Presented By: Biomedical Engineering
Next-Generation Bioelectronic Medicines: Crossing the Valley of Death
Kip A. Ludwig, Ph.D.
BME welcomes Faculty Candidate
Kip A. Ludwig, Ph.D.
Associate Director of Mayo Neural Engineering Laboratories
Mayo Clinic Hospital, Rochester MN
Monday, Oct. 30, 2017
9:00 – 10:00 a.m.
1123 LBME
“Next-Generation Bioelectronic Medicines: Crossing the Valley of Death”
ABSTRACT: Bioelectronic Medicine is an emerging field that capitalizes on minimally-invasive technology to stimulate the autonomic nervous system in order to evoke therapeutic biomolecular changes at the end-organ. In this seminar Dr. Kip Ludwig will discuss his unique experience spanning industry, government, and academia in translating Bioelectronic Medicines from initial proof-of-concept on the bench to commercially approved clinical therapies. Based on this experience he will describe his vision for establishing ‘parallel translation’ to accelerate the integration of new Bioelectronic Medicines into routine clinical practice. Parallel translation is predicated on 1) using bleeding-edge high-resolution technologies in small animal models to provide mechanistic understanding of neuromodulation therapies, 2) conducting experiments in high-throughput large animal models to better understand design issues of anatomical scale that uniquely impact neuromodulation therapies and 3) taking advantage of existing human surgical opportunities that provide access to the nervous system to quickly and safely obtain human data. Performing these three steps ‘in parallel’ is required to more efficiently cross the proverbial ‘valley of death’ for device translation, by simultaneously addressing key unknowns in the business case necessary to obtain funding for advanced clinical trials.
Dr. Ludwig currently serves as the Associate Director of the Mayo Neural Engineering Laboratories (NEL) and leads the Bioelectronic Medicines Laboratory within the NEL. Prior to Mayo Dr. Ludwig served as the Program Director for Neural Engineering at the National Institutes of Health (NIH). He co-led the NIH CREATE Devices translational program, led the NIH translational programs under the White House BRAIN Initiative, and led a trans-NIH planning team in developing the ~250 million dollar SPARC Program to stimulate advances in neuromodulation therapies for organ systems. Dr. Ludwig also worked in the neuromodulation industry as a research scientist where he conceived, developed and demonstrated the chronic efficacy of a next-generation minimally-invasive stimulation device to treat hypertension and heart failure. Through his industry work he oversaw Good Laboratory Practice (GLP) and non-GLPstudies enabling clinical trials in Europe and the United States, as well as participated in the protocol development and execution of those trials. Dr. Ludwig’s device is now approved for sale in seven countries and has progressed to a Phase III ‘Pivotal’ trial in the United States for FDA approval. Based on the European data, his electrode concept was awarded LifeScience Alley’s ‘Life-Saving Breakthrough of the Year’ in 2014.
Kip A. Ludwig, Ph.D.
Associate Director of Mayo Neural Engineering Laboratories
Mayo Clinic Hospital, Rochester MN
Monday, Oct. 30, 2017
9:00 – 10:00 a.m.
1123 LBME
“Next-Generation Bioelectronic Medicines: Crossing the Valley of Death”
ABSTRACT: Bioelectronic Medicine is an emerging field that capitalizes on minimally-invasive technology to stimulate the autonomic nervous system in order to evoke therapeutic biomolecular changes at the end-organ. In this seminar Dr. Kip Ludwig will discuss his unique experience spanning industry, government, and academia in translating Bioelectronic Medicines from initial proof-of-concept on the bench to commercially approved clinical therapies. Based on this experience he will describe his vision for establishing ‘parallel translation’ to accelerate the integration of new Bioelectronic Medicines into routine clinical practice. Parallel translation is predicated on 1) using bleeding-edge high-resolution technologies in small animal models to provide mechanistic understanding of neuromodulation therapies, 2) conducting experiments in high-throughput large animal models to better understand design issues of anatomical scale that uniquely impact neuromodulation therapies and 3) taking advantage of existing human surgical opportunities that provide access to the nervous system to quickly and safely obtain human data. Performing these three steps ‘in parallel’ is required to more efficiently cross the proverbial ‘valley of death’ for device translation, by simultaneously addressing key unknowns in the business case necessary to obtain funding for advanced clinical trials.
Dr. Ludwig currently serves as the Associate Director of the Mayo Neural Engineering Laboratories (NEL) and leads the Bioelectronic Medicines Laboratory within the NEL. Prior to Mayo Dr. Ludwig served as the Program Director for Neural Engineering at the National Institutes of Health (NIH). He co-led the NIH CREATE Devices translational program, led the NIH translational programs under the White House BRAIN Initiative, and led a trans-NIH planning team in developing the ~250 million dollar SPARC Program to stimulate advances in neuromodulation therapies for organ systems. Dr. Ludwig also worked in the neuromodulation industry as a research scientist where he conceived, developed and demonstrated the chronic efficacy of a next-generation minimally-invasive stimulation device to treat hypertension and heart failure. Through his industry work he oversaw Good Laboratory Practice (GLP) and non-GLPstudies enabling clinical trials in Europe and the United States, as well as participated in the protocol development and execution of those trials. Dr. Ludwig’s device is now approved for sale in seven countries and has progressed to a Phase III ‘Pivotal’ trial in the United States for FDA approval. Based on the European data, his electrode concept was awarded LifeScience Alley’s ‘Life-Saving Breakthrough of the Year’ in 2014.
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