Biographies


EXECUTIVE COMMITTEE

Chair

PHILIP KATZ is a Partner in the law firm of Hogan Lovells in Washington, DC, and Practice Area Leader of the firm's pharmaceutical and biotechnology practice group. His practice focuses primarily on advising companies, trade associations, and individuals in matters arising from Food and Drug Administration (FDA) regulation of drugs (prescription and over-the-counter) and biologics. He helps clients anticipate and address regulatory issues in their day-to-day business operations and strategic planning, and advocates on their behalf at FDA, before state agencies and in court. His practice includes a particular focus on issues involving product development, approval, and life cycle management (including application of the Hatch-Waxman Act and the Biosimilars Price Competition and Innovation Act), responding to agency enforcement activities, and counseling in business transactions. Before practicing law, he was a legislative staff member in the U.S. House of Representatives and a lobbyist. Mr. Katz received his BA with distinction from the University of Virginia and his JD, magna cum laude, Order of the Coif, from Georgetown University Law Center.

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Vice Chair

SHEILA M. HEMEON-HEYER, RAC is the Founder and President of Heyer Regulatory Solutions LLC, providing global regulatory submission and compliance consulting services to the medical device industry. Ms. Heyer has 25 years of experience in Regulatory Affairs, beginning at FDA where she was a Scientific Reviewer in the CDRH Office of Device Evaluation and was responsible for reviewing 510(k), IDE and PMA applications for orthopedic, physical medicine and surgical devices. After leaving FDA, Ms. Heyer was Director of Regulatory Services for Medical Device Consultants, Inc. (MDCI), providing regulatory, clinical and quality consulting services to the medical device industry and managing complex projects across the medical product lifecyle. She joined Boston Scientific Corporation (BSC) in April, 2005 as Vice President, Global Regulatory Affairs, where she was responsible for worldwide regulatory strategies and execution. Ms. Heyer holds a BS in Biomedical Engineering from Boston University, an MS in Biomechanics from the University of Massachusetts at Amherst and a JD from Western New England College School of Law. She is Regulatory Affairs Certified, a Fellow of the Regulatory Affairs Professional Society and serves on the Board of Directors for The Food and Drug Law Institute (FDLI).

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Immediate Past Chair

ELIZABETH H. ANDERSON is Executive Vice President-Legal and General Counsel for the Personal Care Products Council (PCPC). She is responsible for handling legal and regulatory issues facing the industry. Ms. Anderson also serves as PCPC's staff liaison to the Legal Executive Committee, the group responsible for guiding PCPC policy in the legal and regulatory areas. She has served as a member of the Editorial Advisory Board of the Food and Drug Law Journal and co-authored "The Cosmetics Regulatory Process" chapter in another publication by The Food and Drug Law Institute (FDLI). She currently serves as Vice Chair on FDLI's Board of Directors. Before joining PCPC, Ms. Anderson was responsible for the legal and regulatory affairs of Beiersdorf, Inc., a manufacturer of over-the-counter (OTC) drugs, medical devices and cosmetics in Norwalk, Connecticut. Ms. Anderson graduated with honors from Bowdoin College and received her law degree from Boston College Law School. Fluent in German, she spent two years at the Institute of European Studies in Vienna, Austria.

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Treasurer

PATRICIA B. SHRADER is Senior Vice President, Corporate Regulatory and External Affairs at Medtronic, Inc. Previously, she served as Senior Vice President, Corporate Regulatory and External Affairs for BD, a medical technology company. In this position, she was responsible for all regulatory activities within BD worldwide, as well as serving as the primary interface with agencies and trade associates. She also has responsibility for Government Relations/Public Policy, Communications/Public Relations and Social Investing. Prior to joining BD, Ms. Shrader was Counsel with the law firm of Hogan & Hartson (now Hogan Lovells), where her practice focused primarily on medical devices, with an emphasis on product submissions and GMP issues. Before joining Hogan & Hartson, she was the Director of Quality Assurance and Regulatory Affairs at Whittaker Bioproducts, Inc. Ms. Shrader serves on the Board of Directors for The Food and Drug Law Institute (FDLI). She is a frequent speaker at various professional meetings and is active in FDLI, AdvaMed, and RAPS. She has also contributed numerous articles to MDM Magazine and IVD Technology. Ms. Shrader received her JD from Georgetown University Law Center.

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Secretary and General Counsel

JEFFREY N. GIBBS is a Director in the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC. In this role, he advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Prior to entering private practice, he was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA). He has written extensively on FDA regulatory topics, and was previously Chair of the Editorial Advisory Board of the Food and Drug Law Journal. He is currently General Counsel of The Food and Drug Law Institute (FDLI) and a member of FDLI's Board of Directors. He is also on the editorial advisory board of IVD Technology, and was a member of the Human Subjects Research Board for George Mason University. Mr. Gibbs is a graduate of Princeton University and New York University School of Law.

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President & CEO

Amy Comstock Rick, J.D., is the President and Chief Executive Officer of the Food and Drug Law Institute, having joined in August, 2014.  Prior to joining FDLI, Ms. Rick was the Chief Executive Officer of the Parkinson’s Action Network (PAN) from 2003-2014.  PAN is a Washington D.C.-based national nonprofit focused on educating the public and government leaders on better policies for research and therapy development and an improved quality of life for people living with Parkinson’s disease.  Ms. Rick has also served as the President of the Coalition for the Advancement of Medical Research, on the Boards of Directors of Research!America, the National Health Council, and the American Brain Coalition.  Before joining PAN, she was the Senate-confirmed Director of the U.S. Office of Government Ethics from 2000-2003 and the Associate Counsel to the President in the White House Counsel’s Office from 1998-2000.  Ms. Rick began her federal service as a career attorney at the U.S. Department of Education in 1989 and became the Assistant General Counsel for Ethics in 1993.  Prior to her government service, Ms. Rick was an associate attorney at the law firm of Beveridge & Diamond.  She received a Bachelor of Arts degree from Bard College and a Juris Doctor degree from the University of Michigan. 

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AT-LARGE

STEVE H. ARMSTRONG is the Senior Food Law Counsel at Campbell Soup Company. He is responsible for counseling Campbell’s businesses around the world on food safety, labeling compliance and food policy. He advises Campbell’s U.S. businesses on compliance and policy matters involving the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), as well as food agencies in Europe and Asia. Mr. Armstrong came to Campbell in January 2007 from Energizer’s Schick-Wilkinson Sword Division, where he served as Senior Marketing Counsel. He has had over 18 years of experience in advising companies on marketing and regulatory matters, having previously worked as an Assistant General Counsel at Unilever United States, and Division Counsel at Colgate-Palmolive Company. Before beginning his in-house practice, Mr. Armstrong advised clients on commercial litigation and regulatory matters at the law firm of Townley & Updike in New York City. Prior to entering law school, he had over twelve years’ experience as a journalist, including a five-year stint as an editor at The Miami Herald. Mr. Armstrong received his Bachelor’s degree in history and literature from Harvard College and earned his JD from Columbia University.

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FREDERICK R. BALL is a Partner at the law firm of Duane Morris LLP in Chicago, IL. He is vice-chair of Duane Morris's White-Collar Government Regulatory Division of the Trial Practice Group and heads its Pharmaceutical, Pharmacy and Food Group. He focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters with the FDA, DEA, CMS and other federal and state regulatory agencies. Mr. Ball helps generic pharmaceutical companies, biologics manufacturers, food companies (including supplement manufacturers), pharmacies, long-term care providers and other health care providers navigate the complex challenges faced by state and federal regulation of their industries, including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, fraud and abuse laws including and labeling and advertising requirements. Mr. Ball also assists generic manufacturers bring products to market through patent analysis and Hatch-Waxman litigation. He is experienced in conducting internal investigations and advising companies on actions following the investigation. Finally, he helps companies maintain their trade secrets and competitive advantage through trade secrets litigation and enforcement of restrictive covenants. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financially and legally. In his spare time, he is an adjunct professor of law at DePaul University School of Law and serves on the FDLI Board. He is admitted to the Illinois State Bar, the Trial Bar of the U.S. District Court for the Northern District of Illinois, the Seventh Circuit and the U.S. Supreme Court. A member of the American and Illinois State bar associations, Mr. Ball is a 1996 cum laude graduate of Cornell Law School and a graduate of the University of Colorado at Boulder.

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BARBARA A. BINZAK BLUMENFELD, PhD is Counsel in the Food and Drug Administration and Pharmaceuticals practice at the law firm of Buchanan Ingersoll & Rooney PC in Washington, DC. She focuses her practice on clients whose products are subject to FDA regulations, which includes drugs, foods, dietary supplements, medical devices and radiation-emitting products. Dr. Binzak Blumenfeld advises clients on issues related to over-the-counter drug regulation, drug exclusivity, food and dietary supplement labeling and advertising and import detention of FDA-regulated products. She previously participated in Buchanan's summer associate program. She also served as a research assistant for Dr. Daniel Callahan of The Hastings Center researching, collecting and organizing information for his book What Price Better Health? Hazards of the Research Imperative. Dr. Binzak Blumenfeld also interned with the National Institutes of Health in the Office of Policy, Planning and Communications at the National Human Genome Research Institute. In 2003, she served as executive articles editor of Health Matrix: Journal of Law-Medicine at Case Western Reserve University. She is also the winner of the second place writing award given by the Food and Drug Law Institute (FDLI) in their 2001-2002 H. Thomas Austern Memorial Writing Competition for her article on pharmacogenomics. She currently serves on FDLI's Board of Directors. Dr. Binzak Blumenfeld received a BA in biology from Cardinal Stritch University in Milwaukee, WI and a PhD in molecular biology from Mayo Graduate School in Rochester, MN.

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LEWIS A. GROSSMAN, PhD, is Professor of Law at the American University Washington College of Law (WCL). He is also Of Counsel with the food and drug group at Covington & Burling LLP. He joined the faculty of Washington College of Law in 1997 and became Professor of Law in 2003 and was previously Associate Dean for Scholarship. He teaches, writes, and lectures in the areas of food and drug law, civil procedure and American legal history. Prior to joining the faculty of WCL, he was an Associate at Covington & Burling, and before that was clerk for Chief Judge Abner Mikva, U.S. Court of Appeals, DC Circuit. Dr. Grossman is coauthor (with Peter Barton Hutt and Richard A. Merrill) of Food and Drug Law: Cases and Materials 3d ed. (Foundation Press, 2007). He is a member of the National Academies’ Institute of Medicine (IOM) Committee for Review of FDA’s Role in Ensuring Safe Food and was a legal consultant for the IOM Committee on the Framework for Evaluating the Safety of Dietary Supplements. He earned his BA, summa cum laude, from Yale University and his JD, magna cum laude, from Harvard Law School. Dr. Grossman received his PhD in History from Yale University, where he earned the George Washington Egleston Prize for Best Dissertation in American History.

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LESLIE T. KRASNY is a partner in the law firm of Keller and Heckman LLP, and manages the San Francisco office. She practices regulatory law, focusing on food and dietary supplements. Her areas of expertise include safety, labeling, advertising, recalls, inspections, ingredient evaluation, claim substantiation, Proposition 65, and biotechnology. She has 30 years of legal experience, with law firms and also in-house, as Vice President and General Counsel of Dole Packaged Foods Company. Her clients include growers, manufacturers, distributors, importers, retailers, foodservice chains and trade associations, and she serves as General Counsel to the Produce Marketing Association. She is a frequent speaker and writer on food law issues, is a member of the Editorial Advisory Board of Food Processing Magazine, and wrote a chapter in The Food and Drug Law Institute's (FDLI) book on the Food Safety Modernization Act. She was formerly a member of the FDLI Food and Dietary Supplements Committee, and currently serves on the FDLI Board of Directors. Ms. Krasny has an MA in cell and molecular biology, and worked in pharmacology research at the University of California, San Francisco School of Medicine and at Stanford University School of Medicine before attending law school. She received her law degree from the University of California, Hastings College of the Law.

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JOY LIU is a Partner at the law firm of Ropes & Gray LLP in Washington, DC. In this role, she represents large pharmaceutical, biotechnology, and medical device companies on a broad range of FDA regulatory issues. She counsels clients on promotional compliance matters, Hatch-Waxman exclusivity strategies, and government investigations, among other issues. Ms. Liu also provides FDA regulatory due diligence support for corporate transactional matters (e.g., licensing deals and M&A) and for securities filings for publicly traded life sciences companies. She has significant experience with the advertising and promotion of pharmaceuticals and medical devices. While on a seven-month secondment to a major pharmaceutical company, Ms. Liu served as the sole product attorney for a $3 billion product, sitting on the promotional review committee and also advising the client on issues arising under the Anti-Kickback Statute and the False Claims Act. She has also served as the legal representative on review committees of emerging companies with single products. Ms. Liu received an AB from Harvard College and a JD from Columbia Law School.

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DESIREE RALLS-MORRISON is the Senior Vice President, Secretary, and General Counsel at Boehringer Ingelheim. Previously, Ms. Ralls-Morrison served in a number of roles at Johnson & Johnson, including General Counsel for the Consumer Group and as a member of the Law Department Operating Committee and the Consumer Group Operating Committee. In that capacity she oversaw the Consumer Legal Group and had responsibility for legal matters across the Consumer Companies globally. Other positions included Assistant General Counsel for Johnson & Johnson, and Vice President of Law, OTC and Nutritionals for McNeil Consumer Healthcare. She sat on the Management Board for McNeil Consumer Healthcare and was a member of the Leadership Team for OTC, Nutritionals, and Wellness & Prevention since 2007. Ms. Ralls-Morrison has been employed by Johnson & Johnson since April, 2005. Prior to employment at Johnson & Johnson, Ms. Ralls-Morrison served as a regulatory and product liability lawyer for Merck & Co., Inc. for 8 years. Her primary responsibilities included the Merck Vaccine Division, where she managed significant and critical vaccine litigation for Merck in Europe and the U.S. Prior to her employment at Merck she was in private legal practice at the New York law firm Kelley, Drye & Warren as a securities lawyer, and at Shipman & Goodwin in Hartford, CT as a litigator. Ms. Ralls-Morrison is a 1992 graduate of Harvard Law School and in 1988 she received her undergraduate degree in Economics and Political Science from Wesleyan University in Connecticut.

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DANIEL F. SHAW is Vice President and Deputy General Counsel of H. J. Heinz Company. He is responsible for its North American legal affairs. In addition to food law, he is involved with a variety of other legal work, including mergers and acquisitions, general commercial and regulatory. He began his career with the U.S. Department of Justice and subsequently moved to a Washington, DC law firm with a food, drug and legislative practice. Mr. Shaw graduated from Williams College and received his JD from the Dickinson School of Law.

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PETER E. TAMBORSKI is General Counsel for the Sugar Creek Packing Company, a food company based in Washington Court House, OH that has operations in Ohio, Kansas, Illinois and Missouri. His responsibilities include management of all legal issues for the company, including corporate, employment, safety, litigation and regulatory matters. Mr. Tamborski practiced for 20 years as an associate and then partner at Smith & Schnacke LLP and Thompson Hine LLP in Ohio before assuming his current position in 2002. For the past eight years, he has interacted with a wide variety of food companies, food safety professionals and regulatory agencies in the management of Sugar Creek’s business, which focuses on both raw and RTE proteins (bacon, turkey and chicken products) and sandwich products. His experience includes management of co-packing, private label and food service matters. Mr. Tamborski received his BA in government from Centre College and his JD from Chase Law School at Northern Kentucky University. He is admitted to practice before the Ohio Supreme Court, the United States Court of Appeals for the Sixth Circuit and the Supreme Court of the United States.

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ALLISON M. ZIEVE is Director of Public Citizen Litigation Group and general counsel of Public Citizen, a non-profit membership organization devoted to research, advocacy, and education on a wide range of public health and consumer safety issues. Among other areas, her litigation practice includes food and drug law, open government, and access to courts issues. She has published articles on federal preemption of state law, tobacco regulation, and the Freedom of Information Act for publications such as Internal Medicine News, Regulatory Affairs Journal (UK), TRIAL Magazine, and various BNA legal publications. In addition, Ms. Zieve teaches a course on dietary supplement and food regulation at Georgetown University Law School. She also serves as a public member of the Administrative Conference of the United States, a trustee of the Client Security Fund of the District of Columbia Bar, and as a judge of the American Constitution Society's Richard D. Cudahy Writing Competition on Regulatory and Administrative Law. In addition, she serves on the Board of The Food and Drug Law Institute. Ms. Zieve graduated from Brown University and Yale Law School.

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