Speaker Bios
Just added to the agenda: Senator Orrin G. Hatch
& Representative Henry A. Waxman
Bios will be added as speakers are confirmed.
Search bios by last name by clicking on a letter below:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
DAVID WILLIAM KENNEDY ACHESON, MD, FRCP is the Associate Commissioner for Foods, in the Office of Food Protection, Office of the Commissioner, Food and Drug Administration (FDA). He provides advice and counsel to the Commissioner on strategic and substantive food safety and food defense matters and works with individual FDA product centers, as well as the Office of Regulatory Affairs to coordinate FDA’s food safety and defense assignments and commitments. In addition, he serves as the Commissioner’s direct liaison to the U.S. Department of Health and Human Services (HHS) and to other U.S. departments and agencies on food safety and food defense related inter-agency initiatives. Dr. Acheson is developing an agency-wide, visionary strategy for food safety and defense. The strategy will identify and characterize changes in the global food safety and defense system, and identify current and future challenges and opportunities. It will name potential barriers, gaps, and most critical needs in a food safety and defense system. The strategy will serve as the framework in helping the agency prioritize and address food safety and defense challenges. As a Center for Food Safety and Applied Nutrition (CFSAN) office director, Dr. Acheson had the lead for emergency response, as well as outreach and communications to industry, state and consumers on issues pertaining to the Center. Previously, Dr. Acheson served as Chief Medical Officer and Director of the Office of Food Defense, Communication and Emergency Response at CFSAN. Before joining the agency, Dr. Acheson held several research and academic positions. He has served as an associate professor at the University of Maryland Medical School in Baltimore, where he focused on research of foodborne pathogens and, prior to that, as an associate professor at Tufts University in Boston. There he undertook basic molecular pathogenesis research on foodborne pathogens. Dr. Acheson is a graduate of the University of London Medical School in the United Kingdom, with training in internal medicine and infectious diseases. He has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. Additionally, Dr. Acheson is a Fellow of both the Royal College of Physicians (London) and the Infectious Disease Society of America.
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EDWARD JOHN ALLERA is one of the managing Shareholders of the Washington, DC office of the law firm of Buchanan Ingersoll and chairman of the firm’s Food and Drug Group. His practice focuses on the development of new products and business opportunities in the areas regulated by the Food and Drug Administration (FDA) as well as protecting existing products through the product life cycle extension process. He advises clients on FDA requirements, regulations, and traditional matters as well as FDA litigation issues. Mr. Allera’s practice also includes the growing interaction of FDA and the Center for Medicare and Medicaid Services. He was previously an associate chief counsel for enforcement with FDA and worked as a pharmacist. He has spoken and written extensively on food and drug law in the U.S. and internationally. Mr. Allera received his BS from West Virginia University and his JD from Georgetown University.
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SUSAN ALPERT, PhD, MD is Senior Vice President, Chief Regulatory Officer, for Medtronic, Inc. She was formerly the Vice President, Regulatory Sciences at C.R. Bard, Inc., Murray Hill, New Jersey. Formerly, she was Director of the Office of Device Evaluation (ODE) at the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) and a Director of Food Safety at the Center for Food Safety and Nutrition (CFSAN). Prior to that, she was a Medical Officer in the Division of Anti-Infective Drug Products in the Center for Drug Evaluation and Research (CDER), where she also served as a supervisor for anti-infective and dermatological drug products. Dr. Alpert received her A.B. in biology from Barnard College, Columbia University and her PhD in medical microbiology from New York University School of Medicine. She earned her MD at the University of Miami School of Medicine. She trained in Pediatrics at Montefiore Hospital, Albert Einstein School of Medicine in New York, and completed her training in pediatric infectious diseases at Children’s' Hospital in Washington, DC as part of a joint program with the FDA.
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STEVEN 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 marketing matters. He advises Campbell’s U.S. businesses on compliance matters involving the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA), as well as challenges before the National Advertising Division (NAD) of the Council of Better Business Bureaus. Mr. Armstrong came to Campbell in January 2007 from Energizer's Schick-Wilkinson Sword Division. He has had over 15 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 litigation and regulatory matters at the law firm of Townley & Updike in New York. 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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CRAIG M. AUDET is Vice President and Head of the US Regulatory Affairs Marketed Products Group at Sanofi-Aventis. In this role, he is responsible for four groups charged with developing and implementing regulatory strategies for prescription and OTC drugs, medical devices, and cosmetics in the areas of advertising and promotion, labeling, product defense, clinical trials, and product development and maintenance. Prior to joining Sanofi-Aventis, Mr. Audet served as the Cardiovascular Global Therapeutic Area Leader at Pfizer, where he had worldwide regulatory responsibility for the company’s cardiovascular drug product portfolio (Phase II-IV). Mr. Audet began his regulatory career working with drug/device combination products. During his more than 22 years in industry, Mr. Audet has been involved with the development of global regulatory strategies and submissions and has experience working effectively with the FDA, EMEA, and national health authorities on medical device PMA, IDE, 510(k), and CE Mark submissions, as well as pharmaceutical IND, NDA, sNDA, Mutual Recognition, Centralized, and CTD submissions. Mr. Audet holds a BS in biology from Boston College.
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DEBORAH M. AUTOR, JD is the Director of the Office of Compliance in the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). She has also served as the Associate Director for Compliance Policy in the Office of Compliance. The CDER Office of Compliance promotes and protects public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs. Before joining FDA, Ms. Autor was a Trial Attorney with the U.S. Department of Justice, Office of Consumer Litigation, where she litigated civil and criminal cases on behalf of FDA. Prior to that, she practiced food and drug law at the firms of Weil, Gotshal & Manges and Buc Levitt & Beardsley. Ms. Autor obtained her BA from Barnard College, Columbia University and her JD, magna cum laude, from Boston University School of Law.
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IVY S. BAER JD, MPH is Director and Regulatory Counsel at the Association of American Medical Colleges (AAMC). In this position, she advises and educates members on a broad range of regulatory and legal issues that are of particular importance to teaching institutions and their faculty physicians. Ms. Baer serves as primary staff person to the AAMC’s Compliance Officers’ Forum and the Group on Faculty Practice. She is a member of the American Health Lawyers Association and served as co-chair of the American Health Lawyers Association annual meeting on Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions from 2004-2009. Prior to working at the AAMC, Ms. Baer worked for the Mid-Atlantic Region of Kaiser Permanente, a federal regulatory agency, and a public interest group. Ms. Baer holds a Bachelor's degree with honors from Johns Hopkins University; a law degree from Emory University; and Masters of Public Health degree from the Harvard School of Public Health.
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JOHN D. BAKER is a Supervisory Veterinary Medical Officer in the Center for Veterinary Medicine, Food and Drug Administration.
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FREDERICK (RICK) R. BALL is a Partner with the law firm of Duane Morris LLP in Chicago, IL. He concentrates his practice in areas in which companies or individuals are adverse to state or federal governments, including administrative, civil and criminal matters, with the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), Centers for Medicare and Medicaid Services (CMS) and other regulatory agencies. Mr. Ball conducts internal investigations for healthcare companies in the area of compliance and advises them on implementing corporate compliance programs and corporate integrity agreements. Mr. Ball also regularly deals with enforcement of noncompetition agreements, protection of trade secrets and regulatory compliance. He regularly publishes and presents on issues related to pharmaceutical law including compliance, promotion, reimbursement and enforcement. Mr. Ball graduated from the University of Colorado at Boulder and received his JD, cum laude, from Cornell Law School.
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EDWARD M. BASILE is a Senior Partner at the law firm of King & Spalding LLP and has over twenty-five years of experience interpreting the laws and regulations administered by the Food and Drug Administration (FDA). His current practice includes representing large, medium and small medical device, pharmaceutical, and biotechnology companies. Mr. Basile has advised these clients on strategies for obtaining FDA approvals of new products and reclassification, and on compliance issues, including combination products, criminal investigations, inspections, recalls, labeling, promotion, and advertising issues, and proposals to ban or withdraw approval of products. Mr. Basile has also represented clients in litigation with FDA and serves as national FDA counsel for a number of medical device manufacturers involved in mass tort litigation. Prior to joining King & Spalding, Mr. Basile served as Deputy General Counsel of the Health Industry Manufacturers Association (HIMA), now called AdvaMed. While there he established himself as one of the nation’s leading authorities on the interpretation of the federal laws governing FDA’s regulation of medical devices. He served as Associate Chief for Drugs & Biologics and Associate Chief Counsel for Enforcement in the Chief Counsel’s office at FDA. While at FDA, Mr. Basile had extensive litigation experience and advised top agency management on issues of national importance, such as the licensing of the initial HIV diagnostic tests. He has published numerous articles on FDA’s laws and regulations and is a frequent lecturer on a variety of FDA law issues for the Food and Drug Law Institute and other organizations sponsoring educational programs. Mr. Basile received his BS in Mechanical Engineering from Lafayette College and his law degree from the National Law Center at George Washington University, where he graduated Order of the Coif.
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SCOTT BASS heads the Global Life Sciences Team at Sidley Austin LLP. He coordinates pharmaceutical, medical device, food and dietary supplement matters in the United States, Europe and Asia. He is ranked internationally among the top authorities on Food and Drug Administration (FDA)-related enforcement and regulatory issues, and has led audits and investigations involving off-label promotion, pharmacovigilance, Prescription Drug Marketing Act (PDMA), good manufacturing practice (GMP), and fraud and abuse issues, as well as Drug Enforcement Administration (DEA) and Federal Trade Commission (FTC) matters. Mr. Bass served as an adjunct professor at Georgetown University Graduate School, as Co-Chair of the American Bar Association Food and Drug Law Committee, Chairman of the New York State Bar Association Section on Food, Drug and Cosmetic Law, and as an expert in a European Union (EU) Commission study and as an advisor on new China drug and device legislation. He has published many articles and books in the pharmaceutical, dietary supplement and functional foods fields, including Marketing Dietary Supplements and The Dietary Supplement Health and Education Act: A Legislative History and Analysis, published by the Food and Drug Law Institute. Mr. Bass received his JD, cum laude, from the University of Michigan Law School.
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KATE C. BEARDSLEY is a Partner in the law office of Buc & Beardsley in Washington, DC where she represents clients interested in biologics, drugs, and medical devices. She has been a member of the Secretary’s Advisory Committee on Genetic Testing, and the Vice-Chair of the American Association of Tissue Banks Government Regulation Committee. Previously, Ms. Beardsley served as a Special Counsel in the U.S. Office of Management and Budget, and was Deputy Director of the U.S. Regulatory Council where she worked with the Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and Consumer Product Safety Commission. Before forming Buc & Beardsley, she was associated with the law firm of Weil, Gotshal & Manges and, before that, Nixon, Hargrave, Devans, and Doyle. Ms. Beardsley received her BA from Smith College and her JD from Emory University School of Law, where she was an editor of the Law Review.
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DON L. BELL, II is Senior Vice President and General Counsel for the National Association of Chain Drug Stores (NACDS). Mr. Bell advises NACDS and chain pharmacies regarding federal drug laws, fraud and abuse laws, Medicare and Medicaid reimbursement, antitrust and employment law, and many other statutes and regulations that affect NACDS and its members. He is also responsible for managing ongoing litigation that affect pharmacies. He helps analyze and draft proposed legislation, and helps work with federal and state government agencies. Mr. Bell regularly writes articles and other informational materials regarding legislation, litigation and regulations that affect the pharmaceutical industry. He is a member of the DC, Maryland and Virginia bars and has been admitted to practice before the US Supreme Court. Mr. Bell came to NACDS after working with Proskauer Rose LLP, a New York-based law firm where he practiced healthcare litigation. Mr. Bell received his BA from Northwestern University and his JD from George Washington University.
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TRACY PALMER BERNS is Chief Regulatory Counsel at Covidien (formerly Tyco Healthcare) working with the corporate quality and regulatory groups on regulatory matters. Covidien is a global manufacturer of medical devices and supplies, diagnostic imaging agents, pharmaceuticals and other healthcare products. Prior to joining Covidien, Ms. Berns worked with a number of medical device firms in regulatory and legal capacities, including C.R. Bard, Inc., ABIOMED, Inc. and Thermo Electron. In addition, Ms. Berns has served as a Senior Consultant with EXPERTech Associates and worked in private practice at law firms in Washington, DC specializing in Food and Drug Administration regulatory law. Ms. Berns received her BA from Knox College and her JD from Columbia University.
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JOAN WILMARTH BLAIR is International Affairs Advisor to the Director/Deputy Director, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). As International Affairs Advisor, Ms. Blair is responsible for providing policy recommendations and guidance to the Center’s leadership regarding international issues that affect the products and firms regulated by the Center and serves as CBER’s primary point of engagement with the Agency on all international matters. She liaises with other U.S. government agencies, international organizations and representatives of foreign governments, and leads CBER’s engagement as a World Health Organization (WHO) Collaborating Center for Biological Standardization. She has been with FDA since 1992. Ms. Blair earned her AB from Bryn Mawr College and her MA in International Affairs from the School of Advanced International Studies of Johns Hopkins University.
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ALAN R. BLAKE is the Chief Executive Officer and co-founder of Yorktown Technologies, L.P., the exclusive licensor of GloFish® fluorescent fish. After more than five years on the market, GloFish are among the top-selling fish in the ornamental fish industry, and they remain the only biotech animal commercially available to the public in the United States. Since co-founding the company in 2001, Mr. Blake has gained extensive knowledge and expertise in the scientific, legal, marketing, public relations and regulatory issues related to commercializing biotech animals. Mr. Blake has also served as the primary spokesman for GloFish, which has been featured in virtually all major domestic broadcast, print, and radio venues, as well as dozens of international outlets, with over 750,000,000 media impressions. Mr. Blake has been an active member of the Biotechnology Industry Organization’s (BIO) Animal Biotechnology Committee since 2003, and he has chaired panel discussions for BIO and the World Aquaculture Society.
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SHELDON T. BRADSHAW is a Partner and Co-chair at Hunton & Williams LLP. Prior to this position, Mr. Bradshaw served as Chief Counsel of the Food and Drug Administration (FDA), where he was responsible for providing legal advice to the secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to FDA’s senior leadership on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. Prior to joining FDA, Mr. Bradshaw served as the Principal Deputy Assistant Attorney General in the Civil Rights Division at the United States Department of Justice and, immediately prior to that, he served as a Deputy Assistant Attorney General in the Department of Justice's Office of Legal Counsel. He worked as an associate in the Washington, DC, office of Howrey, Simon, Arnold, & White LLP and, as a law clerk to Judge Karen J. Williams of the U.S. Court of Appeals for the Fourth Circuit. Mr. Bradshaw received his BA from Brigham Young University and his JD from the George Washington University School of Law, where he served as Managing Editor of the George Washington Law Review.
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SCOTT A. BRUBAKER, CTBS is the Chief Policy Officer at the American Association of Tissue Banks (AATB) located in McLean, VA. Mr. Brubaker’s main duties are to liaison with the Food and Drug Administration, the Centers for Disease Control and Prevention and other professional organizations nationally and internationally who are standards-setting or regulating bodies for cell and tissue banking. Prior to joining the AATB, he acquired 18 years of experience in tissue banking and organ donation at LifeNet in Virginia Beach, VA.
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GLENN N. BYRD, MBA, RAC, is Director of Regulatory Affairs, Advertising and Promotion at MedImmune, Inc. He heads up the Advertising and Promotions team and is responsible for managing all regulatory activities associated with external communications for MedImmune products. Prior to joining MedImmune, he was responsible for all regulatory activities for marketed products at PDL BioPharma Inc. including global submissions and promotional activities. Previously, Mr. Byrd served as the Chief of the Advertising and Promotional Labeling Branch (APLB), the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). He managed the team responsible for regulatory review, approval, and enforcement of advertising and promotional labeling materials for biologic drugs and devices, review of blood donor incentive programs and review of proprietary names for biologic drugs. Before joining CBER, he spent several years in private industry working on regulatory strategy, combination products, medical devices, and clinical trial design and management in consulting firms and contract research organizations (CROs). He spent several years in FDA’s Center for Devices and Radiological Health (CDRH) as a scientific reviewer in the Interventional Cardiology Devices Branch. Mr. Byrd received his BS in Aerospace and Ocean Engineering from Virginia Tech, his RAC from the Regulatory Affairs Professionals Society and his M.BA from Hood College.
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JEFFREY W. CANAVAN, MPA, RN is a Staff Officer in the Labeling and Program Delivery Division, Office of Policy and Program Development, Food Safety and Inspection Service (FSIS) with the United States Department of Agriculture (USDA).
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JOY A. CAVAGNARO, PhD, DABT, RAC is President of Access BIO a consultancy specializing in science-based regulatory strategies and preclinical product development services to facilitate biomedical research and emerging technologies. Dr. Cavagnaro has over 25 years experience in biotech spanning academia, the Clinical Research Organization(CRO) and biotech industries and government. Prior to establishing Access BIO, Dr. Cavagnaro was VP of Regulatory Affairs at Human Genome Sciences (HGS). Dr. Cavagnaro enjoyed a career in government at the Center for Biologics Evaluation and Research (CBER) at U.S. Food and Drug Administration (FDA) before rejoining industry. During her tenure at FDA, she was appointed to the Senior Biomedical Research Service, served as FDA’s topic lead for safety for the International Conference on Harmonization (ICH) initiative for seven years and rapporteur for the ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals. Prior to joining FDA, Dr. Cavagnaro was principal study director for biotechnology products at Covance (formerly Hazelton Labs). Dr. Cavagnaro is Past Chair of the Regulatory Affairs Professional Society and the National Capital Area Chapter of the Society of Toxicology and Past Chair and Founder of BioSafe, a focused expert science committee within BIO which indentifies key scientific and regulatory issues and developments related to the preclinical safety evaluation of biopharmaceutical products. Dr. Cavagnaro is current North American Chair of DIA’s Biotech SIAC and is a Chair of Chesapeake Research Review’s Independent Institutional Review Board (IRB). She is also Chair of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy and was the U.S. BIO representative to the 2006 Association of British Pharmaceutical Industry/BioIndustry Association (ABPI/BIA) Early Stage Clinical Trials Taskforce. Dr. Cavagnaro serves on a number of scientific advisory boards and consults and lectures internationally in the area of preclinical development of novel therapies. She has recently contributed to and edited the book entitled “Preclinical Safety Evaluation of Biopharmaceuticals: A Science-based Approach to Facilitating Clinical Trials” John Wiley and Sons, NJ (2008). Dr. Cavagnaro received her PhD in Biochemistry at the UNC Chapel Hill followed by postgraduate work at Duke and Boston University Medical Centers.
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CHARLES M. CLAPTON serves as Chief Counsel, Minority Staff, for the Committee on Health, Education, Labor, and Pensions, U.S. Senate.
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DOROTHY J. CLARKE, JD, RAC is Vice President, Regulatory Affairs, Office of Compliance for the Medical Devices & Diagnostics at Johnson & Johnson (J&J). Her responsibilities cover global medical device regulatory affairs, compliance and operations, regulatory policy and crisis management. Ms. Clarke previously worked in the J&J law department as a regulatory and management board lawyer. Prior to joining Johnson & Johnson, Ms. Clarke was in private practice as a health lawyer, representing drug and device companies, hospitals, physicians and other providers in the areas of regulatory and health care compliance, contracting, licensure, and health policy. Ms. Clarke is a member of the Regulatory Affairs Professionals Society and has fulfilled the requirements of the RAC. She received her BA in history from Wesleyan University and her JD from New York University School of Law.
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CHRISTOPHER A. COLE is a Litigation Partner in the Washington, DC of Manatt, Phelps & Phillips, LLP. He leads the firm’s false advertising litigation practice, which is one of the busiest in the nation. Mr. Cole represents a diverse roster of clients in comparative advertising battles under the Lanham Act and challenges before the National Advertising Division (NAD). His clients include major food and beverage, consumer products, agricultural and telecommunications companies. He also regularly advises regarding the development, approval, substantiation and clearance of advertising and labeling claims. Additionally, Mr. Cole handles a broad array of related commercial litigation, including unfair competition, product disparagement, class action, patent, and defense of government enforcement proceedings. He is currently serving as the Chairman of the Board of the Asthma and Allergy Foundation of America. He holds a BS in Biology from Yale University and an MS in Marine Biology from the University of Miami, Rosenstiel School of Marine and Atmospheric Science. He is a magna cum laudegraduate of the Boston University School of Law.
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CATHERINE (KATE) M. COOK, JD is Acting Associate Director for Regulations and Policy at the Center for Devices and Radiological Health at the Food and Drug Administration (FDA). She has advised the agency on legal issues related to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act since 1994. Ms. Cook received her JD from the New York University School of Law.
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RICHARD M. COOPER is a Partner in the Washington, DC law firm of Williams & Connolly LLP. He has contributed articles to professional journals, has taught food and drug law at Georgetown University Law Center, and has served on advisory committees of the Institute of Medicine and the National Research Council and the Congressional Office of Technology Assessment, as Chairman of the Editorial Board of the Food and Drug Law Journal. He has been a member of the American Law Institute. Mr. Cooper edited the Food and Drug Law Institute (FDLI) book, Food and Drug Law (1991), and co-edited the FDLI books, Fundamentals of Law and Regulation (1997) and Food and Drug Law and Regulation (2008). Previously, Mr. Cooper was Chief Counsel of the Food and Drug Administration (FDA) from late 1977 through 1979. In 1977, he was a special assistant to James R. Schlesinger and a senior member of the Office of Energy Policy and Planning, Executive Office of the President, where he helped to develop the National Energy Plan. In 1970-71, he also did legal work in Uganda for the Government of Uganda. He was a Rhodes Scholar, President of the Harvard Law Review, and a law clerk to Justice William J. Brennan, Jr., of the U.S. Supreme Court. Mr. Cooper received a BA, summa cum laude, from Haverford College, a B.A., First Class with Congratulations, from Oxford University, and a JD,summa cum laude, from Harvard Law School.
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TONY CORBO is the Senior Lobbyist for the food campaign at Food & Water Watch. He is responsible for food-related legislative and regulatory issues that come before Congress and the Executive Branch and has worked in that capacity since March 2000 for both Public Citizen and its spin-off Food & Water Watch. Mr. Corbo has extensive organizing experience having directed major public employee representation campaigns in several states. He has also directed political campaigns at various levels, and he served as the administrative assistant to Congressman Gary Condit (D-CA) from 1990 to 1992. He holds a Bachelor of Arts degree in Public Affairs from The George Washington University and a Master's degree in Industrial and Labor Relations from Cornell University.
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J. JOSEPH CORBY is the Executive Director for the Association of Food & Drug Officials (AFDO) and continues to work on a part time basis for the U.S. Food & Drug Administration’s State Training Branch. He is also a member of the University of Florida Food Science & Human Nutrition Advisory Council. Previously, Mr. Corby worked for the New York State Department of Agriculture and Markets, Division of Food Safety and Inspection for 37.5 years. His service with the Department included the development of numerous food safety training programs for regulators and industry, the design of the Division’s risk based inspection system, and authoring the states smoked fish regulations. He also collaborated with FDA’s Upstate New York Import Operations in designing the Imported Food Initiative Project where state inspectors were commissioned to conduct imported food inspections and surveillance – a first of its kind in this country. Mr. Corby was a FDA Commissioned Officer and Cornell University Certified Instructor for Human Resources Development. He also served as Faculty Advisor for Food Processing Technology at SUNY Morrisville and was a member of Cornell University's Institute of Food Science Advisory Council. He has been a member of the Central Atlantic States Association of Food and Drug Officials (CASA) since 1975 and has served as the Niagara Frontier Conference President, North East New York Conference Executive Board Representative, and CASA President. His awards include the CASA Award in 1991, CASA Service Recognition Award in 1992, and CASA Lifetime Achievement Award in 2008 as well as the William V. Hickey Award in 1995 for outstanding service in the field of food sanitation and the Emmitt Gauhn Award. With AFDO, he was the Chairperson for the Food Committee, where he spearheaded the development of several model codes, food processing guidelines for industry and government regulators, training programs, AFDO’s Food Code Pocket Guide, and official AFDO comments to national food safety issues. In addition to the Food Committee, he continues to serve on AFDO’s Seafood Committee, International and Government Relations Committee, Meat and Poultry Committee, and FoodSHIELD Steering Committee.
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NICOLE COUTRELIS is a Partner of Coutrelis & Associes, a French law firm with offices in Paris and Brussels, specializing in European Union (EU) law, mainly in antitrust, agriculture, food and drug regulations, alcoholic beverages, free movement of goods, and all matters related to the Single Market. She is in charge of the Food Law and Customs Practice of the firm, counseling, lobbying, and litigating in France, in other Member States of the EU, and before the European Court of Justice and Court of First Instance in Luxembourg. Before starting her private practice, Ms. Coutrelis was at the French “Office National Interprofessional des Cereales” (Cereals Authority) where she was in-charge of the European Affairs. She was then nominated at the French Permanent Representation to the EC in Brussels (“Attache Agricole”) and later joined the Legal Service of the European Commission where she was in charge of antitrust matters. Ms. Coutrelis is President of the European Food Law Association, Vice President of the International Wine Law Association, and a member of the International Bar Association (IBA). She is the author of many articles and conferences related to European food law.
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GERALD J. DAL PAN, MD, MHS became the Director of the Office of Surveillance and Epidemiology (known then as the Office of Drug Safety) in US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) in November 2005. Prior to that, he was the Director of the Division of Surveillance, Research, and Communication Support in CDER's Office of Drug Safety, a position he held since December 2003. He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins University. Dr. Dal Pan trained in Internal Medicine at the Hospital of the University of Pennsylvania, and in Neurology at Johns Hopkins Hospital. He is board certified in Internal Medicine and Neurology. He was an instructor in the Neurology Department at Johns Hopkins. Dr. Dal Pan next worked for Guilford Pharmaceuticals in Baltimore, and then for HHI Clinical Research and Statistical Services in Hunt Valley, MD. He joined the FDA in July 2000 as a medical officer in the Division of Anesthetic, Critical Care, and Addiction Drug Products.
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STEFAN DAYAGI is President of Pajunk Medical Systems LP, the United States’ (U.S.) subsidiary of Pajunk Medical Technology GmbH in Geisingen, Germany. He built up the entity since 2003 and is among others responsible for the Food and Drug Administration (FDA) compliance and quality assurance of the U.S. company. Mr. Dayagi is also Executive Vice President of the German American Trade Center responsible for setting up operations in the U.S. for small and midsize German companies. He has served over 35 years in the industry and has held several management positions with Philips Electronics, Yxlon International and De Laval. He is a member of the German American Chamber of Commerce and is on the Board of Directors of the American-Israel Chamber of Commerce. Mr. Dayagi received his Engineering degree from the Technical University of Hamburg, Germany and his Management and Business education from the Stockholm School of Economics.
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JILL B. DEAL is a Partner with the law firm of Venable, LLP. She focuses on food and drug law, specifically, the Food and Drug Administration (FDA) approval and marketing of therapeutic products. Ms. Deal has provided counsel on numerous successful drug, medical device and biologic approval issues and appeals before the agency, and has successfully represented companies in complex litigation involving the FDA approval processes and other regulatory issues, including those arising from the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). Additionally, she assists U.S. and European companies seeking to understand and participate in the US and European Union (EU) regulatory regimes in areas such as pharmaceuticals (biotechnology), medical devices, foods and cosmetics regulation, consumer product advertising, labeling, product safety and product liability. She specializes in the interface of patent laws and food & drug laws in the US and EU, and advises regularly on U.S. laws governing foods, dietary supplements, drugs (including biologicals), cosmetics and medical devices. She has authored numerous publications on food and drug topics. She has served as Vice Chairman of the Food and Drug Law Committee of the Administrative Law Committee of the American Bar Association. She has worked on the Eucomed Working Group on the implementation of the European Community’s new medical devices law. Ms. Deal received her BS in Political Science from the University of California, Berkeley, and her JD from the Catholic University of America.
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JODY DEFORD is an Attorney in the law firm of Ice Miller LLP in Indianapolis, IN. She regularly counsels clients in the pharmaceutical and medical device industry regarding compliance with Food and Drug Administrattion (FDA) regulations, contract issues and risk management. She also counsels clients in the food, feed and veterinary products industry with respect to compliance with federal and state regulations. In addition to her regulatory practice, Ms. DeFord also represents clients in both federal and state courts, and in alternative dispute resolution. Her litigation practice focuses on commercial disputes, the defense of pharmaceutical and medical device manufacturers, the defense of commercial product manufacturers, toxic tort litigation, and litigated probate and trust matters. Ms. DeFord is an active member of the Indianapolis Bar Association and currently serves on the Steering Committee for the Bar Association Leadership program. She is an emeritus member of the board of directors of Dress for Success Indianapolis, a local non-profit that helps low-income women in the central Indiana community achieve self-sufficiency, and the immediate past President of OPTIONS Alumni, a philanthropy program of the Women's Fund of Central Indiana. Ms. DeFord is admitted to practice law in the State of Indiana, as well as before the U.S. District Courts for the Northern and Southern Districts of Indiana. She earned her BA from Indiana University and her JD, cum laude, from Indiana University School of Law – Indianapolis.
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DAVID H. DORSEY is a Senior Fellow in the Health Office of Senator Edward M. Kennedy on the Senate Health, Education, Labor, and Pensions Committee. He works mainly on legislation and oversight that affects the Food and Drug Administration. Mr. Dorsey worked on several significant pieces of legislation that became law during the 107th, 108th, 109th, and 110th Congresses, including the Best Pharmaceuticals for Children Act; the 2002 reauthorization of the Prescription Drug User Fee Act; the food safety provisions and enhancements of controls on dangerous biological agents and toxins in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; the Medical Device User Fee and Modernization Act of 2002; the Animal Drug User Fee Act; the Pediatric Research Equity Act of 2003; the generic drug provisions in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; the Project BioShield Act of 2004; the Minor Use and Minor Species Animal Health Act of 2004; the Dietary Supplement and Nonprescription Drug Consumer Protection Act; and the Food and Drug Administration Amendments Act of 2007. He currently is concentrating on food safety and follow-on biologics for Senator Kennedy. Before working in Senator Kennedy's Health Office, Mr. Dorsey worked at the Food and Drug Administration in the Office of the Chief Counsel on the regulation of medical devices, tobacco products, food labeling, and dietary supplements. He clerked for the Honorable William Bryant on the Federal District Court for the District of Columbia and is a 1991 graduate of the Yale Law School. Mr. Dorsey earned a Bachelor’s degree from Haverford College and a Master’s degree in mathematics from Princeton University.
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MELVIN S. DROZEN is a Partner in the Washington, DC law firm of Keller and Heckman. He provides advice to clients on a broad spectrum of Food and Drug Administration (FDA), Federal Trade Commission, U.S. Department of Agriculture, and Environmental Protection Agency regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to entering private practice, Mr. Drozen was an attorney in the General Counsel’s Office of FDA for seven years where he represented FDA in a variety of food and drug litigation and provided agency personnel with counsel on food, drug, and veterinary product matters. Before that, he was Assistant District Attorney in Brooklyn, NY. Mr. Drozen’s practice also extends to the international regulation and requirements for food and drugs and he has interfaced with relevant regulators in South America, Europe, Asia, and Australia on these subjects. As part of his practice, he also frequently counsels clients on topics being considered by the various committees of the Codex Alimentarius commission and the International Conference on Harmonization. Mr. Drozen received his BA from Georgetown University and his JD from Brooklyn Law School.
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LAURA R. EPSTEIN has been Associate Chief Counsel in the Food and Drug Division of the Office of General Counsel, U.S. Department of Health and Human Services for over ten years. She has counseled the Food and Drug Administration (FDA) Center for Veterinary Medicine on issues including genetically engineered animals, bovine spongiform encephalopathy (BSE), user fees, monkey pox, minor use and minor species, specific new animal drug approvals and feed-related issues. She has counseled the FDA Center for Devices and Radiological Health on issues including mammography, preemption, genetic testing, the Clinical Laboratory Improvement Amendments, and a wide range of in vitro diagnostic issues.
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CHERYL A. FALVEY is the General Counsel of the United States Consumer Product Safety Commission (CPSC). The General Counsel is the Commission's chief legal officer and adviser. The office's major functions are representing the Commission in court and providing legal counsel to the Commission and its operating divisions. Ms. Falvey advises the Commission on all legal issues arising under the statutes it administers and has been particularly involved in the interpretation and implementation of the new Consumer Product Safety Improvement Act. Ms. Falvey also helps assure Commission compliance with such statutes and regulations as the Administrative Procedure Act, the Government in the Sunshine Act, the Freedom of Information Act, the Civil Service Reform Act, the Ethics in Government Act, and the Commission's own internal rules and directives. Prior to joining the Commission, Ms. Falvey was a partner in the law firm of Akin, Gump, Strauss, Hauer & Feld, LLP where she was the head of the litigation practice group in Washington, DC. Ms. Falvey received her BA from Wellesley College and her JD from the Georgetown University Law Center. She is a member of the Virginia, New York and District of Columbia Bars.
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MARILYN N. FLACK is the Director, Division of Patient Safety Partnerships for the Food and Drug Administration’s (FDA) Office of Surveillance and Biometrics in the Center for Devices and Radiological Health (CDRH). She has been working in postmarket for 11 years, building and implementing the Medical Product Safety Network (MedSun). This is FDA's collaborative effort with the clinical community. Prior to that, she was the Clinical and Regulatory Director for a medical device company, and was an expert reviewer in the Center's Office of Device Evaluation for four years. Prior to joining FDA, Marilyn was a clinical audiologist for 23 years. Her Masters Degree in Audiology is from the University of Maryland.
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TRACEY H. FORFA, JD is the Executive Director of the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine. Prior to joining CVM, she was an Associate Ombudsman in the Office of the Chief Mediator and Ombudsman, FDA. Ms. Forfa started her FDA career in the Center for Biologics Evaluation and Research. She has also served as an appellate law clerk. Ms. Forfa received a BA from the College of Wooster and her JD from the University of Baltimore School of Law.
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VASILIOS (BILL) H. FRANKOS, PhD serves as the Director in the Division of Dietary Supplement Programs (DDSP) and the lead scientist for dietary supplements for the U.S Food and Drug Administration (FDA) and is responsible for the full implementation of the DSHEA Act of 1994. He directs and coordinates policy and administrative activities within the Division. He advises on policy and management issues on dietary supplement programs, new dietary ingredient safety assessments, good manufacturing practice, adverse reaction monitoring, and related activities pertaining to dietary supplements. Before becoming the Director of DDSP Dr. Frankos also served as Special Assistant for Dietary Supplement Science Review providing toxicological and pharmacological evaluation of data used to assess the risks posed by dietary supplement products, Staff Science Advisor in the Office of the Commissioner, and as a Senior Toxicologist in the Center for Food Safety and Applied Nutrition. He has over 30 years experience in the toxicological and pharmacological evaluation of data used to assess the safety of FDA regulated products. In addition to his FDA activities, he spent 18 years as a Principal in the consulting firm ENVIRON International Corp. Dr. Frankos received his MS in molecular biology from the University of Maryland, and his PhD in Pharmacology and Toxicology from the University of Maryland Pharmacy School.
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JEFFREY N. GIBBS is a Principal in the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC Prior to entering private practice, he was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA). While at the FDA, Mr. Gibbs received the FDA Award of Merit. He also served as Special Assistant United States Attorney in the District of Columbia in the Civil Division. Since entering private practice, he has assisted medical device, diagnostic and pharmaceutical companies with a variety of regulatory issues, including FDA product approval, product labeling, clinical studies, promotional and marketing programs, FDA enforcement actions, and product liability counseling. 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 on the editorial advisory board of IVD Technology and Guide to Good Clinical Practices, and is 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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VIRGINIA A. GIBSON is Chief of the Civil Division of the United States Attorney’s Office for the Eastern District of Pennsylvania. Previously, she served as the Civil Chief and the Executive Assistant United States Attorney for the District of Delaware, where she supervised both criminal and civil healthcare fraud. She teaches courses in Health Care Fraud as adjunct faculty at Temple and Widener University Schools of Law. Previously, Ms. Gibson was associated with the Philadelphia firm of Drinker Biddle and Reath and advocated for children through the Support Center for Child Advocates, serving on its Board and as its President.
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BARBARA P. GLENN, PhD is Managing Director of Animal Biotechnology in the Food & Agriculture Section at the Biotechnology Industry Organization (BIO) in Washington, DC. She is responsible for leading the animal biotechnology program that seeks to provide industry leadership on science and regulatory issues for the ethical application of biotechnology used to improve animal and human health for the public good. Previously, Dr. Glenn was Research Dairy Scientist with the U.S. Department of Agriculture, Agricultural Research Service in Beltsville, MD conducting research on energy and protein metabolism in lactating dairy cows. She then served as Executive Vice President – Scientific Liaison for the Federation of Animal Science Societies, in Washington DC, prior to joining BIO. Dr. Glenn has served as President of the American Society of Animal Science, Chair of the Coalition on Funding Agricultural Research Missions and is a Fellow with the American Association for the Advancement of Science. She has served as a member of the National Academy of Sciences Board on Agriculture and Natural Resources, and on the Food and Drug Administration’s Veterinary Medicine Advisory Committee. Dr. Glenn is currently a member of the board of directors for National Coalition for Food and Agricultural Research. She earned a Bachelor of Science degree in Animal Science from the University of Kentucky and received her PhD in Ruminant Nutrition. In addition she was a Postdoctoral Research Associate with the University of Maryland.
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GREGORY J. GLOVER, MD, a registered patent attorney and non-practicing physician with Pharmaceutical Law Group PC, is one of the nation’s experts on the complex interaction of food and drug laws and intellectual property, including the patent and non-patent provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). Dr. Glover represents life sciences companies, investors and trade associations on strategic product development issues, including market protection analyses based on intellectual property laws, Food and Drug Administration (FDA) regulations and patent portfolio evaluations. He has also testified on behalf of the research-based pharmaceutical industry before committees of both houses of Congress on legislative matters affecting market protection for pharmaceutical, biotechnology and medical device products, and he has made presentations on behalf of research-based companies on market protection issues before FDA, the Federal Trade Commission and the Department of Justice. Greg received his AB in biochemical sciences from Harvard College and his JD from Harvard Law School. Following law school, he completed medical school at Duke University and served as an intern at New England Deaconess Hospital in Boston, MA.
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JESSE L. GOODMAN, MD, MPH is Acting Chief Scientist of the Food and Drug Administration (FDA) and will be a key advisor to the Commissioner on scientific, medical and public health issues. Dr. Goodman served as Director and Deputy Director for the Center for Biologics Evaluation and Research (CBER) where he was responsible for overseeing a broad range of medical, public health and policy activities such as clinical and public health issues; pandemic and emerging infectious disease threats; bioterrorism preparedness and response; antimicrobial resistance; innovative product development; and blood, tissue and vaccine safety and availability. He has worked closely with the Centers for Disease Control (CDC), National Institutes of Health (NIH) and other U.S. Department of Health and Human Services (HHS) components, academia and the private sector. In 1995, his NIH-funded laboratory isolated the etiologic agent of a new disease, human granulocytic ehrlichiosis (HGE) and subsequently characterized fundamental events involved in infection of leukocytes, including its cellular receptor. He has been an active clinician, scientist, administrator and educator, and is the author of numerous peer reviewed scientific publications. He is Senior Editor of the book Tick Borne Diseases of Humans published by the ASM Press in 2005 and is a Staff Physician and Infectious Diseases Consultant at the NIH Clinical Center and the National Naval Medical Center/Walter Reed Army Medical Center, as well as Adjunct Professor of Medicine at the University of Minnesota. He came to FDA in late 1998 from the University of Minnesota where he joined the Faculty in 1985 and most recently served as Professor of Medicine and Director of the Division of Infectious Diseases. He has received honors and awards including election to the American Society for Clinical Investigation (ASCI) and has served on a number of committees and review panels for groups such as NIH, CDC, the Minnesota Department of Health and the Institute of Medicine. Dr. Goodman is a graduate of Harvard College, and received his MD at Albert Einstein; he did his residency and Fellowship training at the Hospital of the University of Pennsylvania and at University of California, Los Angeles (UCLA), where he was also Chief Medical Resident, and is Board Certified in Internal Medicine, Oncology and Infectious Diseases. He trained in the virology laboratory of Jack Stevens at UCLA and has had an active laboratory program in the pathogenesis of infectious diseases, in particular tick-borne infections. Dr. Goodman obtained his MPH at the University of Minnesota.
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SCOTT GOTTLIEB, MD is a Fellow with the American Enterprise Institute (AEI), a Washington, DC-based think tank. Dr. Gottlieb is also a practicing physician. He was formerly the Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration (FDA) where he was a senior advisor to the Commissioner on all major agency matters including regulations, policy and administrative programs. That office works with all of the FDA Centers on implementing and coordinating the agency’s regulatory and administrative policies aimed at advancing the public health. Prior to his position at FDA, he worked as a Resident Fellow at AEI and also spent time as an American medical correspondent for the British Medical Journal. Additionally, he was a private consultant/speaker to investment firms and the pharmaceutical industry. Previously, Dr. Gottlieb worked as a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services; Director of Medical Policy Development, FDA; and Senior Advisor for Medical Technology to the FDA Commissioner. Dr. Gottlieb received his BA in economics from Wesleyan University and his MD from Mount Sinai School of Medicine.
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CHRISTOPHER L. HAGENBUSH is a Partner in the law firm of Patton Boggs LLP, Washington, DC. With his diverse experience in managing a variety of U.S. and international legal and business issues, he helps clients confront complex business, legal and policy challenges in the food, drug and medical device industries. Before joining the firm, he worked as in-house counsel for The Coca-Cola Company. In his most recent position as Senior Counsel, Mr. Hagenbush managed legal and regulatory matters related to formulation, production, labeling and advertising of beverages, as well as product safety, security and quality. He represented the company’s interests before the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) in addition to self-regulatory, international and supra-national regulatory bodies, plus trade associations, NGOs and other non-profit organizations. He worked in Tokyo, Japan for Coca-Cola as General Counsel for the Asia-Pacific region. For more than 10 years, Mr. Hagenbush was Chief Counsel for Food Law for The Coca-Cola Company in Atlanta, Georgia and was Associate General Counsel in Houston, Texas for the company’s Foods Division. Earlier in his career, he was Legal Director for the consumer products division of Schering Plough, Associate Counsel for S.C. Johnson and Sons, Inc, and Senior Attorney for Miles Laboratories. He was an adjunct faculty member at Georgia State College of Law in the Food and Drug Law area during the Fall of 2005 and 2006. He currently serves on the FDLI Board of Directors. Mr. Hagenbush received his AB from Indiana University and his JD from Indiana University School of Law at Indianapolis.
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MARTIN J. HAHN is a Partner in the Washington, DC law firm of Hogan & Hartson, LLP, and is a member of the firm's Food and Agriculture Practice Group. His practice focuses on a wide variety of regulatory issues affecting the food and dietary supplement industries. Mr. Hahn assists food and dietary supplement companies in complying with the numerous statutes, regulations, and guidances implemented by FDA and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture. He also represents numerous food trade associations. In the area of food labeling, Mr. Hahn has been actively involved in the implementation of the Food Allergen, Labeling and Consumer Protection Act (FALCPA) and in the areas of nutrition labeling, health claims, qualified health claims, structure/function claims, and nutrient content claims. In the area of food safety, he advises clients in determining the regulatory status of food ingredients and has prepared generally recognized as safe (GRAS), food additive, and color additive petitions for submission to FDA. With regard to dietary supplements, he has advised clients on all aspects of the Dietary Supplement Health and Education Act of 1994. He also specializes in the regulation of functional foods, infant formulas, and medical foods. Mr. Hahn has published articles on the FDA regulation of functional foods, the labeling and product liability issues presented by food allergens, complying with the Hazard Analysis Critical Control Point (HACCP) regulations for seafood, meat, and poultry and the regulation of foods derived from biotechnology. He is a frequent speaker on food labeling and food safety. Mr. Hahn received his BS, cum laude, in food technology from Ohio State University and his JD from Northwestern University School of Law.
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RALPH F. HALL is Distinguished Visiting Practitioner & Professor at the University of Minnesota School of Law and is also of Counsel in the law firm of Baker & Daniels in Indianapolis, IN. He is currently visiting Professor of law at Indiana University School of Law – Indianapolis. He has experience in the areas of Food and Drug Administration (FDA) and healthcare law and applying those regulatory systems to the medical device industry, the design and implementation of regulatory compliance programs, with FDA enforcement actions, in managing complex patent litigation and licensing matters, and in general corporate counseling. Prior to rejoining Baker & Daniels, Mr. Hall was with Guidant Corporation where he served as Senior Vice President and Deputy General Counsel – Litigation and Compliance. He also served as Special Counsel to Guidant’s Board of Director’s Compliance Committee and to Guidant’s Compliance Office. Earlier, he was General Counsel of Guidant’s Cardiac Rhythm Management group. Prior to joining Guidant, Mr. Hall was with Eli Lilly and Company where he served in a number of legal roles, including chief environmental counsel. He speaks frequently at legal seminars on a variety of subjects. He also serves as the CEO of MR3 Medical, LLC. Mr. Hall received his AB, magna cum laude, from Indiana University and his JD, cum laude, from the University of Michigan Law School.
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MARTINE L. HARTOGENSIS, DVM is the Deputy Director for the Office of Surveillance and Compliance in the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA). She joined the FDA in 2001 as a Veterinary Medical Officer where she served as the Center’s Promotion and Advertising Liaison and post-approval product manager of veterinary antiparasitics. Before joining FDA, Martine was an associate veterinarian in a small animal practice in Middleburg, VA. Dr. Hartogensis received her BS in Animal Science from Virginia Tech and her DVM from the Virginia-Maryland Regional College of Veterinary Medicine.
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BRIAN E. HARVEY, MD, PhD is Vice President, Regulatory Policy with Sanofi-Avenits, where he reports to the Global Head of Regulatory Affairs. Dr. Harvey leads the sanofi-aventis Corporate Regulatory Affairs (CRA) office in Bethesda, MD and interacts with the Food and Drug Administration (FDA), C-Path Institute and key industry representatives on behalf of sanofi-aventis. He represents sanofi-aventis on the Pharmaceutical Research and Manufactures of America (PhRMA) Regulatory Affairs Coordination Committee (RACC), Asian Pacific Technical Committee and International Biologics and Biotechnology Taskforce/Biologics Key Issues Team. He is a member of the Biotechnology Industry Organization (BIO) Regulatory Affairs Committee (RAC). Dr. Harvey provides support to CRA teams during the product development process and to the sanofi-aventis Washington, DC office. Dr. Harvey joined sanofi-aventis from the FDA, where he had worked in the medical devices (CDRH), biologics (CBER) and drugs (CDER) centers. Most recently, he was the director of FDA’s Division of Gastroenterology Products. He was previously the Deputy Office Director for CDER’s Office of Drug Evaluation, having come to CDER from CBER in 2003. He started at FDA in 1995 as a medical officer in CDRH’s Gastroenterology and Renal Devices Branch. In 2000-2001, Dr. Harvey represented FDA as an American Political Science Association (APSA) Congressional Fellow, where he worked on health and scientific issues in the U.S. Senate. Dr. Harvey graduated with honors from Middlebury College in Vermont. He completed his PhD in biochemistry, followed by his MD degree at the University of Connecticut.
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ORRIN G. HATCH is a United States Senator for Utah. As the former Chairman and now ranking Republican of the Senate Judiciary Committee, Senator Hatch is a leader in the fight for tougher anti-crime laws, civil justice reform to unclog the courts, and legislation to protect individual property rights. He also takes an active role in the confirmation of all judicial nominations, including justices of the Supreme Court, and has a direct impact on such issues as civil rights, immigration, antitrust and consumer protection, and issues related to the Constitution. Senator Hatch is also the 2nd ranking Republican on the Senate Committee on Finance, where he serves as the top Republican on the Subcommittee on International Trade, the Subcommittee on Taxation and IRS Oversight, and the Subcommittee on Health Care. As a member of the Finance Committee, he has been a leading advocate for policies to encourage savings and investment, such as the Capital Formation Act of 1997, as well as other growth tax bills. He also played a key part in enacting the welfare reform bill, known as the Personal Responsibility and Work Opportunity Reconciliation Act of 1996. He was particularly involved in the provisions relating to state training prerogatives and child care. Now in his fifth term as Utah’s senator, Senator Hatch has championed a variety of legislative cases. Among his many achievements and initiatives are the balanced budget amendment to the Constitution, the religious Freedom Restoration Act, the Omnibus Property Rights Act, the Antiterrorism and Effective Death Penalty Act, the Child Care and Development Block Grant Act, Health and Education Act, FDA reform, the Orphan Drug Act, the Ryan White AIDS Care legislation which provides needed services for adults and children afflicted with HIV, the Job Training Partnership Act, designation of the Mormon Trail, the Utah School Trust Lands Exchange Act, the Childrens Health Insurance Program (CHIP), and the Radiation Exposure Compensation Act for the Utah downwinders. Senator Hatch is also a member of the Senate Select Committee on Intelligence, the Committee on Indian Affairs, and the Joint Economic Committee. Prior to his election to the Senate in 1976, Senator Hatch was a practicing attorney, first in Pennsylvania and then in Utah. He graduated from Brigham Young University, received his JD from the University of Pittsburgh Law School, with honors, and has since been awarded an Honorary Doctor of Laws from Pepperdine University, and honorary doctorates from the University of Maryland, Southern Utah State University, and the Cumberland School of Law at Samford University.
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JOHN E. HEINTZ is a Partner at Kelley Drye & Warren LLP. He chairs the Firm's Insurance Recovery and Washington, DC Litigation Practice Groups, and has nearly 30 years of experience in the fields of corporate insurance coverage and other complex, multiparty litigation. Mr. Heintz has successfully represented clients in securing coverage for asbestos, lead, environmental contamination, class-action discrimination, directors’ and officers’ liabilities, and medical product liability claims, and property and business interruption losses arising out of the 9/11 attacks and other catastrophic events. In the course of those representations, Mr. Heintz has obtained favorable rulings for his clients in numerous landmark appellate cases at the state and federal levels. Mr. Heintz was a named partner at Gilbert Heintz & Randolph, which he co-founded in 2001. Previously, he served as chairman of the insurance coverage practice at Howrey LLP. He is also a member of the American Bar Association (ABA) Section on Litigation, Insurance Committee and the Director of the Washington Lawyers' Committee. Mr. Heintz received his BA from Cornell University, his MPA from Princeton University and his JD from New York University.
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MARK A. HELLER is a Partner in the law firm of Goodwin Procter LLP, Washington, DC., is chair of the firm’s Food and Drug Administration (FDA) Group and is a member of the Life Sciences Practice. He focuses on FDA and Federal Trade Commission (FTC) laws and enforcement counseling and litigation. He represents a broad base of clients in all aspects of the FDA’s product approval processes and in compliance matters ranging from administrative notices of violation to enforcement actions. He also represents clients in obtaining device and drug approvals and in responding to agency investigations – those concerning device and drug promotion, good manufacturing practices, product importation, and in filing comments within the agency to help shape regulatory and policy initiatives. Mr. Heller works closely with clients to develop strategies to maximize their effectiveness in dealing with FDA’s processes. Previously, he spent almost ten years in the FDA’s General Counsel’s office, where he was actively involved in offensive and defensive litigation. During his last six years with FDA, Mr. Heller was the Associate Chief Counsel for Medical Devices. He is listed in Chambers USA: America’s Leading Lawyers for Business; The Best Lawyers in America; is prominently featured as one of three “leading” lawyers in the 2006/2007/2008 PLC Cross-border Life Sciences Handbook in the USA Regulatory (medical devices) category; Legal Times of Washington, as one of the top 11 FDA lawyers; the FDA Practice Area section of the Washington DC Super Lawyers, March 2007 edition; and in the Washingtonian magazine, as one of the top FDA lawyers. Mr. Heller received his BA and JD from the University of Wisconsin.
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KAY HOLCOMBE is Senior Policy Advisor at Genzyme Corporation. Prior to this position, Ms. Holcombe served as Executive Vice President of Policy Directions, Inc., a public relations and government relations consulting firm which provided strategic planning, legislative and policy advice to a variety of clients in the healthcare industry and academia. From 1993-1997, Ms. Holcombe was a professional health legislative staff member and senior health policy advisor to the House Commerce Committee. From 1991-1993, she was Deputy Associate Commissioner for Legislative Affairs at FDA. Prior to this, Ms. Holcombe held several positions in government, industry, and academia. Ms. Holcombe received her BS in chemistry education from the University of Illinois and her MS in chemistry from the University of Virginia.
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DAVID J. HOROWITZ, JD is the Assistant Commissioner for Policy and leads the Office of Policy in the Office of the Commissioner (July 2008 – Present) at the U.S. Food and Drug Administration (FDA). He previously served as Deputy Associate Commissioner for Compliance Policy in FDA’s Office of Regulatory Affairs (ORA) (2005 - 2008), where he served as principal advisor to the Associate Commissioner for Regulatory Affairs (ACRA) on policy development and implementation. Prior to that time, he served as Director of Compliance in FDA’s Center for Drug Evaluation and Research (CDER) (2000 – 2005). He began his career at FDA in the Office of the Chief Counsel, serving as Associate Chief Counsel for Enforcement and Associate Chief Counsel for Drugs (1991 - 2000). Mr. Horowitz earned a BA in Public Policy from Brown and a JD from the University of Virginia.
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SALLY L. JONES is the Acting Director, Labeling and Program Delivery Division, Office of Policy and Program Development in the Food Safety and Inspection Service (FSIS) at the United States Department of Agriculture (USDA). The office has primary responsibility for the development and delivery of USDA policies and programs on food labeling, food standards, and food additives used in the safe production of meat, poultry, and egg products distributed in domestic commerce and exported to the United States. For the past 16 years she has focused primarily on nutrition-related claims and information, other special labeling claims, and coordination of activities with similar staffs in the Food and Drug Administration. Before joining the labeling staff, she was a member of the FSIS staff that provided review and evaluation of packaging materials, and cleaning and maintenance compounds. She received her Bachelors of Chemistry and earned a Masters of Science degree in Food Science and Human Nutrition.
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JAMES J. KELLY, Esq is the current President & CEO of the Food and Drug Law Institute (FDLI). Before joining FDLI in 2006, Mr. Kelly was President & CEO at Carl Zeiss, Inc., the U.S. subsidiary of the German-based manufacturer of precision optics used in a wide range of applications, including medical, ophthalmic, biomedical research and pharmaceutical. At Zeiss, Mr. Kelly held a variety of executive positions, including general manager for the Microscopy Group, general counsel and vice-president corporate marketing. Prior to Zeiss, he served as vice-president, general counsel and, later, head of human resources at Siemens Medical, one of the largest healthcare industry suppliers in the world. Mr. Kelly began his career in the general practice of law in New York City after earning his JD from Villanova Law School. He has his undergraduate degree from St. Joseph's University and is a member of the New York State Bar. He has also served as vice-chairman of the German-American Chamber of Commerce in New York.
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RICHARD F. KINGHAM is a Partner in the London and Washington, DC offices of the law firm of Covington & Burling. Since joining the firm in 1973, he has concentrated on the regulation of pharmaceuticals and other products. He has advised industry associations in the United States and Europe, as well as most of the major pharmaceutical manufacturers and biotechnology companies. He has taught food and drug law and related subjects at the University of Virginia School of Law, the Georgetown University Law Center, and Cardiff University in the United Kingdom. Mr. Kingham has served on committees of the Institute of Medicine of the National Academy of Sciences and the National Institutes of Health. He has written numerous articles and book chapters on food and drug regulation and frequently speaks to industry and professional groups. Mr. Kingham received his AB from George Washington University and his JD from the University of Virginia, where he served as articles editor of the Virginia Law Review.
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DANIEL A. KRACOV is a Partner in the law firm of Arnold & Porter LLP in Washington, DC where he heads the Food and Drug Administration (FDA) and Healthcare Practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics and medical devices. Mr. Kracov regularly handles product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely-recognized expertise in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative strategies. Mr. Kracov received his undergraduate degree, magna cum laude, from the University of Maryland and his JD from the University of Virginia.
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ARETA L. KUPCHYK is a Partner with Reed Smith in Washington, DC, where she counsels clients on drug, biologics, medical device and biotechnology matters. Previously, she served for nearly ten years in the Food and Drug Administration’s (FDA's) Office of the Chief Counsel as Associate Chief Counsel for Biologics and Drug, as well as Assistant General Counsel for Litigation. While at FDA, Ms. Kupchyk provided legal counsel to the Commissioner's Office, the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) on a wide range of pre-approval and post-approval issues, including clinical trial requirements and good manufacturing practice regulations. Ms. Kupchyk worked extensively on a number of special topics, such as FDA’s Good Tissue Practice regulations, cellular and gene therapy, bioengineered plants grown to produce pharmaceutical materials, xenotransplantation, medical errors, BSE and thimerosol-related issues, women subjects in clinical trials and the application integrity policy (AIP). She received numerous honors while at the agency, including the FDA Commissioner’s Special Recognition Award and the Health and Human Services General Counsel’s Award for Leadership. Ms. Kupchyk received her JD, with honors, from the University of Maryland School of Law, where she was inducted into the Order of the Coif.
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ANDREA C. LEVINE is the Director of the National Advertising Division (NAD) and a Vice President of the Council of Better Business Bureaus. She leads a team of experienced lawyers who form an important part of the advertising industry’s voluntary self-regulation system. Their role is to foster truth and accuracy in national advertising. Ms. Levine oversees an advertising monitoring and review process that has the confidence and cooperation of most of the nation’s leading advertisers. NAD has resolved close to 5,000 advertising cases over the past 38 years, and 96% of the parties comply with NAD’s recommendations although the system operates without legal sanctions or regulatory authority. Ms. Levine received her BA from New York University and her JD from Brooklyn Law School.
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GREGORY H. LEVINE is a Partner in the Washington, DC office of the law firm of Ropes & Gray LLP. Mr. Levine focuses his practice on Food and Drug Administration (FDA) regulation of pharmaceuticals, biotechnology, medical devices and cosmetics. He also counsels pharmaceutical and medical device clients on compliance with health care fraud and abuse laws. Mr. Levine regularly represents clients before state and federal regulators on all phases of product life cycle and assists clients with internal and government compliance investigations and enforcement actions. A former legislative staff member in the U.S. House of Representatives and former member of a White House healthcare reform task force, he is a frequent speaker on subjects relating to pharmaceuticals, biologics and medical devices. He received an AB, magna cum laude, from Brown University and his JD, magna cum laude, from the Georgetown University Law Center.
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GEOFFREY M. LEVITT is Associate General Counsel and Chief Regulatory Counsel at Wyeth where he is responsible for a wide range of legal/regulatory issues related to Board of Health regulation and compliance worldwide. Prior to joining Wyeth in April 2001, Mr. Levitt was a Partner and Co-chair of the food and drug law group at Venable, Baetjer, Howard & Civiletti in Washington, DC. He has published and lectured extensively on food and drug law, and is a past member of the editorial board of the Food and Drug Law Journal and a current member of the editorial board of the FDA Advertising and Promotion Manual. Mr. Levitt is a recipient of the Food and Drug Law Institute's 2009 Distinguished Service and Leadership Award and serves as a Director of the Institute. His most recent publications include the book Competitive Challenges in the Drug Approval Process: Generics, Hybrids and Follow-on Biologics (2005) and the chapter “The Drugs/Biologics Approval Process” in A Practical Guide to Food and Drug Law and Regulation (Food and Drug Law Institute, 3d ed. 2008). Mr. Levitt received his BA from Columbia University and his JD from Harvard Law School.
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HELEN LEWIS is the Director of Corporate Compliance and Regulatory Affairs for Dentsply International located in York, PA.
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STEVEN E. LINBERG, PhD is Managing Director, Vice President and Treasurer for Chiesi Pharmaceuticals Inc., a wholly owned Subsidiary of Chiesi Farmaceutici SpA, Parma, Italy. Dr. Linberg has primary responsibility for the day-to-day running of Chiesi Group’s U.S. Affiliate, and participates in the global development of Chiesi’s drug products with a primary focus on the U.S. He has over 30 years of both academic clinical research, and drug and biologics development, with experience in directing overall program development, and in individual trial design, execution and reporting. Dr. Linberg has held senior positions both within the pharmaceutical industry and at contract research organizations. He is the editor and a contributing author to the text Expediting Drug and Biologics Development, now in its 3rd edition, and teaches graduate courses in Drug and Biologics Development and Clinical Trial Design and Execution for the Johns Hopkins University. He received a BA in Biology from the University of Delaware, and an MS and PhD in Applied Physiology from the Pennsylvania State University.
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VIRGINIA (GINNIE) LUDWIG, MS, MBA is the Associate Director, State Health Policy, at AstraZeneca. Her responsibilities include serving as the in house expert on sales and marketing, drug distribution, privacy, environmental, lobbying and ethics, pedigree, Medicare and Medicaid and drug diversion issues. She was elected by her peers to serve as chair of the International Pharmaceutical Privacy Consortium State Working Group and has served in that capacity since 2006. Ms. Ludwig also serves on a number of the Pharmaceutical Research and Manufacturers of America (PhRMA) committees including the State Policy Section, The Supply Chain Security Group, and State Activities Focus Group. She has over twenty years in the pharmaceutical industry in sales, marketing, and public policy. Ms. Ludwig received a BA in Social Science and MS in education from The State University of New York and an MBA from the University of Southern California.
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MURRAY (MAC) M. LUMPKIN, MD, MSc is the Deputy Commissioner for International Programs, Office of the Commissioner, U.S. Food and Drug Administration (FDA). He is responsible for overseeing all of the FDA's international activities, including its interactions with its foreign counterpart agencies and major multinational public health organizations, its foreign confidentiality and other agreements, its foreign capacity building and harmonization programs, its interactions with foreign embassies in Washington, and the activities of the eight major geographic offices of FDA’s Office of International Programs. These offices include the 13 new foreign FDA posts in China, Europe, India, Latin America and the Middle East. His FDA career began in 1989 when he was recruited to be Director of the Division of Anti-infective Drug Products in the Center for Drug Evaluation and Research (CDER). Four years later, he became Deputy Center Director of CDER and was instrumental in implementing the first and second Prescription Drug User Fee Acts (PDUFA) and the pediatric trials incentive legislation. He has been a Deputy Commissioner since 2001. His undergraduate degree is from Davidson, his medical degree from Wake Forest, and his MSc degree (as a Fulbright Scholar) from the University of London. His pediatric and pediatric infectious disease training were both at the Mayo Clinic in Rochester, Minnesota.
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DIANE M. MALONEY, JD is the Associate Director for Policy in the Food and Drug Administration’s (FDA's) Center for Biologics Evaluation and Research (CBER). Ms. Maloney oversees CBER’s policy formulation and development as well as the center's regulations and guidance development. She also is responsible for representing the center on numerous cross-cutting agency and departmental initiatives. Prior to coming to CBER, she served as Associate Chief Counsel for Drugs and Biologics in FDA's Office of the Chief Counsel (OCC). Ms. Maloney received her JD from the University of Maryland School of Law.
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JOHN R. MANTHEI is a Partner in Latham & Watkins’ the Washington, DC office and is Global Co-Chair of the firm’s Healthcare & Life Sciences Practice Group. Mr. Manthei’s practice focuses on regulatory and legislative matters involving the Food and Drug Administration (FDA) for the medical device, pharmaceutical, biotechnology and food industries. Prior to joining Latham, Mr. Manthei served as Majority Counsel for the US House of Representatives’ Committee on Commerce. He also served as the primary congressional staff contact in the House with the FDA Commissioner’s Office and Center Directors in developing FDA policy. Currently, Mr. Manthei serves as outside FDA counsel to the Medical Device Manufacturers Association (MDMA) and is a member of the Food & Drug Law Institute’s Advisory Committee for Drugs and Biologics. In 2006, Mr. Manthei was named by Washingtonian Magazine one of the top “40 Lawyers under 40.” He has also authored numerous articles on FDA regulatory matters, and has been a featured speaker and lecturer on FDA regulatory and policy matters at numerous industry events. Mr. Manthei received his BA, magna cum laude, Phi Beta Kappa, from Miami University in Oxford, OH, and his JD from the University of Wisconsin School of Law.
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JUDITH K. MERITZ is a Shareholder at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC in Washington, DC. She concentrates her practice in Food and Drug Administration (FDA) compliance counseling in the areas of drugs, devices and biologics. She also offers regulatory expertise in the areas of Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), DOT and Environmental Protection Agency (EPA). Previously, Ms. Meritz was a Partner in the Health Law Practice Group at Blank Rome LLP. Ms. Meritz also served as Assistant General Counsel for the American Red Cross (ARC) responsible for regulatory affairs. In this capacity, she was the Chief Counsel to the BioMedical Services group providing guidance to ARC headquarters staff, as well as field blood regions and national testing labs, with particular emphasis on compliance with FDA regulations and the FDA Amended Consent Decree. Prior to joining ARC, she served as Vice President, Regulatory Affairs at E-Z-EM, Inc, a manufacturer of drugs, devices and diagnostics. Her responsibilities included providing counsel to domestic and international business divisions regarding all aspects of regulatory affairs and governmental compliance including quality control, product labeling, registrations, recalls, complaint handling and safety and environmental compliance. Former positions include Director of Regulatory Affairs and Regulatory Counsel for Henry Schein, Inc, the largest distributor and private labeler of products for office-based healthcare practitioners. She began her legal career as an Assistant Regional Counsel for the U.S. Environmental Protection Agency, Region II. Recently, she completed a chapter in an FDA news publication on Crisis Communications and a chapter on Food and Drug Law Client Strategies for Aspatore Books. She is the chairperson for FDLI’s Law Journal Editorial Advisory Board, serves on the Dean’s Advisory Council and serves as Alumni Chapter President of the School of Public Affairs at American University, Washington, DC. Ms. Meritz received her BA from American University, and dual master degrees from the University of Michigan in Higher Education and Political Science and her law degree from Pace University.
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THOMAS J. MILLER, CEO of Siemens Healthcare’s Workflow & Solutions Division, a recognized expert in medical technology and healthcare information technology, is passionate about leveraging these innovations to transform medicine. A 20-plus year veteran with Siemens, he has served on the Executive Board of Siemens Medical Solutions, as President/CEO of its IT division, Vice President of Business Development, Head of the Magnetic Resonance Product Division, as well as leading the U.S. sales and service organization. Mr. Miller holds a BS in Nuclear Engineering with a minor in English Literature from the University of Massachusetts, and a Master's degree from Harvard Medical School/MIT's joint program in Medical Physics.
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ROBERT B. NICHOLAS is a Partner in the Washington, DC office of McDermott, Will & Emery. He is head of the firm’s Food and Drug Administration (FDA) and Biotechnology Practice Group in the Health Law Department, where he represents companies and non-profit institutions on government (agency and legislative) and business matters involving biomedical, agricultural and environmental applications of biotechnology and related technologies. The Practice Group regularly assists with obtaining federal and state government approvals to test and market new products in the biomedical, agricultural, and environmental fields; participates in agency rulemaking and enforcement proceedings; lobbies on behalf of the biotechnology industry; obtains financing and negotiates business deals for biotechnology companies. Mr. Nicholas served previously as Chief Counsel to Vice President Gore when he was Chairman of the Oversight Subcommittee of the House of Representatives’ Committee on Science and Technology, and as Counsel to the President’s Council on Environmental Quality. Prior to coming to Washington, Mr. Nicholas was a trial attorney and served as a Deputy Attorney General for the Commonwealth of Pennsylvania. Mr. Nicholas is a frequent public speaker and author on various biotechnology industry and veterinary medicine issues. He currently serves as Vice Chairman of the Special Committee on Biotechnology of the American Bar Association and as an Editor of the Biotechnology Law Journal. Mr. Nicholas received his AB from St. Lawrence University and his JD from Boston University.
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STEVEN M. NIEDELMAN is a Senior Consultant with Crowell & Moring LLP, specializing in Food and Drug matters in the Health Care Group. He provides strategic advice and insight to companies involved in or facing Food and Drug Administration (FDA) enforcement actions, ranging from evaluating and responding to FDA-483’s to firms under Consent decree. Mr. Niedelman develops corrective actions that assure business needs and regulatory requirements are properly balanced so that compliance is achieved without compromising business objectives. He assists with problem risk management issues as well as crisis management affecting problem products and issues, and provides training and coaching to executive management about FDA’s expectations and how it entwines with their management responsibility. Prior to joining Crowell & Moring, Mr. Niedelman was Executive Vice President of Quintiles Consulting, a global food and drug consulting firm that focused on the pharmaceutical, medical device and biotech industries. Mr. Niedelman retired from the Food and Drug Administration after 34 years as the Deputy Associate Commissioner for Regulatory Operations and COO of the Office of Regulatory Affairs providing direct oversight over FDA’s field offices and laboratories, Office of Criminal Investigations and Office of Enforcement. Prior to that he served as the Director of FDA’s Office of Enforcement, where as Chairman of FDA’s Compliance Policy Council assured consistent interpretation of regulatory, recall and enforcement policies and procedures across all the five scientific specialty centers within FDA. Mr. Niedelman spent nearly 24 years at the center for Devices and Radiological Health (CDRH) where he held several management positions throughout the Office of Compliance. He was responsible for implementing many of the statutory requirements and creating and shaping many of the regulations and policies affecting the sale, distribution, manufacture and promotion of medical devices. He began his career with FDA as a Consumer Safety Office in FDA’s New York District office. Mr. Niedelman earned a Bachelor’s Degree in Biology and Chemistry from the College of Emporia.
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KARL M. NOBERT, JD, MBA practices in the Food and Drug Administration (FDA) group in K&L Gates' Washington, DC office. His work includes advising clients on regulatory issues associated with the manufacturing, marketing and sale of Rx and generic drug products, over-the-counter drugs, biologics and veterinary products. With fellow K&L Gates attorney Gary Yingling, Mr. Nobert published an article in the June 2008 edition of the Journal of the American Veterinary Medical Association discussing the use of stem cells in veterinary medicine and its likely regulation. He received his undergraduate degree from the University of North Carolina at Chapel Hill, and his JD and MBA from Villanova University.
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JAMES T. O'REILLY is Counsel to Baker & Daniels, Indianapolis, IN, and a Visiting Professor of Law at the University of Cincinnati. He retired in February 1998 as Associate General Counsel for The Procter & Gamble Company (P&G) after almost twenty-four years of representing P&G before headquarters and field officials of the Food and Drug Administration (FDA) and other federal and state agencies. Mr. O'Reilly is the author of numerous textbooks, including the standard reference text Food and Drug Administration (West) and FDLI’s 2002 book Food Safety Crisis Manuel. He formerly headed the American Bar Association's (ABA) FDA Committee, the ABA Section of Administrative Law & Regulatory Practice, and the FDLI Program Advisory Committee. His students at the University of Cincinnati won numerous FDLI writing awards over his twenty-nine years of teaching. Mr. O'Reilly is a graduate of Boston College and the University of Virginia School of Law.
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JOHN M. PACKMAN is Senior Counsel, Food Law, at The Coca-Cola Company. Mr. Packman provides advice on food-related regulatory issues, advertising substantiation, particularly in connection with the development of new products. He works with clients in the company’s business units and the Scientific and Regulatory Affairs, Public Affairs, Quality, Innovation and Incident Management/Crisis Response functions. Before joining the company in 1997, Mr. Packman worked for The Quaker Oats Company and the Mead Johnson Nutritionals division of Bristol-Myers Squibb Company. Before moving in-house, he practiced litigation and food and drug law at Arent Fox in Washington, DC Mr. Packman received his AB from Princeton and his JD from Harvard.
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FRANCIS B. PALUMBO, PhD, Esq is Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy in Baltimore, MD. He is a licensed pharmacist and a member of the Maryland Bar. He has practiced both pharmacy and law. Dr. Palumbo and his colleagues at the University of Maryland conducted much of the early work on drug use review, a subject on which they have published widely. He has been the principal investigator on major federal research grants examining the use of drugs in long term care patients. Dr. Palumbo has many journal articles and presentations to his credit and co-authored a book on containing costs in third party drug programs. He maintains an interest in pharmacoeconomics, pharmacoepidemiology and health services research as well as healthcare and food and drug law. He has been very active in several national professional organizations, including the American Pharmaceutical Association where he served as President of the Academy of Pharmaceutical Research and Science, and the American Society for Pharmacy Law where he serves on the Board of Directors. Dr. Palumbo received a BS in Pharmacy from the Medical University of South Carolina, and MS and his PhD in Health Care Administration from the University of Mississippi and JD from the University of Baltimore Law Center.
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DOUGLAS PEDDICORD, PhD, MA serves as Executive Director of the Association of Clinical Research Organizations (ACRO), is a Managing Partner of Oldaker, Belair & Wittie LLP, and serves as President of Washington Health Strategies Group, LLC. In these capacities, Dr. Peddicord provides a full range of consulting, lobbying and association management services to healthcare organizations. Previously, he was Vice President of Washington Health Advocates, representing physician and patient groups, health systems, and professional societies. Following a career as a clinical psychologist, Dr. Peddicord came to Capitol Hill as an American Association for the Advancement of Science (AAAS) Fellow and was a health policy advisor to then-Congressman (now Senator) Benjamin Cardin (D-MD). Currently, he provides strategic and policy advice and representation to healthcare organizations on matters including Medicare coverage and payment policy, health information technologies and medical privacy, and drug development activities including oversight by the Food and Drug Administration (FDA) and other regulatory agencies around the world. He is on a number of boards and committees, including the steering committee of the Clinical Trials Transformation Initiative (CTTI), a public-private collaborative spearheaded by the Office of Critical Path Programs of FDA. Having pursued undergraduate studies at Amherst College and the University of Bridgeport, Dr. Peddicord received a Master's degree and a PhD in Clinical Psychology from Adelphi University. He is licensed as a psychologist in Maryland.
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JEANNIE M. PERRON, DVM is an Of Counsel at the law firm of Covington & Burling LLP in Washington, DC. Her practice emphasis is food and drug law, particularly animal food and drug law, and animal welfare cases. She has authored or co-authored numerous articles and chapters in various publications. She is a member of a number of state and federal bars and the U.S. Patent and Trademark Office. Dr. Perron received her JD from George Washington University and her DVM from Texas A&M University.
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PHILIP J. PHILLIPS, MBA is the Director of the Medical Device Practice at Becker & Associates Consulting, Inc. He has 24 years of experience in Food & Drug Administration (FDA) regulation of medical devices, having focused on the development and implementation of numerous regulatory strategies regarding the design, manufacture and marketing of medical devices in the United States. Mr. Phillips is knowledgeable in a wide range of regulatory matters, including FDA jurisdiction, device classification, clinical trials, human subject protection, and product labeling, promotion and advertising. He has experience explaining and defending positions before the United States Congress; the Department of Health and Human Services (DHHS); FDA and its advisory committees; as well as other federal agencies. He has represented the United States government in negotiations with the European Union and is an authority on dispute resolution and interacting effectively with FDA and related agencies. Mr. Phillips has served as an expert witness in court proceedings and is a frequently invited speaker at scientific and regulatory forums. He has received numerous awards for his accomplishments, including two DHHS Distinguished Service Awards and three FDA Awards of Merit. Most recently, Mr. Phillips served as the Deputy Director for Science and Regulatory Policy in FDA’s Center for Devices and Radiological Health (CDRH’s) Office of Device Evaluation (ODE), where he led successful efforts to modernize medical device regulation. In addition to serving as ODE’s Deputy Director for Science and Regulatory Policy, he served as Director of Program Operations, Interim Director for the Division of General and Restorative Devices, Deputy Director for the Division of Ophthalmic Devices and the Chief of the Surgical and Diagnostics Devices Branch. Mr. Phillips received his BS in Microbiology from the University of Maryland and his MBA from the George Washington University. Mr. Phillips also completed the George Washington University Contemporary Executive Development Program.
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BERT W. REIN is a founding Partner of Wiley Rein LLP. Mr. Rein specializes in using constitutional law issues, such as First Amendment and due process, to challenge emerging legislative and regulatory policy. He recently represented Wyeth in Wyeth v. Levine, a major test of federal preemption arising from Food and Drug Administration (FDA) regulation of drug labeling. The case, which culminated in a Supreme Court of the United States ruling that FDA oversight of drug labeling does not prevent state-level consumer liability lawsuits against drug companies, received considerable public attention, with Mr. Rein cited frequently in the press speaking on behalf of Wyeth. Mr. Rein is widely recognized as a leading litigator and international law expert. He was recognized by Legal Times as Washington’s “Leading Food and Drug Lawyer” for being a “key player in some of the highest-profile food-and-drug conflicts in recent years.” He is a member of American Bar Association (ABA), Section of Antitrust Law and a member of the Food and Drug Law Institute. Mr. Rein earned his LLB, summa cum laude, from Harvard Law School, where he served as Notes Editor for the Harvard Law Review. He received his BA, summa cum laude, from Amherst College.
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JOHN B. REISS, PhD is a Partner and Chairman of the Health Law Practice Group of Saul Ewing LLP in Philadelphia, PA. Dr. Reiss concentrates his practice in matters related to healthcare including mergers and acquisitions; developing and implementing provider networks; corporate, partnership and contractual arrangements and ventures; Medicare, Medicaid and other insurance coverage and payment issues; developing and implementing compliance audits and plans; Food Drug Administration drug and device issues; NJ certificate of need, licensure and other regulatory matters; medical staff credentialing and disputes and patient care problems. Previously Dr. Reiss served as the Director, Office of Health Regulation, U.S. Department of Health and Human Services. There he was responsible for the review of federal regulations of hospital, nursing homes and HMOs to reduce the regulatory burden and ensure public benefits were provided in the most efficient way with the least disruption to providers of care. From 1975-1979, he served as Assistant Commissioner, New Jersey State Department of Health, where he was responsible for development of the DRG prospective payment system for hospitals and for other regulation of healthcare facilities. While serving in the educational community, Dr. Reiss was Associate Professor of Economics at Stockton State College and held the position of Assistant Professor of Economics at Allegheny College. A frequent lecturer and author, he has spoken before many organizations at the national, state, and local levels regarding legal, governmental, healthcare, and environmental issues. Dr. Reiss received his BA from Exeter University in Exeter, Devon, England, his AM and PhD in economics from Washington University, St. Louis, MO, and his law degree from Temple University School of Law.
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ROBERT A. RHOADES is Director, Quality Systems and Compliance Practice at Becker & Associates. Within his thirty-one-year career, Mr. Rhoades has held a variety of leadership positions in Quality Management, counseling senior executives in Food and Drug Administration (FDA) regulated companies regarding compliance and its impact on corporate performance and direction. His experience spans the Quality discipline from managing the Quality function at Baxter and Bausch & Lomb, to planning and implementing quality management and performance improvement systems for client companies around the world. He has led numerous compliance-related projects in the form of due diligence reviews for acquisition targets, the development of a complex corrective action plan which averted escalation of enforcement actions by the FDA, and the successful resolution of numerous Warning Letters, including those involving import detentions for foreign manufacturers. Mr. Rhoades has also worked in concert with client counsel on a wide variety of legal cases. Most recently, he was selected by client counsel to assist in the worldwide heparin contamination investigation. He is frequently an invited speaker at pharmaceutical and medical device conferences in both the U.S. and Europe, and has authored several articles on quality-related topics. His first book, Risky Business: Managing The Quality of America’s Medicines, was released by FDANews, and is now available as an updated Second Edition. A second book, Sustaining Compliance: Strategies for Maintaining Drug Quality, was released in 2005. Mr. Rhoades holds a Bachelor of Science degree in Microbiology from Purdue University and a Master of Business Administration in Strategic Planning and Operations Management from Lake Forest (IL) Graduate School of Management.
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LARISA RUDENKO, PhD serves the Food and Drug Administration (FDA) as Senior Advisor for Biotechnology at the Office of New Animal Drug Evaluation at the Center for Veterinary Medicine. In that capacity, she has worked within the agency, at the U.S. Government (USG) coordinating level, and internationally with public and private sector stakeholders to develop a coherent, transparent, science-based policy for the regulation of animal biotechnology. Dr. Rudenko serves as an expert on Food and Agriculture Organization (FAO) – World Health Organization (WHO) Codex Alimentarius Task Forces, FAO-WHO Expert Consultations, Organization for Economic Co- operation and Development (OECD) Working Groups, international and various other review committees and scientific advisory panels. Prior to her FDA appointment, Dr. Rudenko was a Founder and Partner of Integrative Biostrategies (IB) LLC, a Washington, DC-and Houston-based technical and regulatory support consulting firm. Before starting IB, Dr. Rudenko was a Managing Director of The Life Sciences Consultancy, LLC, where she provided scientific and regulatory consulting services. Previously, she was a senior manager at the ENVIRON International Corporation providing health and environmental risk services. Dr. Rudenko received her AB degree from Bowdoin College and her PhD in Cellular and Molecular Pharmacology from the State University of New York at Stony Brook following dissertation research at the Brookhaven National Laboratory; she is also a Diplomate of the American Board of Toxicology.
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ALAN M. RULIS, PhD is Senior Managing Scientist, Chemical Regulation and Food Safety at Exponent, Inc. Prior to joining Exponent, Dr. Rulis spent nearly 30 years at the U.S. Food and Drug Administration (FDA), including nine years as Director of the FDA’s Office of Food Additive Safety. He served in the federal government’s Senior Executive Service from 1996 to 2003, and as Senior Advisor for Special Projects in the FDA’s Center for Food Safety and Applied Nutrition from 2004 until his retirement from federal service in June 2006. With a scientific background that spans both the physical and biological sciences, Dr. Rulis brings a broad perspective to a range of complex scientific, regulatory and policy issues in the public health arena. As Director of the Office of Food Additive Safety, Dr. Rulis was responsible for FDA’s premarket safety evaluation of new food and color additives, packaging materials used in contact with food, generally recognized as safe (GRAS) food ingredients, and the safety of foods developed through modern biotechnology. He has experience in all aspects of the safety evaluation of food chemicals, including toxicological testing requirements and guidelines; the chemistry, purity and specifications of permitted food ingredients; and the dietary intake estimation of new food ingredients, additives, and other food components. Dr. Rulis is internationally recognized, having served as an advisor to the U.N. Food and Agriculture Organization/World Health Organization (FAO/WHO) Joint Expert Committee on Food Additives. For six consecutive years, he headed the U. S. Delegation to the FAO/WHO Codex Committee on Food Additives and Contaminants in The Hague. In that role, he worked with representatives from a number of countries to develop the General Standard for Food Additives, an international roster of food additives permitted in global food commerce. Dr. Rulis was an original collaborator on FDA’s carcinogenic impurities policy for food additives. Also he developed the scientific basis for FDA’s Threshold of Regulation policy for addressing potential carcinogenic risks from food contact materials. He helped establish the agency’s Priority-based Assessment of Food Additives, a continuously updated repository of chemical and toxicological information on food and color additives and other food chemicals permitted in the United States. Dr. Rulis has received numerous awards including the Presidential Meritorious Executive Rank Award. He has published several book chapters as well as numerous articles in scientific and other scholarly journals. He represented FDA in numerous venues throughout his government career, and currently speaks and writes on a range of subjects. He received his BA from Augustana College and his PhD in chemistry from the University of Wisconsin, Madison.
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KATHLEEN M. SANZO is a Partner in the FDA/Healthcare Regulation Practice Group in the Washington, DC office of Morgan Lewis. Her practice focuses on all regulatory and compliance matters of the Food and Drug Administration (FDA) relating to bulk and finished prescription and over-the-counter drug manufacture, approval, marketing, and distribution; cosmetic regulation and advertising: biotechnology drug regulation, pre-clinical and clinical testing, drug and device promotional and labeling issues, food additive and dietary supplement matters, state and federal privacy, regulatory, and enforcement matters of the Office of Inspector General of the Department of Health and Human Services and the Centers for Medicare and Medicaid Services, and regulatory and compliance matters of the Federal Trade Commission and related state enforcement agencies. Before joining the firm, she clerked in the FDA's Office of General Counsel and was a Fellow of FDLI. Ms. Sanzo is vice-chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice and a member of the Regulatory Affairs Professionals Society. She was selected as part of an exclusive list of prestigious “Outstanding Fraud and Compliance Lawyers – 2004” by Nightingale’s Healthcare News. Ms. Sanzo received her AB from Duke University, her JD from Emory University Law School, and her LLM from the National Law Center at George Washington University.
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MARC J. SCHEINESON is a Partner in the Washington, DC office of Alston & Bird. He heads the firm’s food and drug law practice. He has practiced food and drug law, healthcare law, and administrative law for over 20 years in national law firms and at the Food and Drug Administration (FDA). His practice focuses on determining the “regulatory course of least resistance” to market medical products, and assisting clients with legal research issues, drug and medical device applications, compliance, and enforcement matters. Mr. Scheineson provides legal, regulatory, and legislative counsel to a variety of marketers, research institutions, professional associations, and manufacturers of pharmaceutical and biological drug products, medical devices, cosmetics, dietary supplements, and traditional foods. He is a frequent speaker in industry forums. He is also experienced with the application of the Office of the Inspector General (OIG) anti-kickback statute, HIPAA privacy rules, clinical trial regulation, human research protection, scientific misconduct, technology transfer and licensing, advertising and promotion law, and advises on the FDA regulatory aspects of healthcare transactions. He previously served as Associate Commissioner for Legislative Affairs at the FDA. He came to Washington, DC to serve as Legislative Assistant and Counsel to Rep. Bill Gradison (R-OH), the ranking member of the Health Committee of the Committee on Ways and Means. In addition, he has worked as a Senior Vice President of Ketchum Communications and as a Principal in its government relations unit. Mr. Scheineson is a former Co-Chairman of the American Bar Association’s Committee on Food and Drug Law; chaired its Task Force on FDA Reform and is a former Chairman of the Young Lawyers Section of the Bar Association of the District of Columbia. He received his BA and JD from the University of Cincinnati and its College of Law and his LLM from the Georgetown University Law Center.
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DAVID B. SCHMICKEL, JD, PhD is with FoxKiser in Washington DC. Prior to joining FoxKiser, he was a detailee, from the National Institutes of Health, to Senator Enzi’s Health Policy Group for the Senate’s Health Education Labor and Pensions Committee. He previously served as Patent and Legal Counsel to the Biotechnology Industry Organization. Dr. Schmickel earned his BS from the University of Maryland, his PhD from John Hopkins University, and his JD from the University of Baltimore.
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BARBARA O. SCHNEEMAN, PhD is Director, Office of Nutrition, Labeling, and Dietary Supplements (ONLDS), in the Center for Food Safety and Applied Nutrition (CFSAN), with the Food and Drug Administration (FDA). She oversees the development of policy and regulations for dietary supplements, nutrition labeling and food standards, infant formula, and medical foods. Prior to joining FDA, she served as a member of the faculty and administration at the University of California, Davis. She held a faculty appointment in the Departments of Nutrition, Food Science and Technology, and Internal Medicine in the School of Medicine. Dr. Schneeman has served as Assistant Administrator for Nutrition in the Agricultural Research Service in the U.S. Department of Agriculture. She has many professional activities and honors to her credit. Dr. Schneeman received her BS from the University of California, Davis in food science and technology, and her PhD in nutrition from the University of California, Berkeley.
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WILLIAM B. SCHULTZ is a Partner in the law firm of Zuckerman Spaeder in Washington, DC, where he represents clients in court, before Congress and at the Food and Drug Administration (FDA). Prior to joining Zuckerman Spaeder, he held the position of Deputy Assistant Attorney General, Civil Division, U.S. Department of Justice, where he supervised the Civil Division’s Appellate Litigation and the Department’s lawsuit against the tobacco industry. He also served as Deputy Commissioner for Policy at the Food and Drug Administration (1994-1998) and as Counsel for the Subcommittee on Health and the Environment, U.S. House of Representatives, Committee on Energy and Commerce (1990-1994). Prior to entering the government, Mr. Schultz was an attorney at Public Citizen Litigation Group, where he represented groups in the Congressional consideration of the Hatch-Waxman Act of 1984. He also served as a law clerk to U.S. District Judge William B. Bryant and for several years was an Adjunct Professor at Georgetown University Law Center, teaching courses in Food and Drug Law and Civil Litigation. Mr. Schultz received his BA from Yale University and his JD from the University of Virginia Law School. He is currently the Chair of the Food and Drug Law Institute.
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RICHARD A. SCOTLAND is the Senior Vice President of Regulatory Affairs for GTC Biotherapeutics, Inc. located in Framingham, MA.
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JEFFREY M. SENGER is Deputy Chief Counsel of the Food and Drug Administration (FDA). As the senior career lawyer at the FDA, he manages the legal affairs of the agency, approving regulations, guidance documents, and warning letters issued by FDA; overseeing FDA-related litigation; and providing legal advice to the FDA Commissioner and senior leadership at the Department of Health and Human Services. He has spoken on FDA-related issues for numerous organizations around the country and is a member of a Food and Drug Law Institute Editorial Advisory Board. He previously served as Senior Counsel in the Office of the Associate Attorney General at the United States Department of Justice, where he assisted in overseeing the work of more than 2000 lawyers, including the office that provides counsel and legal representation to the FDA. He has served as lead counsel in numerous civil and criminal trials before juries and judges in federal and state courts, and argued cases in the United States circuit courts of appeals. He has also prosecuted felony criminal cases as a Special Assistant United States Attorney. He began his career as a law clerk for a United States District Court judge. An award-winning author, he wrote a book entitled Federal Dispute Resolution (Wiley 2003) and numerous law review articles. He has taught trial advocacy, mediation, and negotiation at Harvard Law School, and he is an elected member of the American Law Institute. He has testified as an expert witness before the United States Congress and has spoken on behalf of the United States government on five continents. He is an honors graduate of Harvard College and Harvard Law School.
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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 performs a variety of mergers and acquisitions, general commercial and regulatory work. 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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RACHEL SHER serves as Counsel, Majority Staff, for the Committee on Energy and Commerce, U.S. House of Representatives.
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PATRICIA B. SHRADER is Senior Vice President, Corporate Regulatory and External Affairs for BD. In this position she is 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. Previously, Ms. Shrader was counsel with the law firm of Hogan & Hartson. Her practice focused primarily on medical devices, with an emphasis on product submissions and GMP issues. Prior to 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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BRUCE A. SILVERGLADE is Director of Legal Affairs at the Center for Science in the Public Interest (CSPI), a nonprofit consumer advocacy organization supported by approximately one million members. Mr. Silverglade coordinates CSPI's legislative and regulatory activities on food labeling and advertising, dietary supplements, nutrition policy, and international issues. He has also supervised federal court litigation and served as counsel in federal court cases involving product labeling and advertising. In 1988 he organized a broad-based coalition effort by health, medical and consumer organizations that culminated in the enactment of the Nutrition Labeling and Education Act of 1990 (NLEA). Prior to joining CSPI, Mr. Silverglade worked at the Federal Trade Commission as a Staff Attorney and later served as an Attorney-Advisor to the Director of the Bureau of Consumer Protection’s Office of Policy and Planning. Mr. Silverglade received his BA, cum laude, in political science from the University of Illinois, where he was a member of Phi Beta Kappa, and his JD from Boston College. He also studied at Harvard Law School as a Special Student in Law and Public Policy.
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ALAN SLOBODIN, Esq is the Republican Chief Counsel for Oversight and Investigations at the House Energy and Commerce Committee. He previously served as the Majority Deputy Chief Counsel for Oversight and Investigations at the Committee, and has been with the Committee since 1995. As an oversight counsel, he has been responsible for oversight and investigations involving public health, with a particular focus on the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Mr. Slobodin is a graduate of the George Washington University Law Center and a magna cum laude graduate of Temple University.
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ROBERT M. SPILLER, JR. worked thirty-two years as a Food and Drug Administration (FDA) lawyer, beginning in 1971 as a trial attorney and retiring in 2003 as one of the Associate Chief Counsel for Enforcement. In that career, he prepared, reviewed, supervised and presented cases in administrative hearings, formal and informal; in Federal Magistrate’s court; in United States District courts; and argued in a number of the United States Courts of Appeal. His case assignments included each of the various enforcement remedies under the Federal Food, Drug and Cosmetic Act: seizures of violative products, injunctions of violative firms and individuals, and prosecutions of violative firms and individuals. Mr. Spiller’s assigned criminal cases included grand jury investigations. Some of the cases and all of the administrative hearings involved the preparation, presentation and cross examination of sophisticated scientific testimony. He was a special Assistant United States Attorney for some criminal and one civil case, the later on behalf of the United States Department of Agriculture in a beef condemnation case. Mr. Spiller’s practice included advising FDA investigators, compliance officers, and special agents on inspection, warrant and subpoena issues, as well as working with them in preparation of case referrals to the Department of Justice and in presenting these cases. He taught course segments in courses for FDA attorneys, Food and Drug Law Institute and Association of Food and Drug Officials members, as well as for many state and federal investigators, special agents, analysts and compliance officers. Currently, Mr. Spiller is a contract instructor in Food and Drug Law. He earned his Bachelor of Science in Business Administration from Virginia Polytechnic Institute (now called Virginia Tech), and a Juris Doctor degree from the University of Virginia Law School.
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EDWARD A. STEELE is the President of EAS Consulting Group, which he formed in 2006. Mr. Steele has 30 years of Food and Drug Administration (FDA) experience managing the planning, development, implementation and evaluation of FDA’s food and cosmetic programs. In 1994, he joined AAC/Kendle as Vice President of the Food, Dietary Supplement & Cosmetic Consulting Division. Under his leadership, and through the efforts of the outstanding staff that he had assembled, AAC/Kendle was recognized as a global leader in the food, dietary supplement and cosmetic consulting field. During the last 2 years at AAC/Kendle, Mr. Steele served as President of the Rockville, MD office. In 1964 Mr. Steele began his career as an FDA analytical chemist in the New York District. Mr. Steele then moved to FDA Headquarters in Washington DC where he held various positions of increasing responsibility at the Center for Food Safety and Applied Nutrition (CFSAN). In addition to managing FDA’s Compliance and Industry Programs for much of his career he provided support to the Center Director on all science policy matters, established FDA’s Office of Seafood, coordinated international affairs, and managed the Center’s education and technical assistance programs. He holds an MBA in management and has been the recipient of various awards including the FDA Award of Merit and the Meritorious Citation Award.
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STEPHEN F. SUNDLOF, DVM, PhD is the Director of the Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug Administration (FDA). He was appointed to this position in January 2008. In this capacity, he provides executive leadership to the Center’s development and implementation of programs and policies relative to the composition, quality, safety, and labeling of foods, food and color additives, dietary supplements and cosmetics. In the 14 years preceding this appointment, Dr. Sundlof served as Director of FDA’s Center for Veterinary Medicine. Prior to joining FDA, he was a professor at the University of Florida, College of Veterinary Medicine. Dr. Sundlof has published numerous articles in scientific journals on drug residues and food safety. He presently serves as chairman of the WHO/FAO Codex Alimentarius Committee on Residues of Veterinary Drugs in Foods and is past president of the American Academy of Veterinary Pharmacology and Therapeutics. He received both his Doctorate in Veterinary Medicine and PhD in toxicology from the University of Illinois, and is a diplomat of the American Board of Veterinary Toxicology.
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LINDA A. SUYDAM, DPA is the President and Principal Spokesperson for Consumer Healthcare Products Association (CHPA). Since joining CHPA, she has directed the establishment of the Consumer Health Education Center (CHEC), CHPA’s educational foundation; increased opportunities for synergistic cooperation between member firms by establishing the annual Market Exchange and retail immersion events; and enhanced the Association’s positive relationship with the Food and Drug Administration (FDA) through educational seminars, conferences and joint learning opportunities. Prior to joining CHPA, she had a 21-year career at FDA, rising from an entry-level position to Senior Associate Commissioner. Dr. Suydam left the agency for three years to serve as the Associate Vice President for of the Health Sciences Center at the University of New Mexico with responsibility for planning, development public relations and marketing. During her FDA career, she received the Presidential Meritorious Rank Award, the Department of Health and Human Services Distinguished Service Award and the Public Health Service Superior Service Award. She is a member of several boards of directors, including the World Self-Medication Industry Federation, the Food and Drug Law Institute Board and the Sewall-Belmont House & Museum. Dr. Suydam received her BA from the College of New Jersey, her MA from George Washington University, and her MPA and DPA from the University of Southern California.
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MICHAEL A. SWIT is a Vice President at The Weinberg Group Inc., where he is responsible for ensuring the development and execution of an array of Food and Drug Administration (FDA) and European regulatory services to both direct clients and through outside counsel. His responsibilities include product development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional regulatory activities, labeling and advertising, and clinical research efforts for various life sciences companies, as well as those in the food and dietary supplement industries. Prior to joining The Weinberg Group, Mr. Swit was a member of the FDA Law Group within the Life Sciences National Practice Group in the La Jolla, CA office of Heller, Ehrman, White & McAuliffe. He has extensive experience in all aspects of FDA regulation with a particular emphasis on drugs and medical device law and regulation. In addition to his private FDA regulatory law experience, Mr. Swit served as vice president and general counsel of Par Pharmaceutical from 1990 to 1993. He then served from 1994 to 1998 as CEO of Washington Business information, Inc. (WBII). At WBII, now known as FDAnews, he developed a number of new FDA regulatory information products, including the publisher's first software program in the FDA arena and a treatise on crisis management for FDA-regulated firms entitled When Lightning Strikes. Mr. Swit's private law practice also includes stints with McKenna & Cuneo in the firm's Washington, DC office and San Diego offices. He first practiced FDA regulatory law with the DC office of Burditt & Radzius. Mr. Swit has taught and written on a wide variety of subjects relating to FDA law including co-directing an annual three-day intensive course on the generic drug approval process, serving on the Editorial Board of the Food & Drug Law Journal, and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved, published by WBII. Mr. Swit received his AB, magna cum laude, with high honors in history from Bowdoin College and his law degree from Emory University. He is a member of the DC, Virginia and California bars.
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STEPHEN D. TERMAN is a Principal at Olsson Frank Weeda Terman Bode Matz PC. Mr. Terman concentrates his practice in medical device law, Food and Drug Administration (FDA) regulatory issues, and litigation. While at Olsson Frank Weeda Terman Bode Matz PC, he has represented over 200 corporations, individuals and associations in civil, criminal and regulatory matters. Mr. Terman’s expertise covers all areas of medical device law including the Quality System Regulation, Medical Device Reporting, IDE, 510(k) and PMA submissions. He has helped companies respond to FDA inspectional observations, Warning Letters and recalls, as well as civil penalty actions, injunctions, clinical disqualifications and criminal prosecutions. Until joining the firm in 1990, he served as Associate General Counsel of the former Health Industry Manufacturers Association (HIMA), now AdvaMed, a national trade association representing over 300 medical device, diagnostic product and healthcare information systems manufacturers. While at HIMA, he was responsible for handling the Association’s FDA-related legal, regulatory, and Congressional issues. Before joining HIMA in 1987, Mr. Terman served as Associate Chief Counsel for Enforcement, U.S. Food and Drug Administration, where he received the prestigious Award of Merit for outstanding consumer protection efforts, and the Commendable Service Award in recognition of superior performance in litigating complex enforcement cases raising significant questions concerning the agency’s jurisdiction and the scope of its authority. Mr. Terman worked for the U.S. Food and Drug Administration from 1976-1987. Mr. Terman has given hundreds of speeches and is a frequent lecturer before trade and professional groups including AdvaMed, RAPS, FDLI, IBC, AAMI, HMS and AFDO. In 1995, Mr. Terman successfully defended a former USCI Bard employee charged with conspiracy to defraud the FDA in U.S. George Maloney, et. al., in Boston Massachusetts. In 2007, Mr. Terman was honored by the Washingtonian Magazine as one of Washington, DC’s top FDA lawyers. Mr. Terman received his BS in economics from the University of Maryland where he was Phi Kappa Phi. He received his JD also from the University of Maryland. He is currently a member of the District of Columbia Bar.
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ROSEANN B. TERMINI is an attorney with over 24 years of extensive experience in food and drug law. She is a Professor of Widener University School of Law. Following her appellate clerkship, she served as the sole corporate counsel for a pharmaceutical company and as a regulatory affairs attorney. As senior deputy attorney general, Office of Attorney General, she successfully litigated and prosecuted numerous cases at the trial and appellate levels. Her special appointment involved drafting regulations and implementation procedures for the Plain Language Consumer Contract Act. Ms. Termini initiated the inaugural online food and drug law courses at Widener and she taught food and drug law at Penn State Dickinson Law. She was awarded the 2008 dedicated teacher award at Widener. She is involved in distance learning in executive pharmacy and biotech programs at the University of Georgia, Johns Hopkins, St. Joseph’s, Drexel and Temple Universities. Other core food and drug law courses include dietary supplement law, advanced topics and the Legal Environment of Business-ECommerce. Ms. Termini has authored numerous articles and books in scholarly publications primarily focusing on food and drug law issues; however, she has written about the environment, constitutional issues and Plain English drafting. Recently she authored books entitled: Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements and Statutory CD are for regulators and the regulated community. She has served on various committees and boards. She received the first statewide Pennsylvania Bar Association Plain English Clarity award. Ms. Termini is also a food, pharmaceutical and medical device law consultant. Ms. Termini received her BS, magna cum laude, from Drexel University, her MEd, Fellow, from Temple University and her JD from Temple University School of Law.
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BRADLEY MERRILL THOMPSON is a Shareholder in the law firm of Epstein Becker & Green. P.C. There he counsels medical device and drug companies on a wide range of Food and Drug Administration (FDA) regulatory, reimbursement and clinical trial issues. For trade associations, Mr. Thompson has served as counsel to AdvaMed for payment issues, as General Counsel to the Combination Products Coalition and for 17 years as Counsel and Secretary for the Indiana Medical Device Manufacturers Council. He has taught at Indiana University School of Law and Columbia Law School, served as China Correspondent for the Regulatory Affairs Journal, and serves on the editorial boards for Medical Device & Diagnostic Industry, the Food & Drug Law Journal and BNA’s Medical Device Law & Industry Report. Previously he was an editorial board member of Regulatory Affairs. Mr. Thompson also services as Co-Chair of the Food & Drug Law Committee of the Administrative Law Section of the American Bar Association, and as a member of the Medical Device Committee of the Food and Drug Law Institute (FDLI). Mr. Thompson has authored a book entitled FDA's Regulation of Medical Devices (Interpharm Press, 1995), co-authored two chapters in a book entitled “Guide to Medicare Coverage Decision-making and Appeals” published by the American Bar Association (2002) and one chapter in “Off-Label Communications: A Guide to Sales and Marketing Compliance” published by FDLI (2008), and frequently publishes articles and speaks at educational conferences.Mr. Thompson was included in 100 Notable People in the Medical Device Industry (Medical Device & Diagnostics Industry, June 2004), and has been named a “SuperLawyer” in Indiana. In addition to practicing law, Mr. Thompson serves on a variety of for-profit and non-profit boards, including the Indiana Health Industry Forum and HealthNet, a network of community health clinics. Mr. Thompson received his BA, cum laude, and an MBA from the University of Illinois and his JD, cum laude, from the University of Michigan Law School.
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MARTIN TIEMANN, DVM is the Director Pharmacovigilance and Product Stewardship at Intervet/Schering Plough Animal Health. He is responsible for overseeing the regulatory compliance of pharmacovigilance and drug safety activities, as well as ensuring the review and approval of all advertising and promotional materials. He is an active member of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Pharmacovigilance Expert Working Group Controlled List of Terms Global Task Force. Before joining the company, Dr. Tiemann was head of Regulatory Affairs and Technical Services for Merial Canada. He is a graduate of the University of Montreal School of Veterinary Medicine, and was a partner in a mixed animal practice for 20 years before joining industry.
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ELAINE H. TSENG is a Partner with King & Spalding, LLP in San Francisco, California where she is a member the Food and Drug Administration (FDA)/Healthcare group. Ms. Tseng focuses her practice on the representation of organizations subject to FDA and related laws and regulations, including members of the medical device, pharmaceutical and biopharmaceutical industries. Her work includes counseling companies on a range of FDA and related pre-approval, approval, compliance and enforcement matters, including clinical trials regulation, approval strategies, promotion and advertising, recalls and good manufacturing practice/quality systems. Previously, Ms. Tseng served as regulatory counsel at FDA, where she was involved in the development of regulations, guidances, policies and responses to citizen petitions concerning FDA's regulatory scheme for pharmaceuticals, including risk management, drug exclusivities, and follow-on biologics. At FDA, she received the Secretary of Health and Human Services' Distinguished Service Award and other FDA honors. Ms. Tseng is a graduate of Cornell University and Harvard Law School.
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JOHN P. VENARDOS is Vice President, Worldwide Regulatory and Government Affairs at Herbalife. He leads a team of seasoned professionals who represent the company with regulators and elected officials in 70 countries where the company conducts business. He focuses on issues involving products, the Herbalife business opportunity and their distribution. Mr. Venardos ensures product labels, claims and advertising are compliant with each market, based on scientific substantiation and local regulations. He is responsible for dietary supplement 403(r)(6) notifications to the Food and Drug Administration (FDA), and for keeping FDA informed should the company receive any serious adverse event reports. They also work to ease international non-tariff barriers to trade. In addition, he coordinates the company’s successful political action committee. Currently, Mr. Venardos and his team are identifying ways nutritional products can promote wellness and in prevention as Congress tackles healthcare reform. Prior to joining Herbalife, he was with Pfizer in New York where he handled global government and regulatory affairs for food ingredients and pharmaceuticals (including the first application of biotechnology to be approved for use in food). Previously, Mr. Venardos worked for Donald Rumsfeld, then Chairman of G.D. Searle, where he handled government and regulatory affairs for Searle’s NutraSweet unit. He is a founding Board member of the Coalition to Preserve DSHEA, chairs the National Nutritional Foods Association of Japan, and is active with the American Botanical Council, American Herbal Products Association, the Direct Selling Association, the Institute of Food Technologists, the International Alliance of Dietary/Food Supplement Associations, Natural Products Association. Mr. Venardos serves on the board of the World Federation of Direct Selling Associations and is a lecturer and author of several published articles. Mr. Venardos received his BA in Political Science and Speech from Illinois Wesleyan University and completed studies for a Master’s degree from Southern Illinois University.
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DAVID C. VLADECK is a Professor of Law at Georgetown University Law Center. He teaches courses in federal courts, government processes, civil procedure, first amendment litigation, and co-directs the Institute for Public Representation, a clinical law program at the Law Center where he handles a broad array of civil rights, civil liberties, first amendment, open government, and regulatory litigation. Prior to joining the Georgetown faculty in 2002, Professor Vladeck spent nearly 30 years with Public Citizen Litigation Group, serving as its Director from1992 to 2002. He has handled a wide range of complex litigation, primary in federal courts, including first amendment, health and safety, civil rights, class actions, preemption and open government cases. He has argued a number of First Amendment and civil rights cases before the United States Supreme Court, and more than 60 cases before the federal courts of appeal and state courts of last resort. Professor Vladeck testifies frequently before Congress, advises Members of Congress on legal matters, and writes on administrative law, preemption, first amendment, legal ethics, and access to justice issues. He serves as a Scholar with the Center for Progressive Reform and on the boards of various non-profit organizations. He is a member of the American Law Institute and the Institute of Medicine’s Committee on Strategies to Reduce Sodium Intake. He has also served on the Council of the Administrative Law and Regulatory Practice Section of the American Bar Association, as a Public Member of the Administrative Conference of the United States, and as the Chair of the Administrative Law Section of the District of Columbia Bar. In May 2008, Legal Times of Washington recognized himas one of 30 “champions of justice,” and one of the 90 greatest lawyers in Washington, DC, over the past 30 years. Professor Vladeck received his undergraduate degree from New York University, his law degree from Columbia University School of Law, and an LLM degree from Georgetown University Law Center.
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ANDREW C. VON ESCHENBACH, MD is the Senior Advisor or Greenleaf Health LLC. He is also the former Commissioner of the Food and Drug Administration (FDA). Before joining FDA, he was the Director of the National Cancer Institute (NCI). Additionally, he served as Executive Vice President and Chief Academic Officer of the University of Texas M. D. Anderson Cancer Center in Houston. At M. D. Anderson, he also served as Vice President for Academic Affairs and held the Roy M. and Phyllis Gough Huffington Clinical Research Distinguished Chair in Urologic Oncology. Dr. von Eschenbach was founding director of the Prostate Cancer Research Program and was instrumental in fostering integrated research programs in the biology, epidemiology, prevention, and treatment of prostate cancer at M. D. Anderson, and also directed the Genitourinary Cancer Center there. Dr. von Eschenbach joined M. D. Anderson as a urologic oncology fellow in 1976 and was invited to join the faculty the following year. Six years later, 1983, he was named chairman of the Department of Urology. Other positions held at M. D. Anderson include Consulting Professor of Cell Biology and Professor of Urology. Dr. von Eschenbach is a founding member of C-Change and was president-elect of the American Cancer Society at the time of his appointment to the NCI. In addition, he has made significant contributions to the scientific literature with numerous articles, books and book chapters. Dr. von Eschenbach has also served as an editorial board member of several leading journals and on several organizational boards. Many influential organizations have recognized him for his leadership and accomplishments. He has been included in “The Best Doctors in America” publications and in 2006, Time Magazine chose him as one of the 100 most influential people to shape the world. Dr. von Eschenbach earned a BS from St. Joseph's University and his medical degree from Georgetown University School of Medicine. He completed internship at Philadelphia General Hospital and residency in urologic at Pennsylvania Hospital in Philadelphia and then was an instructor in urology at the University of Pennsylvania School of Medicine. He also served as a Lieutenant Commander in the U.S. Navy Medical Corps.
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HENRY A. WAXMAN is a Member of the House of Representatives and represents California’s 30th Congressional District. In January 2009, Rep. Waxman became the Chairman of the House Energy and Commerce Committee. He has fought for universal health insurance, comprehensive Medicare and Medicaid coverage, tobacco regulation and AIDS research and treatment, air and water quality standards, pesticide regulations, nursing home quality standards, women’s health research and reproductive, affordable prescription drugs and community rights to know about pollution levels. He has sponsored health bills that include the Ryan White CARE Act, the Nutrition Labeling and Education Act, the Breast and Cervical Cancer Mortality Prevention Act, the Safe Medical Devices Act, the Patent Term Restoration and Drug Competition Act and the Orphan Drug Act. Rep. Waxman is a leader in efforts to assist the elderly and is a strong defender of the Social Security System. He fought moves to reduce benefits and to increase the retirement age and he was a co-author of legislation that abolished mandatory retirement for Federal employees and raised the retirement age in the private sector from 65 to 70. A longtime champion of environmental and public health protection, Chairman Waxman introduced the first bill in Congress to stabilize the climate in 1992. He was also a primary author of the 1990 Clean Air Act. He also sponsored the 1986 and 1996 Safe Drinking Water Act Amendments, the 1996 Food Quality Act, the Radon Abatement Act, and the Lead Contamination Control Act. He is continuing to pursue legislation to control indoor air pollution, and global warming. From 2007-2009, Rep. Waxman was the Chairman of the Committee on Oversight and Government Reform, the principal investigative committee in the House of Representatives. He also repeatedly fought efforts by the Environmental Protection Agency (EPA) to relax important air pollution and drinking water protections and by the U.S. Food and Drug Administration (FDA) to weaken enforcement of the Federal Food, Drug and Cosmetic Act. Rep. Waxman is considered an expert on Middle East policy and effective proponent of American aid to guarantee Israel’s security and survival. He previously served three terms in the California State Assembly. He received a bachelor’s degree in political science from UCLA and he received his JD from the UCLA Law School.
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KAREN A. WEAVER is a Partner at Baker & Hostetler in Los Angeles, CA. Also a registered pharmacist, Ms. Weaver assists clients in Food and Drug Administration (FDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC) and United States Department of Agriculture (USDA) -regulated industries with matters related to pharmaceutical and medical device approval; clinical trial development and analysis of data; biotechnology licensing and technical transfer; and food, cosmetic and dietary supplement regulatory compliance. Ms. Weaver counsels clients on related issues such as recalls, import and export matters, in- and out licensing, and medical device, drug, dietary supplement and consumer product advertising and promotion. Her clients include academic medical centers, pharmaceutical, medical device and food manufacturers and distributors , raw material suppliers and direct marketing companies . She defends clients in administrative practice by responding to enforcement actions such as Warning Letters, 483 Inspectional Observations , product detentions and seizures , and competitor National Advertising Division (NAD) challenges, as well as defending clients in litigation with the FTC and in private actions filed in state and Federal court, including actions based on unfair competition litigation under the federal Lanham Act and California's 17200 (unfair competition) and 17500 (false advertising) statutes , product's liability matters and California’s Proposition 65. Ms. Weaver provides regulatory due diligence support for the acquisition and sale of medical device, pharmaceutical and other healthcare companies. Additionally, she counsels clients on patent, trademark and copyright strategy. Ms. Weaver serves as legal advisory counsel for the Natural Products Association’s TruLabel Program. Ms. Weaver has held corporate positions that augment her current practice. She was responsible for pharmacy operations and compliance of a joint program between Baxter Healthcare and Sandoz Pharmaceuticals, currently a division of Novartis, she promoted pharmaceuticals for Schering - Plough, and she was in-house litigation counsel at a major communications company. She earned her BS in Pharmacy from the University of Toledo and her JD from DePaul University College of Law.
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LINDA A. WILLETT is a Partner in the New York office of the law firm Sedgwick, Detert, Moran & Arnold LLP and chair of the firm’s Drug and Medical Device practice group. Ms. Willett has more than a decade of experience as Vice President and Deputy General Counsel for Bristol-Myers Squibb. Prior to going in-house, she was a Partner at a law firm specializing in product liability litigation, and while there served as national counsel in breast implant litigation. Ms. Willett has managed complex litigation, counseled corporate leaders on the development of global business strategies, made challenging risk assessments, and advised on acquisitions and divestitures. During her tenure at Bristol-Myers Squibb, Ms. Willett supervised lawyers in almost every practice group. Most recently, she acted as lead counsel for the Health Care Group of companies and also supervised attorneys in the employment, litigation and trademark groups. She has managed external litigation budgets and been in charge of strategic management and resolution of risk issues, including major patent litigation, and government civil and criminal investigations. Ms. Willett also has played a major role in reviewing antitrust, insurance and regulatory disputes. She has negotiated settlements in numerous investigations as well as in major commercial and product liability matters. Deeply involved in diversity and women’s programs, Ms. Willett has won awards from the Minority Corporate Counsel Association and the Puerto Rican Legal Defense and Education Fund. She has served on boards for many community organizations and professional associations, including the Learning Spring School, Legal Momentum, a women’s rights advocacy group, New York Lawyers for the Public Interest, and Salvation Army. Ms. Willett received her BS from Indiana University of Pennsylvania and her JD from Rutgers University Law School.
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JANET WOODCOCK, MD is the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). Dr. Woodcock held various positions within the Office of the Commissioner, FDA from October 2003- April 1, 2008 as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director, Critical Path Programs. She oversaw scientific and medical regulatory operations for FDA. Dr. Woodcock served as Director, Center for Drug Evaluation and Research at FDA 1994-2005. She previously served in other positions at FDA including Director, Office of Therapeutics Research and Review and Acting Deputy Director, Center for Biologics Evaluation and Research. Dr. Woodcock received her MD from Northwestern Medical School, and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco.
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ALLISON M. ZIEVE is an Attorney at Public Citizen, a not-for-profit membership organization devoted to research, advocacy, and education on a wide range of public health and consumer safety issues. Among other areas, Ms. Zieve's practice areas include food and drug law, open government, and federal preemption. Ms. Zieve has represented plaintiffs in numerous cases involving the question whether regulation by the Food and Drug Administration preempts product liability claims seeking damages for injuries caused by FDA-regulated products. For instance, she argued Riegel v. Medtronic, Inc. and Warner-Lambert Co. v. Kent, in the United States Supreme Court's 2007 Term, and she was cert-stage co-counsel in Wyeth v. Levine, decided by the Court earlier this year. Ms. Zieve has written articles for Internal Medicine News, Regulatory Affairs Journal (UK), TRIAL Magazine, and various BNA legal publications. Ms. Zieve received her AB, magna cum laude, from Brown University and graduated from Yale Law School.
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DIANA ZUCKERMAN, PhD is the President of the National Research Center for Women & Families, a think tank that works to improve policies and programs that affect the health and safety of adults and children. In that capacity, she has testified about medical products and Food and Drug Administration (FDA) policies several dozen times before Congress, FDA Advisory Committees and the FDA Science Board. Her expertise on FDA issues dates back to her work as a Congressional staffer in the U.S. House of Representatives and Senate from 1983-95, where she was responsible for a dozen Congressional investigations and hearings on a wide range of health issues, including FDA regulation of breast implants, jaw implants and cold medication. In the U.S. Senate in 1994, her report for the Senate Veterans Affairs Committee indicated that an experimental drug given to soldiers could be the cause of Gulf War illnesses, a theory that was confirmed many years later by a RAND report and a Veterans Administration report. In 1995, Dr. Zuckerman served as a senior policy advisor in the White House, working for First Lady Hillary Rodham Clinton and the Office of Science and Technology Policy. Since 1996, she has served in leadership positions at non-profit organizations, and has been president of the National Research Center for Women & Families since 1999. In addition, Dr. Zuckerman is a fellow at the University of Pennsylvania Center for Bioethics. She serves on numerous boards and commissions, including the Board of Directors of the Congressionally mandated Reagan-Udall Foundation, a public/private partnership established to assist the FDA, and of the Alliance for a Stronger FDA, a nonprofit of industry and consumer groups that lobbies for additional resources for the FDA. Dr. Zuckerman is widely quoted in the media on FDA issues and is the author of several books and book chapters, and dozens of articles in academic journals and national newspapers. She received her BA from Smith College, her MA and Ph.D. from Ohio State University, and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. She started her career as a faculty member at Vassar College and Yale University, then went to Harvard to direct a longitudinal research study, moving to Washington as a Congressional Science Fellow.
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