Janet M. Vargo

Throughout her 17-year career in the medical products industry, Dr. Vargo has advised companies and negotiated with regulatory bodies on clinical trial designs and regulatory strategies for innovative, state-of-the-art devices, diagnostics, biomarkers, biologics, and combination products. She has managed global clinical and regulatory operations both through internal teams and outsourced models. Dr. Vargo has planned and executed major organizational changes resulting from mergers, acquisitions, or outsourcing. In addition to designing and executing pivotal clinical studies, she evaluates early phase clinical and non-clinical data to help inform pivotal study designs, and evaluates new business opportunities from clinical, regulatory, and key stakeholder adoption perspectives. In addition to her role at Carmell Therapeutics, Dr. Vargo serves as a Strategic Advisor of Clinical Development & Regulatory Affairs in the Medical Device Practice of YourEncore™, a leading provider of resource and consulting services in the Life Sciences space. From 2012 to 2015 Dr. Vargo was Board Member and Head of Clinical and Regulatory Affairs for Mentor, LLC, a Johnson & Johnson Company.

Prior to her work at Mentor she advised on clinical trial design, device and biologics safety analyses, due diligence efforts, and regulatory strategy for new-to-the-world products for the entire Johnson & Johnson Medical Device and Diagnostic sector from 2011 to 2015. In her corporate Johnson & Johnson position, Janet originated and led a Johnson & Johnson enterprise-wide program to leverage the company’s vast internal expertise to benefit higher-risk, novel product development efforts. This Independent Review Program helped to develop Johnson & Johnson’s talent and improved the probability of success for business-critical development programs. Janet obtained her doctorate in Behavioral Neuroscience at Miami University of Ohio, with emphases in mechanisms of recovery of function after brain injury, statistics, and experimental design.