The FDA When There’s An App For That

There is a lot happening on the medical device front these days around MDDS (Medical Device Data Systems) and the FDA is paying close attention with new regulations, guidance and requests for comment. 

With the  April 2012 compliance deadline less than 8 months away, AZBio Member John C. Hoffman of QMR is paying close attention too and keeping our community in the loop via the AZBio  Resource Network Group on LinkedIn.  If you and your team are working in the MDDS space, you’ll want to get connected and join the discussion.

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Roche Appoints Mara G. Aspinall President of Ventana Medical Systems, Inc.

VENTANA MEDICAL SYSTEMS, INC. President MARA ASPINALL
TUCSON, Ariz., Aug. 1, 2011 /PRNewswire/ — Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, announced today the appointment of Mara Aspinall to the role of President, Ventana Medical Systems, Inc.  Aspinall was most recently Founder, President, and CEO of On-Q-ity, a start-up diagnostics company focused on circulating tumor cell technology.  Continue reading

SynCardia Freedom Driver allows patients waiting for a heart transplant the freedom to go home

Until now, patients with artificial hearts had to stay in the hospital until a
donor heart was available for transplant. The wait involved being hooked up to
an enormous machine weighing over 400 pounds, and could last years.Now, a new portable device from SynCardia Systems, Inc, called the “Freedom” driver allows patients waiting for a heart transplant the freedom to be out and about instead of in the hospital. Compact enough to fit into a backpack, users plug the device into a standard outlet at home.Continue reading

AZBio Members in the News – week of July 18, 2011

July 24, 2011

BIO2011 Community College Day in Washington, D.C. features the work of Xan Simonson and her team in the Mesa Public Schools.  (Bio-Link)

Ccp2011 13 simonson[slideshare id=8667853&w=425&h=355&sc=no]

View more presentations from bio-link

July 21, 2011
FDA Announces release of Draft Guidance for Industry and Food
and Drug Administration Staff – Mobile Medical Applications

July 20, 2011

Tucson Arizona’s University Medical Center (UMC) Ranked Among Nation’s ‘Best Hospitals’

July 18, 2011

Shane C. Burgess, director of the Institute for Genomics, Biocomputing and Biotechnology at Mississippi State University, has been appointed the new dean of the College of Agriculture and Life Sciences at the University of Arizona. His areas of expertise include cancer biology, virology, proteomics, immunology and bioinformatics.: http://uanews.org/node/40689

Advancing Science and taking a LEED position

Dr. Jack Dean, Dr. Ken Wertman, Joan Koerber-Walker, and Mike Capaldi with Sanofi US LEED GOLD emblem. Photo courtesy of Sanofi US.  All Rights ReservedOn Tuesday July 12, 2011, I traveled to Southern Arizona to join Dr. Ken Wertman and the team at Sanofi US as they celebrated another milestone. This time it is not for groundbreaking advancements in human and animal health. Instead we were recognizing the team’s achievement of  LEED Gold Certification at their home in Oro Valley, Arizona and congratulating the team that made it happen. Laboratories are very difficult to certify because of demands posed by air handling and other challenges in an environment where scientific experimentation is taking place. Sanofi-aventis U.S. strives to limit the environmental impact of their business and the team is proud of having achieved a Leadership in Energy and Environment Design (LEED) certification.

LEED is a building rating system that was developed by the US Green Building Council in 2000 and is a nationally accepted benchmark for design, construction and operations of high performance “green buildings”. The 110,350 square-foot site was constructed in Oro Valley Innovation Park with the grand opening held on January 13, 2010. Of all the buildings in the U.S. that are LEED certified, only two percent are laboratories. Sanofi  US  operates two of those laboratories, one in Cambridge, MA and the one here in Oro Valley just north of Tucson, Arizona.

Another highlight of the trip was getting to spend some time with Dr. Ken Wertman and learning more about his journey, why Sanofi  US chooses Arizona, and what they do here.

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For Business and Bio there is new opportunity in the cloud

There’s lots of talk of cloud computing these days.  From basic accounting to sales and from marketing/media to HR management companies are leveraging new resources to move forward faster.

But the cloud is not just for administrative applications.  Cloud computing is causing a major shift in how we tackle complex scientific opportunities.  Check out this video from IBM on how researchers from ETH Zurich, IBM and high-performance cloud computing are leading in the bioscience field across the cloud.

 

Looking Back and Looking Forward

During his 5-year tenure leading at the University of Arizona, President Robert Shelton created both an impressive tenure and laid the foundation for a  lasting legacy.  Shelton will depart the UA at the end of next month, having served five years as the institution’s 19th president. He will become executive director of the Fiesta Bowl, beginning August 1, 2011.   Read more here.

Thank you President Shelton for your  commitment to the U of A, to our bioscience  community and to our state.Continue reading