MSRI 2020 - Research/Patient Perspective - Kelly Owens
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MSRI 2020 - Research/Patient Perspective - Kelly Owens

MSRI Workshop for Clinical Translation of Implantable Devices August 27-28, 2020 Sponsored by the National Science Foundation and hosted by University of California San Diego Bioelectronic neuromodulation devices are evolving as the gold standard of care for a variety of diseases in the nervous system and beyond. They are projected to impact millions of people, and their market is expected to reach ~ $16.6B by 2025. Despite research demonstrating the effectiveness of implantable devices being developed at universities and small businesses across the nation, technological advances that could permit safer and more effective interrogation and modulation paradigms are unable to attain FDA clearance due to the uncertified nature of the university labs, thus halting innovation at the bench and reducing the benefit of research to patients and taxpayers. The National Science Foundation’s (NSF’s) Mid-scale Research Infrastructure (MSRI) program offers an opportunity to bridge this gap between academic research and development of implantable bioelectronic devices for clinical translation through the support of an infrastructure for a National Neurotechnology Alliance at UC San Diego. The objective of this workshop is to bring leaders in human neuromodulation devices to discuss the current progress and gaps in the clinical translation of neuromodulation devices developed in universities and startups. This workshop ]outlines the needs for an infrastructure to fill this gap, and help prepare participants for submission of an MSRI proposal to the NSF. One primary objective of the workshop is to outline the needs for a certified good manufacturing practice (CGMP) facility within a university campus that will help accelerate innovative neurotechnology efforts across the country and place the U.S. at the forefront of implantable medical devices. The 2-day workshop sponsored by the NSF and organized by the Qualcomm Institute at UC San Diego and Platt & Associates, Inc. was held virtually. https://sites.google.com/eng.ucsd.edu/msri-workshop/home
Kevin Tracey - Brain-Body Interactions
01:03:01
Kevin Tracey Discusses the Current Progress in the Field of Bioelectronic Medicine
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Kevin Tracey Discusses the Current Progress in the Field of Bioelectronic Medicine

Dr. Kevin Tracey is the president and CEO of the Feinstein Institutes for Medical Research. He is very well-known and well-cited for his seminal research within the field of neuromodulation, particularly as it relates to the immune response. In this episode, he discusses the current progress being made in the field of bioelectronic medicine, as well as how it compares to pharmaceutical treatments. Top three takeaways: The power in bioelectronic medicine is in the fact that rather than sending out a drug into the body and hoping it affects the target area, the target is identified and the device is designed and manufactured around it. Since testing in mice is an important precursor to human clinical trials, the field of bioelectronic medicine has been greatly slowed down by the lack of available tools for device implantation in mice. The field of bioelectronic medicine is in its early stages with regard to clinical testing; as such, its efficacy relative to pharmaceutical approaches is not yet fully understood. [0:00] Ladan introduces the episode and the guest, Dr. Kevin Tracey [2:00] Tracey discusses his background in research in bioelectronic medicine and neuromodulation in the immune system [6:00] What’s so powerful about bioelectronic medicine is that it’s scalable, replicable, and generates testable hypotheses. The device is designed around the target. [9:00] Side effects are the main limiting factor for drugs. With devices, the side effects are easier to understand and manage since a specific nerve and region are targeted, as opposed to drugs, which have a systemic effect. [12:30] Tracey co-founded SetPoint Medical with Dr. Shaw Warren, and it was founded to establish a mechanism to test the idea of harnessing the inflammatory reflex in human clinical trials [16:45] When stimulating the vagus nerve, several fibers are stimulated. Despite this, controlling the amount of current delivered through stimulation can control which organs (such as the heart or spleen) are affected. [20:30] The field of bioelectronic medicine has been slowed down by the absence of available tools that can be used for mice [23:45] Bioelectronic medicine is still in its early stages and is new in terms of clinical testing and adoption; at this point, we don’t fully know its efficacy relative to pharmaceuticals [27:00] One study found that patients who have not responded to drugs or to vagus nerve stimulation did respond when a combination of the two was used [31:00] The advantage of targeting close to the organ is more localized stimulation, but the disadvantage is that some of these organs are difficult to access [34:00] The mission of the Feinstein Institute for Bioelectronic Medicine is to produce the necessary knowledge in bioelectronic medicine to cure disease [37:00] The new labs the Feinstein Institute is building are investigating the neural control of drug targets, neural information processing, sensory and motor signals to nerves, and previously unrecognized neurons that control aspects of the immune response