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A MichBio e-publication
August 2014

Member News
Pfizer, 23andMe team up to study bowel disease

Rubicon Genomics expands; aims to increase workforce by 40% in 2015

Q&A with Stephen Lanier: Wayne State's new research chief

Members, submit your company news for inclusion in MichBio's website, biolink, and more.
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October 6-8

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On the Road
Stephen Rapundalo, PhD 
President & CEO, MichBio
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. [Read more]

2014 MichBio Expo & Conference
Regulating Innovation:
Advancing Access to Healthcare

September 30-October 1, 2014
MotorCity Casino Hotel in Detroit, MI

Visit for complete event details or follow the quick links below.
Legal Column
"Laws of Nature" and Current Controversies in Patenting Biomarker Technology
James F. Kamp, Honigman Miller Schwartz and Cohn LLP

In Diamond v. Chakrabarty (1980), the U.S. Supreme Court described the realm of patentable subject matter as "anything under the sun that is made by man." In the same decision, the Supreme Court also stated that "laws of nature, physical phenomena, and abstract ideas" were not patentable subject matter because "such discoveries are 'manifestations of ...nature, free to all men and reserved exclusively to none.'"  Thirty-four years after Chakrabarty, and in the wake of the Supreme Court's 2012 decision in Mayo Collaborative Services v. Prometheus Labs., Inc., the boundary between unpatentable "laws of nature" and patentable subject matter remains as controversial as ever, especially in medical arts concerning biomarker technology. [Read more.]
Regulatory Column
Don't Fear the Audit
Joseph Szyperski, MEDBIO, Inc.

As a play on the 70's song from Blue Oyster Cult, it is good to remember that audits, be they First-Party (internal), Second-Party (customer), or Third-Party (ISO or FDA), are not entirely bad things for a company in the Med-Tech industry. In fact, they can be one of the best ways for a growing company to realize short-comings in, and make improvements to, their Quality System. [Read more.]

The MichBio Online Member Community: A Business Leads Generation Tool

Do you know about our online community and resources? Using your MichBio website login, members can access special purchasing program offers, restricted content areas of the website, and can also view other member and nonmember profiles.

Not only do we save your business money and offer great resources through our website, but by utilizing the built-in features of our online directory in conjunction with your membership login, your benefits also include access to a fantastic business leads generation tool - you can even contact other members directly through the online system!

If you haven't looked into your profile in a while, or just want to see what new features are available, you owe it to your company to see what's to offer.

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