Author Archives: D3Bio

OMB releases Federal Grant Reform Guidance developed by COFAR

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As 2013 came to a close, on December 26, 2013, the Office of Management Budget (OMB) issued the long-awaited final rule to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, more commonly known as the “Super Circular.” This rule finalizes OMB’s proposed guidance from February 1, 2013, and represents the culmination of an effort that was more than two years in the making. Among other things, this rule streamlines eight Federal regulations (including OMB Circulars A-110, A-122, and A-133) into a single, comprehensive policy guide and affords the Federal government the ability to better administer the $600 billion awarded annually for grants, cooperative agreements, and other types of financial assistance. This will have important implications for all nonprofit recipients of, and applicants for, Federal grants and cooperative agreements (“awards”). (Source and Super Circular summary:  Venable, LLP)

 

(NSF Video: http://youtu.be/xBmjulDwDWk)

To assist organizations in understanding the final rule, OMB  hosted an informational webcast on December 20, 2013 with team members from  COFAR agencies. The recorded webcast is shown above.  For more information visit www.cfo.gov/cofar.

To view the Super Circular, click here.

While effective December 26, 2013, actual  roll out by agencies will continue throughout 2014.  It will be imperative for nonprofit organizations to assess their current practices and policies and take appropriate steps to ensure that they conform with the final rule in a timely manner.

 

SynCardia raises $14M in December to Fund Rapid Growth

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Privately held SynCardia Systems, Inc. announced, on December 17th, that it had raised $14 million to fund the rapid growth of the only approved medical device that eliminates the symptoms and source of end-stage heart failure, the SynCardia temporary Total Artificial Heart. The SynCardia Total Artificial Heart is the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart.Continue reading→

Telemedicine is everybody’s business

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Arizona Telemedicine Program is a Model ‘Telehealth Technology Innovation Accelerator’ for the Telemedicine Industry:  A number of outstanding telemedicine programs, owned by different health-care organizations, work together on telemedicine challenges ranging from legal and regulatory issues, to telecommunications technology, to reimbursement.Continue reading→

TGen, Nemucore and Barrow team up under $3M Ivy Foundation grant

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Ivy Foundation awards $3 million grant, supporting brain cancer research in Arizona

 

The Ben & Catherine Ivy Foundation announced a $3 million grant to the Translational Genomics Research Institute (TGen), Nemucore Medical Innovations Inc., and Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center to help fund significant brain tumor research in Arizona. ( Dateline:  December 18, 2013)

 

The collaboration of TGen, Nemucore and Barrow will pursue ways to optimize targeted therapies delivered by nanotechnology systems to treat glioblastoma, the most common and most aggressive form of malignant brain tumors.

 

This project is a primary example of translational research, moving laboratory findings as soon as practicable to patient care. Laboratory success should result in eventual follow-on efforts in the biomanufacturing of personalized medicine and implementation of new therapies in clinical trials.

 

“We are excited about this innovative approach to research, especially the collaboration between two major Arizona institutions: TGen and Barrow,” said Catherine Ivy, Founder and President of the Ivy Foundation. “Knowing there is a tangible way to develop therapies specific to the needs of patients will enhance the care and treatment of every brain tumor patient—and that is priceless.”

 

One of the goals of this Ivy Foundation grant is to enable TGen, Nemucore and Barrow to collaboratively align their findings toward the goal of creating new medications that can bridge the body’s blood-brain barrier, which in the past has hampered the successful implementation of intravenous brain-cancer drugs.

 

Each of the collaborators is a leader in their respective fields:

•TGen’s genomic sequencing—in which all 3 billion base-pair letters of human DNA are spelled out, in order—can be used to create molecular profiles of patients and match specific therapies to diseases, providing the promise of better clinical results while minimizing side effects.

•Nemucore specializes in the development of life-saving cancer nanomedicines, in which drugs are packaged in ways that evade cancer defenses, delivering medications that can knockout tumors.

•Barrow, which is internationally known for its treatment of neurological disorders and treats one of the highest volumes of brain tumors in the United States, will conduct preclinical work to design nanomedicines for better access to the tumor, and will also provide the setting for clinical trials, in which patients are the first to benefit from new therapies.

 

“Working with the research team from the outset of the study will be helpful. We can advise them on methods or components as they develop novel formulations suitable for crossing the blood-brain barrier,” said Dr. Tim Coleman, CEO of Nemucore. “Without this type of integrated approach it would take much longer to translate these individualized investigational therapies to the clinic.”

 

Based on the research findings, the team would work with a strategic manufacturing partner, Blue Ocean Biomanufacturing, to develop methods to manufacture personalized medicine for the treatment of glioblastoma.

 

Coleman also is CEO of Blue Ocean, which is developing a cutting edge, fully flexible manufacturing facility in Peoria, Arizona. With a focus on small-batch pharmaceuticals and personalized medicine, Blue Ocean will advance breakthrough technologies for producing biopharmaceuticals with reasonable economics. This revolutionary technology will make it possible to use the genetics of a single patient’s tumor to customize and produce the medicine specific to them.

 

“Barrow’s collaboration with TGen and Nemucore is unique in that we will develop novel drug delivery technology that fully spans basic academic science through bench top translation and manufacturing,” says Dr. Rachael Sirianni, assistant professor at the Barrow Brain Tumor Research Center. “Our first and foremost goal is to improve the prospects for patients diagnosed with glioblastoma, and to translate our academic science into safe and effective therapies. This innovative partnership between our respective institutions and the funding provided by the Ivy Foundation will make it possible to bring forward academic research to benefit patients at Barrow and elsewhere.”

 

“This grant is a tremendous step in changing the way medicine is developed in Arizona,” said Dr. Michael Berens, TGen Deputy Director for Research Resources and Director of TGen’s Cancer and Cell Biology Division. “This project should enable us to develop treatments that will bridge the blood-brain barrier. I wholeheartedly thank the Ivy Foundation for their continuing support of the work we are doing to find new and effective treatments for the patients afflicted with this most aggressive form of cancer.”

 

Provided by The Translational Genomics Research Institute