BioMatters Spring 2018 by MichBio

Anniversary Special Edition

FALL 2018

A magazine showcasing Michiganâ&#x20AC;&#x2122;s biosciences industry

DRIVING BIO-INDUSTRY GROWTH

Foley Hoag is MichBIO’s preferred legal counsel for its entrepreneurial members. Our service oﬀerings include:

Foley Hoag’s MichBIO lawyers possess in-depth knowledge frequently sought after by emerging life sciences companies. Our cross-disciplinary team of legal professionals is dedicated to the advancement of MichBIO members at every phase of your company’s life cycle: as you develop your business plan, launch

• Entity formation • Contract drafting and negotiation • Website terms and conditions

commercialize your discoveries.

• Data privacy and security (privacy policies, HIPAA, EU and Big Data) • Corporate governance

appointments set at other times, to review basic details relevant to life sciences start-ups.

• Corporate structure tax issues • Licensing and strategic alliances

services, and substantial deferrals of legal fees

• Employment/human resource legal issues • IP services including patents and trademarks

companies can take advantage of alternative fee arrangements for longer-term engagements.

• FDA and regulatory issues Our attorneys will also attend MichBIO events and give periodic presentations on legal topics of interest.

Contact a member of the FOLEY HOAG MichBIO Team:

Colin Zick

DeAnn Smith

617.832.1275

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Sarah Cooleybeck 617.832.1284 scooleybeck@foleyhoag.com

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Remi Kathawa

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PRESIDENT’S MESSAGE It’s a celebration! Times two. MichBio, first and foremost, is commemorating 25 years as a statewide industry trade association and the growth of Michigan’s biosciences industry over that period. And to top it off, it’s the 10th anniversary of BioMatters™, so this issue comes with some extra weight — literally. The magazine is celebrating these two memorable occasions with a “megaissue” that features so many of our member organizations. This fall’s publication is a superb reflection of the strength and vastness of Michigan’s bio-industry, comprised of its research universities and clinical institutions, private and public companies, and other related and supporting enterprises, that cut across multiple technology sectors — from medical devices, pharmaceuticals, agricultural and industrial biotechnology, diagnostics and testing, academic and clinical research, informatics and health information technology, to the distribution of products in the aforementioned areas. The pride and unity an anniversary inspire makes it an ideal time to ask the Michigan biosciences community to think together about why their work matters for our state’s economy and the quality of life and well-being of its citizens, as well as those around the world that our industry serves.

“The pride and unity an anniversary inspire makes it an ideal time to ask the Michigan biosciences community to think together about why their work matters for our state’s economy...”

We hope you enjoy reading our members’ stories and learning about how each has evolved and achieved success with the hard work and passion of many dedicated bio-industry professionals. Looking back on their journeys can be more than mere nostalgia — it can inform, encourage strategic reflection, and help us grow. Every magazine, as much as it looks like a finished product when it is published, is really a living creature. For the last ten years, MichBio staff have tried to feature the very best that Michigan’s biosciences industry offers, the trends and latest developments, viewpoints and achievements, and the organizations and people that make it all happen. It takes perseverance and flexibility, of course, but primarily, it takes teamwork. Over the years, many MichBio staff persons, as well as freelance writers, proofreaders, designers, and other professionals have worked to produce BioMatters™. We’re proud of its quality and revel knowing that it’s one of very few such publications produced by a state biosciences organization.

I salute all of them and their efforts, and of course, we thank our readers. If it weren’t for all of them, we wouldn’t celebrate with this issue. Their contribution has been, still is and certainly will be crucial to everything that makes BioMatters™ a vibrant reality. In that spirit, as always, let us know how we can best help and support your endeavors, and showcase Michigan’s bio-industry growth.

Sincerely,

STEPHEN RAPUNDALO, PHD President and CEO, MichBio

BIOMATTERS | FALL 2018

YOUR SCIENCE OUR EXPERTISE The U-M Life Sciences Institute offers: • High-throughput screening of extensive small molecule, natural product and siRNA libraries

• Comprehensive cloning, protein purification and X-ray crystallography • Expert consultation

• Assay development and optimization

Available for academic and industry projects. CONTACT: lsi-centers@umich.edu

lsi.umich.edu

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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Alisha Brown Editor Director, Marketing and Communications

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

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SILVER 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 and Chief Operating Officer

PRESIDENT AND CEO Stephen Rapundalo, PhD MichBio, President and CEO SECRETARY Vacant TREASURER Sandra Pennell Vericel, Controller

MICHBIO BOARD DIRECTORS

BRONZE

Sean Callaghan Medbio Inc. Vice President of Operations and General Manager

Stephenie Morley, DVM Zomedica COO and Vice President, Product Development

Robert DeRyke Terumo Cardiovascular Group President and CEO

Paul Morris AlixPartners, LLP Global Finance Lead, Enterprise Improvement

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

Teri Nizzardini, MS, SPHR, SHRM-SCP MPI Research, a Charles River Company Vice President, Human Resources

Jamie Kemler Stryker Corporation Vice President, Intellectual Property Business Strategy Ken Massey, PhD Wayne State University Senior Director, Venture Development, Technology Commercialization Fredrik Molnar Michigan Economic Development Corporation Vice President, Entrepreneurship and Business Development

PATRON

Dave Morin Impellia President and COO

Edward Pagani, PhD University of Michigan Associate Director, Health Technologies, Office of Tech Transfer Stephen Rapundalo, PhD MichBio President and CEO John J.H. Schwarz, MD Family Health Center Physician and Former U.S. Representative Tom Ross Grand River Aseptic Manufacturing President and CEO Christopher J. Stein Ferndale Pharma Group, Inc. Executive Vice President and COO

BioMatters is published bi-annually 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 ALISHA BROWN AT ALISHA@MICHBIO.ORG. BIOMATTERS | FALL 2018

Anniversary Special Edition

on How the 06 | Reflecting Organization Began Mickey Katz-Pek and Denis Callewaert, PhD

MichBio at 25 08 | Stephen Rapundalo, PhD

10 |

MichBio

11 |

Making Microtomy Safer for Histoloy Laboratories

Announcing the Pantheon Award

Aquaro Histology

Growing Sustainable Health and 12 | Nutrition Products From Algae Zivo Biosciences

Science Companies Find 14 | Life Solid Foundation in Ann Arbor Ann Arbor Spark

Unique Business Model and 16 | aA Commitment to Community Arbor Assays

Learned After a 17 | Lessons Decade of Supporting BioIndustry Growth Worldwide E.M.M.A. International

TruStory 18 | The Trucent and Ingenuity Power 19 | Synergy the American Dream MS Bioworks

20 |

Discovering Cisplastin

22 |

MSU Innovation Center

Pushing the Boundaries of Genomics Swift Biosciences

Drug Discovery with 23 | Michigan Roots Lycera

Recruiting the Future 24 | Pfizer Keys to Increasing Your 26 | 4Speed to Market Disher

46 WANT TO RECEIVE BIOMATTERS?

28 |

Oral Fluid Drug Testing Forensic Fluids

Make Research Possible in 30 | Helping Michigan and Beyond

Cayman Chemical

Biosciences: By the 32 | Michigan Numbers MichBio

Clinical Research Organization 34 | AFocused on Education, Trust, and Growth MMS Holdings

Preclinical Oncology 35 | Premier Contract Research Organization Mi Bioresearch

Contract Manufacturing 36 | Taking to the Next Level Excel

TEAM Pharma Advances 38 | Drug Development in Michigan for a Decade TEAM Pharma

Michigan Medical 39 | Your Communications Agency JB Ashtin

Molecular Biology 40 | Driving and Biotech Manufacturing in West Michigan Empirical Bioscience

Swedish Company 42 | Established Larodan Makes a Second Home in Michigan Larodan

Test for Endoscopes 43 | NOW! Healthmark Michigan has a Rich Legacy as the 44 | Birthplace of Innovation BlueWillow

Science of Public Health 46 | The NSF international Proteos, Inc. Celebrates 15 Years 48 | Proteos, Inc. a New Way Forward for 49 | Delivering Precision Oncology Strata Oncology

50 | After the Elevator Pitch

Trusted guide for new product 29 | Adevelopment in2being, LLC

Visit michbio.org/subscribe

BIOMATTERS | FALL 2018

REFLECTING MICKEY KATZ-PEK,

program, requiring federal agencies with annual R&D Budgets exceeding $100M to allocate fixed percentages of their extramural R&D budgets for small business innovation research. My interest was sparked.

Has it really been 25 years since the founding of the Michigan Biotechnology Association (MBA)? What was the MBA, and is now MichBio, has seen a lot in the last quarter century, so, why and how did it all begin?

In 1986, two scientists and I, all in Reproductive Endocrinology at UM, launched BioQuant, Inc. with help from SBIR funding and, shortly thereafter, the first investment .the Enterprise Development Fund (EDF Ventures). BioQuant later merged with Pacific Biometrics in California.

In order to put the founding and development of the MBA in context, it will help to provide some background – the stimulus at the local and national level around translating research into commercialization and where my personal path intersected that opportunity.

I left BioQuant as an employee in 1990 and launched Biotechnology Business Consultants (BBC), now in its 28th year, with the goal of helping other start-ups with their SBIR submissions. BBC quickly added commercialization plans and later, licensing strategies and negotiations, regulatory paths, market research, business planning and occasional corporate management. Today, BBC continues to expand its business model and has 9 full-time staff with contracts in 31 states.

Founder and Founding Board Chair

I spent 16 years at University of Michigan (UM) Medical School as an academic administrator, but became interested in technology transfer around 1977, when Governor Milliken first launched ‘Centers of Excellence’. In my opinion, nothing made sense – why was the Michigan Biotechnology Institute (MBI) in East Lansing instead of Ann Arbor; the Highway Safety Institute in Ann Arbor instead of Detroit; the Metropolitan Center for High Technology incubator in Detroit instead of aligned with the MBI? These were political locations, not ones created from positions of technological strength. In 1982, the Small Business Innovation Development Act established the Small Business Innovation Research (SBIR)

MICHBIO | michbio.org

As my expertise in business development grew, BBC was recruited in 1992 by MERRA, a statewide technology-focused economic development organization, to educate academics and entrepreneurs on grant requirements and limitations for NIH funding, technology transfer, grant preparation, and commercialization with the underlying goal of bringing some of our federal tax dollars back to Michigan. Since 2001 (when we first started counting), BBC has trained at least 1300 individuals in Michigan, and countless others outside the state, through its contracts with economic development

ON HOW THE ORGANIZATION BEGAN

organizations, universities and individual companies. At the same time as BBC was beginning work with MERRA, on the national scale, two small trade organizations – the Industrial Biotechnology Association and the Association of Biotechnology Companies—merged to form the Biotechnology Industry Organization (BIO). In 1993, BIO held their first meeting in Washington, DC that included industry leaders, investors, scientists, and entrepreneurs, all trying to decide what to focus on first. Scientists wanted to focus on gene therapy, lawyers on policy, and venture capitalists how to value SBIR awards. Back in Michigan, Tom Borton, PhD at Michigan Energy and Resources Research Association (MERRA),, and I surveyed dozens of entrepreneurs and academics trying to understand what they expected from an organization like BIO. It became evident that a statewide BIO affiliate would need to focus on biotechnology, medical devices and instrumentation. Thus, the MBA was formed in 1993 with a two-track system – a President with a science degree (PhD, MD) and a Chairperson with a business or legal background. David Herzig, PhD (director of Pfizer’s Intellectual Property at the time) became President, I became Chairperson, and others joined the board.

DENIS CALLEWAERT, PHD Founder and Founding Board Director

The universities agreed to host an inaugural MBA event that brought in more than 125 attendees, including venture capitalists from New York, representatives from big pharma, device companies, the NIH and BIO -over half of which became our first members. The first Michigan Biotech Expo was held in 1998 with over 600 attendees and Nobel awardee in chemistry, Paul Berg, PhD., as keynote speaker! The first two expos were created and managed by BBC and subsequently (and happily) handed over to the MBA when it was in a position to hire its first director, Steve Michelson. The MBA accomplished a great deal – finding a voice in our State to support stem-cell research, educating researchers on FDA requirements and patent law, helping academics understand the nuances between grants focused on basic research and those on innovative technology and commercialization, building an invaluable bio-industry network, and identifying potential partners with our academic institutions, among other accomplishments. I would be remiss not to thank the State of Michigan and its academic institutions’ support of MERRA, and Keith Blurton’s (MERRA’s President) encouragement to forge ahead. I’m certain that I speak for all involved in the early years of the MBA congratulations for 25 years of success to the organization and all who benefited from its existence! I’m very proud to have been part of its beginnings, and wish you continued success for years to come. ■ MICKEY KATZ-PEK

As a founder of MichBio, I am thrilled that the organization has reached a quarter century and continues to be a driving force in attracting and keeping biotech talent and businesses in Michigan. When I think back to the founding of the organization, I am struck by the forces that came together to put me in a position to help give birth to and set the course for this vital organization. Born and bred on the East side of Detroit, I completed my undergraduate studies at the University of Detroit and my Ph.D. at Wayne State University. In 1974 I accepted a position in Oakland University’s Department of Chemistry performing NIH-sponsored research on tumor immunology. I also led the development of Oakland’s undergraduate Biochemisty program and its Center for Biomedical Research, which I Directed until 2007. Throughout my career, I’ve always been drawn to the practical applications of biochemistry. So, after a few consulting jobs, I formed my first biotech company, Proteins International (PI) in 1983 and then, a year later, founded Oxford Biomedical Research (OBR). Protein International’s technology was acquired by a major pharmaceutical company, and I was able to focus my non-academic efforts on OBR. Also in 1983, NIH launched its Small Business Innovation Research (SBIR) program was launched, and both PI and OBR were among the first awardees. That led to a request for me to speak at conferences focused on securing Federal funding and promoting high-tech entrepreneurship in the state. It was at those conferences that I met Mickey Katz-Pek, then president of BioQuant. Mickey and I discussed the resources

that would help our companies, and companies throughout Michigan, thrive. Our combined interest in the future of the bio-industry, led to the formation of MichBio in 1993. Oxford Biomedical was among the first member companies, and I was one of the first MichBio directors. Oxford Biomedical now offers over 950 products and maintains a commitment of supplying the global biomedical research community with state-of-the-art research tools including recombinant proteins, antibodies and assay kits. Just last year, in 2017, Oxford Biomedical formed a food science division, the Food Quality Testing Corp. (FQT) that is focused on completing development of FryCheck™, a rapid test for restaurants and food processors to monitor their frying oils. This simple, inexpensive test will help ensure food quality while maximizing oil life. As a lifetime member and founder, I recognize that MichBio has been an invaluable resource for my companies. The organization provides networking events, negotiates discounts on supplies, and has provided me with recommendations on business connections for web development and market research. Even after 25 years the organization has stayed true to its mission of helping grow the bioindustry in Michigan. ■ DENIS CALLEWAERT, PHD

BIOMATTERS | FALL 2018

MICHBIO AT

A CLEAR MISSION, A LASTING IMPACT Twenty-five years is a notable milestone and provides MichBio with an opportunity to recommit to the founding mission of the organization. As the statewide biosciences industry trade organization, the work of MichBio, now and in the future, should reflect the original vision of the founders: “To promote the growth of the biosciences industry in Michigan.” To frame the impact of MichBio’s work on the Michigan biosciences community and begin the collaborative process of defining the future of the organization, it is helpful to trace MichBio’s history. As noted by Mickey Katz-Pek and Denis Callawaert, PhD in the preceding articles, they and the other key contributors to MichBio’s formation, realized the need for a biotechnology association in late 1992 and early 1993. At that time, as noted by MichBio archives, there was an upsurge in the launch of new biotech companies in Michigan, a change at the state’s research universities relative to technology development and transfer, increased federal funding for SBIR grants, and a mandate that federal labs participate in tech transfer. Together, those factors created synergy for the biosciences industry as well as a need for partnerships and information sharing. In February and March of 1993, a bioscience community assessment showed a desire for assistance in identifying sources of investment capital, opportunities to network with other

MICHBIO | michbio.org

state-based companies, and education on the latest technology development. As a result, the Michigan Biotechnology Association (MBA) was born with about eleven members (companies and institutions; thirtyfour, if you count individuals too). The first meeting was convened on September 28, 1993, and 80-100 professionals gathered for the General Session and organizational dinner. During the early years MBA focused on hosting networking and educational programs, as well as advocating for the biotech industry on matters like NIH/SBIR funding and state support for company formation and commercialization. By 2000, the Association was able to hire its first in-house executive director and focused its efforts on growing membership and building organizational infrastructure and capacity. In 2001, the formal name of the Association changed to the Michigan Biosciences Industry Association (MBIA) to signify a focus beyond the narrow definition of biotechnology. In 2002, “MichBio” was adopted as the legal d/b/a along with a double helix-themed logo to create a more publicly recognizable brand. Then, in 2004, the Michigan Medical Device Manufacturers and Suppliers Association closed its door and MichBio embraced its role as the face of the broader bioscience industry in Michigan. In 2013, the Association’s logo was changed to reflect its bio-industry foundation and statewide constituency in a modern, bold way.

Today, the Association has almost two hundred members and is the only recognized statewide organization for the medical device, pharmaceutical, research, diagnostics and testing, bioscience distribution, agri- and industrial biotech, and informatics/health information technology sectors. As a result, MichBio is the accepted state affiliate of the Advanced Medical Technology Association (AdvaMed), Medical Device Manufacturers Association (MDMA), and Biotechnology Innovation Organization (BIO). In addition, it is closely aligned with the Pharmaceutical Research & Manufacturers of America (PhRMA). Working with these and other national partners, MichBio’s visibility as the representative voice of Michigan’s bio-industry is now unequaled in its history. Over the years, MichBio has worked diligently to expand its portfolio of member services and benefits. The Association’s Preferred Purchasing Program has grown from zero to ranking top 5 nationally for both buyer spending and savings. It has added a Career Center to assist companies with talent recruitment in Michigan, reimagined an old grant program, BioConnections™, into a partnering platform, and, of course, launched BioMatters™ as a flagship publication whose quality is unrivaled amongst other state bioscience groups. Along the way, MichBio has expanded programming to include the one-of-a-kind CEO Leaders’ Club, launched a very successful Women of MichBio franchise, introduced MichBio U webinars, and partnered with the research universities to host sector-specific forums like the Michigan Drug Discovery Symposium.

MichBio’s increased capacity, commitment to its founding tenets, and continued dedication to the Michigan bio-industry makes the Association better resourced than ever and poised to deliver more value and impact to the biosciences community. So, during our 25th year, MichBio is celebrating the commitment, loyalty, and dedication of its founders, Board volunteers, members and staff who have contributed to the Association over the years. The alumnae group includes over 120 individuals, as noted in the listing that follows, whose support has been generous and untiring, and whose belief in the Organization’s mission has been unwavering. MichBio will continue to focus its efforts, programs, initiatives, advocacy and strategies towards developing Michigan into a global leader in the biosciences and is confident that Michigan has the elements necessary to attain this strategic vision. The bio-community in Michigan has a tremendous impact on the health and economic well-being of every citizen in the state, and many around the globe—MichBio is dedicated to spreading public awareness of that impact. ■

Help ensure that the founders’ visions and hope continue to be realized by engaging with MichBio and your bioscience colleagues as we enter the next 25 years of driving industry growth in Michigan.

PROUDLY SERVING MICHIGAN’S BIO-INDUSTRY SECTORS

MEDICAL DEVICE

R&D/TESTING

PHARMA

INFORMATICS/HEALTH IT

AGRI-BIOSCIENCES

LOGISTICS

STEPHEN RAPUNDALO, PHD

BIOMATTERS | FALL 2018

ANNOUNCING THE

PANTHEON AWARD A Legacy of Achievement

MichBio is proud to herald the launch of the Michigan Bioscience Pantheon Award. The Award is meant to recognize the pioneers and inspirational leaders with the rare combination of vision, creativity, passion and acumen required to foster change. It honors their excellent scientific discoveries and/or business triumphs that have made a difference in health and welfare around the world, and impacted the stateâ&#x20AC;&#x2122;s economy in a meaningful manner. The passion and commitment demonstrated by these leaders to their organizations and the broader biosciences industry is a testament to the legacy they have created. The Pantheon Award is a small way for us to congratulate these luminaries on their lasting influence.

We extend our heartfelt gratitude to the following giants of Michiganâ&#x20AC;&#x2122;s biosciences industry. Tom Borton, PhD Former, Director of Environmental and Energy Research MERRA John Brown Chairman Emeritus Stryker Corporation Denis Callewaert, PhD President and CEO Oxford Biomedical Research and Oxford Laboratories James Herbert Executive Chairman Neogen Corporation David Herzig, PhD Former Vice President, Development Parke-Davis Pharmaceutical Research Jean Kantrowitz Founder L-VAD Technology, Inc and ViaDerm Mickey Katz-Pek Founder Biotechnology Business Consultants Roger Newton, PhD, FAHA, FACN Founder Esperion Therapeutics Dick Sarns Founder Sarns, Inc., and NuStep, Inc. Ron Williams, PhD Founder and Chairman Medbio, Inc.

MICHBIO | michbio.org

Making Microtomy Safer for Histology Laboratories BY MEGHAN CUDDIHY, PHD, AQUARO HISTOLOGY

Several years ago, Vince Alessi was working in a neurology research lab, using a microtome to cut thin slices of mouse brain before carefully transferring them to a microscope slide. After preparing what seemed like thousands of slides, he thought, “there has to be a better way.” Thus was the genesis of Aquaro Histology, a thriving Ann Arbor-based company dedicated to developing products to streamline the tissue preparation process and improve its safety. Virtually every tissue biopsy, including animal tissues used in drug discovery and other areas of research, is brought to a histology laboratory. Lab histologists preserve the tissue, cut it into thin sections, and place it onto slides. The sections are then stained and sent to a pathologist for diagnosis. This process of preparing and mounting tissue sections, called microtomy, is central to histology and pathology, and, as Vince realized, was the only step in the histology workflow that had not been automated, so much so, that the microtomy process of today would look very familiar to a histologist trained in 1950 despite automation of other histology functions.

On a mission to relieve histologists of the tedious task, Vince sought partners to help him build a prototype of a device that would interface with existing microtomes and automate the transfer and mounting of sections onto slides.

The Aquaro team produced a prototype of the Aquaro ASM (Automated Section Mounting) system and presented it to the National Society for Histotechnology to an enormously positive response—the reduction of repetitive motions meant that the incidence of carpal tunnel syndrome and tendonitis among histologists might be lessened, and the possibility of multitasking while cutting multiple sections meant labs could increase efficiency. In addition, automating microtomy could improve the consistency of slide quality, made even more important with the emergence of digital pathology and companion diagnostics. In mid-2017, after extensive prototype testing, Aquaro Biosystems raised a Series A investment from Telegraph Hill Partners to bring the Aquaro ASM™ to market. Simultaneously, they rebranded as Aquaro Histology to better reflect the purpose of the company. Aquaro Histology expanded, and the new team developed and launched the Aquaro Wishbone™, a handheld tool allowing histologists to change and align microtome blades without touching them. The Wishbone is expected to reduce the likelihood of injury due to blade changes and reduce the loss of valuable specimen tissue due to misaligned blades. An idea hatched from a frustrated student has yielded a strong company with multiple products. Aquaro Histology is poised to change microtomy through automation and innovation to reduce injuries, improve consistency, and increase lab efficiency. ■

Joined by Ann Arbor engineers, Nolan Orfield and Collin Rich, the trio formed Aquaro Biosystems. Aquaro conducted interviews of hundreds of histology professionals to determine if the manual microtomy process disrupted laboratory workflow—the overwhelming response was “Yes!” In fact, not only was the process tedious, but it could lead to repetitive motion injuries like tendonitis and carpal tunnel syndrome.

AQUAROHISTO.COM

BIOMATTERS | FALL 2018

Growing Sustainable Health and Nutrition Products From Algae ADAPTED BY ALISHA BROWN FROM ORIGINAL STORIES BY ANDREW DAHL, PRESIDENT AND CEO, ZIVO BIOSCIENCE

Non-GMO, sustainable, natural, superfood, antibiotic-free and hormonefree. These are all buzzwords used by the beauty, nutrition, and fitness industries. 12

MICHBIO | michbio.org

Consumers want products that they can feel good about putting in, or on, their bodies. Politicians and regulators want to ensure that those products are free of harmful side effects. Businesses want products that can be produced at a consistently high-quality at the lowest possible cost. ZIVO Bioscience has such a product. Formerly Health Enhancement Products, Inc, ZIVO Bioscience is a Michigan-based company dedicated to the study, development and commercialization of natural nutritional compounds and bioactive molecules derived from its proprietary algal strains. The company is committed to creating products that are beneficial to consumers, through promotion of

health, beauty, and wellness, free of harmful side-effects, and sustainably produced. For more than a decade, ZIVO Bioscience has worked in partnership with Arizona State University and Synthetic Genomics, Inc. (SGI) to optimize, through natural selection, a largely unknown, wild freshwater algae strain for commercial phototrophic production. The strain, which can be produced in shallow ponds made of readily accessible materials, grows rapidly, uses significantly less water-that can be recycled multiple times-than soybeans, can be harvested year-round, and requires significantly less energy to produce than corn or grass-fed beef, making it agriculturally and environmentally viable.

“What’s more, in powdered form, the strain contains 45% pure protein and 26% fiber, is low-odor and tasteless, all of which favors rapid adoption and acceptance by consumers,” says Andrew Dahl, ZIVO President and CEO, “It makes no difference if we could optimize the strain for sustainable production if no one would buy it—we also had to ensure that the algae was commercially viable.” He continued, “Of course, the next question people ask us is why algae? And that gives me the opportunity to talk about the nutritional, beauty, and health benefits that algae may provide for both humans and animals.”

Specifically, the benefits offered by algaebased foods and nutritional supplements may include:

With so many potential benefits of incorporating algaebased products in human and animal nutrition, cosmetics, and pharmaceuticals, we, at ZIVO, are committed to studying and commercializing our algae strain,” says Dahl. “In the future, we hope that algae-based products are a large part of the health, beauty, and pharmaceutical industries.” ZIVO Bioscience is looking to partner with a global food or supplement company to collaborate on its human food and supplement initiative, and its livestock and companion animal feed initiative. As a clean, sustainable, non-GMO source of protein, micronutrients and support for a healthy immune response, the ZIVO strain is patent -protected and proprietary. ■

• Antioxidant activity from the non-starch polysaccharides (NSP’s) and carotenoids in algae that may incorporate collagen, lactoferrin and certain types of flavanols, • Relief from systemic inflammation and aid to joint health from the wealth of vitamins, micronutrients, minerals and naturally-occurring, anti-inflammatory small molecular entities,

ZIVOBIOSCIENCE.COM

• Stress control and protection from cellular damage caused by free radicals through the inhibition of nitric oxide production, • Optimized metabolic health through the promotion of digestive and metabolic efficiency, • Protection from UV damage and heat stress when applied topically, • Promotion of bovine mammary gland health and dairy production, and • Reduction of the reliance on antibiotics for poultry growth through natural promotion of animal health

BIOMATTERS | FALL 2018

LIFE SCIENCE COMPANIES FIND SOLID FOUNDATION IN ANN ARBOR Region Eager to Continue Building on Heritage of Success BY PAUL KRUTKO, PRESIDENT AND CEO, ANN ARBOR SPARK

Ann Arbor’s life sciences sector has grown rapidly in the past decade, but it’s always been an innovator in the biotech industry. The heart-lung machine used in the first heart transplant was developed and manufactured here. The foundation of Jonas Salk’s polio vaccine was researched and developed at University of Michigan (U-M).

MICHBIO | michbio.org

Since then, the life sciences sector in Ann Arbor has expanded to include pharmaceuticals, medical devices, diagnostics, and bioinformatics. The sector includes 280+ firms and employs more than 6,000 people in the region. Ann Arbor is where business intersects with advanced research, out-of-the-box thinkers, abundant financial resources, a vibrant economic development initiative and an immense talent pool.

Researching Cancer Risk and Detection to Save Canine and Human Lives Zomedica Pharmaceuticals Corp. (NYSE American:ZOM) (TSX-V:ZOM), is an Ann Arbor-based veterinary diagnostic and pharmaceutical company that creates products for companion animals (canine, feline, and equine). Their product portfolio includes innovative diagnostics and therapeutics that emphasize patient and practice health. Zomedica is a terrific example of the vibrant life science industry in the Ann Arbor region. In 2017, Zomedica raised over $11 million of capital to advance business development, went public on the New York and Toronto Stock Exchanges, and entered into a license and supply agreement with Celsee, Inc. Under the agreement, Zomedica will have animal health exclusive global rights to develop and market Celsee’s liquid biopsy platform for use by veterinarians to diagnose cancer. Here in Ann Arbor, Zomedica is using Celsee’s technology to develop and market ZM-017, a blood test that helps veterinarians diagnose cancer in dogs. The potential for this innovative work is impressive as The Veterinary Cancer Society estimates that 50 percent of dogs over the age of 10 and one-in-four dogs overall will develop cancer. Armune BioScience, a leading scientific research and diagnostic company developing cancer risk assessment and detection methodologies, also resides in the Ann Arbor region. Although the company announced in early January its acquisition by Madison, Wisc.-based Exact Sciences, Armune BioSciences continues to conduct research in Ann Arbor that is built on a library of biomarkers licensed from U-M to test the body’s immune response to prostate, lung, and breast cancer.

institutes, including its Life Sciences Institute, Kellogg Eye Center, Biomechanics Research Laboratory, and the Biomedical Research Core Facility. In total, U-M is ranked second in the U.S. for research spending, investing $1.4 billion annually. Building on U-M’s incredible foundation, Ann Arbor SPARK’s is focused on developing connections between the public, private, and academic sectors to grow the region’s economy. That work encourages growth in key industries, such as biotechnology, where companies like Zomedica and Armune BioScience can tap into the local resources and talent to further their success. Ann Arbor SPARK provided Zomedica assistance as they established an Ann Arbor presence, helped connect them to various resources in the community, and awarded them a business acceleration program grant to assist with web development and marketing strategy. Armune BioScience received critical funding from the Michigan Angel Fund, administered by Ann Arbor SPARK, and was connected to key resources in the community, including the Ann Arbor SPARK Job Portal, the Michigan Economic Development Corp and U-M’s Business Engagement Center.

Ann Arbor: Resources, Talent, Support Combined to Grow Biotech Industry Ann Arbor is known as Startup City USA and that holds true for emerging biotech companies as well as existing, global brands. The incredible range of talent, culture of research and development, and commitment to making critical resources available to businesses in all stages of growth, provide the perfect catalyst for commercializing biotech innovations in this region. ■

Go Blue for R&D There’s no denying the impact U-M has on Ann Arbor’s reputation as a destination for life science companies. U-M ranks among the world’s top universities with graduate and professional programs consistently listed among the nation’s top 10. The University houses numerous research

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BIOMATTERS | FALL 2018

A Unique Business Model and A Commitment to Community

BY SARAH ZAPOLNIK, MARKETING ASSISTANT, ARBOR ASSAYS

Arbor Assays specializes in the development of high sensitivity immunoassay, activity, and detection kits, high-purity inhibitors, and antibodies for drug discovery and basic research. Their mission is to build the highest quality and most sensitive detection and immunoassay products for clinically important biomolecules. Founded in 2007 as Luminos LLC, the company has always been committed to preserving the environment and to their Ann Arbor home — every kit is researched, developed, manufactured, quality controlled and shipped from their location in Ann Arbor, Michigan. In 2009, they changed their name to Arbor Assays to reflect those commitments and, on January 1, 2017, Arbor Assays became the world’s first employee-owned life sciences company. Arbor Assays is owned by a perpetual employee benefit trust whose board of directors ensures that the company remains an independent entity for the benefit of customers and employees. For the customer, employee ownership means that the company can be counted on to continuously experiment, innovate, and provide high-quality products. For employees, ownership means increased job security and career satisfaction without the fear that Arbor Assays will be sold out to a larger development company. Employee ownership offers a unique opportunity for increased leadership, transparency about company decisions and strategy, and a chance to collectively share in the company’s success, but it is just one part of the unique culture at Arbor Assays. While their specialty is

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kit creation, Arbor Assays makes a point of giving to other scientific causes that help the community. Every year, and for every kit they sell, a portion of their sales is donated to a designated charity supporting medical research. This initiative is known as “Research the Cure”. In 2018, the company is proud to be supporting the Michael J. Fox Foundation for Parkinson’s Research. In addition to charitable donations for every kit sold, Arbor Assays has established the “You Publish, We Donate” program. Every time the company receives a copy of a paper published using one or more of their products, Arbor Assays makes a one-time donation of $25 to the Sierra Club, Oxfam, or the Save the Children Fund. As a team, Arbor Assays employees participate in the annual Walk MS fundraiser to help raise money and awareness for multiple sclerosis research and the services provided by the National Multiple Sclerosis Society. Since their founding in 2007, the business and team has continued to grow, expanding into the new ventures of custom assay development and sample testing services. Arbor Assays prides themselves on their unique ownership structure and their company culture that allows them to provide customers with the best products, technical support, and customer experience. ■

ARBORASSAYS.COM

E.M.M.A. International

LESSONS LEARNED AFTER A DECADE OF SUPPORTING BIOINDUSTRY GROWTH WORLDWIDE BY KIRA JABRI, EMMA INTERNATIONAL AND ALISHA BROWN, DIRECTOR OF MARKETING AND COMMUNICATIONS, MICHBIO

“One of my favorite things about the work I get to do is that first jump into a new project—the initial assessment of the quality manufacturing systems, the process of meeting and getting to know the often brilliant people at our client companies, the digging in to the details,” says Dr. Carmine Jabri, President and CEO of EMMA. International Consulting Group. “That’s where I’m most at home, in the weeds of the processes.” In fact, in the details is where EMMA International has made a name for itself. The company, recently highlighted as one of Insights Success’ “50 Best Companies to Watch in 2018,” is a global leader in management consulting providing quality, regulatory, and compliance services to the Biotechnology, Pharmaceutical, and Medical Device Industries. EMMA International’s mission is to provide significant value to its clients’ operations by working within their corporate culture and alongside their employees to do the “heavy lifting” required to make improvements meaningful and permanent. “We’ve always sought to be the ‘one-stop-shop’ for our clients—we want to help them understand the regulatory process, help them set up certified, manufacturing systems, and ensure they can produce the highest quality products that do the most possible good,” continued Jabri. “The all-encompassing approach to consulting has given us insight into the global bio-industry that is hard to come by elsewhere—we’ve learned some key lessons along the way.”

EMMA International can be a valuable partner to companies of all sizes and at all stages. With headquarters in Farmington Hills, Michigan and offices around the globe, the company has expertise in international regulatory processes, is in touch with industry markets around the world, and has resources available to help solve even the most complex problems.

EMMA International uses that insight to provide a framework for their consulting services. Among those “lessons learned” are the following: 1. If it isn’t sustainable, it won’t be permanent. One of the biggest challenges many companies face is trying to design systems and processes that can scale up as they grow-a slightly cumbersome process can work well for one product and a small team, but it will breakdown when a large team tries to use it for multiple products. The best processes are often the simplest.

2. Your most important critic is your customer. Many companies underutilize customer complaints. Customers can be a major source of critical information about design failures and production issues that may start small but can end up causing widespread product dissatisfaction. Listen to your current customers and you’ll inevitably win new ones.

3. You can’t make a superior product with inferior ingredients. Many companies are either unable to assess the quality of their suppliers, or unwilling to pay more for, what they perceive to be, the same quality of raw materials. This leads to unnecessary, and difficult to explain, product failure. The best products are made from the best materials.

4. Expect challenge and learn from it. Often the most valuable lessons come in the most difficult to accept packages. Challenges to your way of thinking, to your design, and to your processes are sources of information—invite challenge and use it to steer your company in the right direction. ■

EMMAINTERNATIONAL.COM BIOMATTERS | FALL 2018

The TruStory A New Identity Reinvigorates the Dexter Fluid Purification Company, Trucent BY JOHN HOLOWATY, MARKETING AND SALES SPECIALIST, TRUCENT

In June of 2017 Trucent was founded after the environmental services division of Dexter-based Valicor was sold, taking the name with it. The remaining five business divisions, originally part of Valicor, had the opportunity to rebrand and came together as Trucent. Located in their historic headquarters, Trucent leads and pioneers intelligent, engineered solutions to complex challenges in fluid separation, ethanol and corn oil extraction, and plant process optimization. They specialize in aqueous protein concentrates, industrial fluid, oleochemicals, nutraceutical lipids, and dry mill corn ethanol production. The Trucent combination of expert process analytics, technology development, and site-based customer service leads to the creation of new co-product streams, lower operating costs, and improved quality. Retaining the existing Valicor leadership, Trucent is now positioned to take its business to the next level and has announced aggressive expansion plans which will take its services to three additional locations covering Mexico, Canada and the Pacific Coast. With an investment of $9 million, Trucent is committed to fortifying and expanding its industry-leading fluid separation and purification services. Trucent CEO, and Valicor founder, Tom Czartoski says, “We are extremely pleased with our new brand and identity. It has, and will, allow us to focus on bringing innovations to

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the market and capitalize on the expertise and commitment of the same great team of people that has long served our customers’ needs.” He added, “Trucent continues to represent what Valicor has always been known for: industry leadership, innovation, and being challenge-driven and customer-obsessed. Bring us your challenge, immerse us in your process, and let us help you find ways to reduce waste, find new revenue streams and become more sustainable.” The Trucent team partners with organizations who specialize in water treatment, biofuels, industrial manufacturing and more to analyze their processes, identify opportunities to recapture resources through purification or fluid separation, develops a company-specific solution, and then aids in implementation. This in-depth partnership allows Trucent companies to save money on valuable resources, create more efficient waste-processing, and become more sustainable. ■

TRUCENT.COM

Synergy and Ingenuity Power the American Dream BY DAVID ALLEN, CO -FOUNDER AND DIRECTOR OF OPERATIONS

MS Bioworks was founded in 2010 by four co-founders with the objective of bringing state-of-the-art mass spectrometry services to the life science community. Mass what you ask? Mass spectrometry (hereafter referred to as MS) describes the process of using instruments called mass spectrometers to identify, quantify, and characterize proteins and chemicals of interest. Researchers all over the world use MS in everything from primate research to drug development—simply, if it is a living plant, animal, or microorganism, MS has an application. Problem is, the bleeding edge instruments are very complex, expensive (~1M each depending on the type, model, and essential service contracts) and require a considerable amount of experience and training to maximize their sensitivity and correctly interpret the resultant data. The MS Bioworks founders—one homegrown American, two very sharp Englishmen, and one amazingly talented Sri Lankan—became experts in protein MS, all honing their crafts in Ann Arbor companies for years. Finding themselves together in a company that would soon go out of business, the team formed MS Bioworks to bring their expertise to the life science community. With the financial crisis in full effect in 2010, financial capital was scarce—banks needed collateral, venture capitalists wanted tangible products instead of services, and grants funding was limited to companies with the backing of a major institution. Fortunately, the team found a partner in Promega Corporation in Madison, WI who supplied them with funding and two instruments for their fledgling laboratory. In exchange, MS Bioworks offered extreme discounts on R&D, assistance with all things MS related (even interviewing potential mass spectrometrists for the

Promega lab in Madison), and, most importantly, technical advice which helped Promega navigate the MS world. Now, eight years after that initial partnership, Promega remains a good friend to MS Bioworks and continues to rely them when needed. MS Bioworks continues to purchase Promega’s reagents. Today, MS Bioworks has over 1000 active clients in just about every US state and over 14 countries including two distributors in Japan. Universities, major pharma companies, biotechs, commercial enterprises, and government institutions have found reliable and trustworthy scientists to carry out their critical MS testing needs in MS Bioworks. The company now has four state-of-the-art mass spectrometers all using the ThermoFisher Orbitrap™ technology. What’s more, the use of robotics and the reinvestment of profits into cutting-edge technologies, allows the company to provide its valuable technology and expertise to organizations around the world at a fraction of the cost of establishing, staffing, and maintaining a lab of their own. MS Bioworks has even had the opportunity to give back to the community by donating to the University of Michigan Mott’s Children’s Hospital each year, with total donations of $155,000.00 so far. Not bad for four broke (but talented) guys trying to grasp the American dream. ■

MSBIOWORKS.COM

BIOMATTERS | FALL 2018

Hamilton, who won gold at the 1984 Winter Olympics, was diagnosed with stage 3 testicular cancer in 1997. It had spread to his stomach.

DISCOVERING CISPLASTIN THE PENICILLIN OF CANCER DRUGS

“When they told me, I was like, ‘I want it to be something else,’” shared Hamilton. “But they said, ‘No, this is a good one to get, if you had to choose one,’ which is kind of crazy. But I’m grateful there was a proven treatment. I know many cancers don’t really have one.” That proven treatment was cisplatin. This year marks the 40th anniversary of the FDA approval of cisplatin as an anti-cancer drug, and even now cisplatin is saving lives and making new discoveries possible at MSU. Discovered at Michigan State University in 1965, the chemical compound prevents the DNA in cancer cells from replicating, confusing them and causing them to die. “The fact that I’m still here 21 years later is kind of amazing.”

The Aha Moment BY AMBER SHINN, ADAPTED FROM ORIGINAL STORIES BY ROBIN MINER SWARTZ

Cancer doesn’t care if you have a gold medal. Legendary figure skater Scott Hamilton has had it three times.

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Fifty-three years ago, in 1965, Dr. Barnett Rosenberg emerged from his lab at MSU and proclaimed to a group of grad students, “I’ve just cured cancer!” What Rosenberg and his research partner, microbiologist Loretta Van Camp, discovered were the first glimpses of cisplatin — what would later be referred to as the “penicillin of cancer drugs.”

In August, MSU convened researchers from around the world for the Cisplatin Celebration, a cancer treatment symposium. Learn more at chemistry.msu.edu/cisplatin.

The chemical compound cisplatinum interferes with the growth of cancer cells, slowing their advance in the body. The drug cisplatin is used to treat many types of cancer, but it’s most widely prescribed for testicular, ovarian, bladder, lung and stomach cancers. It has become the gold standard to which many new cancer medicines are compared. The discovery, patenting and FDA approval of cisplatin was a 13-year process--a rarity in the research world. “These are home runs that happen very rarely,” said Dr. Richard Chylla, executive director of MSU Technologies. “This is one of those handful of success stories where the impact of its discovery is far more important than the money the discovery made,” Chylla said. “Cisplatin has had a huge impact on society. It’s a cancer workhorse.” Resources earned from sales of cisplatin and its derivative, carboplatin, fuel lab work and investments by the MSU Foundation, through offices such as MSU Technologies. There, they support investments in research and economic development initiatives through the commercialization of cutting-edge technologies invented by MSU faculty, staff, and students. “The fact that I work in an office that is the legacy of something like this is huge,” Chylla said. “The royalties allowed us to build capacity, fund research, to do a lot of

things. But when we look at the success of our office, we’re looking at what kind of impact we have: This discovery has literally saved millions of lives.”

Paying it forward Twelve weeks of treatment including cisplatin cured Hamilton’s testicular cancer. “I’d tell anyone who would listen that the greatest gifts given are to those who may never know the origin of that gift,” he said. “I didn’t know MSU developed cisplatin. It’s amazing. I can now say thank you for giving me my life back.” Incredibly, Hamilton has battled cancer twice more since 1997. Both times he’s had brain cancer. Both times he’s fought it successfully. As a result, he’s driven to help others diagnosed with cancer. The Scott Hamilton CARES Foundation supports innovative cancer treatment research and helps create resources for cancer patients and caregivers to learn about chemo drugs and side effects in clear terms. Hamilton attributes all his work helping cancer patients and survivors to his athletic background, and said if cisplatin hadn’t saved his life, he wouldn’t have been able to do the work he’s doing now. ■

“I’m grateful,” he said. “It’s great to celebrate this discovery. It’s right up there with penicillin, polio vaccines, all these great drugs that have saved lives - and what’s happened because of all those lives being saved. It’s the butterfly effect.” INNOVATIONCENTER.MSU.EDU/CISPLATIN

BIOMATTERS | FALL 2018

Pushing the Boundaries of Genomics Technology developed at Swift Biosciences is revolutionizing DNA sequencing BY JESSY ROBISON, SWIFT BIOSCIENCES

DNA sequencing has evolved at an astonishing pace. During the past 30 years, this groundbreaking technology enabled researchers to decode individual bases of the human genome and countless other organisms and plants. The resultant data has spawned transformative applications in basic research, translational medicine, cancer research and agricultural biotech. With rapid improvements in speed and dramatic cost reductions, sequencing is penetrating clinical research, personalized medicine, consumer genomics and pharma R&D. Today, scientists want comprehensive analysis of every cell in every tissue at every developmental stage (including epigenetic modifications), in health and disease. A major bottleneck is the efficient sample preparation (e.g., “libraries”) before DNA sequence analysis. These challenges are particularly acute for complex clinical samples, such as saliva, tissue, and liquid biopsy. Swift Biosciences removes these obstacles by providing robust solutions that accelerate genome sequencing and mutation discovery. “Born and raised” in Ann Arbor, Swift designs reagent kits to help laboratories analyze challenging specimens faster, easier, and with higher sensitivity while being compatible with leading instrumentation. Swift Biosciences is the only biotechnology company to offer library preparation solutions on all three major sequencing platforms, including Pacific Biosciences®, Illumina®, and Ion Torrent™. Swift supports 24 -library products across six categories, including eight new products in 2018. “Swift Biosciences delivers library prep products that accelerate discovery and help maximize the incredible potential of next-generation sequencing,” said Nathan Wood, Swift CEO. “We offer a suite of products that ensure labs can get the most accurate, efficient and relevant data from their samples.”

Genomic sequencing has indeed revolutionized every segment of biological science, driving a new understanding of the role of genetic markers and variants across a range of diseases. This rapid pace of progress has led to the application of DNA sequencing technology to very challenging samples, including clinical specimens (blood, tissue, saliva), environmental samples (e.g., soil or water) or precious limited-volume specimens such as biopsies from blood and fine-needle aspirates. While these samples represent a vast repository of scientific potential, they can be degraded or very diluted, often rendered unreadable by conventional systems. Swift’s novel chemistries and reagent library kits provide simpler and more comprehensive solutions, capable of analyzing degraded, diluted and rare biological samples more reliably and cost-effectively. Swift’s technologies produce higher conversion rates of input material, allowing more genomic DNA to be converted into ready-to-run libraries. Scientists can use less material to obtain better, more complete genome coverage. In addition to better sensitivity, Swift’s technologies offer faster, easier and more accurate workflows which increase lab productivity. “We challenge ourselves to push the technological boundaries.” Wood said. “Swift is strategically positioned to meet the future needs of clinical and research laboratories.” A leader in NGS library prep since 2013, Swift Biosciences recently expanded to a 17,570-square-foot state of the art technology lab within the Michigan Innovation Headquarters (MI-HQ) in Ann Arbor to accommodate future expansion. ■

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MICHBIO | michbio.org

Drug Discovery with Michigan Roots BY PETER TOOGOOD, PHD, SENIOR VICE PRESIDENT, CHEMISTRY AND CHEMICAL BIOLOGY, LYCERA

Lycera is an Ann Arbor-based pharmaceutical company focused on the discovery and development of new medicines for cancer and autoimmune disease. In the wake of the Pfizer departure from Ann Arbor in 2007, a small group of chemists and biologists joined together to help to lay the foundation for the next era of drug discovery in Michigan. Since its founding, Lycera has worked on numerous projects including two novel drug candidates that have progressed into human clinical trials. Lycera’s most advanced program is a small molecule for treating cancer known as LYC-55716. This molecule works by stimulating the immune system to better recognize and destroy cancer cells, an approach known as immunooncology. LYC-55716 has already completed a phase 1 trial in patients with cancer and is currently being explored, either on its own or in combination with a marketed drug called Keytruda®, for the treatment of six different types of cancer. LYC-55716 works via a completely novel mechanism that has not been previously tested in humans and to date is the only molecule of its class that has successfully advanced into human clinical trials. This kind of drug discovery is an integral part of the Lycera’s identity. The research group at Lycera prides itself on being able to identify and advance new areas of research before they become widely adopted. This ability to get ahead of the curve has attracted major collaborations with the likes of Merck and Celgene, which have brought significant amounts of funding into the company. Research projects that have stemmed from these collaborations continue to be pursued outside of Lycera. One component of Lycera’s success in this regard is its ability to leverage the intellectual and research firepower of its internal team with a network of collaborators both

locally and around the globe. The company considers this blend of internal and external capabilities as key to its ability to be agile and productive in the highly competitive space of drug discovery. As Lycera has grown to its current size of approximately 40 employees, the company has added offices in Philadelphia and New York. However, the research team has remained firmly in Ann Arbor and is proud of its Michigan ties. Last year Lycera’s lease on space at the University of Michigan’s North University Research Campus expired requiring the Ann Arbor group to move to new labs. Finding nothing appropriate available, the team worked with Milford-based iDesign Solutions and Ann Arbor-headquartered JS Vig to design and construct brand new lab and office space in Pittsfield Township. The move has been hugely successful, creating a state-of-the-art research facility to match the cutting-edge drug discovery efforts of the research team. Lycera employees appreciate the local support and quality of life that has nurtured their creativity for more than 10 years and actively seek ways to give back. They may be seen at networking events, lecturing at the University of Michigan, coaching sports and sitting on the boards of local schools and arts organizations. Last year the company sponsored a UMS production of Porgy and Bess. In contrast to the many bioscience companies making their home in Boston or San Francisco, Lycera is a company that relishes its Michigan roots and wants to stay. ■

LYCERA.COM BIOMATTERS | FALL 2018

Recruiting the Future SUBMITTED BY RICK CHAMBERS

A Bioscience Giant with Michigan Roots on Growing the Workforce

Forgive Ron Perry for being guarded when a stranger recently approached him at a gas station. Newly arrived in Michigan, Perry spent years working in East Coast towns where, let’s say such an approach would have been suspicious. As it turned out, the man was a local doctor who admired Perry’s car. They’ve since forged a strong friendship. Perry, a Michigan State University alum who recently became the site leader for Pfizer Inc.’s manufacturing plant in Kalamazoo County, says that experience illustrates a key element in attracting life science employees to Michigan. “The culture here is relational. That has a positive, tangible effect on people,” Perry says. “An attractive culture and environment are significant drivers to recruiting today’s workers.” Recruiting is high on Perry’s to-do list as Pfizer grows its U.S. biopharmaceutical manufacturing

MICHBIO | michbio.org

presence to the tune of $5 billion, including a half-billion-dollar expansion in Michigan.

Trajectory for Growth Headquartered in New York City, Pfizer’s legacy has deep Michigan roots through acquisitions of ParkeDavis and The Upjohn Company. The company’s footprint here changed over the years. In Rochester it operates a sterile injectable facility with about 100 people. Portage is home to Pfizer’s largest production site, which produces sterile injectable, liquid and semi-solid medicines, and active pharmaceutical ingredients for 113 international markets. It employs over 2,300 people. That number will grow. In July, Pfizer announced plans to invest $465 million to build in Portage a new, class-leading sterile injectable pharmaceutical production facility. Expected to be completed in 2021, this facility will incorporate the most technically advanced aseptic manufacturing

equipment, systems and design, including multiple, selfcontained modular manufacturing lines. It also raises the demand for highly skilled employees; Pfizer expects to need at least 450 new workers in the next few years.

Perry notes a caring and collaborative culture builds loyalty and commitment among colleagues. Additionally, he says today’s workers want to make a difference in the world.

“There’s a powerful talent war going on,” Perry says. “Other West Michigan companies are growing, too, including Stryker, Kellogg, Whirlpool, Perrigo, Steelcase, Denso and more. We’re competing for the same type of talent at a time of record-low unemployment. Further, we need to sustainably build our workforce to support the next generation.”

“At Pfizer, we make medicines that save lives. We make medicines that give hope. It’s all about helping people,” says Perry. “I can’t imagine more meaningful work than that.”

Redefining Career

Recruiting biopharmaceutical talent today requires a strategy much broader than competitive salaries.

“Challenging jobs and compensation are only part of the equation,” he says. “There are also other key decision drivers such as meaningfulness, fairness and equity, culture and environment, and a collaborative and social workplace.” For years, the conventional wisdom held that a successful career involved college and eventually an office job. Options are much more diverse now.

“We have a huge need for people in skilled trades,” says Perry. “But there are fewer candidates due to multiple factors. This needs to be changed.” Pfizer’s approach includes exposing young people to those careers. The Portage site recently hosted a group of students from disadvantaged households, and showed them opportunities that don’t require college degrees. The company also has a growing apprentice program and is exploring co-op initiatives.

No Compromise As Pfizer grows its Michigan presence and prepares for its growth, Perry understands the need to build the depth of his bench strength. “Making sterile pharmaceutical products is extremely complex,” says Perry. “Many production areas must be kept more sterile than operating rooms. The technologies we use are complicated. We must meet the evolving regulatory demands of every country where we do business. Patients trust us to deliver the highest quality medicines in every dose. “This requires a committed workforce, know-how and efficiency,” he adds. “It comes down to our people. We need the best and most engaged, always, if we’re to meet our commitments to patients. “We can’t, and we won’t, compromise any of that.” ■

PFIZER.COM

Perry believes creative partnerships between industry, academia, government and nonprofits could drive more people toward high-tech manufacturing careers. “Together, we can raise awareness of what’s available, what’s needed for these jobs, and how to develop the right skills,” he says. “We can make opportunity visible and accessible to more people.”

BIOMATTERS | FALL 2018

Innovation Workshops Unify Teams and Bring Directional Clarity

Speed to market, or the art of transforming an idea into a product faster than anyone else, is an essential skill for new product development, especially in the area of bioscience.

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4 Keys to Increasing Your Speed to Market BY LAURA ANTHONY, GRAPHIC DESIGNER AND COPYWRITER, DISHER

The speed-to-market mindset has gained momentum and relevance due to three trends: 1) The increasing speed of innovation in todayâ&#x20AC;&#x2122;s economy, 2) The accessibility to technology and funding for individuals means anyone can be your competition, and 3) Consumers have been conditioned for instant gratification by companies like Amazon.

Is faster always better? Of course not. Some use speed to market as an excuse to cut corners resulting in the development of unnecessary or low-quality products that fail in the market. Nevertheless, more time spent in development does not always equate to a better product. These four keys will help you increase speed to market, without sacrificing anything along the way.

1) FOCUS

3) MOTIVATION.

Speed does not equal velocity. The difference? Speed measures how fast an object is going (i.e. 70 mph); velocity is speed in a defined direction (i.e. 70 mph south). Organizations can develop products with speed, but if the focus is not right — they can quickly head in the wrong direction. It is crucial to start with a well-defined vision.

When interviewing, look for a person that is both energized and energizing. Individual culture inspires company culture and hiring motivated individuals who back up what they say with examples of follow-though is important. Project managers need to ensure their teams have the tools and information they need to knock out their work,and avoid lapses in motivation from delays.

2) AGILITY

4) EFFICIENCY

Our society is so accustomed to Google Maps. Users can see every part of the journey before they even begin. The beauty and burden of new product development is that it is impossible to plan for every scenario that might be encounter, sometimes making it feel like a journey without direction. That’s where agility in project management is beneficial. Agile project management is when every member of the team can recognize and react appropriately to a new variable or risk. Team members must embrace and expect change, and communicate often to manage scope, schedule, and budget changes. Throughout the process of development, new feedback will drive changes in direction, a fail-fast, fail-forward approach is where agile teams learn from mistakes and iterate forward, saving time and resources. (See Figure A).

One of the biggest tragedies in new product development is poor implementation of business processes. Project leaders should keep each process simple.They should be convinced of the “Why” before focusing on the “What”. Processes should have the goal of making the business run more efficiently for everyone. The ordinary task of timely decision-making can have the extraordinary result of greatly motivating a team. ■

DISHER is a nationallyrecognized product development, talent solutions, and business consulting firm. One of DISHER’s sweet spots is helping companies efficiently develop new products by offering usercentered research, innovation workshops, industrial design, prototyping, and engineering. Contact DISHER to help bring your next bioscience product to market with speed and excellence.

Figure A: Build-Measure-Learn Feedback Loop

DISHER.COM

BIOMATTERS | FALL 2018

Oral Fluid Drug Testing The Michigan Laboratory Start-Up that Took Off BY JOAN VANSICKLER, FORENSIC FLUIDS

In 2005, Forensic Fluids Laboratories was founded in Kalamazoo, Michigan by Bridget Lorenz Lemberg, a Forensic Toxicologist and Pharmacologist with a simple plan; to open the nation’s first woman-owned, drug testing laboratory specializing in oral fluid. Bridget had more than twenty years of experience in toxicology and pharmacology that she used to develop methodologies for oral fluid drug testing with confirmation by liquid chromatography-tandem mass spectrometry (LC/MS/MS). With her business plan in hand, along with her extensive experience, all she had to do was convince the bankers to lend a lot of money to an unemployed woman who would be the first, no, the only woman in the United States to own a drug testing laboratory. The bankers said no. They did not understand the industry and believed it was an unorthodox idea. What they didn’t realize was that oral fluid drug testing took away the degradation of peeing in a cup and eliminated the pain of being poked with a needle. An oral swab takes just minutes to collect and can be done right in an office with no gender specific issues. They didn’t realize this could change the drug testing industry as they knew it. Bridget believed in her idea and began her business with one used mass spectrometer. She went out and made the contacts, gathered the drug tests, ran the screening and confirmation tests in a small rented laboratory and delivered the results singlehandedly. Forensic Fluids Laboratories was born of innovation while many start-up companies were also being created by displaced scientists, the victims of the closing of Pfizer’s Research Division in Kalamazoo. The environment was ripe for tech, med and bio companies. Western Michigan University was investing in providing educational opportunities to encourage young scientists. The Southwest Michigan Innovation Center was built in the Business

Technology and Research Park at WMU. Forensic Fluids Laboratories offered jobs to many of the young scientists seeking experience. Located in the historic 225 Parsons Street building The Kalamazoo Enterprise Center, Forensic Fluids Laboratories occupies the very same building where Orville Gibson first started the Gibson Guitar Corporation and where Heritage Guitar, Inc. still resides. By early 2016, the lab had grown from one room to 10,000 square feet and was overflowing into available spaces throughout the building. Plans began to renovate the back half of the building into a state-ofthe-art facility capable of accommodating the company’s expanding workforce. In early 2017, all departments, personnel, instruments, and equipment were moved and integrated into the new 30,000 square foot location. The change was completed just in time for the staff to celebrate Forensic Fluids Laboratories’ twelfth year anniversary in the newer, larger facility. In mid-2017, a 2nd shift was added to support growth and to continue the standard of delivering oral fluid test results in 24 hours or less. Considering the current opioid epidemic, this can be the difference between life and death and have a tremendous impact on families throughout the country. Much of the oral fluid drug testing business is with Children’s Services, Drug Courts, Family Services and other agencies. Today, Forensic Fluids Laboratories employs 97 people of which 26 were hired in the last year. Projected growth is estimated at 140 by 2020. Forensic Fluids Laboratories is always hiring; please visit the Forensic Fluids Laboratories website for more information and job opportunities. ■

FORENSICFLUIDS.COM

MICHBIO | michbio.org

in2being, LLC

A TRUSTED GUIDE FOR NEW PRODUCT DEVELOPMENT

BY ANN MCARTHUR

What does a pioneer on the Oregon Trail have in common with someone trying to get a new product to market? They both need a guide — someone who knows the road, who will walk alongside them and will help overcome the many challenges and obstacles along the way. in2being, LLC, Michigan’s leading medical and life science product development firm, is that guide.

Parunak continues, “Our culture is focused on continuous improvement. Each time we identify something we do well, we build on it with new roles and new employees. For us, those are major milestones in how effective we are in serving our clients.” Today, in2being, LLC occupies a beautiful new facility in Saline and employs ten people.

In 2003, Gene Parunak and Aaron Kehrer were working together as engineers at a Michigan startup life sciences company. As they worked through complex design projects, they felt the need for a partner company to give them counsel and help bridge the gap between their skillsets as engineers and what was required to manufacture a finished product. No such partner was available.

As a new product development guide, in2being, LLC offers much more than mere consulting: the company doesn’t simply tell clients what to do, but walks alongside them every step of the way, shouldering the burdens as a partner and helping execute critical tasks so they can survive and thrive.

As Parunak explains, “One problem was that manufacturers knew in general what they would be able to do, but we would have to put a mature design in front of them before they could give us specific help. We needed a partner who could guide us from the idea and initial design to something they could actually manufacture that worked how we intended.” Over the next seven years as they worked design projects, Parunak and Kehrer learned how manufacturing processes work, where the limitations are, and how to account for those limitations in their design effort. They also learned how to design processes that would satisfy the expectations of the FDA and other regulators so that the product could get market clearance.

As Parunak and Kehrer look to the future of in2being, LLC they plan to focus on increasing the company’s capacity for the three things it does well. First, in2being, LLC educates innovators so they understand the development pathway using everything from informal consulting to in-depth, two-day workshops. The company also lectures and mentors students in the University of Michigan’s biomedical engineering program. Second, in2being de-risks client projects, helping to solve technical issues that impact device functionality so that it can move forward. Third, the company executes the development process to create manufacturing and regulatory-ready prototypes and documentation that can go out for regulatory clearance and manufacturing success. ■

The road to a fully commercialized product is a long one, in2being, LLC can be your guide.

In 2010 Parunak started in2being, LLC, the company he and Kehrer felt they had needed years earlier. At first, Parunak worked alone at home with just a computer and some CAD software, and then a year later, Kehrer joined him. As their clientele and funding grew, they acquired equipment and employees to build prototypes. Since then in2being, LCC has grown steadily as has its capacity to serve its clients’ needs.

IN2BEING.COM

BIOMATTERS | FALL 2018

Helping Make Research Possible in Michigan and Beyond BY DR. KIRK MAXEY, PRESIDENT AND CEO, CAYMAN CHEMICAL COMPANY

Headquartered in Ann Arbor, Michigan, Cayman Chemical Company supplies scientists worldwide with the resources necessary for advancing human and animal health.

Cayman was founded in 1980 by the current CEO, Dr. Kirk Maxey, during his first year of medical school at the University of Michigan. Beyond the immediate need to help pay for tuition and living expenses, Dr. Maxey sought to demonstrate the value of naturally growing gorgonian coral as a renewable, economically viable source of prostaglandinsâ&#x20AC;&#x201D;the potent lipids that act on almost all cells and tissues to control diverse biological functions. His vision was to provide affordable, high-quality prostaglandins to the research community. Within a matter of months, the new company, named for the Caribbean island where the coral was harvested, offered five prostaglandin standards. Over the next decade, Cayman hired skilled organic chemists who developed methods for synthetic

MICHBIO | michbio.org

production of prostaglandins and their medically important analogs. Financial progress of the operation afforded Cayman the opportunity to acquire a small Colorado-based biochemical company, AIA Reagents, in 1988. With this acquisition, Cayman could respond to a market demand for a method of quantification of bioactive materials. Caymanâ&#x20AC;&#x2122;s biochemical division developed antibodies and immunoassays to detect steroids, lipids, and neuropeptides in various sample types. By the mid-1990s, catalog sales surpassed $10 million, employees totaled 100, and Cayman was able to purchase the first facility in its now four-building campus. Cayman recognized the need to move beyond the bioactive lipid brand to sustain company growth. In the early 2000s,

resources were invested in new facilities and personnel, taking full advantage of the Ann Arbor Pfizer facility closure in 2006 to hire additional medicinal chemists. With an expanded chemistry division, Cayman capitalized on its experience with endogenous cannabinoids to begin manufacturing high-purity Schedule I-V controlled substances to federally licensed laboratories for forensic analysis and to qualified academic institutions for ongoing research. This product line included reference standards for identification of synthetic cannabinoids such as K2 and Spice seized by law enforcement and eventually expanded to include fentanyls and other opioids that emerged during the opioid crisis. To this day, Cayman collaborates with scientists, law enforcement, and policy experts alike to combat these overdose epidemics and prevent the rise of future drugs of abuse. In 2006, Cayman extended internationally, opening a large-scale synthesis facility in the Czech Republic, while its Michigan campus continued to grow with the purchase of a separate biochemical facility to house recombinant protein and antibody production, assay development, and protein crystallization. With the combined experience of Cayman’s biochemical and chemical divisions and the necessary facilities located within the Ann Arbor campus, Cayman became suitably poised to undertake a legitimate drug discovery effort. Its approach to this is unique: Every Cayman scientist involved in drug discovery also contributes to the manufacture and development of catalog products and fulfillment of custom chemical syntheses and contract services. This not only provides revenue-producing projects to complete when not actively involved in drug discovery, but also generates a pipeline for innovative new research products.

such as spinal fusion surgery or bone fracture repair. Today, Cayman continues to expand its drug discovery efforts, while at the same time offering a catalog of >14,000 products and contract research services that leverage the experience of Cayman’s 150 scientists. A scientific advisory board of highly established researchers regularly consults on key projects to keep the company forward-thinking. Cayman is deeply committed to giving back to the community that supported these achievements. Cayman supports research symposiums for local universities and other research institutions, hosts student internships, and offers grants to young scientists. In addition, Cayman’s nonprofit organization CABRI was established to help those with unmet biomedical needs by supporting research to understand the orphan diseases that are often overlooked by the pharmaceutical industry.

Through all these endeavors, Cayman remains committed to its origins and its founding vision: To provide affordable, high-quality biomedical products and to serve the research community. ■

CAYMANCHEM.COM

The first drug discovery project Cayman undertook drew on the knowledge of prostaglandin A2, the coral extract that launched the company. This project involved the development of small molecule agonists of the EP4 receptor, one of four receptors of prostaglandin E2, in order to promote new bone growth for therapeutic use in conditions

BIOMATTERS | FALL 2018

MICHBIO

BY THE NUMBERS MichBio was launched in 1993 as the Michigan Biotechnology Association (MBA) with a collection of companies, institutions and individuals as initial members. Now known as the Michigan Biosciences Industry Association – the organization represents the interests of the following sectors:

MEDICAL DEVICE

R&D/TESTING

PHARMA

INFORMATICS/HEALTH IT

AGRI-BIOSCIENCES

LOGISTICS

Our members represent regions across Michigan including Detroit, Ann Arbor, Kalamazoo, Grand Rapids, Flint, Midland, Traverse City, Houghton and Marquette in the Upper Peninsula, and everywhere in between. They include large multi-nationals and everything down to small emerging startups, as well as clinical/academic research centers, government and non-profit organizations and biosciencerelated service providers. MichBio strives to provide member value and engagement by offering business solutions and opportunities to learn, connect, partner and influence.

Savings on Business Products Services Industry, Networking and Educational Events Advocacy: State and Federal Business Referrals & Partnering Career Center Services & Discounts News Distribution: Website, Social Media & Email BioLink Newsletter BioMatters™ Magazine Entrepreneurial Support Services: Legal, Investors & Partnering Special Interest Committees Premium Members Receive Additional Benefits including advertising and event passes! 32

MICHBIO | michbio.org

OVER 25 YEARS, MEMBERSHIP HAS GROWN OVER FIFTEEN-FOLD TO ALMOST 200 MEMBERS. MICHBIO MEMBERS BY CATEGORY

MICHBIO WORKS TO ENSURE A SUSTAINABLE FUTURE FOR MICHIGAN’S BIOSCIENCES INDUSTRY.

RECOGNIZING THOSE WHO ‘MADE’ MICHBIO

DIRECTORS & OFFICERS

Hubbard, Robert

Schwarz, Joe

Alhir, Saad

Kantrowitz, Jean

Sell, Douglas

Anderson, Arik

Katz-Pek, Mickey

Sensoli, Steve

Aronin, Greg

Kelly, Pat

Serota, David

Ashba, Paul

Kerppola, Raili

Sevrain, Christophe

Bantel, Karen

Kielb, Mark

Sherblom, James

Broome, Barry

Klein, Barry

Shorthouse, Barry

A special thanks to all the professionals and leaders who’ve contributed to the success of MichBio since its inception in 1993. The passion for helping the Association fueled many others to do the same, and made the organization strong and purposeful.

Callaghan, Sean

Kemler, Jamie

Smith, DeAnn

Callawaert, Denis

Kurek, Michael

Spillman, Charles

Calvo, Daniel

Lawler, Colm

Staebler, Ned

Campbell, Mary

Mason, Jeff

Stein, Chris

Chamberlain, Linda

Massey, Ken

Stief, Eric

Your generosity of time and engagement humble us. Your commitment to doing all you can motivates us to work harder, accomplish more and make the Association a valued asset to the state’s bioscience community. In so doing your actions have helped drive bio-industry growth in Michigan.

Charlton, Randal

Mayleben, Tim

Studer-Rabeler, Karen

Cohen, David

McCleod, Kevin

Waters, Bart

Collet, Thomas

McCurren, Kevin

Weighous, Tony

Colonnese, Tim

McMaster, Gary

Williams, Jeff

DeRyke, Robert

Mickel, Steve

Wilson, George

DiSante, Anne

Molnar, Fred

Windish, Deborah

With a heartfelt gratitude. THANK YOU.

Elliott, Patrick

Morin, Dave

Wolpert, Stephen

Erb, Judith

Morley, Stephanie

Worzel, Bill

Evans, Nicholas

Morris, Paul

Zeikus, Greg

Flodin, Fred

Morton, Douglas

Zimmerman, David

Freeman, Jim

Mulder, Brent

Freshley, John

Munk, Stephen

OFFICERS (EX OFFICIO)

Fuentes, Richard

Nizzardini, Teri

Collins, Jill

Gage, Doug

Oriel, Pat

DeGraff, Greg

Garfinkle, Jan

Oxender, Dale

DeHayes, Christina

Gibbons, Christine

Padhye, Vikas

Fiedler, Charles

Goldner, Steve

Pagani, Ed

Raham, Michael

Grieb, Teri

Pape, Michael

Schtur, John

Grogan, Dale

Ratcliffe, Howard

Waltner, Paul

Hagen, Michael

Reinhart, Fred

Hasemann, Charles

Rice, Jennifer

EXEC. DIRECTOR/CEO

Heacock, Steve

Robb, Robert

Gensheimer, Jan

Herzig, David

Rogers, Tina

Rapundalo, Stephen

Hoerter, Jim

Ross, Tom

Witt, Michael

Hopper, Russ

Schwartz, Steve

Apologies for any omissions.

MichBio Saved Members

$15,819,541

MICHBIO IS THRIVING – MEMBER NUMBERS, SAVINGS, BENEFITS AND VALUE SAY IT ALL.

in 2017

BIOMATTERS | FALL 2018

A Clinical Research Organization Focused on Education, Trust, and Growth BY DON MCLEAN, MBA, SR. MANAGER, GLOBAL MARKETING AND COMMUNICATIONS

In the wake of Pfizer’s departure from Ann Arbor, many people were searching for work, including the founder of the clinical research organization (CRO) MMS Holdings, Dr. Uma Sharma. MMS Holdings was committed to helping sponsors bring products to market that positively affect patient lives. Their commitment to that mission has turned the company into an award-winning global CRO powerhouse working with the top pharmaceutical and biotech companies as a preferred provider. Even as a capable global partner, MMS’ culture has remained flexible and accommodating to support small pharma and biotech companies and drive growth in both established and emerging markets. Recently, the clinical development lead of one small biopharma said, “From Day 1, it has been a pleasure working with MMS. The team’s enthusiasm, knowledge, understanding and appreciation of the project are absolutely second-to-none in the industry.” MMS attributes its continued success to a corporate culture that focuses on providing the company’s human resources with the tools and education needed to be successful, and to the commitment to be a valuable partner to their clients.

Strong growth, combined with low attrition When Dr. Sharma founded MMS in 2006, growing the office from a few people in Canton, Mich. to hundreds on four continents may have seemed like a pipe dream. This reality and the company’s double-digit year-over-year growth are the result of putting people first and creating teams rooted in good science with unwavering dedicated. At its Asia headquarters in Bangalore, India, MMS has among the lowest regional attrition rates in the pharma and CRO industries. According to Business Standard, the region has annual attrition rates near 35 percent, while MMS has always retained a rate below six percent in the region. In the U.S., the company maintains an attrition rate of 3.5 percent.

MICHBIO | michbio.org

“Our most important asset is the people who work at MMS throughout the world. They have a data and sciencefirst matched and an unmatched drive to meet our customer’s needs,” said Michelle Gayari, Head of Global Operations, MMS.

Focus on education This people-first culture led MMS to build a robust internal learning management system with more that 750 training modules for use by its employees worldwide. Overtime, that led the company to provide training outside of the organization to sponsor teams as well. Gayari added “From the onset, MMS has been an organization focused on compliance and strength of process, and a key component is supporting each colleague’s need to be continually learning and stretching within this fastpaced industry.” In May of 2018, MMS announced a partnership with the University of Findlay to provide online medical writing and clinical trial disclosures courses. “Partnering with MMS allows us to provide unique course offerings available in few places,” said Debra Parker, Pharm.D., Dean of the College of Pharmacy at the University of Findlay. “Students and working professionals alike have expressed a great deal of interest in the program.”

Partnerships = trust In addition to a focus on people and education, longlasting relationships with sponsors have led MMS to a 97 percent customer satisfaction rate—demonstrated when Pfizer selected MMS as its preferred provider for plainlanguage summaries, when Paratek selected MMS to support new drug development (NDA) submissions, and when Gemphire Therapeutics selected MMS to support aspects of its clinical data.

Premier Preclinical Oncology Contract Research Organization “The choice in collaborating with MMS… was simple, given their deep scientific knowledge and strategic resource models,” said Dr. Steven Gullans, CEO, Gemphire. In 2018, MMS won a Leading By Example award at a top 10 pharma company’s 2018 supplier forum and was named Best Global Biotech CRO in the International Life Sciences Awards 2018 by Global Health & Pharma (GHP) Magazine. ■

The head of R&D at one sponsor company recently described MMS best, saying, “MMS is the only company I would reach out to, big or small. MMS understood and worked within our capabilities and with the unconventional strategies we were forced into by the nature of being small and underfunded. [MMS] worked with us, diligently, beyond expectations, and got us over the finish line to success.”

BY KAYLA YURGAITES, MIBIORESEARCH

MI Bioresearch (MI) is a premier preclinical oncology Contract Research Organization (CRO) and collaborates closely with biopharmaceutical companies to help them develop new cancer treatments. MI’s team leverages its cancer biology scientific expertise and a wide breadth of research tools and techniques to test the in vitro and in vivo effects of the experimental treatments. A big driver of MI’s growth and success has been in the field of immuno-oncology which is a hotbed of activity in cancer research and the biotech investment community. MI is continually expanding its service offerings in line with their customer’s needs. Recent additions have included phosphoflow cytometry, immunohistochemistry, and clinically translatable focal-beam radiation studies using Xstrahl’s Small Animal Radiation Research Platform (SARRP). Demand for MI’s services has put them in a high-growth phase over the last two years, which shows in the fact that they have doubled their operations team in the past year. MI currently has several scientific and support positions open and in the process of being filled. New hires join a company that is known for personalized collaborations with clients; creating custom research study plans, and uncovering and quantifying the necessary findings for their clients to bring new cancer treatments to patients. MI Bioresearch came into being through the re-branding and re-focusing of its precursor company, Molecular Imaging, Inc., in the spring of 2016. The MI Bioresearch name and brand quickly established high credibility and strong market presence and is the goto CRO for several high-profile biotech companies developing the next generation of cancer treatments.

One Focus. One Purpose. Oncology Research. MMSHOLDINGS.COM

See MI’s current job openings by visiting their careers page at https://www.mibioresearch.com/about/careers. ■

MIBIORESEARCH.COM

BIOMATTERS | FALL 2018

Taking Contract Manufacturing to the Next Level BY ADAM COLE, PRESIDENT & CEO,EXCEL MEDICAL

The Intangible Features of a Successful Partnership

Excel Medical Products is an FDA registered and ISO 13485 certified medical device OEM and contract manufacturer. Excel is one of only a handful of medical device contract manufacturers operating in the metropolitan Detroit area, serving the needs of local and regional medical device firms in bringing their products to market. The company was founded in 2003 in Fenton, Michigan, and subsequently relocated to a larger facility in Wixom in 2014 to support company growth and operations. Over the last 15 years, Excel has continuously expanded its contract manufacturing capabilities to provide inventors and engineers with a full package of services to simplify their outsourced projects. Excel works with medical devices in various stages of

MICHBIO | michbio.org

product development. From mere concept, through clinical trials and regulatory approvals, and ultimately into production and distribution, Excel is often involved every step of the way. The team at Excel has decades of experience in the medical device industry. With this experience, the team has not only acquired extensive expertise in medical device contract manufacturing, but they have developed many successful and lasting relationships with customers. It is clear that successful contract manufacturing relationships develop through a consistent history of producing high quality products, on time, and within budget, however, there are a number of intangible features of truly successful and lasting contract manufacturing relationships that may be harder to identify.

Look for these intangible features in your next manufacturing partner and your contact relationship will be successful. FLEXIBILITY

TRUST

The medical device industry is a fast-paced business environment in which time to market can be critical for success. In order to meet sensitive deadlines, contract manufacturers need to adapt to ever-evolving business circumstances. Priorities and deadlines can change at the drop of a hat, so it is very important that a contract manufacturer is flexible and adaptive to deliver according to customer preferences.

Entrusting a medical device manufacturing project to another company is a very big deal. The success of a medical device product is not only key for the bottom line of medical device OEMs, but can be critical to the health of real patients. Trust is hard earned over time, and can be lost easily in mere moments. A successful contract manufacturing relationship is one that cultivates and nurtures trust through the fulfillment of defined responsibilities from both sides. â&#x2013;

ATTENTION TO DETAIL In order to consistently maintain the highest standards of medical device quality, it is crucial that details are not overlooked, no matter how small. A contract manufacturer should spend the time to refine procedures and thoroughly train production staff to ensure that standards are met and that efficiencies (and therefore cost savings) can be realized. Since customer perception can affect the success of a product, what some may take to be minor details (such as the orientation of labels and carton sealing tape) merit attention. Part of the intangible equation for a successful contract manufacturing partnership is the attitude and motivation of the contract manufacturer to treat customer product as if it were their own.

EXCELMEDICALPRODUCTS.COM

COMMUNICATION Good communication is a key component to the success of virtually any kind of relationship, and a contract manufacturing relationship is no different. It is important for product or service requirements and responsibilities to be defined as clearly as possible in the relationship, beginning with the very first request for quotation. Open, accurate, and responsive communication throughout the product lifecycle can save time and money, and help to build the trust required for a successful and lasting contract manufacturing relationship.

BIOMATTERS | FALL 2018

TEAM Pharma Advances Drug Development in Michigan for a Decade BY DAN TORRES, CEO & CFO, TEAM PHARMA

Founded in 2008, TEAM Pharma, Inc is a Contract Research Organization that specializes in development of solid dosage formulations, scale-up, and problem solving. The founders, CEO Dan Torres, a 20-year veteran of Perrigo, and President John Lee, from the Pharmacy Research area of the Upjohn-Pharmacia-Pfizer companies, have extensive experience in bringing new chemical entities and generic formulations from inception to commercialization. Together, they started TEAM Pharma as a small formulation company in Martin, Michigan. As the company grew and added additional scientific and support staff, analytical capabilities, and Quality Assurance, it graduated to a Good Manufacturing Practice (GMP) compliant facility in a renovated, historic building in Kalamazoo, MI. Over the past 8 years, TEAM Pharma has brought their experience and range of services to use in a variety of industries from human and animal pharmaceuticals to nutritional and chemical. The company welcomes the most challenging projects and finds the greatest rewards in saving their customers time, money, and speed to market. Team Pharma has expertise in many solid dosing areas including tablets, multi-layer tablets, capsules, controlled release products, multi-particulates, powder handling and sachets, in addition to their experience in early stage

MICHBIO | michbio.org

development through commercialization, including design and execution of laboratory, pilot scale and validation batches, clinical supply manufacturing, packaging and labeling, and submission documentation. The GMP facility, procedures and processes have been audited and approved for companies developing Active Pharmaceutical Ingredients for market. In addition to their formulation and commercializing services, TEAM Pharma also manufactures an ultraviolet sterilizer, the UV4-C, for liquids that is currently in use at major pharmaceutical companies. The sterilizer includes an innovative ultraviolet sensor and design to ensure application of consistent ultraviolet radiation to the liquid. Several studies, including testing by the United States Department of Argiculture, have indicated that, in fluids spiked with viruses and bacteria, the Team Pharma ultraviolet sterilizer reduces the bioburden of the fluids to safe levels. In the future, TEAM Pharma looks forward to continued expansion, new challenges, and innovative problem solving to save their clients time and money. For more information contact Dan Torres (dtorres@teampharmaceutical.com). â&#x2013;

TEAMPHARMACEUTICAL.COM

JB Ashtin

YOUR MICHIGAN MEDICAL COMMUNICATIONS AGENCY Pop quiz: What is a medical communications agency?

“Our commitment to excellence embodies the principles of integrity, trust, fairness, and transparency, which are the heart of our company’s core values and integral to all our customer interactions.” — Beth Dwyer, Vice President, Business Development

BY JUSTIN LOUGHREY, SENIOR COORDINATOR, CLIENT SERVICES, JB ASHTIN

Don’t know? Most people don’t. But interestingly, Michiganders indirectly get health information from them every day. Specifically, medical communications agencies (also called MedComms) are in the business of educating healthcare providers, patients, patient advocates, and caregivers on thousands of different diseases, available treatment options, emerging therapies, best practices, and technological innovations. Many MedComms are based in the Northeastern United States, mostly around New York, Boston, and Philadelphia. There is, however, a leading medical communications agency located right here in Michigan—JB Ashtin. Since 1999, JB Ashtin has been providing customized, strategic education and communication solutions to their clients that consist of large global pharmaceutical companies all the way to emerging biotech start-ups, including some

based in Michigan. The company’s biomedical scientists, strategists, writers, editors, speakers’ bureau coordinators, marketers, event managers, and client service professionals are acknowledged experts in providing what is known in the industry as scientific storytelling. That is, using narrative principles and strategies to translate, distill, and communicate complex medical and biotechnical information to broad audiences, while at the same time increasing interest and engagement. JB Ashtin’s primary business goal is simple—to be each of their client’s favorite partner. And, in fact, the company has been a long-term preferred and agency-of-record partner for some accounts going back 10 and even 20 years. JB Ashtin’s staff members have been a tremendous asset to clients’ medical affairs, global medical communications, patient advocacy, commercial, sales, and corporate communications groups. (continued on next page)

BIOMATTERS | FALL 2018

Driving Molecular Biology and Biotech Manufacturing in West Michigan BY DES O’FARRELL, PRESIDENT, EMPIRICAL BIOSCIENCE

Empirical Bioscience: from incubator to full commercialization in rapid time

Founded in Grand Rapids in 2014, Empirical Bioscience designs and manufactures high-grade molecular biology products used in polymerase chain reactions (PCR) of human, animal and plant DNA. The company offers a comprehensive line of products covering sample preparation, DNA synthesis and DNA amplification. Most recently the company started offering Oligonucleotide Synthesis services and Contract Assay Development services. Its reagents have been optimized for use in a wide range of research and commercial applications including, veterinary diagnostics, environmental testing, agricultural applications, clinical diagnostics, molecular biology research and education. Before officially becoming Empirical Bioscience, the company existed as

MICHBIO | michbio.org

Syzygy Biotech LLC for five years at the SmartZone incubator space at the Cook-DeVos Life Science Center on Grand Rapids’ “Medical Mile.” Today, just four very busy years since becoming Empirical, the company offers a broad line of products to support all aspects of molecular testing, from DNA extraction and synthesis to DNA amplification. It counts many leading universities, hospitals and biotech companies among its growing list of customers and operates out of a new dedicated 6,000-square foot facility where manufacturing and product development are conducted on-site. In 2015 the facility obtained full ISO 13485 certification assuring conformance to international class quality standards set by the life science industry. The company is also FDA registered.

“It has been a whirlwind, to be sure, but it has been exciting to see the vision fulfilled and to see the development of the team here in Grand Rapids,” confesses Des O-Farrell, President of Empirical Bioscience. “The majority of our staff is local talent recruited from in-state colleges including Grand Valley State University, Calvin College, Wayne State University and Michigan Technical University which really shows the strong foundation the bioscience industry has in Michigan.” He continued, “It’s also a great example of a city, its economic development partners, and entrepreneurs working together to turn an idea into a successful and growing business that meets real needs in the market while providing good jobs, fulfilling work and economic value in the community.” This collaboration has allowed Empirical to expand its offerings and now provides custom products and contract manufacturing services including Enzyme Expression & Purification, custom mixed formulations and custom concentrations, assay optimization, and contract manufacturing of private label products and bulk manufacturing services. Empirical also offers many of its product lines in Lyophilized form, offering single reaction bead formats and bulk lyophilized formats. In addition, Empirical recently expanded into oligonucleotides by acquiring a position in an established North American manufacturer. This now positions the company to fully support the requirements of molecular testing as a single source developer and supplier of complete assay solutions. The company has an extensive new product pipeline that will allow it to offer new, advanced products and services to research, commercial testing and biotech companies. ■

YOUR MICHIGAN MEDICAL COMMUNICATIONS AGENCY (continued)

“We are always looking for the most impactful ways to help our clients communicate their preclinical and clinical data, whether through triedand-true communication tactics such as journal articles, conference posters, or abstracts, to social media and elaborate digital formats.” — Joni Bradley, PharmD, President/CEO

Every member of JB Ashtin’s team focuses on quality and consistency and brings the highest level of accountability to their clients’ projects. So, the real question is – why would your organization work with a medical communications agency located across the country, when you can partner with a Michigan-based one with a long history of supporting the Michigan bioscience industry? Not quite sure if your business could benefit from JB Ashtin’s services?

CHECK OUT THE INFOGRAPHIC:

EMPIRICALBIOSCIENCE.COM

Key Dates at Empirical Bioscience 2009 Syzgy Biotech Inc incorporated 2014 Name changed to Empirical Bioscience 2015 Facility obtains ISO 13485 certification

Announces Taq DNA polymerase labeled for storage at ambient temperature (15-25C) for up to 30 days and for refrigeration at 4C for up to 90 days

Introduced RTScript, a cDNA synthesis kit

Enhanced labeling for Taq Master Mix line including FlashTaq HostStart Master Mix and rEVAultion qPCR Master Mix products for storage at ambient temperature (15-25C) for up to 60 days and for refrigeration at 4C for up to 180 days

2017 Release of Agarose Gel Extraction Kit

Release of Plasmid Mini-Prep Kit Release of PCR Purification Kit Introduction of PFU-50 ultra-high fidelity polymerase Announced 2X qPCR Probe Master Mix

Contact JB Ashtin at 734-459-3144 for more information on how they can deliver customized communication solutions that fit your needs. Or send your contact information to info@jbashtin.com. Check out the company at jbashtin.com and follow them on social media. ■

JBASHTIN.COM

BIOMATTERS | FALL 2018

Established Swedish Company Larodan Makes a Second Home in Michigan BY SETH HUFF, NORTH AMERICAN DIRECTOR, LARODAN

Established in 1963 in Stockholm, Sweden, Larodan develops, manufactures and markets a comprehensive range of high purity, research grade Lipids for the international market. Lipids are biologically important for energy storage, signaling, and as structural components in cellular membranes. In addition, Lipid related compounds are becoming increasingly relevant not only in bioscientific research and food science, but also in materials engineering and traditional industry. Research grade lipids are manufactured both synthetically and by extraction and purification from natural sources. Remaining as a privately held company since its founding, Larodan’s headquarters and manufacturing facilities at Stockholm’s Karolinska Institute. With over five decades of industry experience and a team of talented chemists and support staff, Larodan has become one of the leaders in their field. As consistent with Larodan’s mission to provide competent, timely and affordable service, customers throughout the world are served both directly by Larodan and in collaboration with the company’s highly competent distribution partners. Larodan aims to be the optimal partner for lipid related research, irrespective of the customer’s need or location. To further its mission within North America, Larodan has recently established a permanent presence in the United States with an office in Michigan—whose central geographic location, proximity to Canada, and thriving educational and life science industries are excellent resources. The North American branch aims to provide even better service to all customers in the US and Canada, and to gain

a better understanding of this essential market. Using this knowledge, Larodan seeks to foster growth through meaningful collaborations and customer relationships.

The company’s extensive product portfolio includes: •

Fatty Acids and oxylipins (including prostaglandins)

•

Acylglycerols (glycerides)

•

Phospholipids and sterols

•

Sphingolipids

Additional categories of products include wax esters, fatty alcohols, saturated hydrocarbons, carnitines, sterols, polyprenols, dolichols, and glycines. These products are used for scientific research, product development and in industrial processes by customers involved in analytical, organic and bio chemistry, biophysics, cell and molecular biology, nanotechnology, pharmaceutical product development and food science. In addition to these standard products, they also have the capability to take on custom projects and special production. Larodan also provides specialty research chemicals to the Nordic market, in collaboration with international research chemical companies who are dedicated to their fields of expertise, focusing on market-leading products that fill important needs for their customers. Amongst the products are stable and radioactive isotope compounds, NMR consumables and specialty biochemicals as well as environmental and forensic standards. ■

LARODAN.COM 42

MICHBIO | michbio.org

NOW! Test for Endoscopes BY KAUMUDI KULKARNI, M.S., MANAGER OF RESEARCH AND DEVELOPMENT, HEALTHMARK INDUSTRIES

Healthmark Industries is a Michigan company founded in 1969 that has spent nearly five decades developing innovative and cost-effective solutions that aid the healthcare industry in meeting its sterilization, decontamination, storage, transport and labeling needs. Among Healthmarkâ&#x20AC;&#x2122;s many products are tools for effective cleaning verification, and microbial surveillance of endoscopes. Throughout its history, Healthmark has been a leader in the sterilization, cleaning verification and the microbial surveillance segment of the market, demonstrated most recently with its NOW! Test to detect endoscope contamination. The NOW! Test is a test to check flexible endoscopes for gram negative bacteria after reprocessing. Gram negative bacteria act as indicators for bacterial contamination in endoscopes and reduce the risk of false positives associated with the gram-positive bacteria that occur normally as skin flora. The test detects gram negative bacteria (>10 CFU) that may be potentially left behind in reprocessed endoscopes. The NOW! Test works by detecting an enzyme mechanism that is typical to gram negative bacteria. This unique enzyme-based detection method involves a fluorogenic substrate which, when comes in contact with a specific enzyme present in gram negative bacteria, produces fluorescence. This fluorescence is read by the fluorometer and the reading correlates to the amount of the bacterial enzyme present and relates to the number of gram negative bacterial cells present.

The NOW! Test is designed to be used rapidly (results in >12 hours) within an endoscopy clinic or facility. Simply flush sterile water through the endoscope lumen, collect the water and sample this recaptured water with the test. If the fluorometer reading is positive for Gram negative bacteria, reprocess the endoscope following manufacturer guidelines prior to use. The test detects gram negative bacteria like E. coli, Pseudomonas aeruginosa, Klebsiella, Salmonella and Legionella, associated with patient infection after endoscopic procedures. The test also detects the presence of the multidrug resistant CRE strains of these organisms. When it comes to patient safety, microbial surveillance of endoscopes is of great significance. The need for endoscope monitoring is especially pronounced if the healthcare facility has recently adopted a new cleaning or disinfection protocol, if there is a recent nosocomial outbreak that needs to be investigated or if a perfect quality assurance program is not in place in the facility. The NOW! Test can help reduce the microbial surveillance burden on facilities, by providing a fast and easy testing method, and help to control the unnecessary transmission of illness or infection of patients. Healthmark will continue to develop innovative solutions for microbial surveillance, cleaning validation and verification, sterilization, storage, transport, and labeling needs within the bioscience industry in Michigan. â&#x2013;

HMARK.COM

BIOMATTERS | FALL 2018

Michigan has a Rich Legacy as the Birthplace of Innovation BlueWillow is a part of that legacy.

Founded as NanoBio Corporation in 2000 by Dr. James Baker, a leading physician and researcher at the University of Michigan, BlueWillow is an Ann Arbor-based biopharmaceutical company focused on the development of intranasal vaccines for respiratory and sexually transmitted infections. For the past 18 years, the company has been conducting innovative research that has the potential to evolve the healthcare landscape through the utilization of its oil-in-water emulsion. The mixture, made up of tiny droplets of soybean oil and solvent about 1/400th the width of the average human hair, explodes on contact with skin and binds with bacteria. The company recently shifted to the development of nanoemulsion vaccines after generating compelling supportive

MICHBIO | michbio.org

data. With that shift in focus came the new name, BlueWillow, a subtle nod to the University of Michigan and the company’s established roots in the bioscience industry. BlueWillow continued to harness its patented NanoVax adjuvant technology that uses the nanoemulsion in intranasal vaccines that elicit both mucosal and systemic immunity, a clear differentiator to traditional intramuscular vaccines that do not provide mucosal protection. “Mucosal surfaces are areas where most infectious pathogens enter the body. Having the ability to attack these invaders before they become a problem is a turning point in the world of vaccine development,” said Dave Peralta, CEO of BlueWillow. “Our

NanoVax platform has the potential to create effective vaccines for diseases that are currently unpreventable or untreatable through vaccination.” BlueWillow vaccines target respiratory infections including RSV, pertussis, influenza and anthrax, and sexually transmitted infections (STI’s) including genital herpes (HSV-2) and chlamydia. Current anthrax vaccines require many vaccinations and come with side effects. RSV is highly contagious and is the number one cause of childhood hospitalization worldwide. Pandemic influenza can quickly spread across populations with serious risk of illness or death. Recognizing the lack of effective vaccines for these infections, the company is committed to creating therapeutic and preventive vaccines that could impact countless lives globally. For example, current flu vaccines are administered via injection which makes access to vaccines difficult in some areas, provides a barrier to individuals who cannot receive vaccine injections, and contributes to the pandemic nature of the flu. Providing an intranasal option could lessen the number of people who go unvaccinated while also providing mucosal immunity. BlueWillow’s seasonal influenza vaccines have demonstrated safety and immunogenicity in Phase 1 human clinical studies.

and infertility,” Peralta said. “Knowing that our platform has the potential to become the first vaccine in existence to prevent the serious issues caused by chlamydia is inspiring. We can change lives.” BlueWillow recently closed $10 million in Series A financing for the development of intranasal vaccines for respiratory and sexually transmitted infections. The round was led by North Coast Technology Investors, Line Moon Ventures and the University of Michigan through its MINTS initiative. With this funding and continued support from the NIH, BlueWillow is rapidly approaching Phase 1 human clinical studies in multiple programs. With the company’s commitment to preventing disease so that people can lead healthy lives, it is clear that the promise of this unique technology will contribute to Michigan’s biotech economy for decades to come. ■

BLUEWILLOW.COM

In addition, the company’s NanoVax technology has the capacity to improve the efficacy of important respiratory vaccines and prevent sexually transmitted infections including HSV-2, which impacts more than 500 million people, and chlamydia, which infects 3 million people each year. “Chlamydia is one of the most common STIs in the United States and 75 percent of women with the infection have no symptoms. Without treatment, women are at risk for reproductive complications including pelvic inflammatory disease

BIOMATTERS | FALL 2018

NSF INTERNATIONAL

THE SCIENCE OF PUBLIC HEALTH BY KEN BEARDEN, SENIOR COMMUNICATIONS SPECIALIST, NSF INTERNATIONAL

Operating in an age of acronyms poses an occasional challenge for NSF International, an Ann Arbor-based organization employing 2,800 people worldwide to support its public health mission.

MICHBIO | michbio.org

The organization is sometimes confused with that other “NSF” – the federal government’s National Science Foundation. While Ann Arbor’s NSF was founded in 1944 – six years before the National Science Foundation – and originally called the “National Sanitation Foundation,” the name was changed to NSF International in 1990, reflecting its expanding scope of services and global scale. Today, NSF International employs microbiologists, toxicologists, chemists, engineers, and environmental and public health professionals to facilitate the development of public health and safety standards. Its goal is straightforward: to protect the food we eat, the water we drink, the healthcare products we use, the air we breathe and the environment we share. Separately, NSF International also offers auditing, education, risk management and consulting services to a wide variety of industries – from dietary supplements, food and water systems to sustainability, automotive parts and health sciences. The organization also owns and operates Quality Assurance International (QAI), one of the largest certifiers of USDA organic products.

Consumer Trust and the Culture of Transparency

The Ann Arbor organization works with government, academia, industry and consumers to align standards with the regulatory requirements of organizations like the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). It’s accredited by the American National Standards Institute (ANSI) to help develop American National Standards using an open, consensus-based process. NSF holds more than 70 unique accreditations, licenses, certifications and recognitions worldwide. With more than 305,000 square feet of accredited, stateof-the-art labs in North America, Latin America, Europe and Asia, including more than 130,000 square feet in the Ann Arbor location, the organization tests more than 30,000 products annually. NSF International is also a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment. ■

FIVE THINGS YOU DIDN’T KNOW ABOUT NSF INTERNATIONAL

Consumers care about the quality and safety of the products they buy, and are empowered by digital resources to seek out information about the origin of products and how they’ve been handled throughout the supply chain. Standards, auditing and testing criteria, developed by independent certification bodies like NSF International, help lead to greater consumer confidence and allow companies to provide more transparency. Now more than ever, it’s critical to have rigorous standards that consumers, regulators and industry can rely upon – and trustworthy organizations to help develop and maintain them.

1. NSF International facilitated the development of the American National Standards for all materials and products that treat or come in contact with drinking water. In 1990, the U.S. EPA replaced its own drinking water product advisory program with these NSF/ANSI standards.

NSF International takes its public health mission seriously. It’s an independent and accredited non-governmental organization, deeply rooted in science and with a unique public service heritage widely recognized as the “gold standard” for quality. NSF certified products and systems earn the NSF mark, which is trusted and respected by consumers, manufacturers, retailers and regulatory agencies. More than 520,000 products are currently NSF certified, and over 85,000 are certified by QAI, an NSF International company.

3. NSF International and the National Science Foundation co-hosted the first-ever Legionella Conference in April 2018.

The organization is a committed, trusted partner whose technical expertise, quality and service is firmly rooted in uncompromising integrity. Established at the University of Michigan’s School of Public Health, the organization helped create U.S. sanitation and food safety standards at a time when national standards did not exist. Today, NSF International has facilitated the development and maintenance of over 90 consensus-based standards and testing programs to help improve public health and safety.

2. NSF International owns and operates QAI, the leading certifier for the USDA organic program.

4. NSF’s Certified for Sport® program is required or recommended by sports organizations including MLB, NHL, CFL, PGA, LPGA, CCES and CPSDA. NSF’s Certified for Sport® program screens for over 272 athletically banned substances. 5. Most municipal health departments require commercial kitchens to use only NSF certified equipment – from cutting boards and utensils to deli meat slicers and refrigerators.

NSF.ORG

BIOMATTERS | FALL 2018

Proteos occupies 8,000 sq. ft. of laboratory space within the Western Michigan University Homer Stryker M.D. School of Medicine (WMed) Innovation Center

Proteos provides custom protein expression services in mammalian (shown), insect, and bacterial expression systems from the 30 mL scale up to 60 L batches

Proteos, Inc. Celebrates 15 Years

BY JASON HAINEAULT, PROTEOS

Proteos, Inc., a contract research organization located in Kalamazoo, is celebrating 15 years of providing the highest quality recombinant protein expression and purification services to members of the biotechnology community. They offer products and services that help researchers build a quality foundation for drug discovery in a wide variety of research areas, including oncology, immunology, infectious diseases, neurobiology, and vaccine development and are especially proud of their partnership with the Michael J. Fox Foundation (MJFF) for Parkinson’s disease research. Proteos supplies MJFF grantees with standardized pre-qualified protein tools to aid in their research. The company’s protein tools have been delivered to Parkinson’s Disease researchers across the globe. Founded in 2003 by Clark W. Smith, PhD. and Robert L. Heinrikson, PhD., Proteos is an anchor tenant occupying 8,000 sq. ft. of laboratory space within the Western Michigan University Homer Stryker M.D. School of Medicine (WMed) Innovation Center. The company specializes in highly-customized contract research projects, working closely with clients to design personalized workplans that utilize the team’s expertise to solve complex protein production problems. Workplans are designed to include data-driven decision points for real-time communication with the client. This work model allows greater client control and project flexibility, resulting in greater levels of project success and client satisfaction. The scientific team is tremendously skilled with backgrounds in chemistry, biochemistry, molecular biology, and structural biology, including two veterans of the pharmaceutical industry with more than 30 years of combined experience. Part of the original vision for Proteos was to provide long-time Upjohn/ Pharmacia/Pfizer scientists with local jobs following the elimination of Pfizer human health research departments in Kalamazoo. In that regard, six former employees were able to complete their scientific careers in Kalamazoo and retire from

Proteos. Since its founding, Proteos has undergone multiple transition phases, surviving the economic downturn in 2008, and has recently enjoyed multiple years of steady growth. Proteos has continued to retain scientific talent in Kalamazoo with current scientists averaging over 8 years of service. Earlier this year, Proteos was awarded the 2018 SmartZone Best Small Business of the Year by Michigan Celebrates Small Business. Companies recognized as a “Best Small Business” through Michigan Celebrates Small Business were selected by their regional Procurement Technical Assistance Center (PTAC), Small Business Development Center (SBDC), or SmartZone. Honorees and winners were selected based on their demonstration of successful growth and contributions to the economy of Michigan. Michigan Celebrates Small Business (MCSB) remains on the forefront of championing small business and fostering the entrepreneurial spirit in Michigan. The MCSB’s role is to serve as a catalyst for creating an entrepreneurial culture while inspiring the next generation of entrepreneurs. MCSB brings together the resources of collaborative partners and supporters so that they may raise the profile of small businesses in Michigan, build a network of entrepreneurial companies, and tell the stories of successful, growing Michigan entrepreneurs. Proteos had previously been recognized in 2006 by Michigan Celebrates Small Business as a Michigan 50 Companies to Watch awardee. In January of 2018, Proteos announced that the company would begin restructuring and transitioning to a majority employee-owned company. This transition allows long-time employees the opportunity to move into executive leadership roles in the organization. Moving forward, Proteos remains steadfast in its commitment to exemplary client service and employee satisfaction in the biotechnology industry. ■

PROTEOS.COM 48

MICHBIO | michbio.org

Delivering a New Way Forward for Precision Oncology BY JUSTIN BROWN, PHD, DIRECTOR, CLINICAL BUSINESS DEVELOPMENT

Strata Oncology, Inc., an Ann Arbor-based precision oncology company, is creating a new standard of care for cancer patients, one where molecular profiling, clinical trial participation and continuous learning to inform care and research are the norm. The company was founded in 2016 by CEO Dan Rhodes (BS, PhD, University of Michigan), Scott Tomlins (MD, PhD, University of Michigan) and Keith Flaherty, MD (oncologist at Harvard Medical School and Mass General Hospital). Strata Oncology was launched with a $12 million Series A funding round from Arboretum Ventures and Baird Capital. Despite advances in precision medicine, the majority of advanced cancer patients still do not benefit from comprehensive tumor molecular profiling or precision therapy trials. Health systems need a cost-effective, systemwide solution for precision oncology, one that integrates cutting-edge molecular profiling and precision therapy trials with routine care, so that all advanced cancer patient have the opportunity to benefit. Biopharma companies need a mechanism to rapidly and predictably enroll registrationenabling precision therapy trials. Strata Oncology believes a new model that integrates molecular profiling and cuttingedge clinical research will dramatically improve treatment options, while speeding the path to drug approvals. The Strata Trial serves as the foundation of the companyâ&#x20AC;&#x2122;s approach by providing a standardized genomic testing protocol to deliver precision oncology health system-wide. The trial provides comprehensive tumor molecular profiling for 100,000 advanced cancer patients at no cost and proactive enrollment support for a portfolio of pharma-sponsored precision therapy trials. Testing is performed at Strata Oncologyâ&#x20AC;&#x2122;s high-throughput, CLIA-certified laboratory in

Ann Arbor. The company is selecting the most promising pharma-sponsored precision therapy trials and building a collaborative network of leading health systems to accelerate precision medicine for cancer patients. Since 2016, Strata Oncology has partnered with 12 leading health systems across the U.S. representing more than 90,000 new cancer patients annually. These systems leverage infrastructure provided by Strata Oncology to implement a comprehensive, streamlined precision oncology program featuring tumor molecular profiling for all advanced cancer patients, robust software and data tools, and matching to a portfolio of precision therapy trials. This large network of trial-ready health systems, with fully pre-screened advanced cancer populations, enables rapid and predictable enrollment of precision therapy trials. The company has also announced partnerships with several biopharma companies to accelerate development of new precision cancer medicines. In May, the company announced a $26 million Series B funding round. New investors Pfizer Ventures, Merck Global Health Innovation Fund, Deerfield Management and Renaissance Venture Capital Fund were joined by existing investors Arboretum Ventures and Baird Capital. Strata will use the funding to accelerate growth in a number of key areas including expansion of its network of health system partners and development of a clinical-genomic database to catalyze development of the next generation of cancer medicines. â&#x2013;

STRATAONCOLOGY.COM

BIOMATTERS | FALL 2018

AFTER THE

ELEVATOR PITCH ABKO Labs, LLC is a Warren-based Safety Compliance facility seeking licensure under Michiganâ&#x20AC;&#x2122;s Medical Marihuana Facilities Licensing Act (MMFLA) passed in 2016. The MMFLA requires comprehensive testing of medical marihuana and derivative products to ensure that what reaches the consumer is safe and free from contaminants. When enacted, the MMFLA created a seed-to-sale tracking system that requires participation from a cooperative network of professions each providing a different service within the industry. There are three levels of Growers based on their number of plants, who sell to Processors that turn harvested marihuana into oils, extracts, edibles, etc, which are then sold to consumers through a licensed Provisioning Center.

MICHBIO | michbio.org

As a Safety Compliance facility, ABKO Labs will visit Growers to collect samples of flower and Processors to collect samples of derivatives and physically inspect them for foreign matter. The sample undergoes potency testing, microbial and mycotoxin testing, and chemical residue testing for pesticides, fungicides, and insecticides. Additionally, we test for heavy metals, water activity including moisture content, and for residual solvents in extracts. Only after a sample passes our testing can the batch be sold through the Provisioning Center. ABKO Labs, LLC received pre-qualification status in April.

ABKOLABS.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. All the way around, Michigan bioscience businesses are truly improving the quality of life for patients and consumers.

Advanced Interactive Response Systems (AIRS) has launched their new Moisture Exchange Nasal Cannula (MENC). This nasal cannula incorporates an antimicrobial moisture exchange tubing that humidifies oxygen in a clean and portable way without needing water. The tubing brings in water particles from the air that automatically combine with and humidify the oxygen so that it mimics the userâ&#x20AC;&#x2122;s environment. The nasal cannula has a universal end that attaches to all standard oxygen equipment. In addition, AIRS is currently working on a 510k filing for the FDA for their Oxygen Flow Monitor (OFM). Once FDA clearance is granted, the OFM will be available for purchase. The OFM attaches to oxygen tanks, concentrators or bulk systems to monitor the flow of oxygen and the patients SPO2 with heart rate. The OFM

works with an app that remotely monitors all data and can alert the user and caregiver of any issues. These innovative products are beneficial to oxygen patients in all settings, including hospitals, long-term care facilities and home care situations. AIRS products are uniquely designed to be portable, reliable and userfriendly, with a focus on improving quality of care and life for oxygen users. AIRS is a woman-founded and Michigan-owned company focused on respiratory care solutions.

OXYGENALARMS.COM

BIOMATTERS | FALL 2018

AFTER THE ELEVATOR PITCH

Arbor Grace, Inc. is a Michigan-based company, developing cutting-edge, human-centric medical devices. Launched out of an Executive MBA program at the University of Michigan, the company seeks to promote patient engagement in treatment and improve outcomes by tackling a range of unmet needs in the medical device space. Patrick Powell, Arbor Grace president and co-founder says, “I discussed medical devices at length with numerous physicians during my time in the MBA program. These physicians were deeply proud of the work that they do but were concerned that available medical devices lacked proper human-centric design—meaning that while the devices work, they don’t always consider the usability needs of the patient as thoroughly as their clinical needs, resulting in lower patient engagement.” He continued, “We founded Arbor Grace to specifically address these unmet needs and improve patient outcomes and quality of life.”

Arbor Grace is currently promoting their BLUE KangarooTM product line, a neonate jaundice and warming suite that treats jaundice while promoting parent and infant bonding and improving treatment outcomes. The company has also developed Super-ExpressTM, a wearable breast pump that better serves mothers with more convenient expression, and, is developing an advanced wound therapy line called BREATHETM. Additionally, Arbor Grace offers engineering and development services, including prototyping, and is excited to work with healthcare inventors who need a seasoned, qualified partner to help move their approach from whiteboard to market. For additional information, please email: contactus@arborgrace.com

ARBORGRACE.COM

BōNWRx (pronounced “Bone Works”) is a privately held company that develops and produces innovative products for orthopedics, spine, neurosurgery, and regenerative medicine.

absorber in the spine and reduces the chance of fracturing vertebrae above and below the injection site. Additionally, the material interdigitates within the trabeculea, adheres to bone and has no heat & no monomer.

BōNWRx first commercialized product, VK100, is used for percutaneous vertebral augmentation. It is a propriety elastomer with unique mechanical properties that stabilizes and restores the function of vertebrae without exposing the patient, or the medical personnel, to the potential harmful, and sometimes fatal, effects of the current leading treatment, acrylic bone cements known as PMMA. The elastic quality of VK100 acts as a shock

VK100 is cleared for use by the European Regulators with CE Marking by British Standards Institute (BSI). US FDA clearance is expected within the coming months.

MICHBIO | michbio.org

BONWRX.COM

The company’s flagship assay, MATURA96, features functionally mature human cardia monolayers in 96 well plates for high throughput electrophysiology screening. “To put it simply, the screening protocol we have developed uses human cardiac cells, instead of animal cells, to test the electrical flow in the heart so researchers can get information back on fatal drug side effects including heart arrhythmias and toxicity,” says Dr. José Jalife, CARTOX co-founder and Director of the UM Center for Arrhythmia Research. “Researchers could use the protocol to test both healthy and diseased tissue.”

AFTER THE ELEVATOR PITCH

Founded in 2016 by two University of Michigan faculty, CARTOX has developed novel, high throughput human cardiotoxicity screening platforms. The company’s assays, which use human tissue, are a major improvement over the existing animal-based paradigms for pre-clinical cardiotoxicity and proarrhythmia screening.

He continues, “Using the diseased cell lines gives researches the benefit of determining the efficacy of their drug in preventing heart attacks or arrhythmias while they study its safety.” CARTOX received FDA validation for its pluripotent stem cell-derived screening assay, the Comprehensive In Vitro Proarrhythmia Assay or CiPA, for pre-clinical regulatory screening. In addition to Dr. José Jalife, the company was founded by Dr. Todd Herron (Director, UM Cardiovascular Regeneration Core Laboratory). Early stage funding was obtained from the NIH SBIR program. CARTOX is located in the UM Venture Accelerator and is exploring its strategic options, including securing a commercialization partner for kitted products or contract research organization (CRO) activities.

Diseased tissue used for testing is derived using iPSC lines that include cardiac disease-causing gene mutations or by stimulating a heart attack in vitro.

DataSpeaks is a Michigan company committed to improving efficiency in drug development, optimizing patient care, and promoting data-driven decision-making. Their premier product, the Science of Individuality Measurement Algorithm (SIMA), can transform multiple streams of patient-generated, genetic, and sensor data (from wearable or implantable devices), into actionable, integrated, and personalized assessments of risks and benefits for drugs in a patient’s regimen. DataSpeaks President and SIMA inventor, Curt Bagne said, “The SIMA system puts a precision touch on drug therapy and development. We all know that small genetic variances can cause drugs to behave in disparate ways in different subjects. However, clinical trial data often only looks at average behaviors among very large, random samples. The sheer size and randomization of data sets masks the effects of individual differences and makes it nearly impossible to isolate any specific characteristic that impacts drug efficacy.”

He continued, “If you consider that genetic differences are only one factor among hundreds that could impact individual drug efficacy, you can begin to understand why effective drug therapy and drug development are difficult, and expensive, businesses.” The SIMA scoring systems analyzes many individual characteristics simultaneously, overlays drug testing or new medication data, and can help produce an accurate picture of the interaction between an individual and a drug in real-time. This could allow for faster drug development and for real-time alerts for health care practitioners about the need for dose adjustments or medication switches. DataSpeaks is currently seeking assistance to continue development and commercialization of SIMA.

DATASPEAKS.COM

BIOMATTERS | FALL 2018

AFTER THE ELEVATOR PITCH

Founded by an award-winning cancer biologist and survivor, epiSCI is an early-stage biotechnology drug company on a mission to develop oncology therapies for carcinomas—the solid cancers in internal organs that represent 95% of all cancer—with a patient’s recovery and quality of life in mind. epiSCI is pioneering the intuitive controls missing from oncology R&D—the normal epithelial stem cells that renew organs throughout a person’s life. Oncology research generally relies on embryonic stem cells (ESC) or induced pluripotent stem cells (iPSC) which can mitigate research effectiveness and lead to drug failure.

epiSCI’s combination of personalized medicine and cell technology puts matched normal and cancer stem cells in a laboratory environment that best resembles the healthy or diseased organ, providing information on biomarkers and druggable pathways for testing of epiSCI or partner company therapeutic agents. The result is effective treatments can be brought to market faster, unsafe drugs fail faster, and there is an overall reduction in drug development cost.

More simply, epithelial stem cells exist in a person’s organs and, when the cells are normal, regenerate those organs during their life. However, if the cells lose control of their function they lead to carcinomas. Studying the similarities and differences between the normal organ-based stem

epiSCI is currently assembling a new team and embracing conscious capitalism to achieve exceptional productivity within the $110 billion oncology market.

Functional Fluidics is a Detroit-based company committed to setting the standard for blood function diagnostics in Sickle Cell Disease and a wide range of bleeding and clotting disorders. The company has created a suite of assays that can aid clinicians in the treatment of a variety of diseases and drug developers in clinical trials.

that assess red blood cell health. For example, our Flow Adhesion assay measures blood cell adhesion under physiologic flow, which is predictive of microvascular blood flow disturbances. Our Membrane Fragility assay measures the risk of hemolysis by subjecting cells to increasing amounts of mechanical stress.” Clinical indications of the Functional Fluidics assays include Sickle cell disease and other primary RBC disorders, diabetic vasculopathy, pulmonary hypertension, stroke, transfusion medicine, and medical device-induced RBC damage.

Functional Fluidics Founder and CEO Patrick Hines says, “To put it simply, red blood cells (RBC) deliver oxygen throughout the body. When those cells are damaged or unhealthy in some way the consequences can be catastrophic. There are no clinically validated assays available to assess the health or functionality of red blood cells, and this leaves clinicians in the dark when treating patients and hinders the ability of pharmaceutical companies to test the efficacy of their drugs.” He continues, “To help solve this problem, Functional Fluidics has developed several complimentary biomarkers

cells and the cancer-causing cells can lead researchers to more effective drug and treatment options.

MICHBIO | michbio.org

EPI-SCI.COM

Functional Fluidics is certified as a CLIA Laboratory and plans to begin offering a send out test for monitoring sickle cell disease in 2019. FUNCTIONALFLUIDICS.COM

Delivered as software-as-a-service, prairi accepts data from virtually any sensor-based or biometric system and continually generates new insights as its dataset expands.

Impellia co-founder Dave Morin says, “Despite their proliferation, wearables such as player trackers, biometric sensors and smart clothing do not address the injury prevention, rehabilitation and performance optimization needs of athletic and sports medicine. These technologies often collect data in an unconnected silo with limited analytics which is unusable for decision-making.”

These insights empower sports medicine professionals and athletes to customize training, rehabilitation, and injury prevention regimens specific to the unique needs of each player or patient they treat, increasing their efficiency and effectiveness.

He continued, “Our ‘prairi’ software platform combines this sensor and biometric data with scientifically-validated algorithms to easily and expertly make sense of human metrics. It connects the dots – turning robust data from any source into useful, comprehensive and actionable information for performance readiness and physical resiliency optimization.”

AFTER THE ELEVATOR PITCH

Impellia is a human performance software that provides individualized, predictive analytics to help athletes optimize performance and improve injury resiliency.

Impellia has offices in Ypsilanti, MI and Pittsburgh, PA and was founded by attorney and marketing executive Richard Walker, serial entrepreneur Dave Morin and 15-year NFL quarterback Charlie Batch. The company’s advisory board is comprised of nationally-renowned experts in the fields of sports performance, sports medicine and nutrition. Impellia actively works with athletic and healthcare organizations across the country and is rapidly expanding, having doubled its workforce size in 2018. IMPELLIA.CO

IndividuALLytics™ combines the power of “All” (population communities) with power of over time “Individual” data to better engage patients and care teams in personalized treatment for chronic disease and mental health disorders. Working out of Michigan Life Sciences Innovation Center (MLSIC) in Plymouth, MI, the company is working with leaders in Alzheimer’s disease and dementia to improve patient and family care giver outcomes on an individual basis that scales to help many millions of patients. Their Digital Health Operating System 3.0™, uses a unique cloud software to integrate treatment best practices via N of 1 predictive analytics with data collection, reporting, and communication, to enhance productivity of professional care teams. This has the potential to cut chronic care costs by over 20% while improving outcomes and quality of life. IndividuALLytics™ has MVP (Minimal Viable Product) capability ready to partner with Doctors on improved

connected care for Alzheimer’s Disease/Dementia patients and their family care giver. Seamlessly integrated with wearable devices, smartphones, connected home, and specialized tele-care, the MVP generates simple reports that show personalized treatments and compliance that allow for easy, continuous monitoring and personalization of care. In addition, IndividuALLytics™ provides partners with leading full-service digital health consulting, science, and software accelerators in the areas of: Behavioral Science, Individual Science, Outcomes and Predictive Analytics, Psycho-Social Interaction Science, Strategic Marketing & Business Development with Multi-Channel Communication Expertise, Digital Health/Software Application Consulting, and Study Design. Companies like Johnson & Johnson, Kaiser-Permanente, GSK, Pfizer, Abbot, and others, have been helped by IndividuALLytics™ experts. Email: info@individuALLytics.com . INDIVIDUALLYTICS.COM

BIOMATTERS | FALL 2018

AFTER THE ELEVATOR PITCH

JV Biolabs is a Michigan-based pharmaceutical and contract research organization founded in 2009. The company is focused on identifying and developing skin repair agents for pharmaceutical and cosmeceutical products and conducting pre-clinical research on the safety and efficacy of such agents. Stemming from decades of experience in skin cell and tissue biology for founder James Varani, PhD. and in inflammation and disease-related tissue injury for president Kent Johnson, PhD, the pair is positioned to advance research on non-irritating retinoids and identify natural products with retinoid-like activity for use in skin repair and wound healing with the specific focus of skin improvement in at-risk skin. Dr. Varani says, “Chronological aging, photodamage, metabolic diseases like diabetes, and the use of steroids and certain metabolic inhibitors cause atrophic changes in the skin. When that skin is wounded, it is more difficult for the wounds to heal than it is in healthy skin, potentially

One-in-five needle biopsy procedures are repeated due to poor sample quality. This delays diagnosis, places an unnecessary strain on patients, and puts the financial burden of unreimbursed repeated testing on hospitals. MedKairos will put an end to this inefficiency. Founded by University of Michigan medical student Michael Moore, MedKairos is redefining the digital pathology space. Their flagship product, Bioptic™ is an automated staining and scanning platform, partnered with a unique software package, that verifies biopsy viability with a more than 99% certainty. Using Bioptic™, clinicians can determine if a sample is of adequate size and quality at the point-of-care saving time and money while dramatically improving the quality of care. The company intends to replace manual quality assessment as the lead strategy in biopsy analysis and substitute it with a more consistent and accurate approach.

MICHBIO | michbio.org

leading to chronic, non-healing ulcers. We are attempting to develop agents for use in drugs and cosmetics that can aid in skin repair without irritation.” In addition to their own research, the team at JV Biolabs has developed sophisticated tissue models including human skin in long-term organ culture and human skin-SCID mouse transplant models, as well as primary cultures of human skin cells in monolayer culture. These models allow the company to conduct contract pre-clinical research for clients to identify the potential efficacy and toxicity of agents designed for skin use without the significant investment of resources required for clinical proof-of-concept studies. For more information visit jobiolabs.com or email info@ jvbiolabs.com. JVBIOLABS.COM

This offers the accountability that both patients and clinicians deserve. With a diverse team of engineers, clinicians, and business veterans on board, MedKairos is positioned to launch Bioptic™ in late 2019. Initially targeting thyroid biopsies, the company will enter an $85 million market that evaluates over 1.2 million biopsies per year. MedKairos intends to expand its platform, adding lung, lymph node, breast, pancreatic, and gastrointestinal biopsies, rounding out a $536 million quality assessment market. Looking forward, their platform is designed to incorporate interchangeable staining and optical techniques that will become the gold standard in cytology sample management. MedKairos’ Bioptic™ offers the consistency and adaptability necessary to become the global leader in this space. MEDKAIROS.COM

MTX-211 was co-invented by Drs. Judith Sebolt-Leopold and Christopher Whitehead and patents filed by the

The U.S. medical device industry has more than one crisis on its hands: a dramatic rise in FDA device recalls and a decade of bad inspections where a third or more had citations. Pundits have blamed poor risk management on the part of manufacturers for recalls and ignored without comment the steady volume of citations. Device recalls, while increasing in number, are doing so at a rate that correlates with the number of new products on the market, i.e. new products are introduced at an increasing rate in recent years, and recall events have risen as a result. At the same time, FDA inspections with Official or Voluntary actions have resulted in consistently high percentages for a decade — stuck between 30% and 40%, there have been no signs of improvement. These are symptoms of complacency. It is not a new phenomenon. The solution is the development of inventive solutions to decades old problems. Think Über and AirBnB. Menlo Park Software is an Ann Arbor-based information technology company working to resolve these dilemmas with a focus on process improvement that combines an

AFTER THE ELEVATOR PITCH

Mekanistic Therapeutics is an Ann Arbor-based, University of Michigan spin-out dedicated to the development of a new generation of rationally designed kinase inhibitors to selectively inhibit multiple cancer drivers. The company’s lead molecule, MTX-211, is a first-in-class drug candidate specifically designed to address resistance mechanisms frequently encountered in the treatment of KRAS mutant cancers. KRAS mutations occur with high incidence in colorectal, pancreatic, and lung cancers, presenting a significant unmet medical need and large addressable market. MTX-211 targets the compensatory signaling that continues to drive the growth and survival of KRAS mutant cancers treated with currently available drugs. MTX-211 is well tolerated and highly active in treating mouse models established from colorectal cancer patients diagnosed with KRAS mutant disease.

University of Michigan. MTX-211 and related compounds have a strong IP position and the company has sought broad patent coverage that encompasses major markets of interest to pharma. The patent estate includes several provisional and PCT application in process that cover a diverse set of molecules and multiple commercial opportunities. Mekanistic Therapeutics, co-founded by Drs. SeboltLeopold and Whitehead, has a management team with extensive pharmaceutical company experience, encompassing deep oncology-focused drug discovery and development expertise. The company has a capital efficient and expedient clinical development plan to assess proof-of-concept with the potential for accelerated FDA approval. Mekanistic Therapeutics has received STTR/ SBIR funding from the NIH and is seeking seed investment to fund manufacturing, toxicology studies, and filing of an investigational new drug application to the FDA. MEKANISTIC.COM

innovative approach to risk management with increased compliance tracking and accountability. The company has an active campaign to identify problems and validate potential solutions through extensive, industry-wide surveys and interviews. Join Menlo Park Software today and help lay the foundation for a future of medical device manufacturing with fewer device recalls and compliance violations. Menlo Park Software was founded in 2010 as a vehicle for innovation by CEO Richard Bollinger. He designed and built the startup, prototyped potential solutions and wrote business plans while working as a management consultant in the areas of risk management and process improvement. In 2012, Menlo Park Software won $1,000.00 from the GLEQ (now known as MiQuest) for the New Business Idea, Third Place Award, in the Phase I GLEQ Business Plan Competition. MENLOPARKSOFTWARE.COM BIOMATTERS | FALL 2018

AFTER THE ELEVATOR PITCH

PreDxion Bio is a precision medicine company founded in Ann Arbor, Michigan. PreDxion Bio is focused on fundamentally changing critical care medicine by leveraging unique real-time insights into inflammatory biology, provided by our MicroKine™ assay platform, to develop best-in-class predictive algorithms and enable individualized precision medicine therapy for criticallyill patients. Each year in the United States, there are over 25 million ICU and ED admissions due to an out-of-control systemic inflammatory response caused by infections, trauma/ burns, surgery, or even cancers. These admissions account for approximately half of all in-patient hospitalization costs – or over $300B – and result in over 500,000 deaths annually. PreDxion Bio has developed MicroKine, a real-time inflammatory biomarker detection platform, to monitor a patient’s inflammatory response in less than 20 minutes.

Safety in Motion (SiM) is a new medical device company founded in 2018 by a team of retired automotive executives who employ automotive technologies to study athletic performance, vestibular anomalies, concussions, balances and traumatic brain injury. The company’s leading head injury researcher, Priya Prasad, PhD, is the developer of the Prasad/Mertz Head Injury Criteria risk curves used in the automotive market worldwide. SiM’s mission is to develop a standardized scientific tool for use by athletic teams and health care professionals to diagnose concussion, including a model useable in K-12 school and club sports, to keep athletes of all ages safe and to ensure the long-term sustainability of sports. To that end, SiM has developed a balance monitoring device capable of registering over 10,000 data points per second paired with a proprietary algorithm measuring over 30 separate parameters. AP, lateral and vector plane information is displayed in velocity, statically and over

Our patent-pending technology, leveraging technology developed at the University of Michigan, is 1000-times more sensitive, precise and accurate than current ‘gold-standard’ technologies and delivers results in mere minutes. PreDxion Bio has received FDA Breakthrough Device designation and is nearing clinical trials to evaluate the MicroKine platform for use in guiding precision therapies in critically-ill patients at multiple clinical trial sites across the country. PreDxion Bio was founded by Walker McHugh, who serves as CEO, and Timothy Cornell, who is currently Chief of Pediatric Critical Care at the Lucile Packard Children’s Hospital at Stanford University. PreDxion Bio is backed by Y Combinator, Invest Detroit, and individual investors. PreDxion Bio has also received funding from the National Institutes of Health, MTRAC, and the Michigan Economic Development Corporation. PREDXIONBIO.COM

time providing a granularity of data that far exceeds the capability of any currently available medical equipment and can be used to precisely measure balance deficiencies or improvements making it useful for diagnosis and assessment of progress. Core balance declines can be linked to concussion, subconcussive cumulative head trauma and other neuro/ vestibular anomalies, while improvements in core balance parameters reflect core strength improvements, athletic conditioning and performance readiness. The device allows for balance parameters to be compared to age specific normative data to give predictive indexes and an assessment guideline for elderly fall risk. For more information on the Prasad/Mertz Head Injury Criteria visit: http://www.smf.org/docs/articles/hic/Priya_ Prasad_1999_IRCOBI.pdf SIM-TECHNOLOGIES.COM

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One such challenged drug is fenretinide, which has been shown in extensive clinical trials to be a safe and effective anticancer therapy with targeted cancer destroying activity. Fenretinide was developed in the 1980’s, clinically tested in more than 3,000 women and demonstrated to be safe after long periods of use. Subsequently, it evolved into a cancer therapeutic shown to be safe and effective in treating several other cancers. Despite the success of fenretinide in treating cancer, the drug was abandoned due to its poor solubility and low bioavailability—i.e. it was not approved for use because it fails to deliver clinically effective doses of medication to tumor cells because of its low solubility.

The Skeletal Tissue Engineering Laboratory, or STEL Technologies LLC, is an Ann Arbor based Regenerative Medicine company that engineers biological tissue implants for tissue replacement and repairs to musculoskeletal injuries. ACL and Rotator Cuff injuries are some of the most common orthopedic injuries, responsible for more than 800,000 reconstructive surgeries per year in the US. Unfortunately, current tools for soft tissue repair use materials that do not promote regeneration and are associated with up to 90% re-injury rates and high incidence of post-traumatic osteoarthritis. The mission of STEL Technologies, LLC is to develop fully biologic grafts that recapitulate native soft tissues and restore natural mobility and function. Surgeons and thought leaders in the orthopedic community, including the Associate Director for Research from Zimmer Biomet are tremendously excited about the potential for this

AFTER THE ELEVATOR PITCH

SciTech Development, LLC (“SCITECH”) is a clinical stage, biopharmaceutical company that has developed unique nano-delivery systems (SciTech Delivery Vehicle - SDV) to enable intravenous (IV) delivery of water-insoluble drugs.

When combined with the SciTech Delivery Vehicle in the ST-001 formulation, fenretinide can be safely delivered to cancer cells in a higher concentration, prospectively achieving therapeutically effective doses without the toxic side effects observed with other delivery systems. SCITECH’s immediate goal is to reconfirm fenretinide’s safety and efficacy in its new formulation during an upcoming accelerated clinical trial, opening the potential for use in numerous cancers. In concert with the above, SCITECH has also developed a topical version of nano-fenretinide for the treatment of various pre-cancerous and cancer conditions of the skin and SDV is being evaluated for the delivery of other challenged drugs similar to fenretinide.

SCITECHDEVELOPMENT.COM

technology. “Such a graft could advance the state of care for patients, particularly young patients, with soft tissue injury.” STEL’s first two products, the multi-phasic bone and ligament CGEM™ (Cell Generated Extracellular Matrix) graft and the ETG-RC (Engineered Tendon Graft for Rotator Cuff Repair) are both produced using adult bonemarrow derived stem cells and recapitulate the native soft tissues to restore natural mobility and function. STEL Technologies, a University of Michigan spinout, was founded by Dr. Lisa Larkin, CEO, Dr. Ellen Arruda, CSO, and Dr. Edward Wojtys, CMO, as a spinout from the University of Michigan. The team has raised more than $3M in non-dilutive funding and anticipates a INDenabling first-in-human trial by 2020.

SITES.GOOGLE.COM/A/UMICH.EDU/LARKIN-LAB/

BIOMATTERS | FALL 2018

AFTER THE ELEVATOR PITCH

Telocyte is a global biotechnology company using telomerase gene therapy to treat Alzheimer’s by resetting gene expression and enabling normal cell function. Their mission is not to help patients “live with Alzheimer’s”, but to ensure we can all live without it. Telocyte’s gene therapy program represents a radically different approach from existing interventions. The Telocyte method allows fundamental, effective intervention in age-related diseases that result from celluar detrioisation. such as dementias, vascular disease, osteoarthritis, and osteoporosis. Based on a robust clinical understanding of age-related disease and consistent animal data, Telocyte expects to prevent and largely reverse cognitive decline in patients with moderate Alzheimer’s. Their FDA phase 1 human trials will require six months to signal a strong positive clinical intervention.

TheraB Medical is a medical device company commercializing its first product, SnugLit—a wearable, portable solution to infant jaundice that promotes maternal-infant bonding and breastfeeding while covering nearly twice the surface area of traditional methods. SnugLit is being developed in partnership with over 200 medical professionals across Michigan. Neonatal jaundice affects over 60% of all babies in some form. Hospital maternity wards currently use outdated light therapy systems that require constant monitoring by nursing staff, the use of multiple therapy units at one time, and cause prolonged separation of mother and child, resulting in stress and difficulties breastfeeding. The mission of TheraB is to change the approach of phototherapy to a method that fosters maternal-infant bonding, breastfeeding and family togetherness rather than focusing only on treating the condition. While this alone dramatically impacts the early developmental outcomes, it can also reduce hospital stays and nursing staff time spent on these patients.

Telocyte has an experienced Science Advisory Board team, all with practical experience in neurology, human gene therapy trials, Alzheimer’s FDA trials, and biotechnology. Detailed information is available in Cells, Aging, and Human Disease (our Oxford University Press textbook), or The Telomerase Revolution, which the Wall Street Journal named one of the year’s best science books. The former provides a magisterial academic treatment and the latter offers the public a clear explanation of how aging and agerelated diseases work, and why we strongly believe that we can clinically intervene in a novel and far more effective manner for a future beyond Alzheimer’s.

TELOCYTE.COM

TheraB has signed a letter of intent with the largest phototherapy rental company in the country for an order of 70 units to be delivered upon FDA approval. They have also worked with over 12 hospitals in the customer discovery, product design, and development processes- all of which will likely be first adopters of SnugLit. TheraB was originally founded in 2014 by Alexa Jones (Founder and CEO) and two other students as an undergraduate project in the College of Engineering at Michigan State University. After performing initial customer discovery interviews with Labor and Delivery nurses in Michigan, a gap in the market was found and the first version of SnugLit was created. Since then, the company has successfully raised a $350k pre-seed round of funding as well as over $80k in grant and award funds. In 2017, the company was recognized as one of the top 10 women-led startups by the Small Business Administration’s InnovateHER competition in Washington D.C. TheraB is currently raising a seed round that will bring SnugLit to market in approximately 9 months. THERABMEDICAL.COM

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BioMatters Spring 2018

Articles inside

Cayman Chemical: Helping Make Research Possible in Michigan and Beyond

in2being - A Trusted Guide for New Product Development

Keys to Increasing Your Speed to Market

Recruiting the Future

Michigan has a Rich Legacy as the Birthplace of Innovation

EMMA International Talks Lessons Learned

Zivo Bioscience and Algae

MichBio Through the Years