AZBio Comments on the FDA 510K

 as submitted to the FDA on September 23, 2011

RE: Docket No. FDA-2011-N-0556

[Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years”; Request for Comments]

On behalf of the Arizona BioIndustry Association (AZBIO), I appreciate the opportunity to submit  comments to the Food and Drug Administration’s (FDA’s) Center for Devices and  Radiological Health (CDRH) on the Institute of Medicine’s (IOM’s) report,  “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at  35 Years” (Docket No. FDA-2011-N-0556).Continue reading

2011 AZBio Awards Honorees Announced

The Arizona BioIndustry is Moving Forward Faster in 2011

The Arizona BioIndustry Association has selected finalists and honorees for its annual awards gala to be held at the Sheraton Wild Horse Pass on Oct. 13.  Awards to be presented include: 2011 Michael A. Cusanovich  Educator of the Year, Fast Lane Company Awards, the Arizona Bioscience Company of the Year, the Jon W. McGarity Bioscience Leader of the Year Award, and the Arizona Bioscience Researcher of the Year Award.

Continue reading

Join AZBio at the Personalized Medicine World Conference

The Journey to Commercialization

PMWC 2012′s “Into The Clinic” session delves into both companies’ and clinicians’ perspectives with a particular focus on the benefits that patients presently gain from Personalized Medicine, as well as on approaches arriving in the near future.

This is one of six sessions showcased in the PMWC 2012 program.    Join AZBio and come build your knowledge-base by interacting with Personalized Medicine’s VIP players …only at the PMWC 2012.

View partial list of PMWC 2012 speakers

The PMWC Program Includes:

  • Emerging Technologies, chaired by Lee Hood, Institute for Systems Biology
  • Into The Clinic, chaired by Ralph Snyderman, Duke University
  • Regulatory Myths & Facts, chaired by Larry Lesko, UF
  • Economics: Payer Session, chaired by Felix Frueh, Medco
  • Rx/Dx Opportunities, chaired by Scott Patterson, Amgen & Mara Aspinall, Ventana MS
  • NextGen Health IT, chaired by Brett Davis, Oracle Health

View PMWC 2012 program developing here!



Conference Details:
Date: January 23-24, 2012
Location: Computer History Museum, Mountain View. Click here for map and directions
Accommodations: Reserve your PMWC 2012 rate today
Contact Information: Tal Behar-

National LambdaRail appoints Crow as head of Chairman’s Advisory Council

September 14, 2011

Patrick Soon-Shiong, chairman and CEO of National LambdaRail, announced the appointment of ASU President Michael M. Crow as head of a new Chairman’s Advisory Council.Aided by a $100 million guarantee from the Chan Soon-Shiong Institute for Advanced Health to upgrade and extend its network to support big science projects, the council will help guide the new mission of National LambdaRail, the 12,000-mile-high-performance communications network linking the nation’s leading research institutions.Continue reading

Regenesis Biomedical takes to the stage at the AdvaMed 2011 MedTech

Regenesis Biomedical to Participate in the AdvaMed 2011 MedTech Conference:  Selected to present in the Wound Management category and serve as a panelist on Emerging Growth Companies.

Scottsdale, Arizona, September 5, 2011 — Regenesis Biomedical, Inc., a medical technology company focused on regenerative medicine, announced today that it was selected to present at the AdvaMed 2011 MedTech conference. Regenesis presents in the Wound Management category. The aim of the conference is to connect companies that have an innovative medical technology to parties interested in investing capital, partnering, or initiating strategic alliances.Continue reading

The latest from Biozona News

Cancer center expects influx

09/11/2011 | Arizona Republic | Ken Alltucker

It’s  two weeks before the new Banner MD Anderson Cancer Center opens for       patients, but its new appointment calendar is filling quickly. The early       interest has Banner Health CEO Peter Fine and his staff talking about plans to expand the facility, which is 133,000 square feet. But Fine acknowledges that metro Phoenix patients will be the ultimate judge of how quickly the center grows.

Gowan partners with Colombia company to promote  ‘green’ products    09/09/2011 | Yuma Sun | Chris McDaniel

Gowan Company of Yuma has reached an agreement with EcoFlora, a company in Colombia, to create a joint venture called EcoFlora AGRO. Through this       joint venture, Gowan Company and its global marketing companies will be       the exclusive partner in developing, registering, and marketing EcoFlora’s current unique plant extract based portfolio and their robust product pipeline.

Executive profile: R.F. ‘Rick’ Shangraw Jr. of Arizona State University  09/09/2011 | Phoenix Business Journal | Patrick O’Grady

Rick Shangraw has seen technology and growth from both the public and private
sectors. Shangraw currently heads up Arizona State University’s Office of       Knowledge Enterprise Development, which is designed to take the best of the university’s ideas and turn them into commercial realities.

UA-linked hospitals get new names    09/08/2011 | Arizona Daily Star | Stephanie Innes

University  Medical Center is now called the University of Arizona Medical       Center-University Campus. And University Physicians Healthcare Hospital  at Kino will now be known as the University of Arizona Medical Center-South Campus. Both hospitals are part of the University of Arizona Health Network, which is the new name for the entity that formed in the summer of 2010 when University Medical Center Corp. merged with University Physicians Healthcare.

Phoenix OKs construction of $17 mil parking garage on       Biomedical Campus   09/08/2011 | Downtown Devil | Jessica Zook

The  City of Phoenix approved a proposal Wednesday for the construction of a     $17 million parking garage downtown. The Boyer Company gained approval as    the real-estate developer for the garage, which will serve the growing Phoenix Biomedical Campus and will be on the southeast corner of Fillmore and Fifth streets. Construction is scheduled to start in November 2012 and be complete by early February 2014.

Arizona has netted $2.6B in health-related stimulus  since 2009
09/07/2011 | Business Journal | Angela Gonzales

Since the enactment of the American Recovery and Reinvestment Act of 2009, the U.S. Department of Health and Human Services has made $2.6 billion in       stimulus funds available in Arizona. Of that, $2.2 billion went for the       increased federal share of state Medicaid costs, while another $106 million went to scientific research, facilities and equipment.

Innovations make tech incubator live up to its name
(editorial)  09/07/2011 | Arizona Republic

The Innovations Technology Incubator is part of Chandler’s mission to create       high-wage jobs for residents. The idea is to grow and foster ideas in science and technology. Once that happens, entrepreneurs would leave Innovations to buy or lease buildings, purchase equipment and create jobs in Chandler. Christine Mackay, Chandler’s economic-development director, says the city has been approached by new companies and existing tenants that need more space. The current facility is 100 percent occupied.

Regents panel OKs UA plans for 2 new research buildings  09/02/2011 | Arizona Daily Star | Becky Pallack

The University of Arizona is adding two new research buildings on the north       side of Speedway to its wish list. Capital improvement plans were approved by an Arizona Board of Regents committee on Thursday. A proposed $85 million bioscience lab facility would be built near the Bio5 building  for disease research.

ASU scientists receive $5 mil for DNA research   09/01/2011
| State Press | Kharli Mandeville

What if there was a way for doctors to know what diseases their patients were       susceptible to before they even showed symptoms? Two Biodesign Institute       researchers have been awarded more than $5 million in grants to further       pursue research into a cutting edge technology to sequence an individual’s genetic information, or genome.

NAU researcher thrust into the maelstrom after 9/11

ERIC BETZ Sun Staff  Reporter  |  Monday, September 12, 2011

On the morning of September 11, 2001, Paul Keim was out for a run with his  dog on Observatory Mesa, oblivious to the events unfolding along the eastern  seaboard.

He was training for a marathon that he would never run.

Within weeks, he would be sitting on the hood of his Toyota on the tarmac at  Flagstaff Pulliam Airport when a blonde woman walked off a Gulfstream jet and  handed him a package.

“Dr. Keim, this is the anthrax,” she told him.   Read more at the Arizona Daily Sun   

Study: Medical Device Tax Could Cost Jobs, Stifle Innovation

WASHINGTON,D.C. –The medical device tax, if implemented, could cost tens of thousands of jobs, almost double the industry’s total taxes, raise the effective tax rate to among the highest in the world, and harm U.S. competiveness, according to a study released today by the Advanced Medical Technology Association (AdvaMed).  The new study, “Employment Effects of the New Excise Tax on the Medical Device Industry,” by Manhattan Institute senior fellow Diana Furchtgott-Roth and Hudson Institute senior fellow Harold Furchtgott-Roth, outlines a number of economic harms likely to result from the tax.Continue reading

ASU to develop early diagnostics against colorectal cancer

Leland Hartwell, Nobel laureate and chief scientist at the Biodesign Insitute's Center for Sustainable Health at Arizona State University

ASU’s Leland Hartwell, Nobel laureate and chief scientist at the Biodesign Institute’s Center for Sustainable Health, spearheaded the agreement with Jianping Wang, director of the SYSU Gastrointestinal Institute of the Sixth Affiliated Hospital in Guangzhou, Guangdong, China.

ASU, China’s Sun Yat-Sen University partner

Arizona State University and China’s Sun Yat-Sen University (SYSU) have formalized a research collaboration aimed at developing early and predictive diagnostics to improve patient outcomes for colorectal cancer.  ASU’s Leland Hartwell, Nobel laureate and chief scientist at the Biodesign Institute’s Center for Sustainable Health, spearheaded the agreement with Jianping Wang, director of the SYSU Gastrointestinal Institute of the Sixth Affiliated Hospital in Guangzhou, Guangdong, China.

“Recent advances in molecular technologies promise great improvements in medical care through prevention and early detection of disease,” Hartwell said.

Read more at ASU News