Crow, Newfeld elected AAAS Fellows

 Two faculty members of Arizona State University, including ASU President Michael Crow, are among the 702 newly elected American Association for the Advancement of Science (AAAS) Fellows. A prestigious international scientific society, AAAS is the world’s largest general scientific society.Continue reading

IRS Issues Final Medical Device Regulations

The Internal Revenue Service today released the final regulations on the Medical Device Tax which will go into effect in January of 2013 unless it is repealed between now and the end of the calendar year.

Industry groups from across the country have been actively working with both the IRS and with Congress to share with them the far reaching impacts that the tax will  have on both new innovations and currrent products developed and/or manufactured on shore.

In a report earlier today,  of Fierce Biotechg shared: that the agency is adopting very few of the suggested changes to the law’s major  provisions.

“The final regulations do not adopt this suggestion.” That’s a phrase you get  used to when reading the IRS’s 58-page document on the 2.3% tax. Commenters had  asked for exceptions for devices with medical and non-medical uses, more  specific definitions of “taxable medical devices” and provisions that would  account for a device’s pricing before applying the tax, among other things.

All of these were weighed, debated and ultimately rejected by the IRS, which  by and large affirmed its last guidance, something we covered  in detail last month. In sum, that leaves a 2.3% tax on medical devices as  defined by the FDA,  with exemptions for devices that are sold directly to consumers, destined for  further manufacture or slated to be sold outside the U.S. (Source:  IRS pays little mind to industry feedback in final device tax regs – FierceMedicalDevices )

The new IRS regulations cover 58 pages.  To download a copy, please click here:  Medical Device Tax Final Rules 2012-29628_PI

 

RiboMed Receives Three Additional Patents for Disease Diagnostics Methods

RiboMed Biotechnologies Inc., a leading Epigenetics-Based Diagnostics company, today announced that the U.S. Patent and Trademark Office has issued three additional patents covering the use of their core technology, Abscription® (Abortive Transcription), for disease and biowarfare agent related biomarker detection. The patents expand protection to MethylMagnet® and MethylMeter®, RiboMed’s bisulfite-free DNA methylation detection products and assays, including a new prognostic test for brain cancer, G-CIMP DecisionDxContinue reading

UA has Hart: Inaugurating the 21st President

By La Monica Everett-Haynes, University Communications |             November 30, 2012

In her inaugural address, UA President Ann Weaver Hart charged members of the campus and community to think and act in more progressive and unconventional ways to aid in the success of the University.Continue reading

Positioning Arizona To Be A Center of Bio and Health Innovation Excellence

In October, we came together to recognize the achievements of leaders in bio-innovation from across Arizona and to celebrate the “birthdays” of initiatives and organizations that have brought us to where we are today.

Celebrations and recognition are important opportunities to recharge and reconnect.  Each achievement is a mile marker along the road we have been traveling to make Arizona a tier one bioscience state.  We have made significant progress over the last decade as noted in the Battelle/BIO  State Industry Development Report for 2012 but we still have more road to travel and obstacles to overcome as does our industry as a whole.   These challenges and opportunities are outlined in a recent article by the Brookings Institute relating to the September release of the Report from the  President’s Council of Advisors on Science and Technology (PCAST) in September:

Biomedical Innovation in a Challenging Fiscal Environment

The U.S. biomedical “innovation ecosystem”—encompassing the universe of stakeholders and activities directed toward understanding disease areas and developing novel treatments for them—is in a period of stress. As noted in the September release of the  report by the President’s Council of Advisors on Science and Technology (PCAST), significant scientific advances over the last 25 years have moved us toward a better understanding of the biologic underpinnings of some of the most debilitating diseases that affect the U.S. population. While novel treatment options for many of these disease areas have been developed over this time period, recent history has demonstrated that advances in basic research have not consistently translated into substantial progress in the production of novel treatments and cures. The rate at which new biomedical products are entering the market has remained relatively constant over the last few decades, while the cost and time associated with the development of new products appears to have steadily increased. Seeing the advances in novel treatments that have been made during this time may lead many to believe that increased funding for early stage research and development can relieve the stress on the innovation ecosystem. In today’s economy, however, this notion may well prove unachievable as additional public funds are unlikely to be available and private investment is constricted. These trends point toward the need for novel strategies to improve productivity in biomedical innovation and efficiently move medical products from scientific discovery to clinical practice.

Click here to read the full article on the Brookings Institute “Up Front” Blog.

The author, Gregory W. Daniel, Managing Director for Evidence Development & Innovation at the Engelberg Center for Health Care Reform at Brookings, is speaking to the challenge our industry must rise to meet, but he could be equally be speaking to us here in Arizona.  The next decade is ours to shape and Arizona’s ‘collaborative gene’  could be the catalyst we need to progress to a leadership position nationally and globally as a center for bio-innovation.

Collaboration begins with connecting the dots.

Here in Arizona we have multiple centers of excellence that have developed or grown over the last decade including (but not limited to):

Global Leaders

  • Ventana Medical Systems, Inc., a member of the Roche Group, is a world leader and innovator of tissue-based diagnostic solutions for patients worldwide.
  • Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions to improve the lives of everyone.  The team at Sanofi works to prevent and treat today’s diseases , as well as those we may face tomorrow.
  • Cord Blood Registry is home to the largest private cord blood stem cell collection in the world and is a leading center for stem cell research from processing to application.
  • Medtronic’s Tempe Campus is home to teams that  develop and manufacture innovative medical device technology and therapies to treat chronic disease worldwide.
  • W.L.Gore  and Associates, through its Gore Medical Products Division have provided creative therapeutic solutions to complex medical problems for 35 years.
  • SynCardia Systems, Inc.  is the privately-held manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart.
  • Ulthera has pioneered new ultrasound applications and has the only  non-invasive procedure FDA-approved to lift skin on the neck, chin and brow

Health Information Technology

  • GlobalMed, a privately held telemedicine company headquartered in Scottsdale, Arizona, is the leader of telemedicine companies in telehealth hardware and software R&D, design, engineering, manufacture and support. #95 on the Inc. 500 list and #7 in healthcare, their team of telemedicine software developers and engineers work closely with scientific and medical professionals—from concept to application—to understand and translate unmet needs into next-generation integrated telemedicine tools unsurpassed in quality, affordability and flexibility.
  • The Arizona Telemedicine Program is a large, multidisciplinary, university-based program that provides telemedicine services, distance learning, informatics training, and telemedicine technology assessment capabilities to communities throughout Arizona, the sixth largest state in the United States, in square miles. The program has succeeded in creating partnerships among a wide variety of not-for-profit and profit healthcare organizations, and has created new interagency relationships within the state government.
  • The CSS Institute, organized as a 501 (c) 3 non-profit medical research entity, was established in 2011 with core funding from Dr. Patrick Soon-Shiong and his wife Michele B. Chan, who have pledged through their family foundation $1 billion for healthcare and health information projects. The CSS Institute currently operates in both California and Arizona and is exploring relationships with other states. In April 2011 it announced the construction of data centers in Phoenix and Scottsdale dedicated to health information storage, and also the construction of a dedicated supercomputer in Phoenix. All these have since become operational and are now being connected with National LambdaRail. The CSS Institute’s funding for NLR comes through the Institute’s National Coalition for Health Integration, itself a 501 (c) 3 established in 2009 specifically to advance bio-informatics, the health grid and the creation of a national health information network.

Research Centers of Excellence

  • The Critical Path Institute is setting the standards that make cures. C-Path improves efficiency of the development of drugs, diagnostics, and medical devices by creating new data standards, measurement standards, and methods standards.
  • The Translational Genomics Research Institute (TGen) and the International Genomics Institute (IGC) are leading in ground breaking genomics research
  • TGen and the University of Arizona Cancer Center (UACC) partner with NFCR Center for Targeted Cancer Therapies (NCTCT), created in 2002, which is dedicated to discovering new therapies to treat pancreatic cancer, the nation’s fourth leading cause of cancer death.
  • The Keim Lab at Northern Arizona University and TGen North are national centers of excellence in pathogen genomics
  • The Biodesign Institute at Arizona State University is working to make a difference are: biomedicine & health outcomes, sustainability and security that are “use-inspired,” as well as “bio-inspired” solutions.
  • BIO5 at the University of Arizona is home to teams collaborating across  five disciplines: Agriculture. Engineering. Medicine. Pharmacy. Teams work together to forge solutions to the complex biology-based challenges affecting humanity today.
  • The Arizona Alzheimer’s Consortium (AAC)is the nation’s leading model of statewide collaboration in Alzheimer’s disease research. Established in 1998, the Consortium capitalizes on its participating institutions’ complementary strengths in brain imaging computer science, genomics, the basic and cognitive neurosciences and clinical and neuropathology research to promote the scientific understanding and early detection of Alzheimer’s disease and find effective disease-stopping and prevention therapies. The Arizona Alzheimer’s Consortium is a 501(c)(3) organization that includes the state-supported Arizona Alzheimer’s Research Center (AARC), the National Institute on Aging (NIA)-funded Arizona Disease Core Center (Arizona ADCC), and independently funded research programs. Its seven member institutions include: Arizona State University, the Barrow Neurological Institute, the Mayo Clinic Arizona, the Banner Sun Health Research Institute, the Translational Genomics Research Institute (TGen), the University of Arizona, and the recently established Banner Alzheimer’s Institute. Its three affiliated institutions include Banner Good Samaritan Medical Center, the Southern Arizona Veterans Administration Health Care System and the University Physician’s Hospital at Kino.
  • The UA’s College of Medicine Phoenix is setting new standards in medical education as they pioneer new programs as the first medical school to be built from the ground up anywhere in the US in the last three decades. A collabroative effort between the UA, the City of Phoenix, and
  • Science Foundation Arizona funds STEM Education and research grants in areas of strategic importance, helping to ensure Arizona’s competitive future.

These are only a few examples of the many assets our bioscience community has produced.  Each of them stand out as great examples of collaborative innovation and connect us to the national and global bioscience efforts. They also serve as magnets, attracting top talent that is drawn to opportunities to work with others towards a common goal.

When we combine this with emerging health  innovations from companies including Calimmune (HIV/AIDS), Regenesis (Regenerative Medicine), Global Cancer Diagnostics (Lung Cancer). VisionGate (Lung Cancer), and many more, we begin to see patterns of dots that can be connected in improve both health and the economy of the state.  (To view hundreds of companies that dot Arizona’s Bioscience Landscape, click here.)

Connecting the dots and activating our ‘collaborative gene’ to create new solutions that will allow us to do more in ways that are both efficient and effective will create new opportunities in 2013 and beyond.

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Tip #4 for Moving Forward Faster in 2013

Work with AZBio to help you “connect the dots.”

As Arizona’s statewide bioindustry association, AZBio is uniquely positioned to connect individuals and organizations inside Arizona and across the country.  AZBio members come from all sectors of Arizona’s health care and life science industry and lead in the discovery, development, and delivery of new  technologies that will deliver solutions to some of the world’s greatest challenges relative to Health, Energy, and Agriculture.

In addition to making connections across our industry, AZBio also works with Arizona’s economic development and elected leaders to help make Arizona competititive and attractive to current and future bioscience enterprises by fostering an environment where lifescience companies can launch and grow.