Spring 2019 BioMatters

IN THIS ISSUE:

06 PATIENTS ARE THE MOST IMPORTANT BOTTOM LINE LISA SIMMS BOOTH

12 HOW CAN A FACILITY PROMOTE DISCOVERY? DESIGNING FOR TEAM SCIENCE. HED

22 AFTER THE ELEVATOR PITCH EMERGING COMPANIES

30 THE POWERFUL LENS OF METAGENOMICS SWIFT BIOSCIENCE

SPRING 2019

A magazine showcasing Michigan’s biosciences industry

THE HUMAN CONNECTION BIOSCIENCES AT THE PERSONAL LEVEL

PURE POTENTIAL

Ann Arbor. A city where people and businesses have the resources and opportunities to bring new ideas to life. Rated the most educated city in the U.S. by Wallethub.com, Ann Arbor’s breadth of talent supports a wide range of specializations and industries, including life sciences, software engineering and mobility. From tech startups to global investors, Ann Arbor is a smart choice for any forward-thinking business.

michiganbusiness.org/AnnArbor

PRESIDENT’S MESSAGE Bioscience innovation leads to the discovery and development of new therapies, diagnostic methods, drug delivery systems, medical devices, renewable chemicals, biofuels and food/nutritional products that save and improve lives.

Such products and technologies offer patients hope of better health outcomes and quality of life.

Michigan’s bioscience companies, as well as the state’s academic and clinical research institutions, work in all those areas with precisely that patientcentric focus. Across multiple disease, therapeutic and consumer product areas, the stories in this BioMatters™ issue are clear evidence of the bioindustry’s dedication to maintaining the human connection in their work.

“A commitment to health and well-being guides us all in the bio-industry, and the results of our efforts shine through the powerful, personal stories of those we impact daily with our innovative treatments, technologies and products.”

From my own experience as a pharmaceutical R&D scientist and manager, I know only too well the passion that drives bioscience researchers and innovators to change the human condition. Nothing makes me more proud than when a family member, friend or stranger thanks me for my efforts in having helped develop such drugs like Lipitor®, Accupril®, Lyrica® and Eliquis®, among others, that have had a positive impact on their lives or that of their loved ones.

A commitment to health and well-being guides us all in the bio-industry, and the results of our efforts shine through the powerful, personal stories of those we impact daily with our innovative treatments, technologies and products.

For us, the sense of urgency is real and compels us to challenge the boundaries of science, to make discoveries and to gain new knowledge. Innovation transforms those discoveries into inventions and moves them to market in the face of numerous and arduous challenges. Throughout, we do the right thing to ensure safe, efficacious and meaningful products.

We are proud of the work we do, proud of the employees who embody and give expression to our mission and who are driven by an urgency to serve and give back.

This BioMatters™ issue showcases Michigan’s vibrant biosciences cluster and the innovation that furthers the bio-industry’s success and its focus on improving health and well-being. Michigan’s bio-industry truly puts the human condition first.

Sincerely,

STEPHEN RAPUNDALO, PHD President and CEO, MichBio BIOMATTERS | SPRING 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.

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.

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MICHBIO | michbio.org

California Illinois Michigan Minnesota Texas Washington, D.C.

www.dykema.com

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

PREMIUM MEMBERS GOLD

Stephen Rapundalo, PhD President and CEO Alisha Brown Editor Director, Marketing and Communications

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

Elizabeth Morgan Foster Director, Membership and Operations

Designer: Daina Fuson Designs Printer: Progressive Printing

Nancy Marcotte Manager, Finance

© Copyright Michigan Biosciences Industry Association, DBA MichBio

SILVER MICHBIO BOARD OFFICERS CHAIRMAN Paul Morris 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 Vacant TREASURER Sandra Pennell, CPA Vericel, Controller

MICHBIO BOARD DIRECTORS

BRONZE

Sean Callaghan 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 Ken Massey, PhD Wayne State University Senior Director, Venture Development, Technology Commercialization Kevin McLeod NOVUS Biotechnology Fund General Partner

PATRON

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

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

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 | SPRING 2019

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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

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TABLE OF CONTENTS

08

14

28 WANT TO RECEIVE BIOMATTERS?

06 |

Patients are the Most Important Bottom Line

08 |

Taking Engineering to Heart

10 |

Food Security, Bird Flu, and Michigan

12 |

How Can A Facility Promote Discovery?

Designing for Team Science.

14 |

The Journey of a Plasma Donation

16 |

From Biofuels to Baby Care

18 |

Michigan Biosciences: By the Numbers

20 |

Biotechnology Ecosystem: By the Numbers & Issue Spotlight

22 |

After the Elevator Pitch

27 |

Consultants to Meet

28 |

What is BioArtography?

30 |

The Powerful Lens of Metagenomics

31 |

New MichBio Member

Lisa Simms Booth

Packaging Compliance Labs

Zoetis

HED

CSL Behring

Ecovia Renewables

MichBio

BIO

Emerging Companies

miLEAD & Ruby Leaf

BioArtography

Swift Bioscience

Kestrel Management

Visit michbio.org/subscribe

BIOMATTERS | SPRING 2019

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PATIENTS are the Most Important BOTTOM LINE

BY LISA SIMMS BOOTH

In my remarks at the 2018 MichBio Expo, I talked about the changing landscape in medical research and healthcare delivery as patient voices, preferences, and experiences are more integrated – making them partners rather than bystanders. You can see this change manifested in how the US Food and Drug Administration (FDA) has prioritized patient-focused drug development as part of the regulatory process. We saw expansion of opportunities for patient input being factored into regulatory decisions as part of the 21st Century Cures Act. And, we see it every day in new approaches to clinical trial design, efforts to capture patient outcomes data, and patient organizations driving the research and development process.

At the Biden Cancer Initiative, we are committed to creating the cancer research and care systems that patients think we already have.

This means we are focused on two things: changing the culture of research and care, and driving the “urgency of now” so that we can improve health outcomes and save lives.

We believe that we need to create a system that fosters innovation and creativity, rewards risktaking, and gives patients what they deserve – a system that puts saving lives above anything else.

At the Biden Cancer Initiative, we think about

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every patient, every family, every community having to deal with a cancer diagnosis and the complex and confusing maze they must navigate.

What can we do as an oncology community to improve their experience and improve outcomes?

And what can we do at the Biden Cancer Initiative to bring together the collaborations needed to make this happen?

The patient is not alone in their journey and that is why we engage with the broader community in cancer. Over the last two years, Dr. Jill Biden has visited with communities all around the country and has learned valuable information from caregivers, oncology nurses, patient navigators, and oncology social workers. We did this because we understand that the systems change doesn’t matter if we don’t understand what is needed by those on the front lines with patients and their families. At our June 2018 meeting of the Biden Cancer Collaborative, we heard valuable input from leaders from over eighty cancer and patient advocacy organizations providing valuable insight on where we can work together on common issues, share best practices, and better serve our patient communities.

For me, my advocacy career started with a focus on social justice issues which fortified my passionate belief in the power that each of us has when we work together toward common goals.

I had never worked in science or health yet a twist of fate led me to work for an organization fighting to speed the delivery of new promise from medical research.

FEATURED GUEST ARTICLE

Our approach is grounded in seven principles that illustrate our commitment to culture change with the patient at the center. Those principles are:

I would not have known that I would have found my true passion to raise the voice of those dealing with cancer and other diseases. That job coincided with my mom’s diagnosis with ovarian cancer – so I’ve lived this journey up close and personal.

My mom passed away eight years ago and my passion for this work is for her and all the other people I have met over the years. I want to save families from going through what we went through, I’m sure you know people that have been impacted by cancer. Remember them, when you are exhausted, frustrated or you can’t remember why you got into this field of work. Do it for them – it’s not just about the bottom line. Patients and their families can’t wait – the clock is ticking.

LISA SIMMS BOOTH Senior Director of Patient and Public Engagement, Biden Cancer Initiative Alumna of Michigan State University

1.

Share data and knowledge — As Biden Cancer Initiative co-chair Dr. Biden has said, “Right now, if we stopped research entirely, if we never spent another dime on finding new cures — we could still save thousands more lives by doing one thing: sharing data and knowledge that already exists.”

2.

Ensure affordable access to the best in care for all people — Where you live should not determine your health outcomes and for too many, quality health care is geographically out of reach.

3.

Bring patients into the design of our research and care systems — In almost every other industry, decisions are made by understanding and anticipating the needs and wants of consumers or are developed based on the user experience.

And yet, when it comes to developing life-saving products, we are still in the early days of directly engaging the patient community.

4.

Reduce disparities in cancer outcomes — Technological and scientific advances have transformed cancer research and care, and yet, too many communities do not have access to these breakthroughs because of their ethnic background or economic status. Tools are being developed to reach these communities, but they aren’t yet enough to address the scope of the need.

5.

Put progress ahead of personal gain — A close look at how we fund research, encourage innovation, and support young scientists is needed so we can align incentives with outcomes that matter – better health outcomes for patients.

6.

Find new solutions, disseminate — It’s no longer enough to have pilot projects and demonstration initiatives. We must scale what works, know what doesn’t, and learn from experiences as they unfold.

7.

Help people navigate their journey — The twists and turns of one’s cancer journey can be so complex that it leaves patients, their families and support networks confused and unsure. We must focus on providing easy access to high quality information for the challenges that face patients from diagnosis to survivorship.

For more information on the Biden Cancer Initiative visit BIDENCANCER.ORG. For more information on cancer specific disparities visit SHCLLC.INFO/CANCER-INDEX-ATLAS/

BIOMATTERS | SPRING 2019

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TAKING ENGINEERING TO HEART

BY JODI STANLEY, WRITER, PACKAGING COMPLIANCE LABS AND SARAH ROSENBLUM, DIRECTOR OF BUSINESS DEVELOPMENT AND MARKETING, PACKAGING COMPLIANCE LABS

Packaging Compliance Labs is eyeing its third major expansion after doubling its space just one year ago. Co-founders Matt Lapham and Ryan Erickson recognize the significance--and the seriousness--of their upward trajectory.

Lapham noted, “We never want to lose sight of the people who need the medical products we work with.”

The medical market packaging engineering and testing firm works hard to protect that small-business, customercentric mindset from the pitfalls of big business. Lapham stated, “We are fortunate to work with global leaders and major corporations, but we also work with small startups and OEMs. Every one of those clients is in the business of bringing life-improving or life-saving products to people and families.

We honor that reality with our clients. Internally, we have a continuous improvement culture that keeps us mindful.”

MAJOR MILESTONES Recently, Ryan Erickson, Vice President of Engineering attended an open-heart surgery at a northeast Ohio hospital.

The observation allowed him to experience the full journey of a life-saving medical device, like those for which he designs packaging systems every day.

Scrubbed and gowned, Erickson had listened intently as the cardiovascular surgeon explained that the open-heart surgery would repair a congenital heart condition that had not only severely affected the patient’s quality of life, but had been a looming threat to her life altogether. The surgeon explained that the procedure would replace a defective aortic valve with a prosthetic valve.

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Seeing the heart lay on ice while the ECMO (Extracorporeal membrane oxygenation) machine sustained the patient’s life and the surgeon implanted the valve was sobering. Yet, it helped Erickson prepare for upcoming projects engineering packaging for emerging technology in prosthetic cardiac devices.

Within hours, the young patient, with a fully functioning heart, was wheeled to recovery with a new chance at a healthier, more active life.

Back in Michigan, Erickson reported that it had been meaningful to reflect on the young patient’s new hope for the future and how her family must have felt. He went on to tell his team that the experience had driven home the weight and significance of their work. After hearing the story, it was easy for the team to agree that every strict quality assurance measure they follow is worth the effort.

Even PCL’s in-house training programs emphasize the human side of the medical device equation, whether lab or engineering. Quality Manager and Senior Packaging Engineer Ryan Ott noted, “We hammer the message home that whether designing a joint replacement package or running a transit test, oversights could hurt someone—and that someone could be your mom, your grandma, your child or brother.”

PACKAGING COMPLIANCE LABS

COINCIDENCE AND CONSEQUENCE Erickson added that just as his operating room visit was so inspiring, it brought to mind a past project that had hit close to home in the opposite way.

He recalled, “A client distributed a wide variety of popular health care products. That client was outsourcing the packaging of this product line, as happens all the time, and had received some negative reports that led them to enlist PCL to research and investigate the potential problems.“ “It just so happened around that time, a PCL family member had cause to use these products and had ordered them online.

When they arrived, the PCL employee saw the products at the home of their family member and was alarmed to see multiple failures and defects in the “sterile” packaging. Confiscating the packaged products, our team member advised the family member to seek a substitute.”

Erickson continued, “Examining those products in the PCL lab, our findings showed a flagrant disregard for quality control that was confirmed upon visiting the outsourced facility. We don’t usually see the actual products we test. In this case, timing was everything—and unfortunately for the client, the concerns reported were valid.”

“We had product from the marketplace, we’d confirmed the failures, and our investigative visit to the outsourced facility fueled our report and recommendations to help our client restore their quality standards– starting with severing the relationship with the careless, non-compliant vendor.”

It is stories like these that make the day-to-day work feel worthwhile and exciting. Packaging Compliance Labs is proud to be part of the MI Bio community!

PKGCOMPLIANCE.COM BIOMATTERS | SPRING 2019

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Food Security, Bird Flu, and Michigan: How One Company is Leading Efforts Internationally to Combat the Growing Challenge of Transboundary Animal Diseases

BY ALISHA BROWN, DIRECTOR OF MARKETING AND COMMUNICATIONS AT MICHBIO

In March of 2017 more than 125,000 chickens at two commercial farms in Tennessee were quarantined and later culled to prevent the spread of the Avian influenza strain H7N9.

That was a small outbreak. Especially when compared to the more than 17 million birds at 42 commercial farms in British Columbia that were slaughtered in 2004 to stop the spread of Highly Pathogenic Avian Influenza (HPAI). That outbreak wiped out more than 90% of the local poultry population and caused more than $380 million in gross economic impact.

Animal diseases, including Avian Influenza, Bovine Blue Tongue, African Swine Fever, Foot and Mouth Disease and others, impact the lives and livelihoods of people around the globe, cause concerns in food security, drive up consumer prices, and, in some cases, can be transmitted to humans.

These diseases, and others, are considered Veterinary Transboundary and Emerging Animal Diseases (TEDs) and are exactly the type of challenge the international team at Zoetis helps to combat To be classified as a Veterinary Transboundary and Emerging Animal Disease, the disease must be easily spread among nations, cause significant impact to the economy or the food security of those nations, and require coordinated effort to control it. Rapid response is essential, and Zoetis strives to be first to the know and fast to market with solutions. With products sold in more than 100 countries and Research and Development headquarters in Kalamazoo, Michigan, Zoetis is uniquely situation to evaluate and respond to the threat of TEDs.

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When an outbreak of porcine epidemic diarrhea killed millions of piglets in the U.S. in 2013, Zoetis developed and received a conditional license from the U.S. Department of Agriculture (USDA) for a vaccine in only 14 months to help pork producers and swine veterinarians protect healthy pregnant female pigs (sows and gilts) from the devastating disease.

In 2014, Zoetis was swift to help farmers control Schmallenberg virus with authorization in the European Union of their Zulvac SBV vaccine. First identified in late 2011 in Germany and subsequently in eight countries, the virus infects cattle sheep and goats causing fever, diarrhea, and reduced milk yield in adult animals. In pregnant animals, in can infect the nervous system of the fetus causing brain damage and skeletal defects.

In addition to working quickly to bring vaccines to market for epidemic diseases, the team at Zoetis focuses on prevention through thorough evaluation of emerging and potentially emerging illnesses.

ZOETIS

“The Zoetis Center for Transboundary and Emerging Diseases’ strong alliances with academic and government centers of excellence in disease surveillance worldwide allows our team of experts to determine which diseases are likely to emerge and cause problems so that we may focus our R&D resources toward developing preventative vaccines for those diseases,” said Dr. John Hardham, Research Director at the Zoetis Center for Transboundary and Emerging Diseases.

Dr. Hardham added that expertise in traditional and rational vaccine development, as well as, regulatory affairs and flexible, high-quality manufacturing that makes it possible to scale up product manufacturing in response to a disease outbreak are also essential to Zoetis’ success.

In addition to a wide range of vaccines, Zoetis’ diverse portfolio of approximately 300 produce lines includes medicines, point-of-care diagnostic instruments and tests, genetic tests, and biodevices for livestock and companion animals.

ZOETIS.COM

BIOMATTERS | SPRING 2019

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How Can A Facility Promote Discovery?

Designing for Team Science.

BY EMILY HAVELKA, CPSM, MARKETING SERVICES, HED

Wayne State University’s Integrative Bioscience Center (IBio) in Detroit, MI houses researchers from five separate colleges at WSU – environmental sciences, medicine, biomedical and systems engineering, and biobehavioral health – who work side-byside solving urban health issues that plague Detroit residents.

Obesity, asthma, diabetes, hypertension, and cardiovascular diseases are all tackled collectively, in a single facility, by experts in these different disciplines.

Before the opening of IBio in 2015, research at Wayne State was conducted in small, heavily-specialized and isolated teams scattered in multiple facilities. That arrangement severely limited the opportunities for multidisciplinary cross-pollination of ideas, and for the graceful adaptation of the facilities to the ever-changing team sizes that occur with varying funding.

HED (Harley Ellis Devereaux) was brought in to create a space that would solve both of those challenges and help to realize a shift in the WSU research philosophy that was transitioning from individual and independent investigator teams to a multidisciplinary research approach with cross-functional collaborations.

The new facility provides approximately 205,000 gross square feet in support of research themes, not departments, including Biomedical Engineering, Cardiovascular, Diabetes and Metabolism, Behavioral Science and Computational Biology.

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“Inside, IBio leverages standard offices, workstation modules and lab bench configurations,” says HED Studio Leader Chris Vogelheim. “The high degree of visibility between team members is augmented by open meeting and group work spaces that are shared by all the teams.

Because there is nothing “owned” or inherently specialized about these settings, teams can easily reconfigure, and research themes are free to shrink or grow as their funding allows.”

He continued, “IBio was crafted not only to accommodate individual research, but also to foster interconnection and invite the kind of serendipitous juxtapositions of work, research and thinking that change lives and impact entire communities through unprecedented breakthroughs. In IBio, behavioral and environmental scientists are working alongside heart disease and diabetes researchers to develop more complete understandings of these ailments.”

Originally a historic Albert Kahn building, IBio’s restoration and prominent placement on Woodward Avenue makes an important statement in Detroit about investment in the city and focus on local and global health issues. In reimagining the ways researchers can enrich—and advance—each other’s work through collaborative problem-solving, IBio is powerfully reshaping the ways we understand, study and treat systemic urban health risks, worldwide.

HED

RESULTS •

HED provided full Design, Architecture, Laboratory Planning, Sustainability Planning, and Mechanical, Electrical, Plumbing and Structural Engineering services.

•

To meet critical state funding deadlines, HED completed early design on an accelerated five-week timeline.

•

HED was able to maximize efficiencies in the floorplan, allowing the final area of the completed building to be 3,000 square feet smaller than the program: yielding an initial-cost savings of $1.1 million plus significant reductions in annual life cycle costs.

•

A LEED-Gold certified structure, IBio achieves every IEQ credit in LEED, with energy consumption measured at 60% below the Labs21 baseline.

Founded in Detroit in 1908, HED is a thought leader in architectural and engineering design with over 100 years of continuous practice. Our focus is Science & Technology and Corporate & Commercial projects. We leverage the synergies across these different project types to create better spaces by helping clients better solve their problems and find efficiencies.

Our designs inspire innovation and collaboration, maximize energy performance, and help our clients to keep on the leading edge of their rapidly-changing industries.

With more than 420 professionals in Detroit, Boston, Chicago, Dallas, Los Angeles, San Diego, Sacramento, and San Francisco, HED has the design expertise, dedicated teams, and strong project management capabilities to allow us to quickly deliver innovative and transformative design solutions to every client, every time.

HED.DESIGN

AWARDS •

R&D Magazine Renovated Lab of the Year (2017)

•

AIA Detroit Honor Award (2016)

•

CREW Detroit Honor Award (2016)

BIOMATTERS | SPRING 2019

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The Journey of a Plasma Donation:

Did you know that you have Gold in your Veins?

BY CSL BEHRING COMMUNICATIONS TEAM

Donating plasma is a simple process – much like donating blood. However, once the plasma is collected, it starts a long journey before ultimately becoming the main ingredient in a life-saving therapy for a person in need.

The process utilizes an apheresis technology similar to that used by blood banks to collect platelets. As a result, the red cells and other cellular constituents are returned to the donor while the liquid plasma is retained.

Plasma contains a large number of proteins that have potential therapeutic uses in both patients who lack those proteins (replacement therapy) and for disease modulation.

The plasma that is collected is not for direct transfusion but rather for further manufacture. Therefore, many units from many donors are pooled in order to generate a therapy through a process called plasma fractionation.

THE PLASMA DONOR Healthy adults between the ages of 18-65 who weigh at least 110 pounds (50kg) are eligible to donate.

The potential donor must have a permanent address and consent to undergo a medical examination before their first donation. Donors also must have two tests performed in the plasma center to determine if they are healthy enough to donate before each donation (hematocrit and protein level).

On the first visit they not only answer a lengthy questionnaire but undergo a brief physical examination.

On subsequent visits, donors must answer a shorter health questionnaire. Plasma is only used for an injectable product after two successful donations in a six-month period. The process assures the procedure is safe for the donor and the plasma collected will be safe for the patient.

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THE PLASMA DONATION PROCESS Two hundred seventeen CSL Plasma collection centers throughout the US, Hungary, and Germany, including 18 in Michigan, welcome donors every day. The donation process takes about 45 to 90 minutes. During that time, blood is drawn, plasma is separated from red blood cells and collected, and then the cells are returned to the donor.

(A process called plasmapheresis) •

One-donation results in 21 to 30 oz. (625 to 880 ml.) of plasma, depending on the donor’s body weight.

•

Because the donor’s cells are returned at each donation and the donor receives 500 ml of saline to help replace lost fluid, plasma donors are safely able to donate twice per week.

TESTING AND INVENTORY HOLD Samples from every plasma unit are sent to the CSL Plasma Knoxville, Tennessee Laboratory to be tested for hepatitis parvovirus and human immunodeficiency virus. Plasma units can be released for use after a 60-day hold if all tests were negative and all other qualifying criteria have been met.

The hold allows for the removal all units collected from a donor in the prior 60 days if either a positive test occurs or disqualifying information is obtained. The qualified units are shipped from our Plasma Logistic Center to a manufacturing facility. We have two logistics centers in the US (Indiana and Texas) and one in Germany.

MANUFACTURING The frozen plasma units are shipped to CSL manufacturing sites in Illinois, Germany or Switzerland where they are fractionated into various proteins that are further purified into therapeutic products.

•

Manufacturing biotherapies from plasma takes about 9 months

CSL BEHRING

THE PATIENT

ENSURING PRODUCT SAFETY

It takes about 9 months for a donation to result in a therapy ready for patient use. Plasma therapies are used to treat bleeding disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. They are also used in cardiac surgery, organ transplantation, burn treatments and to prevent hemolytic diseases in newborns.

To ensure the highest quality plasma-derived biotherapies, CSL applies four layers of safety in the manufacturing process:

•

•

•

Careful plasma donor selection/ screening

•

Plasma testing that can detect viruses even before a donor has symptoms

More than 1,200 plasma donations are needed to treat one person with hemophilia for a one-year supply of medicine 1.

•

60-day hold/ quarantine

•

Purification/ viral reduction and elimination during manufacturing

More than 130 plasma donations are needed to treat one person with a primary immune deficiency for one-year supply of medicine.1.

•

Pharmacovigilance which involves follow up of clinical experience with products

CSL Behring Knoxville Lab

A plasma journey starts and ends with a single person – the donor and the patient.

CSL Plasma is focused on ensuring that at every stop along the way, the plasma is treated with the same respect as the person it came from and the person it’s headed for.

CSLBEHRING.COM 1

Plasma Protein Therapeutics Association

BIOMATTERS | SPRING 2019

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FROM BIOFUELS TO BABY CARE: One Michigan Company’s Journey in Superabsorbent Polymers

BY ALISHA BROWN, DIRECTOR OF MARKETING AND COMMUNICATIONS, MICHBIO SOURCE MATERIAL PROVIDED BY ECOVIA RENEWABLES

In 2013 then University of Michigan doctoral student Jeremy Minty was on a mission—reduce the global dependency on fossil fuels and tackle climate change.

His approach? Fermentation of renewable biomass to create a sustainable biofuel.

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Little did he know then his passion for sustainable products would take him into another industry altogether— baby diapers.

With annual disposable diaper waste in excess of 3.5 million tons in the United States alone, the diaper industry is a major contributor of non-biodegradable landfill waste.

While environmentally conscious parents have greener diaper options, including cloth and compostable diapers, they lack the convenience, absorbency, and cost-effectiveness offered by traditional disposables.

What the diaper industry needs is a superabsorbent, affordably produced, biodegradable, non-toxic diaper filling—that’s where Jeremy Minty and Ecovia Renewables come in.

Minty’s research in fermentation processes led to the creation of a bio polymer capable of absorbing 300400 times its volume in water and retaining it even under pressure—a key factor in effective diapers.

“When we first started working with the polymer we were overwhelmed by the number of possible applications,”

ECOVIA RENEWABLES

says Minty, now co-founder and CEO of Ecovia Renewables, “everything from a non-toxic thickening agent in food, to topical functional cosmetic ingredients, to waste water treatment, and an absorbent filling for diapers. Honestly, the possibilities were endless.”

He continued, “Once we really wrapped our heads around all potential uses, we knew we had to incorporate.”

In 2014, Minty partnered with Drew Hertig and Dr. Xiaoxia “Nina” Lin to found Ecovia Renewables. Since then the company has secured more than $3.6 million dollars in grants and investments and has developed a partnership with Seppic, a subsidiary of Air Liquid Healthcare that specializes in the development of specialty ingredients for health and beauty products.

Co-founder and Chief Business Officer, Drew Hertig says of the journey, “If you had told me four years ago that we would go from thinking about biofuels to having a partnership with a French cosmetics company, be developing baby diapers, and having a staff of eight working with over three million dollars in funding, I would have thought you were crazy, but here we are, it’s 2019 and we’re trying to make the world a cleaner place with biodegradable disposable diapers.”

The process to create Ecovia’s biopolymers uses 100% renewable feedstocks like glucose and glycerol and the company is working to develop highly scalable manufacturing processes that will drive the cost down and make it an affordable solution for the mass production needs of the various potential industries.

A future with affordable biodegradable diapers is an attractive one for Minty, who celebrated the birth of his first child in 2018.

“Seeing first hand the amount of waste that just one child can produce and adding in the desire to have non-toxic baby products available for my own child, makes this work important to me in a way I didn’t expect when we started,” says Minty. “I am excited to give other parents options for safe and sustainable diapers for their children.”

THE ECOVIA SOLUTION Through a microbial fermentation process, Ecovia is able to turn renewable raw materials, including waste products like glycerol (a biodiesel by-product), into a polymer. Ecovia then purifies and modifies that polymer to create their trademarked superabsorbent AzuraGel. The gel is non-toxic, biodegradable, and sustainable to produce.

ECOVIARENEWABLES.COM

In addition to diapers and other consumer care products, the gel has agricultural potential as an additive to soil and mulch to increase moisture retention and adhesion which would reduce irrigation requirements and control erosion by preventing soil washout.

Top Photo: Ian graves, research and development engineer, examines the new pilot-scale bioreactor. Credit: Ecovia Renewables Inc. Bottom Photos: (Left) Fully swollen superabsorbent biopolymer.

Credit: Evan Dougherty (Right) Samuel Kohley, innovation manager, holds fully swollen superabsorbent biopolymer. Credit: Ecovia Renewables Inc.

BIOMATTERS | SPRING 2019

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MICHBIO

BY THE NUMBERS

CAPACITY, CAPABILITY, COMPETENCY Agri-Biosciences

BIO-INDUSTRY IMPACT

1,772

*

BIOSCIENCE ESTABLISHMENTS

1.7%

$28

ECONOMIC IMPACT †

40,205

*

ESTABLISHMENTS

608

AVERAGE BIOSCIENCE SALARY

BIOSCIENCE VC INVESTMENT 2014-17 ($M)

16.9% R&D/Testing

6.2%

BiOSCIENCE JOBS

133,695* $83,357*

Pharma

46.4%

BILLION

11TH

TOTAL EMPLOYMENT IMPACT

29%

29%

* TEConomy/BIO Investment Innovation and Job Creation in a growing U.S. Bioscience Industry, 2018

EMPLOYMENT

19.4% 1.6%

POSITIONED FOR GROWTH

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MICHBIO | michbio.org

Logistics

28.8%

MEDICAL DEVICE STATE

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

Medical Device

21%

MICHBIO: BY THE NUMBERS

MI BIOSCIENCE JOBS OPENINGSNON-STEM 2017OPENINGS STEM OPENINGS

TOP MI STEM/TECHNICAL JOB OPENINGS 2016-17 R&D Scientists/Technicians

1,249

1549

3637 2688 2620 2858 1963 2215

3966

3703 2552 2768 2566 2836 2872 1634 2309 2010

2011

2012

2013

2014

2015

2016

2017

OCCUPATION

# JOB POSTINGS

Engineers/Engineering Technicians

1,125

Sales

985

Clinical/Medical

872

Mfg./Production/Operations

723

IT/Data Mgmt/Computer Science

642

Regulatory/Compliance

YEAR

329 0

250

500

750

1,000

1,250

# POSTINGS

DEGREE REQUIREMENTS FOR MI BIO-INDUSTRY EDUCATION LEVEL High School/Vocational

%

23.4

JOBS

1323

Associate

9.2

518

Bachelor’s

63.3

3575

2.6

148

1.6

88

Master’s Doctoral

TOP SKILL CLUSTERS IN MI JOB OPENINGS Chemistry, Biology and Laboratory Research Product Development and Manufacturing Processes General and Specialized Sales and Practices Administrative and Clerical Tasks Productivity Tools Business Process, Analysis and Strategy Quality Assurance and Control Business and Operations Management Information Technology Project Management Occupational Health and Safety Customer and Client Support Budget Management Medical and Clinical Research Marketing and Public Relations: Packaging and Labeling Legal, Regulation and Law Compliance People Management Data Analysis

6 0

9 8 8 10

23 20 19 19 18 16 15 14 12

20

27 27

30

32

39

45

40

50

% REQUIRED AVERAGED ACROSS DEGREE

BIOMATTERS | SPRING 2019

19

MichBio is a state affiliate of the Biotechnology Innovation Organization (BIO).

THE BIOTECHNOLOGY ECOSYSTEM: BY THE NUMBERS As The Economist magazine has noted, “Creating new drugs through biotechnology is at the risky end of a business in which superhuman stamina and bottomless pockets are minimum requirements.” 1 Here are key numbers to understanding the biopharmaceutical innovation ecosystem and its pricing dynamics:

70% of innovative clinical programs are being led by small companies, which rely heavily on venture capitalists, angel investors or partnerships with larger pharmaceutical companies to provide the enormous amounts of private capital required to fund these challenging and incredibly risky endeavors. 2 90% of clinical programs ultimately fail to lead

to an FDA approval; in fact, the success rate of clinical trials can be even less, particularly in areas like Alzheimer’s and cancer. 3

92% of biopharmaceutical companies are unprofitable at any given time. 4 10–15 Years is the average time it takes

to secure FDA approval of a new medicine, from initial discovery of a potential new molecule or approach, through pre-clinical and clinical programs, through the FDA regulatory and approval processes. 5

$2.6 Billion is the average cost to develop and secure approval of a new medicine, taking into account all the trial and error and research failures along the way, and the cost of capital; this figure has skyrocketed in recent years, doubling since just 2003. 6

36th is where the biopharmaceutical industry ranks among domestic industries in terms of return on equity, despite the popular media narrative of excessive drug industry profits. 7 89% of prescriptions in the US are for lower-cost generic copies of oncebranded pharmaceuticals. 8 THE U.S. PRODUCES MORE NEW DRUGS THAN THE REST OF THE WORLD COMBINED Switzerland

2018: A BREAKTHROUGH YEAR • •

•

• • •

¹ 2 3

4 5 6 7 8

59 novel drugs approved in 2018.

Second consecutive year with more than 50 novel drug approvals.

First-ever approval of an RNA interference therapy, opening an entirely new class of treatments for patients with rare diseases.

16 new cancer therapies approved.

A new class of drugs for migraine prevention.

First new drug for endometriosis in over a decade.

13%

U.S.

Japan

8%

57%

8% 6% 6%

UK

Germany France

Percentages do not add up to 100% due to rounding.

Source: Milken Institute; Xconomy, “Which Countries Excel in Creating New Drugs?

It’s Complicated” 2014; Kneller, Nature Biotechnology, 2012

The Economist, February 15, 2014 Emerging Therapeutic Company Investment and Deal Trends 2007–2016, BIO Industry Analysis, 2017.

Clinical Development Success Rates 2006–2015, BIO Industry Analysis, 2016; for example, since 1998, 123 medicines in development for Alzheimer’s have not made it through clinical trials, while only 4 have been approved — resulting in a 97% failure rate. See PhRMA, Researching Alzheimer’s Medicines: Setbacks and Stepping Stones, Summer 2015.

Factset, BIO Industry Analysis.

DiMasi J., Grabowski, H., Hansen, R. Innovation in the Pharmaceutical Industry: New estimates of R&D Costs. Journal of Health Economics, 2016.

Ibid.

Factset, BIO Industry Analysis.

Association for Accessible Medicines. Generic Drug Access & Savings in the U.S. (2016).

bio.org

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MICHBIO | michbio.org

BIO: BY THE NUMBERS

BIOMEDICAL INNOVATION CAN HELP SOLVE THE OPIOID CRISIS Opioid addiction is plaguing communities across the country, leaving in its wake countless victims, devastated families

and economic ruin. Long-term solutions to combating this crisis will depend upon biomedical innovation and the development of novel and safer, next generation therapies to treat both pain and addiction. To get these new innovations to the patients whose lives depend on them, we must ensure that the policy and regulatory environment keeps pace with advances happening in the lab.

Unfortunately, the reality is that investments in treatments for pain and addiction are not at the levels of other therapeutic areas because of market and regulatory barriers. The public and private sectors must work together to remove these barriers to investment and unleash the full potential of biomedical innovation to solve the opioid crisis.

At BIO, we are committed to unleashing the power of scientific innovation to develop solutions that will allow for an America free of prescription opioid addiction. Our companies are dedicated to achieving this by changing the paradigm for the treatment of pain and addiction through an advanced understanding of the biology of these complex diseases and enabling access to and development of innovative medicines and approaches to treatment.

By the Numbers

91 people die every day

>1,000

Source: Centers for Disease Control (CDC)

men & women are treated in emergency rooms daily for misusing these prescription painkillers

The epidemic is costing our nation an estimated $79 billion annually in health and social costs

Source: CDC

Source: CDC

from opioid overdoses

New Treatments on the Horizon

106 Clinical Programs for Novel Pain Drugs* 20

40

Phase I

Phase III

60

33 53

Phase II

Source: Princeton economist Alan Krueger

BIO’s Member Companies: Innovation in Action

>70 companies working on novel pain therapies

0

Opioid abuse may explain 20% drop in American men’s labor force participation

20

*excludes migraine

BIO and Member Companies Seek Solutions BIO and its members are committed to developing solutions to address America’s opioid crisis by: Advancing our understanding of the biology of pain and addiction to enable the development of innovative treatments for pain and addiction and ensure appropriate and optimal use of existing therapies.

Ensuring patients suffering from pain or addiction are able to receive the right treatment at the right time with the right support, without stigma.

Stimulating R&D focused on developing innovative approaches to effectively treat pain and opioid addiction and prevent abuse.

The biopharmaceutical industry offers real solutions to this devastating crisis. Emerging biotechnology companies and established enterprises are working hard to transform the standard of care for pain and addiction through novel and safer next generation therapies.

Example: One technology is an injectable that treats knee pain using capsaicin, a by-product produced of chili peppers.

Example: New therapies that target the body’s peripheral nervous system to treat pain without inducing addictive side effects.

Example: Novel and safer products for postsurgical pain control and partnering with large hospital chains to develop alternative approaches for pain management.

Example: One new medicine helps prevent patients from relapsing to opioid dependence and overdosing following detox.

Example: Abuse-deterrent formulations of existing therapies that mitigate or prevent abuse of the therapy. grapples with opioid abuse and searches for answers, we “AslookAmerica to biomedical innovation for the solutions we need and deserve.

Thanks to extraordinary science and prolific thinking, our industry is uniquely positioned to help solve this crisis through the advances of next generation therapies and cutting-edge technologies.”

— Jim Greenwood, President & CEO Biotechnology Innovation Organization

bio.org/opioid drugcostfacts.org

BIOMATTERS | SPRING 2019

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AFTER THE

ELEVATOR PITCH Arbor Grace, Inc. is a Michigan-based company, developing human-centric medical devices. Launched out of an Executive MBA program at the University of Michigan, the company seeks to promote patient engagement and improve treatment outcomes by tackling a range of unmet needs in the medical device space.

Arbor Grace is currently promoting BLUE KangarooTM, a jaundice and warming suite of therapy products that treats neonatal jaundice while promoting parent and infant bonding leading to improved treatment outcomes.

The company is presently engaged in clinical trials with hospitals systems in the United States and Nigeria.

Patrick Powell, Arbor Grace president and co-founder says, “I discussed medical devices at length with numerous physicians during my time in the EMBA program.

Physicians are clearly proud of the work they do but expressed concern that medical devices lack proper human-centric design—meaning that while the devices clinically work, they don’t always consider the usability needs of the patient as thoroughly as their clinical needs, resulting in lower patient engagement.”

Additionally, Arbor Grace offers engineering and development services, including prototyping, and is excited to work with healthcare inventors who need a seasoned, qualified partner to help move their approach from whiteboard to market.

He continued, “We founded Arbor Grace to specifically address these unmet needs to improve patient outcomes and quality of life.”

22

MICHBIO | michbio.org

For additional information, please email: contactus@arborgrace.com

ARBORGRACE.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.

ARTham Therapeutics is a biopharmaceutical R&D company launched in July 2018 as a spin out of Takeda Pharmaceuticals. The goal is to deliver “medicines that matter” for patients, by prosecuting a compelling portfolio of four projects, identified by repositioning existing pharma assets. ARTham is a virtual R&D company that seeks the best academic and business partners to rapidly develop high value clinical candidates.

ARTHAM’S PIPELINE INCLUDES: Two clinical stage projects: 1. ART-648, the first PDE4 inhibitor candidate for effective treatment of NASH. NASH is a progressive form of NAFLD (Non-Alcoholic Fatty Liver Disease) that in some patients advances to fibrosis due to inflammatory processes and result in cirrhosis or liver cancer. There is no approved pharmacotherapy for NASH. ART-648 is currently in Ph1 with data expected in 3Q2019 and will enter Ph2a in 4Q2019.

NASH is often underdiagnosed and considered to be a silent disease in early stages and estimated global

occurrence is about one billion. In United States, NAFLD is estimated to be the most common cause of chronic liver disease, affecting between 80 and 100 million individuals, amongst whom nearly 25% progress to NASH. 2. ART-001, a first in class selective PI3K alpha inhibitor for the treatment of vascular malformations that includes venous malformations and pediatric orphan disease, Klippel Trenaunay syndrome. These are devastating diseases that significantly reduce quality of life and can cause extreme pain.

Two preclinical projects: 3. EP2/4 dual antagonists for immune-oncology indications 4. PDE4/5 dual inhibitiors for inflammatory and fibrotic disorders

ARTHAMTHER.COM

BIOMATTERS | SPRING 2019

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AFTER THE ELEVATOR PITCH

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

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

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

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

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

Impellia has offices in Ypsilanti, MI and Pittsburgh, PA and was founded by attorney and marketing executive Richard Walker, serial entrepreneur Dave Morin and 15-year NFL quarterback Charlie Batch. The company’s advisory board is comprised of nationally-renowned experts in the fields of sports performance, sports medicine and nutrition.

Impellia actively works with athletic and healthcare organizations across the country and is rapidly expanding, having doubled its workforce size in 2018.

IMPELLIA.CO

Foley Hoag is proud to serve as MichBIO’s preferred legal counsel for its entrepreneurial members.

BOSTON | NEW YORK | PARIS | WASHINGTON, D.C.

24

MICHBIO | michbio.org

foleyhoag.com

“Currently the only way to verify the quality of a biopsy is to manually stain and assess the sample during the procedure prior to sending it to a pathologist for diagnosis,” says Michael Moore, Pathware co-founder and CEO. “The availability of this manual review can be inconsistent at best, which leads to tens of thousands of rejected samples and millions spent on repeat testing. Our goal is to eliminate that inefficiency and offer the accountability that both patients and clinicians deserve.”

Pathware’s flagship product, Bioptic™, is an automated 3D biopsy imaging platform, partnered with a unique

Each year in the United States, there are over 25 million intensive care and emergency room admissions due to out-of-control systemic inflammatory responses caused by infections, trauma or burns, surgeries, or even cancers.

These admissions account for approximately half of all in-patient hospitalization costs – over 2% of the U.S. GDP – and result in over 1 million deaths annually.

To address this problem, PreDxion Bio has developed MicroKine, a real-time biomarker detection platform that monitor’s a patient’s inflammatory response in under twenty minutes.

“Our patent-pending diagnostic tool, which leverages technology developed at the University of Michigan, is 1000-times more sensitive, precise and accurate than the current ‘gold-standard’ technologies and delivers results in mere minutes,” said PreDxion Bio co-founder and CEO Walker McHugh.

AFTER THE ELEVATOR PITCH

The number of pathologists around the globe is declining, yet tissue biopsies remain one of the most essential diagnostic tools in healthcare. This decline, compounded by the challenge that one-in-five needle biopsy procedures is repeated because of poor sample quality, delays diagnosis, places an unnecessary strain on patients, and puts the financial burden of unreimbursed repeated testing on hospitals. Pathware, formerly MedKairos, is working to end this inefficiency.

software package, that verifies biopsy viability in realtime with a more than 99% certainty. Using Bioptic™, clinicians can view the entire sample to determine if it is of adequate size and quality at the point-of-care, saving time and money while dramatically improving patient satisfaction and outcomes.

With a diverse team of engineers, clinicians, and business veterans on board, Pathware is positioned to launch Bioptic™ in late 2019. Initially targeting fine needle biopsies, the company will enter a market that evaluates more than 2.7 million biopsies annually and has the potential to impact an equal number of patient lives. The company intends to expand its platform to secondary markets such as veterinary cytology, urine blood analysis, and vaginal STI swabs to dramatically increase the value and clinical impact that the platform is capable of globally. Pathware’s Bioptic™ offers the consistency and adaptability necessary to become the global leader in the field of digital cytology.

PATHWARE.COM

He continued, “Patients in these critical care environments need access to technology that can detect an inflammatory response fast enough to one day allow health care professionals to intervene with appropriate treatment and save lives.”

PreDxion Bio has received FDA Breakthrough Device designation and is nearing clinical trials to evaluate the MicroKine platform for use in guiding precision therapies in critically-ill patients at multiple clinical trial sites across the country. In addition to Walker, PreDxion Bio was founded by Timothy Cornell, who is currently Chief of Pediatric Critical Care at the Lucile Packard Children’s Hospital at Stanford University.

PreDxion Bio is backed by Y Combinator, Invest Detroit, and individual investors. PreDxion Bio has also received funding from the National Institutes of Health, MTRAC, and the Michigan Economic Development Corporation.

PREDXIONBIO.COM BIOMATTERS | SPRING 2019

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AFTER THE ELEVATOR PITCH

PURE GREEN™ LLC, provides true medicinal cannabis.

The company’s flagship products are precisely-tuned, patent-pending therapeutic tablets that dissolve under the tongue in seconds, take effect in minutes, and last for hours.

The cannabis-containing tablets are engineered to provide relief from chronic pain, anxiety, sleep issues and general inflammation without creating a traditional cannabis high.

Since formation in 2017, Pure Green has completed eight clinical trails and filed four patent applications, and, in 2018, the company was granted Michigan licenses for Medical Marijuana processing, cultivation and retail.

Currently in growth mode, Pure Green has 35 plus employees in multiple locations who are actively organizing national and international licensing agreements for the company’s sublingual formulations, as well as, proceeding with FDA sanctioned clinical

Safety in Motion, Inc. (SiM) was founded in 2015 by a team of Michigan automotive executives who brought their experience in engineering and automotive safety systems to the study of athletic performance, vestibular anomalies, concussion, balance concerns, and traumatic brain injury (TBI). The company’s leading head injury researcher, Priya Prasad, PhD, is the developer of the standardized Prasad/ Mertz Head Injury Criteria risk curves (HIC scale), which are used in the automotive industry worldwide to measure head injury in crashes and evaluate air-bag effectiveness.

SiM has developed a portable force plate (SiM-1000) that the military, athletic teams and health care professionals are currently using in their research to help diagnose concussion (TBI), reduce athletic injury, predict fall risk and ensure the long-term sustainability of sports.

“One way to help diagnose and monitor concussion, subconcussive incidents, and neuro or vestibular anomalies is through an analysis of an individual’s balance,” said

trials for OTC/Rx products for PTSD relief and opioid addition recovery.

With the 2020 Michigan cannabis market projected at $3.2 billion and national markets exceeding $25 billion, Pure Green is focused on product development and brand growth to facilitate market penetration in cannabis, as well as, traditional pharmaceutical markets.

Through research and exploration of the science behind medical cannabis, Pure Green’s mission is to shift perception of the cannabis plant, garner acceptance of its medical benefits, and facilitate the use of medical cannabis for a range of chronic ailments to impact health and wellbeing around the globe.

PUREGREENCANNA.COM

SiM CEO Walter Borda, citing references to the health industry’s accepted BESS Test and to the newly developed SCAT-5 Test.

The SiM device performs these tests electronically capturing over 10,000 data points per second. It is paired with proprietary algorithms measuring over 30 parameters to produce detailed, granular, consistent data that far exceeds the capability of existing medical equipment.

The device is currently being investigated by major South East Michigan hospitals, Wayne State University, the Department of Defense and college athletic teams.

“Concussive and sub-concussive events (TBI) are a major concern for the DoD. The ability to compare a soldier’s balance following a concussive event to baseline data will allow the military to more timely target treatment recommendations, measure return to normal, and help reduce duty downtime,” Borda said.

SIM-TECHNOLOGIES.COM

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MICHBIO | michbio.org

CONSULTANTS TO MEET miLEAD Consulting Group provides data-driven solutions to help stimulate market growth and sustainability in the Midwest biotechnology industry. As a consulting firm established and led entirely by scientific PhD candidates, postdoctoral researchers, and MBA students at the University of Michigan, miLEAD calls upon the critical thinking and analytical training acquired as doctoral students to address client needs. From faculty researchers to large multinational companies, miLEAD has worked with a diverse portfolio of clients to guide business decisions in the biotechnology, pharmaceutical, IT, and engineering industries.

In 6-8 week long engagements, miLEAD consultants work to solve problems through market research, competitive landscape analysis, customer discovery, commercialization and grant writing, and fundraising strategy. miLEAD has helped clients identify

Ruby Leaf, a science communication and consulting company whose newest service helps new life science business owners effortlessly manage the startup process.

You focus on the science, we’ll handle the details.

“Scientist, business owners have a lot on their plate,” says Ruby Leaf Founder Marquicia Pierce, “they are trying to balance research with starting a business which means they can’t focus on any one thing. That’s where Ruby Leaf comes in.”

With a team of professional program managers with experience serving academic start-ups, Ruby Leaf can take on the burden of the administrative, business details common for start-ups. Ruby Leaf provides an instant team with real people to handle registering the company, setting up grant programs (SBIR/STTR registrations), and acting as a go-between with web-designers, accountants, and lawyers. The Ruby Leaf team provides weekly updates and monthly reports to ensure their clients have vital information at their fingertips.

emerging global markets and trends, drafted SBIR commercialization plans, and conducted nationwide searches for venture capital funding to help raise $2M in Series A investments.

Since its inception in 2015, miLEAD has completed over 45 projects with 25+ clients, many of whom return for additional services. miLEAD has been recognized nationally by the journal Science as a unique opportunity for students to gain real-world consulting experience while also providing quality service at an affordable price. More than 70 miLEAD alumni have graduated to successful careers in consulting, biotech, academia, and science communication.

MILEAD.ORG

Pierce continued, “We have a custom-built platform to integrate all the data and information you need for all the various registrations processes. No more going from site to site inputting the same data over and over again.

You can view all your connections in a single dashboard where you can easily see updates, registration timelines, due dates, and progress. You can get website updates from IRS.gov (EIN), DnB.com (D&B), SAM.gov, SBIR. gov, Bluehost.com, WordPress sites, QuickBooks, and more. We also work directly with your graphic designer, accountant, and program officers to give them needed information.”

The perfect solution for Entrepreneurs-in-residence, tech transfer office portfolio companies, incubators, and new academic startups. At Ruby Leaf, the mission is to catalyze the life science entrepreneur community and help make new business creation easy.

RUBYLEAFMEDIA.COM BIOMATTERS | SPRING 2019

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What is BioArtography?

BY DEBORAH L. GUMUCIO, PH.D., PROFESSOR AND DIRECTOR, BIOARTOGRAPHY PROJECT, UNIVERSITY OF MICHIGAN

BioArtography is a unique blend of art, science and photography. The images are all taken by researchers during the course of their investigations. Most are “micrographs”, taken with the aid of a microscope, and include a variety of cells, tissues and organs from humans, mice, fish, chicks, fruit flies, worms, yeast and more. The goal of this research is to learn enough about the structure and function of these cells and tissues to find new ways to treat maladies that result from organ disease and improve understanding of the human body and the world around it. But, in the course of these studies, some amazingly beautiful structures appear—shared here in the context of BioArtography.

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MICHBIO | michbio.org

BIOARTOGRAPHY

MILKSHAKE This is an image of a mouse mammary gland.

The fluorescent staining highlights the grape-like alveolar units, many thousands of which bud out of the mammary tree in response to circulating steroid hormones of pregnancy.

The alveoli contain specialized milk producing cells that secrete the milk into the lumen of the ductal system to feed the newborn. When the pups mature and start to eat solid food these alveoli regress. They are then completely rebuilt from resident stem cells at the next pregnancy.

WHAT IS THE MISSION OF BIOARTOGRAPHY? FUNDRAISING: The BioArtography project started in 2005.

The project was initiated to raise money so that trainees in the sciences could attend important national and international meetings to present their work, extend their knowledge boundaries and network with experts in their field. This mission has been successful, sending nearly 100 trainees to important meetings in the last 13 years, but the project is about more than fundraising.

PUBLIC OUTREACH: BioArtography is a wonderful opportunity to educate the public about important scientific discoveries. Each image is sold with a description of the underlying research which explains, in lay language, the scientific goals of the work. What can the lowly fruit fly teach us about Down’s syndrome? Why are human embryonic stem cells being used to understand organ development in a dish? How can the eyes of a zebrafish model human retinal degeneration?

The hope is that, as people come to better understand this work, they will appreciate how intricate, interconnected and complex these biological systems are and they will support and advocate for scientific research.

WEARING HIS HEART ON HIS SLEEVE This is an image of skin cells that have been reprogrammed into heart cells; the striped appearance of the cells is very characteristic of normal heart cells. They can even connect together to beat in the culture dish. The purpose of this experiment was to be able to study how a specific gene mutation found in a person alters heart cell function. Here, a biopsy of the patient’s skin could be used to study the patient’s heart function in the laboratory in the hopes of better understanding the disease and finding a cure.

SCIENTIFIC COMMUNICATION: BioArtography also teaches scientists how to be better communicators. Because science can be highly technical, researchers can forget how (or not take the time) to explain to their friends and neighbors what they are doing and why they are doing it. But expanding this dialog is critically important--misconceptions and misinformation are best handled by providing real-world examples of scientific discovery.

Become a “Friend of BioArt” and support the scientists and trainees who make this work possible.

HOW TO MAKE A FLY This image shows the male reproductive system of the fruit fly (Drosophila melanogaster). The spiraling testes (in red and gold) produces sperm and the accessory glands (in deep blue) produce secretions for seminal fluid, similar to the human prostate gland.

The aqua-colored structure is the ejaculatory duct, where the sperm and seminal fluid mix. We are studying the accessory glands in the fly as a model system to study the interplay of genetics and aging that underlie tumorigenesis in the human prostate.

BIOARTOGRAPHY.COM BIOMATTERS | SPRING 2019

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THE POWERFUL LENS OF METAGENOMICS

BY CAMILLE CAPPELLO, DIRECTOR, GLOBAL MARKETING, SWIFT BIOSCIENCE

Increasingly, disease diagnosis and treatment involve defining the intricate microbial communities that are part of everyday human life. Complex microbiomes, e.g. bacteria, archaea, and fungi, exist in the air, water and soil, as well as, in symbiosis with humans, and are important indicators of environmental and human health.

Ann Arbor based Swift Bioscience creates tools that aid in the comprehensive examination of these microscopic communities with the hope of unlocking their role in health and wellness.

“We are now only beginning to outline the role of bacteria and fungi in health and have barely scratched the surface of the influence of these organisms on disease,” says Drew McUsic, PhD and product manager at Swift. “If you consider that a single person can have trillions of microbes making up 400 different species within their digestive tract, and that each person’s tract is unique based on their family history, environment, and food consumption, you can begin to appreciate the enormity of the task it is to fully analyze and understand these microbial communities.”

Analysis of the microbiome is a complex and often expensive task performed via next generation sequencing

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MICHBIO | michbio.org

(NGS) technology using one of two methods. Shotgun sequencing, with Swift’s 2S Turbo Kit, is used to obtain a comprehensive analysis of all DNA within a sample.

Whereas, the targeted approach, with Swift’s 16S+ITS Amplicon Kit, is used to examine a specific portion of a larger sample.

Both techniques provide important information about bacterial and fungal communities, with shotgun sequencing being more exhaustive, and giving insight into larger community function, while the targeted approach results in a more straight-forward interpretation of the sample with less expensive data acquisition.

“The comprehensive nature of shotgun analysis is often cost prohibitive, so we developed the Amplicon panel to give researchers the ability to quickly read the variability of ribosomal RNA genes that exists in a microbial community,” continued McUsic. “From there they can reasonably extrapolate and assess the specific bacteria and fungi species present in the larger sample at a much lower cost.”

Targeted NGS using the 16S+ITS Amplicon kit can be used to assess infectious diseases, biofuels, environmental remediation, agricultural procedures, water treatment systems, and forensic and ecological samples.

The Amplicon panel uses Swift’s newly launched technology to produce the best results from sequencing both 16s rRNA and ITS genes, giving the highest quality data while saving time and reducing costs. The panel is one-

SWIFT BIOSCIENCE

NEW MICHBIO MEMBER

Founded in 1998, Kestrel Management helps organizations manage operational risks, design and implement management systems, make process improvements, and assure regulatory compliance. Kestrel’s senior consultants work to understand potential client risks, and to then build tailored systems/ processes and management tools that ensure compliance and yield improved operational practices.

Kestrel offers a suite of integrated services in the following areas: of-a-kind, as it is the only one in existence that covers all variable regions of the 16S rRNA (V1-V9), ITS1 and 2, all in a single PCR reaction. More simply, the panel can assess bacteria, archaea, and fungi in a sample simultaneously. ***

•

Operational Risk Management

•

Management Systems

•

Compliance Assurance

•

Process Analysis, Improvement & Business Continuity

McUsic continued, “Using Swift’s 16S+ITS kit, researchers, hospitals and service labs can examine the abundance of ‘good’ and ‘bad’ bacteria in samples taken from an individual’s digestive tract. These microbial populations can change based on treatment with antibiotics, chemotherapy, etc, and can give powerful insight as to their role in maintaining human health. As researchers continue to study these communities, physicians can better diagnose and treat disease and improve patient outcomes.”

•

Food Safety

The powerful lens of metagenomics is enabling researchers to unravel the mysteries of the microbial community and their impact on human health.

Company expertise ranges from hands-on experience in EPA hazardous waste management, OSHA lab standard support, and hazardous pharmaceutical disposal strategies, to management systems development and implementation (e.g., ISO 9001, ISO 14001, ISO 45001, ISO 13485, ISO/IEC 17025), to compliance efficiency tools and training.

Kestrel has 20 years of experience and success on projects that require skills in regulatory strategy, negotiations, expert analysis, systems development—and, equally important— trust and relationship building. Some of the highest value assistance the organization provides to clients is in the early stages of project planning and strategy development, particularly in the sequencing of compliance and audits, management systems development, and Corrective Action Plan (CAP) management and completion.

Kestrel places a special emphasis on helping clients develop effective policies and strategies and integrate them into their cultures. Using a systems model that is aligned with business objectives and capabilities, Kestrel is committed to helping companies to grow while optimizing compliance and improving overall performance.

SWIFTBIOSCI.COM KESTRELMANAGEMENT.COM ***This product is for Research Use Only.

Not for use in diagnostic procedures.

BIOMATTERS | SPRING 2019

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7:39 PM Reading time.

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