September 'On the Road' with Stephen Rapundalo
Thursday, September 24, 2015
This update gets us back on our regular monthly timeline. There was plenty of activity over the last month, especially as everyone came back from their summer vacations.
|Richard Neubig, Barbara Slusher, Stephen Rapundalo at the Cutting Edge / Drug Discovery & Development in Michigan Symposium
September began with some travels around the state to visit various companies.
First stop was in Grand Rapids where I visited with Empirical Bioscience. The company (formerly known as Syzygy Biotech) is a designer and manufacturer of reagents for the research, education, and diagnostic markets. While a small organization, Empirical has best-in-class and cost-effective PCR products for human, animal, and plant DNA — anything from off-the-shelf TAQ reagents to a condition-specific solution. Check them out if you’re in the PCR business…you’ll be glad you did – and it’s made in Michigan!
Then I stopped by to meet with Susan Elwell, Facility Manager, Vention Sterilization Services (formerly Sterile Services, Inc.). The firm has provided quality contract EtO sterilization services since 1990. They have four large chambers and a single smaller one and can easily handle loads from one cart to eight pallets. Vention Medical, one of the world's leading medical device manufacturers, purchased the facility from Medtronic in early June. It’s located right next door to another Vention facility (the former Atek Medical) that does contract manufacturing primarily for Medtronic.
I pad a quick visit to NxGen MDx to see founder, Alan Mack and catch up the firm’s growth. I hadn’t been there since their launch in 2012. NxGen is a leading laboratory for precise genetic carrier screening for over 120 genetically inherited diseases. It was a 2015 awardee for “Michigan 50 Companies to Watch.”
Then it was down to Kalamazoo. However, I first made an unannounced stop at Drug & Laboratory Disposal located in Plainwell. The company collects hazardous wastes including almost all chemical, medical, scintillation, and household hazardous wastes. In DLD can also provide assistance with regulatory compliance.
In Kalamazoo, I stopped in at the Southwest Michigan Innovation Center to visit with Jim McKim, Founder and President at IONTOX. IONTOX is divided into three businesses: consulting, product development and sales, and custom R&D. IONTOX consulting provides expertise in the areas of general toxicology, in vitro toxicology, safety screening of chemicals, drugs, and personal care products. This includes risk assessment, data interpretation, and regulatory acceptance. IONTOX Products focuses on the development of new and innovative products to support in vitro testing. IONTOX Labs provides custom R&D services to the pharmaceutical, chemical, and personal care markets.
A couple of days later, I was back in West Michigan with a visit first to the Albemarle Fine Chemicals facility in South Haven. They have over three decades of high-quality commercial experience in the GMP production of pharmaceutical intermediates and APIs and pharmaceutical intermediates. In addition, the facility performs custom/contract services, such as chemical route selection, process development, small scale production, laboratory testing and more. Currently, Albemarle is looking to sell the South Haven facility, along with two other Fine Chemicals sites, as a separate enterprise.
Then it was a return trip to Kalamazoo, where I caught up with Amy Shipley, PhD, Assistant Dean for Research Compliance at the Western Michigan Homer Stryker MD School of Medicine. In July, the clinical research leadership, expertise, and resources at Borgess Medical Center and Bronson Methodist Hospital transitioned to the medical school to establish the Center for Clinical Research. This integration better facilitates clinical research in southwest Michigan, including greater access to clinical research by medical students and residents/fellows, and more importantly brings access to the latest, most advanced therapies to benefit patients in the region. Thomas Blok, MD, director of research services at Bronson, will serve as the medical school’s assistant dean for clinical research.
Right before the Labor Day weekend, Dave McGuire and I visited Brett Williams, President and CEO at Essen Bioscience. The privately-held company is headquartered in Ann Arbor and a world leader in the field of cell-based in vitro assays and instrumentation. Also, we made impromptu stops at GeneCodes, NeuMoDx, Xoran Technologies (providing innovative CT imaging solutions for instant diagnosis at point of care) and Everist Health (a personalized medicine company which develops and commercializes medically unique diagnostics, prognostics and therapeutic selection technologies), but not surprisingly most everybody had already left to enjoy last gasp of summer.
After the holiday MichBio co-hosted the inaugural Cutting Edge: Drug Discovery and Development in Michigan Symposium with the University Research Corridor at the Kellogg Conference Center in East Lansing. The event was a huge success with attendance just shy of 200, and included 30 poster presentations and 16 exhibits. The day and a half program included panel discussions on medicinal chemistry, pre-clinical and clinical development, funding drug discovery enterprises, and industry-academic partnerships. In addition, academic researchers presented on drug discovery applications in orphan diseases, anti-infectives and clinical stage validation. Max Wicha, MD from the University of Michigan gave the “Founder’s Tale” and described the start-up journey for OncoMed. The Day 1 Keynote presentation was Barbara Slusher, PhD, Professor of Neurology, Psychiatry, and Neuroscience at Johns Hopkins School of Medicine, Director of their Drug Discovery program, and Founder/President of the Academic Drug Discovery Consortium. Roger Newton, PhD, Founder, Executive Vice President and CSO at Esperion Therapeutics was the Keynote presenter on Day 2 and closed out the Symposium.
With barely any time to recover, I was on the road again the very next day to meet with representatives at the Canadian Consulate in Detroit about cross-border initiatives and mutual bio-industry interests.
It was back to Detroit last week for the USPTO-sponsored Biotech/Chem/Pharm Customer Partnership Meeting. The day long workshop touched on numerous topics including patent classification, double patenting, third party submission and more. The event was held simultaneously at the agency’s Alexandria headquarters and as a webex with almost 250 participants. Noel Day, PhD, Partner at Honigman Miller Scwhartz and Cohn LLP, was the lone Michigan-based speaker and provided a practitioner’s perspective on U.S.C. Code 101, i.e., subject matter eligibility. I left early during the lunch break and headed up to Grand Blanc for my monthly strategic planning meeting at Genesys Health to review progress towards developing a healthcare innovation center concept on their sprawling campus.
Mid-week I attended the 50th Anniversary of the Michigan Newborn Screening Program. The State’s Department of Community Health and its BioTrust hosted a Symposium at the Lansing Center. Attendees represented healthcare providers, genetic counselors, laboratory personnel, and practitioners to the day-long event. I was there in my capacity as a member of the BioTrust’s Community Values Advisory Board and its Scientific Advisory Board (a peer-review group who advises on applications for newborn bloodspots to be used for research purposes).
Then I made my way over to Troy for the annual Medical Main Street INNO-VENTION Reception. The evening proved to be an excellent networking opportunity where I met several new digital health start-ups.
The early fall is shaping up to be a busy one. Don’t forget the next MichBio U webinar to be presented by Ximedica – How to Integrate User Research into Your MedTech Development Process – is set for September 29. Also, we’ll be hosting Sandbox Industries at our BioConnections™ Partnering Day on September 25th – the focus will be on health IT and/or agri-bio start-ups.
That’s it for now… I’ll check in with you in October.