Author Archive: AZBio

Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Pediatric Schizophrenia

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PHOENIX, AZ, Nov 24, 2014 (Marketwired via COMTEX) — Insys Therapeutics, Inc. INSY, +0.44% a specialty pharmaceutical company that is developing and commercializing innovative drugs and novel drug delivery systems, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) candidate for the treatment of pediatric schizophrenia. This marks the fifth ODD for the company’s CBD program.Continue reading→

ASU’s Project Honey Bee paired up with DCU’s MedEx

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The transatlantic flight of Project HoneyBee

honey bee

Inspired by the honeybee, nature’s best collector and communicator of information, Project HoneyBee seeks to validate wearable sensor data in order to improve patient outcomes.
Photo by: “Apis mellifera flying” by Muhammad Mahdi Karim
Another transformative collaboration has emerged from the Transatlantic Higher Education Partnership between Arizona State University and Dublin City University – the launch of Project HoneyBee.

In conjunction with its successful MedEx Wellness Program, Dublin City University (DCU) has signed on to launch a Project HoneyBee observational clinical trial. MedEx is a chronic illness rehabilitation program that offers medically designed and supervised exercise classes to patients with diverse chronic illnesses.

As part of the HoneyBee collaboration, medical director, Noel McCaffrey, will incorporate methods from Mayo Clinic physician and ASU professor James Levine’s feasibility study for physical monitoring of diabetes patients into MedEx’s Diabetes Health Steps program.

“We’re excited to test the HoneyBee approach with our MedEx participants. We believe by leveraging technology, we can improve their health outcomes dramatically,” said Christine Loscher, director of health technologies at DCU.

Inspired by the honeybee, nature’s best collector and communicator of information, Project HoneyBee seeks to validate wearable sensor data in order to improve patient outcomes. Since its inception, the initiative has partnered with the health systems in Maricopa County, creating a living laboratory for evaluating the clinical utility of wearable devices to improve health outcomes.

HoneyBee’s eight ongoing observational clinical trials currently test 10 different devices for particular physiological parameters. Each trial has 25 to 50 patients. The overarching goal is to help shift health practitioners’ focus to cost-effective and outcome-effective prevention and early intervention strategies. A critical element of these studies is validating data from low-cost consumer wearable technologies for applications in clinical settings.

Lee Hartwell, HoneyBee’s chief scientist at the ASU Biodesign Institute’s Center for Sustainable Health, said, “We’re very interested in how Project HoneyBee will work in DCU’s context. We hope to learn from and collaborate with each other in our quest for efficient, effective solutions that deliver better health outcomes.”

One of the key differences between HoneyBee observational clinical trials in Arizona versus the trial in Dublin will be the context within which the devices are being tested, as well as the health care providers engaged in the study. In Dublin, third-year lifestyle intervention students will be embedded in the trial; in Arizona, doctoral nurse practitioners serve as research fellows.

“This is a fantastic opportunity to see how the Project HoneyBee model can be replicated in Europe, along with similar efforts underway in Asia,” said Michael Birt, director of HoneyBee.

This latest announcement is another major collaboration between the two universities, and came during the recent DCU visit to ASU. The other major initiatives include establishing the world’s first International School of Biomedical Diagnostics, creating a Biodesign Europe (modeled on ASU’s Biodesign Institute and delivering a combined effort toward 21st-century health care solutions) and the development of a joint program in student entrepreneurship that will inspire a global perspective.

Joe Caspermeyer, Joseph.Caspermeyer@asu.edu
(480) 727-0369
Biodesign Institute

New Autism Study Safety Data to be Presented at the Translational Neuroscience Cell Symposium

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Cord Blood Registry® (CBR®) announced today that Dr. Michael G. Chez principal investigator at Sutter Neuroscience Institute will present data from the first ever FDA-registered study on the safety of autologous umbilical cord blood (AUCB) stem cells in treating autism at the Translational Neuroscience: Bridging the Gap Between Basic Research Discoveries and Clinical Applications Cell Symposium on November 14 2014 in Arlington Virginia.Continue reading→