Welcome and Introduction
Reimbursement: Understanding Key Concepts to Maximize Business Success
Tom Hughes, Senior Principal Advisor, RCRI, Inc.
Tom Hughes is Sr. Principal Advisor at RCRI leading the strategic consulting organization’s health economics and reimbursement initiatives. Tom is a senior level executive and attorney, with nearly 20 years of experience in the medical technology industry, specializing in medical device reimbursement. He has built reimbursement teams for medical device companies, implemented payer relations programs , lobbied federal and state decision makers, and advised Senior Management as well as Sales, Marketing and Clinical on development of reimbursement/health economic strategies and business development. Prior to his work in the medical technology industry, Tom practiced healthcare law with a major Minneapolis law firm where he represented physicians, hospitals and other providers.
Initiating Regulatory & Quality
Carol Ryerson, Senior Principal Advisor, RCRI, Inc.
Carol Ryerson is currently a Senior Principal Advisor at RCRI, Inc. She has 30 years of experience in the medical device and diagnostic industry and has held senior positions in Regulatory and Clinical Affairs at Eastman Kodak, Ortho Clinical Diagnostics, Genzyme Diagnostics and Sekisui Diagnostics. She holds a Bachelor’s degree in Chemistry from the College of the Holy Cross, and a Ph. D. in Biochemistry from M.I.T. (Massachusetts Institute of Technology). In her consulting practice, she assists clients with developing global regulatory strategies, negotiating with FDA, and preparing for and executing premarket submissions to the FDA, EU and other international authorities. Dr. Ryerson was recently elected to a three-year term on the board of the Association of Medical Diagnostics Manufacturers.
Pi (π) Day IP: Creating a Well-Rounded Intellectual Property Strategy
Heather B. Repicky, Partner, Nutter
Heather B. Repicky is a partner in the Litigation Department and a member of the firm’s IP and Patent Litigation practice group. She focuses her practice on civil litigation, with an emphasis on IP and complex commercial matters. Heather represents clients in all stages of the litigation lifecycle—pre-trial, trial, and appeal—in both state and federal courts. Because Heather spends the majority of her practice litigating IP cases, she has a depth of knowledge on patent, trademark, copyright, and trade secret issues facing companies both large and small. This knowledge, combined with her strategic thinking, garners positive results for clients.
Derek Roller, Partner, Nutter
Derek Roller is a partner in Nutter’s Intellectual Property Department who has a wide range of experience spanning both patent prosecution and contested proceedings. Clients rely on Derek to help them navigate through patent and trademark application preparation and prosecution, as well as more specialized procedures, such as inter partes review, reexamination, and litigation. Derek is also well-versed in a variety of other IP projects, including strategic portfolio planning, preparing opinions on patent infringement and validity, as well as conducting freedom to operate and inventorship studies.