Archives: Speakers

Seth A. Kaufman, MSHCA, CCRA, is the Sr. Director, Clinical Affairs at Axonics Modulation Technologies. Axonics Modulation Technologies, Inc. (NASDAQ:AXNX) is a medical technology company focused on the design, development, and commercialization of innovative and minimally invasive sacral neuromodulation (“SNM”) solutions. SNM therapy is primarily used to treat patients with overactive bladder (“OAB”), fecal incontinence (“FI”) and urinary retention (“UR”). Axonics currently has marketing approvals in Europe, Canada, and Australia for OAB, FI, and UR. He has 20+ years of life science industry experience focusing on clinical research. He has worked for numerous sponsors as well as consulting for a “Big 4”. He also has past experience with epidemiological research with the US Department of Defense. He has deep knowledge and demonstrated experience with: Good Clinical Practices; ICH; and 21 CFR Parts 50, 54, 56, 312 and 812 as well as established practice with key tools, processes and procedures for clinical operations of many therapeutic areas for complex clinical trials.

Tenley Koepnick has worked in the clinical trial industry for more than 30 years.  She is the Sr Director, Global Clinical Operations for Transcather Heart Valves at Edwards Lifesciences, Inc based in Irvine, CA and manages a global team of 100+ people across many different clinical and operational disciplines. Tenley is passionate about getting needed heart valve treatments to all patients and improving access to clinical trial participation for women.  Her work focuses on delivering exceptional service to clinical trial sites and vendors and ensuring high quality trial results for the advancement of cardiovascular health.  Tenley’s creative side surfaces in her big-picture, out-of-the-box thinking.  When she’s not executing trials, she can be found enjoying the outdoors or designing interior spaces.