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A MichBio e-publication
September 2014

Member News
Members, submit your company news for inclusion in MichBio's website, biolink, and more.
MichBio Events
Sept. 30-Oct. 1

October 9

October 21

Featured Events
September 29-October 3

October 6-8

October 15

October 21

View more online or submit your member company's event for inclusion in MichBio's website, biolink, and more.
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On the Road
Stephen Rapundalo, PhD 
President & CEO, MichBio
The last month has been extremely busy as we put the final planning touches to the 2014 MichBio Expo & Conference and prepared the next issue of BioMatters... more on that later.

In late August I visited Thermo Fisher Immunodiagnostics (i.e., Phadia U.S.) in Portage and met with the Medical Director, Rob Reinhardt, MD. It was a great opportunity to be updated on the company's integration into the Thermo corporate family and changes in management, organization and operations.
[Read more]

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

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

There is still time to register! Visit for complete event details.
Legal Column
Isolated Genes are Still Eligible for Patent Protection Outside of the U.S.
Rebecca Cantor, Brooks Kushman

In the mid-1990s, Myriad Genetics, in collaboration with other institutions, discovered the BRCA1 and BRCA2 genes, which can be used to predict whether an individual will develop certain types of breast and ovarian cancer. After discovering these genes, Myriad filed a number of patent applications that claimed, among other things, the isolated sequences for these genes. Using these patents, Myriad was able to maintain a monopoly on diagnostic testing for the BRCA1 and BRCA2 genes. As a result, diagnostic testing for mutations in these genes became very expensive. [Read more.]
Regulatory Column
Make Regulatory Compliance Easy by Not Thinking About It
Norm Howe, Validation & Compliance Institute

Companies go through two stages when they try to become compliant with FDA regulations. Stage one is to write all the procedures that translate the regulations into specific actions for the employees. That's hard enough. In stage two the company has to get all its employees to follow those procedures. [Read more.]
Welcome New Members
Coleman Search Consulting

Coleman Search Consulting  (CSC) was formed in January 2009 to provide an executive search model to specifically meet the needs of client organizations, offering outstanding research, responsiveness to the client, and a high level of accountability. CSC supports a broad array of businesses and organizations in recruiting both functional and business unit leadership in multiple industries including Life Science; Medical and Laboratory instrumentation, Equipment and Supplies; Medical Device and multiple industrial manufacturing companies and business service providers.


Pharmaceutical Product Development (PPD)

Discovering and bringing one new drug to the public typically costs a pharmaceutical or biotechnology company on average more than $1 billion and takes an average of 10 to 15 years. PPD's comprehensive portfolio of services, spanning early discovery through post-approval, features integrated laboratory, Phase I-IV, and consulting services to provide end-to-end solutions.

R&D Advisors

Regulatory affairs outsourcing solutions for drugs, biologics, and devices including regulatory strategy, regulatory writing, and regulatory submissions in paper and electronic format (eCTD, and eCopy).

Funding Opportunities
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