Overview
Join FDLI as we launch our newest book, How FDA Really Works: Insights from the Experts. Hear directly from many of the authors and the co-editors, who will highlight their best tips and tactics for how to get the most out of your relationship with FDA. This is a first-of-its-kind book, providing information and expertise to help navigate the complexities of myriad FDA processes across regulated industries. At this event, the authors will provide their insights and observations for effectively communicating with the agency on items ranging from product applications to regulatory compliance and policy matters, with ample opportunity to ask questions.
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How FDA Really Works: Insights from the Experts
Edited by Wayne L. Pines and Jessica L. Zeller, with 24 chapters from contributing authors
For those seeking to navigate a product application, address a regulatory issue, or establish or change a policy, success in navigating the Food and Drug Administration maze can be formidable. In a first-of-its-kind book, authors who are top experts in their fields share their essential insights from their experiences interacting with FDA—or as FDA employees themselves—to help illuminate the complexities of the regulatory process and provide observations for effectively communicating with the agency.
Speakers
James N. Czaban, Chairman, FDA Practice Group, Loeb & Loeb LLP
Wayne L. Pines, APCO Worldwide
Anand Shah, Leonard Davis Institute of Health Economics, University of Pennsylvania
Nicole Taylor Smith
Jessica L. Zeller, Edwards Lifesciences
JAMES N. (JIM) CZABAN is a partner at Loeb & Loeb LLP and has 30 years of food and drug law experience, having advised leading companies in virtually every FDA-regulated industry on matters of regulatory strategy, compliance, and FDA enforcement actions. Jim has been recognized as a Global Elite Thought Leader in life sciences law by Who’s Who Legal-Life Sciences and is the author of numerous publications in this field. Throughout his career, Jim has contributed substantially to the mission of FDLI through his volunteer efforts, including service on FDLI’s Audit Committee, the Thomas Austern Writing Awards Committee, as co-chair of FDLI’s Annual Conference, as co-author of the new drug approval chapter in FDLI’s food and drug law treatise, and as a speaker at dozens of FDLI conferences. He is a graduate of the University of Virginia School of law and the University of California, Berkeley.
WAYNE L. PINES is co-editor of this book, is a member of APCO Worldwide’s International Advisory Council and is president of health care at APCO. He provides strategic counsel to companies and organizations facing crisis situations and communications and regulatory or policy challenges, especially those involving FDA-regulated products. Pines served ten years at FDA as chief of consumer education and information, chief of press relations, and associate commissioner for public affairs. He was the chief media spokesman for FDA for seven years and was the founding editor of FDA Consumer magazine. He has authored or edited 15 books about regulatory issues, crisis communications, and the FDA, including about the product approval processes, FDA’s regulation of medical communications, and the history of FDA. He is widely published and frequently quoted in the media. In 2020, he served as a consultant to the FDA commissioner on COVID-19. Pines was a director and former chairman of the MedStar Health Research Institute, which oversees research at ten hospitals in the Washington–Baltimore area. He is a founder, director, and former president of the Alliance for a Stronger FDA; a founder of the FDA Alumni Association; a member of the Public Health Service’s first Task Force on AIDS Education; executive vice president of a large, international public relations agency; chairman of a health care market research firm; and a member of the Executive Committee of the Regional Board of the Anti-Defamation League.
ANAND SHAH is an Adjunct Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania. He is an Operating Advisor to Clayton, Dubilier & Rice. Dr. Shah served as the Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration. He was Senior Medical Advisor at the Centers for Medicare & Medicaid Services (CMS) and Chief Medical Officer of the CMS Innovation Center. Dr. Shah earned an MD from the University of Pennsylvania, MPH in health care management and policy from the Harvard School of Public Health, and a BS in economics from Duke University. He is on the board of directors of Adagio Therapeutics, Big Health, Hero, and M2Gen.
NICOLE TAYLOR SMITH is a recognized expert in U.S. and international medical device/medtech/pharma and digital health regulatory law and policy. From 2008–2016, she served in various roles at FDA, including Associate Chief Counsel, Office of the General Counsel, HHS, and Acting Deputy and Assistant Country Director in FDA’s Beijing, China, office. In the private sector, her roles include Vice President, Global Regulatory Policy, Medtronic, and Senior Director, Global Policy & Intelligence, Johnson & Johnson. Nicole started her career at the law firm King & Spalding, where she counseled clients on FDA regulatory and compliance matters and served as regulatory counsel in major products liability litigation.
JESSICA L. ZELLER, co-editor of this book, is Vice President – Quality, Regulatory, and Public Affairs Counsel at Edwards Lifesciences based out of Irvine, CA. Edwards is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Jessica routinely counsels on global medical device regulatory compliance matters and quality systems concerns, including interacting with government regulators. She was previously FDA’s inaugural ORA Ombudsman, focusing on problem-solving with respect to FDA’s field offices, including inspections, imports, and other agency processes and procedures. Additionally, Jessica has served as the Deputy Director of Compliance and Enforcement for FDA’s Center for Tobacco Products, as a litigation attorney in FDA’s Office of Chief Counsel, and as the lead FDA lawyer for Procter & Gamble. Jessica holds a JD/MA (Bioethics) from University of Virginia and a BS (Biology) from Xavier University. She approaches life with curiosity, generally asking three too many questions and ascribing to the motto that “good enough isn’t.” She is currently living in Southern California and watching in awe as her two daughters find their way in the world with grace, poise, and completely appropriate boldness and humility.Virtual Learning FAQ
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