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News and Press: MichBio News

August 'On the Road' with Stephen Rapundalo

Thursday, August 21, 2014   (0 Comments)
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 Stephen Rapundalo

The summer vacation season curtailed people’s calendars and my travels over the last month. Nonetheless, we begin this report much like we ended the previous month—meeting with state legislators. Representatives from Novartis, Amgen, and BIO along with their contract lobbyists and myself met with Rep. Ken Yonker (R-Caledonia), sponsor of HB 5598. The bill would permit the substitution of biosimilar drugs by pharmacists for innovator biologics. Our small bio-industry coalition group provided some background information and discussed five key principles essential to include in any biosimilar substitution legislation as promoted by BIO and other groups (see our upcoming Advocacy Alert and State Affairs policy page for more information).  Rep. Yonker engaged with the group and indicated his willingness to take under serious consideration our concerns. The bill is likely to be taken up in early September when the Legislature re-convenes. We then met with House policy staff on the same topic.

The following week I arranged for Steve Klemm, CSO at Leonardo Biosystems, and I to meet with Tim Mayleben and Roger Newton at Esperion Therapeutics. We discussed commercialization and start-up growth strategies. From there I made a quick pit stop to meet with Vince Groppi, PhD, Vice-President and CSO at Essen Bioscience. Essen has seen very good growth over the last few years and its most recent investment by SFW Capital Partners will allow the company to expand its applications and assays, develop and introduce innovative new products, and continue to enhance its sales, service, and support capabilities.

The next day I traveled up to Grand Rapids where I visited Corium International. The company is a commercial stage biopharmaceutical company focused on the development, manufacture, and commercialization of specialty pharmaceutical products that leverage a broad experience in transdermal and transmucosal delivery systems. Corium was incorporated in Michigan in 1995 as Corium Corporation and in 1996 as Converting Systems, Inc. In 2002, these companies were merged and re-named Corium International, Inc. The principal executive offices and R&D operations are located in Menlo Park, CA, while significant pilot-scale and commercial-scale manufacturing facilities remain in Grand Rapids. It is the sole commercial supplier of such marketed products as Clonidine Transdermal Delivery System, or TDS, Fentanyl TDS, and four Crest Advanced Seal Whitestrips products. It is also developing a number of proprietary compounds that are advancing through clinical trials.

While in town, I popped over to Spectrum Innovations, the skunk works group for Spectrum Health System. Brent Mulder, Senior Director of Innovations, brought me up to speed on their efforts to support innovators/entrepreneurs and commercialization of novel technologies emerging from the hospital.

The last week of July started off in Lansing. My first stop was at Emergent BioSolutions where I met with Adam Havey, Executive Vice President and President, BioDefense Division, and Mark Alley, Senior Director, Risk Management and Public Affairs. I got caught up on their facility’s expansion, as well as the growth and diversification in product development and markets. 

I traveled the short distance to downtown Lansing where I met with Tom Stewart at Quantum Medical Concepts. This is a new startup investment fund launched by the Michigan State Medical Society that will provide capital for Michigan-based early stage medical companies. The fund plans to support 2 companies per year in amounts of up to $250,000. 

Then it was on to meet with David Armstrong, CEO of Greenstone Financial. I was joined by Tim Colonnese, President and CEO of KTM Industries, and Tom Diets, Project Director of Innovation 5. We discussed next steps in developing and providing function to an agri-biotech/bio-based technology sector group to replace and expand the mission of the former BioAlliance of Mid-Michigan. The day ended with a meeting with Charlie Hasenman and Doug Gage at Michigan State University. We talked about ongoing and future collaborative efforts on a number of fronts.

July ended with a visit to the Detroit Clinical Research Center, a health research institution that supports clinical research studies across all hospitals and medical facilities in South, Mid, and East Michigan and located in Farmington Hills. Max Rashed, President and CEO, updated me on their expansion and new partnerships insofar as Phase 1 trials are concerned. From there I sped down to Detroit to meet with Ken Massey, Senior Director of Venture Development at Wayne State University’s Technology Commercialization Office. That was followed by my attendance at TechTown’s DTX Launch Detroit Showcase, an annual pitch competition for student entrepreneurs.

Last week I traveled once again to Lansing where I sat down with Rep. Mike Callton (R-Nashville) who has sponsored patent (“troll”) abuse legislation. While the bill’s language includes a carve-out for bio-industry companies with marketed products (i.e., those under Hatch-Waxman), it does not address potential unintended consequences for small start-ups in R&D mode or university technology transfer offices. MichBio is working with BIO and the University of Michigan to ensure that our concerns are addressed as the legislation moves forward this fall. Learn more details in an upcoming Advocacy Alert.

While in Lansing, I had the opportunity to visit PlasLabs, a manufacturer of containment and isolation “glove boxes” for scientific research (hypoxia chamber, PCR chambers, etc.). The company has been around since 1967... heck, I was buying their products from the 80s through 2005 while at Parke-Davis and Pfizer. High quality, creative engineering for a diversity of applications is PlasLabs’ call to fame. The company conducts the majority of its business internationally says its President and CEO, Dave Regan. I ended the day by stopping by BBC’s Open House at their new Ann Arbor location.

Lastly, MichBio hosted CRG Capital Partners on August 7-8 as part of its BioConnectionsTM. The Beverly Hills-based equity firm focuses on revenue-based companies. Don Newman, Founder and Managing Partner, visited with the intent to pursue possible investment opportunities here in the state. We developed a full day of meetings for him, and the next morning had a great introductory meeting with Michael Finney, President and CEO at the MEDC, and some of his senior executives. Don and CRG will be back in September to continue his search for opportunities. Contact MichBio if you wish to see if your company qualifies for CRG.

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