Author Archive: AZBio

Add YOUR Voice to the FDA PDUFA VI Negotiations

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In August, the Biotechnology Industry Organization (BIO)  announces a first-of-its-kind survey tool on FDA/Sponsor Interactions During Drug Development to better inform policy initiatives designed to improve FDA and drug sponsor coordination and communication during drug development. This will serve to inform the next reauthorization of the Prescription Drug User Fee Act (PDUFA VI), which will begin in late 2015 with final enactment expected in 2017.

“Sponsor input is critically important for BIO and the entire industry to understand the real challenges associated with the regulatory process to help guide our discussions with FDA and ultimately work with Congress to establish new and effective measures to implement under PDUFA VI,” said John Maraganore, PhD, CEO of Alnylam Pharmaceuticals and Chair of BIO’s Emerging Companies Section Governing Board.

Survey responses will help assess FDA-sponsor interactions during drug development and address problems, particularly those that result from inconsistencies between review divisions.

The survey will focus on individual clinical programs for products that are in the pre-clinical testing phase through the clinical testing phase, prior to submission of an initial NDA/BLA, and responses will be held strictly confidential, blinded, and aggregated.

Sponsor input will help identify areas where policies, regulations, and practices are working well and should not be changed; and identify areas where policies, regulations, and practices need improvement in order to make the process more efficient and effective.

Participants will have access to the survey tool 24 hours a day, seven days a week so that responses can be updated on a continual basis.  The survey is open to all biopharmaceutical representatives regardless of membership within BIO. Participants will be provided with an annual report on the survey results and invited to join exclusive BIO webinars to discuss survey results with industry leaders and regulatory experts.

The survey can be accessed at https://fdasurvey.bio.org.

 

Dr. Maraganore discussed the upcoming PDUFA VI reauthorization in a recent BIO Buzz Center video interview that can be accessed here.

UofA breaks ground on 245K SF Biosciences Partnership Building

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Posted October 16, 2014  by   AZBIG Media (Republished with permission)

With a shovel of dirt, construction began Thursday on the 10-story Biosciences Partnership Building; the latest development in downtown Phoenix.

 

University of Arizona President Ann Weaver Hart and Phoenix Mayor Greg Stanton tilled the soil ceremoniously marking the beginning of the 2-year design and construction for the 245,000-square foot research building on the Phoenix Biomedical Campus.

 

“This building will foster collaborations with scientists that will lead to more cures, better treatments and bring more federal and private dollars to the state,” said President Hart. “We will pursue expanded partnerships with industry that we hope will lead to groundbreaking discoveries in the areas of neuroscience, cardiovascular and thoracic science. This building will allow us to further these efforts and, ultimately, improve lives.”

 

As announced earlier this year by the university and the City of Phoenix, plans are in place to construct the 10-story, 245,000-square-foot research building just north of the Health Sciences Education Building on the downtown campus.

 

“This building will serve the medical school and beyond with important research and faculty to teach the next generation of health professionals,” Stanton said. “Of course, this just adds to the economic vibrancy of downtown. The research facility initially will bring construction jobs, and then high-paying, research-related jobs, including specialized technicians and other support staff for faculty and scientists.”

 

The 2-year construction on the $136 million building is expected to translate into nearly 500 jobs initially and another 360 permanent jobs at build out.

 

“The Bioscience Partnership Building represents yet another milestone as the city and the university develop a major academic medical center in downtown Phoenix,” said Stuart D. Flynn, MD, dean of the University of Arizona College of Medicine – Phoenix. “Research in this building, in collaboration with our partners, will advance healthcare for all and expand our role as an economic driver for the city, valley, and state.”

 

The building is the latest development in the steady expansion of the downtown Phoenix Biomedical Campus and expanding academic medical center. In 2012, the award-winning Health Sciences Education Building opened, housing health education for both the UA and Northern Arizona University. Construction continues on The University of Arizona Cancer Center at Dignity Health St. Joseph’s. The cancer center, a 220,000-square foot outpatient and research facility, is scheduled to be completed in 2015.

 

The Phoenix Biomedical Campus plays host to four UA health science colleges – the Mel and Enid Zuckerman College of Public Health as well as the colleges of nursing and pharmacy. Also on campus are three NAU programs – physician’s assistant, physical therapy and occupational therapy as part of the university’s College of Health and Human Services. Arizona State University’s School of Nutrition and Health Innovation is housed in the Arizona Biomedical Collaborative 1 building just southwest of the education building and immediately south of the Translational Genomic Research Institute (TGen).

 

The funding for the Biosciences Partnership Building comes from the Stimulus Plan for Economic and Educational Development bonds approved by the legislature in 2008that paid for construction of the Health Sciences Education Building and related campus improvements. Research focus areas include neurosciences, healthcare outcomes, cancer and precision medicine.