YourEncore, a provider of proven expertise for the biopharma, medical devices & diagnostics, and consumer goods industries, is bringing together a group of high-profile executives to lead its Medical Devices & Diagnostics Practice.
Leaders of the YourEncore Medical Devices & Diagnostics Practice will leverage their deep knowledge of the regulatory, quality, clinical, and supply chain landscape in the medical devices and diagnostics industry. The team has senior-level executive leaders, each with an average of 20 years of experience in medical devices and diagnostics. YourEncore also has a robust network of more than 250 medical devices professionals in its practice to provide experienced counsel and support for client engagements.
Baylor-Henry is the former Worldwide Vice President of Regulatory Affairs for Johnson & Johnson (J&J) Medical Devices and Diagnostics where she was directly responsible for coordinating the regulatory strategy for the approval of a wide portfolio of products globally, ranging from contact lens to sterilization products. She also worked for the U.S. Food & Drug Administration (FDA), where she served as the FDA’s National Health Fraud case coordinator and the Director of the Division of Drug Marketing, Advertising, and Communications. Baylor-Henry received her Pharmacy degree from Howard University’s College of Pharmacy and her law degree from Catholic University’s Columbus School of Law.
Others joining the practice as Strategic Advisors include:
- Donna Godward, M.B.A., previously Chief Quality Officer for J&J Medical Devices and Diagnostics, where she provided strategic direction and oversight for all areas of quality and regulatory compliance across the global Medical Devices & Diagnostics business sector. She partnered with the sector’s Company Group Chairmen, the Vice President of Global Medical Devices & Diagnostics Supply Chain and the Chief Science & Technology Officer to assure end-to-end quality and regulatory compliance, from development through manufacturing, distribution and end-customer use. Prior to joining J&J, Godward held positions in quality, regulatory and operations with Merck, Bristol Myers Squibb, and Steris Corporation. She earned a B.A. in Biological Sciences from Indiana University and a M.B.A from Washington University.
- Judith Meritz, J.D., previously Associate General Counsel at Covidien/Medtronic. Meritz specializes in compliance counseling concerning FDA and other international regulatory authority matters including inspections, enforcement actions, product approval strategies, marketing and advertising programs, quality control, and complaint handling. She also served as Assistant General Counsel for the American Red Cross (ARC) with emphasis on compliance with the FDA amended Consent Decree. Previously, she held senior regulatory positions at E-Z-EM, Inc., and Henry Schein, Inc. and was the medical devices practices leader for two major Washington D.C. law firms. She currently serves on the Advisory Board of Bloomberg BNA Medical Devices and Industry Report. Meritz received her B.A. from American University, dual master degrees in Higher Education and Political Science from the University of Michigan, and her law degree from Pace University School of Law.
- Victor (Vic) Chance, previously Vice President of External Operations and Chief Supply Chain Procurement Officer for J&J Medical Devices and Diagnostics. There he was responsible for the external supplier network and all associated performance improvement initiatives. Chance also served as Worldwide Vice President of Operations for J&J’s Cordis franchise, responsible for directing the company’s global manufacturing, supply chain management, and strategic sourcing functions. The Cordis Operations organization introduced the breakthrough Cypher drug eluting stent and received the Shingo Prize for Manufacturing and was a two-time winner of Industry Week’s “America’s Best Plants” award. Chance also served as Vice President of Worldwide Operations for Ortho-Clinical Diagnostics, responsible for supply chain, distribution, and field service functions. He received his B.S. in Aviation Management from Auburn University and his master’s degree in Engineering Management from the University of Bridgeport.
- Janet M. Vargo, Ph.D., previously Board Member and Head of Clinical and Regulatory Affairs for Mentor, LLC, a J&J Company. For J&J’s Medical Devices and Diagnostics sector, in the Office of the Chief Medical Officer, Dr. Vargo was responsible for sector-wide clinical trial design, device and biologics safety analyses, due diligence efforts, and regulatory strategy for new-to-the-world products. Dr. Vargo also served as head of Health Informatics and the Independent Review Program where she brought enterprise-wide experts together to evaluate development and commercial plans for key, high-risk J&J products to improve probability of regulatory and commercial success. Dr. Vargo earned her doctorate in Behavioral Neuroscience at Miami University, Oxford, Ohio, with emphases in mechanisms of recovery of function after brain injury, statistics, and experimental design.