FDA TPLC Advisory Program (TAP): Piloting a New Approach

NOTE: This webinar has been indefinitely postponed. 

The FDA’s Center for Devices and Radiological Health (CDRH) launched the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to help spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health. TAP’s primary goal is to expedite patient access to innovative medical devices by providing early, frequent, and strategic communications with the FDA and by facilitating engagement with other key parties for developers of devices of public health importance. To achieve this goal, a dedicated cadre of FDA TAP Advisors proactively provide solutions-focused engagement that is tailored to each TAP Innovator’s needs in advancing devices to market and patient access. In this seminar, FDA TAP Advisors will discuss this pilot program and provide participants input on when in their regulatory journey TAP may be an option for them. 

ABOUT THE SPEAKERS:

Kimberly Knish, MS, CCRP, RAC
Kimberly is a TAP Advisor within FDA’s Center for Devices and Radiological Health, Total Product Life Cycle (TPLC) Advisory Program (TAP). In this role, she establishes and cultivates a wide network of synergistic relationships across the entire medical technology innovation ecosystem and integrates ecosystem, sponsor, and lead reviewer input into strategic planning options intended to reduce stakeholder risk and maximize the opportunities of timely commercial rollout and sustainable patient access. She brings to the FDA 30 years of medical technology industry experience within clinical affairs, regulatory affairs, health economics, reimbursement and quality systems. She has been involved with all phases of medical device development (concept through obsolescence) involving device types from Class III implantables to wearables and remote monitors. Therapeutic expertise spans cardiovascular, nervous, digestive, endocrine, respiratory, and skeletal systems. Kimberly holds a B.A. degree in Biology from the College of St. Benedict, a M.S. degree in Management from Cardinal Stritch University and has professional certifications in clinical research (CCRP) and regulatory affairs (RAC).

April Marrone, PhD, MBA
April is a Senior Advisor in the FDA/CDRH Total Product Lifecycle Program (TAP) since November 2023. Prior to her current role, April has served on the Obesity and Hepatobiliary Devices Team as the acting Assistant Director, Team Lead, Lead Reviewer, and chemistry consultant since 2014. In addition to supervisory, leadership, and medical device review responsibilities, April has promoted improvement in product manufacturing and quality through developing device specific FDA guidance documents, creating review tools to ensure consistency and quality in device review, and publishing external manuscripts on topics relevant to the FDA and industry on topics in the obesity and hepatobiliary device space. April has served as a Commissioner Fellowship Program (CFP) preceptor, mentor to new reviewers and advisors, and has developed and instructed Reviewer Certification Program courses. 

Prior to joining CDRH in 2014, April was a Commissioner Fellow at FDA’s National Center for Toxicology Research (NCTR) and has served on the CFP Advisory Board. During her tenure at the NCTR, April did research to develop novel epigenetic approaches to safely assess the safety and carcinogenicity of FDA regulated products. Prior to joining the FDA, April was a post-doctoral scientist at the University of Pittsburgh, Children’s Hospital of Pittsburgh where she studied epigenetic regulation of congenital kidney disease in a mouse model. April also completed post-doctoral training at the Max Planck Institute for Biophysical Chemistry where she studied genetic and epigenetic regulation of neuromuscular disease. April has a PhD in Chemistry and BS in Physics from the University of Central Florida and an MBA from Florida Institute of Technology.