FDA Releases Long-Awaited Quality Metrics Guidance

On a Monday in July 2015, the US Food and Drug Administration (FDA) released a draft guidance detailing how it plans to use quality metrics to improve its ability to conduct risk-based inspections and predict or mitigate potential drug shortages.

NFL, GE award up to $10M to advance mild traumatic brain injury knowledge, diagnosis

In a continuing effort dubbed the Head Health Initiative, the NFL and partner GE have made awards of $500,000 to the 6 winners of the first of four planned research challenges.  This is in addition to $300,000 in grants that it gave to 16 winners in the first round. Between them, they may be awarded a total of up to $10 million.The latest winners include three corporations and three academic groups: Banyan Biomarkers of San Diego, CA; BrainScope of Bethesda, MD; Quanterix of Lexington, MA; the Medical College of Wisconsin in Milwaukee, WI; the University of California, Santa Barbara at Santa Barbara, CA; and the University of Montana in Missoula, MO.

BrainScope is already the beneficiary of millions in government grants, particularly from the Department of Defense (DOD), which has invested more than $27 million into its technology development in a quest to aid soldiers with brain injuries on the battlefield.  In May, the FDA cleared a smartphone-based EEG device to detect traumatic brain injury from the startup.

Quanterix brings to bear its ultra-sensitive diagnostic Single Molecule Array (Simoa) technology that it says is able to measure individual proteins at concentrations of 1,000 time less than other immunoassays, while Banyan Biomarkers is developing a point-of-care test for traumatic brain injury.  Banyan also has a DOD connection, in 2010 the U.S. military agency backed a 2,000-patient, pivotal clinical trial of its TBI test with a $26.3 million contract.

Among the academics, the Medical College of Wisconsin is using MRI scans to examine the relationship between sports-related concussions on brain structure and function; the UCSB Brain Imaging Center is developing statistical methods to help enable the detection of damage to deep connections in the brain after a mild head injury; and the University of Montana is working on blood-based biomarkers after a TBI including plasma microRNAs.

GE and the NFL launched the Head Health Initiative, of which this first challenge is a part, in March 2013 as a four-year, $60 million collaboration.  That includes $10 million each year devoted to R&D investment in a particular research challenge area.  The pair have already launched a second challenge focused on better brain protection from TBI and real-time head impact tracking; emerging sports apparel and equipment company Under Armour has signed on as part of it, as well as an upcoming third challenge.

The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) is also involved with the trio in the third challenge, which is slated to focus on novel next-generation materials that can better absorb or dissipate energy that could be used in protective gear.  “We are truly impressed by the quality of the work and the measurable progress being made by these winning organizations,” said Alan Gilbert, director of health policy, government and community strategy for GE healthymagination, in a statement.  “There are a number of breakthrough ideas that are advancing our understanding of the brain and have applications not only on the playing field but also extend to neurodegenerative diseases such as ALS, Parkinson’s and Alzheimer’s.”

REFERENCE:  Fierce Medical Devices; 23 JUL 2015; Stacy Lawrence

NIH-backed scientists develop wireless, remote-controlled brain implant

Amid growing interest in innovative neurological devices to treat brain disorders, scientists supported by the National Institutes of Health (NIH) are developing a wireless, remote-controlled probe that could inject drugs and highlight neurons inside the brain.