BioMatters Fall 2016

IN THIS ISSUE:

08 ENSURING A STRONG BIOSCIENCE WORKFORCE IN MICHIGAN MICHBIO

12 TRANSFORMING DOCTORAL EDUCATION IN THE SCIENCES THE BEST WAY WAYNE STATE UNIVERSITY

18 AFTER THE ELEVATOR PITCH

22 COMMANDING THE LIFECYCLE DISCONNECT DYNAMIC COMPUTER CORPORATION

FALL 2016

A magazine showcasing Michigan’s biosciences industry

BUILDING STEM TALENT IN MICHIGAN

MichBio announces a new partnership with Foley Hoag LLP, a leading provider of legal services to life science entrepreneurs and investors.

MichBio Member Exclusives for Legal Services Critical to Early Stage Companies Free consultations through: • •

Direct hotline via MichBio@foleyhoag.com

Discounts through a legal start-up package offering: •

Corporate formation

•

Contract drafting

•

Data privacy and security

•

IP audits and reviews

•

Trademark registration

•

Website term and conditions

Alternative fee approaches M2 (MI-MA) partnering-connection referral program

Foley Hoag is proud to help MichBio drive Bio-Industry growth in Michigan.

Learn more at MichBio.org

PRESIDENT’S MESSAGE With this issue of BioMatters, we return to the customary format of spotlighting the breadth and substance of Michigan’s biosciences industry. Indeed, it is a growing cluster as evidenced by this year’s TEConomy/BIO report on the health of the industry.

Michigan’s metrics demonstrated strong growth – readers can find that in our “By The Numbers” section, and Peter Pellerito pens a great “Guest Viewpoint” on the implications of that expansion for the state’s economy.

Having a skilled workforce and a sustainable talent pipeline is at the root of maintaining a robust, statewide bio-industry. The Michigan Bio-Industry Roadmap for Success, a strategic growth plan released in February 2016 underscored access to talent as the most important element in ensuring a viable and competitive biosciences cluster.

“Having a skilled workforce and a sustainable talent pipeline is at the root of maintaining a robust, statewide bio-industry. ”

With that in mind, our lead article illustrates how a committed bio-industry leader, impassioned to develop talent, is doing so one intern at a time. The resulting experiences are better equipping trainees to enter the workforce and become lasting employees that successfully contribute to their organizations.

But the development begins even earlier in the educational process. Several articles showcase the various institutional Science, Technology, Engineering and Math (STEM) training programs that are preparing young minds, especially from underrepresented constituencies, for the bioscience careers of the future.

Conversely, we spotlight Project Lead The Way, a program that instructs science teachers on how to instruct biology, chemistry and engineering principles effectively through more contemporary problem-solving and applied approaches.

We complete the issue by featuring how creative and expert talent are not only starting new entrepreneurial ventures (“After the Elevator Pitch”), but also bringing the necessary service and compliance support to the state’s bioscience companies.

All these stories provide a mere glimpse of what Michigan’s bio-industry already offers. By every account, it’s strong and growing, with a future that looks bright indeed.

Sincerely,

STEPHEN RAPUNDALO, PHD President & CEO, MichBio

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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 GOLD

Stephen Rapundalo, PhD President and CEO

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Kate Oesterle Editor Director, Marketing & Communications Elizabeth Morgan Foster Manager, Membership & Operations

Designer: Daina Fuson Designs Printer: Progressive Printing

Nancy Marcotte Manager, Finance

© Copyright Michigan Biosciences Industry Association DBA MichBio

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

MICHBIO BOARD OFFICERS CHAIRMAN Paul Morris AlixPartners, LLP Global Finance Lead, Enterprise Improvement VICE CHAIRMAN Christopher J. Stein Ferndale Pharma Group, Inc. Executive Vice President & Chief Operating Officer

PRESIDENT AND CEO Stephen Rapundalo, PhD MichBio President and CEO SECRETARY Vacant TREASURER Vacant

MICHBIO BOARD DIRECTORS

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Tim Colonnese KTM Industries President and CEO

Stephenie Morley, DVM Zomedica Chief Operations Officer

Robert DeRyke Terumo Cardiovascular Group President, Electromechanical Systems Division

Paul Morris AlixPartners, LLP Global Finance Lead, Enterprise Improvement

Nicholas Evans Genesys Health Vice President, Business Development and CDO

Edward Pagani, PhD University of Michigan Associate Director, Health Technologies, Office of Technology Transfer

Dale Grogan Michigan Accelerator Fund 1, LP Managing Director

Stephen Rapundalo, PhD MichBio President and CEO

Charles Hasemann, PhD Michigan State University Assistant Vice President for Innovation & Economic Development

John J.H. Schwarz, MD Family Health Center Physician and Former U.S. Representative

Ken Massey, PhD Wayne State University Senior Director, Venture Development, Technology Commercialization

PATRON

Kevin McLeod Novus Biotechnology Fund 1 General Partner

David Serota, PhD DABT MPI Research Director of Research, Senior Vice President, Drug Safety, Senior Principal Study Christopher J. Stein Ferndale Pharma Group, Inc. Executive Vice President & Chief Operating Officer

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 KATE OESTERLE AT KATE@MICHBIO.ORG. BIOMATTERS | FALL 2016

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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 Program Grows Small, Global 06 | Internship Business and Local Kalamazoo Students Global Clinical Connections

a Strong Bioscience 08 | Ensuring Workforce in Michigan

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MichBIo

Research-Based Inter-institutional 10 | ACollaboration to Diversify the Biomedical Workforce ReBUILDetroit

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Transforming Doctoral Education in the Sciences the BEST Way Wayne State University

Lead The Way’s Biomedical Science 14 | Project Pathway: Building a Bridge to Michigan’s Biosciences Sector Project Lead The Way

16 | Michigan Biosciences: By the Numbers

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MichBio

18 | After the Elevator Pitch

Emerging Companies

22 | Commanding the Lifecycle Disconnect Dynamic Computer Corporation

Michigan’s Par Sterile Products: 24 | Rochester A Thriving Legacy

Par Sterile Products

26 | Rooted in Michigan, Serving the Globe E.M.M.A.

28 | Breaking Down the Barriers of Packaging Packaging Compliance Labs

28 WANT TO RECEIVE BIOMATTERS?

31 |

Building Michigan’s Biosciences Industry Peter M. Pellerito

Visit michbio.org/subscribe

BIOMATTERS | FALL 2016

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Global Clinical Connections (GCC) knows the trials of the clinical world from the pharmaceuticals to business growth.

The Kalamazoo-based business specializes in clinical supply chain management, traversing the turbulent waters of global regulatory and economic surf. To steer and support the team, they enlist local student talent.

“Interns augment the company and fill the gaps that cannot be filled in a small start-up budget,” Loretta Cipkus Dubray says, founder and CEO of GCC.1 The company supplements aspects of the supply chain from drug product manufacturing through global distribution of packaged and labeled supplies in over 45 countries.

GCC continues to grow in clientele and international presence, and Goldman Sachs recently named them one of the top 10,000 small businesses. While full-time staff are experienced in clinical solutions, interns build the scaffolding for company growth. GCC has offered 61 internships since its founding in 2008, ranging from graphic design to computer engineering. The interns have composed annual newsletters, business cards, job training manuals, client/networking lists, and marketing initiatives.

“One of my missions is to help students get a job,” Dubray says. While the unemployment rate for college graduates declined to pre-recession level this year, the underemployment rate — graduates working jobs where a 6

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S T N E UD college degree is not required — hovers at 45 percent as of March 2016, according to the Federal Reserve Bank.2 GCC’s student internships bridge educational background with professional development, propelling them into better employment opportunities. “[When] we helped to set up the company’s first newsletter, we took verbiage from a previous intern project and made it into an eight segment newsletter,” Andrew Kovacs says, one of the first interns at GCC. “We tried different formats - changing the subject line, where your eye looked on the page, etc. - and the response rate changed.” The newsletter project proved useful in interviews and taught Kovacs to demonstrate why he made a decision.

While lack of engagement among workers persists as the top workforce management problem, unpaid internships are in the spotlight for questionable ethics. As a development strategy, GCC has always paid their interns and granted them autonomy.

“Since it [is] a smaller organization, I felt what we did was directly growing the organization,” Kovacs says. “You had to be relatively self-driven to be there. If you could present the value of task, Loretta would consider it [and] allow you to self-manage.”

Almost half of small companies grant autonomy to workers as a talent-management tool, according to the 2012 Economist Intelligence Unit Survey. As company size grows, management becomes more bureaucratic.3 The impact of their work, too, becomes less noticeable.

“I did not know any other intern that had such an opportunity and I spoke about that in every interview post-college,” Brian Budchuck says, a former intern who currently works in marketing & advertising in downtown Detroit. Budchuck expressed gratitude for his time at GCC, citing his presentation to the company’s board of directors as a highlight. “It was the first chance to present to clients and get real feedback.” He also learned how to build relationships with vendors and clients even through phone and webinars.

FEATURE STORY

“I did not know any other intern that had such an opportunity and I spoke about that in every interview post-college.” Brian Budchuck Peter Jones, currently a computer-engineering student at Michigan State University, also emphasized the real-world experiences at GCC including his first board presentation.

“I was extremely nervous,” Jones says. “It was a higher level than anything in school. We present to really intelligent people who ask questions as you speak. But the next summer, I was much more relaxed and prepared to explain myself accurately.”

The company has yet to hire interns in the actual business scope. Dubray explains the field is “complicated and regulated.” The interns know the general scope, but cannot legally know specific company demands. Fortunately, the students work around their restrictions.

“What [GCC] does and who they consult is very niche. We figured out a Google AdWords plan to further her business,” Ashley Budchuck says, who works in the same marketing & advertising firm as her brother in Detroit. Her work, along with other interns, will eventually allow Dubray to hire full-time, entry-level marketing employees.

Beyond growth, interns add a sense of urgency and fun to the workday.

“It flips the mood when interns enter and wave hello, or they ask about new regulations or recent news that the adults sometimes forget. They stimulate discussion; they keep us fresh.”

But a study by Goleman et al. reverses the situation; a fruitful employer-employee relationship starts with the boss.4 They argue, “The leader’s mood and behaviors drive the moods and behaviors of everyone else.” Each intern describes their own relationship with Dubray, how she offers assistance when needed, the resources to be successful, and frank feedback. ■

GCC excels in balancing company growth with that of their interns. Other small businesses may find success in their internship model and similar benefits: a variety of skill sets in the interns, eager students, and an energized workforce.

1 Global Clinical Connections. 1615 W Centre Ave # 203, Portage, MI 49024.

(269) 488-3277 http://www.globalclinicalconnections.com/ 2 “The Labor Market for Recent College Graduates.” The Labor Market for Recent College Graduates. N.p., n.d. Web. 21 July 2016. https://www.newyorkfed.org/ research/college-labor-market/college-labor-market_underemployment_rates.html 3 “Challenges for Human Resource Management and Global Business Strategy Future HR Trends.” Future HR Trends Challenges for Human Resource Management and Global Business Strategy Comments. N.p., n.d. Web. 21 July 2016. http://futurehrtrends.eiu.com/report-2014/challenges-human-resource-management/ 4 Goleman, D., R. Boyatzis and A. McKee: 2001, ‘Primal Leadership: The Hidden Driver of Great Performance’, Harvard Business Review 79(11), 42.

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ENSURING A STRONG

BIOSCIENCE WORKFORCE IN MICHIGAN

Building Talent for a Global Innovation Economy Bioscience companies, like other high-tech businesses, thrive best in regions that place a priority on science, technology, engineering and mathematics (STEM) education.

Without a doubt, the availability and quality of talent has become an essential competitive factor in today’s innovationdriven economy.

Ensuring a steady pipeline of talent to sustain Michigan’s future bio-industry is the real challenge. The state cannot afford to be complacent. While demand by bioscience companies is strong and continues to grow, significant challenges lie ahead for Michigan’s capacity to meet the bio-industry’s needs – an aging current workforce, competition from other regions for talent, mediocre state science standards, among others.

The Michigan Bio-Industry Roadmap for Success (www.michbio.org/MIBioindustryRoadmap), a statewide strategic growth plan, released by MichBio in February 2016 underscored talent development as a key priority if Michigan is to become a major biosciences hub. Despite being ranked 8th nationally in the number of university-conferred STEM degrees, bioscience employers regularly bemoan over the inadequacies in finding sufficient talent with the required skillsets. Why is that? Clearly, an imbalance exists between what Michigan’s schools are producing and what the bio-industry needs insofar as a workforce.

To address the problem, Michigan must lay a strong foundation of STEM skills throughout K-12. Students of all backgrounds, but especially those from underserved populations, should 8

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be better prepared for the rigors of post-secondary education and future bioscience occupations. Conversely, instructional programs must be expanded for teachers to be trained adequately in the latest scientific principles and technologies.

Experiential learning experiences and greater connections to bio-industry employers and applied subject matter should be integrated in post-secondary curricula. The incumbent workforce needs expanded opportunities to upgrade skills and training. In short, new education-to-employment systems must be established that directly meet the needs of the biosciences economy. Lastly, employer requirements, talent gaps and strategies to grow a stronger bioscience workforce must be identified, developed into a clear plan of action, and a range of talent development programs implemented to improve Michigan’s ability to attract and retain top bioscience talent.

At the end of the day, there’s only so much the bio-industry can do itself to attract and retain talent. The rest of the formula is up to a wider community of stakeholders – our universities, community colleges and vocational programs, as well as our elected officials and policymakers, philanthropic organizations, and communities-at-large – partnered around a common vision. At the same time, the so-called “intangibles” must be of the highest quality, namely livable communities with strong supporting services and quality of life amenities.

The development of a 21st century biosciences workforce must be a true statewide priority. Even as an economic imperative to improve the STEM competitiveness of Michigan’s workforce is clear, there is a compelling social obligation too. STEM education provides the building blocks to prepare students for success in an increasingly technological and complex global community. STEM literacy is foundational to a strong and vibrant society. ■

FEATURE STORY

MichBio Part of National Biosciences Workforce Analysis.

The Coalition of State Bioscience Institutes (CSBI), of which MichBio is a founding member, released the 2016 Life Sciences Workforce Trends Report that provides a national snapshot of the talent needs in the life sciences industry.

MichBio Helps Lead Development of Bioscience Skill Standards.

What must all entry-level workers know and perform to function in the diverse and ever-changing biosciences industry?

That question was answered this summer with the release of two seminal talent/workforce development reports. The Community College Consortium for Bioscience Credentials (c3bc), a partnership of 12 community colleges across the U.S. coordinated by the National Center for the Biotechnology Workforce, published Skill Standards for Bioscience Technicians and c3bc Medical Device Skill Standards as guides for educators and industry employers The skill standards were developed over several years under the aegis of a $15 million grant from the U.S. Department of Labor. Grant and c3bc leaders set an ambitious goal of improving education programs and fill the geographical, industry-sector, and skill-based gaps existing within the bioscience industry.

The c3bc project delivered comprehensive skill standards for entry-level jobs within the bio-manufacturing, medical device, and biotechnology laboratory areas, as well as those shared by all these domains. They can now be used as blueprints in building technical education programs as they identify specific jobs, as well as the required knowledge and competencies for such roles.

What makes the new standards unique, was that for the first time, bio-industry stakeholders were fully engaged throughout the process and served to validate the final product. A National c3bc Advisory Council, co-chaired by MichBio CEO Stephen Rapundalo and comprised of educators and 22 representatives from bioscience companies, oversaw the skills development efforts. ■

FULL VERSIONS OF THE REPORTS CAN BE FOUND AT BIOTECHWORKFORCE.ORG.

Over a hundred senior executives offered important insights, including Michigan companies like Diplomat, Ferndale Pharma, Molecular Imaging, Inc., MPI Research, NSF International, Pfizer, Terumo Cardiovascular and Zoetis. Several themes emerged regarding current hiring practices and future workforce needs.

The significance of soft skills cannot be underscored enough, especially an ability to communicate effectively, possess excellent interpersonal skills and work collaboratively in teams. In addition, having talent with strong critical thinking and problem-solving skills was viewed as essential for business success.

Second, ongoing employee training and development was deemed critical for talent retention and keeping employee’s technical and business skills relevant.

Employers recognized two areas of future workforce need: 1) those proficient in all aspects of “big data” collection and management, including database managers, bioinformaticists, and biostatisticians, and 2) professionals with a deep understanding of the changing regulatory and compliance requirements, along with pricing and reimbursement regulations, for all stages of the bioscience business life cycle. ■

FOR A FULL VERSION OF THIS REPORT, VISIT CSBIOINSTITUTES.ORG/ WORKFORCE-DEVELOPMENT. BIOMATTERS | FALL 2016

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ReBUILDetroit

A Research-Based Inter-institutional Collaboration to Diversify the Biomedical Workforce SUBMITTED BY JEANNE ANDREOLI ON BEHALF OF THE REBUILDETROIT STEERING COMMITTEE

Educational opportunities can fuel the academic renaissance of Detroit.

Three institutions of higher education in Detroit have come together in a collaboration to open new opportunities for Detroit students.

Research Enhancement for BUILDing Detroit (ReBUILDetroit) involves faculty, staff and students from Marygrove College (MG), University of Detroit Mercy (UDM), and Wayne State University (WSU).

With the support of a $21.4 M grant from the National Institutes of Health, the Consortium is implementing innovative, evidenced-based, and cutting-edge programming to engage undergraduate students from underrepresented groups in biomedical research. The program combines a unique model of student preparation and rigorous research opportunities in a nurturing learning community with crossinstitutional undergraduate research training opportunities.

The comprehensive student preparation model includes recruiting students using a holistic evaluation of their qualifications and providing them with a series of intense, guiding steps for their acclimation into a biomedical research mindset. Student success support includes intentional and intrusive mentoring, financial support, close faculty engagement and mentoring, ongoing workshops to overcome academic and non-academic barriers, and consortium-wide activities. Through this program, students can develop the

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self-confidence, self-efficacy and sense of belonging necessary to persist to graduation and enter biomedical careers.

Our students (ReBUILDetroit Scholars) enter a unique Summer Enrichment Program (SEP) that brings a cohort of students together as pre-freshmen for a rigorous 7-week summer experience to help them transition to college, both socially and mentally. Scholars attend classes and workshops at their home institution to strengthen their academic skills and acclimate themselves to biomedical research fields. More importantly, they meet faculty, staff and peer mentors and bond through inter-institutional activities that help them coalesce into a supportive community of scholars, critical to student intellectual development and important for the student’s sense of belonging. It is during this period, that they also learn more detail about their selected biomedical discipline and build their identity as scientists.

Based on the recommendations from the PCAST report Engage to Excel and the Vision and Change movement, the Consortium is restructuring their curricula to incorporate authentic research experiences in the foundational courses and adopt the Research Coordination Network (RCN) model in target courses (biology, chemistry, social sciences) across all three institutions so that the students contribute to a common research project in each discipline. These research-focused courses are academically intensive and introduce scholars to the concept of what research is and what it entails, including struggling with occasional failure and the uncertainty inherent to authentic research questions.

Students collect data related to faculty research projects as part of these courses and present their findings in poster

REBUILDETROIT

presentations at an end of the academic year Consortium event. These courses have proven to increase student selfconfidence as scientists and dramatically improve retention in college. Given that students in Detroit often take non-linear paths through college for a variety of reasons, it is essential to help align the training across institutions to facilitate success if students articulate between institutions. The consortium structure allows a common level of achievement and academic preparation of students across the institutions and enhances faculty interaction between schools. Since students know their peers at the other institutions, it also breaks down the barriers at the student level and provides a network of individuals ready to help scholars who transfer between colleges.

Upon successful completion of their first year of college, scholars are matched with faculty research mentors to begin their undergraduate research careers during an 8-10-week long summer research internship in a laboratory. The Summer Research Internship kicks off with a research orientation and a Lab Coat Ceremony as a symbolic gesture to welcome all of the ReBUILDetroit Scholars into the research community.

The ReBUILDetroit Scholars are then actively engaged in a mentored research setting at one of the institutions for the duration of the summer. Scholars periodically gather throughout the summer to share their experiences and affirm their newfound identity as research scientists through the inter-institutional learning community. The mentored summer research experience culminates at a consortiumwide symposium where Scholars present their work at a poster presentation. This year, the symposium was held at the Charles Wright Museum on September, 13, 2016.

Several scholars also presented the results of their work at the National ABRCMS meeting, in Tampa, Florida.

Scholars are expected to continue their research in subsequent semesters and summers until graduation.

While some students will opt to enter the biomedical research workforce at that the time of their graduation, it is anticipated that around half of the students will pursue advanced degrees.

The program, now in its 3rd year, continues to develop and expand. We encourage our Scholars to seek out opportunities either through national undergraduate research programs or research/internships with local companies that allow them to apply their knowledge and skills to real-world problems.

This allows our Scholars to explore the full potential of their biomedical training and the diversity of employment opportunities available to well-trained scientists while simultaneously diversifying the biomedical research field with a talented pool of ReBUILDetroit graduates. â–

For further information on ReBUILDetroit, the institutions involved or opportunities to collaborate with us, please go to rebuildetoit.org, or feel free to contact Mr. John Powell, Web and Social Media Technologist for ReBUILDetroit at 313-993-1510 or by email at powelljc1@udmercy.edu.

REBUILDETROIT.ORG

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Transforming Doctoral Education in the Sciences the BEST Way The Broadening Experiences in Scientific Training (BEST) Program at Wayne State University

BY AMBIKA MATHUR, PHD, CHRISTINE CHOW, PHD, AND HEIDI KENAGA, PHD, WAYNE STATE UNIVERSITY

“The BEST Program provided me with a great opportunity to explore career options outside of academia while completing my doctorate in cancer biology,” says Dr. Sidra Ahsan, Product Manager at Advaita, a bioinformatics startup in Plymouth, Michigan.

“My first inclination after finishing my Ph.D. was to secure a postdoc and then an assistant professorship, but I knew research funding is tight, so I was also interested in industry positions. I just didn’t know how to go about preparing myself to make a transition.” In 2014, Dr. Ahsan received a BEST award to engage in an 8-week summer career exploration at Advaita while continuing her dissertation research on neurofibromatosis-type I in Dr. Michael Tainsky’s lab at Wayne State. Other BEST program participants have been awarded similar career exploration opportunities at companies such as Cayman Chemical, Arbor Assays, MMS Holdings, Coca-Cola, and the Journal of Clinical Investigation; government and state agencies like the U.S. Department of Agriculture and Detroit Health and Wellness; and international groups such as the World Health Organization.

How is Wayne State able to do this? In 2013, the university was one of 17 institutions nationwide to receive a five-year, $1.8 million grant from the National Institutes of Health (NIH) to help doctoral trainees and postdoctoral scientists learn about the multiple career pathways open to them and prepare them for the needs of an evolving job market in the 21st-century economy. This federal initiative will enable Wayne State, one of three research-intensive universities in Michigan, to take a leadership role in transforming

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graduate education in the biomedical and life sciences. While completing their doctorate, participants in the BEST Program can take advantage of additional training that focuses on how their scientific skills, problem-solving abilities and analytical acumen are transferable to other domains. These areas include the biotech and pharmaceutical industries, patent and intellectual property law, state and federal government, science communication, and undergraduate college teaching.

In addition to the on-site career exploration opportunities like Dr. Ahsan’s at Advaita, BEST participants learn more about the skill sets required for positions in nonacademic settings via afternoon seminars and Saturday workshops conducted on campus by Wayne alumni, faculty facilitators, and industry partners.

BEST has sparked student interest in learning more about alternative career options as well as professional development opportunities offered

by Wayne State as part of their graduate training.

WAYNE STATE UNIVERSITY

TOP: Wayne State doctoral students attend BEST workshop on careers in law.

(Photo courtesy of Sarah Mexicotte) RIGHT: WSU faculty Dr. Tim Stemmler directs doctoral trainees in the lab. (Photo courtesy of Carmen Gamlin)

For the 2016-17 year, the Graduate School will offer a slate of job skill workshops on such topics as converting a CV to a resume, creating a LinkedIn page, learning how to network, and preparing for an interview. In addition, the Graduate School has established a 1-credit online career course oriented toward graduate students interested in preparing for a career outside of academia. Offered during the spring/ summer term, the course is built around exercises and assignments that registrants may use to build a professional portfolio necessary for employment in highly skilled positions.

Evaluation data for the last two years indicate that BEST participants are learning how to align the abilities they already possess with employers’ needs and expectations.

For Dr. Ahsan, the internship at Advaita was especially valuable for providing a broader view of the biomedical research enterprise and “the business side of science, which you don’t get in a PhD program.” Upon graduation, she applied to Advaita for a permanent position and was quickly hired as a “good fit.” Dr. Ahsan’s long-term goal is to eventually start her own company in the Detroit metro area, and the BEST program has helped launch her on this career path.

Programs like BEST have the potential to positively impact the biomedical workforce in the Detroit Metro area and the entire state. Doctoral recipients are among the most highly trained workers in the labor force, and their education makes them well suited for complex projects requiring independent, self-sufficient thinkers who can focus on innovative ways to solve problems. Our 15-year data show that half of Wayne State’s doctoral alumni pursue careers

in the state of Michigan. Thus, helping these motivated individuals find satisfying career options in Michigan can help stimulate economic development and act as an impetus for inventive partnerships between the industry and research sectors in the region. Dr. Heidi Kenaga, the BEST Program Manager, would be happy to talk with industry leaders interested in partnering with Wayne State’s BEST Program to launch exciting career explorations such as Dr. Ahsan’s at Advaita.

The BEST grant expires in two years, but the leadership team (co-PIs Dean of the Graduate School Ambika Mathur; Professor of Chemistry Dr. Christine Chow; Heidi Kenaga, the Program Manager; and members of the BEST Steering Committee) is working hard to develop program curriculum, facilitate faculty engagement, and build the infrastructure that will help sustain the BEST initiative at the university beyond 2018. ■

NIH BEST

wayne state university

For details about the national NIH-BEST initiative, see nihbest.org

WAYNE.EDU/GRADSCHOOL/BEST

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Madison High School and PLTW Biomedical Sciences Master Teacher, Katie McGormley

PROJECT LEAD THE WAY’S BIOMEDICAL SCIENCE PATHWAY: BUILDING A BRIDGE TO MICHIGAN’S BIOSCIENCES SECTOR

BY KATIE McGORMLEY

ELISA. Microarray. PCR. Protein Purification. These applications are not your average high school science labs; but for one school in southeastern Michigan – and several more across the country – they are.

In 2013, a rural Michigan school hired instructor Katie McGormley to build a Project Lead The Way (PLTW) Biomedical Science program – a rigorous program that delivers an activity-, project-, and problem- based model and prepares students to apply critical thinking and problem solving to real-world biomedical scenarios and investigations.

McGormley was perfect for the job. As a PLTW Master Teacher, she had previously built a successful PLTW Biomedical Science program for a math and science charter school in Charleston, South Carolina. She was prepared to advertise the program, recruit and retain students, order specialized science equipment and supplies, establish sustainability plans, build relationships with local businesses, and most importantly, inspire her students to consider the biomedical sciences as a future profession.

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But when she first moved to Adrian, Michigan, McGormley knew she had a challenge. There were only four schools in the entire state that offered the PLTW Biomedical Science pathway, as well as a culture of students previously not exposed to project-based science inquiry curricula. She needed to engage and excite students to re-think science on a whole new level. PLTW’s Biomedical Science curriculum made that easy.

Providing an engaging, hands-on, and transformative learning experience, PLTW empowers students to develop critical lab skills and a scientific mindset that prepares them to compete in a global economy.

It introduces them to a wide variety of biomedical career opportunities and the path to achieve those careers.

Today, Madison High School, where McGormley teachers, offers three out of the four available PLTW Biomedical Science courses: Principles of Biomedical Science, Human Body

PROJECT LEAD THE WAY

Systems, and Medical Interventions. The program is seeing results. Many of the students who take PLTW biomedical courses in conjunction with their core science classes say the PLTW courses reinforce the concepts taught in many of the other sciences, but enjoy the PLTW courses more because they are hands-on, student-led, teacher facilitated, technologybased, and challenging. Students like to be challenged when the content is meaningful to them.

Concepts that students explore through the PLTW Biomedical Science courses include applied forensics, how to detect infection using bioinformatics, gene expression using Microarray, evaluating DNA using PCR and gel electrophoresis, constructing 3-D models such as prosthetics, and bacterial genetic recombination using plasmids.

Through real-world cases, students explore and role-play a wide range of biomedical professions related to immunology, surgery, genetics, pharmacology, medical devices, and diagnostics. Students in classes like McGormley’s have the advantage of learning critical lab skills at an earlier age and develop scientific mindsets well ahead of their peers from other schools.

Three years after moving to Michigan, McGormley is encouraged to see that PLTW’s Biomedical Science program footprint has grown to 25 schools across the state. Eastern Michigan University and Lawrence Technical University in Southfield are partners with PLTW, assisting with the rigorous PLTW teacher training programs and ongoing professional development conferences that are critical to teachers’ success and growth. Companies like General Motors, ArcelorMittal, Toyota USA Foundation, the Dow Chemical Company, Verizon,

and Denso are also involved, providing school grants to help with the implementation and growth of PLTW programs.

While PLTW’s Biomedical Science programs have grown in the state, Michigan’s biomedical field has grown substantially as well, meaning that demand for biomedical professionals will likely continue to outpace the supply of qualified, skilled professionals coming from schools across the state. Currently, there is a bio-industry hub centrally located in southeastern Michigan that includes diagnostics/research products, testing, medical laboratories, medical devices and equipment, pharmaceuticals, consumer healthcare, and university research institutions.

It is critical for Michigan’s economy that teachers across the state can bridge the gap from secondary education to careers and help students see the opportunities like those in southeastern Michigan.

So as McGormley continues to build the interest of her program and promote PLTW throughout the region, the question remains, will her students – and those across the state – successfully enter and choose to stay in the bioscience sectors of Michigan? McGormley believes they will. Those in education and the bioscience industry can help by continuing to serve as role models for students and supporting K-12 PLTW biomedical science education. ■ PLTW.ORG

Madison High School Seniors, Alexis Brant and Katlyn Teague, performing a simulated ELISA testing spinal fluid for bacterial meningitis in the Medical Interventions course.

BIOMATTERS | FALL 2016

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MICHIGAN BIOSCIENCES:

BY THE NUMBERS MICHIGAN BIO-INDUSTRY QUICK FACTS

1,833

*

44,277*

BIOSCIENCE ESTABLISHMENTS

BiOSCIENCE JOBS

248,348* $83,482

*

AVERAGE BIOSCIENCE SALARY

$28

BILLION

BIOSCIENCE PERFORMANCE METRICS* BIOSCIENCE R&D (FY 2014) $1.214 billion*

VENTURE CAPITAL INVESTMENT (2012-2015) 666.5 million †

PATENTS (2012-2015) 2,333 †

† Summated from Battelle/AdvaMed The Economic Impact of the U.S. Advanced Medical Technology Industry. PhRMA Biopharmaceuticals Sector Impact on Michigan’s Economy , 2016. * TEConomy/BIO The Value of Bioscience Innovation in Growing Jobs and Improving the Quality of Life, 2016.

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MICHBIO | michbio.org

TOTAL EMPLOYMENT IMPACT

ECONOMIC IMPACT †

MICHBIO

Medical Devices

DISTRIBUTION OF MICHIGAN BIOSCIENCE EMPLOYMENT

BY SECTOR

26.5%

Pharma & Therapeutics

Distribution/ Logistics

19.9%

27.4%

Ag/Food/Industrial

1.4%

R&D/Testing Labs

24.8%

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

BIOMATTERS | FALL 2016

17

AFTER THE

ELEVATOR PITCH Advaita Corporation, a bioinformatics company, develops bioinformatics software tools for research and pharmaceutical industries. The company has developed a novel analysis approach that helps translate the gigabytes of data produced as a result of gene and protein expression experiments into a better understanding of the underlying biological phenomena. A patented approach delivers clearer results and novel insights that cannot be achieved with any other commercial analysis software.

Advaita’s flagship tool, iPathwayGuide™ is a geneexpression analysis tool that allows researchers to conduct gene, pathway, gene ontology, disease and predicted miRNA analyses. In addition, iPathwayGuide™ is the only platform that allows for a meta-analysis across multiple conditions. The product already has well over 8,000 registered users at major universities and research organizations in over 100 countries.

A second product, iVariantGuide™ offers an intuitive approach to filtering and identifying genetic sequence variants of interest. The application then provide a systems biology perspective to see which pathways,

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MICHBIO | michbio.org

biological processes, molecular functions and cellular components are impacted and their relationships to other systems.

Customers can also utilize iBioGuide™, a proprietary knowledge base constructed with over 100 million biological relationships, that allows searches to find related genes, microRNAs, pathways, biological processes, molecular functions, cellular components, drugs, diseases, and references.

The company also provides consulting services that include analyzing and interpreting pathways, building biological models, identifying and prioritizing biomarkers, interpreting expression data, creating report summaries and graphics, and data interpretation training.

Advaita was founded in 2005 by Soran Draghici, PhD, President and CEO, as a spinout from Wayne State University. The company has received over $4.5M in grant funding from both federal and state resources.

ADVAITABIO.COM

Michigan continues to be a leader in advancing biosciences research and commercialization, thanks to its rich pipeline of intellectual property. A whole new crop of startups are germinating in the state, which is good news for the regional cluster of established companies that are focused on innovation in therapeutics, medical devices, healthcare technologies, clinical diagnostics and agri-/industrial biotechnology.

Renewal is crucial to sustaining and growing an innovation cluster like San Diego’s life sciences community.

All the way around, Michigan bioscience businesses are truly improving the quality of life for patients and consumers. In this issue of BioMatters, we profile six entrepreneurial companies about their pioneering work.

™ PaceSetter Section Mounting System

Aquaro Biosystems® is an Ann Arbor-based startup that has developed several patented technologies and a device, the PaceSetter™, which is designed to relieve the major workflow bottleneck in histology laboratories.

Clinical histology labs process biopsy tissue by embedding it in wax, slicing it into thin sections, placing the sections onto slides, and staining them. These histological processes have been increasingly become automated except those of slicing tissue embedded in wax and placing the resulting sections onto slides consistently. Aquaro’s PaceSetter has transformed these manual steps into a single push-button operation. The instrument interfaces with standard microtomes and offers flexible degrees of automation for use in a wide variety of workflows.

Programmable tissue section positioning and arrangement is possible for better reproducibility, and specimen blocks and slide racks can be easily maneuvered. A built-in water filtration feature minimizes cross-contamination, and a programmable temperature control results in optimal de-wrinkling. The PaceSetter offers increased efficiency, throughput, quality, and consistency, while minimizing

human error. As a result, downstream diagnostic processes are improved and clinical and research histology operations can realize significant cost savings.

No direct competition exists for Aquaro’s platform technology aside from the current manual cutting and processing methods. The marketplace is wide-open, the company is targeting both high-volume research markets and clinical laboratory markets; combined, both represent a total addressable market of approximately $1.3 billion in US and $3 billion worldwide.

Aquaro was co-founded by Vince Alessi, Nolan Orfield, and Collin Rich. The CEO is industry veteran Alberto Elli that leads the company as it continues its product development and market validation, as well as gearing up for commercialization late in 2016.

Attaches to existing microtomes

AQUAROBIO.COM

BIOMATTERS | FALL 2016

19

AFTER THE ELEVATOR SPEECH

Celsee Diagnostics, formerly DeNovo Sciences, is an innovator of cutting-edge products in the emerging liquidbiopsy field. The goal of the Plymouth, MI-based company is to transform cancer diagnostics by creating precise, accurate, and reliable tools for research and clinical diagnostics development.

For many metastatic and recurrent cancers, such as lung and prostate, procuring repeat biopsy samples is extremely challenging. Liquid biopsy is a less invasive alternative especially in cases where patient monitoring is critical to therapeutic decision-making.

Celsee Diagnostics offers a fully automated circulating tumor cells (CTC) detection system know as the Celsee PREP100™, that has the ability to analyze biomarkers at a single-cell level.

Downstream molecular and genetic analysis on single cells is a crucial component in the development of personalized therapy. This laboratory-based platform enables the user to process samples at the site of collection, substantially reducing time to result, and the label-free isolation method ensures unlimited assay expansion.

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A newer version, Celsee PREP400™, automates all the steps from the Celsee PREP100™ allowing laboratory personnel the ability to load test samples and walk away for complete sample-to-result processing. The advanced instrument processes the primary sample capturing CTCs and micro-metastases in their own isolation chambers then treats the rare cells with Celsee Diagnostics’ reagents.

Reagent cartridges are pre-loaded with all the chemistries required to complete an immunochemistry test.

The company has recently entered into development partnerships to determine the technical ability of its automated testing platform to identify mutations in cancer cell lines and clinical blood specimens, along with assessing DNA viability. Celsee’s management team is made up of seasoned industry veterans and led by serial entrepreneur founder, President and CEO, Kalyan Handique, Ph.D.

CELSEE.COM

Functional Fluidics LLC, is well on its way to setting the standard for blood function diagnostics in sickle cell disease, and a wide range of bleeding and clotting disorders.

The company was founded by Patrick Hines, MD/PhD, a physician in the intensive care unit at Children’s Hospital of Michigan in Detroit and assistant professor of pediatric critical care medicine at Wayne State University.

for both testing and instrumentation is estimated to be around $500million, providing Functional Fluidics a lucrative revenue model. Clinically, the technology may help clinicians assess which drugs to use to treat patients when clotting is a concern, particularly in patients with sickle cell anemia, thereby creating a secondary and large contract testing market.

Functional Fluidics has developed a method for evaluating blood function in a simulated blood flow environment using a microfluidic platform. Already the company offers this assessment on a contract basis by helping pharmaceutical companies and academic investigators evaluate drugs designed to treat sickle red blood cell sludging and platelet-mediated thrombosis in a simulated blood flow environment. The research market alone,

Building on the growing contract research enterprise, Functional Fluidics ultimately plans to develop a standalone research instrument that utilizes the proprietary microfluidic-based assay technology, as well as validating and commercializing a series of clinical diagnostic tests.

MICHBIO | michbio.org

FUNCTIONALFLUIDICS.COM

Safety in Motion, Inc. (SiM) based in Northville, MI was formed in 2013 to bring leading-edge automotive safety technologies and engineering skills to the development of new medical devices. Its first product, the SIM–1000, is a balance and cognitive assessment tool to be used by trainers and health care professions in their efforts to diagnose concussion in the gym, clinic, hospital and fieldof-play.

The SIM–1000 applies immediate, objective, computerbased scientific measurement to assess balance deficiency and cognitive impairment, and thereby aid in the rapid diagnosis of a concussion. It allows professionals to determine whether an athlete is potentially injured, plays, sits or needs to seek immediate medical treatment.

Importantly, the SIM–1000 also enables professionals to follow and assess improvement or degradation of the subject over time immediately following a suspected concussion.

In 2015/16, 150 tests using live participants were conducted to refine the tool’s engineering and algorithm, and to better correlate the SIM–1000’s balance findings with those derived using the current, subjective gold standard

ZIVO Bioscience, Inc. (OTCQB:ZIVO), formerly Health Enhancement Products, Inc., is a Michigan-based biotech company engaged in the investigation of the health benefits of bioactive compounds derived from its proprietary algal cultures, and the development of natural bioactive compounds for use as dietary supplements and food ingredients, as well as biologically derived and synthetic candidates for medicinal and pharmaceutical applications in humans and animals, specifically focused on autoimmune and inflammatory response modulation.

A capital infusion in early 2016 allowed ZIVO to ramp up its compliance and go-to-market program, which ranges from commercial pilot production to post-processing, encapsulation and pelletizing. Preparation of sufficient product will allow for additional safety testing as an orally administered product for human and animal consumption. . This same work is also applicable to concluding studies to optimize recovery from bovine mastitis (inflammation of the udder), with the potential to offer organic and

domestic concussion assessment BESS test, with the result that much of the subjectivity and operator error of the BESS test was eliminated. SiM has also added the SCAT3 test to the device, which is an internationally recognized, standardized tool for evaluating injured athletes for concussion.

Grants from the Michigan Economic Development Corporation’s BAF program coordinated by OU, Inc. in spring 2016 enabled SiM to design, build and test the unique circuit board, algorithm and hardware used in the SIM–1000 device, as well as build an additional 12 beta units. Currently, these units are being used and tested throughout Michigan in multiple field locations at schools, hospitals, clinics and sports organizations. SiM expects to roll out salable field/clinic ready units to customers in the fourth quarter, 2016. Please contact SiM’s Sales Manager at 248-761-1716 if you are interested in adding this tool to your health care inventory.

SIM-TECHNOLOGIES.COM

production dairy producers a natural, antibiotic-free option to control mastitis, a condition with no available approved treatment.

“We’ve reached a stage in development and validation where potential customers and partners can begin to see how this all comes together in the form of a licensing platform,” states CEO Andrew Dahl. “The markets, the applications, the regulations and the manufacturing options have begun to coalesce, and we believe the momentum is going to increase from here forward.”

In a parallel development, ZIVO is exploring several nearterm applications, where the original natural biomass is minimally processed, relying primarily on its signature proteins and non-starch carbohydrates to offer an exceptional natural nutritive profile.

ZIVOBIOSCIENCE.COM BIOMATTERS | FALL 2016

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C O M M AVACCINE NDING ANTHRAX THE LIFECYCLE DISCONNECT SUBMITTED BY DYNAMIC COMPUTER CORPORATION

This Michigan IT supplier helps medical device manufacturers manage supply chain risks and ensure regulatory compliance.

How can a medical device manufacturer keep the long and highly regulated lifecycle of their human digital imaging or diagnostics product aligned with the fastchanging hardware and software at the product’s core? Having the right IT supplier is key. And that supplier, for major medical device makers today, is MichBio member Dynamic Computer Corporation of Farmington Hills, Michigan. For 20+ years, this value-added IT reseller has specialized in helping medical device industry leaders command the “lifecycle disconnect” between the devices themselves and the devices’ integrated IT. “A complete medical machine or device may go essentially unchanged for a decade or more,” explains Farida Ali, Dynamic’s CEO. “This is partly due to regulations. But it’s also

22

MICHBIO | michbio.org

because of the complicated science behind a device. Innovations can take time. And the device may simply be a great piece of equipment that users rely upon every day.”

A widely used medical device’s life will end only after the long process of FDA approval has identified a proven replacement. Not so, however, for the device’s integrated IT. As Farida notes, “Mere months may pass between significant upgrades in a particular hardware or software technology component critical to the device’s performance.”

This doesn’t need to be a problem – as long as the device manufacturer stays on top of IT vendors’ plans for all relied-upon technology. But if taken by surprise, a genuine disaster can occur. Farida tells of a U.S. manufacturer that lost months

DYNAMIC COMPUTER CORPORATION

of sales from a flagship product when they learned, without advance word, that a power supply connected to the IT part of the device had been replaced with the next-generation power supply. The new part was incompatible, so the device didn’t work and couldn’t ship. “That,” says Farida, “made it immediately clear why attentive IT lifecycle management is so crucial.”

Dynamic has given the name Q-wrxSM to the proprietary package of services it provides to help customers manage their product lifecycles and ensure IT regulatory compliance.

Q-wrxSM is based on Dynamic’s ISO-certified quality management system. It combines end-to-end and aheadof-the-curve IT configuration, asset management, and logistics processes. This exceptional attention to detail enables Dynamic to deliver “deployment-ready IT” for their customers. Per Farida, “We distinguish ourselves less by what we do than by the thoroughness, precision, and efficiency with which we do it.”

Single-sourcing IT through Dynamic is the customer’s first step to gaining the Q-wrxSM advantage. Dynamic closely collaborates with the customer to conduct a thorough review of the relevant IT systems.

“We seek every opportunity to identify the most cost-effective products,” says Farida. “And we keep track of technology changes.

For instance, when we learn that an OEM is taking a needed part out of inventory, we notify the customer who may need to make a strategic last-time buy. Then, for the longer term, we help them find replacement parts. That can relieve a major headache for a device manufacturer.”

Dynamic has long-standing relationships with over 500 IT manufacturers. This enables vendor-neutral purchasing decisions, finely calibrated and scaled to meet specific customer needs. Dynamic can also extend its preferred pricing arrangements to customers, so there’s an opportunity for significant savings. Dynamic can sometimes even negotiate more favorable pricing from the customer’s existing OEMs. Customers rely on Q-wrxSM to help streamline their IT processes and mitigate supply chain risks. Dynamic’s technical services team works closely with the customer to design, test, and validate their Q-wrxSM solution. Systems are specified, tested, and approved in the company’s secure facility. Dynamic then takes over responsibility for all logistical details. This includes kitting, tagging, labeling, shipping, tracking, storage, and warehousing to assure the least possible interruption to the customer’s operations.

The Q-wrxSM goal, says Farida, is “zero out of-the-box failures on the customer’s end.” This helps customers improve quality, increase efficiency, and reduce costs. In the words of the CIO of a Fortune 500 company: “Our Q-wrxSM solution has cut the time necessary for some IT set-up and maintenance tasks from two to three months to two to three days.”

Through Q-wrxSM, Dynamic also provides detailed documentation of all managed systems – from complete asset and process information to work instructions. Dynamic keeps these records as long as customers need them or regulators require them. It helps keep Dynamic’s government-regulated customers audit-ready and audit-proof.

Dynamic is a long-time Michigan business success story. Fida Bohra, Farida’s father, founded the company in 1979 as a computer retailer. By the time Farida joined Dynamic in 1994, the company had evolved into a value-added IT reseller. Three years later, Dynamic won its first major customer in medical device manufacturing. By 2009, the company had earned ISO 9001:2008 certification for overall quality management. Then, in 2014, Dynamic qualified to ISO 13485:2008 standards, a particularly stringent requirement for quality management in medical device manufacturing.

Building on its success in the medical devices arena, Dynamic has moved into government contracting, another compliant industry where lives may hang in the balance. In 2013, Dynamic earned GSA Contract #GS-35F-175AA under Schedule 70. Two years later, the company was named a Prime Contractor under NASA SEWP V, the government-wide acquisition contract managed by the National Aeronautics and Space Administration. SEWP V is the largest federal IT contract, and it now includes IT-based medical devices and software. Leading device makers are exploring how they may be able to expand their government business through Dynamic’s SEWP V contract. ■

DCC-ONLINE.COM

Dynamic Computer Corporations Headquarters in Farmington Hills, Michigan TOP RIGHT: Farida Ali, Dynamic Computer Corporation’s CEO

BIOMATTERS | FALL 2016

23

ROCHESTER MICHIGAN’S PAR STERILE PRODUCTS: A THRIVING LEGACY

SUBMITTED BY PAR STERILE PRODUCTS

Many of the advancements that have been made in biological medicine and virus vaccines during the past hundred or more years began at 870 Parkdale Road, Rochester, Michigan.

For nearly 15 years CfPIE has delivered in-depth training to Established in 1908, about the time the first Model-T Ford automobiles went into production, this facility was one of the world’s first and largest for biologics manufacture. In fact, the facility operated under U.S. Biological License Number One and was a production center of vaccines for polio-myelitis, influenza, adenovirus, rabies, and smallpox, and antitoxins used against tetanus, gangrene, and diphtheria. It truly represents one of the landmark manufacturing facilities in the history of the biopharmaceutical industry.

That legacy at 870 Parkdale Road thrives today as Par Sterile Products, a subsidiary of Par Pharmaceutical, an operating company of Endo International plc. Par Sterile Products develops and manufactures branded and generic aseptic injectable products and provides contract manufacturing services to the biopharmaceutical and pharmaceutical industry.

Par Sterile Products’ iconic brands such as Aplisol® and Adrenalin® have been relied upon by physicians and patients for decades. While proud of its heritage, Par is even prouder of the great things it is accomplishing today. In a sterile injectables world frequently plagued by compliance issues and product shortages, Par Sterile Products stands as a highly regarded partner based on its trade service levels and record of regulatory compliance. In return for the trust that is placed in it, Par Sterile Products is committed to providing products of uncompromising quality. In fulfilling this mission, Par Sterile Products delivers value to its customers and the physicians and patients who rely on it.

People Achieving Results, is lived at Rochester each and every day.

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MICHBIO | michbio.org

PAR STERILE PRODUCTS

Par Sterile Products currently markets a portfolio of twenty specialty injectable products, including Vasostrict®, Brevital®, Dantrium®, Pitocin®, dexmedetomidine, and ethacrynate sodium. Since 2013, Par Sterile Products has launched eight new products and possesses a robust new product pipeline in the injectable space, having developed a pipeline of nineteen products, more than half of which have been submitted for FDA approval. Par Sterile Products expects a half-dozen new filings annually for FDA review and approval, fueled by its commitment to investment in research and development and bolstered by the addition of new equipment and capabilities to serve the industry.

As a complement to its generic and brand business, the facility has a history of providing contract manufacturing services. Today, Par Sterile Products’ Contract Manufacturing Business supports U.S. Government Medical Countermeasure programs as a dose manufacturer for critical vaccines in the event of potential public health emergencies as well as for commercial products serving the biopharmaceutical and pharmaceutical industry.

The reliability and stability of supply and the launch of new products would not be possible without the dedicated workforce at Rochester. Indeed, the backbone of success of Par Sterile Products is the people. In fact, in many cases, the people of the Rochester facility have spanned generations

of family members. Today, the facility employs over 430 technicians, scientists, engineers and professionals drawing staff from across Michigan and beyond. Par’s motto, People Achieving Results, is lived at Rochester each and every day.

From U.S. Biological License Number One to today, the Rochester facility represents a legacy in the supply of drug products relied upon by physicians and patients.

Par Sterile Products is well positioned for further growth, being large enough to maintain a significant trade presence, yet agile enough to provide maximum attention to its customers. ■

Par Sterile Products remains poised to continue its track record of success.

PARSTERILEPRODUCTS.COM

LET’S WORK TOGETHER TO

GROW IDEAS INTO BUSINESS

SUCCESS STORIES. Y

ou might be surprised at what you find at the MSU Innovation Center: Access to nearly 5,000 researchers, $526 million in annual R&D expenditures, and 644 research and instructional buildings, scale-up facilities, pilot plants and lab space.

We have the world-class ingredients that entrepreneurs, investors, and inventors are looking for, all in one place: Business-CONNECT links the right people and resources to develop your idea MSU Technologies offers the best MSU ideas ready for commercial licensing Spartan Innovations creates investment-ready businesses from MSU ideas

Learn more today: www.InnovationCenter.msu.edu

Dr. Gemma Reguera was awarded the 2016 Innovator of the Year Award by the MSU Innovation Center for for her work in Microbial Electrochemical Reactors.

BIOMATTERS | FALL 2016

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E.M.M.A. INTERNATIONAL CONSULTING GROUP –

ROOTED IN MICHIGAN, SERVING THE GLOBE SUBMITTED BY E.M.M.A. INTERNATIONAL CONSULTING GROUP

With a focus on quality systems, regulatory affairs, and compliance services across a broad range of industries regulated by the Food & Drug Administration (FDA) biotechnology, pharmaceuticals, medical devices, food and beverages, laboratories, hospitals and healthcare, etc.

- E.M.M.A. International Consulting Group, Inc. (E.M.M.A. International) serves businesses from startups to global corporations. Since its inception, the company has been recognized as a one-stop-shop for all regulatory and compliance needs.

After long and successful careers in the healthcare industry, co-founders and principal partners, Carmine Jabri, PhD, MSQM, MHA (President and CEO) and Kira Jabri, MPH, MSW (Vice President and COO) decided it was time to combine their unique skill sets and experience towards providing a one-of-a-kind perspective to consulting services. Recognizing that Michigan’s long-standing legacy in bioscience research, development and manufacturing has experienced rapid growth in recent years, E.M.M.A International strategically moved its management consulting operations from Washington, D.C. to Farmington Hills in 2013.

E.M.M.A. International manages and operates a network of consultants, experts, and practitioners who are strategically located throughout the U.S., Europe and Asia.

Carmine Jabri, President and CEO and Kira Jabri, Vice President and COO

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MICHBIO | michbio.org

The firm provides a portfolio of customizable services in the areas of compliance, ISO Standards, quality systems & regulatory affairs.

In the compliance space, E.M.M.A. International specializes in providing solutions that help client organizations comply with FDA and international regulatory agencies. These include everything from 483 and Warning Letter responses, to remediation strategies, labeling and website reviews, audits and gap analyses, as well as mock FDA inspections and regulatory submissions.

E.M.M.A. International provides organizations with the consulting support they need to implement quality systems and registrations through third-party providers for a full suite of certifications encompassing ISO (i.e., International Organization for Standardization) 9001:2015, ISO 17025:2005, ISO 13485:2003, OHSAS 18001:2007, ISO 14001:2015, ISO/TS 16949:2009, and ISO 15189:2012.

While it has a wide reach and capability in compliance, E.M.M.A. International’s core competency lies in its ability to develop and implement integrated Quality Management Systems (QMS) that conform to a multitude of international regulatory requirements and/or ISO standards. As FDA regulations become more stringent, E.M.M.A. International strives to serve companies in Michigan and beyond by helping them to develop an individualized plan to mitigate major challenges in implementing QMS processes.

EMMAINTERNATIONAL.COM

E.M.M.A. INTERNATIONAL CONSULTING GROUP

Their team of consultants is expert in Corrective and Preventive Action (CAPA) processes, manufacturing quality assurance/quality compliance, validation, quality audits, customer complaint handling, design controls, and supplier quality. E.M.M.A. International can assist with all the necessary procedures, work instructions and forms, as well as provide training, mentoring and coaching where necessary. In addition, the firm assists organizations in perfecting existing systems and procedures to ensure efficient product development and manufacturing operations.

E.M.M.A. International’s regulatory affairs’ services leverage an approach that is designed to deliver a high quality, cost effective solution for lifecycle maintenance of established products. Regulatory affairs services include both pre-approval and postapproval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks. The firm’s primary consulting services for regulatory affairs include certifications, clinical trials, submissions & filings, recalls, and compliance issues. ■

While E.M.M.A. International enjoys national and international recognition, its strong Michigan roots and commitment to the region are what drive its ultimate goal of becoming the premier regulatory compliance consulting house in support of the state’s >$24 billion bio-industry.

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better.

stryker.com

BIOMATTERS | FALL 2016

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BREAKING DOWN THE BARRIERS OF PACKAGING

Fusing healthcare package design, development and validation into one streamlined experience.

SUBMITTED BY PACKAGING COMPLIANCE LABS

Many medical device manufacturers are increasingly relying on expert contract labs to meet the ever-tightening federal regulations for sterile packaging, as well as to avoid making substantial investments in their own testing equipment.

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MICHBIO | michbio.org

PACKAGING COMPLIANCE LABS

Packaging Compliance Labs (PCL) is a medical device and pharmaceutical packaging engineering partner that provides design, development and validation services to the healthcare manufacturing industry.

Founded by Matthew Lapham and Ryan Erickson in 2014, PCL has brought a top notch laboratory and engineering team to the Michigan area. This has not only helped boost the already strong biomedical presence in Grand Rapids, but also bring business into the Michigan economy that would’ve otherwise gone elsewhere. With clients from around the nation and world, PCL has developed a system to help companies accelerate to market by breaking down the barriers of packaging.

Many companies aren’t knowledgeable about the complexities of packaging. PCL works with medical device manufactures to ensure the packaging equipment and sterile packaging used for their products meet criteria established by the U.S. Food and Drug Administration (FDA).

The company is backed by a full service ISO 17025 accredited testing lab equipped with ASTM and ISTA test methods for healthcare packaging validation. Additionally, the PCL engineering team has developed a proven process for packaging design & development with expertise in getting clinically-safe and cost effective packaging solutions to market. This system, known as the “Speed to Market Program” runs through the core of every project to help clients make data-driven decisions and build confidence in successful product launches.

Many medical device manufacturers are increasingly relying on expert contract labs to meet the ever-tightening federal regulations for sterile packaging, as well as to avoid making substantial investments in their own testing equipment. PCL is relying on that trend to accelerate its own growth.

Within the biomedical industry of Michigan and around the world, the need for FDA adherence is becoming more and more vital. An example of this in the field, has been the recent change in spinal medical device FDA requirements.

Recently, the FDA has changed the requirements on these devices, so that they must be sterile in packaging. Prior to this requirement the infection rate on spinal surgeries was between 1 and 12 percent, causing problems for patients, surgeons, and hospitals. Increased rates of infection can raise post-operation costs for hospitals and diminish surgeons’ reputations, leaving healthcare providers clamoring for change.

The demand is matched with updated standards required by the FDA. Within the bio-industry of Michigan, this means that proper packaging validation for medical device companies

becomes more important. The combination of more strict requirements and complete packaging validation tests could potentially lower post-operation infection rates significantly and improve regulatory compliance. With a lower infection rates, hospitals will be able to boast a more successful surgery performance outcomes, and therefore attract more spinal surgeons and patients to the immediate medical area.

While this transition to sterile packaging for spinal devices will help the infection rate, it does not fully solve it. The reality is that it will take many years for non-sterile packages to phase off of hospital shelves. In many case, spinal devices can sit for years inside a hospital supply room before being used. This means that the recirculated devices will still be available until they are either used or retired.

To determine these shelf life times, medical device companies utilize accelerated aging tests to test the durability and usability of a device over time. By ensuring the lifespan of a spinal product, hospitals know exactly when to retire unused devices. This practice saves lives by avoiding unsterile, outdated, and decayed products from being used in the surgery room.

Although it will take time, it is easy to understand the importance of this change in the spinal device industry. As the medical field advances, especially in Michigan, it is vital to ensure the safety of these devices after they enter into the real world hospital environment. PCL and their engineering team works with spinal and other device manufacturers to ensure their product packaging is safe and sterile so it is completely effective not only upon arrival, but during the course of its hospital shelf life.

PCL has made it its mission to service the ever-expanding medical industry in Michigan and beyond. Vice President, Ryan Erickson, commented, “Michigan was left with a void from the automotive industry that the medical industry has now begun to fill.” Parallel with the growth of the medical industry, PCL also grows to fit the needs for medical package testing and engineer consulting. Matthew Lapham, President, predicts to double their engineering team by the end of next year, and has plans to increase their lab by 5,000 square feet in November 2016. Together, Matt and Ryan plan to help Michigan fill an unmet need with successful medical products packaged and delivered to hospitals all over the world. In so doing, PCL views itself as an essential driver to growing Michigan’s reputation as a hub for medical device manufacturing. ■

PKGCOMPLIANCE.COM BIOMATTERS | FALL 2016

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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.

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734.763.0614 techtransfer@umich.edu

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MICHBIO | michbio.org

GUEST VIEWPOINT

Building Michigan’s

BIOSCIENCES INDUSTRY

BY PETER M. PELLERITO, SENIOR ADVISOR, FEDERAL/STATE ECONOMIC DEVELOPMENT POLICY & UNIVERSITY RELATIONS, BIOTECHNOLOGY INNOVATION ORGANIZATION

Michigan is entering its seventh year of strong economic recovery after many challenging years, but there is still more work to be done.

Although the Big Three and the rest of the auto industry need to play a large role in Michigan’s economic recovery, it’s also clear that the innovation economy and diversification into other high-tech industries are extraordinarily important to Michigan’s future.

Since 2012, Michigan’s sizable bioscience industry has grown by 5.7 percent, according to recent data released by the Biotechnology Innovation Organization (BIO). Our state’s drugs and pharmaceuticals sector experienced double-digit job growth – 11 percent – during this two-year time period.

All told, by 2014, more than 44,000 Michiganders were employed by 1,833 bioscience business establishments across the state. The average wage for the industry is $83,482, almost 75 percent higher than the average total private sector salary.

The men and women employed by the biosciences industry aren’t just helping to drive Michigan’s economy forward, they are helping to uncover the answers to some of our world’s most pressing life challenges. They are looking for treatments and cures to devastating chronic diseases such as Alzheimer’s, cancer, and Parkinson’s, developing next generation renewable chemicals and fuels, and ensuring.

Much of this work is being done at Michigan’s best-in-class institutions of higher education, including

University of Michigan, which just launched the MTRAC for Life Sciences Innovation Hub to support translational research projects in life sciences with commercial potential.

This Hub will focus on projects from across the state, reinforcing the commitment of the Michigan Strategic Fund, the Michigan Economic Development Corporation and U of M to innovation and entrepreneurship. Investing in these new technologies is an important key to growing our local innovation economy and creating more high-wage jobs for our region.

This hub will have an excellent base to work from.

Michigan’s research universities conducted more than $1.2 billion in bioscience-related R&D in 2014, placing it among the top tier of all states. Between 2012 and 2015, the state received more than $2.4 billion in awards from the National Institutes of Health, and more than $660 million in venture capital expenditures. More than 2,300 patents were recently issued in biosciences-related technologies, the bulk of which focused on medical devices and drugs/pharmaceuticals

The positive momentum that we are seeing in Michigan’s overall economy, and in our biosciences industry, is helping to drive our state forward while also helping patients and their families lead healthier, more fulfilling lives.

The strengthening of Michigan’s biosciences industry comes thanks to an impressive talent pool as well as the efforts of lawmakers and other key policymakers who are working to break down barriers that could hamper innovation. Moreover, a long-term commitment and partnership around a common vision by all stakeholders will help our bio-industry thrive in Michigan, and ensure a bright future economic future. ■ WWW.BIO.ORG/VALUE-BIOSCIENCE-INNOVATION-GROWINGJOBS-AND-IMPROVING-QUALITY-LIFE-2016

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That saves lives every day.

VRW..........................................................................................32 Want to advertise in the next issue of BioMatters? Contact Kate@michbio.org

© Copyright Pfizer Inc. All Rights Reserved.

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MICHBIO | michbio.org

Driven to discover the cure

We proudly support MichBio and Michigan’s bioscience industry.

Learn about Terumo Cardiovascular Group at terumo-cvgroup.com

Terumo® is a registered trademark of Terumo Corporation. ©2016 Terumo Cardiovascular Systems Corporation. August 2016. 874222

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