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.

Continue reading

Life Sciences in the Fast Lane

MP900438890[1]This year at the AZBio Awards and Expo our theme is all about forward motion.  Specifically, how  we move forward…faster.

From global innovations like IBM’s WATSON on Thursday night October 13, 2011 to panels of CEOs and leaders along with  nationally recognized thought leaders who will take the stage Friday October 14, 2011,  the conversations are geared up to deliver  the information and ideas  we  need to move our industry and our economy forward…faster.

A single accelerator? Continue reading

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

New UA Agriculture, Life Sciences Dean Chosen

Shane Burgess

Mississippi State University’s Shane C. Burgess brings literally a world of experience in genetics and veterinary science with him to the UA.

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.

Burgess succeeds Eugene G. Sander, who recently retired as dean and vice provost and will serve as UA president beginning Aug. 1, while the Arizona Board of Regents searches for a new chief executive.

A native of New Zealand, Burgess has worked around the world as a practicing veterinarian and scientist. Currently, he is the associate dean for strategic initiatives and economic development in MSU’s College of Veterinary Medicine and a professor in the department of basic sciences in the vet school.

His areas of expertise include cancer biology, virology, proteomics, immunology and bioinformatics. Since 1997 he has written 110 peer-reviewed publications.  Read more from the story by By Jeff Harrison, University Communications, July 18, 2011 (U of A NOW) at: 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.

Continue reading

AZBio News for July 2011

UA Study Plays Key Role in International Lung Research30 year study points to new biomarkers for COPD and other lung diseases.

Dr. Cheryl Nickerson of ASU BiodesignFinal countdown: Space Shuttle Atlantis to carry next generation vaccine candidate on last space voyageIts final trip may open a new era of research into infectious diseases, thanks to space bound experiments conducted by Cheryl Nickerson, and Roy Curtiss III, along with their colleagues at Arizona State University’s Biodesign Institute.

Science Foundation Arizona ups jobs, investment through grants (Phoenix Business Journal)

$2.2M Grant awarded to Fund Heart Failure Study at University of Arizona

Nominations open for the 2011 AZBIO Awards

Phoenix Partnership to Strengthen UA Medical Education