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News and Press: MichBio News

May 'On the Road' with Stephen Rapundalo

Thursday, May 28, 2015   (0 Comments)
Posted by: Stephen Rapundalo
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R. H. David Johnston and Stephen Rapundalo (L-R)

April ended with a number of meetings around the state. 

First I attended a joint gathering of the Community Values Advisory Board (CVAB), Scientific Review Board (SRB), Board of Directors of the Michigan BioTrust for Health and the Michigan Department of Community Health’s Institutional Review Board (IRB) in Lansing. The BioTrust is a program to oversee our state's stored blood spots and their use in health research. The four different advisory and review boards oversee BioTrust policies and operations. Board members represent the major state universities, research institutions, disease and advocacy organizations, community groups and the general public. I’ve been a member of the BioTrust’s CVAB and SRB for a number of years. The joint meeting reviewed activities by each of the Boards in relation to the BioTrust’s mission. 

That same day I participated in a follow up meeting with the Michigan Department of Licensing & Regulatory Affairs and Attorney General’s Office regarding the Pharmacy Practice and Drug Control Act. We received assurances that an exemption amendment supported by MichBio and other medical device manufacturers/wholesalers will remain intact. What this means is that such stakeholders will not be required to retain a pharmacist-in-charge (PIC) to be the authorized representative and allow the company to sell its products in the state. The remainder of discussions centered on criteria that would define a PIC or designated facility manager to be required by pharmaceutical manufacturers/wholesalers or those handling combination products.

The next day I attended the 28th Annual Meeting of Shareholders of the Stryker Corporation. Kevin Lobo, CEO, graciously invited me to participate and it was a great opportunity to hear about the company’s phenomenal growth and its bright commercial future.

Then I sped over to Detroit for an evening reception at the Detroit Institute of Arts to honor a visit by the Governor General of Canada (the Queen’s representative in Canada who carries out her constitutional responsibilities). It was a real treat to meet His Excellency the Right Honorable David Johnston as he harkens from my hometown of Sudbury, Ontario. So we had a great chat about growing up in the “Original UP,” playing hockey (he with the famous Esposito brothers), and other good Canuck stuff.

The month ended with our Policy Call-In that featured Rep. Fred Upton, Chairman of the U.S. House Energy & Commerce Committee. He discussed the 21st Century Cures initiative, its discussion draft, and expectations for its legislative progress. Elizabeth Pika Sharp from AdvaMed and Jeanne Haggerty from BIO both reviewed key elements of the discussion draft of greatest implications for the medical device and biopharma sectors (see associated article in this issue).

Brian Lewis (MEDEC), Jason Field (Life Sciences Ontario), and Rapundalo (L-R)

I attended my first MedCon 2015 Conference in Cincinnati from May 5-8. It’s one of two regulatory meetings (the other is PharmaCon for pharmaceutical professionals) hosted by Xavier Health and the FDA (and promoted by MichBio to its members). The approximately 450 attendees at this three-day public conference heard about the latest regulatory policies and procedures directly from FDA management and included presentations from key FDA officials and industry experts with small group breakout sessions. The conference is intended for companies of all sizes and employees at all levels. It was a phenomenal meeting with incredible access to FDA personnel. Stryker, Emergent BioSolutions, RTI Surgical, Orchid Orthopedic, and Tekna were just some of the Michigan companies represented. I would recommend these two meetings as they are of the highest caliber, with the latest regulatory information, clear case studies, and great networking.

Mid-month featured meetings or teleconferences with Foley Hoag in Boston, the Michigan Discovering Cures coalition, VirginiaBio, National Advisory Committee for the Community College Consortium for Biotechnology Credentials, and my monthly University of Michigan Institutional Biosafety Committee.

Last week began with my regular meeting at Genesys Health in Grand Blanc where we’re developing a life sciences cluster plan. On Wednesday, I began with a meeting with Kimberly Jones, PhD, Vice President of Product Development at ProQuest, an Ann Arbor-based global information-content and technology company. Later I participated in a half-day program “What Now? Career Paths for PhD’s in the Biological Sciences” at the U-M, a two-day workshop for career exploration. The next day, MichBio co-hosted a Michigan Biosciences Legislative Caucus meeting on biosimilars (see associated article in this issue) for staff and legislators in Lansing. 

I finished off the week attending the announcement of the Cross-Border Life Sciences Hub by the Windsor-Essex (Ontario) Economic Development Corporation. An area within Hotel-Dieu Grace Healthcare has been set up as an incubator that will help businesses that are creating pharmaceuticals, medical devices, and other health-related products establish a commercial presence in Canada. These businesses can request support such as market analysis, manufacturing expertise or clinicians. Everist Health, based in Ann Arbor, is the first tenant in the new facility.

 

See you next month!


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