BioMatters FALL 2014
A MichBio Publication Showcasing Michigan’s Biosciences Industry
Michigan Sets a Foundation for Growth FEATURED
6 Success Breeds Bio-Success STATE UNIVERSITY 10 WAYNE Partners Enter Through the Front Door
14 PARADIGM Harnessing the Power of Genomics
BIOECONOMY INSTITUTE 22 MSU Scaling Up
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PRESIDENT’S MESSAGE
Welcome to Michigan’s Thriving Biosciences Industry!
STAFF Stephen T. Rapundalo, PhD President & CEO srapundalo@michbio.org 734.527.9144 Katie Trevathan Director, Marketing & Communications katie@michbio.org 734.527.9147 David McGuire Director, Operations & Membership david@michbio.org 734.527.9150 Nancy Marcotte Manager, Finance nancy@michbio.org 734.527.9145
CONTACT Physical Address 3520 Green Court, Suite 175 Ann Arbor, Michigan 48105-1175 Mailing Address P.O. Box 130199 Ann Arbor, Michigan 48113-0199 Phone 734.527.9150 Fax
We’re pleased to share with you the 10th issue of BioMatters™, which highlights the very best of Michigan’s biosciences industry. The stories show plenty and varied examples of remarkable discovery, technology, talent, and human compassion. Collectively they describe how research, development, and manufacturing efforts are leading to new products that are benefiting the health and welfare of humankind. Michigan’s advantage in knowledge, people, and entrepreneurial spirit is full-grown. The last decade has witnessed the implementation of support service programs, investment funding and attraction, business incentives, and talent enhancement initiatives, while creating a culture of risk-taking. The resulting bio-industry ecosystem is robust and has spawned the birth of almost two hundred new startups. Our feature article (p.6) describes how some of these companies have realized commercial success and are creating a pipeline of innovation and business growth, and then introduces you to the latest crop of entrepreneurs as we profile their bioscience ventures. With that as a backdrop, this BioMatters issue visits with a spectrum of other educational, academic research, and private sector enterprises. Our world-renowned universities and colleges are leading the way! Read how Kettering University’s learning model allows students to become exceptionally qualified to enter the biosciences workforce (p.19). Similarly, Wayne State University is implementing its NIH-funded BEST program to develop skilled bioscience talent (p.10). On the research front, the Center for Chemical Genomics at the University of Michigan’s Life Science Institute is engaged in identifying potential drug candidates (p.27); the Bioeconomy Institute at Michigan State University, a former Pfizer production facility, is now providing contract scale up and de-risking services while serving as a regional business incubator funded by the federal government’s i6 program (p.22); and The Front Door at Wayne State is truly opening doors for industry collaborations (p.12). The biosciences private sector is booming. Grand Rapids-based Medbio (p.31) has become the vendor of choice for many multi-national biopharma companies and small biotech startups. Paradigm, a recent public-private joint venture is ushering in the age of personalized medicine and helping doctors to tailor cancer treatments for their patients (p.14). Learn how Xoran Technologies is revolutionizing point-of-care imaging (p.17). Lastly, Avomeen, a four-year old company, is rapidly expanding its contract pharmaceutical sciences and manufacturing services to biopharma clients (p.29). Want to discover more of Michigan’s bio-industry? Then peruse archived issues of BioMatters at www.michbio.org/biomatters or simply contact me at srapundalo@michbio.org, and I’ll be happy to introduce you to everything that is this great state’s biosciences community. Let MichBio connect you to Michigan’s bioscience companies, business services, assets, and markets.
734.302.4933 Website www.michbio.org Email info@michbio.org
Stephen Rapundalo, PhD President & CEO MichBio
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BioMatters | Fall 2014
PREMIUM MEMBERS
OFFICERS & DIRECTORS
GOLD
EXECUTIVE OFFICERS Chairman Stephen Munk, PhD Ash Stevens, Inc., President and CEO
SILVER
Vice Chairman Kevin McCurren Grand Valley State University, Executive Director, Center for Entrepreneurship and Innovation President and CEO Stephen T. Rapundalo, PhD MichBio, President and CEO Secretary Tina Rogers, PhD, MBA, DABT Midwest Life Science Advisors LLC, CEO and Founder
DIRECTORS Arik Anderson Terumo Cardiovascular Systems Corp., Vice President, Global R&D and Marketing Doug Gage, PhD Michigan State University, Director, BioEconomy Network Dale Grogan Michigan Accelerator Fund I, Managing Director Sanjay Gupta Wellness + Prevention, Inc. (a J&J Company), President Tim Mayleben Esperion Therapeutics, President and CEO
MEDIA A LIFE SCIENCE CONNEC T BRAND
Kevin McCurren Grand Valley State University, Executive Director, Center for Entrepreneurship and Innovation
A LIFE SCIENCE CONNEC T BRAND
MichBio | www.michbio.org
Paul Morris AlixPartners LLP, Finance Director, Enterprise Improvement Stephen Munk, PhD Ash Stevens, Inc. President and CEO Stephen T. Rapundalo, PhD MichBio, President and CEO Tina Rogers, PhD, MBA, DABT Midwest Life Science Advisors LLC, CEO and Founder John J.H. Schwarz, MD Battle Creek Family Health Center, Physician, Former U.S. Representative
BRONZE
PATRON
Kevin McLeod Michigan Medical Device Accelerator, Managing Director
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Ned Staebler Wayne State University, Vice President, Economic Development Christopher J. Stein Ferndale Pharma Group Inc., Executive Vice President and COO George Wilson Beaumont Health System, Chief of Radiation Biology, Scientific Director, Beaumont Biobank David Zimmermann Kalexsyn, Inc., CEO
BioMatters TABLE OF CONTENTS
6 10
17
Featured Articles Success Breeds Bio-Success Poised for Success
Wayne State University The Best of the Best: Broadening Experiences in Scientific Training Program
19
Partners Enter Through the Front Door
14
22
Paradigm Harnessing the Power of Genomics to Help Personalize Therapy for Cancer Patients Nationwide
26
Xoran Technologies The Ann Arbor Startup that Changed the Point-of-Care Imaging Platform
Kettering University Applied Biology. Reimagined.
MSU Bioeconomy Institute Scaling Up Companies, Future Entrepreneurs
27
29
31
Entrepreneurs After the Elevator Speech
U-M Center for Chemical Genomics High-Throughput Screening: Accelerating Academic Drug Discovery at the University of Michigan
Avomeen Analytical Expanding Pharmaceutical Services to Meet High Demand of Michigan Contract Pharma
Medbio, Inc. A Medical Device Company Doing it ‘The Right Way’
If you are interested in submitting an article or an advertisement for the next issue of BioMatters, email katie@michbio.org. Want to receive BioMatters? Visit www.michbio.org/subscribe.
ADVERTISERS Ash Stevens.............................. 2
Medbio, Inc.............................30
Terumo Cardiovascular Systems.....21
Dykema................................... 2
MichBio.................................IFC
Healthmark.............................33
Michigan State University Innovation Center......................33
University of Michigan Center for Chemical Genomics...............28
Hylant..................................... 2 Johnson & Johnson....................30
MPI Research............................21
VWR....................................... 1 Wayne State University...............13
Stryker.................................... 1
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BioMatters | Fall 2014
FEATURE STORY
Success Breeds
Bio-Success
By Rick Haglund
Michigan’s biosciences industry was once dominated by pharmaceutical giants including Pfizer, Upjohn, and Warner Lambert. Startups struggled to find venture capital, management talent, and support from state government. “My first time around, support for the life sciences were almost nonexistent,” said Roger Newton, who founded Esperion Therapeutics in 1998. No more. There are hundreds of startup and early stage biosciences
MichBio | www.michbio.org
companies being fueled by venture capital, talented scientists and business managers, and capital formation programs offered by state government and the Michigan Economic Development Corporation.
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Successful exits from venture funding have helped dozens of serial entrepreneurs start new biosciences companies and grow the life sciences ecosystem in the state. Here are the stories of four of the best.
ROGER NEWTON
ADAM CHIASSON
DAN RHODES
of its devices, which are used by labs
Esperion went public later that year,
raising about $73 million in an initial
and researchers working on treatments
public offering. The company’s stock is
for cancers and HIV infections, said BD
traded on the NASDAQ exchange.
Accuri site leader Adam Chiasson.
Mayleben said Esperion hopes to
Its flow meters that measure cells
ESPERION THERAPEUTICS
have ETC-1002 on the market by 2018.
sell for around $50,000, about the
third of the costs of some competitors’
Roger Newton created one of
“The frustration with the original
Michigan’s most successful bioscience
Esperion was that we had a big portfolio of
machines. Researchers can set up and
startups 16 years ago. Now he’s trying
promising drugs that was never realized,”
start using the devices in about 30
to do it again—with the same company.
he said. “The goal for all of us is to take
minutes, he said.
Newton, who led the development
ETC-1002 all the way to approval.”
www.esperion.com
auto industry, came to Accuri in 2009.
of Lipitor, the best-selling drug of all time, founded Esperion Therapeutics in
Chiasson, who formerly worked in the
While corporate acquisitions sometimes
Plymouth Township in 1998 to develop
don’t work out, the sale of Accuri to BD
new cholesterol drugs. He sold it to
has been beneficial.
Pfizer in 2004 for $1.3 billion.
But when Pfizer shut down its
sprawling research complex in Ann Arbor in 2007, it also closed Esperion.
Newton restarted the company
in 2008, now located in Ann Arbor, and is focusing efforts on getting Food and Drug Administration approval for a non-statin drug, known as ETC1002, designed to lower LDL, or “bad” cholesterol, without the side effects that some people report with statins. A few employees from the old Esperion have rejoined the new company, including former chief operating officer Tim Mayleben, who became CEO last year. Newton is the company’s chief science officer.
“Tim is a magnificent fundraiser and
has vast connections in the financial world,” Newton said. “We have what I call tandem leadership. I’m the science guy and he’s the financier.”
It’s working so far. Newton raised
$22.75 million in venture capital to buy back the Esperion name and the rights to develop ETC-1002 in 2008. He and Mayleben raised an additional $33 million in venture funding in 2013.
ACCURI CYTOMETERS
“We continue to grow aggressively
by leveraging the worldwide footprint of BD, which is the market leader in
Accuri Cytometers went from
medical instruments,” he said.
being a startup formed 14 years ago
www.bdbiosciences.com
at a kitchen table using technology developed at the University of Michigan to a leader in producing sophisticated meters that count and sorts cells.
Founded by Jen Baird and Colin Rich
in Ann Arbor, the company was acquired by New Jersey-based medical devices giant Becton, Dickinson & Co. for $200 million in 2011.
The sale was engineered by Accuri
CEO Jeff Williams, who also led the sale of Ann Arbor-based HandyLab, while he was CEO there, in 2009 to BD for $275 million.
But the Accuri sale turned out to
have a happier ending for Michigan’s biosciences community than the acquisition of HandyLab, which BD closed in 2010, moving its operations to the East Coast.
Accuri is thriving in Ann Arbor, where
employment has grown from 30 workers at the time of the sale to 65 today.
The company’s competitive
advantage is in the relatively low cost
7
THERMO FISHER SCIENTIFIC (FORMERLY COMPENDIA BIOSCIENCE)
It’s not unusual for a technology startup
founder to leave his company as it grows and requires professional management or is sold to a larger company.
But Dan Rhodes is still running the
former Compendia Bioscience, an Ann Arbor-based bioinformatics company he co-founded in 2006, even after two sales involving the business.
Compendia, which developed
a cancer-profiling database used by top drug researchers was sold to Carlsbad, CA-based Life Technologies in 2012. Life Technologies was in turn sold to Waltham, MA-based Thermo Fisher Scientific in 2014.
BioMatters | Fall 2014
anytime soon. He was just trying to keep the lights on.
“When I got there my intent was to
survive,” Dacko said, “Our primary goal was to grow a technology that could help millions of people.” TED DACKO
Rhodes remains as Thermo
Fisher Scientific’s vice president of bioinformatics, leading its Ann Arbor operation of 55 employees.
The team he oversees is developing
new diagnostic products that will allow it to measure and interpret data from its oncology database.
“Ultimately we want to help cancer
patients get the right drugs for their types of cancers,” he said. “We’re now building the products we’ve always dreamed of.”
Rhodes has come a long way since
co-founding Compendia with University of Michigan medical school professor Arul Chinnaiyan, while Rhodes was still a doctoral student at U-M.
“I was a scientist by training and had
no clue about the process of developing a business,” he said. “The hard part for me was just getting things going.”
“Michigan was a fantastic place
for us. There’s a great technology ecosystem in Ann Arbor. And we got a lot of support from Ann Arbor SPARK, the Michigan Economic Development Corporation, and U-M. All of that made the formation and growth of our company possible.”
www.thermofisher.com
The company was founded in 1998
by University of Michigan professor Victor Strecher and Gov. Rick Snyder, who was then a venture capitalist.
HealthMedia, located in Ann Arbor,
nearly collapsed when the dot-com bubble burst.
“We had some tough times,” he
said. “We had raised a lot of money early on, but had a huge cash burn rate. We almost ran out of money.”
Dacko said the company had to
lay off about 60 of its 80 employees in order to survive. But he was eventually able to lead a turnaround and by 2007 the company’s phones were “ringing off the hook” with inquiries from interested investors, he said.
HealthMedia was sold in 2008 to
healthcare products giant Johnson & Johnson, which renamed it Wellness & Prevention. Although the sale price was not disclosed, media reports put the figure at between $100 million and $200 million, making it one of Michigan’s most successful startups.
“We went from no revenue to $18
to $20 million of revenue and a sale to Johnson & Johnson,” said Dacko, who left the company in 2010 and started Arbor Dakota, which provides management services to early stage companies.
Wellness & Prevention remains
in Ann Arbor. The company does not disclose employment figures but says it has “a large number of employees” in the city. It is being led by President Sanjay Gupta and is part of Johnson &
WELLNESS + PREVENTION INC. (FORMERLY HEALTHMEDIA)
Ted Dacko said when he became
Johnson’s Health and Wellness Solutions division based in New Jersey.
www.wellnessandpreventioninc.com
CEO of HealthMedia in 2000 he wasn’t looking to sell the online health coaching service for a huge profit
MichBio | www.michbio.org
8
Poised for Success Michigan now has a pipeline flowing with startups to continue its impressive growth in the biosciences industry. What companies will become the next success story?
ELI THOMSSEN
PAUL MCCREADIE
TOM ROSS
ARMUNE BIOSCIENCE
DELPHINUS MEDICAL TECHNOLOGIES
GRAND RIVER ASEPTIC MANUFACTURING
medical diagnostics company formed
in 2005 to test for prostate, lung,
company developed ultrasound
Institute and Grand Valley State
and breast cancers using technology
technology to address a problem
University, the company provides
licensed from the University of
with breast mammography: too many
contract manufacturing services for
Michigan.
false positives.
the aseptic filling of vials and syringes
in clinical drug trials.
Armune is a Kalamazoo-based
The company, founded by the
This Plymouth Township-based
“For women with dense breasts,
Founded in 2004 by the Van Andel
Ajohn Group, a business accelerator
and that’s 40 percent of the population,
in Kalamazoo, is preparing for the
mammography doesn’t work well at
investors, led by the Charter Group,
introduction of its first product, Apifiny,
all,” said Paul McCreadie, chairman of
acquired a majority interest in the
a prostate cancer diagnostic test.
Delphinus and a managing director of
company in 2010 and have been
Arboretum Ventures, a venture capital
growing the business.
said he hopes to introduce the Apifiny,
investor in the company.
which will be used by urologists, yet
registered with the Food and Drug
this year.
its SoftVue platform used to detect
Administration to begin production
breast cancer, Delphinus won approval
from its Grand Rapids facility in 2011.
ready to launch,” he said.
from the Food and Drug Administration
in January to begin selling it.
$9.8 million investment from Michigan’s
million to prepare for the market
Municipal Employees Retirement
launch and fund a research and
to have two of its devices in major
System. Company President Tom Ross
development program to develop
research hospitals next year.
said in a statement that the investment
additional cancer diagnostic tests.
will allow it to expand its customer
from technologies developed by the
base and capabilities and upgrade
a former Merck & Co. executive, as
Karmanos Cancer Institute in Detroit.
its plant.
its chief operating officer. Esposito
www.delphinusmt.com
Eli Thomssen, the company’s CEO,
“As soon as we get funding, we’re Armune is hoping to raise $7.5
In May, Armune hired David Esposito,
will be responsible for the Apifiny
After years of development of
McCreadie said the company plans
Delphinus was founded in 2009
A group of venture capital
Grand River Aseptic became
In June, the company won a
“We have a great company,
fantastic employees and a bright
commercialization strategy and
future,” he said.
expansion of the company’s sales
www.grandriverasepticmfg.com
and marketing efforts.
www.armune.com
9
BioMatters | Fall 2014
GRADUATE RESEARCH EXHIBITION
WAYNE STATE UNIVERSITY
The Best of the BEST:
BROADENING EXPERIENCES IN SCIENTIFIC TRAINING PROGRAM By Andrew L. Feig, PhD & Ambika Mathur, PhD, Wayne State University
How do doctoral programs in the biomedical sciences prepare students for careers? Typical doctoral programs follow what is essentially an apprenticeship model. A PhD student works together with a chosen advisor for a period of several years, during which the student learns through individualized mentorship what it takes to develop new knowledge in the field and disseminate that information in the form of publications. However, according to data from the 2012 National Institutes of Health (NIH) Workforce Development Report, only about 20 percent of biomedical PhDs ultimately take jobs as university faculty. An additional 20 percent take teaching positions at a variety of levels, including community colleges, undergraduate institutions, and comprehensive universities. The other 60 percent of biomedical doctoral graduates enter a wide range of positions distributed throughout the economy. The question is:
MichBio | www.michbio.org
Do our current doctoral programs serve the needs of our students given the wide range of career trajectories? To address these issues, the NIH developed the BEST program—Broadening Experiences in Scientific Training. Its goal is to explore new paradigms related to providing more comprehensive career development for doctoral students. Wayne State University is one of ten institutions to receive NIH-BEST funds and the only one in the Midwest. The award, $1.8 million over five years, is funding an exploration of several new concepts in graduate education and leading to major institutional improvements to doctoral training at Wayne State. The concept behind the WSU-BEST program is to allow PhD students to broadly explore career opportunities and help them understand how they can use their degrees to navigate their career paths. Using data on where alumni of the WSU biomedical doctoral programs were employed, the program identified six
10
career tracks beyond the standard PhD > Post-doc > faculty position mold. These tracks include: • Healthcare and scientific communication • Biotech/pharmaceutical/ entrepreneurship • Government affairs and compliance • Patent law and intellectual property • Advocacy/not-for-profit agencies • Teaching careers—primarily undergraduate institutions The program is structured around Individual Development Plans (IDPs) to help students frame their long-term career objectives. It then uses a threephase approach that allows students to develop the skills necessary for success. The first phase—an initial exploration—uses informational sessions regarding each career track. Doctoral alumni who work in these areas are brought to campus to speak with current students about their career pathways.
Alumni are encouraged to share their personal narratives about how they made the transition to where they are today and provide an overview of the life of PhD holders in those fields. The second phase of the development offers more detailed knowledge of the career path. Prepared in collaboration with external partners, a daylong workshop focuses on skills students need to make a valuable contribution during an internship with companies, agencies, and offices related to each career pathway. The third phase culminates in an internship experience with a partner organization. Internships are structured around the type of work to be done and vary in their structure. Some are simple eight-week, full-time positions, while others are once-a-week assignments over the course of 15-20 weeks. The structure is dictated by the type of work being done. In some cases, an intern may be working on an intense short-term project; in other cases, he or she is better served by obtaining a
longitudinal view of a lengthy process. The needs of the internship partner and respect for the learning objectives of the intern are discussed while structuring the experience. Programs like WSU-BEST have the potential for huge impact on the biomedical workforce in Michigan and surrounding areas. Doctoral recipients are among our most highly trained workers, and the doctoral experience makes them well suited for complex projects requiring independent, self-sufficient thinkers who can manage intricate tasks with many moving parts. Helping such self-motivated individuals find satisfying career options in Michigan can be a significant driving force for economic development and opens the door for creative new partnerships. Karen Weist, graduate school career services director, is happy to speak with corporate leaders interested in developing exciting internship opportunities in collaboration with
the WSU-BEST program. Karen can be reached at karen.weist@wayne.edu for more information. Through this collaboration, Wayne State and industry leaders can help shape tomorrow’s workforce to ensure they have the skills necessary to make Michigan a leader in biomedical innovation, and to take advantage of this pool of highly talented individuals looking for opportunities in and around the state.
WSU-BEST Program Wayne State University Graduate School 5057 Woodward, Room 6305 Detroit, MI 48202 313.577.2170 gradschool.wayne.edu/best
STUDENTS SHOWCASE THEIR WORK TO PEERS AND INDUSTRY PROFESSIONALS AT WAYNE STATE’S GRADUATE RESEARCH EXHIBITION
11
BioMatters | Fall 2014
CO NAME WAYNE STATE UNIVERSITY
Partners Enter Through the Front Door
WSU FRONT DOOR STAFF IN FRONT OF THE MULTIDISCIPLINARY BIOMEDICAL RESEARCH BUILDING, THE UNIVERSITY’S LARGESTEVER CONSTRUCTION PROJECT, SET TO OPEN IN 2015.
The marriage of medicine and engineering has led to rapid growth in biomedical research, with new discoveries being made every day in university labs and research centers. Students who master this discipline will become industry leaders, and many businesses are eager to partner with respected research universities to be at the forefront of this thriving field. Wayne State University is inviting those businesses to knock on its front door. Or, more accurately, The Front Door—the portal that connects businesses with the university to collaborate on research, license university patents, find student interns, and build mutually beneficial partnerships. Located in Detroit’s vibrant Midtown neighborhood, Wayne State is one of the nation’s premier research universities. Featuring highly regarded colleges of engineering and pharmacy, as well as the nation’s largest single-campus medical school, it’s on the cutting edge of biomedical research, renowned for its expert faculty, dedicated students, and state-of-the-art laboratories. The university’s Multidisciplinary Biomedical Research Building, scheduled to open in 2015, will be home to researchers pursuing the latest advancements in cardiovascular disease, metabolic disorders, biomedical engineering, systems biology, bioinformatics/computational biology, and translational behavioral science. Leading Wayne State’s life sciences programs is President M. Roy Wilson, who joined the university in 2012 after serving
MichBio | www.michbio.org
as deputy director for strategic scientific planning and program coordination at the National Institute on Minority Health and Health Disparities (NIMHD) of the National Institutes of Health (NIH). Access to this expertise is crucial for businesses looking for the next breakthrough in biomedicine, and The Front Door prides itself on the collaborative and cost-effective opportunities available to startups seeking a foothold in the industry. “Part of the reason we are located in TechTown (Wayne State’s business incubator on the north side of campus) is that so many small companies are going through the startup process and looking for the kind of key resources that Wayne State can provide, such as a faculty member with expertise in nanoengineering or equipment we have that they could use,” said Dennis Atkinson, director of corporate engagement for The Front Door, which is part of Wayne State’s Office of the Vice President for Economic Development. Business-university relationships can extend even further. Companies can work with Wayne State to develop a capstone project in which students work to solve an industry problem, or they can form internships that give the students a leg up and the company an infusion of energy and enthusiasm. In developing these “strategic internships,” Front Door staff members meet one-on-one with company representatives to strategize and work in concert with Wayne State’s career services office to make sure each businesses’ message effectively gets to the student who can be the best fit. 12
The Front Door also assists companies that wish to sponsor or participate in projects underway in the university’s research centers or become involved in licensing university technologies through the technology commercialization office. Because many businesses are in the fields of engineering and biomedical research, The Front Door also employs an industrial liaison to explicitly assist with their complex needs. “As a state institution, one of our charges is to help local industry—especially small businesses—do better and grow. All of these connections can help them do that,” says Atkinson. The university is also part of the prestigious Michigan Corporate Relations Network (MCRN), which offers several programs to help the state’s businesses. The partnership is beneficial to the university as well. It allows Wayne State to showcase its assets, highlight its faculty and let people know that it is a world-class, unique urban research university with many opportunities to get involved. As companies partner with the university and grow, their success benefits the city and state, making these partnerships crucial to transforming Michigan’s economy.
Portions of this article were previously published in Wayne
State magazine’s winter 2013 edition.
The Front Door in the Office of Economic Development Wayne State University 440 Burroughs Avenue, Suite 205 Detroit, MI 48202 888.WSU.DOOR thefrontdoor.wayne.edu/about
13
BioMatters | Fall 2014
PARADIGM
LAB TECHNOLOGIST BEN LOWE EXTRACTING DNA WITH A QIASYMPHONY LIQUID HANDLING INSTRUMENT
HARNESSING THE POWER OF GENOMICS TO HELP PERSONALIZE THERAPY FOR CANCER PATIENTS NATIONWIDE PCDx is a New Paradigm of NextGeneration Sequencing-Based Cancer Testing Currently Available to Help Improve Patient Care The Paradigm Cancer Diagnostic (PCDx) developed at the University of Michigan is a new and advanced test for cancer patients with late stage and difficult to treat cancers. Commercially available under CLIA, PCDx returns results in 4-5 business days of specimen receipt. Utilizing next-generation sequencing (NGS), the evidence-driven analysis provides a comprehensive genomic landscape of the patient’s cancer, including DNA mutations, copy number alterations, gene fusions and rearrangements, and most uniquely, a comprehensive RNA analysis. The goal of the PCDx testing is to help match the cancer patient with therapies and biomarker-driven clinical trials that are likely to be more effective based on associations with the key cancers pathways. The experience of the Paradigm leadership team in
MichBio | www.michbio.org
pioneering this area of medicine, combined with history of successfully running of The Cancer Genome Atlas Project (TCGA) has helped accelerate them past other competitors in the market. The PCDx test has one of the largest FDA approved drug associations of any tumor profiling service currently available. Furthermore, this effort builds upon the foundation established by Paradigm’s leadership in a pivotal and hallmark clinical trial, demonstrating that molecularly directed therapy was more effective than standard of care treatment in improving the progression free survival (PFS) rate of cancer patients with refractory, metastatic cancer. The prospective clinical trial was published in the Journal of Clinical Oncology in October of 2010.1
1.
Von Hoff, D.,et al. Pilot Study Using Molecular Profiling of Patient’s Tumors to Find Potential Targets and Select Treatment for Their Refractory Cancers. J Clin Oncol. 20;28(33):4877-83. Epub 2010 Oct 4.
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BACKGROUND Launched in August of 2012, Paradigm is a spin off non-profit company envisioned and launched by Robert J. Penny MD, PhD and Jay Hess MD, PhD, from the University of Michigan and the International Genomics Consortium (Phoenix, AZ). By building upon experience gained from creating and successfully running the Molecular Profiling Institute (now Caris Life Sciences) and helping to lead the NIH-sponsored TCGA project, Paradigm’s expert team in genomics, pathology, oncology, informatics, and translational medicine is delivering advanced genomic testing to help drive targeted therapies to patient care. Paradigm builds upon and joins the success of the MI-ONCOSEQ cancer research-sequencing program at the University of Michigan with a highly accurate clinical grade next generation sequencing test on formalin fixed paraffin sections. MI-ONCOSEQ, Paradigm, and MLabs cover a needed and unique spectrum of services for the
nation spanning from research (MIONCOSEQ) to a mixture of standard of care testing; multiplexed early adoption therapies with a subset of clinical trial analysis (Paradigm); to accepted individual standard of care testing and surgical pathology consultation (MLabs).
“Paradigm’s experience, translational expertise, and broad-reaching laboratory capabilities position us well as an organization to make a significant and long-lasting impact on improving the care of cancer patients both nationally and internationally.”
CLINICAL NEED In the U.S. alone, there are an estimated 2.5 million cancer patients with advanced solid tumor disease that are actively undergoing therapy.1,2 Many of these patients suffer from common forms cancers such as breast cancer and colorectal cancer but have exhausted standard of care therapies. Others are suffering from rare cancers such as sarcomas with a limited or no standard of care. Others are confronting particularly aggressive cancers, such as non-small cell lung cancer (NSCLC) or pancreatic cancer. With continued advances in the development of targeted therapies as well as our better biological understanding of efficacy of existing therapies, tumor profiling has emerged as an important clinical option to help better inform a patient’s cancer treatment.
translocations, and mRNA expression. NGS has emerged over the past few years as a technological breakthrough enabling the analysis and interrogation of numerous alterations in the tumor in a cost-efficient, confident, and rapid manner. “PCDx is a best-in-class cancer testing service and the only one currently available that provides a combined NGS genomic analysis including mRNA on standard formalin processed tissue,” notes Penny. “For patients that need our services, we
understand that time is of the essence. Paradigm’s ability to interrogate the patient’s cancer for key genomic alterations with clinical quality at >5000x depth of coverage in 4-5 business days is a differentiator in helping to improve patient care.” The PCDx test is for cancer patients with solid tumors when first-line or second-line treatment or standard of care options are not working. PCDx may also be clinically appropriate for patients with cancers that are rare or of an aggressive nature with limited treatment options.
EVIDENCE DRIVEN ANALYSIS At the heart of the PCDx service, lies a sophisticated biomarker evidence engine built by a team of experts. Years in the making, the purpose of this “engine” is to ensure that the PCDx testing and associated clinical report most accurately reflects the
THE PCDX CANCER TESTING SERVICE Through a sophisticated multiplexed analysis of a tumor’s DNA, RNA, and protein via IHC (to be available in coming months), Paradigm provides patients and physicians with a blueprint of a patient’s cancer, what drugs and clinical trials are associated with these pathways, and the associated level of evidence to support the use of a drug on that pathway in that cancer lineage. This approach helps reveal potential treatment options that are tailored to the underlying genomics of what is driving the tumor and may otherwise not have been considered. PCDx provides a clinically actionable, broad-spectrum analysis covering over 114 “genes” (soon to be 130) with over 500 regions of interest including DNA mutations, DNA copy number variation, DNA chromosomal inversions, deletions,
2. ACS Cancer Facts 2014
DR. ERIC KALDJIAN, PATHOLOGIST, AND SHARRON LADD, ASSISTANT DIRECTOR OF IHC, READING SLIDES
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BioMatters | Fall 2014
LAB TECHNOLOGIST HALEY RUPP PERFORMING NEXT GENERATION SEQUENCING
current state of translational medicine in oncology. This team of biomarker experts has reviewed over 100,000 peerreviewed clinical abstracts and scientific journal articles as part of establishing this critical information tool.
BUILDING SYNERGY WITH THE UMHS As a collaborative effort, the Paradigm team is able to not only tap into the laboratory capabilities of the University of Michigan Health System, but also the considerable knowledge-base present and thought leadership available. “Our relationship with the University of Michigan Health System is a winwin,” said Penny. “We see Paradigm’s aggressive and earlier broad based biomarker NGS clinical testing aligning quite well with the later stage biomarker testing already performed at MLabs and the cutting-edge cancer sequencing research discovery efforts of Dr. Arul Chinnaiyan with MI-ONCOSEQ.”
executing on growth and commercial expansion, prospective clinical validation studies, and forging strategic biopharma relationships. In March 2014, Paradigm officially announced a partnership with CRO Pharmatech, where Paradigm will provide rapid molecular diagnostic profiling for patients with solid tumors to help better position them for treatment and biomarker driven clinical trials. Paradigm also announced a groundbreaking clinical study with the Indiana University to provide NGS in a prospective clinical trial for triple negative breast
WHAT THE FUTURE HOLDS FOR PARADIGM While Paradigm has been focused on the development and technical validation of the PCDx cancer testing service, they are now strategically positioning and LASER CAPTURE ENRICHMENT MACHINE
MichBio | www.michbio.org
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cancer patients to test whether certain treatment choices improve survival rates. The trial will enroll 130 women who have received standard surgery and chemotherapy but who are at high risk for relapse. Half will receive the standard of care, while genomic sequencing will direct therapy for the other half. Paradigm also forged strategic partnerships with two biopharma companies, TESARO and Forma Therapeutics, to help innovatively characterize patients that enable their clinical trials to be more precise and have better outcomes as well as develop tests to most effectively analyze those alterations. “These are important as well as exciting times for both Paradigm and the field of oncology,” explains Penny. “Paradigm’s experience, translational expertise, and broad-reaching laboratory capabilities position us well as an organization to make a significant and long-lasting impact on improving the care of cancer patients both nationally and internationally.”
Paradigm 2900 Huron Parkway Ann Arbor, MI 48105 800.862.7284 www.paradigmdx.org
XORAN TECHNOLOGIES
SAMPLE SINUS IMAGE FROM MINICAT SCANNER
THE ANN ARBOR STARTUP THAT
Changed the Point-of-Care Imaging Platform OUR PRODUCTS
overall time to achieve a more precise
that has increased the safety and
The MiniCAT is an upright cone-beam
diagnosis. The MiniCAT also offers a
efficiency of physician clinics around
CT scanner designed for high-resolution,
radiation dose that is up to 90 percent
the world. Ann Arbor-based Xoran
bone window imaging of the sinuses,
less than full-body CT scanners.1 Without
Technologies’ first in-office imaging
temporal bones, and skull base (see
the option for upfront CT scanning, the
unit was a dental CT scanner called the
image on p.18). The system allows
delivery of care can introduce multiple
i-CAT, which was licensed to Imaging
patients to obtain a CT scan at the
inefficiencies including treatment delay,
Sciences International, a Danaher
point of service, instead of being sent
antibiotic overuse, and the expense
corporation. Then, with the vision to
off-site to a hospital or imaging center.
of additional visits before obtaining a
improve patient care and reduce waste
This streamlined approach reduces the
treatment plan.2
In-office imaging is a concept
and inefficiency in healthcare, Xoran focused their efforts toward a medical office-based CT scanner called the MiniCAT. Ten years later, with nearly 500 MiniCATs placed within ENT and allergy offices across the globe, their vision has become a reality.
Xoran Technologies was founded
in 2001 by two University of Michigan research scientists and, with funding from NIH SBIR grants, the company launched its specialized point-of-care CT scanner from the research lab to the commercial market in 2004. Xoran now resides in a 60,000 square foot building in Ann Arbor and has a dynamic team of employees dedicated to its future growth.
XCAT IN USE IN OPERATING ROOM
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BioMatters | Fall 2014
within the OR is a safer and more
to a new level of innovation,” said
for increased patient and physician
efficient alternative. The xCAT’s ability
Teicher. “As a privately held company,
convenience. It compels practices to
to perform intra-operative scans allows
Xoran is extremely excited to enter into
improve outcomes, decrease healthcare
for instant identification of surgical
the investment community, launching
costs, and utilize more innovative
completeness. The product has been
its first investment structure in the
technology,” explains Xoran’s Director
successfully used in recent years by
company’s history. We feel confident
of Marketing Rachel Gajda. According
renowned otolaryngology surgeons
that in closing our initial round, we
to a survey performed at Northwestern
around the world during sinus surgeries
will be able to expedite and deliver
and cochlear implant procedures. Xoran
on our project pipeline in a much
currently has dedicated resources
more expeditious manner. We will also
collaboratively working on a redesign
be able to utilize that investment to
of the product that will broaden its
source exceptional talent from the
use and allow for penetration into
state of Michigan.”
“The MiniCAT is the perfect solution
“The xCAT is capable for use within almost any acute care or outpatient care setting across a variety of specialties—such as otolaryngology, neurosurgery, sports medicine, and veterinary clinics. The market opportunity for this product is very encouraging.”
additional markets.
“The xCAT is capable for use within
almost any acute care or outpatient care setting across a variety of specialties—such as otolaryngology,
Xoran Technologies, LLC
neurosurgery, sports medicine, and
5210 South State Road
veterinary clinics,” Xoran CEO Michael
Ann Arbor, MI 48108
Teicher said. “The market opportunity
800.709.6726
for this product is very encouraging.” University, upfront CT scanning can save
the U.S. healthcare industry on the
products within the next 18 months.
order of $1.2 billion dollars per year.1
They are currently working closely
Performing the scans within the office
with design and engineering firms from
also offers an extra revenue source for
around the Ann Arbor area, and hope
the practice. These benefits demonstrate
to have the same success with their
a clear advantage for in-office CT imaging
new endeavors as they did with their
from multiple perspectives.
current products.
During the success and adoption
www.xorantech.com
Xoran plans to launch two new
“This year has been the
of the MiniCAT in the market, Xoran
most successful
saw an opportunity to expand their
for the company
point-of-service imaging technology
since 2006. The
into the operating room (OR). Their
projects we have
goal was to design a scanner that was
on the horizon
mobile and compact enough to be
will bring Xoran
1. Leung R, Kern R, Jordan N, Almassian S, Conley D, Tan BK, Chandra R. Upfront computed tomography scanning is more cost-beneficial than empiric medical therapy in the initial management of chronic rhinosinusitis. Int Forum Allergy Rhinol, 2011; Nov-Dec;1(6):471-80. 2.
Conley D, Pearlman A, Zhou K, Chandra R, Kern R. The role of point-of-care CT in the management of chronic rhinosinusitis: a case controlled study. Ear, Nose and Throat Journal. 2011; 90(8): 377-391.
easily wheeled directly to the bedside of an OR patient. Patients within the Intensive Care Unit (ICU) frequently undergo diagnostic imaging procedures that require them to be taken to other areas of the hospital. There
MINICAT COMPACT, UPRIGHT VOLUME COMPUTED TOMOGRAPHY SYSTEM DESIGNED FOR HIGH-RESOLUTION, BONE WINDOW IMAGING OF THE SINUSES, TEMPORAL BONES, AND SKULL BASE.
are numerous risks involved with intra-hospital patient transport, which is why point-of-care imaging
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KETTERING UNIVERSITY
DR. CHERYL SAMANIEGO WORKING WITH STUDENTS IN THE HUMAN BIOLOGY LAB
APPLIED BIOLOGY.
REIMAGINED. Denis Volobuev didn’t move from his hometown in Missouri to Flint, Michigan, to study in a typical biology program. So far his undergraduate experience in the Kettering University applied biology program has been anything but ordinary. “One of the major things I’ve been able to do here my first year is work with other departments,” said Volobuev, a sophomore. “While doing research with biology professors, I have had the opportunity to work with chemical engineering faculty on a biogas project, and chemistry and chemical engineering faculty on a nanoparticles project.” Kettering’s educational model allows students to gain experience in multidisciplinary settings, making them more well-rounded and versatile. The small class sizes and the university’s unique co-op structure that requires students to alternate terms between
classroom/lab learning on campus and paid work experience in their field of study were all selling points to Volobuev. His current co-op position is with OrthoMichigan, one of Michigan’s largest orthopedic practices, as a physician’s scribe. His ability to engage in meaningful research immediately with faculty at Kettering, combined with his experience in the professional field as a co-op employee, has given him a big picture view of the biomedical field that few college students receive as undergraduates. “There is a connection between medicine and research, because you can’t have one without the other,” he said. “Someone has to find out how things work, someone has to create the product in the end, and the doctor has to apply it to the patient. Research at Kettering and working in my chosen field, prepare me for my future as a practicing physician and researcher.”
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The hands-on nature of Kettering’s curriculum and co-op program has been invaluable for Volobuev, reinforcing his decision to leave his home state to pursue his education. “At Kettering, if you try and fail, we want you to try again until you get it right,” said Dr. Jim Cohen, assistant professor of applied biology at Kettering University. “This type of curiosity and perseverance makes our students able to excel in the workforce.” Kettering University is known nationally for its engineering programs. In recent years, the university has added many new majors, applying the co-op/experiential education principles that Kettering was founded on in 1919. New academic programs have been created such as chemistry/biochemistry, chemical engineering, and the pre-med course of study.
BioMatters | Fall 2014
“The new applied biology program was an essential program for Kettering to add,” said Dr. James Zhang, Kettering University provost and senior vice president for academic affairs. “Biology is a core discipline at virtually every university in the United States with a commitment to STEM education and it will strengthen our existing bio-based programs including pre-med, biochemistry, bioinformatics, mechanical engineering-biology specialty, and mathematical biology.” The applied biology program was launched in 2012 with support from the C.S. Mott Foundation. The support helped with the creation of modern laboratory space and the purchase of state of the art lab equipment. The major differentiator for Kettering University’s applied biology program compared to others is the fact that an experiential learning program is built into the biology curriculum. “Throughout their tenure at Kettering, students gain valuable research and work experience both
STUDENT DENIS VOLOBUEV WORKING IN THE BIOLOGICAL HOOD
on- and off-campus, said Dr. Stacy Seeley, department head of chemistry, biochemistry, chemical engineering, and applied biology. “Students will graduate from Kettering with 2.5 years of paid, professional experience in their field, giving them an advantage over peers at other institutions.” “Our students have the opportunity to mature and to contribute to a company or institution throughout their time at Kettering,” said Dr. Cheryl Samaniego, assistant professor of applied biology at Kettering University.
STUDENTS WORKING IN THE MOLECULAR BIOLOGY LAB
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“We design coursework that is researchdriven, cutting-edge, interdisciplinary, and hands-on which prepares students for their co-op experiences.” Two laboratory-intensive courses taken sophomore year, “Biological Techniques I and II,” were strategically designed to align with what students would encounter in industrial and research settings. These courses equip students with the proficiency and confidence to tackle the challenges of working in research and development or quality control labs in the biological or health sciences industries. Current biochemistry and biology students at Kettering are employed at companies such as JHP Pharmaceuticals, Emergent Biosolutions, Neogen, Argonne National Labs, MPI Research, Stryker, and Corning; and pre-med students are employed at Hurley Medical Center and Michigan Health Specialists, in addition to OrthoMichigan. “Problems facing biologists in the workforce today are multi-faceted,” said Dr. Michelle Ammerman, assistant
professor of applied biology. “Our curriculum has been created with more chemistry and math than traditional biology programs, and every independent research project is multidisciplinary to give students extra exposure to those subject areas.” Another key difference in Kettering’s program is the immediate focus on laboratory skill development. In traditional programs, this typically happens during a student’s senior year. At Kettering, because of the need for students to be productive contributors to their co-op employers, this skill development is a focus from the moment they step on campus. By the end of their sophomore year, Kettering students are skilled in basic laboratory technique and troubleshooting, keeping a lab notebook, creating and performing experimental protocols, solution and media preparation, sterile technique,
microscopy, tissue culture, and biological techniques such as protein and DNA electrophoresis, nucleic acid isolation and mutagenesis, PCR, molecular cloning, and protein purification. In addition, students also become familiar with numerous types of instrumentation including UV/Vis spectrophotometry, FTIR, GC/MS, and high resolution NMR. Applied biology students at Kettering perform research with a professor of their choice during at least one academic term. The research is intensively student-driven—students are trained directly by the professor, but the students work independently. The fact that the applied biology program is housed within a department with chemists, biochemists, and chemical engineers presents many opportunities for collaborative research.
The applied biology program at Kettering University has been reimagined to position students ahead of their peers at other institutions. The forward thinking program features a heavy lab-based curriculum, paid experiential learning opportunities, and required undergraduate research opportunities in a multidisciplinary environment. Imagine the possibilities!
Kettering UNIVERSITY
Kettering University 1700 University Avenue Flint, MI 48504 810.762.9500 www.kettering.edu
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www.terumo-cvgroup.com | www.terumoheart.com Terumo® is a registered trademark of Terumo Corporation. ©2014 Terumo Cardiovascular Systems Corporation 851541
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BioMatters | Fall 2014
STUDENTS LEARN HOW TO MAKE BIODIESEL DURING THE LAB BENCH TO PLANT WORKSHOP
MSU BIOECONOMY INSTITUTE
SCALING UP
COMPANIES, FUTURE ENTREPRENEURS When Michigan State University (MSU) accepted the Bioeconomy Institute in 2007 as a gift from Pfizer, Inc., they took on a $50 million plus property in Holland, MI that was poised to set MSU apart from any other university in the world. Helping to develop key components of various chemical projects, the Bioeconomy Institute has made itself invaluable to several growing chemical companies across the nation and has attracted new business development to the state. The Institute offers a wide range of services that appeal to both startup and well-established companies. The facilities are capable of replicating and testing what happens in a lab setting in full-scale production—also known as scale up, and production services, conducting sponsored research and testing, and facilitating business incubation opportunities, as well
MichBio | www.michbio.org
as renting lab space and providing educational programming and training. All of these services are funded through facility revenue and grant money; no tuition money is used for operations.
“Our role at Michigan State is not only economic development and helping entrepreneurial businesses develop “green” chemical technologies and green chemistry but helping small companies survive the challenges of commercialization quickly.”
“We have 30,000 liters of scale up capacity and we use that to scale up processes for small companies. So, for companies that cannot afford that
22
infrastructure, which is a very large expenditure, we are able to bring them to market very quickly,” explained Bill Freckman, the director of operations who also managed the facility’s operations during his days with Pfizer. “Our role at Michigan State is not only economic development and helping entrepreneurial businesses develop “green” chemical technologies and green chemistry but helping small companies survive the challenges of commercialization quickly.” To date the Bioeconomy Institute, with grants from the Michigan Economic Development Corporation and the U.S. Department of Commerce’s Economic Development Administration, has helped scale up processes for more than a dozen companies ranging from two-person operations to Fortune 500 companies.
The Bioeconomy Institute also has the ability to provide unique opportunities to students at both the undergraduate and graduate level. “Students that weren’t sure about attending grad school, or those who were just not ready, have the opportunity to go on to that level after experiencing a summer here,” Thomas Guarr, director of research and development, said. Guarr leads the institute’s summer internship program for undergraduate students. This summer the facility is host to ten interns from universities across the state. The ideas for the student projects Guarr develops come from talking to other researchers, or something he saw at a conference, or read in a journal and looks to the students to project their own theories, assumptions, and test. “Sometimes it works, and sometimes not,” Guarr says of the projects. His definition of research? “If it worked every time then it would just be called ‘search.’” Guarr earned a BA in chemistry— summa cum laude—from Benedictine College in Atchison, KS in 1979. He then
THOMAS GUARR
studied chemistry at the University of Rochester in upstate New York, where he earned a master’s in 1982 and a PhD in 1984. That was followed by postdoctoral research in chemistry at the California Institute of Technology from 1984 to 1986. He taught at the University of Kentucky from 1986 to 1993, where he achieved the level of associate professor with tenure after starting out as an assistant professor. In 1994, Guarr found himself on the commercial side of chemistry for Holland-based Gentex. It was there that he got to experience the practical side of innovation and was named as
one of the inventors on 58 patents obtained by the company. However, it was the appeal of being in on the early stages of development and the opportunity to work on revolutionary ideas and products that attracted him to join MSU in 2012. “Being from Holland, I wanted to see this place become successful.” Guarr said. “We have taken an empty facility with great potential to a place that helps startups and businesses prove their ideas. We provide opportunities for students to gain valuable experience. So, we not only scale up companies and compounds, we scale up future entrepreneurs, job creators, and researchers.”
MSU Bioeconomy Institute 242 Howard Ave. Holland, MI 49424 616.395.8923 bioeconinst.msu.edu
4,000 LITER GLASS LINED REACTORS AT THE MSU BIOECONOMY INSTITUTE
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BioMatters | Fall 2014
ENTREPRENEURS
AFTER THE
Elevator Speech By Tom Beaman
Michigan continues to lead the way in advancements in medical, pharmacological, and bioscience research, thanks to its rich store of intellectual capital. From research aimed at mitigating the side effects of radiation and chemotherapy in cancer patients, to reducing hospital acquired infections to assuring that patients on oxygen know when their supplies are running low, Michigan’s bioscience businesses are truly improving the quality of life. In this issue of BioMatters, we profile six entrepreneurial companies about their pioneering work.
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PERFECTA 3D HANGING DROP PLATE
3D BIOMATRIX INC. 3D Biomatrix Inc. of Ann Arbor is expanding the concept of the humble petri dish by providing researchers with a tool that allows cell cultures to be grown and studied in three dimensions as they actually occur in the body. “When you put cells in a two-dimensional petri dish they flatten like a pancake and may react to drug tests differently than they would in their natural state,” says President and CEO Laura Schrader. “We offer a more physiologically relevant option for cancer, stem cell, and toxicology research.” The three-year-old firm’s patented Perfecta 3D hanging drop plate (a modified well plate) lets researchers replicate a three-dimensional tissue environment in a droplet of suspended media. The company’s technology emerged from work originally performed in the University of Michigan’s department of biomedical engineering. Schrader, an Olivet College business graduate and former medical device consultant, was recruited in 2010 to lead the company, which included securing $1.5 million of angel investment. 3D Biomatrix today has over 30 distributors worldwide and hundreds of customers, including pharmaceutical firms, biotech startups, universities, and governments. “As drugs move though the development pipeline it’s often discovered that they don’t work,” Schrader says. “Our product allows researchers to get to a more physiological model much earlier in the process. If they fail earlier or see promising drugs that they may have missed in a two dimensional environment, it’s going to potentially move the right drugs forward faster. That’s our goal, to help the patient get better faster.”
www.3dbiomatrix.com
(L-R) DR. BEN CHEN (DIRECTOR), DR. JIAJIU SHAW (PRESIDENT), DR. FRED VALERIOTE (CEO)
21st Century Therapeutics
21ST CENTURY THERAPEUTICS While radiotherapy and chemotherapy can be effective cancer treatments, patients often suffer side effects that seemingly add insult to injury. Beyond hair loss and nausea, cancer treatments can damage the central nervous system and many organs. One doctor has said the way to tell if a patient was getting sufficient doses of an adrenal cancer drug is when they can’t walk unassisted. After ten years, during which he studied 100 compounds and received 16 patents, Dr. JiaJiu (JJ) Shaw, president of 21st Century Therapeutics, Inc. (21CTI) in Detroit’s TechTown, believes UTL-5g, a small-molecule tumor necrosis factor alpha (TNF-a) inhibitor, has the potential to significantly reduce the side effects of cancer treatments, while causing few reactions of its own. “Many drugs often lose their efficacy when they are metabolized by the liver,” Shaw says. “In animal testing, we have shown that UTL-5g, as well as its resulting metabolized compounds, are effective in protecting the liver, kidneys, lungs, skin, and bloodmaking mechanisms from side effects of radiotherapy and chemotherapy.” Privately held 21CTI was started in 2002 by Dr. Frederick Valeriote, who serves as CEO, and has received millions of dollars in Small Business Innovation Research grants from the National Institutes of Health. In collaboration with Henry Ford Health Systems, the company has collected over 20,000 extracts from plants and marine sponges. “We have identified over 100 preliminary leads for secondary screening as potential chemotherapy agents,” Valeriote says. “If we see some promising compounds from all these natural sources, we will go forward with development.”
OXYGEN FLOW ALARM
AIRS As a respiratory therapist for over a decade, Valerie Obenchain has seen her share of tense moments when a patient’s portable oxygen tank had run out or a home concentrator wasn’t delivering the correct percentage of oxygen. “I found case studies from around the world where patients had died because of oxygen issues,” she says. “I looked high and low for an oxygen alarm system and when I couldn’t find one I said, ‘Darn it, it’s time to make them myself.’” With degrees in business and respiratory therapy and a compelling desire to help her patients, Obenchain formed Advanced Interactive Response Systems (AIRS), LLC in 2013 out of her home in Newaygo, Michigan and built a prototype system. As the designs got more complex—adding visual and audible alarms, automated back-up capabilities, and text notifications—Obenchain hired an electrical engineer to design the systems and a patent lawyer for her issued patent and patent continuation— all with her own money. “I believe I’ve found a niche that wasn’t being addressed and AIRS is going to try to fill it,” Obenchain says. “I’m looking at potential investors, licensing options, and am starting to attend more conferences to get the word out. As soon as I’m close to being cleared by the FDA I’ll start hiring additional staff. I’ve known a lot of people, including my grandmother, who fear having issues with their oxygen supplies. I want to be able to help them improve the quality of their lives.”
www.oxygenalarms.com
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BioMatters | Fall 2014
JULIA C. OWENS
MARK ARIZMENDI
ATTEROCOR
HEALTHCURE LLC
IRISENSE, LLC
Adrenal cancer, which arises from the cortex of the adrenal glands that produce hormones that regulate, among many other things, blood pressure and the body’s ability to manage stress, is extremely rare. The only approved treatment is mitotane, a synthetic derivative of the pesticide DDT that is very poorly tolerated and has minimal efficacy. When pharmaceutical executive Dr. Raili Kerppola was diagnosed with adrenal cancer in 2010, she set off to work with her husband, a professor of biological chemistry at the University of Michigan, and others to identify alternative treatments, including a promising compound called ATR-101. Kerppola succumbed to the disease in 2013, but her work lives on at Atterocor, the company she formed in 2012 with Dr. Gary D. Hammer, the Millie Schembechler Professor of Adrenal Cancer at the University of Michigan, and Dr. Julia C. Owens. As president and CEO of the startup, Owens spearheaded the charge to raise $16 million of venture capital financing, which allowed it to begin clinical testing in 2013 in collaboration with the University of Michigan and the University of Texas MD Anderson Cancer Center. “Adrenal cancer is very bad, but it also generates hormones (steroids) that result in complications that make treatment even harder,” Owens says. “ATR-101 selectively inhibits the enzyme that is necessary to provide the starting point for the synthesis of those steroids. The promise of this compound is that it will directly target the cancer in the adrenal cortex without many of the side effects that limit mitotane’s ability to have any effect.”
On any given day, one in 25 hospital patients in the U.S. contracts at least one healthcare associated infection (HAI). More than 722,000 HAIs were recorded in 2011, each costing up to $45,000 to treat and resulting in over 75,000 patient deaths. Armed with a new product called Goldshield that was developed and licensed at Emory University in Atlanta, Ann Arbor-based HealthCure LLC hopes to dramatically reduce HAI’s and save hospitals millions of dollars. “Traditionally hospitals use bleach to kill bacteria, but within eight hours they spike back up to pre-treatment levels,” says HealthCure CEO and managing partner Mark Arizmendi. “When Goldshield is applied after bleach, hard surfaces, linens, and privacy curtains maintain dramatically reduced bacteria levels for 30 days.” The company claims that the product kills bacteria, including Methicillin-resistant Staphylococcus Aureus (MRSA) and Vancomycin-resistant Enterococci (VRE), electromechanically, not chemically, so they cannot develop a resistance. After private investors from Detroit pledged $475,000 to launch the business in 2008, Northwestern Capital Partners LLC in Ann Arbor, Physicians Choice Laboratory Services in Charlotte, North Carolina, and Oakwood Healthcare in Dearborn provided additional funding. Oakwood became HealthCure’s first customer in 2013, realizing an average reduction in HAIs of 27 percent in a 330-bed commercial launch and a triple-digit return on investment. “Our plan is to expand in Michigan and raise one more round of venture capital in late 2014,” Arizmendi says. “With its low cost of doing business and access to great intellectual capital and management talent, Michigan has some real advantages for startups.”
IRISense, LLC has emerged from the University of Toledo College of Engineering with a concept that may someday benefit millions of diabetes sufferers—a reliable, non-invasive way to test blood sugar levels. “Like every cell in your body, the aqueous humor, the fluid between the cornea and the iris, contains glucose. IRISense technology uses a camera and an algorithm personalized to your system to measure glucose levels based on the way light is refracted through the aqueous humor,” says Brent L. Cousino, IRISense CEO. He says early studies have indicated an accuracy rate of 85 percent, compared to 70 percent with continuous glucose monitors and 98 percent using blood glucometers. The company hopes its technology can help raise the rate of patient compliance—currently only 30 percent—with recommendations made by doctors for testing blood sugar. “Like anything in life, the easier it is the more likely it’ll get done. That’s our secret sauce. There’s no pain and it’s going to be real easy,” Cousino says. Although the product is still in the development phase and there have been no discussions with the FDA, IRISense has begun to integrate its technology into a smartphone app that uses the device’s camera to capture and process images of the eye to compute glucose levels. “One of the beauties of our technology is that it’s relatively simple,” Cousino says. “You’ll just snap a good image and then get an answer seconds later.”
www.atterocor.com
BENCH-TOP PROTOTYPE BEING USED FOR CLINICAL AND DEVELOPMENTAL STUDIES
www.healthcure.biz
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www.irisense.net
MARTHA LARSEN IS THE HIGH-THROUGHPUT SCREENING DIRECTOR OF THE CENTER FOR CHEMICAL GENOMICS.
PHOTO: SCOTT SODERBERG
U-M CENTER FOR CHEMICAL GENOMICS
HIGH-THROUGHPUT SCREENING: Accelerating Academic Drug Discovery at the University of Michigan
By David Sherman, Director of the Center for Chemical Genomics, the Hans W. Vahlteich Professor of Medicinal Chemistry, and Associate Dean for Research and Graduate Education in the College of Pharmacy at University of Michigan
In Ann Arbor in 2004, leaders at the Life Sciences Institute at the University of Michigan (U-M) saw an opportunity to increase and enhance early-stage drug discovery research on campus and in the region with the establishment of a high-throughput screening center, one of the first to be located in an academic institution. The Center for Chemical Genomics (CCG), housed in the Life Sciences Institute, brought libraries of small molecules and natural product extracts to the university. Staffed by former pharmaceutical personnel who brought a range of specialties to high-throughout screening, the CCG is the starting point for much of the early-stage drugdiscovery work happening at U-M. The center is tightly connected to campus resources in structural biology, medicinal chemistry, and pharmacokinetics. The advantages for drug-discovery research in an academic environment are clear: the spirit of collaboration, mandate to share knowledge, willingness to investigate areas less financially rewarding but with great potential to improve human health, and the sheer breadth of experience define the culture of research at University of Michigan.
This culture differs from the traditional pharmaceutical culture of guarding findings and making profit-based decisions, and we believe that academic drug discovery has become a robust and fundamentally important complement to industry drug development. The primary objective of the CCG is to assist biomedical researchers at U-M, other academic institutions, and at pharmaceutical and biotechnology companies in identifying small molecules, genes, or natural products for drug and molecular probe discovery. Researchers seeking to collaborate with the CCG provide information about bioassay development status, target information, key staff, and lab members as well as funding and reagent resources. The center’s scientific staff meets with the investigator and lab members to discuss objectives, resources, and timelines and works closely with the biology collaborator to achieve timely statistical development parameters, pilot data, and initial hit rates. Since 2004 over 160 HTS campaigns have been completed at the CCG, and the screening libraries of small molecules and natural product extracts have grown to over 200,000 and 33,000, respectively.
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The impact has been felt across the U-M research community: Research originating from high-throughput screening at U-M has generated more than 70 publications, supported more than 350 grant applications and generated over $75M in support. Since 2009, the CCG has submitted more than 20 patent applications. Consistent with the educational mission of the university, the CCG has provided
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A B C D E F G H I J K L M N O P
HEAT MAP OF AN ASSAY PLATE FROM MSCREEN DATABASE DEPICTING DOSE-RESPONSE ACTIVITY OF AN ENZYME INVOLVED IN CANCER CELL PROLIFERATION.
training and education to more than 275 graduate students and postdoctoral fellows through active engagement in screening campaigns or classroom studies. In addition to providing services for over 70 U-M investigators, the CCG has also performed screens for 10 other academic centers and for several biotech companies. For chemoinformatics, the CCG uses MScreen, a custom-designed relational database that has computational tools for every stage of screening and follow-up. There is also a programming systems analyst available to assist with custom queries. All assay data from the CCG is entered into MScreen for access by HTS staff. If acceptable parameters are obtained, the center performs a compound pilot screen using a library of established drug and biologically active compounds. The pilot screen and any subsequent screens are entered to MScreen for access by all authorized users. MScreen offers an invaluable tool for all users of the CCG, and this fall the CCG plans to make the system available to other institutions through MSITES, a software-for-service agreement. Importantly, the CCG works closely with the U-M College of Pharmacy Vahlteich Medicinal Chemistry Core (VMCC) with consultations on library selection, clustering and triage tools, hit compound reorders, and lead selection. The VMCC also has chemoinformatics resources: computational chemistry, virtual screening and drug design, ligand-and structure-based methods, calculated properties, QM calculations, and combinatorial library design.
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a central role in drug discovery, both in academia and industry. The addition of dedicated core labs to provide the critical resources needed to support and develop HTS discoveries (structural biology, medicinal chemistry, and pharmacokinetics) has served to maximize the impact of high-throughput screening on biomedical research at U-M, and promises to transform University of Michigan into a leader in academic drug discovery.
The HTS core laboratory has several collections of drugs and known bioactives, focused libraries (autophagy, kinases, epigenetics), over 30,000 natural product extracts, a Center for Chemical Genomics 20M in-silico library (vendor compound Life Sciences Institute structures available for searching) and University of Michigan the siRNA Dharmacon human and mouse 734.615.9317 genomes. For assay support, the core www.lsi.umich.edu/ccg has robotics and liquid dispensers for 96-, 384- and 1536-well assays. The assay detection instruments include multifunction plate readers, highthroughput flow, high-content (image) analysis, and protein thermostability instruments. In addition to the equipment and libraries, the CCG provides hands-on training, instruction and assistance with all aspects of assay development, highthroughput screening and early stage drug discovery, as well as grant assistance, custom library assembly, assay • Competitive rates • Reliable and rapid results development, and • Unique natural product • Target validation extract library • Viable lead drug equipment training. • 170,000+ small molecule candidates The University compounds • Wide-ranging expertise of Michigan has fully embraced the principle that high-throughput CONTACT US: 734.615.9317 | lsi.umich.edu/ccg screening can and will continue to have
HIGHTHROUGHPUT SCREENING FOR DRUG DISCOVERY
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AVOMEEN ANALYTICAL
SHRI THANEDAR
Expanding Pharmaceutical Services to
MEET HIGH DEMAND OF MICHIGAN CONTRACT PHARMA
By Shri Thanedar, PhD, CEO and chief chemist of Avomeen Analytical Services
Shri Thanedar, PhD began Avomeen Analytical Services in 2010 as a new entrepreneurial venture. A veteran of the CRO industry, Thanedar has more than 25 years of experience supporting companies nationwide with services including preformulation, formulation development, method development and validation, chemical characterization, extractables and leachables testing, stability and release testing, and litigation support services. The company is headquartered in Ann Arbor, MI in a 25,000-square-foot state-of-the-art facility consisting of segregated cGMP labs, clean rooms, and formulation suites. The laboratory houses powerful analytical instrumentation including FTIR, NMR, GCMS, HPLC, LCMS, PIXE, Raman, SEM, EDXA, and others.
The laboratory houses powerful analytical instrumentation including FTIR, NMR, GCMS, HPLC, LCMS, PIXE, Raman, SEM, EDXA, and others. Avomeen has over 32 employees with expertise in formulation, pharmaceutical development, and analytical testing.
Avomeen has over 32 employees with expertise in formulation, pharmaceutical development, and analytical testing. The company serves clients across the nation and throughout the world as a premier laboratory for investigational chemical analysis and product development.
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Their pharmaceutical specialists partner with researchers, manufacturers, and others throughout the development cycle from pre-clinical to post NDA-approval. This summer Avomeen further expanded their capabilities to include clinical trial materials (CTM) manufacturing for clinical phases I-IIb. Brand new formulation suites and ISO-7 compliant clean rooms were added to the facility to support the manufacturing of solid, semi-solid, and non-sterile liquid pharmaceutical products. They are excited to be introducing these new services to Michigan and look forward to the continual growth of their pharmaceutical support services. In addition to the creation of new products, Avomeen specializes
BioMatters | Fall 2014
in investigational chemical analysis. They combine testing methods and chemists’ expertise to derive customized solutions to any problem. Recently they performed a degradation analysis for a particularly interesting case to identify potential harmful oxidation products of a tablet’s active pharmaceutical ingredient (API). Using LCMS, HPLC chemists analyzed the tablet’s oxidation products in comparison to oxidation products synthesized by our in-house chemists. The comparison provided the identity of the degradation product while the initial analysis provided quantitative data. The amount of impurity fell below the FDA reporting threshold and the identified degradation product proved to be safe and have no effect on the efficacy of the pharmaceutical product. They recently also performed an extractables/leachables analysis for
a new pharmaceutical product to be stored in PET bottles. Avomeen’s chemists chose analytical methods to assess specificity, linearity, accuracy, precision, and robustness. They then validated these methods through a series of tests. The quantification and characterization of the extractables was determined using GCMS, LCMS, HPLC, and UV-Vis. A leachables study was performed on the drug solution via HPLC. The conclusion of the study demonstrated that there were no leachables found above the Analytical Evaluation Threshold (AET) and that the drug product was clear for FDA submission. As the premier laboratory in the metro Detroit, Avomeen Analytical Services uses analytical chemistry techniques to solve a wide range of complex pharmaceutical and medical device development problems.
Specialties include: pharmaceutical analysis, preformulation, formulation development, method development and validation, stability and release testing, extractables/leachables analysis, investigative chemical analysis, contamination identification, medical device testing, and litigation support.
Avomeen Analytical Services 4840 Venture Drive Ann Arbor, MI 48108 800.930.5450 www.avomeen.com
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MEDBIO, INC.
MEDBIO EMPLOYEES ASSEMBLE PARTS IN ONE OF THE FACILITY’S ISO-CERTIFIED CLEAN ROOMS
A medical device company
DOING IT ‘THE RIGHT WAY’ West Michigan-based Medbio, Inc. is an ISO 13485:2003-certified and FDA-registered contract manufacturer offering innovative manufacturing solutions for the life sciences. The company specializes in precision injection molding, assembly, packaging, project management, and design support of implantable, disposable, diagnostic, and instrumentation components for orthopedic, cardiovascular, ophthalmology, neurology, and biotechnology manufacturers. Medbio was founded in 2004 by an experienced team of medical device professionals, including three members of the current leadership team. In October 2006, Ronald A. and Christopher R. Williams joined the company, further bolstering the depth and breadth of the company’s experience.
Ron Williams is a pioneer in Michigan’s medical device community; he previously founded and owned DLP Inc., a successful medical device company acquired by Medtronic in 1994. He is still active in his 70s as chairman of Medbio’s board and, along with the rest of Medbio’s management, shares a common vision of a company based on integrity, doing it right the first time, and building customer partnerships.
“We have a strong medical device industry in Michigan, and we need to collaborate to grow. We have been fortunate to work and share with other great manufacturers, allowing us to benchmark each other and improve our processes.”
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In September 2011, Medbio moved into a new 45,000-square-foot facility on the southeast side of Grand Rapids, Michigan. The facility includes 19 molding presses contained in a certified, ISO-Class-8 clean room and a micro-molding press contained in a modular, certified, ISO-Class-7 clean room. In addition, it contains four certified, modular, ISO-Class-7 clean rooms for assembly and packaging of finished goods. Medbio supports each step of the production process. They can take a medical device project from finished drawings through final assembly and packaging. They meet all quality standards, provide documentation, and aid in the navigation of necessary regulatory approvals. The company’s flexibility allows for the development and manufacturing of large-scale projects or small, custom programs.
BioMatters | Fall 2014
It serves major biopharma and device manufacturers as well as smaller biotechs. Medbio is a nimble company not limited by the adage “that’s the way we’ve always done it.” If a qualityrelated issue arises, such as sub-par tool design or process inefficiencies, Medbio has the flexibility, desire, and skill to correct it immediately. The Medbio team has a passion for making customers successful by utilizing their collective experience in design, manufacturing, and product commercialization to improve upon part designs, reduce capital costs, and ensure consistency in manufacturing (often using automation or cavitypressure transducers). The desire to uniquely solve customers’ problems inspires Medbio’s passion for innovation. The Medbio team has developed a system for the oxygen-free molding of certain resin grades to eliminate oxidation and created injection-compression tooling that achieves consistent membranes as thin as .006” to accommodate demanding customer designs. Every Medbio employee has a core belief in the life-saving benefits of the products being manufactured and a top-down commitment to quality, service, and value. They consider each customer a partner and strive for a transparent relationship with
open channels of communication. And through repeat customer referrals, Medbio has earned a reputation of excellence in this industry—one they strive to improve daily. This partnership philosophy continues through the organization where employees regularly meet with President Chris Williams and department managers in a round-table discussion format. Considered rare in companies over 100 people, Medbio’s president knows everyone by name and values their opinions. Medbio works with many local and state agencies as well as several regional and national trade organizations, including MichBio. “One of my priorities is to promote Michigan as a single-source design and manufacturing destination for the large, medical device OEMs,” said John Woodhouse, director of sales and marketing. “We all need to promote Michigan as we travel across the country. We have everything the customer needs, and we can handle their projects from concept to finished, packaged devices.” Medbio has also worked with the MEDC, The Right Place, Manufacturer’s Council, Cascade Township, MI-Device, Southwest Michigan Accelerator Fund, and many others. “We have a strong medical device industry in Michigan, and we need to collaborate to grow.
PANORAMIC VIEW OF MEDBIO’S ISO 13485:2009-CERTIFIED CLEAN ROOM FACILITY
MichBio | www.michbio.org
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We have been fortunate to work and share with other great manufacturers, allowing us to benchmark each other and improve our processes,” said Woodhouse. For additional information please contact John Woodhouse, Medbio’s director of sales and marketing, at jwoodhouse@medbioinc.com.
Medbio, Inc. 5346 36th Street Grand Rapids, MI 49512 616.245.0214 www.medbioinc.com
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BioMatters | Fall 2014
P.O. Box 130199 Ann Arbor, MI 48113-0199
STAYWITH CONNECTED MICHBIO CEO LEADERS’ CLUB An opportunity for senior executives of MichBio member companies to develop strategic relationships, exchange ideas, and help develop future leaders. Sponsored by AlixPartners. October 9 Vincent Forlenza, CEO of BD Ann Arbor, MI October 21 Joseph Papa, CEO of Perrigo Kalamazoo, MI
www.michbio.org/ceoleadersclub
BIO BIZ LINK
A resource for finding CROs, CMOs, and contract suppliers for the bioscience industry. (An “Angie’s List®” for the bio-industry.)
MICHBIO U Educational one-hour webinars open to both MichBio members (free) and nonmembers (fee). Recent topics include FDA inspection prep/best practices (presented by the Validation and Compliance Institute), regulatory strategy (presented by in2being), Unique Device Identification (presented by LSPedia), and supply chain assurance (presented by NSF International). Sponsored by Bank of America Merrill Lynch.
www.michbio.org/michbiou
BIOCONNECTIONS A business growth referral program that connects members with vendors, suppliers, consultants, thought-leaders, investors/funders, business/licensing executives, and CEOs.
www.michbio.org/bioconnections
www.michbio.org/biobiz
www.michbio.org/social-media Keep up to date on the Michigan bioscience industry by subscribing to our e-newsletter, biolink: www.michbio.org/subscribe.