Marc Russo on running clinical trials in Australia and the INS
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
Release Date: 12/06/2021
Neural Implant podcast - the people behind Brain-Machine Interface revolutions
is the galactic head of admonishment and also executive vice president of data science at . There they do contract work for machine learning in neuroscience and neurotech. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services Top 3 Takeaways: "One of the arguments I've often made is that it isn't only the hardware that holds us back. It is the software. When the software reaches a level of sophistication, suddenly the hardware is orders of magnitude more impactful." "Clearly we have learned how to understand patterns. We call these latent...
info_outlineNeural Implant podcast - the people behind Brain-Machine Interface revolutions
is the CEO and founder of which is an AI Platform for collecting data from the brain using eye movements. ***This podcast is sponsored by Iris Biomedical, check out their Neurotech Startup Services Top 3 Takeaways: "There wasn't any significant innovation in the eye tracking technology for the last 15 years. And we thought that if we use modern computer vision and image processing techniques, we could make it much more accessible and easy to use, which in turn would open up new applications and create whole new industries." "We've just launched in the United States. The Communication...
info_outlineNeural Implant podcast - the people behind Brain-Machine Interface revolutions
is a Professor of Neurosurgery and Ophthalmology at Stanford University. His research has focused on understanding the spatiotemporal patterns of electrical activity in the retina that convey visual information to the brain, and their origins in retinal circuitry, using large-scale multi-electrode recordings. His ongoing work now focuses on using basic science knowledge along with electrical stimulation to develop a novel high-fidelity artificial retina for treating incurable blindness. ***This podcast is sponsored by Ripple Neuro, check out their Neuroscience Research Tools Top 3 Takeaways:...
info_outlineNeural Implant podcast - the people behind Brain-Machine Interface revolutions
is the host of the which talks about Medtech Device industry. They talk about the success storiies, advice, pitfalls, trends and more. Duane also helps run which accelerates medical technology to improve patient lives. Finally, Duane and Giovanni Lauricella have started the about how to raise money for medtech companies. Top 3 Takeways: "Actually defining the problem too is a big issue. And it's something that I didn't really realize was an issue. They're asking questions that are going to validate their problem rather than actually going out and doing some in-depth research. Is this...
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Brock Lindsey and Jack Gelman are researchers at West Virginia University. Brock is an orthopedic oncologist who deals with bone and muscle tumors. Jack is a plastic surgeon interested in peripheral nerve surgery. Together they work on targeted muscle reinnervation in osseoimplants to bring back control for amputees. Top 3 Takeaways: Integrating prosthetics into the bone allows for better bone health since the bones are then under load Neuromas are transected nerves that continue to grow and cause pain. They've removed some that are the size of golf balls WVU has done 28 of these...
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A few weeks ago the Physicians Committee for Responsible Medicine (PCRM) based on a Freedom of Information request to look at the records of animals involved in trials at Elon Musk's Neuralink company. PCRM alleges that 15/23 monkeys used in the experiments have died and that they have been treated poorly. In a rare move from a Musk company, Neuralink published a explaining their position explaining some of the nuances of what happened. In this episode, I go over some of the facts of this case, my experience with animal studies, and then play a good which goes into more detail. ...
info_outlineNeural Implant podcast - the people behind Brain-Machine Interface revolutions
is a Quality and Regulatory Affairs Consultant in the field of Medical Devices. He is also the host of the MedTech Podcast where he talks to leaders in the field of Medical Technologies Top 3 Takeaways: "Once you understand your product, who's going to be using it, you can then build a risk assessment around that. But if you do not know what your product is, and you do not know the modes of failure, you really are going to struggle with this process." "So the UK is relatively easy for software devices. The EU has now become more difficult. Whereas previously the EU was considered to be...
info_outlineNeural Implant podcast - the people behind Brain-Machine Interface revolutions
Adam Sefler and Radhika Gupta head up which is a distinct for-profit entity affiliated with the non-profit NeuroTechX. They offer consulting and recruitment services with the vision to aid in the commercialization of neurotechnology at a global scale. Top 3 Takeaways: "Our projects range from [client] projects coming right out of labs, to setting up a whole new division for a larger company, to describing and setting the marketing strategy for an [international] startup, to doing C-level executive search[es] on the recruiting side, but […], that's by no means a complete list of...
info_outlineNeural Implant podcast - the people behind Brain-Machine Interface revolutions
Mark Domyahn is a partner at JD Lymon where they help companies develop healthcare strategies. They help companies understand their unique value proposition and optimize their market potential. Top 3 Takeaways: "the FDA writes zero checks. They give you a license to hunt, but they don't guarantee you kill anything" "What I'm hearing more and more is the first question out of investor's mouth isn't what's your FDA pathway, it's what's your reimbursement strategy. Because FDA is at least a somewhat known entity. And they're the last entity that will tell you as a company "if you do this...
info_outlineNeural Implant podcast - the people behind Brain-Machine Interface revolutions
is the Vice President of Neurology Regulatory Affairs at MCRA where he helps neurotech companies get through the challenges of being approved by the FDA. Tim has had over 16 years in the regulatory side of things before now advising the companies. Top 3 Takeaways: "A big part of what I'm doing right now. It's trying to help them figure out, okay. What are you trying to do? How can I help you put that in FDA's language and language that FDA is going to understand?" "I think probably the biggest success is that Applied VR got their Denovo granted just a few weeks ago. We supported them...
info_outlineDr Marc Russo is the president of the International Neuromodulation Society which is a nonprofit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation. Dr Russo runs a large multidisciplinary pain clinic in Australia. He has conducted a number of first-in-man studies of novel neuromodulation implants as well as designing unique leads and waveforms in spinal cord stimulation (SCS).
Top 3 Takeaways:
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"Over more than a 20 year journey now we understand that these patients are best treated early rather than later. The best traded with as close to zero levels of opioids. And that doses higher than 40 milligrams per day, actually worsen outcomes for spinal cord stimulation,"
- "High dose exogenous opioid prescription can actually induce epigenetic change in the genome of a patient so that even if you remove something such as opioids after five years, the body doesn't return to its former expression of proteins and then maybe actually permanent changes that may have worse outcome."
- "What's in a book is not sacrosanct and that you need to not just blindly apply something that you read in a book and think that it was, descended from the tablets of Moses. You actually need to think of what are you doing and does that apply to this particular patient?"
0:45 "And do you want to introduce yourself?"
1:45 "What changes have you seen?"
3:45 "In bioelectronic medicine it's beneficial to have a combination of drugs and stimulation, but you're saying that's the opposite in pain? Is it something like a numbing effect or what's the justification that you found for this?"
5:45 "Is opioid something that lingers?"
7:30 "What are some other trends that you've noticed along your 20 years of working in the field?"
10:00 "So the stimulation is not something that's there forever that they're going to have to manage forever?"
11:30 What's it like running a clinical trials unit?
13:30 "What's the pain clinic, like what's the makeup of this and do hospitals send people to you or how does it work?"
15:15 "What would be the advantage of doing a clinical trial in Australia?"
16:30 "What's that process like, a clinical trial, and how long, how many patients are involved?"
19:00 "What would be a good clinical trial versus a bad clinical trial?"
24:00 "Is there anything that we didn't talk about that you wanted to mention?"