that as our sweet spot,” said David Sahner, MD, senior director of clinical translation at SRI and leader of the new facility.

for Clinical Research in Ann Arbor, and the Beaumont Health Research Coordinating Center in Royal Oak.

VISUALLY INSPECT SMALL LUMENS WITH REMARKABLE CLARITY

FLEXIBLE INSPECTION SCOPE

SRI is in talks with the Beaumont Health System and others about getting patient referrals for its upcoming trials. The Oakland University William Beaumont School of Medicine and Beaumont Health System helped attract SRI to Michigan and plans to collaborate with it in translational research.

THIS IMPROVED DESIGN PROVIDES HIGH QUALITY IMAGES OF THE INSIDE OF DIFFICULT TO OBSERVE LUMENS. ITS STRENGTH AND FLEXIBILITY MAKE IT THE PERFECT VISUAL INSPECTION TOOL.

SRI’s Plymouth operation has 13 beds, three infusion chairs, and will offer overnight stays.

“We’re extremely excited to be here,” Sahner said. “Michigan has a deep reservoir of talent to allow the state to develop a vibrant clinical trials economy.” ■

The Flexible Inspection Scope includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft. Designed for

A FULL LISTING OF ALL MICHIGAN-BASED TRIALS CAN BE FOUND ON THE U.S. NATIONAL INSTITUTES OF HEALTH’S WEBSITE: WWW.CLINICALTRIALS.GOV

instruments 3.2mm in diameter or larger, this is a perfect tool to get a visualization of any potentially soiled tool.

1

“Search for Studies.” ClinicalTrials.gov. U.S. National Institutes of Health, n.d. Web. 19 May 2015.

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MICHBIO | michbio.org

SISU GLOBAL HEALTH AND IN2BEING

IT TAKES A VILLAGE: Determined entrepreneurs tap Michigan startup resources to develop first product and its path to market Three Michigan entrepreneurs met, stayed in touch, and eventually realized their complementary skill sets made a great union.

SUBMITTED BY SISU GLOBAL HEALTH AND IN2BEING

Three Michigan entrepreneurs met, stayed in touch, and eventually realized their complementary skill sets made a great union.

Ambitious and persistent social entrepreneurs, Sisu Global Health’s co-founders, Carolyn Yarina, Gillian Henker, and Katie Kirsch tackle challenges head on with energy and resourcefulness.

The company sticks out in a crowd; Sisu combines a focus both on profits and health outcomes. Using a human-centered design strategy, the company has leveraged Michigan resources across the state to develop their first medical device and its path to market.

Hemafuse, the initial entrant from their portfolio, will advance Sisu’s

broader vision: the commercialization of medical devices into emerging markets in partnership with established medical device companies and NGOs. The Hemafuse alleviates issues of blood access, in part by creating a new blood source outside of typical donor blood. The device salvages and recycles blood in cases of internal hemorrhage. The concept rose out of a senior design project in the University of Michigan’s Mechanical Engineering program and first progressed into a company called DIIME, Design Innovations for Infants and Mothers Everywhere. DIIME evolved and rebranded into Sisu Global Health in February 2014.

BIOMATTERS | SPRING 2015

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Sisu Global Health’s co-founders, (L-R) Katie Kirsch, Carolyn Yarina, Gillian Henker, use a market approach to address critical healthcare needs in developing countries.

IT TAKES A VILLAGE

countries, such as India, making these countries more approachable for a scalable and profitable business proposition.

Autologous blood transfusion is the retransfusion of blood or blood components to the same individual from whom they were taken. Most autologous transfusion machines are meant for long-term, orthopedic or cardiac surgeries; Hemafuse is intended for emergency situations.

The current autologous blood transfusion procedure used in Sub-Saharan Africa, and performed as a last resort in tertiary hospitals, takes substantial time and human resources. Blood is salvaged with a kitchen soup ladle and filtered with gauze. Alternatively, the Hemafuse is significantly safer, and one person can perform the procedure in one third the time.

The device functions much like a giant syringe to suction blood through a filter when a handle is pulled up. When the handle is pushed down, the blood is transferred directly to a blood bag in a closed system.

The design was inspired through four years of observation and usability testing in Ghana’s largest, most technical hospitals. The portable Hemafuse is electricity-independent, and able to work within cultural, and some religious, beliefs around blood transfusion. Its main use is for internal hemorrhages related to pregnancy complications in the first trimester, such as ruptured ectopic pregnancies, which have a much higher rate of occurrence in many developing country settings. Other use cases are still being explored, including internal hemorrhages caused by trauma, such as a traffic accident.

Why choose Africa as a market entry point? Many Sub-Saharan African countries, particularly Ghana and Zimbabwe, have a more-centralized and lessfragmented healthcare system than other developing

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MICHBIO | michbio.org

“The strategy is to work directly with our local partners to disseminate technology that not only solves the clinical problem, but also addresses other issues that have prevented life-saving technologies to stick in these African health systems. We have been approached by several different organizations to commercialize technology in the autologous transfusion market, but the real test will be scaling the Hemafuse,” discussed Katie Kirsch, Chief Marketing Officer, Sisu Global Health.

It takes a village to raise a child and to bring an emerging company’s first product to market. Sisu has leveraged Michigan resources to create results.

Over the past year, in2being, Tiger Studios, the Geek Group, and GR Current all played a role in the growth of the company, offering to raise a advice, services, child and to bring an emerging and handson help. The company’s first product to founders also market. Sisu has leveraged received funding Michigan resources to from the Business Accelerator Fund create results.” and guidance through the Michigan Small Business Development Center to achieve several of its product development milestones.

“IT TAKES A VILLAGE

SISU GLOBAL HEALTH AND IN2BEING

TOP: In a fact-finding trip to Ghana, Gillian Henker discusses the Hemafuse with Dr. Peter Paul Bacheyie, Head of the Blood Bank, Dr. David Kobila, Head of the OB/GYN department, and a visiting OB/GYN consultant, Dr. Samuel Amoaka, at Tamale Teaching Hospital. RIGHT: On the same trip to Ghana Katie Kirsch and Gillian Henker show the Hemafuse to an Anesthesiology Technician at Tamale Teaching Hospital.

Saline-based in2being plays an ongoing role in product development, making sure the design is vetted for both manufacturability and scalability down the road, and is positioned to meet international safety requirements for clinical devices.

“When Sisu needed to quickly put functional mockups in doctors’ hands in Africa, in2being got them through that milestone within a tight 1-month timeframe. Currently, we are working on product planning, design for manufacturability, and ongoing product development for their African clinical trial units,” commented Gene Parunak, Managing Director, in2being.

of state-wide resources. Saving Lives at Birth, a consortium of USAID, the Bill and Melinda Gates Foundation, UKAID, Grand Challenges Canada, and the government of Norway, awarded the company a $250k grant in 2014. In addition, Sisu participated in, and won an award in the Biosciences Showcase at the 2014 MichBio Conference and Expo. Inventiveness helps also. The company utilized online funding site, indiegogo.com, to set up a campaign to finance a recent fact-finding trip to Zimbabwe.

Sisu recently announced that it has become a part of DreamIt Health, a nationally-rated startup accelerator in Baltimore. There, Carolyn, Gillian, and Katie are working with top blood experts at Johns Hopkins University, mentors in global health, and autologous transfusion companies to advance their goal of using a market approach to address critical healthcare needs in developing countries. ■

Sisu’s business model includes selling to hospitals through wholesale distributors with ongoing regional expansion. This supply chain will allow the company to introduce other technologies from their portfolio of maternal and blood access solutions in addition to other devices that are deemed needed and qualified by the company’s African healthcare partners.

The company is a prime example of what an early-stage company can accomplish when it takes advantage

WWW.SISUGLOBALHEALTH.COM

WWW.IN2BEING.COM

BIOMATTERS | SPRING 2015

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MICHIGAN BIOSCIENCES:

BY THE NUMBERS MICHIGAN BIO-INDUSTRY QUICK FACTS

1,760

*

AVERAGE BIOSCIENCE SALARY

$81,296

*

41,892*

BIOSCIENCE JOBS

BIO COMPANIES & ORGANIZATIONS

205,952*

$15

BILLION

ACADEMIC BIO-RESEARCH TOTAL R&D $2.09 billion

†

BIOSCIENCE R&D $1.24 billion*

SCIENCE/ENGINEERING DEGREES 14,238 †

PATENTS PER 1,000 S&E INDIVIDUALS 4,598 †

* Battelle/BIO State Bioscience Jobs, Investments, and Innovation, 2014. † National Science Board, Science and Engineering Indicators, 2014.

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#9

IN NATION 2012

#10

IN NATION 2012

#7

IN NATION 2011

#6

IN NATION 2012

TOTAL EMPLOYMENT IMPACT

ECONOMIC IMPACT

MICHBIO

INVESTMENT AND FUNDING

9 26

ANGEL FUNDS IN MICHIGAN

$350*

TOTAL BIOSCIENCE INVESTMENT

VC FIRMS IN MICHIGAN

$505

LIFE SCIENCES CORRIDOR FUND/21ST CENTURY JOBS FUND (1999-2011)

MILLION

MILLION

LEARN MORE: michiganbusiness.org/start-up/capital

BUSINESS PLAN

DEBT

Great Lakes Entrepreneurs Quest: $100,000 in prizes

GRANTS

EQUITY

VC/PRIVATE EQUITY

Michigan Angel Fund

•

21st Century Investment Fund

•

Michigan Pre-Seed Fund 2.0

•

Accelerator Fund Program

•

Michigan Pre-Seed Fund Investment Program

•

InvestMichigan! Fund

•

Pure Michigan Venture Match Fund

•

Venture Michigan Fund I & II

Accelerate MI Innovation Competition: $1M in cash prizes; largest in world

•

•

•

Michigan Pre-Seed Fund Loan Program

Emerging Technology Fund

STATE COMMERCIALIZATION RESOURCE PROGRAMS •

Michigan Corporate Relations Network (M-CRN)

•

Michigan Manufacturing Technology Center

LEARN MORE:

•

Michigan Technical Education Centers (M-TECH)

michiganbusiness.org/start-up/business-assistance

•

Pure Michigan Talent Connect

michiganbusiness.org/start-up/entrepreneurial-opportunity

•

Tech Talent Transfer Network

michiganbusiness.org/start-up/talent

Medical Devices

DISTRIBUTION OF MICHIGAN BIO COMPANIES

BY SECTOR

35%

IT/mHealth

9%

Pharma & Therapeutics

Distribution/ Logistics

18%

6%

Ag/Food/Industrial

14%

R&D/Testing Labs

18%

BIOMATTERS | SPRING 2015

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A SAMPLE OF GLOBAL BIOSCIENCE BRANDS IN MICHIGAN MICHIGAN BIOSCIENCES: BY THE NUMBERS

ABBOTT NUTRITION

KELLOGG COMPANY

ALBEMARLE

MEAD JOHNSON

AMWAY

NEOGEN CORPORATION

BAYER CROPSCIENCE

NESTLÉ NUTRITION

BECKMAN COULTER

ORCHID ORTHOPEDIC SOLUTIONS

CARDINAL HEALTH

PAR PHARMACEUTICALS

THE DOW CHEMICAL COMPANY

PERRIGO COMPANY PLC

GENERAL MILLS

POST FOODS

JOHNSON & JOHNSON

RTI SURGICAL

KALSEC

THERMO FISHER SCIENTIFIC

BIOSCIENCES INDUSTRY DISTRIBUTION IN MICHIGAN Ag/Food/Nutrition & BioBased Products/Energy Medical Devices & Equipment Pharmaceuticals & Consumer Health Care Diagnostics/Research Products, Testing, & Medical Laboratories SmartZoneSM/Incubator University/Tech Center Clinical Trials Phase I Unit

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NSF HEALTH SCIENCES

Global public health organization launches

QUALITY MANUFACTURING STANDARD

BY MAXINE FRITZ, EXECUTIVE VICE PRESIDENT AT NSF HEALTH SCIENCES PHARMA BIOTECH

For decades pharmaceutical excipients were largely ignored by pharmaceutical companies, regulators and the public. This is primarily because they were wrongly considered inert ingredients despite most pharmaceutical formulations contain 70 to 90 percent excipients.

In the past, most efforts and focus on risk, GMPs (good manufacturing practices), regulations, and legislation have been on active pharmaceutical ingredients (APIs). However, the globalization of the pharmaceutical industry, combined with a regulatory focus on preventing counterfeits and adulterated products, has shined a light on the need for appropriate excipient quality and controls. Michiganbased public health organization NSF International has stepped in to help the excipients industry develop a solution.

The Food and Drug Administration Safety and Innovation Act (FDASIA) includes several provisions focused on ensuring safety and quality in the increasingly global pharmaceutical supply chain.

Importantly, this applies to suppliers of excipients as well as APIs. Most manufacturers know how to adhere to GMPs for their finished products, but FDASIA now requires manufactures to verify and document that the raw materials and excipients used in finished products are also meeting the appropriate GMPs. In the past, many manufacturers relied on ingredient testing or questionnaires sent to suppliers to assure GMPs.

This is no longer sufficient. To comply with the FDASIA, manufacturers will need to audit their ingredient suppliers themselves or use a thirdparty auditor to verify the quality and safety of raw materials. This presents a special challenge since most excipients are manufactured in bulk and sold to many industries, not just the pharmaceutical industry.

And typically the pharmaceutical industry isn’t the largest buyer of these excipients. For example, only .02 percent of cellulose is used in pharmaceutical products. The pharmaceutical industry will need to work closely with its excipient manufacturers to ensure they are manufacturing ingredients with the appropriate GMPs in mind.

This is why global public health organization NSF International has published the first American National Standard for pharmaceutical excipients - NSF/IPEC/ ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. The new standard and its corollary auditing program assists pharmaceutical companies in verifying regulatory compliance and strengthening safety and quality throughout the excipient supply chain by providing a harmonized and comprehensive set of criteria for quality management systems used in the manufacture of pharmaceutical excipients worldwide.

The NSF/IPEC/ANSI 363 standard was developed in partnership with the International Pharmaceutical Excipients Council (IPEC) with balanced input from a committee of pharmaceutical excipient experts from regulatory, industry, and academic fields. The standard references 14 regulatory guidelines and industry standards for excipients, including U.S. Food and Drug Administration regulations, International

BIOMATTERS | SPRING 2015

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NSF: QUALITY MANUFACTURING STANDARD

Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients.

John Giannone, Chairman, IPEC-Americas explains, “Excipient manufacturers certified to the NSF/IPEC/ANSI 363 standard demonstrate that their excipients are manufactured to the appropriate GMPs for pharmaceutical use, which in most cases results in fewer customer audits.

Both regulators and industry benefit from the time and cost savings of a harmonized excipient GMP standard like NSF/IPEC/ANSI 363.”

Since excipient suppliers tend to manufacturer and sell materials to several markets — each with slightly different standards — it can be a real burden for them to host multiple audits. One advantage of working with NSF International is the option of bundled audits, where NSF audits the excipient manufacturing facility to multiple regulatory and industry standards for food and dietary supplements in addition to excipient GMPs. This helps further reduce cost and time associated with multiple audits, while meeting the needs and expectations of customers in many different sectors.

Pharmaceutical companies purchasing excipients certified to the NSF/IPEC/ANSI 363 standard are provided additional assurance of excipient quality and can elect to purchase audit reports.

For more information about NSF International’s pharmaceutical excipient auditing program, please contact Austin Caudle by phone +1 734-545-3376 or email excipients@nsf.org, or visit NSF International’s website. ■

TO PURCHASE A COPY OF NSF/IPEC/ANSI 363, VISIT THE NSF INTERNATIONAL BOOKSTORE.

WWW.NSF.ORG

150,000-liter fermentation vessel

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PFIZER CENTRESOURCE

GLOBAL PHARMACEUTICAL REACH WITH WITH

MICHIGAN ROOTS SUBMITTED BY PFIZER CENTRESOURCE

Pfizer CentreSource (PCS) has called Kalamazoo, Michigan its global headquarters for over 40 years with regional sales offices in Kalamazoo, Brussels, and Singapore comprising 37 employees.

Pfizer CentreSource is the contract manufacturing sales organization within Pfizer providing customers with a multitude of steroid active pharmaceutical ingredients (APIs), biologic drug substance, and drug product solutions through its access to Pfizer Global Supply manufacturing facilities around the world.

Initially, PCS’s biologic technology platform was used to efficiently produce steroid active pharmaceutical ingredients via their fermentation facilities in Kalamazoo.

The development of the fermentation technology allowed the company to eliminate many synthetic chemistry steps.

This produced two key outcomes: (1) becoming a steward of the environment by eliminating hazardous waste and (2) reducing the cost of life saving medicines for patients.

Fermentation technology has continued to evolve and develop which provides a significant competitive advantage for Pfizer’s Michigan manufacturing facility. By continually investing in novel fermentation technology, PCS has continued to provide its customers with increasing value and remain fiercely competitive in a challenging global market.

This technology platform has enabled the Kalamazoo site to become and maintain its status as a world leader in the production of steroid APIs. Kalamazoo is also a leader in synthetic steroid chemistry where the upstream fermentation technology is leveraged to produce high purity steroid active ingredients at globally competitive cost.

The Kalamazoo site is also home to one of Pfizer’s most prestigious fermentation technology groups that provide the research and development efforts needed to sustain a technological advantage. This group has not only developed fermentation and bioconversions for steroid applications but also for a number of non-steroidal molecules that are highly important to Pfizer’s global supply chain. The group works closely with the Kalamazoo site process technology group and manufacturing to ensure new technology is

scalable and implemented right first time. This operational excellence culture is a key component in ensuring the site remains globally competitive for years to come as it provides an innovation pipeline that’s constantly pushing the boundaries of steroid manufacturing excellence.

Beyond Kalamazoo manufactured APIs, PCS manages a complex network of offerings as advanced biotechnology platforms were developed within the Pfizer network.

PCS now provides biologic drug substance to third party customers from our global biologic manufacturing network including Andover (Massachusetts), Strängnäs (Sweden), Sanford (North Carolina), and Pearl River (New York). Each manufacturing location has unique capabilities in biotechnology including mammalian cell, microbial fermentation, recombinant proteins, antibody drug conjugates, and protein conjugation.

This represents only a few of the many biotechnology platforms Pfizer CentreSource offers its customers. While the key technology platforms are highly important, it is the knowledge base and expertise of the highly trained workforce that differentiates Pfizer CentreSource from other contract manufacturing organizations. Successful partnerships require leading technology, expertise, state-ofthe-art equipment and facilities, and most importantly the right people.

Pfizer CentreSource is certainly a hidden gem in the burgeoning Michigan biotechnology movement. PCS remains committed to further developing and growing our biotechnology offerings and business to help facilitate solutions to complex customer requirements. ■

Kalamazoo site aerial view: Home to Pfizer CentreSource

WWW.PFIZERCENTRESOURCE.COM

BIOMATTERS | SPRING 2015

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ANTHRAX VACCINE

ROOTED IN MICHIGAN SUBMITTED BY EMERGENT BIOSOLUTIONS

Emergent BioSolutions’ history is deeply rooted in Lansing, Michigan, where it was first established in 1998 through the acquisition of the Michigan Biologic Products Institute, the vaccine production facilities of the State of Michigan.

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Emergent started out with a single site, 170 employees, and one product, BioThrax® (Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine for the prevention of anthrax disease. Since then, the company has evolved into a highly successful global specialty biopharmaceutical company listed on the New York Stock Exchange. The company has grown from one to ten locations, from 170 to 1,300 employees worldwide, and has expanded its portfolio from one to nine products that address chemical and biological threats, infectious diseases, hematology/ oncology, transplantation, and autoimmune disorders.

“In my ten-year career with Emergent, I have seen the company grow both organically and through acquisitions.

Our business has diversified, but our dedication to our mission – to protect and enhance life – remains the same. I am proud to work with such talented professionals whose daily display of passion, commitment, and innovation fuel the company to achieve more successes,” shared Adam Havey, EVP and President of the Biodefense Division.

Since its founding, Emergent has focused on becoming a leading medical countermeasure supplier to government customers. The company’s anthrax vaccine is used to protect servicemen and women who are deployed to high threat areas and is delivered to the U.S. Strategic National Stockpile (SNS) as part of the U.S. government’s biodefense strategy to protect the nation.

EMERGENT BIOSOLUTIONS

To date, BioThrax has been administered to more than 3 million military personnel and over 90 million doses have been contracted by the U.S. government for the SNS. In pursuit of its mission, Emergent adopted a growth strategy that leverages its leadership in the biodefense space, government contracting expertise, and advanced product development and manufacturing core competencies to enhance its product portfolio and broaden the company’s arsenal of medical countermeasures.

In 2014, Emergent acquired Cangene Corporation and expanded its portfolio with three medical countermeasures, which are also being supplied to the SNS: •

BATTM (Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine)) — The only FDA-licensed therapeutic for treatment of symptomatic botulism following suspected or documented exposure to the botulinum neurotoxin serotypes A, B, C, D, E, F, or G.

•

VIGIV (Vaccinia Immune Globulin Intravenous (Human)) — An FDA-licensed therapeutic for treatment of complications due to smallpox vaccination.

•

AnthrasilTM (Anthrax Immune Globulin Intravenous (Human)) — An FDA-licensed therapeutic for treatment of inhalational anthrax.

In 2013, Emergent acquired RSDL® (Reactive Skin Decontamination Lotion Kit), which neutralizes or removes chemical warfare agents from the skin. Used to protect military and first responders in more than 35 countries, RSDL has also been shown to be effective in removing or neutralizing organophosphates, which are some of the most common and most toxic insecticides used today.

Despite being the only FDA-licensed anthrax vaccine manufacturer, Emergent recognizes that continuous improvement is essential for living their mission as well as for continued business success. Currently, a next generation anthrax vaccine, NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), is being developed in a dry formulation that will enable it to be shipped and stored without the need for cold chain.

One of the company’s notable accomplishments is Emergent’s BioThrax scale up program, which is expected to triple the manufacturing capacity for BioThrax from 7-9 million doses to potentially 20-25 million doses annually in its state-of-the industry manufacturing facility, Building 55. B55, as it is fondly called by employees, is anticipated to gain FDA licensure late this year or early next.

While Emergent was founded in Lansing, its headquarters reside in Gaithersburg, Maryland, along with a product development site, and two manufacturing facilities in Baltimore. Its Bayview Campus in Baltimore has been designated by the U.S. Department of Health and Human Services as one of three Centers for Innovation in Advanced Development and Manufacturing (CIADM) in the country.

CIADM facilities are designed to help facilitate advanced development and domestic surge manufacturing of medical countermeasures for public health threats such as pandemic influenza and Ebola. The company also has sites in Seattle, Winnipeg, Mississippi, and other sales locations around the globe.

Regardless of location, Emergent’s core values of respect, communication, empowerment, innovation, and commitment have united employees throughout the company, specifically, the company’s commitment to social responsibility. The company and its employees are committed to enhancing life not only through the products and services it offers, but also through its philosophy on community involvement. eGIVE or Give, Invest, and Volunteer in Emergent communities is the company’s corporate social responsibility program that enables employees to direct funds to charitable organizations of their choice. Additionally, each employee is given eight hours of paid time off to volunteer for causes they support.

Though the company has grown and matured a great deal since 1998, it has no intention of slowing down any time soon. With aggressive goals and determination to reach them, Emergent is sure to continue its prosperous path in the coming years. ■

WWW.EMERGENTBIOSOLUTIONS.COM @emergentbiosolu

Employee volunteers paint a local elementary school through Emergent’s corporate social responsibility program, GIVE.

BIOMATTERS | SPRING 2015

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SPECIALIZED LIFE SCIENCE TRAINING:

A HIGH-VALUE FOR MICHIGAN BIOSCIENCE COMPANIES SUBMITTED BY CENTER FOR PROFESSIONAL INNOVATION AND EDUCATION, INC.

The Center for Professional Innovation and Education (CfPIE) is the global leader in professional training for the pharmaceutical, biotechnology, medical device, and skin/cosmetics segments of the life sciences industry.

For nearly 15 years CfPIE has delivered in-depth training to Michigan life science companies of all sizes, including Mead Johnson, Par Pharmaceutical, Pfizer, Precision Edge, Ranir, Stryker, and Tetra Discovery Partners.

Placing great value on their clients and partners, CfPIE works to meet their needs with educational offerings in many different formats — including classroom instruction, customized on-site training, and specialized certifications.

These programs provide both individuals and companies with flexible options to improve their personal skills, maintain regulatory compliance, and create greater opportunities for career advancement. Small class sizes with hands-on instruction promote a dynamic learning environment with excellent student-to-teacher interaction.

MichBio members find value When Tetra, an early-stage biotech company with locations in Grand Rapids and Kalamazoo, asked its Director of Chemistry Richard Nugent, PhD to write the Chemistry, Manufacturing, and Controls (CMC) document for one of their new drugs, he turned to CfPIE for training.

“I’ll be writing my first CMC this July and didn’t quite know where to start. I decided to take the intensive two-day course ‘Preparing the CMC Section for NDAs/INDs/CTDs’ and couldn’t be more pleased with my experience,” explained Nugent.

The course was taught by an industry professional who herself had written a number of CMCs. She used many real life examples in her teaching and encouraged her participants to apply the same technique to their coursework. Nugent’s classmates ranged from CMC novices to more seasoned professionals needing a simple refresher, with backgrounds in such fields as scientific writing, engineering, and chemistry.

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The course included an overview of the International Conference on Harmonization (ICH) process and organization of the Common Technical Document (CTD).

It also covered each element required in the drug substance and dug product section of a New Drug Application (NDA) and/or Investigational New Drug (IND).

“I feel much more prepared to tackle our CMC. I know where to start, what to include — or not include, and how to format it properly,” said Nugent. “This course was a good investment of my time.”

Professional education in all aspects of life sciences Every year, CfPIE offers over 300 courses across more than 80 topics to help professionals in the pharmaceutical, biotechnology, medical device, and skin/cosmetics industries stay ahead of ever-changing regulations, increasing competition, and advancing scientific discoveries. With courses offered to every level of experience — CfPIE programs satisfy scientific, managerial, administrative, and marketing needs. ■

CfPIE is fully committed to providing top-quality technical training to Michigan’s life sciences companies.

As a preferred partner of MichBio, they continue to offer discounts on courses to members.

WWW.CFPIE.COM Visit michbio.org/cfpie to learn more about this ongoing partnership — including a full list of course topics and dates, certification information, and course instructor biographies.

CENTER FOR PROFESSIONAL INNOVATION AND EDUCATION, INC.

BIOMATTERS | SPRING 2015

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GROWING CMO TAKES PRIDE IN COMMITMENT TO QUALITY SUBMITTED BY GRAND RIVER ASEPTIC MANUFACTURING, INC.

Grand River Aseptic Manufacturing, Inc. (GRAM) has proven to be a growing leader in the life sciences industry. GRAM has invested significant capital and human resources and is committed to continue building in West Michigan.

Functioning as a full-service, parenteral (injectable) pharmaceutical manufacturer, this Grand Rapids-based company services a portfolio of over a dozen pharmaceutical and biotech companies located all across the country. Thanks to its highly skilled, experienced people and a state-of-theart cleanroom, GRAM assists its customers in developing, formulating, and manufacturing new drug products.

Major milestones The company has had a very exciting history. GRAM was founded in December 2010 with the support of Van Andel Research Institute, Grand Valley State University, and many private investors, primarily based in West Michigan. Officially opening its doors in January of 2011, GRAM started with just nine employees and one customer. Just two years later, in April 2013, GRAM signed its 10th and largest commercial customer. Since that time GRAM has signed additional contracts with several other pharmaceutical companies, opened an additional 28,000 square foot finishing facility, built a team of over 70 employees, and passed three successful FDA inspections.

As the company experienced organic growth, there were a number of pivotal moments that positioned GRAM to become the company it is today.

In August 2013 the company received approval from the Food and Drug Administration (FDA) to manufacture its first 28

MICHBIO | michbio.org

commercial product. This was a significant accomplishment, as the FDA closely regulates the company’s industry and a positive track record with the agency is critical for success.

Not only did GRAM get approval to manufacture a specific commercial product, it received approval for aseptic filling and terminal sterilization for all products. This achievement validated GRAM’s investment in quality and highly skilled staff and gave the company credibility in the marketplace.

GRAM continues to maintain a superior record with the FDA, which reflects the organization’s dedication to performance excellence and to bringing on new customers.

Significant new customer Another pivotal moment for GRAM was the signing of a significant, long-term commercial contract with a multibillion dollar pharmaceutical customer in 2013. GRAM was on track for steady growth prior to winning the business, but the signing of this contract accelerated the company’s growth and trajectory. The project involved many facility upgrades that were needed to meet the throughput demands for commercial manufacturing of the product. GRAM made the upgrades and also secured and updated a second 28,000-square-foot

GRAM finishing facility

GRAND RIVER ASEPTIC MANUFACTURING, INC.

facility. That second facility houses all materials and product, a new 2,000-square-foot analytical laboratory with expanded capabilities and all product finishing activities. GRAM celebrated the opening of the new facility with a ribbon cutting ceremony in August 2014.

To fund this growth and expansion, GRAM successfully raised $9.8 million in new capital in 2014.

Collaborative approach drives results

August 2014 Ribbon Cutting Ceremony: (L-R) Grand Rapids Mayor George Hartwell, GRAM COO Connie Degen, GRAM CEO and President Tom Ross, city of Grand Rapids Economic Development Director Kara Wood, and GRAM Chairman Jerry Arthur.

The significant new customer in 2013 involved the transfer of a high-profile, FDA-approved, generic drug. The goal of the project was to have a successful transfer of the product with a Change Being Affected in 30 days (“CBE-30”) filing with the FDA. GRAM utilized its skilled technical teams and strong project management to implement a plan to complete the project successfully. The technical transfer teams at GRAM and its customer worked in collaboration to meet a myriad of objectives, all while completing the project timely and meeting all regulatory guidelines.

The cross functional team approach allows GRAM to adopt new processes tailored to meet the specific needs of its customers. As a contract manufacturing pharmaceutical company, GRAM has to be flexible and responsive, all while adhering to strict FDA compliance requirements.

GRAM cleanroom

Culture is key GRAM’s success in doing large scale technical transfers and launching commercial production of FDA approved products is a direct result of the company’s culture. GRAM employees are deeply committed to very high quality standards and to meeting customer objectives. Management has set the tone in this respect and strives to ensure that each employee feels as though GRAM is “their company” and to foster a sense of family. This has been accomplished through transparency in all communication, sharing of financial information, and the celebration of victories (of all sizes). With a very strong team environment, GRAM employees will step outside of their functional areas and help other team members push through challenges to meet or exceed customers’ goals and achieve project deliverables.

GRAM has experienced many company- and customerrelated successes and each member of the team knows they contributed directly to achieve that result. The company’s vision is “Enriching lives, it’s that important!” and every person at GRAM plays a role in producing drugs that help save and enrich lives. ■

COMMITTED TO MICHIGAN GRAM is proud to be a new leader in the growing life sciences industry in the state of Michigan.

As the company looks to the future, the outlook is one of dynamic growth and opportunity.

GRAM will continue to increase its presence in the pharmaceutical industry by adding new capabilities, growing its customer base, and creating new jobs. GRAM is proud to call Michigan its home.

WWW.GRANDRIVERASEPTICMFG.COM

BIOMATTERS | SPRING 2015

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LEVERAGING THE POWER of imaging in drug development SUBMITTED BY MOLECULAR IMAGING, INC.

Molecular Imaging, Inc., headquartered in Ann Arbor, MI, helps pharmaceutical and biotechnology companies optimize their discovery and preclinical development investments through in vivo imaging (imaging of living animals).

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MOLECULAR IMAGING, INC.

The original company was founded in 2003 by two University of Michigan researchers whose vision was to combine conventional preclinical cancer models with emerging imaging technologies to better understand the efficacy and safety of possible therapies.

THE VALUE OF IMAGING Patrick McConville, PhD, Molecular Imaging’s Chief Scientific Officer, says that most people are familiar with imaging tools used by doctors – MRI, CT, PET scans, ultrasound, and x-ray – as these have been around for 30 years or more. Only in the last decade, he says, have technologies designed to capture and analyze data from small animals been available, enabling in vivo imaging in the many valuable mouse and rat models of human disease. McConville says that uses of preclinical in vivo imaging commonly fall into one of three categories: ANATOMICAL: The most common use is imaging deep tissue structure and/or volume to determine in animals where the disease is and, often, how it has advanced. This use is in fact identical to imaging use in patients to assess response or progression, e.g. RECIST criteria in cancer. Imaging also makes possible the use of animal models some consider better replicators of human disease, improving the translation of preclinical results to the clinic. For example, imaging allows researchers to implant tumor cells or tissue in the target organ of interest (orthotopic models), rather than below the skin (subcutaneous models).

FUNCTIONAL OR MOLECULAR: McConville says that probes and tracers are being continuously developed for use with in vivo imaging that help determine whether a treatment is having an intended effect or ‘hitting the right biological target.’ This type of information can tell researchers whether their drug is acting in the manner expected, as well as how it is affecting the disease itself. According to Dick Leopold, PhD, the company’s Vice President, Oncology, this approach can allow researchers to validate translational imaging biomarkers by verifying the relationship of response or target modulation measured by traditional methods with data acquired by imaging.

BIODISTRIBUTION: Both scientists also say that much information can be gained from understanding where a drug, biologic, or therapeutic cell goes once it enters a living animal, how it localizes in tissue and how long it takes to be metabolized or excreted. Molecular Imaging radio-labels compounds to track drug, biologic, and therapeutic cell distribution over time for just this purpose.

The biodistribution example highlights three important benefits from in vivo imaging: 1) by imaging a living being, information is gained over time (i.e. longitudinal), providing robust, more clinically relevant data, 2) information is quantitative – that is, data is mathematically extracted from digital images, providing statistically powered, comparative output, and 3) without compromising data quality, longitudinal studies can use fewer animals – something all researchers desire.

WHY MOLECULAR IMAGING, INC. Molecular Imaging’s President, Tom Ludlam, Jr., says the company has a team of 32 skilled scientists and technicians to support this effort, many coming from drug discovery or toxicology departments in pharmaceutical companies. Most are located in Ann Arbor, where in vivo pharmacology and in vitro services in cancer and inflammatory diseases are provided, in addition to a full spectrum of in vivo imaging services. In early 2014, the company opened a second imaging center in La Jolla, CA in collaboration with a consortium of outstanding biomedical research organizations — the University of California at San Diego, the Sanford-Burnham Medical Institute, the Salk Institute, the Scripps Institute for Biomedical Research and the La Jolla Institute of Allergy and Immunology. The balance of the team support in vivo imaging services at this Molecular Imaging Center at the Sanford Consortium or “MICS.” MICS is expanding the validated use of in vivo imaging beyond cancer. Disease areas of commercial interest include fibrosis (kidney, pulmonary), cardiovascular disease (infarction, aortic stenosis), central nervous system diseases (Parkinson’s, stroke, receptor occupancy) and cell tracking, including exploratory work on CAR-Ts, a promising effort in immuno-therapy. Dr. McConville says Molecular Imaging is finding that researchers in therapeutic areas outside cancer are increasingly attracted to the use of in vivo imaging to help answer important questions.

There are thousands of companies worldwide engaged in the development of drugs, biologics, cell therapies, and medical devices. The vast majority are small, venture-funded companies with limited resources and a desire to maximize their R&D investment. Replicating Molecular Imaging’s armamentarium of in vivo imaging tools would cost over $10M. Replicating the skills and experience of the team in Ann Arbor and La Jolla would cost even more. Molecular Imaging has served over 200 companies and conducted over 3,000 studies — 700 of which included in vivo imaging — since its founding in 2003. This gives Molecular Imaging unmatched experience and expertise with this emerging technology.

Molecular Imaging, Inc. is founded on a strong platform of conventional pharmacology, explains Ludlam. But the company’s unique advantage comes from making the power of small animal in vivo imaging available to all companies, large and small. The Molecular Imaging team is convinced that integrating in vivo imaging into preclinical efforts can accelerate and advance these company’s R&D efforts, for their benefit and the benefit of us all. ■

WWW.MOLECULARIMAGING.COM BIOMATTERS | SPRING 2015

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PROTECTING THE NEXT GENERATION OF SCIENCE

BY MELISSA P. CLAMPITT, CHIEF COMMUNICATIONS OFFICER AT BROWNRIGG COMPANIES LTD

The future seems unlimited for the life science industry with ground breaking advancements in every direction. But with each growth and development comes added and unfamiliar risks. Brownrigg Companies is the Michigan, family-owned company providing advanced protection for the next generation of science.

Brownrigg Companies LTD is an independent commercial insurance agency that provides domestic and international insurance products to businesses. Founded by Nancy L. Brownrigg in 1989, she started the agency with a focus to identify and develop insurance programs and products for companies with unique insurance needs.

The agency delivers specialized underwriting, loss control, and claim services to companies. Additionally, the agency provides email alerts, online access, and webinars for life science customers on regulatory information, practices and procedures, which constantly need to monitored and kept up to date. For Brownrigg Companies, working with life science companies is about planning for the future and visualizing possible risks.

“We look at each customer, learn their story, and visit their facilities to understand what insurance program is going to protect the company the best,” said Valissa Naganashe, Vice President of Sales and lead agent for life science companies at Brownrigg Companies.

A woman-owned business born and bred in Michigan Headquartered in Troy, MI with offices in downtown Detroit, Brownrigg Companies has over 15 employees including property and casualty licensed agents, life and health licensed agents, certified insurance service representatives and counselors, and certified workers’ compensation professionals with expertise in specialized insurance products and programs. The Detroit office hosts its innovative sales staff and the agency’s International Department, which caters to companies with global insurance needs such as trade credit insurance, ocean cargo, and foreign property and liability.

Some of the specialized coverages Brownrigg Companies provides to life science companies are products-completed operations liability for biotechnology, research and development, specialty pharmaceutical, and implantable or non-implantable medical device components. Package capabilities include property, automobile, inland marine, crime, boiler and machinery, and workers’ compensation for companies from preclinical and development through marketed products. Through the agency’s international department, companies can also get global coverage to meet specific insurance needs worldwide including foreign clinical trials and product policies in many countries as international package policies.

In addition to the agency being owned and operated by the Brownrigg family, Brownrigg Companies is also a certified woman-owned business (WBE) and assists businesses in meeting their supplier diversity requirements or goals. They are committed to superior service, innovation, competitive products, integrity, professionalism, and personal attention.

WWW.BROWNRIGG.COM

(L-R) David Bagley and Valissa Naganashe

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BROWNRIGG COMPANIES LTD

Innovative.

Trustworthy.

Knowledgeable.

Passionate.

A case study Brownrigg Companies recently worked with a customer whose business includes a laboratory with access to tissue samples. The customer’s specific concern related to temperature changes in their laboratory rooms as well as temperature changes in their refrigerators and freezers, which could damage their product and research. On a daily basis they have approximately $500,000 in product that may become useless in the event of a power interruption or other cause that may change the temperature.

A general property insurance form has an extension for spoilage; however this is normally limited to $5,000. For this customer, Brownrigg Companies ordered an endorsement to increase the value for spoilage to $500,000 for loss in temperature. Shortly after this endorsement was issued, a freezer switch malfunctioned and caused all of freezer’s contents to be lost.

Because Brownrigg Companies increased the coverage to account for spoilage, this loss was covered by the insurance company.

Product Design Project Management Injection Molding Micro Molding

Over Molding Insert Molding Clean Room Molding Clean Room Assembly

Medical Device Biotech Diagnostic Microfluidics

ISO 13485:2003 Certified

www.medbioinc.com Innovative Contract Manufacturing Solutions for the Life Sciences.

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“General insurance policies are often written as a ‘one size fits all’ package and are not the best fit for life science business owners. Though some insurance companies market policies as “life science” forms they often still need modifications to keep up with this rapidly changing field.”

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DCG Thought Leadership that provides specialized experience to support the Life Sciences Industry

DCG Life Sciences Practice – global experience, local presence

ou might be surprised at Y what you find at the MSU Innovation Center: Access

and inventors are looking for, all in one place:

to nearly 5,000 researchers, $500 million in annual R&D expenditures, and 642 research and instructional buildings, scale-up facilities, pilot plants and lab space.

Business-CONNECT links the right people and resources to develop ideas

We have the worldclass ingredients that entrepreneurs, investors,

Spartan Innovations creates investment-ready businesses from MSU ideas

MSU Technologies offers the best MSU ideas ready for commercial licensing

Dr. Anil Jain is the MSU Innovation Center 2014 Innovator of the Year.

A Computer Science & Engineering prof and prolific inventor, his research advances rapid facial and fingerprint recognition used in fighting terrorism and crime.

innovationcenter.msu.edu

Learn more about DCG as we celebrate 25 YEARS IN BUSINESS

@MSU_Innovation

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The Collaborative Bioprocessing Partnership that Gets it Done Right and On Time

DCG 965 East Jefferson Avenue, Detroit, MI 48201 www.dcgroupinc.com 34

MICHBIO | michbio.org

To get your bioprocessing project done right and on time, rely on the collaborative team approach we’ve used to bring over 80 proteins and other large molecules to late phase clinical or commercial-scale production.

From project inception through scale-up and ongoing optimization, you’ll have complete access to our world-class analytical, regulatory, technical support and production expertise – and the confidence that your project is managed with seamless efficiency by a dedicated team of experts, fully committed to your success. This allows us to offer more flexible solutions to your manufacturing challenges, and in accelerated timeframes.

The Americas: +1.269.833.5844 Europe/Middle East/Africa: +32.2.714.6502 Asia Pacific: +65.6419.0248 centresource.info@pfizer.com www.pfizercentresource.com

Dykema: Where Law Meets Science For insightful legal counsel, smart representation and strategic business advice, Michigan’s biotechnology and life science companies turn to Dykema.

Dykema’s biotechnology and life science team represents clients ranging from startups to public companies to nonprofits, in a variety of industry sectors, including pharmaceuticals, diagnostics, health care services, biotechnology, medical devices and equipment, and computer technology and software applicable to the life sciences industry. The Dykema biotechnology and life science team regularly advises companies in capital raising activities (including angel, venture capital and government-related funding sources), mergers and acquisitions, technology licensing transactions, and intellectual property protection and exploitation matters.

To learn more, please contact Jin-Kyu Koh, leader of Dykema’s Biotechnology and Life Science practice, at 313-568-6627 or jkoh@dykema.com.

Exceptional service. Dykema delivers.

www.dykema.com California | Illinois | Michigan | Minnesota | Texas | Washington, D.C. © 2014 Dykema Gossett PLLC Attorney Advertising

MPI RESEARCH ACQUIRES THE JASPER CLINIC Clinical Phase I–IIa Capability MPI Research is renowned in early-stage development for deep scientific expertise and state-of-the-art technology at the world’s largest preclinical research facility. With our acquisition of The Jasper Clinic — a 50-bed clinical trial unit with a long track record in first-in-human studies — we have taken a further significant step towards being the leading integrated resource for early development. We now offer you the full continuum of lead to proof-of-concept services for new drug candidates.

For more information, visit www.mpiresearch.com

REGISTER NOW! cfpie.com

Taking You Further.

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ACCELERA TE the Clinical Trial Process EXpEriEncE

Senior physicians and certified staff with no employee turnover

SPEED

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efficacy

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

www.questri.com Early Phase, Multi-Specialty Unit 31000 Telegraph Rd, Suite 230 Bingham Farms, Michigan 48025

Terumo Cardiovascular Group and Terumo Heart, Inc., are Proud Sponsors of MichBio and Michigan’s Growing Biosciences Industry

Neurology Clinic at MIND 28595 Orchard Lake Road, Suite 301 Farmington Hills, Michigan 48334 248-644-7770 www.questri.com

www.terumo-cvgroup.com | www.terumoheart.com Terumo ® is a registered trademark of Terumo Corporation. ©2015 Terumo Cardiovascular Systems Corporation. March 2015. 860751

ADVERTISERS Center for Professional Innovation and Education.........35 Data Consulting Group.........................................................34 Dykema....................................................................................35 Ferndale Laboratories..........................................................36 Healthmark..............................................................................14 Medbio.....................................................................................33 MichBio.................................................................................. IFC Michigan Economic Development Corporation.................4 Michigan State University....................................................34 MPI Research.........................................................................35 OU INC....................................................................................33 Pfizer........................................................................................34 PhRMA.......................................................................................6 Quest Research Institute......................................................36 Stryker.....................................................................................37 TechTown..................................................................................3 Terumo.....................................................................................36 University of Michigan..........................................................37 VWR............................................................................................2 Wayne State University...........................................................3

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MICHBIO | michbio.org

Together with our customers, we are driven to make healthcare better. www.stryker.com

BIOMATTERS | SPRING 2015

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MichBio P.O. Box 131099 Ann Arbor, MI 48113-0199

UPCOMING EVENTS: JULY 8 CEO LEADERS’ CLUB John Lechleiter, PhD of Eli Lilly and Company Ann Arbor SEPTEMBER 9-10 MICHIGAN DRUG DISCOVERY SYMPOSIUM East Lansing LATE FALL – DETAILS FORTHCOMING MICHIGAN BIO-INDUSTRY GROWTH SUMMIT Lansing

MEMBERS SAVE Remember, MichBio members get discounts on national events such as RESI, the MD&M conferences, and AdvaMed. Details: michbio.org/events

Check our calendar often for more MichBio events like MichBio U webinars, CEO Leaders Clubs’, and BioConnections business growth referral events.

MICHBIO.ORG @MichBio