IN THIS ISSUE:
06 CORE VALUES OF MICHIGAN’S BIOINDUSTRY SHINE IN COMBATTING COVID-19 ISSUE SPOTLIGHT
14 LOOKING TO THE FUTURE OF FOOD AND ANIMAL SAFETY NEOGEN CORPORATION
24 SAMPLE TO RESULT: STATE OF THE ART TESTING SOLUTIONS NEUMODX MOLECULAR
32 COLLABORATING TOWARDS A CURE FOR NF1 THE GILBERT FAMILY FOUNDATION
SPRING/SUMMER 2020
A magazine showcasing Michigan’s biosciences industry
MONEY DOESN’T INSPIRE GREAT IDEAS. GREAT IDEAS INSPIRE MONEY. E N T R EP RE NE UR SH I P & I NNOVATION 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 michiganbusiness.org/entrepreneurship
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PRESIDENT’S MESSAGE If there was ever a time of endless need nationally and around the world, it has been the past half year, as countries, governments and citizens have struggled to contend with the Covid-19 pandemic. Bioscience innovation and the industry across its vast range have risen to meet that challenge of need while grappling with supply chain procurement, distribution and quality challenges, as well as dealing with expanding and pivoting the manufacture of critical medical products like personal protection equipment (PPE) and supplies, and reagents and consumables for the testing of the SARS-CoV-2 virus and antibody. In short, the biosciences industry has focused like no other to ensure that the far-reaching effects of the pandemic on lives and welfare are mitigated to the greatest extent possible. Here in Michigan, our bio-industry stepped up in large way. MichBio witnessed the many efforts and activities firsthand as we ourselves were involved in identifying suppliers, manufacturers, distributors, and in turn facilitating connections with healthcare providers, OEMs, governmental units, and others, who had no shortage of pressing needs.
“The biosciences industry has focused like no other to ensure that the farreaching effects of the pandemic on lives and welfare are mitigated to the greatest extent possible.”
Companies of all sizes responded at the local, regional and global levels within their networks and communities like never before. The common thread was the focus to innovate, retool and deploy new technologies, platforms and resources. The current issue of BioMatters™ highlights some of the innovation emerging from just a tiny selection of our bioscience enterprises. Most notably, the Spotlight article demonstrates the responsiveness and ingenuity demonstrated by companies statewide following an urgent call for PPE and other products desperately needed by frontline healthcare workers. Across therapeutic disciplines in healthcare, in areas of food and environment, using a variety of technology platforms, Michigan companies are making advances that will improve, and in many cases, save lives - attacking cancer, Alzheimer’s, rare genetic and autoimmune diseases and brain injury, ensuring a safe food supply, automating diagnostics, improving invasive procedures, developing robotic surgical solutions, and more. Endless need meets relentless innovation. Michigan’s bio-industry is developing today for the promise of tomorrow. Sincerely,
STEPHEN RAPUNDALO, PHD President and CEO, MichBio
BIOMATTERS | FALL 2019
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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
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MichBio is the biosciences trade association for the state of Michigan. Our goal is to drive the growth of the state’s bio-industry through advocacy, education, connections, and supportive resources.
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CHAIR Ken Massey, PhD Wayne State University Senior Director, Venture Development, Technology Commercialization VICE CHAIR Kevin McLeod C2Dx Founder, President and CEO
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
PATRON
Edward Pagani, PhD University of Michigan Associate Director, Health Technologies, Office of Tech Transfer Ron Perry, MBA Emergent BioSolutions Vice President and General Manager Stephen Rapundalo, PhD MichBio President and CEO Randel Richner, BSN, MPH Richner Consultants Founder and President
Kevin McLeod C2Dx Founder, President and CEO
Tom Ross Grand River Aseptic Manufacturing President and CEO
Fredrick Molnar, MBA Michigan Economic Development Corporation Vice President, Entrepreneurship and Business Development
John J.H. Schwarz, MD Family Health Center Physician and Former U.S. Representative
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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» » » »
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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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22 WANT TO RECEIVE BIOMATTERS?
Visit michbio.org/subscribe
06 |
Core Values of Michigan’s Bio-Industry Shine in Combatting Covid-19
10 |
Buoyant Microbubbles Rise Above the Limitations of Other Isolation Technologies
12 |
One Michigan Company’s Unique Approach to “The Cancer Problem”
14 |
Looking to the Future of Food and Animal Safety
16 |
Memory Loss Meets Its Match
18 |
Michigan Biosciences: By the Numbers
20 |
Critical Moments. Critical Decisions.
22 |
Seeks Innovative Treatments for Patients Who Have Rare and Ultra-Rare Genetic Diseases
24 |
Sample to Result: State of the Art Testing Solutions
26 |
After the Elevator Pitch
29 |
New MichBio Members
30 |
Breast Cancer Treatment is More Effective and Accessible with MammoKnifes
32 |
Viewpoint: Collaborating Towards a Cure for NF1
34 |
Consultants to Meet
Issue Spotlight
Akadeum Life Sciences
Penrose TherapeuTx
Neogen Corporation
Tetra Therapeutics
MichBio
C2Dx
Ultragenyx Pharmaceutical Inc.
NeuMoDx Molecular
Emerging Companies
Therapeutic Health Choice, Symbiote
Ehmet Health
The Gilbert Family Foundation
Innovative Engineered Solutions, Michigan HR Group
BIOMATTERS | FALL 2019
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COLLABORATION, ADAPTABILITY, AND PERSEVERANCE
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MICHBIO | michbio.org
SPOTLIGHT
CORE VALUES OF MICHIGAN’S BIO-INDUSTRY SHINE IN COMBATTING COVID-19 The bioscience industry is no stranger to extreme pressure – being the industry that feeds, fuels, and cures the world holds a unique place in the world economy. Success is measured not in dollars, but in stability of the food chain from sustainable agriculture, environmental conservation and climate change mitigation from bio-fuels, -plastics and -pesticides, quality of life improvement from infant warming blankets, artificial knees, and addiction treatment, and lives saved from prescription medications, diagnostic equipment, and vaccines. Tackling the world’s toughest and most critical problems is what those in the life sciences do every day. Michigan companies are no exception – comprised of more than 1800 companies and 39,000 people, the Michigan bio-industry is home to a thriving mix of small start-ups and large international brands spread among medical device, pharmaceutical,
academic and clinical research institutions, diagnostics and testing organizations, logistics companies, agri-bioscience, and life science related service providers. As the world struggles with the effects of COVID-19, Michigan companies have reinvented their jobs to be done at home, navigated supply chain and cash flow shortages, retooled their manufacturing, research and development efforts to focus on SARS-CoV-2, and dealt with an infrastructure that has pivoted toward fasttracking the essential tools and treatments to combat the new virus – all while facing public pressure to deliver a vaccine in record time and, simultaneously, not lose momentum on their existing research. Even for an industry used to extremes, this is uncharted territory.
BIOMATTERS | FALL 2019
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MICHIGAN’S BIO-INDUSTRY RETURNS TO ITS ROOTS TO COMBAT COVID-19
Collaboration, Adaptability, and Perseverance – A Foundation Critical to Fighting a Pandemic For the industry outsider, understanding the essential qualities of the life sciences is a challenge. When the prevailing media representation of the industry is the profiteering, big business and the pop-culture version is the rogue scientist brazenly testing treatments on themselves, the keys to success in bio-research might be surprising. While business savvy and roguish passion are useful qualities in the life sciences, far and away collaboration, adaptability, and perseverance are the hallmarks of success and represent the industry’s core values. The majority of bio-industry companies are comprised of small teams working on big problems. Take, for example, Tetra Therapeutics a sevenemployee company working on cutting-edge Alzheimer’s treatments, or Vestaron a twelveperson company developing sustainable pesticides that don’t damage pollinator populations or lead to pesticide-resistance. These companies, and others like them, are led by brilliant people with innovative ideas, but they would struggle to be successful without access to information and expertise from other organizations in the form of scientific advisory boards and peer-reviewed research, supportive tools and technologies, and a robust commercialization and investor-friendly ecosystem. That collaboration is the foundation of progress in the life sciences – when coupled with business flexibility and a ‘fail-forward’ mindset, even small organizations can solve big problems. Consider Ecovia Renewables who followed its research to an entirely different industry. The company started on a mission to reduce fossil fuel dependency with a biofuel developed from
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a fermented biomass and realized the polymer had applications in cosmetics, agriculture, and biodegradable baby diapers. Like so many others, Ecovia changed its focus and now has a partnership with a French cosmetics company and a team of eight working on reducing waste from disposable diapers. Of course, that flexibility and perseverance is not unique to small organizations. In 1965 researchers at Michigan State University discovered a chemical that slowed the regeneration of cancer cells cisplatinum. Even though it was evident early on that the chemical had potential in cancer treatment, it took more than 13 years and a series of failed experiments before the drug Cisplatin was finally available for use. Today, more than 40 years later, Cisplatin is still the drug to which all other cancer treatments are compared. And just this year, Esperion Therapeutics launched two new cholesterol-lowering drugs after a decade of determined effort - they are the first oral nonstatin drugs in the lipid-lowering space to hit the market since Lipitor was developed by Parke-Davis Pharmaceutical Research here in Michigan almost 25 years ago. The perseverance of these companies means that thousands battling cancers and high cholesterol have treatment options that would have otherwise gone undiscovered. Built on a solid foundation, the bio-industry has essential qualities and core values that will continue to guide it through the current pandemic.
SPOTLIGHT
CORE VALUES OF COVID-19 LIFE SCIENCE COMPANIES SPUR ACTION AND SUCCESS A Michigan snapshot: FEBRUARY 12TH — nearly a month before the first confirmed case of the novel Coronavirus in Michigan – Ann Arbor-based Arbor Biosciences announced they would be offering their NCov2019 panel free to researchers studying the source and evolution of COVID-19.
APRIL 15TH — Twelve companies received State of Michigan awards, including Genemarkers and Oxus America, to begin the process of retooling their lab operations and manufacturing to expand COVID testing services and oxygen concentrator/ventilator production, respectively.
MARCH 17TH — Pfizer, whose largest manufacturing facility lies in Portage, MI, announced a partnership with BioNTech to co-develop a vaccine candidate for COVID-19.
APRIL 22ND — University of Michigan healthcare workers developed a 3D printed device that could allow multiple patients to be supported with a single ventilator and formed MakeMedical a company that will manufacture and distribute the VentMI.
MARCH 23RD — NxGen MDx announced the immediate launch of their COVID-19 diagnostic test to address the national test shortage. MARCH 27TH — in2being, llc – a medical device development firm - held their first free “COVID Connect” webinar to help companies understand the Emergency Use Authorizations related to COVID-19. That webinar has evolved into a weekly national call with biomedical and medtech stakeholder updates, and a place to connect those with supplies to those in need. MARCH 30TH — Advaita Bioinformatics announced that they were making their high-throughput biomedical pathway analysis software available for free to anyone doing COVID-19 research. They have since, on April 29th in partnership with Henry Ford Health System, used the platform to discover that methylprednisolone prevents some of the worst COVID-19 symptoms and reduces mortality. MARCH 31ST — NeuMoDx Molecular announced they had developed a rapid, high-throughput SARSCoV-2 test approved under the FDA’s Emergency Use Authorization.
APRIL 23RD — Emergent Biosolutions, with facilities in Michigan, became the US manufacturing partner for Johnson & Johnson’s lead vaccine candidate for COVID-19. MAY 5TH — Pfizer and BioNTech dosed their first participants in the Global COVID-19 mRNA Vaccine Development program. JUNE 9TH — MMS Holdings and IGY Life Sciences partnered to develop a COVID-19 antibody treatment that could support elderly and immune compromised individuals who would not be COVID-19 vaccine candidates. JULY 1ST – Pfizer and BioNTech announced initial clinical success in their vaccine candidate, an effort dubbed “Project Lightspeed.” AUGUST 6TH — Grand River Aseptic Manufacturing selected by the US DHHS and DoD to manufacture and distribute COVID-19 vaccines and therapeutics.
These are a few examples from Michigan of life science companies collaborating and pivoting to address the pandemic – there are many more. Individually, each of these progresses the search for vaccines and treatments for COVID-19 incrementally. Together, they can take what is usually a 5 to 10-year process of identifying a new pathogen, assessing the need for intervention, and developing, testing, producing, and implementing a treatment to, hopefully, less than 18 months.
BIOMATTERS | FALL 2019
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AK AD EUM L IFE SCI E N C ES
Buoyant Microbubbles Rise Above the Limitations of Other Isolation Technologies BY MICHAEL MALONEY DIRECTOR OF MARKETING & BUSINESS DEVELOPMENT, AKADEUM LIFE SCIENCES
In the isolation technology market, slow and bulky reigns supreme. With status-quo processes that have not progressed in the past 40 years, the market has been yearning for faster, leaner, more agile products—but nobody could seem to improve upon well-known methods like magneticsbased separation. Nobody, that is, until now. THESE LITTLE BUBBLES ARE MAKING BIG WAVES The greatest innovations are often those that transform an entire industry, and Ann Arbor-based biotechnology company Akadeum Life Sciences has done just that. The team refused to accept the long-standing problems in sample preparation as a necessary evil, so they set out to find a better way. Meeting the needs of evolving industries such as cell therapy and diagnostics, their elegantly simple solution uses buoyant microbubbles to capture and isolate virtually any target from a biological or chemical sample. The shortcomings of current methods—including volume limitations, low throughput, cumbersome workflows, and costly processes—are all solved by microbubbles. Akadeum’s flotation-based separation technology is faster, cheaper, and much simpler than status-quo methods. Moreover, microbubbles can be used with samples of any size—a feat that its predecessors can’t even come close to tackling.
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THE BEAUTY OF SIMPLICITY Akadeum’s goal of being able to process any sample, at any volume, anywhere is certainly within grasp. The company’s current products can be used to capture various types of cells, microbes, nucleic acids, proteins, and more. And—due to the fact that this self-separation is achieved by buoyancy—the technology does not require any specialized equipment and may be carried out in any size of container. By coating Akadeum’s microbubbles with molecules, they are able to seek out and attach to their desired targets. For example, antibody-coated microbubbles may be added to a blood sample to target specific cells, such as T-cells. The microbubbles then gently float the desired targets to the top of the sample, where they can easily be skimmed off.
AKADEUM’S FIGHT AGAINST COVID-19 Amidst the ongoing pandemic, the speed and agility that Akadeum’s technology enables has become even more crucial. As such, the company is focusing its efforts to fight against COVID-19 on both the viral diagnostics and antibody detection fronts.
The Akadeum Advantage
EQUIPMENT FREE
SCALABLE IN VOLUME
SIMPLE & FAST
SCALABLE IN NUMBER
AKADEUM ZOETIS
Microbubbles mix with the sample.
Simple buoyancy driven isolation
Microbubbles capture target cells.
Target cells float to the surface for removal.
Targets nucleic acids, proteins, cells, and more
Currently, Akadeum is developing a novel nucleic acid-engaging microbubble that may be used to quickly test for viral infections across large groups of people. A quick way to test the contagion of large populations will be critical as our communities aim to ease social distancing requirements and return to public gatherings such as work and school.
PAVING A PATH FOR FUTURE ADVANCES To commercialize and support further advancements of Akadeum’s microbubble technology, the company recently completed its Series A financing with support from local and coastal investors, including Michigan Angel Fund, Grand Angels, University of Michigan MINTS, Berkeley Catalyst Fund, Mass Medical Angels, and Agilent Technologies, Inc. (NYSE:A). Akadeum is actively developing its product portfolio, which includes several research-use-only (RUO) kits for cell isolation applications. In parallel, the company is also pursuing business-to-business partnerships for applications in diagnostics, cell therapy, and bioprocessing. One such partnership with Agilent Technologies, Inc. uses the technology to explore a new testing paradigm that could reduce cost and complexity of analytical workflows. Given that Akadeum’s technology can be utilized across multiple large and fast-growing industries,
the addressable market is substantial. And, since microbubbles do not have the same limitations as other methods, the technology is also expected to enable the development of new markets. With shattered limitations, improved processes, and emerging markets on the horizon, Akadeum’s microbubbles have ensured that—in an industry where status quo felt like rock bottom—the only way to go is up. 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.
AKADEUM.COM
BIOMATTERS | FALL 2019
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CAN CER ’ S AC H IL LE’ S H E E L
One Michigan Company’s Unique Approach to “The Cancer Problem” BY JASRAI S. GILL, M.D., EXECUTIVE CLINICAL DIRECTOR, PENROSE THERAPEUTX
Cancer is a scary word. In 2020, there will be an estimated 1.9 million new cancer diagnoses in the United States, with approximately 630,000 of those patients predicted to die from the condition.
Penrose TherapeuTx, a privately-held biopharmaceutical research and development company, has developed orally-formulated small molecules with dramatic, standalone anti-cancer activity across multiple cancer subtypes, including lung, colon, breast, and leukemia. The therapy was inspired by existing small-molecule agents, never-before FDA approved in cancer, that have functioned as tools to elucidate a completely novel anti-cancer mechanism of action within the field of cancer metabolism.
That is the equivalent of losing 1,720 people to cancer every day and makes cancer the second most common cause of death in the U.S. behind only heart disease. The cost is not just in lives, in fact, the U.S. National Cancer Institute estimates that the total cost of cancer care in 2020 will be more than $173 billion. The familial, social, and economic impact of the disease are massive, and for decades people have been trying to solve “the cancer problem” with limited success. Penrose TherapeuTx is a Michigan-based company with a unique solution.
The Company’s Mitochondrial Modifying Agent (MMA) development platform targets the uniquely reprogrammed metabolism of cancer mitochondria. Malignant cancer cell survival hinges on its ability to alter its use of energy, and to protect the most critical part of its energy-producing machinery, the mitochondria. A major player in this process is Hypoxia-Inducible Factor 1-alpha (HIF-1-alpha). In reprogramming the healthy cell via HIF-1-alpha, the cancer cell creates a selective vulnerability, or an Achilles Heel, whereby treatment with Penrose’s MMA drugs leads to cancer cell death while leaving healthy cells untouched. Using data
While the oncology drug development ecosystem has realized significant progress in the fields of immuno-oncology and genome-driven targeted therapies, there remains too little hope for stage 4/metastatic cancer patients. Five-year survival rates for that class of patient are staggeringly low, in large part because cancers either don’t respond to initial therapies or because they develop resistance to the therapy that is being used.
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PENROSE THERAPEUTX
from off-label and compassionate care use of particular MMA drugs in terminal cancer patients and through iterative testing in animal models of cancer, Penrose has arrived upon a true stand-alone, oral anti-cancer protocol with incredible societal potential to solve “the cancer problem.� The Company is currently preparing itself for a clinical trial supervised by the Food and Drug Administration (FDA) expected to begin in the second half of 2021. Resource dependent, the Company is planning on lead indications in relapsed/refractory Stage 4 Acute Myeloid Leukemia (an orphan or rare disease) and relapsed and refractory Stage 4 Non-Small Cell Lung Cancer (the leading cause of cancer deaths worldwide). Next-generation drugs are designed and are currently being tested in cell and mouse models in Plymouth, MI, by the Penrose Science Team. This research leads to the potential for a truly universal anti-cancer platform.
The Company has grown its roots in the Michigan Life Science and Innovation Center, going from a handful of people to 20+ driven team members working hard to advance their scientific efforts. In Michigan, they are surrounded by great talent due to the proximity of leading academic institutions and are proud to be a part of that community.
Every day, Penrose TherapeuTx goes to work intent on solving the cancer problem for the millions affected in the United States and across the globe.
PENROSETHERAPEUTX.COM
BIOMATTERS | FALL 2019
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NEO GEN C OR P OR AT I ON
Looking to the Future of Food and Animal Safety BY DAN LEBLANC, CORPORATE WRITER, NEOGEN CORPORATION
Since its founding in 1982, Lansing, Michigan-based Neogen Corporation (NASDAQ: NEOG) has earned its status as a market-leading company in the development of rapid food safety diagnostics, including tests for the rapid detection of natural toxins, allergens, dairy antibiotics, pathogens, spoilage microorganisms, and sanitation concerns. Odds are strong that the quality and safety of the foods that you regularly eat are verified by a Neogen test. Neogen’s success has been built through testing innovations, such as the development of the first commercially available onsite tests for mycotoxins and food allergens (e.g., peanuts and milk), which enabled food companies to test their products before they were shipped to consumers. Neogen’s customers now include the biggest, best-known food companies in more than 140 countries in the world. Likewise, Neogen has become a market-leading company in the development of animal health products and innovative animal genomic services. The company’s vision to build upon its testing success is to provide food producers, processors and distributors with innovative tools for analysis to make quicker and more informed data-driven decisions on their ranches and farms, as well as throughout the global farm-to-fork food chain. The explosive growth in the fields of biotechnology and computer science has provided food producers and processors with an unprecedented amount of data concerning all aspects of their operations, including test results. Neogen is positioned to help producers and processors make sense of all the new data.
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For example, for most food products, decision making starts very early in the process. When it comes to providing the highest quality and quantity animal protein food products, including meat, milk and eggs, producers start by selecting the best animals for breeding programs. Neogen’s global animal genomics operations turn the seemingly daunting task of interpreting an animal’s genome, which includes billions of nucleotide base pairs, into easily understandable information. For example, cattle producers use Neogen technology to select the best animals for desirable traits, such as higher milk production, more tender steaks, or better disease resistance. These data-driven decisions result in a food supply that is safer, healthier and more environmentally efficient to produce — and more profitable for the producers.
In addition to animal selection, Neogen products can aid with operational decisions aimed at reducing contaminants. The safety and quality of the global food supply is challenged by contaminants on every step of its journey to the dinner plate. Contamination can occur in a farmer’s field, such as sprouts being contaminated with E. coli or corn with a
NEOGEN
mycotoxin, or anywhere in the processing, distribution or retail process, such as with Listeria, or a food allergen in a production environment. For all types of food products - whether they originate from a ranch, farm, field, orchard, or sea, Neogen’s testing products and services provide accurate information that can lead food safety professionals to make decisions that will affect their operations – and potentially their consumers and bottom lines. In some case, those decisions are made easily to protect the safety and quality of food products. For example, if a dairy producer uses a Neogen product to test an incoming load of raw milk for the presence of dairy antibiotics, a positive test will lead to the producer to reject the load and, in doing so, protect the producer’s operations from contaminated product. In other cases, these decisions are not so easy. For example, when a food processor tests its production environment and receives a positive Listeria test result. Was the Listeria detected the result of a persistent problem that must be systematically addressed and remedied by major changes in the processor’s operations? Or, was the Listeria a transient problem — a temporary issue that is not likely to recur?
workflows and continuously monitor and analyze food risk data generated by Neogen’s food safety diagnostic products. By automating and connecting multiple data points through diagnostic testing in a production facility, the food safety data analytics platform enables food producers and processors to harness their data and create a holistic picture around areas of risk that can guide operational data-driven decisions.
Neogen stands ready with the right mission to provide food producers, processors and distributors with innovative tools to make quicker and more informed decisions.
NEOGEN.COM
In an effort to further assist its food safety diagnostic customers interpret their test result data, the company recently developed Neogen Analytics, an innovative platform that enables Neogen customers to automate food safety
BIOMATTERS | FALL 2019
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T E T R A T HER APEU T I C S
Memory Loss Meets Its Match BY MARK GURNEY, CHAIRMAN & CEO, TETRA THERAPEUTICS
In life sciences, it doesn’t get more urgent than solving for neurodegenerative conditions. With more than five million American’s living with Alzheimer’s disease chances are readers will have known or currently know someone with this devastating disease. At a very fundamental level, loss of memory is loss of self and that impacts patients, family members and care givers.
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TETRA THERAPEUTICS
Located in Grand Rapids, Michigan, Tetra Therapeutics is developing therapies for patients with Alzheimer’s disease, Fragile X Syndrome, and other brain disorders that will potentially protect against memory loss and improve how the brain processes and stores information.
A Phase 1 study of Tetra’s lead drug candidate in healthy elderly volunteers suggested a cognitive benefit, as observed in two different tests of speed of processing time in complex attentional tasks. The company is currently conducting Phase 2 clinical trials of BPN14770 in patients with early Alzheimer’s disease and adults with Fragile X Syndrome. Tetra recently came to a merger agreement with Shionogi & Co., Ltd. According to Mark Gurney, the CEO of Tetra, “The merger with Shionogi further validates our platform and the potential for BPN14770 to provide a new treatment option for patients suffering from Alzheimer’s disease and other debilitating disorders affecting the brain”.
Using structure-guided drug design the company has discovered allosteric inhibitors of phosphodiesterase 4 (PDE4), an enzyme family that plays key roles in memory formation, learning, neuroinflammation, and traumatic brain injury.
In Fragile X syndrome, the most common genetic cause of autism, BPN14770 is thought to help promote the maturation and stabilization of brain connections. Tetra is conducting an investigational Phase 2 study of BPN14770 in adults with Fragile X syndrome, an indication for which BPN14770 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA.) The study is examining safety and tolerability as well as any preliminary signals for benefits on behavior, cognition, and biomarkers and the company expects to have topline results later this year.
“While there has been a lot of disappointment and set back when it comes to new drugs to treat Alzheimer’s, I really believe that we will see approval of the first disease modifying treatments for Alzheimer’s disease in the next decade,” said Mark Gurney, founder and CEO of Tetra. “It’s very possible that patients will have access to multiple classes of drugs which improve brain function or which may prevent or slow progression of the disease.” Tetra’s approach to Alzheimer’s disease is different from therapies that consist of monoclonal antibodies that target amyloid beta, a protein whose accumulation in the brain is related to the onset of dementia. Instead, its lead clinical compound, BPN14770 is a novel therapeutic agent that selectively inhibits phosphodiesterase-4D (PDE4D) to enhance early and late stages of memory formation. The compound has demonstrated neuroprotective benefits in preclinical models and has the potential to slow Alzheimer’s disease progression.
TETRATHERAPEUTICS.COM
BIOMATTERS | FALL 2019
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MICHBIO
BY THE NUMBERS
14
LARGEST BIOSCIENCE STATE
10
LARGEST MEDICAL DEVICE STATE
th
MICHIGAN BIO-INDUSTRY QUICK FACTS
39,981*
1,877
*
BiOSCIENCE JOBS
144,184*
th
TOTAL EMPLOYMENT IMPACT
BIOSCIENCE ESTABLISHMENTS
$92,717
*
AVERAGE BIOSCIENCE SALARY
$28
>
BILLION
BIOSCIENCE PERFORMANCE METRICS* BIOSCIENCE R&D (FY 2018)
$1.536 billion* VENTURE CAPITAL INVESTMENT (2016-2019)
$557.6 million* PATENTS (2014-2017)
2,563* † Summated from Battelle/AdvaMed The Economic Impact of the U.S. Advanced Medical Technology Industry. PhRMA Biopharmaceuticals Sector Impact on Michigan’s Economy, 2016. * TEConomy/BIO, the Biosciences Economy: Propelling Life-Saving Treatments, Supporting State and local Communities, 2020
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ECONOMIC IMPACT †
MICHBIO: BY THE NUMBERS
1.9%
DISTRIBUTION OF MICHIGAN BIOSCIENCES INDUSTRY
18%
48%
ESTABLISHMENTS
6.2%
Agri-Biosciences Medical Device
26% 31%
31%
Pharma R&D/Testing
EMPLOYMENT Logistics
1.8%
13.6%
22.6%
BIOMATTERS | FALL 2019
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CRITICAL MOMENTS. CRITICAL DECISIONS. BY KEVIN MCLEOD, FOUNDER, PRESIDENT AND CEO, C2DX
C2Dx, home of the STIC IntraCompartmental Pressure Monitor System, is a privately held medical device company dedicated to providing world class products and services to healthcare professionals, while driving costs out of the healthcare continuum. The company is led by Co-Founder and CEO, Kevin McLeod, with over 20 years of experience in the medical device industry. Kevin assembled a team of medical device industry veterans to continue the legacy of the STIC Pressure Monitor. C2Dx acquired the STIC Pressure Monitor from Stryker at the beginning of 2019. Kevin stated, “Since its introduction 30 years ago, the product has been cited in numerous articles and papers due to its clinical effectiveness, accuracy, and reliability. While at Stryker, I had the pleasure of being intricately involved with building the legacy and growth of this product and wanted to carry it on.” C2Dx started manufacturing the STIC product line in 2019 in Kalamazoo, MI. The STIC Pressure Monitor was designed to aid in the diagnosis of compartment syndrome, which occurs when excessive pressure builds up within a muscle space in the body (lower leg and forearm). Compartment syndrome usually results from bleeding or swelling after an injury. This increased pressure within the compartment impedes blood flow to and from the affected tissue. “There are very few emergencies in orthopedicscompartment syndrome is one of them,” said Dr. Christopher LeBrun (Orthopedic Trauma Surgery, Shock
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Trauma Center at UofMD M/C). There are two types of compartment syndrome, acute or chronic exertional. As acute compartment syndrome (ACS) is commonly caused by fractures or trauma, chronic exertional compartment syndrome is most commonly found in athletes. It can be suspected in any extremity that has sustained high energy soft tissue or bone trauma, arterial disruption, a burn, or limb compression. “Even when physicians are well-versed in the signs and symptoms of compartment syndrome, the clinical presentation is sometimes indefinite and confusing. The one factor that must be present in compartment syndrome is increased tissue pressure,” stated Thomas Whitesides. One common diagnostic method is clinically assessing the patient using the 5 P ’s (pain, pallor, pulselessness, paralysis, paresthesia). Statistically, this method performs poorly when used as a diagnostic tool. Studies have proven sensitivity rates as low as 13-54% using this method, when the STIC yielded sensitivity rates of 94%. Additionally, using the 5 P’s as a clinical assessment can be a poor diagnostic tool when the patient is unconscious or unable to cooperate with the physician. The STIC Intra Compartmental Pressure Monitor System is a convenient, self-contained, reliable unit for both an immediate and/or continuous reading of compartment pressure. The STIC offers several advantages in a compact, versatile instrument and is known for its rapid set-up, accuracy, convenience, and cost effectiveness.
C2DX
With the current COVID-19 crisis, C2Dx took immediate action to assist with keeping frontline healthcare workers protected. As of April 2020, C2Dx partnered with Kalamazoo’s Schupan, a family-owned metals and plastics business, to distribute the Aero|Guard. Mr. McLeod made the decision to partner with Schupan to save lives today and be better prepared for tomorrow.
Combined with other essential PPE, the Aero|Guard helps contain aerosols generated during endotracheal intubation and extubation. Its patent-pending collapsible design offers improved sanitation, easy storage, and quick set-up for intubation protection in the OR, ICU, and ER. “It is vitally important to arm hospitals, not only to combat the current crisis and any potential COVID flareups, but to better prepare for future respiratory pandemics,” said Mr. McLeod. “We are proud to partner with a trusted company like Schupan to provide our customers with this desperately needed product.” C2Dx will continue the gold standard legacy of the STIC monitor while leading in the evolution of the diagnosis and treatment of compartment syndrome. To learn more call 888.902.C2DX (2239) or email c2dx@c2dxinc.com.
C2Dxinc.com
BIOMATTERS | FALL 2019
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U LT R AGEN Y X PH A R M AC E U T I CA L I N C .
Seeks Innovative Treatments for Patients Who Have Rare and Ultra-Rare Genetic Diseases
BY ULTRAGENYX
“There is nothing more powerful than treating patients who have never been treated before. Nothing is more uplifting and compelling than being in the room and treating a patient for the first time. I’ve been trying to recreate that moment over and over again.” - Dr. Emil Kakkis, CEO and President. Rare diseases affect more people than cancer and AIDS combined. There are over 7,000 rare diseases affecting 30 million Americans. In fact, one in every 10 people is affected by rare diseases, half of whom are children. Of those children, 30% will not live to see their 5th birthday with rare diseases accounting for 35% of deaths in the first year of life. Notwithstanding the prevalence of rare diseases and their devastating effects, only 5% of rare diseases have an FDAapproved drug treatment. Ultragenyx believes that long-term innovation in healthcare is critical for the many patients with rare diseases who are
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still waiting for an approved treatment and is dedicated to the goal of providing treatments where none currently exist. Founded in April 2010 by Dr. Emil Kakkis with headquarters in Novato, California, and offices and laboratories in Brisbane (CA), Cambridge (MA), Waltham (MA), Woburn (MA), Miami (FL) and Basel (Switzerland), the company employs 796 people globally, and aims to address diseases with high unmet medical need and clear biology for treatment, for which there are few or no approved therapies to treat the underlying disease. Ultragenyx has a diversified pipeline that includes 2 approved therapies (Mepsevii® and Crysvita® − patients in Michigan are being treated with these therapies) and ~20 programs in clinical or pre-clinical development across multiple modalities (small molecule, biologic, gene therapy and mRNA). Mepsevii® is an enzyme replacement therapy approved in November 2017 for pediatric and adult patients who have mucopolysaccharidosis type VII (MPS VII). MPS VII is an ultra-rare disease, affecting ~200 people in the developed world, that is progressively debilitating and life threatening.
ULTRAGENYX
These patients’ bodies do not produce enough of a particular enzyme that breaks down and recycles complex sugars, leading to abnormal sugar storage within cells and tissues. People with MPS VII may experience joint stiffness, short stature, an enlarged spleen and liver, and heart and lung complications. Crysvita® is a biologic administered via subcutaneous injection approved in April 2018 for pediatric and adult patients who have X-linked hypophosphatemia (XLH). Approximately 48,000 people in the developed world have XLH, an inherited bone disease resulting from excess activity of FGF23. FGF23 blocks phosphate re-absorption by the kidney and suppresses phosphate absorption by the intestine, resulting in abnormally low levels of phosphate and causing weak bones and teeth and affecting bone growth. Children with XLH may experience slowed growth, short stature, skeletal deformities, bowed legs, knock knees, and dental abscesses while adults may experience spontaneous fractures, poor bone mineralization, early degenerative joint disease, chronic pain, dental abscesses, hearing loss, fatigue, muscle stiffness and pain, and impaired mobility. In addition to these approved therapies, Ultragenyx’s Crysvita® for the treatment of tumor-induced osteomalacia (TIO), and triheptanoin for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD) may receive FDA approval in the coming months. Combined, 10,000 – 18,000 people in the world have TIO and LC-FAOD, including approximately 100 babies born each year in the United States with an LC-FAOD diagnosis confirmed by newborn screening – Michigan currently offers a newborn screening for all six sub-types of LC-FAOD.
Ultragenyx is also investigating gene therapies for the potential treatment of rare diseases. The company’s two gene therapy programs currently in clinical development are targeting ornithine transcarbamylase deficiency (OTC deficiency) and glycogen storage disease typa la (GSDla) and could treat the approximately 16,000 people in the developed world who have those conditions. The University of Michigan is one of the clinical trial sites for GSDla. Finally, Ultragenyx is partnering with GeneTx Biotherapeutics LLC to develop a treatment for Angelman Syndrome – a condition affecting approximately 60,000 people in the developed world and causing developmental delays, balance issues, motor impairment, and debilitating seizures. Patients with Angelman Syndrome require continuous care and are unable to live independently despite having a normal lifespan. As evident by the small patient populations and severe symptoms of these rare diseases, a diagnosis can feel like a bolt of lightning that abruptly transforms the future and way of life of the patient and their family. Ultragenyx knows the urgency of rare disease patients’ and caregivers’ hope and believes in an obligation to develop the most effective therapies as quickly as possible and to ensure global majority access for patients who can benefit.
ULTRAGENYX.COM
BIOMATTERS | FALL 2019
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NEU M ODX M OL EC U L A R
Sample to Result: State of the Art Testing Solutions BY ALISHA BROWN, DIRECTOR OF MARKETING AND COMMUNICATIONS, MICHBIO SOURCE MATERIALS PROVIDED BY NEUMODX MOLECULAR
Industry infrastructure, with sophisticated labs appearing at major institutions and companies around the globe, coupled with the ability to measure and analyze the expression of the entire genome, has put an emphasis on speed and accuracy in diagnostic testing. 24
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For the past twenty-five years, the bio-industry has been in the midst of an evolution. Add a global pandemic where the ability to track and trace disease spread is essential to preventing infection and saving lives, and the importance of high-throughput, highly efficient, diagnostic testing has never been more evident. NeuMoDx Molecular, an Ann Arbor-based company led by Sundu Brahmasandra, PhD, is on a mission to enable laboratory professionals to operate more efficiently and costeffectively with a family of scalable molecular testing platforms that fully integrate the entire molecular diagnostic process from “sample to result.”
NeuMoDx offers two ‘flavors’ of NeuMoDx Molecular Systems, the NeuMoDx 288 and NeuMoDx 96. The systems are virtually identical but offer varying levels of capacity and throughput. The NeuMoDx Molecular Systems are fully automated, continuous randomaccess analyzers that utilize proprietary NeuDry reagent technology which integrates magnetic particle affinity capture and real time Polymerase Chain Reaction (PCR) chemistry in a multi-sample microfluidic cartridge. The reagent technology combined with the platform, uniquely incorporates robotics and microfluidics in a way that results in higher throughout, improved performance, and increased efficiency.
NEUMODX MOLECULAR
“Our industry-leading equipment can be loaded with an assay and run with little or no intervention by lab workers,” said Dr. Brahmasandra. “In clinical settings, this enables lab personnel to maximize utilization of their resources, while at the same time significantly improving patient care by reporting accurate diagnostic results in a rapid manner. In the case of COVID-19 diagnostics, such efficiency and accuracy of testing can be a powerful tool in significantly slowing the spread of the disease.” When used with the NeuMoDx SARS-CoV-2 ready-touse reagents, the NeuMoDx Molecular Systems require only three steps to reach a result of a SARS-CoV-2 test and can test approximately 660 patient specimens in a 24 hour period while occupying less than two square meters of lab space. On March 31, NeuMoDx was granted an Emergency Use Authorization from the FDA for their SARS-CoV-2 test. The assay, a rapid, automated in vitro real-time RT-PCR diagnostic test for the direct detection of SARS-CoV-2 Coronavirus RNA from nasopharyngeal, oropharyngeal and nasal swab specimens in transport medium, detects conserved regions of two SARS-CoV-2 genes and uses different fluorophores for each reporting target. “In normal operation,” continued Dr. Brahmasandra, “when the machine is loaded with COVID-19 samples, the first results come back in approximately 80 minutes, with additional results every few minutes continuously until all loaded samples are tested. In a hospital or emergency setting when lab workers are likely conducting multiple diagnostic tests at the same time, the STAT mode can be used and testing for COVID-19 can be done without disrupting any other tests currently loaded. This allows for 80-minute test results without requiring a dedicated machine that may sit idle between patients.”
In addition to COVID-19 testing, NeuMoDx has received FDA 510(k) clearance for its NeuMoDx GBS Assay for the detection of Group B Streptococcus (GBA) DNA in antepartum pregnant women and will continue development of tests to detect and monitor sexually transmitted and infectious diseases.
“At NeuMoDx,” continued Dr. Brahmasandra, “improving clinical molecular diagnostic workflow is all we do and our nearly 140 employees are solely focused on developing, producing, and supporting the world’s most advanced systems for automated, high throughput clinical molecular diagnostics.”
NEUMODX.COM
BIOMATTERS | FALL 2019
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AFTER THE
ELEVATOR PITCH Traverse City-based Cambium Analytica is in the business of solving problems. The company, which is working hard to become a top-tier safety compliance lab serving cannabis cultivators, processors, and caregivers, wants to make sure its clients know exactly what it is in the cannabis they grow, sell, or use. Cambium’s approach? High-throughput, and precise, automated testing. “We knew if we didn’t want a technician sitting in a biology lab pipetting thousands of times – there’s too much potential for human error,” says Alexander Adams, Cambium Analytica CEO. “Our customers come to us to help identify and solve problems in their products and supply, so we knew we needed to create the most accurate testing resource possible, with the smallest opportunity for error.” That’s why the company uses the Agilent Bravo liquidhandling platform which can automate 1 to 94 samples
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per run, mitigate the potential for error and create testing precision. Cambium tests for cannabinoids, pesticides, heavy metals, microbials, residual solvents, terpenes, water activity and moisture content, and foreign matter but their specific area of interest is the agricultural side of the industry. “Our primary goal is to aid our clients in producing cannabis that meets compliance standards while providing information on the nature of their plants,” continues Adams. “It’s easy to forget that cannabis is an agricultural product and understanding, for example, key points in the plant’s growing cycle can help our clients increase the quality of their product.” Cambium Analytica was founded in February 2020 and serves clients throughout the state. CAMBIUMANALYTICA.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.
Elan Technologies applies biomedical engineering to solve some of the world’s most pressing social problems – for example, cigarette smoking, particularly in mainland China. Elan is working to address this growing problem and prevent an epidemic of smoking-related illnesses and deaths outnumbering even those in the United States. Elan has developed a safe and unique patented smoking cessation system that is non-igniting and non-electric and can be used indoors where smoking is typically prohibited. The system includes a disposable smoking cartridge (replaced after 5-7 uses or 2-3 days) and a reusable simulator. The cartridge polymer contains a combination of natural herbs and vegetable products clinically shown to flush nicotine and other cigarette-derived chemicals out of the body and the systems works by passive diffusion coupled with tidal breathing by the user. The principle is similar to that of solid air fresheners, but without toxins such as phthalate esters and terpenes.
The system is designed to be affordable (approximately 80% less expensive than similar retail items currently marketed in the US), distributed through non-profit health organizations and government-sponsored agencies and includes information on the importance of reducing tobacco consumption. Initially, Elan is targeting China, Indonesia, India, and other southeast Asia and African counties with heavy tobacco usage. The company is also working on packages for children that include age-specific cartoon characters and toys with messaging on avoiding tobacco products. Elan plans to use their smoking cessation simulators in the US where adopters will be followed to test adherence and success rates with clinical trials will also ensuring efficacy of the device when coupled with instructional materials.
ELANTECHNOLOGIESSOLUTIONS.COM
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Neurodegenerative disease therapy development guided by systems biology and disease-tracking diagnostics
AFTER THE ELEVATOR PITCH
Traumatic brain injury (TBI) is a leading cause of death and long-term disability worldwide. The cognitive and emotional impacts of TBI are often referred to as a “silent epidemic” that puts patients at increased risk of neurodegenerative disorders such as chronic traumatic encephalopathy, Alzheimer’s and Parkinson’s. Despite the growing evidence that TBI’s are life-altering disease processes, the management of the condition has not change significantly in twenty years and there are no approved pharmaceutical treatments. NeuroTheranostics, Inc (NTI) is a privately-held biotech start-up in Detroit, Michigan focused on developing neuro (brain and spinal cord) injury and degenerative disease therapies guided by disease-tracking diagnostics. The company is developing an intravenous peptide drug, NTI101, to be used in conjunction with the current standard of care and administered within hours of a TBI. The drug, as well as other potential drug candidates, selectively blocks actions of a class of enzymes called proteases.
Millions of patients worldwide suffer from autoimmune diseases, (Type I Diabetes, Rheumatoid Arthritis, Lupus, Multiple Sclerosis, etc.) for which there are no cures and few effective treatments. These diseases are called “autoimmune” because in each of them, T cells of the immune system appear to attack normal, healthy tissues. There are no effective treatments for these diseases because the mechanism behind the T cell response is not understood. For each of these diseases, multiple studies have identified genes of the Major Histocompatibility Complex (MHC) as the strongest genetic linkage to disease susceptibility. The normal function of MHC proteins is to capture and present peptides from viruses or bacteria to T cells, allowing the T cell to respond to an infection. Thus, for fifty years, the prevailing hypothesis has been that in autoimmune diseases, the MHC proteins are presenting a “normal” peptide that the T cells are incorrectly identifying as pathogenic, resulting in a T cell attack on healthy tissues.
These enzymes are typically tightly controlled, but in the event of a traumatic or ischemic brain injury, or in the case of neurodegenerative disorders, the enzymes escape control, change the functions of key brain proteins, produce biologically active peptides that are thought to cause brain damage, and serve as biomarkers of brain damage. NTI-101 hopes to halt the disease process from TBI’s and avoid further neurodegenerative conditions. Other commercial opportunities for the technology platform include specific calpain inhibitor-based functional brain imaging (ex PET) and calpain-related blood biomarkers for TBI. The neuroscientists and biomedicinal chemists at NTI have dedicated their research to the study of proteolytic enzymes of medical relevance in pharmaceutical, academic, hospital and biotech settings, and bring that experience to the future of TBI care and neurodegenerative medicine. NEUROTHERANOSTICS.COM
Unfortunately, despite years of intense searching, not a single disease-inducing peptide has been identified, and thus no disease-specific treatments have been developed. Scientists at PTImmune, are taking a completely different and transformative approach to the problem. They have evidence that direct post-translational modification (PTM) of the MHC proteins themselves results in an altered T cell recognition and response. Thus, specific PTM (phosphorylation, citrullination, transglutamination, acetylation, etc,) of critical amino acids on disease-specific MHC proteins results in T cell activation and immunemediated destruction of otherwise healthy tissues. By identifying and targeting the enzymes responsible for these PTM, PTImmune hopes to develop specific, effective treatments for dozens of high-value autoimmune diseases for which none currently exist. PTIMMUNE.COM
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NEW MICHBIO MEMBER SPOTLIGHT
Including Michigan, cannabis for medicinal use has been legalized in thirty-three states and for recreational use in eleven. With this increase comes the urgent need for deliberate and thorough analysis and testing so that consumers, providers, and caregivers can know exactly what is in the cannabis they ingest or recommend.
Symbiote has a deep-rooted history of product development and Herman Miller DNA. Founder, Travis Randolph, served on the team who launched Herman Miller’s Action Office® and Co/ Struc® Systems. The company, founded in 1983, enabled Travis to develop Co/Struc® compatible products, and later, a complete furniture solution.
Such testing facilitates the move to mandate that legalized cannabis adhere to the same standards as other food and drugs. Therapeutic Health Choice (THC) has set out to be the gold standard for cannabis testing.
The tech boom introduced labs with electrical and data components. Symbiote formed long-term relationships with Apple, Facebook and Google, most recently completing Apple Park Campus.
The THC mission is to provide accurate and reliable analysis to the cannabis industry to ensure that consumers may be educated about cannabis consumable content and contribute to maximizing the quality of its clients’ products through research and development. To that end, THC has developed state-of-the-art practices partnered with regulatory guidance that lead to maximum cannabis safety.
In 1991, Symbiote engineered rows of height-adjustable tables as a wire harness assembly line for Boeing airplane wings. This inspired the ErgoStat®, a Symbiote core product.
As a Michigan-owned and operated organization, Therapeutic Health Choice is committed to ensuring the integrity of the state-regulated cannabis program by executing an ethical business model, advocating for the wellbeing of the public, and earning the trust of the community through the company’s genuine display of professionalism and moral integrity. Beyond providing safety testing for potentially lifechanging cannabis products, THC aspires to enrich the surrounding community, as well as support charities and organizations aligned with medical cannabis research and mental health wellness. Life’s endless need for new and improved medical solutions paired with THC’s relentless pursuit of innovation provides a solid foundation to the cannabis industry in the State.
The West-Michigan company focuses on Healthcare, Academia, Environment, Homeland Security and Defense. It outfits labs doing highly specialized tasks with rock solid, modular furniture that is easy to reconfigure. Symbiote is good at fine-tuning and customizing products for a customer’s specific needs, according to Randolph. “It is furniture for innovative work,” he says. Last year Travis’ son, Barrett, returned to Symbiote after a 7-year period at Herman Miller in R&D and Business Development. In this new role, Barrett is focused on building relationships, expanding markets and delivering value in every project.
SYMBIOTE.COM
THCHOICE.COM BIOMATTERS | FALL 2019
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E HME T HE A LT H
Breast Cancer Treatment is More Effective and Accessible with MammoKnife BY ALISHA BROWN, DIRECTOR OF MARKETING AND COMMUNICATIONS, MICHBIO BASED ON INFORMATION PROVIDED BY EHMET HEALTH
One in eight women will be diagnosed with breast cancer at some point in their lifetime, according to 2014 - 2016 data from the National Cancer Institute. Even with approximately 90% 5-year survival rates, breast cancer still results in over 41,000 deaths per year in the United States and over 260,000 new cases diagnosed each year. Of those, over half undergo radiation as part of their treatment resulting in radiation departments nationwide dedicating nearly one-quarter of their resources to the treatment of breast cancer. Unfortunately, though much progress has been made in early detection, radiation machines used in treatment are often outdated and not specifically designed to treat breast cancer. In addition, women in rural America are faced with a lack of precision therapies near their home contributing to both higher mastectomy and mortality rates. Ehmet Health, with its proprietary technology, will shift the paradigm of care while simultaneously improving patient outcomes and reducing unwanted side effects. Ehmet Health is a privately-held medical device company headquartered in Plymouth, Michigan with an innovative product, the MammoKnife, designed to address the challenges faced by hospitals and patients including complications from radiation, economics around reimbursement, and patient access for breast cancer radiotherapy.
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“Current practices in radiation therapy for breast cancer patients have some concerning aspects,” says Neal Clinthorne, Chief Technology Officer at Ehmet Health, “which are not the fault of the hospital or the doctor but instead result from the expense of radiation equipment.” Most radiation departments rely on a machine capable of treating many types of cancer. In most cases, breast cancer patients will lie in a supine position, on their back, and these linear accelerator-type machines will use radiation beams from two angles to target specific areas on the breast where cancer is present. However, the supine position puts the patient at significant risk for excessive burning or scarring on the skin, as well as, damage to critical organs such as the heart and lungs, as stated by the American Heart Association.
EHMET HEALTH
“Radiation departments are expensive to build, equip and maintain with the average start-up cost running upwards of $10 million,” continued Clinthorne, “which is why many hospitals invest in equipment that can treat many cancers, even if the lack of specialty results in unwanted side-effects for some. The expense is also a reason most rural or small hospitals don’t have radiation therapy departments at all.” A study in Iowa found that 50% of patients travel more than 30 minutes to receive radiation treatment and patients in the most rural areas could travel more than three times that long for treatments that need to take place daily or several times a week. This, when coupled with the high risk for sideeffects, is concerning for patients who may choose to forgo or shorten the recommended treatment. “When you take all of these aspects – the lack of cancerspecific design in radiation machines, the possibility of side-effects, and the logistical impediments faced by many patients,” continued Clinthorne, “you can see the opportunity for innovation.” Ehmet Health’s flagship product, a self-shielded radiation machine designed specifically for treating breast cancer patients, appropriately named the MammoKnife, focuses on two things – allowing patients to lie comfortably in the prone, downward facing, position for effective treatment and being affordable enough that hospitals, regardless of their size, can make the investment without sacrificing their bottom-line.
deployed in a standard trailer, making it the first-of-its-kind precision radiation therapy equipment offered in a mobile setting driving precision radio therapy closer to the patient. Second, MammoKnife allows patients to lie in a prone position with breast tissue resting in a cavity in the machine. The patient can then rotate 360 degrees within the unit to deploy the treatment beams at precisely the right angle – reducing unwanted irradiation of healthy tissue and damage to critical organs near the cancer site, as well as, potentially achieving better cosmetic outcomes.” Michael Teicher, Ehmet Health CEO notes, “The MammoKnife is not just a product, it is a movement that will create a global brand by bringing life-saving technology to women in segments – both demographically and geographically – that have historically been neglected.”
With a team of experienced professionals dedicated to bringing “a distinguished honesty to the medical device industry,” Ehmet Health is working to improve patient outcomes and increase accessibility of radiation treatment for breast cancer patients for the MammoKnife.
“The MammoKnife has two features that set it apart from other radiation machines used for breast cancer,” says Clinthorne. “First – it’s self-shielding which means it doesn’t need to be housed in the typical bunker-style radiation department. In fact, the MammoKnife is designed to be EHMETHEALTH.COM
BIOMATTERS | FALL 2019
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VIEWPOINT
Collaborating Towards a Cure for NF1 YOORI KIM, SCIENTIFIC OFFICER, GILBERT FAMILY FOUNDATION
The Gilbert Family Foundation (GFF) is on an ambitious journey to develop effective treatments and ultimately a ‘cure’ for neurofibromatosis type 1 (NF1). NF1 is a complex rare disease that can lead to more than 20 different types of symptoms; from skin pigmentation to bone malformations to vascular complications to learning disabilities and tumors on nerves almost anywhere in the body. Depending on the location and severity of tumors (both unpredictable factors), individuals with NF1 can experience lifechanging physical deformations, functional deficits, and even death from malignant cancers. Most individuals with NF1 develop some combination of these symptoms by adolescence and their quality of life is impacted for their rest of their lives. Solving the enigma that is NF1 requires expertise and innovation in many disciplines. Bringing the best experts and technologies together is the key to the work that we do at GFF. Take our Vision Restoration Initiative (VRI). Approximately 20 percent of children with NF1 develop tumors in their visual system, called optic
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pathway glioma (OPG). In many of these children, OPGs cause damage to the optic nerves and subsequent blindness. VRI’s goal is to develop treatments that can restore vision loss and prevent further loss. This ambitious goal requires a deep understanding of OPG pathology, visual system anatomy and function, nerve protection and regeneration approaches, not to mention the specialized tools used across these varied disciplines. We saw that as NF1 researchers were gaining more insights into the pathology of OPGs, there were exciting advances being made in other eye diseases and regenerative medicine as well. We thus took on a timely opportunity to bring together leading experts across these disciplines and formulated the VRI ‘Dream Team’ consortium. Twelve world-class researchers across nine research institutions have committed to exchanging research tools, data, ideas, and feedback on each other’s work. GFF convenes the Dream Team regularly to share updates and problem solve challenges together. This ongoing dedicated teamwork will be essential to the success of VRI. While VRI tackles a major symptom of NF1, GFF’s Gene Therapy Initiative (GTI) is another collaborative venture that takes aim at the cause. This involves developing treatments that target the specific genetic abnormalities of NF1, with the ultimate goal of finding a ‘cure’ that could address all possible features of the disorder. In our initial stage of investigation, we are
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interested in identifying which available gene therapy approaches are the most promising for NF1. To answer this question, we have brought together researchers who have expertise in various gene therapy techniques and have experience applying them in other genetic diseases and have teamed them up with traditional NF1 researchers who importantly contribute the fundamental disease expertise. VRI and GTI are living examples of how GFF drives specific technological innovations by enabling and fostering collaboration. We organize regular collaborative meetings, facilitate exchange of information and materials across research labs, and provide a data sharing platform for all our research partners. In addition, as most of our funded researchers have never worked on NF1 before, we are growing the research community that is focused on our rare disease. GFF has undertaken ambitious goals to help restore quality of life for NF1 patients everywhere. Given the complexity of the disorder, we recognized from the getgo that no single individual or organization would be able to accomplish this in our lifetimes, if at all. Thus, we embarked on our journey by bringing together multidisciplinary research teams focused on common goals and creating a culture of collaboration.
GILBERTFAMILYFOUNDATION.ORG
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Foley Hoag is proud to help MichBio drive Bio-Industry growth in Michigan
Learn more at foleyhoag.com BIOMATTERS | FALL 2019
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CONSULTANTS TO MEET THE WORLD WE LIVE IN IS RAPIDLY CHANGING. Scientific and technological advancements that have taken hundreds of years to come to fruition are now being achieved in a matter of months with no signs of slowing down. But even with the rapid changes in the world of science and technology, the simple truth remains; without a physical space to conduct your research, how will your work make an impact? This is where Innovative Engineered Solutions (IES) comes in to play. Located in Clinton Township, IES is a full service Architectural and Engineering firm that specializes in Commercial and Industrial facilities design, including Structural, Mechanical, Electrical, and Civil & Surveying services. For more than fifteen years, IES has had the privilege of serving Clients in a plethora of markets
including Higher Education, Manufacturing, Institutional, Government and R&D across Michigan, Illinois, Ohio and Indiana. With decades of industry experience, the team of licensed professionals have always made it their priority to stay on the cutting-edge of design innovation using 3D Building Information Modeling (BIM) and other software and processes to better serve their Clients. Additionally, IES’s sustainable building design focuses not only on Green Energy Conservation principles but also on the occupants’ health and safety. Whether you wish to construct a brand-new state of the art Bioscience facility or repurpose an existing space to suit your needs, IES is ready to help make your vision a reality and empower you to continue your efforts in moving mankind forward. IES-ENGINEERING.COM
INNOVATION IS VITAL. Within the people sciences, brain scans led to new areas of research where neuroscience now informs organizational practices. One outcome of which has been to overturn how performance management is best done. Michigan HR Group not only tracks these changes, but also adapts them to the needs of their clients. Changes are coming. Even if you thought Netflix and health scientists were on to something, that a pandemic was possible, you were not thinking, “Yeah, 2020 Q1 will be when that happens!” And now whether you are responding to face masks at work, some staff wanting their 300% unemployment checks versus their jobs back, or core compliance, Michigan HR Group can support you by partnering on most anything related to people and process effectiveness.
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Options are endless. Rework your QMS, replace that role, reengineer product design, reimagine onboarding new staff - there are so many things to do or redo. Whatever changes you anticipate or experience, your team is one key to success that you cannot afford to undervalue. You can’t make all the changes at once or even in the next 12 months, but you can choose a couple of changes, skills, resources or solutions to start or build. Help is available. Michigan HR Group’s mission is guiding and protecting owners and leaders through truth and grace. Consider one HR impact area or other improvement you need to learn to do better (Michigan HR can teach you) and one to let go of so you can focus (you can outsource to Michigan HR). MI-HR.COM
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 Thomas Moga at tmoga@dykema.com or Jin Koh at jkoh@dykema.com.
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www.dykema.com
BIOMATTERS | FALL 2019
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ADVERTISERS
Dykema....................................................................................35 Foley Hoag..............................................................................33 Impact Analytical.....................................................................4 Metric Marketing..................................................................IBC Michigan State University .....................................................2 MichBio Preferred Providers...............................................35 Michigan Economic Development Corporation............. IFC Pfizer........................................................................................34 Terumo.....................................................................................33 University of Michigan ...........................................................4 VWR..........................................................................................36
Want to advertise in the next issue of BioMatters? Contact alisha@michbio.org
MICHBIO | michbio.org 22238_BIO Ad outline.indd 1 36Michigan
3/26/2020 2:44:01 PM
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MICHAEL
Akadeum Life Sciences
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