Lead Faculty
Candice Burns, RAC, manager, regulatory affairs, Boston Scientific Inc., manages specialists who support the development and approval of novel peripheral products within the Peripheral Interventions Division at Boston Scientific Corporation, a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Burns has more than 12 years research and development and regulatory experience within the medical device industry.
Sharon Timberlake, MS, RAC, CCRA, director, regulatory affairs, Palomar Medical Technologies Inc., focuses her energies on the development and approval of light and laser technology for cosmetic and general surgery applications worldwide. Timberlake has practiced exclusively in the area of clinical, quality and regulatory affairs for medical device companies for the past 15 years. She is certified in both regulatory and clinical research and received her master's degree in clinical health sciences. She began her career as a clinical research associate for Summit Technology Inc., where she worked on clinical trials that gained FDA premarket approval for the first laser system to treat nearsightedness. Timberlake also spent more than four years developing clinical trials used to support clearance of a breast mapping device at, Assurance Medical, a small start-up company. Timberlake has also overseen IDE clinical studies, developed the quality system policies and procedures for both US and European operations and obtained marketing clearance for embolic materials.
Confirmed Speakers
Antoinette Azevedo, president, e-SubmissionsSolutions.com, founded the organization in an effort to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting life sciences practice. Azevedo's experience ranges from developing strategies for document management and electronic publishing, to implementing fully-validated systems accepted by regulatory authorities worldwide.
Laura Byrd, MS, electrical engineer, Center for Devices and Radiological Health’s Office of Device Evaluation (ODE) is a member of ODE’s Premarket Authorization (PMA) staff. She not only develops and interprets PMA policies, regulations and guidance documents, but also oversees incoming and outgoing PMA documents, ensuring that approval is complete, scientifically sound and in compliance with all regulations. Previously, Byrd was a senior scientific reviewer in the Division of Reproductive, Abdominal, and Radiological Devices in ODE, responsible for reviewing 510(k), IDE and PMA submissions. Byrd holds a master’s degree in medical engineering from The George Washington University.
Lynn Henley, MS, MBA, serves on the Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) staff within the Office of Device Evaluation at the Center for Devices and Radiological Health (CDRH). Henley also has experience in the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Office of the Commissioner. She is a member of the Clinical Expert Review Committee, a CDISC representative for CDRH, and is active in transparency initiatives. She holds master's degrees in biotechnology and business from Johns Hopkins University.
David R. Kalins, consumer safety officer, special assistant to the director, Office of Compliance (OC), CDRH, FDA, has served in the Office of the Director since 1995. His primary duties include serving as OC’s case expert and field liaison, coordinating CDRH communications with FDA’s field force including the Device Field Committee. He also is responsible for managing the center’s Accredited Person’s 3rd Party inspection program. Prior to his current position, Kalins was a supervisor in the Center’s Division of Bioresearch Monitoring. His branch was responsible for special investigations and monitoring the data quality of clinical research used to support the safety and efficacy of medical devices in several different fields including, cardiology, neurology, urology, and radiology. Prior to that he worked as a case management specialist and is experienced in criminal investigations. Kalins started his career with the FDA in 1977 as a field investigator for the Baltimore District Office.
Angela Krueger, regulatory advisor, product jurisdictional officer, Center for Devices and Radiological Health’s Division of Cardiovascular Devices (DCD), is responsible for a variety of device areas, including inferior vena cava (IVC) filters, iliac stents, venous devices and coronary drug-eluting stents and balloons. In addition to her review work, Krueger also participates on several center-wide working groups as a subject matter expert (SME) regarding the review of Premarket Approval (PMA) applications, including electronic submission and review of PMAs.
Eugene Reilly is a public health analyst in FDA’s Center for Devices and Radiological Health (CDRH) Office of Surveillance and Biometrics and works on the systems (and the policies that drive them) that process, display, and analyze medical device adverse event information. Additionally, he also maintains the CDRH Event and Evaluation Codes used in MDRs. Reilly began his career with FDA in the Office of In Vitro Diagnostic Device Evaluation and Safety as a clinical reviewer and compliance officer. Prior to and during his time with FDA, he is a programmer focusing on XML, Python, and Java for databases, web based applications, and computer graphics.
Jeffrey Shapiro, JD, director, Hyman, Phelps & McNamara PC, represents healthcare product companies on FDA-related matters, advising them on a wide variety of issues in the areas of medical devices, combination products and human tissue products, including product approvals, marketing, clinical studies, jurisdictional issues, and enforcement. Shapiro is the co-editor of Promotion of Biomedical Products, a textbook on FDA's regulation of promotion and advertising published by the Food and Drug Law Institute (FDLI); he authored two chapters of this textbook. Shapiro is also the co-author of the book, Combination Products: How to Develop the Optimal Strategic Path for Approval (FDA News 2005). Shapiro writes for Regulatory Focus, Medical Device and Diagnostic Industry (MDDI), the Food and Drug Law Journal, and the Food and Drug Law Institute's (FDLI) Update. Shapiro is on the Editorial Advisory Board of MDDI and Update magazines. Prior to joining HPM, he was a partner in the FDA practice group at Hogan & Hartson. Shapiro holds a JD cum laude from Harvard Law School. He is admitted to practice law in the District of Columbia, California and Pennsylvania.
Marjorie Shulman, RAC, consumer safety officer, Center for Devices and Radiological Health’s Office of Device Evaluation (ODE), has served at CDRH for more than 15 years as an expert on the Premarket Notification Staff (510(k)), which is also responsible for classification and reclassification programs. She is the project officer for ODE and the Office of Communication, Education and Radiation Programs Document Control Centers and CDRH's mailroom. Shulman has worked on numerous policy setting groups within FDA, the most recent being the enactment of the Medical Device User Fee Modernization Act. Shulman holds an MBA from Hood College.
Julie “Brandi” Stuart is the branch chief of the Information Analysis Branch for the Center for Devices and Radiological Health’s Office of Surveillance and Biometrics (OSB). Stuart began her career at FDA 19 years ago. Prior to becoming branch chief she served as a consumer safety officer in the Office of Device Evaluation's Premarket Notification (510(k)) Staff). Her program experience includes medical device premarket programs (device premarket submission regulations and policies, medical device classification, Good Guidance Practices, reprocessed single-use devices). Stuart has served in the Center’s Office of Compliance as a consumer safety officer as well. Her program experience there includes medical device post-market and inspectional programs (quality system regulations, foreign and domestic inspection programs).
Matthew J. Tarosky, RPh, PharmD, EJD, CCRP, is deputy director and special assistant to the director of the Division of Bioresearch Monitoring, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration (FDA). His primary responsibilities relate to the programmatic oversight of clinical and nonclinical inspections of medical device research. He holds a doctorate in pharmacy from the University of Arkansas for Medical Sciences and an Executive Juris Doctor (health law concentration) from Concord University School of Law. He is licensed to practice pharmacy in California, Maryland and Pennsylvania and successfully completed certification as a clinical research professional. His 20 years of service with the US Public Health Service has included various assignments with FDA, including 12 years with the agency’s bioresearch monitoring program.