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Midwest BioResearch
An interview with CEO Michael Schlosser

Life Science CLUSTERS
Winter, 2007

by Tim Williams

Founded in October 2003 by Michael Schlosser, Ph.D., DABT and Sabrina Morton, M.S., DABT and initially capitalised by their own assets including Pfizer stock options and severance, Midwest BioResearch (MBR) has doubled in size each year and now has more than 100 clients. From its early days in the Northwestern University incubator at the Evanston Research Park, the company has recently moved into premises at the Illinois Science + Technology Park just outside Chicago, site of the old Searle headquarters.

MBR’s home is a 16,000 sq. ft. laboratory and office complex in a building that used to house Pfizer’s labs and has recently been upgraded and renovated. The company now employs 45 people, mostly recruited from the large pharma companies around the Chicago area. MBR is a Contract Research Organization (CRO) specialising in drug disposition and toxicology with experience in protein and small molecule bioanalysis, genetic toxicology, and the risk assessment and management of a wide range of compounds, including protein therapeutics. MBR’s labs, equipment and facilities are GLP-compliant. MBR’s core competencies and techniques include immuno-analytical assays, cell-based assays, and traditional chromatography coupled to mass spectrometers for drug and/ or antibody detection and characterization.

Michael Schlosser serves as the President of MBR. His 25 years of experience including work as head of Experimental Toxicology at Ciba-Geigy, head of Experimental Toxicology and Pathology at Astra Pharmaceuticals and Senior Director of Safety Sciences at Pfizer gave him the know-how and confidence to launch his company. And in the highly competitive world of CROs, with their niche markets between the in-house big pharma facilities and the thousands of universitylabs wishing to rent their expertise, you need confidence, business acumen and a fair share of luck.

*Q: How did you find your first customer? Can you tell us who it was?

*For confidentiality I can’t tell you who it was, and they don’t know that they were the first customer, but it was a small, local biotech company who needed our expertise for developing an antibody screening assay to support their protein therapeutic entering late-stage clinical trials; the FDA requested this assay. I still have a copy of this first cheque. They knew the quality and integrity of our team from previous work at Pfizer and trusted us to deliver a rather complicated assay for a complex protein. They were pleased with the results and our program services group is continuing to work with this client in support of their Biologic Licensing Application.

*Q: I see from your website that you studied at the University of Mississippi, a long way from Chicago! What is your background and how has it given you the skills and abilities to run MBR?

*I have always been and still am passionately interested in science. I attended college at Southern Illinois University to pursue zoology and chemistry within their wildlife biology program and then did graduate work in toxicology, a practical science that uses both zoology and chemistry knowledge. I applied to several graduate programs and chose University of Mississippi’s toxicology and pharmacology program because of the quality of the faculty, graduate students, and science there at the time, plus they were offering a stipend higher than the other universities! That program laid a solid foundation in classically taught toxicology and pharmacology, disciplines which require education in biochemistry, organic chemistry, physiology and statistics to name a few. After graduate school, I conducted postdoctoral work at Thomas Jefferson University in Philadelphia where my research focused on the molecular aspects of benzene toxicity.

My first industry job was with Ciba-Geigy in Summit, New Jersey where I left after four years as head of their experimental toxicology unit, just prior to Ciba’s merger with Sandoz. I went to a small British company call Fisons Pharmaceuticals which had a CNS research unit in Rochester, New York where I headed up the toxicology department. In the early 1990’s we had one of the first exploratory development departments, where a group of about 90 scientists were focused on moving a portfolio of CNS drugs from discovery to proof-of-concept testing in the clinic.

Believe it or not, most pharmaceutical companies at that time considered discovery and early clinical development as two separate activities. In 1995 that company was sold to Astra Pharmaceuticals which shut down the Rochester site in 1998. At this time I took a position with Searle, the pharmaceutical arm of Monsanto which soon merged with Pharmacia-Upjohn in 2000 to become a new company with the same name, Pharmacia. Three years later Phamacia was sold to Pfizer which shut down the Chicago site where I worked. So at the end of all those mergers and acquisitions, I had worked for seven different companies but moved only twice.

Through all this I had picked up valuable experience and close friendships, plus my contact with friends from college days, who were now entrepreneurs, had given me the confidence to start up a new company.

*Q: What were the biggest challenges during the early days of MBR and what are the major challenges ahead?

*We had all the usual start-up problems. We were the new kid on the block and, despite our vast experience, impressive laboratories and state-of-the art equipment, it was difficult to be recognised as a viable, long-term Contract Research Organisation (CRO). Luckily we found an excellent and affordable marketing group and, coupled with our industry contacts and quality of work, quickly generated an impressive track record of new and repeat clients to establish ourselves as a CRO during the those early years. To start MBR, we cashed in Pfizer stock options and used our severance pay to cover personal income.

We initially started with two partners and then four others quickly joined us. We also managed to pick up state-of-the-art equipment from Pfizer at very reasonable prices. These events, and having access to a selection of very talented scientists from the Pfizer-Chicago closure, a group already with an entrepreneurial character, presented an ideal, once-in-a-lifetime opportunity.

Now that we have weathered the storm and have a financially sound track record, we tripled our laboratory space by moving back to the old Searle site just outside Chicago. It is great being back in these state-of-the-art labs, with the Searle / Pharmacia ghosts providing fond memories.

*Q: Did any of these challenges affect you and your family personally, as in start-ups this is often the case?

*Support from family and friends was very important when we set up. My wife and three daughters were especially supportive – we learned valuable lessons in going from a fat bigpharma salary to managing our expenses and family organisation on a leaner budget. I think it was good for our family, character-forming! And this time helped educate my growing daughters on the value of money and working together. During the first year, my eldest daughters would help me clean the labs on weekends - we all got involved as a family, even my wife worked a while for MBR.

*Q: Now that you are entering the fifth year of MBR’s existence, what is your forecast for the next year in terms of MBR’s growth and how do you see the biotech market changing as it slowly matures?

*There are big challenges ahead. We have at least doubled in size every 18 months since we started. We presently have 45 staff and expect to be employing about 100 people by 2011. The key to growth is access to capital and a strong management team with an entrepreneurial nature. The challenge is to grow yet still satisfy customer demand through our internal programme of continuous change.

Growth is basically limited by our ability to hire and train new scientists to very high standards: about a third of our staff are ex-Pharmacia and another third are ex-Abbott – Chicago has an excellent talent pool of scientists. Our new location gives us a lot of room for expansion. We are looking at collaborations with pharmaceutical companies and with other CROs who complement our capabilities.

For example, our consultancy group contracts out millions of dollars of work to other CROs for services we do not provide within MBR’s labs. Because of the pharmaceutical industry’s interest in protein therapeutics and our leadership in this discipline, protein bioanalysis will be a major growth area for us.

Basic business fundamentals are driving the growth of protein therapeutics due to recent drug successes, increases in production capacity, and better industry/ regulatory understanding. Another area driving our growth is the success of small and virtual companies developing new therapeutics and requiring consultancy and laboratory expertise in all areas of preclinical development. There are lots of virtual companies out there seeking winning products in biologics and small molecules and they need people like us with expertise in these areas.

Much of Big Pharma are consolidating and outsourcing more of their drug discovery and development programmes – there is an accelerating trend of going to innovative exterior companies for R&D. We are well positioned to take advantage of these future trends.

*Q: How do you structure your personal daily workload? Do you still do lab work or are you too busy running the business and thinking about how to win new customers?

*I start work most days at 8 – 8:30 and finish most days about 12 hours later. I get involved quite a lot with consultancy these days doing risk assessment and due diligence work. My tasks are split between setting the course for MBR, the consultancy work, and developing future sales leads for our company. I do less day-to-day management activities since we have an excellent and experienced management team to handle the lab work.

*Q: Who are your heroes and why?

*I don’t think I can name any individuals but I think my heroes would be people who devote their lives to special causes, helping others without monetary gain. The pastor of our church would be an example.

*Q: What do you do for relaxation?

*I like to get out into wilderness. I draw inspiration from the natural world and enjoy the seclusion. I try to do special things with my daughters and have just come back from 3 days back-packing in Northwest Wisconsin with my eldest daughter who is in high school. It was great to be outdoors with all the wildlife, black bears, timber wolves and such, it is still quite wild there.

*Many thanks Michael for your time and sharing your thoughts with us.

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