Oct 4, 2021

Dr. Ludwig leads the Bioelectronic Medicines Laboratory at the University of Wisconsin, with the goal of developing next-generation neuromodulation therapies that use minimally invasive strategies to highjack the nervous system to treat circuit dysfunction and deliver biomolecules to target areas with unprecedented precision.

Prior to Wisconsin, Dr. Ludwig served as the Program Director for Neural Engineering at the National Institutes of Health. He co-led the Translational Devices Program at NINDS, led the NIH BRAIN Initiative programs to catalyze implantable academic and clinical devices to stimulate and/or record from the central nervous system, and led a trans-NIH planning team in developing the ~250 million dollar S.P.A.R.C. Program to stimulate advances in neuromodulation therapies for organ systems.

Dr. Ludwig also worked in Industry as a research scientist, where his team conceived, developed, and demonstrated the chronic efficacy of a next-generation neural stimulation electrode for reducing blood pressure in both pre-clinical studies and clinical trials. Through his industry work, he oversaw Good Laboratory Practice (GLP) and non-GLP studies enabling clinical trials in Europe and the United States, as well as participated in the protocol development and execution of those trials, leading to approval for sale in seven countries and a U.S. Pivotal trial.

Top 3 Takeaways

• "We actually don't definitively know what we're stimulating for effects in most of our largest markets for neuromodulation therapy.
• "Don't ever date electrical stimulation. It will cheat on you. It's very promiscuous. It also creates a lot of effects in non-neuronal cells. That may be important... electrical stimulation is very dirty. There's no way around it"
• "A lot of things we don't consider as one of the startup company fails. Now we've got a piece of hardware in my neck and I've got nobody who knows how to maintain it."

1:00 "Do you wanna introduce yourself?"

2:00 You've been in academia, industry, and government, what's that like?

5:00 "Before we started recording, you were talking about, drug-resistant drug coatings on neural devices. Why might not that be a good one?"

12:30 "Everybody uses rat models, but that might not be very accurate because humans and rats are different, right?"

15:00 "So what's the solution? Use more human testing?"

18:30 "What's the solution. How did people gain this perspective?"

22:45 "Is this something that we need to wait for AI to be able to solve?"

26:45 "But is that bad? So for me, I'm more engineering-minded, more practical. It's just if it works, it works, right?"

33:45 "The small percentage that makes it through the phase one and I wonder how many, good therapies were out there that just because of chance, fell through.?"

37:15 "So we have to redo statistics, is that what you're saying?"

37:45 " Is there anything that we didn't talk about that you wanted to mention?"