BioMatters Fall 2019: The Evolving Bio-Industry

IN THIS ISSUE:

10 LEADING THE BIOLOGICS REVOLUTION IN AGCHEMS VESTARON

16 PFAS HYPE OR REALITY? PARAGON LABORATORIES

24 ONE MICHIGAN COMPANY BRINGS CORN TO FIGHT AGAINST PLASTIC WASTE KTM INDUSTRIES

28 MICHIGAN’S QUIETLY BOOMING INDUSTRY MEDC

FALL 2019

A magazine showcasing Michigan’s biosciences industry

THE EVOLVING BIO-INDUSTRY: PUSHING THE LIMITS OF HEALTH, WELL-BEING, AND THE ENVIRONMENT

MONEY DOESN’T INSPIRE GREAT IDEAS. GREAT IDEAS INSPIRE MONEY.

ENTREPRENEURSHIP & INNOVATION MEDC is here to help bring great ideas to life, right here in Michigan. We’ll help you gain access to investors, expose you to SmartZones, Michigan’s network of regional tech incubators and connect you to local university resources.

Whether you’re a one-person startup or already established, MEDC offers programs and access to capital that can help your business grow.

Learn more at michigan.org/pure-partnership

PRESIDENT’S MESSAGE Bioscience technologies are part of our daily lives. And they’re more than just new therapies for combating human illnesses.

Applications of bioscience technologies transcend life on earth as we know it.

The result is a diverse set of innovative products and processes that are helping reduce our environmental footprint while enhancing sustainability, address hunger and food safety, advance efficiencies in industrial manufacturing responsibly, and diagnose and treat disease in humans, animals and plants.

We have only tapped a small fragment of the potential of existing and future bioscience technologies. As the stories in this issue of BioMatters™ describe, every day researchers are exploring new ways to improve and ensure our quality of life using bioscience applications.

From the development of eco-friendly pesticides based on spider venom

by Vestaron that hold promise to create an entirely new field in the global insecticide market, to Kalsec, the leading global producer of natural spice and herb flavor extracts, colors, antioxidants, and advanced hop products for the food and beverage industry, and to KTM Industries, with its compostable, biodegradable packaging — these Michigan companies are producing sustainable products that are environmentally responsive.

“By continuing to invest in bioscience companies and in training a skilled workforce with aptitudes for STEM disciplines, we can help ensure the bioindustry is fully equipped to push forward...”

On the diagnostic front, we have Paragon Laboratories testing for water contaminants like PFAS, GeneMarkers using genomics for improving health care, pharmaceutical research and consumer products, and Trident Labs, a toxicology company providing drug screening and other analytical tests for healthcare providers.

And then there’s Arbor Assays, that is researching and developing high quality assay kits to quantitate biomolecules in a variety of biological systems, and Advaita Bioinformatics, whose software tools help analyze gene expression data to find biomarkers and pinpoint possible mechanisms of disease progression and mitigation.

As the Viewpoint by Fred Molnar, Vice President at the Michigan Economic Development Corporation describes, the state’s bio-industry is a key growth engine. By continuing to invest in bioscience companies and in training a skilled workforce with aptitudes for STEM disciplines, we can help ensure the bioindustry is fully equipped to push forward on its path of discovering helpful new applications that address looming challenges while improving global well-being.

This BioMatters™ issue gives further credence to the vibrancy of Michigan’s biosciences cluster and the innovation that evolves for the world’s benefit.

Michigan’s bio-industry is truly pushing the limits of health, well-being and environment.

Sincerely,

STEPHEN RAPUNDALO, PHD President and CEO, MichBio BIOMATTERS | FALL 2019

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MICHBIO | michbio.org

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, connections, and supportive resources.

PREMIUM MEMBERS GOLD full color

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Stephen Rapundalo, PhD President and CEO Alisha Brown Editor Director, Marketing and Communications Elizabeth Morgan Foster Director, Membership and Operations Nancy Marcotte Manager, Finance

MichBio 3520 Green Court, Suite 175 Ann Arbor, MI 48105-1175 734-527-9150 info@michbio.org michbio.org Designer: Daina Fuson Designs Printer: Progressive Printing © Copyright Michigan Biosciences Industry Association, DBA MichBio

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MICHBIO BOARD OFFICERS

SILVER

CHAIRMAN Paul Morris, MBA AlixPartners, LLP Head, Strategic Finance, Digital and Enterprise Improvement VICE CHAIRMAN Ken Massey, PhD Wayne State University Senior Director, Venture Development, Technology Commercialization

PRESIDENT AND CEO Stephen Rapundalo, PhD MichBio President and CEO SECRETARY Robert Donofrio, PhD Neogen Corporation Vice President, Food Safety R&D TREASURER Sandra Pennell, CPA Vericel Controller

MICHBIO BOARD DIRECTORS

BRONZE

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

Dave Morin Impellia President and COO

Robert DeRyke, MBA Terumo Cardiovascular Group President and CEO

Paul Morris, MBA AlixPartners, LLP Head, Strategic Finance, Digital and Enterprise Improvement

Charles Hasemann, PhD Michigan State University Assistant Vice President for Innovation and Economic Development Jamie Kemler, MBA, CLP, RTTP Stryker Corporation Vice President, Intellectual Property Business Strategy Anna Langerveld, PhD Genemarkers, LLC President and Chief Scientific Officer Ken Massey, PhD Wayne State University Senior Director, Venture Development, Technology Commercialization Kevin McLeod NOVUS Biotechnology Fund General Partner

PATRON

Fredrick Molnar, MBA Michigan Economic Development Corporation Vice President, Entrepreneurship and Business Development

Edward Pagani, PhD University of Michigan Associate Director, Health Technologies, Office of Tech Transfer Ron Perry, MBA Pfizer Site Leader, Kalamazoo Pharmaceutical Manufacturing Operations Stephen Rapundalo, PhD MichBio President and CEO Randel Richner, BSN, MPH Richner Consultants Founder and President John J.H. Schwarz, MD Family Health Center Physician and Former U.S. Representative Tom Ross Grand River Aseptic Manufacturing President and CEO

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 2019

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Did you know that the University of Michigan has been responsible for more FDA-approved New Molecular Entities than any other academic institution?

Let’s connect.

734.763.0614 techtransfer@umich.edu *Based on analysis published in 2015 by Drug Discovery Today.

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TABLE OF CONTENTS

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06 |

How Small Observations are Driving a Big Data Revolution in Life Science

08 |

In a Small West Michigan City, There’s a Company with the Smallest of Plans

10 |

Leading the Biologics Revolution in AgChems

Advaita Bioinformatics

Genemarkers

Vestaron

Spice to Food, and Beer, 12 | Adding for Three Generations Kalsec

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24 WANT TO RECEIVE BIOMATTERS?

Visit michbio.org/subscribe

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Global Wildlife Conversation Efforts Have a Valuable Partner in Arbor Assays

16 |

PFAS: Hype or Reality?

18 |

Michigan Biosciences: By the Numbers

20 |

After the Elevator Pitch

24 |

One Michigan Company Brings Corn to Fight Against Plastic Waste

26 |

Using Urine Samples to Make Drug Treatment More Effective

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Michigan’s Quietly Booming Industry

29 |

New MichBio Member

Arbor Assays

Paragon Laboratories

MichBio

Emerging Companies

KTM Industries

Trident Labs

MEDC

APiS North America

30 | Consultants to Meet

ClynProject Consulting, QAaaS-Mi, Slant Communications & Turtle Works

BIOMATTERS | FALL 2019

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How Small Observations are Driving a Big Data Revolution in Life Science

BY ALISHA BROWN, DIRECTOR OF MARKETING AND COMMUNICATIONS, MICHBIO SOURCE MATERIALS AND EDITING PROVIDED BY ADVAITA BIOINFORMATICS

Advancements in experimental tools and laboratory equipment have shifted the challenge in biology from figuring out how to perform an experiment to how to understand the results.

Even 25 years ago, the study of biology looked a lot different than it does now. In the late 90’s and it was not uncommon for a life scientist to spend years studying a single gene across a few conditions. Today, technologies such as microarrays and RNASeq allow the scientists to measure the expression of all genes in the human genome – over 30,000 – in a single experiment.

Simultaneous to that change, the industry infrastructure has evolved with highly sophisticated labs appearing at major institutions and companies around the world, staffed by trained biologists and research assistants, all capable of completing high-throughput studies and amassing enormous amounts of data. So much data, in fact, that it is impossible to understand the results without the aid of computers. The problem, most biologists are not also expert computer programmers, so, undoubtedly, major discoveries sit, buried in data that is too difficult to read.

That is where Sorin Draghici, PhD and his team at Advaita Bioinformatics come in. “I spent eight years as the Director of the Bioinformatics Core at Karmanos Cancer Institute,” says Dr. Draghici. “In that role we were supposed to help researchers analyze data they acquired from their studies,

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but that was a challenge. You see, a highly qualified life scientists usually lacked the programming ability to analyze their data in a significant way.”

He went on, “Even if they were the most qualified person in the world to understand the experiment, they would have to turn that data over to a computer scientist who didn’t have a background in the domain of the experiment and didn’t know what to look for.

The person who had the knowledge didn’t have the tools and the person who had the tools, didn’t have the knowledge.”

He continued, “So the data ended up going through a Procrustean bed consisting of a set of standard steps that rarely fitted the experiment being analyzed. What we really needed was an interactive, easy-to-use tool that allowed the scientist to ask questions of the data without having to know how to code.”

At the same time, Dr. Draghici was teaching computer science at Wayne State University and took up this unique challenge in his research projects. Draghici developed new methods for data analysis that were then made available to the entire research community from his laboratory website.

For the next ten years, the software was used, maintained,

ADVAITA BIOINFORMATICS ZOETIS

and changed by the computer science and lab communities, until it became so complex that it was unsustainable as a university project. Thus, Advaita Bioinformatics was born.

With a leadership team including PhD-level geneticists, biomathematicians, and software engineers, Advaita took the basic ideas from the Wayne State projects and developed their iPathwayGuide, iVariantGuide, and iBioGuide software platforms that give researchers the ability to quickly identify significantly impacted pathways, understand mechanisms of disease and drug actions, identify important genetic variants, etc.

“After demonstrating the power of systems like these,” continued Draghici, “we got subscription orders from many top universities including the University of Michigan, Stanford University, University of Washington, Columbia University, and others. We also signed distribution agreements in New Zealand, Australia, South Africa, with Japan, Korea, and Taiwan soon to be finalized. That type of adoption means that more experiments will be truly understood, more relationships will be uncovered, and more major discoveries will be made.”

After demonstrating its capabilities in the research and academic markets, Advaita is now prepared to deploy their software and technology to shorten the drug discovery pipeline by eliminating candidates that are destined to fail and identifying drugs suitable for repurposing, shorten the duration of clinical trials by identifying patients who are more likely to respond, and enable a true personalized medicine approach by identifying the best drug for a given patient.

With advancements like these that merge the expertise of scientists with the power of computerized data management, the biosciences industry is in the midst of a big revolution to understand even the smallest of measurements.

ADVAITABIO.COM

BIOMATTERS | FALL 2019

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Founded in 2008 by a neuroscientist specializing in genomics with headquarters in downtown Kalamazoo.

In a Small West Michigan City, There’s a Company with the Smallest of Plans

BY J. MICHAEL GETZ, CEO, GENEMARKERS

Home to large international corporations like Pfizer and Zoetis, as well as a new medical school, Kalamazoo is known for advancing science – and that’s just what they are doing at Kalamazoo-based Genemarkers, a CLIA-certified lab focusing on clinical trial support, discovery, and translational research.

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GENEMARKERS

“We now have the ability to identify minute genetic markers that contribute to medication efficacy,” explains neuroscientist Anna Langerveld, PhD, founder of Genemarkers.

Pharmacogenomic (PGX) testing is the key to making the dream of personalized medicine a reality. A PGX test analyzes mutations in genes associated with drug metabolism, transport, and targeting. Health care professionals can use the results to make informed decisions about the most effective (and safe) medication and dosage for an individual patient based on their unique physiology.

“The testing allows us to predict how an individual will interact with a specific drug based on the presence or absence of markers in DNA,” Dr. Langerveld continues.

PGX testing can improve medication efficacy and compliance while reducing adverse drug effects and trial and error in prescribing. Not surprisingly, health care systems and payers are interested in PGX testing as a means of improving population health outcomes and controlling costs.

As a result, Genemarkers is experiencing its greatest amount of growth in over a decade. In 2019, the company hired J. Michael Getz as Chief Executive Officer. Formerly with Detroit Oxygen and Medical Equipment Company, Getz has over 30 years of experience in health care supply management and joint ventures. Dr. Langerveld continues as President and Chief Science Officer overseeing the development of PGX testing for psychiatry, cardiac care, and pain management—specifically the use of opioids.

Michigan had the eighth largest number of overdose deaths in 2018 and the 14th highest overdose death rate in the country.

Research suggests that 50 percent or more of addiction may be related to genetics.

“That made us wonder if our predictive approach to medication management could do the same thing for opioids and identify the genetic markers linked to addiction,” says Langerveld. “Not everyone who takes an opioid becomes addicted to it; many patients use opioids effectively for pain and have no trouble when it’s time to stop, while others struggle to find effective pain relief and others still become addicted to this powerful class of drugs… that’s a clear sign of a genetic component linked to an addiction response.”

In 2017, Genemarkers, Integrated Services of Kalamazoo (then known as Kalamazoo Community Mental Health & Substance Abuse Services), and Ferris State University conducted a pilot study to explore the genetic susceptibility of addiction. Resulting data supported the ongoing development of 2 distinct Genemarkers’ genetic addiction tests.

If adopted, these screening tools could proactively prevent addiction by informing patients and caregivers of a patient’s risk of developing an opioid addiction before opioids are prescribed. This would give providers an opportunity to counsel patients on opioid use and prescribe opioid alternatives when necessary.

The study has the potential to encourage acceptance of addiction as a genetic disease, which could be one of the most powerful forces in the fight against addiction. The result: more people seeking treatment and succeeding in recovery by reducing the stigma surrounding addiction.

Along with further PGX testing for co-occurring disorders, Genemarkers is proving that the smallest details can make the biggest difference.

GENEMARKERSLLC.COM

BIOMATTERS | FALL 2019

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V ESTAR ON’ S T H IR D C H A P T E R

Leading the Biologics Revolution in AgChems

BY ANNA RATH, PRESIDENT AND CEO, VESTARON

THE COMING REVOLUTION IN AGCHEMS Today’s AgChem industry is poised to undergo a similar revolution to the one that the pharmaceutical industry has undergone over the past few decades – namely a transition from small molecule synthetics to biologics. The advantage of small molecule synthetics is that they work as intended – they bind to their desired targets in known and reliable ways and, by extension, have a high-level of efficacy in achieving their purpose. The disadvantage is that they can sometimes also bind to other targets, creating unintended and occasionally harmful side effects. In the pharmaceutical industry, this can lead to negative health consequences. In agriculture, this can lead to environmental damage, and harm to beneficial insects, humans or other animals.

These potential shortcomings led the pharmaceutical industry to broaden its focus to include larger, biologic molecules, namely proteins. These molecules offer the same level of dependable efficacy – binding to a particular target and affecting that target in a known and reliable manner – but with greater specificity and therefore fewer side-effects. Biologics now account for 7 of the top 9 pharmaceutical molecules by revenue, the growth rate of biopharma is double that of conventional, and the clinical success rate of biologics is more than twice that of small molecules.

Despite there being small proteins – peptides – that have long been known to be effective against insects and other agricultural pests, the AgChem industry has not yet made this transition.

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THREE CRITICAL THINGS HAVE HINDERED THAT PROCESS – 1. How to get these molecules through an insect or other pest to their target receptor, 2. How to produce them at a scale and cost that would enable their use in agriculture, and 3. What the regulatory path would be for such molecules.

With the launch of its first family of products based on the Spear® peptide, Vestaron has now successfully addressed all three.

CHAPTER ONE — DEVELOPING THE PLATFORM The first chapter of Vestaron’s life focused on building an R&D platform. Where many had tried and failed to turn these peptides into commercial agricultural pesticides, the Vestaron R&D team optimized the Spear® peptide for efficacy, stability and manufacturability. The team developed formulations that enabled the bioavailability of these peptides for insects, both topically and orally, and created a manufacturing process capable of scale and yield levels sufficient to enable profitability with prices competitive with leading synthetics.

Vestaron then worked with the EPA to define a regulatory path for the first Spear® peptide, based on a path that had previously only been used for whole microbe solutions.

VESTARON

CHAPTER TWO – FOCUSED ON COMMERCIALIZATION With the realization that all of that had worked and the company was close to commercializing a family of products based on the Spear® peptide, Vestaron’s board of directors decided to transform the company from one focused on building an R&D platform to one capable of also manufacturing and commercializing its own products. The transformation began with the hiring of a new, commercially oriented CEO who started a year-long journey to onboard new investors who could support the build-out of operational and commercial capabilities, rampup manufacturing, develop relationships with distribution partners, and refocus the company from R&D proof of concept to product manufacturing.

CHAPTER THREE – LEADING THE REVOLUTION A small number of proven nerve and muscular receptor targets are responsible for the vast majority of the global insecticide market and almost all of them have issues with increasing chemical resistance. Vestaron’s Spear® peptide and robust pipeline of additional peptides are specifically designed to target this handful of proven insecticidal receptors, but because these larger peptides tend to have larger binding sites and often bind at different locations on the receptor than small molecule synthetics, there is no cross-resistance between Vestaron’s peptides and existing classes of chemistry. This means that Vestaron’s peptides

have the ability to reset the resistance clock for these key receptors and provide solutions for growers that are every bit as efficacious as traditional small molecules while having the safety and environmental profile of biologics.

With its first Spear®-based products now on the market in the US, Vestaron is poised for a second major transformation – from a small domestic company, to a global leader in the coming revolution that will see AgChem follow in the footsteps of the pharmaceutical industry and embrace larger, biologic molecules and their potential to deliver innovation and reliable, efficacious solutions in a safe and environmentally-friendly manner.

VESTARON.COM

Photos provided by Christopher Deau Photography at christopherdeauphotography.com

BIOMATTERS | FALL 2019

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Adding Spice to Food, and Beer, for Three Generations

BY KATIE WHALEN, PRINCIPAL SCIENTIST, KALSEC

From the 3700-block of West Main Street, one can see a pristine, white 3-rail horse fence, hear occasional barks of dogs, and smell a hint of rosemary or white pepper on the wind.

Very few Kalamazoo natives could tell you what was happening at this 150-acre site, until a 1-ton boulder engraved with the company name and address was installed at the entrance in 2018.

The sights are remnants from a former quarter-horse farm; the sounds come from the employees’ doggy daycare, and the smells come from the spices and herbs being extracted by Kalsec, Inc. Kalsec crafts natural spice and herb flavor extracts, colors, antioxidants, and advanced hop products for the food and beverage industry. Kalsec products are translated into easyto-use liquids ideal for most formulations: salsa, dressings, sauces, yogurts, candies, snacks, baked goods, beer, and meat.

These extracts are of the highest quality and consistency available. Kalsec is the only company whose expertise and resources encompass a full line of natural, innovative products and solutions to meet the challenges faced by food and beverage manufacturers throughout the industry and around the world.

The company was founded in 1958 by Paul H. Todd Jr. as the Kalamazoo Spice Extraction Company. Todd was a respected businessman and former Congressman.

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He represented the Third Congressional District, which included Kalamazoo County, in the U.S. House of Representatives in the early 1960s.

Todd family roots in the area go back even further to the late 1800s, when Albert May Todd started the peppermint and spearmint oil business in Southwest Michigan. Today, third generation Todd family members lead Kalsec in its mission to be private and sustainable for 100 years.

Over the past 60 years, Kalsec has grown into a global company - selling its products in more than 70 countries directly and through channel partners. In 1995, Kalsec opened an office in the United Kingdom, where it provides local support to the European market with sales, sampling, applications and warehousing capabilities. Located in Mildenhall, United Kingdom, this facility continues to grow to meet the needs of the European market. Then in February 2010, Kalsec opened an office in Shanghai, China to serve its customers in the Asian market similarly.

Kalsec Southwest, located near Denver City, Texas, specializes in the cultivation, harvest, dehydration and extraction of paprika, rosemary and carrot, as well as specialty herbs and spices. At this location extracts are expeller pressed into a line of solvent-free products that are ideal for the growing “clean label” initiative.

KALSEC

While Paul Todd Jr. found a way to create value by applying chemistry to food, the foundations of Kalsec are still deeply rooted in biology. With an entirely natural product line, Kalsec’s scientists rely on the inherently diverse repertoire of biochemical reactions carried out by plants to fill its production pipeline with brilliant colors, hoppy bitterness, and recordbreaking spiciness.

For several decades, Kalsec has been engaged in a breeding program of its chili pepper populations. Year after year, natural selection has been used to select plants that produce high color in the form of carotenoids, or high pungency from capsaicin. This effort has produced the most pungent, machine-harvestable pepper in the world.

In addition to chili extracts, Kalsec is a leading brewing industry supplier of advanced hop products that provide bitterness addition, light stability and foam enhancement.

In 2015, Kalsec established the Kalsec Center for Sustainable Brewing Education, a unique collaborative effort between itself, Kalamazoo Valley Community College, and Western Michigan University.

Beginning Fall 2018, Kalsec acquired laboratory space at the Western Michigan University School of Medicine’s Innovation Center where scientists are conducting research to produce our first natural preservative offerings for the prevention of food spoilage. Scientists carry out challenge studies in model food, such as growth of the human pathogen Salmonella in poultry and observe how the addition of natural extracts and essential oils prevent that growth. This product line will not only prevent human illness but help to reduce the 160 billion pounds of food thrown away in the United States.

KALSEC.COM

BIOMATTERS | FALL 2019

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GLOBAL WILDLIFE CONSERVATION EFFORTS HAVE A VALUABLE PARTNER IN ARBOR ASSAYS

BY SARA ZAPOLNIK, MARKETING ASSOCIATE, ARBOR ASSAYS

Wildlife studies and conservation efforts have been increasing in importance as the imperatives of species and environmental management have been recognized worldwide.

Those efforts require partnerships with the research community, adaptable research tools, and support from organizations that are focused on preserving the natural world for future generations — organizations like Arbor Assays.

Throughout its 10-year collaboration with the International Society of Wildlife Endocrinology (ISWE), Arbor Assays has provided wildlife researchers with the best tools available for hormone and biomarker measurement for conservation research. In addition to traditional animal rescue, species observation, and emergency response efforts, this type of research has become a welcome addition to the mission of zoos, aquariums and conservation institutes. It explores important topics, such as animal care and welfare, species and habitat conservation, and contributes to the understanding of basic animal biology for a myriad of species. As ecosystems face growing pressure from climate change and habitat loss, the need for this type of research is present and ongoing.

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In 2014, Arbor Assays became the official supplier to ISWE of assay kits and reagents for conservation research and that partnership has given the company information vital to the creation of customized assays for the specialized and ever-evolving needs of wildlife researchers. In 2017, this collaboration was deepened and Arbor Assays began actively developing kits to enable these studies to be carried out long term.

With some species of animals and fish living for 200 years, the need for continuous studies and, by extension, a constant, reproducible supply of critical reagents is essential. Arbor Assays, as an employee-owned company, is a valuable partner in these long-term conservation efforts. Structured as a UK Employee Benefit Trust (EBT) Arbor Assays gives employees the ability to participate in the company’s advances and share in the profits, as well as ensuring that the company is focused on a mission that aligns with the passions and goals of the employees.

Traditionally, EBT-held businesses have maintained a unique status of long-term stability, growth, and employee and customer retention, and, for the ISWE, it provides confidence in the longitudinal stability of reagent supply for studies of endangered species.

ARBOR ASSAYS

Wildlife conservation efforts hinge on animal health and well-being, as well as species reproductive success. Assay kits are often used to non-invasively evaluate animal hormone levels and monitor metabolism, reproductive health and stress levels. Accurate measurement of stress biomarkers is a fundamental requirement for studying both behavioral and molecular responses to stress. Arbor Assays provides an extensive range of kits in use around the globe to aid in this type of research while keeping in line with the ISME goal of “helping to advance the use of non-invasive and minimally invasive sampling technologies and assist in standardizing endocrine methods for national and international wildlife studies.”

Committed to that goal, Arbor Assays offers a plate coating and assay training course designed to teach ISWE attendees to coat, block, store and use secondary coated plates for use in steroid assays – like those used in wildlife studies.

This Ann Arbor-based life science company is committed to the study, management, and conservation of wildlife around the globe.

ARBORASSAYS.COM

BIOMATTERS | FALL 2019

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PFAS HYPE OR REALITY?

BY JOHN PARMENTIER, OWNER AND PRESIDENT, PARAGON LABORATORIES

Such widespread use begs the question, are these chemicals as harmful as the level of visibility suggests or is the reaction overblown?

PFAS are an emerging contaminant with high visibility in Michigan and throughout the world. These Perfluoroalkyl and Polyfluoroalkyl man-made chemicals do not break down in the environment and are found in a number of sources, including food, food packaging materials, commercial household products (stain and waterrepellent fabrics, non-stick and cleaning products, paints and polishes), firefighting foams, workplace settings, drinking water, wastewater and groundwater. Such widespread use begs the question, are these chemicals as harmful as the level of visibility suggests or is the reaction overblown?

Paragon Laboratories, Inc. is a privatelyheld provider of chemical, physical, and biological testing laboratory services – their most recent offering is sampling

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and analysis of PFAS. The company is committed to bringing the highest quality PFAS consulting, sampling, and testing services to the environmental market.

PFAS chemicals have been manufactured and used since the 1940s in the United States. Like many chemicals, PFAS were widely adopted due to their unique chemical properties – resistant to heat, water and oil – before the risks they posed were understood. Only recently have their potential health effects been studied, and due to the sheer number of compounds, estimated in the thousands, that research is limited. However, there is evidence that exposure to PFAS can lead to adverse health conditions in humans, including increased cholesterol, low infant birth weights, immune system effects, and certain types of cancer and thyroid disease.

PARAGON LABORATORIES

Further, due to their persistence, the chemicals bio-accumulate in the body over time increasing the likelihood of health-related issues.

But what level is safe?

While no one really knows for certain, many states, led

by Michigan, are now starting to set acceptable limits for PFAS in drinking water. The EPA has set a lifetime health advisory (LTHA) level for two PFAS, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), in drinking water. An LTHA is the level, or amount, below which no harm is expected from the chemical listed in the advisory.

The combined LTHA level for PFOA and PFOS is 70 parts per trillion (ppt). There are other PFAS compounds that do not yet have LTHA levels. Some states have been even more conservative than the EPA, including Michigan which has some advisory limits below 10ppt on certain PFAS chemicals.

For those levels to be attained and the health risks to be fully researched, a trusted laboratory testing partner is essential.

At Paragon Laboratories, Inc., their commitment and focus is on providing customers, and Michigan communities, with best-in-class service for their PFAS initiatives. Currently, Paragon Laboratories is able to achieve detection of many PFAS compounds below 5ppt, with a standard reporting limit for PFOA and PFOS of 2ppt. As the regulations for PFAS continue to evolve, Paragon is committed to being there to help meet the needs for both sampling and analysis by staying current with best practices and technology, including the newly promulgated first EPA methods for PFAS analysis. For more information please visit: https:// www.paragonlaboratories.com/pfas.

The majority of the testing services Paragon performs fall into one of these categories: •

Risk Management

•

Satisfaction of an External Requirement or a Regulation

•

Satisfaction of Data Verification

•

Satisfaction of Internal Process Control

•

Satisfaction of Data Verification

•

Protection of Human Health

•

Protection of the Environment

While the reality of the PFAS threat to human health is yet to be fully understood, Paragon is on the leading edge of PFAS testing and fully committed to answering the question: PFAS chemicals: hype or reality?

While the most recent testing services added at Paragon relate to PFAS chemicals, the company is capable of performing over 225 unique analytical testing procedures.

Their testing services support three primary categories: Fuels & Lubricants, Chemicals, and Waters & Environment.

In business since 1996, Paragon is committed to providing high quality results and outstanding service to all customers. Their clients trust that their testing complies with the most current regulations and program requirements. Thus, Paragon Laboratories employs a management system that meets the specifications of the ISO/IEC 17025:2005 standard.

PARAGONLABORATORIES.COM

See the graphic for more information on other categories in which Paragon Laboratories offers testing services.

BIOMATTERS | FALL 2019

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MICHBIO

BY THE NUMBERS MICHIGAN BIO-INDUSTRY QUICK FACTS

1,772

*

40,205*

BIOSCIENCE ESTABLISHMENTS

BiOSCIENCE JOBS

133,695* $83,357

*

AVERAGE BIOSCIENCE SALARY

$28 BILLION

TOTAL EMPLOYMENT IMPACT

ECONOMIC IMPACT

BIOSCIENCE PERFORMANCE METRICS* BIOSCIENCE R&D (FY 2016)

$1.336 billion* VENTURE CAPITAL INVESTMENT (2014-2017)

$608.6 million* PATENTS (2014-2017)

2,487* † Summated from Battelle/AdvaMed The Economic Impact of the U.S. Advanced Medical Technology Industry. PhRMA Biopharmaceuticals Sector Impact on Michigan’s Economy , 2016.

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* TEConomy/BIO Investment Innovation and Job Creation in Growing US Bioscience Industry, 2018

†

MICHBIO: BY THE NUMBERS

DISTRIBUTION OF MICHIGAN BIOSCIENCES INDUSTRY

1.7%

46.4% ESTABLISHMENTS

29%

16.9% 6.2%

Agri-Biosciences Medical Device Pharma

29%

EMPLOYMENT

21%

28.8% R&D/Testing Logistics

19.4% 1.6%

BIOMATTERS | FALL 2019

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AFTER THE

ELEVATOR PITCH EagleView Imaging, Inc. develops augmented reality technologies to make surgery easier and safer.

in the user, and can be well integrated into a surgeon’s workflow at an affordable price.

In the United States, brain tumor surgeries cost over $1 billion annually. One third of all brain tumor patients go on to develop complications, which increases their costs by 3-5 times that of the non-complicated patients while reducing their quality and longevity of life. EagleView Imaging’s 3D augmented reality environment makes the complex process of planning brain surgery more intuitive and precise. With EagleView’s tool, surgeons can directly interact with a 3D representation of the patient’s anatomy and plan a surgery in a 3D environment that reflects the reality they will face in surgery instead of mentally reconstructing the 3D shape from 2D images. As the result, the surgeons will be better prepared and more confident during surgery and patients will have fewer complications.

To date, several pilot sites, including Henry Ford Hospital and Detroit Medical Center, have already begun to use the company’s early product for resident training and patient consultation. EagleView has also already received purchase orders from early adopters.

Compared with competing products, EagleView’s patent pending solution is easier to use, does not cause dizziness

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The company has been supported by angel investment and SBDC business acceleration funds. In addition to continuous sales to early customers, the company plans to finalize the product features, extend the technologies to other platforms, and file FDA approval.

For more information, email info@eagleviewmedical.com

EAGLEVIEWMEDICAL.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.

FUNITE LLC, Fungal secondary metabolites Funite LLC is an Ann Arbor-based company that produces fine biochemicals from fungi with a focus on research compounds and pharmaceutical precursors. The company was founded to explore the remarkable range of biochemicals produced by the mushrooms everywhere from tropical jungles to our front yards.

Current efforts are focused on biochemicals isolated from fruiting bodies of the Basidiomycetes, a type of mushroom that includes most familiar varieties and toadstools, with a specific focus on the bicyclic peptides produced by mushrooms of Amanita section phalloideae. These include the amanitins, potent inhibitors of RNA polymerase II, and phallotoxins such as phalloidin, which are potent inhibitors of actin depolymerization.

Many important pharmaceuticals and biochemicals have been derived from filamentous fungi, but the Basidiomycetes produce a wide variety of poorly explored secondary metabolites with great potential for use in applications as diverse as insecticides, anti-nematodal compounds, antibiotics, and, most recently, anti-cancer agents.

Funite LLC is a small, family company based on simple principles: minimizing costs and maximizing profits, paced development, debt avoidance, modern management principles and practices, and fun. The company believes that fun is an excellent metric for measuring performance and, more importantly, success.

Funite LLC has been profitable since its inception in 2015, with the goal of maintaining profitability while gradually expanding products and production levels.

FUNITE.SCIENCE

BIOMATTERS | FALL 2019

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AFTER THE ELEVATOR PITCH

GreenMark Biomedical Inc. is a Michigan-based, minimally invasive healthcare company that was founded in 2016 by Dr. Steven Bloembergen with a mission to “enable dentists to preserve teeth through early diagnosis and treatment”. Dr. Bloembergen is a co-founder of EcoSynthetix Inc., a global bio-based nanoparticle manufacturer. In partnership with collaborators at the University of Michigan, GreenMark has expanded upon this proprietary technology by applying it to medicine and dentistry.

The first step in fulfilling the company’s mission is the development and commercialization of LumiCare™, an oral rinse that uses GreenMark’s nanoparticles to illuminate early caries. By illuminating the patient’s mouth with a curing lamp after applying LumiCare™, the dental professional can see where the patient’s teeth are demineralized. This procedure facilitates targeted, preventative treatments to save teeth and enhance the dental practice.

Dental caries —the clinical term for tooth decay— is the most prevalent chronic disease worldwide, affecting over 96% of Americans. Bacteria produce acid from sugary foods, which demineralizes the tooth and leads to cavities if left untreated. By helping dentists battle this disease, GreenMark aims to markedly improve the standard for oral health globally.

GreenMark is currently developing a companion product involving targeted delivery of minerals to restore demineralized areas. By enticing patients with non-invasive procedures, GreenMark’s offerings could represent a multibillion dollar growth opportunity for the dental industry.

Figure:Tooth viewed through orange glasses using a standard dental curing light, after a 30 second application of LumiCare™ followed by a 10 second rinse with water; thus, only subsurface carious lesions illuminate quickly identifying active pre-cavities.

We are constantly reading and hearing about the value of taking 10K steps a day, but what does that actually mean for you and your general wellness? WellMetrix was founded to provide individuals with general wellness indicators so that we can assess our lifestyle choices and how those choices may impact our personal well-being.

The WellMetrix Panel® measures key biomarkers to determine metabolic efficiency with an affordable, simple, and discreet test that can be administered by anyone in the comfort of their own home. The data provided by this test helps to direct a personalized health plan to improve and/or maintain optimal health levels.

Casey Fowler, Vice President of Operations and Product Development for WellMetrix says, “Our panel of biomarkers were carefully selected to indicate the presence and

For additional information, email info@greenmark.bio GREENMARK.BIO

severity of oxidative stress and chronic inflammation in the body. These biomarkers are widely accepted as major underlying factors in a range of human pathological conditions including some of the most common health issues such as cardiovascular disease, diabetes, stroke, and cancer.” Awareness of lifestyle choices that likely contribute to disease development may help mitigate pre-conditions favorable to the onset of disease and impairment and provide a pathway towards preventative healthcare. As the product evolves, additional biomarkers will be added to tailor results to specific populations allowing various measures that can be combined for even more improved insight into personal health.

It is entirely possible that 10K steps a day is enough for you.

But then again, maybe not. Wouldn’t it be nice to know?

WELLMETRIX.COM

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MICHBIO | michbio.org

MICHBIO PREFERRED PURCHASING PROGRAM

The MichBio Preferred Purchasing Program leverages the collective purchasing power of our member companies to obtain steep discounts from our vetted and endorsed vendor portfolio. Members have saved upwards of 900 times their annual membership dues.

FOR MORE INFORMATION VISIT MICHBIO.ORG

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

Dykema’s biotechnology and life science team represents clients ranging from startups to public companies to nonprofits, in a variety of industry sectors, including: • • • •

Pharmaceuticals Diagnostics Health care services Biotechnology

• Medical devices and equipment • Computer technology • Life science software

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

California Illinois Michigan Minnesota Texas Washington, D.C.

www.dykema.com

BIOMATTERS | FALL 2019

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One Michigan Company Brings Corn to Fight Against Plastic Waste

BY TIMOTHY COLONNESE, PRESIDENT, KTM INDUSTRIES

Cornstarch is not generally considered biotechnology. But when Holt-based KTM Industries works its magic, cornstarch becomes an exciting technology that is solving one of the world’s biggest problems – plastic pollution.

In its most-recent figures, the EPA states that half of all the plastic in has ever existed was made in the last 13 years, and that only 9% of the annual plastic sold in the United States is recycled. When considered together, that adds up to really bad news for people and the planet.

While much of the focus of plastic pollution is on consumerbased activity, i.e. retail food containers and shopping bags, a growing amount of plastic use – and resultant waste – is tied to packaging used in e-commerce and other one-time uses. For these applications, most companies select plastic packaging to protect products from breakage in the form

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MICHBIO | michbio.org

of polyethylene or polyurethane foam and to protect from thermal damage in the form of polystyrene (Styrofoam) foam. These materials have been used for over 50 years and are generally considered the standard.

That’s the environment where, in 2002, KTM Industries launched Green Cell Foam as a well-performing substitute for the fossil fuel-based foams that dominate the packaging industry. The cornstarch-based product is an environmentally sustainable alternative to traditional plastic packaging and it doesn’t require recycling. Green Cell Foam is a BPI-certified safe, compostable material that is designed to easily melt-down-the-drain.

Despite some initial successes, most notably with Sony, sales of Green Cell Foam were quite meager over the next several years. The cost premium was considerable and very few companies were really interested in making a switch to new and unproven “green” technologies. Additionally, KTM struggled to persuade major packaging companies to incorporate Green Cell Foam in their supply chains. In short, despite having a breakthrough product that could help solve a global problem, KTM was in trouble.

KTM INDUSTRIES

By 2010, with cash running out, the company changed its approach to the market and began to offer Green Cell Foam directly to companies, bypassing the market’s normal distribution supply chain. Additionally, Michigan State University-trained packaging engineers were hired to offer technical support to prospective customers. With this new approach, Sandoz Pharmaceuticals soon came on board, followed by probiotics-manufacturer Garden of Life. KTM doubled-down on this “DIY” strategy and added fabrication and then testing equipment. With these new value-added services, the list of steady customers grew and the company entered financially stability.

Fast forward to 2019, KTM now supports hundreds of companies across North America in the pharmaceutical, specialty pharmacy, nutritional supplement, food, wine and equipment markets from its 85,000 square foot facility just outside of Lansing.

The team of MSU packaging engineers has expanded to 6 and are supported by an ISTA-certified laboratory capable of providing results accepted by the FDA and URAC. With their bio-tech product KTM supports, among others, the biotechnology and pharmaceutical industries.

Companies looking for a sustainable approach to their packaging consult directly with engineers to design, test, validate and manufacture Green Cell Foam-based solutions that perform as well – or better- than their current plastic materials. The current customer base is a veritable who’s

who of corporate America, including Pepsi, Novartis, Sandoz, Novo Nordisk, Jenny Craig, Garden of Life, Isagenix, Perdue Chicken and ultra-fine wine producers Harlan Estate and Fairchild Wines.

There are several reasons that companies - big and small - have switched to Green Cell Foam. The main reason is that it works remarkably well as a protector of products, but the cost has also decreased over 50% in the last 5 years.

The professional, cordial, timely technical support from the packaging engineers is offered at no charge and, made from non-GMO corn grown in the upper Midwest, Green Cell Foam is the most affordable and most sustainable of all packaging foams.

KTM is continuing to invest in growth. Its new 60,000 square foot facility in Reno, Nevada is poised to open in January 2020 and the company has entered into discussions for European and Australian expansion. KTM is looking at new, complementary “green” technologies to add to its product offerings.

While cornstarch is not the first thing people think of when they think of the bio-industry, KTM’s bio-based solution is now well-positioned to help support Michigan’s growing biotechnology industry.

GREENCELLFOAM.COM

BIOMATTERS | FALL 2019

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T R ID EN T L A B S

Using Urine Samples to Make Drug Treatment More Effective

BY ALISHA BROWN, DIRECTOR OF MARKETING AND COMMUNICATIONS, MICHBIO SOURCE MATERIALS PROVIDED BY TRIDENT LABS

According to the Mayo Clinic up to 70% of Americans take at least one prescription medication every day adding up to more than 4 billion prescriptions filled every year.

For maximum treatment efficacy, most medications must be taken at least 80% of the time, yet 50% of prescriptions are not taken as directed. The result? More than 125,000 preventable deaths each year, and up to $300 billion in avoidable healthcare costs.

On average, patients with chronic conditions who do not adhere to their medications spend $4,000 to $8,000 more each year on healthcare costs than patients who do and, studies show, that for every 10% improvement in medication adherence the average patient, regardless of condition, will reduce their annual health care spending by up to 29%. Known as “America’s other drug problem” medication non-adherence is a major concern for practitioners and patients alike; Trident Laboratories is part of the solution.

Located in Holland, Michigan, Trident Labs provides urine and oral fluid testing services that, among other things, helps practitioners monitor medication adherence in their patients.

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“For most people,” says Lonnie Riley, Chief Operating Officer at Trident, “when they think of urine samples they think of another kind of drug testing – which we do – but they don’t often consider that a doctor could be hoping the results will show that specific drugs are in your system, rather than checking for drugs they wish weren’t there.”

Riley continued, “Getting the right dose of a prescription medication is already a challenge for practitioners since individual patients react to and metabolize drugs in different ways and at different rates. When you add in the complication that almost half of all prescriptions are not taken as directed, you can begin to understand the complexities of achieving success in treatment.”

In all, Trident tests for 123+ compounds most of which fall into the categories of pain management (opiates and opioids), behavioral medicines (antipsychotics and antidepressants), drugs of abuse (heroin, cocaine, and

TRIDENT LABS

methamphetamines), and emerging drugs (carfentanil, synthetic marijuana, kratom, etc). For each test, clients have options for how the results are presented, depending on their specific need, through flexible reporting.

Founded in 2015, the company resides in the Michigan State University Bioeconomy Institute building. In addition to the 123+ medication compounds, Trident also offers a kit for PFAS water testing in drinking water.

“At Trident we want to make sure we are providing testing services that have the biggest impact on the health and well-being of people within our state and around the nation. Medication adherence, drug use and addiction, and PFAS chemicals impacting water safety all have potentially major impacts on public health; providing practitioners, law enforcement personnel, businesses and the general public with those specific tests ensures that they can make informed decisions about treatment plans and interventions,” says Riley. “And, we can turn testing around at industry-leading speeds with most of our results being returned to the customer within 48 hours meaning that important healthcare decisions aren’t being delayed due to testing.”

Medication adherence is a complicated problem, studies show that forgetfulness is the largest single contributor to nonadherence with 70% percent of patients citing it as the reason they stopped taking their medication, with costs and potential side-effects both cited 10% of the time.

While lab testing cannot address the root causes of nonadherence, it can arm practitioners with the information necessary to intervene with individual patients, and that is where Trident is right at home, tackling big problems one test at a time.

TRIDENTBIOMETRICS.COM

BIOMATTERS | FALL 2019

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VIEWPOINT

Michigan’s Quietly BOOMING Industry

BY FRED MOLNAR, VICE PRESIDENT OF ENTREPRENEURSHIP AND INNOVATION, MICHIGAN ECONOMIC DEVELOPMENT CORPORATION

When you think of Michigan, chances are you think of the automotive industry. The state is synonymous with car production— and for good reason.

As home to some of the world’s largest car manufacturers, as well as the American Center for Mobility and the Mcity test facilities for autonomous vehicles, Michigan encompasses the past, present and future of the auto and mobility industry.

Behind the scenes, though, another industry has seen ever-increasing growth and significance and has become one of the state’s largest employers: life sciences. This industry is thriving in Michigan, drawing national attention earlier this year when Ablative Solutions raised $77 million in investments, the largest-known venture capital deal in Michigan history. Ablative’s success is not a fluke or a one-off. Rather, it is indicative of the state’s commitment to, and support of, the life science industry.

The history of life sciences in Michigan is rich. Some of the earliest pharmaceuticals in the country were made in the state, and the polio vaccine field trial was administered and evaluated at the University of Michigan. In fact, the life science industry in Michigan is so strong that even when Pfizer closed its campus in Ann Arbor—where it was once the city’s largest private

employer—it was not a deathblow for the industry in the region. Instead, many employees stayed in the area, and many launched or worked on life science startups.

The life science industry is truly embedded in the state.

Currently, Michigan has the highest concentration of industrial engineers, mechanical engineers and machinists in the United States, while its strong higher-educational system consistently ranks as one of the best for aspiring engineers and medical professionals. The state is brimming with talented individuals who have innovative ideas on improving public well-being and treatment, which is exactly why we need to invest in them and provide them the guidance and resources to launch their ideas.

The Michigan Economic Development Corporation’s Entrepreneurship and Innovation initiative aims to ensure no promising entrepreneurial idea fails because it was unable to locate proper resources.

Through its support of the Michigan Translational Research and Commercialization for Life Sciences Innovation Hub (MTRAC), the MEDC awards funding and connects aspiring university-based ideas with industry and investment experts who guide them through the commercialization process. This program helps entrepreneurs get ideas to market, create jobs in Michigan and engender positive impacts to human health.

For years, life sciences have incubated in the state’s largest research universities, including the University of Michigan, which is home to the MTRAC for Life

Above: A former shuttered Pfizer facility repurposed as an incubator for life science and tech startups. Michigan Life Science and Innovation Center (MLSIC) in Plymouth, MI (www.mlsic.com)

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NEW MICHBIO MEMBER SPOTLIGHT

Sciences Innovation Hub. Historically, this approach has made sense. These universities are home to some of the highest-rated medical and engineering programs in the country, thus inspiring innovative entrepreneurs with ideas prime for commercialization.

But as we have increasingly seen, innovative life science ideas can bud anywhere in the state. Among others, Ablative Solutions was founded in Kalamazoo, bioinformatics company Advaita was founded in Plymouth, and Tetra Discovery Partners working on treatments for Alzheimer’s and brain injuries was founded in Grand Rapids. What’s more, the industry includes far more than pharmaceutical or medical device companies. Consider KTM Industries the makers of corn-based packaging foam or Vestaron working on industry-leading bio-pesticides – Michigan is an ideal location for life science companies.

For that reason, the MEDC is increasing its efforts to be more inclusive and support aspiring entrepreneurs across the entirety of Michigan. The next great medical breakthrough could come from anywhere in the state and having localized support and resources available is crucial. The life science industry may already be in Michigan’s blood, just as the automotive industry is, but with continued support and more widely available resources, we can make it even stronger.

For 28 years, APIS Informationstechnologien GmbH has developed the IQ-Software for global industries where failure is not an option.

The APIS® IQ Software is the most robust tool on the market for companies engaged in research, development, product design, and manufacturing, as well as, healthcare operations’ quality and safety programs, including DFMEA, PFMEA, Requirements Management, and Management Reporting with outcome and statistical analysis.

The IQ-Software tool provides the functionality to meet the demands of audits, customer reviews and industry be st practices.

As the demand for the IQ-Software increased throughout North America, so did the demand for effective training solutions and consultation services, resulting in the formation of the IQ-Software distributor, APiS North America, in 2016 under the direction of President Lynn M. Johnson, Pharm.D. Dr. Johnson calls upon her 22-year healthcare career, spent developing lean processes and strategies for patient care teams, to provide healthcare and business strategy expertise to APiS North America. Paired with Vice President Chad M. Johnson, an expert in both the APIS® IQ-Software and FWEA methodology with nearly 21 years of experience as a Systems Engineer and certified Master Black Belt 6Sigma/DFSS, the APiS North America team is an expert mix of healthcare, business, and lean process knowledge.

APiS North America’s mission is to revolutionize how customers leverage FMEAs within risk management & functional safety efforts to improve products and processes with innovative software products, expert training & consulting, and impeccable attention to customer service. The APiS North America team and the APIS® IQ-Software will do the same for your organization’s quality and safety program.

APIS-IQ.COM

BIOMATTERS | FALL 2019

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CONSULTANTS TO MEET ClynProject Consulting is a Plymouth-based company specializing in clinical project management and clinical monitoring.

In their role as Clinical Project Managers, the company assists in the planning and execution of clinical trials with a focus on the business side of the study – budget, scope, timelines, communications, etc. Simultaneously, as Clinical Research Associates, the company monitors the trial with a focus on study integrity and patient safety working with investigative teams to monitor data collection and to ensure Good Clinical Practice (GCP) and ICH Guidelines are being met. In this combined role, ClynProject Consulting can oversee and manage all aspects of the clinical trial process.

ClynProject Consulting founder and CEO, Alis Vazquez began working in the Pharmaceutical/Biotech industry in 2000 with clients at Teva Pharmaceutical, Sanofi Aventis, AstraZeneca, Symcare (J&J subsidiary), and Spherix Inc.

Additionally, Alis has site and CRO experience, having managed many trials for well-known clients.

Ms. Vazquez has been involved with two NDA (CTD) while working at Sanofi-Aventis, has worked across several Therapeutic areas, and has managed clinical trials in the U.S. and internationally from Phase I to Post Marketing Approval. ClynProject Consulting brings a broad knowledge of experience across therapeutics areas.

ClynProject Consulting is regionally based and follows a business model that allows to offer quality professional services with low overhead at reasonable, competitive industry pricing.

ClynProject Consulting is located at Michigan Life Science and Innovation Center (MLSIC) – it’s Southeastern Michigan’s premier home for life science and other innovation-based startup businesses.

CLYNPROJECTCONSULTING.COM

QAaaS-MI (Quality Assurance as a Service-Michigan) is a consulting company that aims to assist businesses in process development and compliance with innovative technologies like the “Cloud” and/or associated hosted services. The QAaaS-MI team has a unique composition of individuals with IT technical knowledge as well as those with compliance experience, which helps to bridge the gaps and common misunderstandings that can exist between IT and QA. The skills and knowledge the team possesses can help streamline operations and bring business into the new technological horizon.

Knowing that teamwork, research and documentation, and process compliance have never been more crucial to success that they are in today’s risk-based approach to business, QAaaS-MI has solutions in each area that can help reduce risk. QAaaS-MI can help your team function 30

MICHBIO | michbio.org

more effectively through coordination of tasks, activities, and training sessions, can complete independent assessments of outside suppliers and generate the documentation required for decision making, and can provide services necessary to meet all GxP requirements when computer systems, product development, or lab processes must be completed. The company can even help generate specific risk-based processes, if that approach is desired.

In addition to standard ‘as-a-Service’ offerings, QAaaSMI also provides an outlet for innovative thinking and creative business solutions. In short, they aim to use their expertise and progressive thinking to help your business move forward to the New Horizon.

QAAAS-MI.COM

CONSULTANTS TO MEET

Marketing is a challenge for any startup or early growth company. It is particularly difficult to find the right marketing resources for bioscience companies whose products may be highly technical and esoteric.

Slant Communications has over 30 years experience working with biotech, pharmaceutical, medical and healthcare companies. They can help identify communication needs, develop programs and produce materials.

When it comes to marketing, advertising and promotion, small companies have big needs. But they often do not receive the attention they need from large agencies.

Slant Communications thinks big, on a small scale. They provide big time graphic design, content strategy, web development and branding with a small staff that has no empty suits.

There are more new tools for reaching your customers than ever before. New ways of using online marketing, social media, interactive presentations, display and print that change the way people get information and make decisions. Slant’s toolkit includes branding, explainer and promotional video, web development, and just about anything else you may need to promote your product.

Whether it’s product promotion, corporate communication, or public education, Slant looks at the overall need, develops an integrated program, and makes sure everything works together as hard as possible.

Slant Communications is located in Douglas Michigan on the shore of Lake Michigan. They serve clients throughout the state and nationally.

When asked, Swift Biosciences said “Extremely impressed with the team at Slant, they know how to put the customer first and deliver.”

SLANTCOM.COM

Warren-based Turtle Works knows that technology not aligned with your business is painful.

and QuickBooks to fuel business growth. Successfully working with business owners and IT Directors to maximize their available systems functionality in a way that pushes the company forward. Preventing lost company growth and avoiding insufficient return on that investment.

“At Turtle Works, we specialize in helping clients define their goals, assess their technology - the software and systems they use to run their business - and build a plan to align that technology more effectively,” says Josef Wainz President of Turtle Works.

“Growing a business and maintaining profitability takes a vision of where you want to go and focused decisionmaking along the way,” he continued. “Most of the time, leaders don’t have the knowledge they need to apply the right technology to their business processes. Once they acquire the right information, the vision becomes clear and they are able to make the focused decisions for long term results.”

Turtle Works is a certified Microsoft partner with expertise in applying existing Office 365 cloud technologies like SharePoint, Teams, Power BI, PowerApps and Flow, along with on-premise technologies like ERP, SQL Server

You want to cut through the noise that comes with running a business. Applying Key Performance Indicators and setting up systems in a way that reduces workload, streamlines processes; minimizing the opportunities for errors and distractions that impact success. Turtle Works guides leaders to do just that.

“Our name says it all, Turtle Works is about the race between the tortoise and the hare. The hare was faster, but was continually sidetracked by time-wasting distractions, while the tortoise knew where he was going and took the direct route to his destination. It’s a constant reminder, if you are not sure where you are going, speed is not the answer.”

TURTLE.WORKS BIOMATTERS | FALL 2019

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MICHIGAN STATE UNIVERSITY

INN VATION CENTER

The MSU Innovation Center provides a variety of integrated services to the BioTech sector.

Imagine the possibilities: • • • •

Access to more than 5,000 researchers Nearly $600 million in annual R&D expenditures 500-plus research and instructional buildings Advanced facilities, pilot plants and lab spaces

Connect your business to MSU today.

We offer a world-class network for entrepreneurs, investors and inventors who are looking for everything — all in one place: Business-CONNECT Links the right people and resources to develop an idea.

MSU Technologies Offers the best MSU ideas ready for commercial licensing.

Spartan Innovations Creates investment-ready businesses from MSU ideas.

innovationcenter.msu.edu

@msuinnovation

BIOMATTERS | FALL 2019

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