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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

JAMES J. KELLY
President and CEO, FDLI
James J. Kelly, Esq. is the current President & CEO of the Food and Drug Law Institute (FDLI), a leading non-profit educational organization established in 1949 serving the food, drug and medical device industries, attorneys, regulators and consultants.

Before joining FDLI in 2006, Jim 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, Kelly held a variety of executive positions, including general manager for the Microscopy Group, general counsel and vice-president corporate marketing. Prior to Zeiss, Kelly served as vice-president, general counsel and, later, head of human resources at Siemens Medical, one of the largest health care industry suppliers in the world.

Mr. Kelly began his career in the general practice of law in New York City after earning his J.D from Villanova Law School. He has his undergraduate's degree from St. Joseph's University and is a member of the New York State Bar. He has also served vice-chairman of the German-American Chamber of Commerce in New York.

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DAVID WILLIAM KENNEDY ACHESON, MD, FRCP is the Assistant Commissioner for Food Protection in the 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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FARAH K. AHMED is Assistant General Counsel at the Personal Care Products Council (US) (formerly the Cosmetics Toiletry and Fragrance Association). Prior to joining the Council, she was an Associate at the law firm of Kelley Drye Collier Shannon in the Advertising Law and Food and Drug Law Groups. Her practice focused on assisting clients with legal and regulatory issues surrounding the marketing, promotions and labeling of products under joint Food and Drug Administration-Federal Trade Commission (FDA-FTC) and Environmental Protection Agency (EPA)-FTC jurisdiction. She has experience in handling new media, branded entertainment matters and a number of NAD and ERSP challenges. Prior to joining the law firm, Ms. Ahmed worked as an attorney at FDA’s Office of Chief Counsel where she as assigned to the First Amendment Docket involving FDA’s regulation of Direct-to-Consumer Advertising and Off-Label Promotion of prescription drugs. Her agency practice also included regulatory compliance enforcement litigation involving all FDA centers. She is the author of several publications and has had numerous presentations at various programs. Ms. Ahmed received her B.S. in Physiology and Biochemistry from Niagara University and received her law degree from the University of Virginia School of Law.

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EDWARD JOHN ALLERA is one of the managing Shareholders of the Washington, D.C. 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 B.S. from West Virginia University and his J.D. from Georgetown University.

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LESLIE K. BALL, MD, FAAP, CAPT, USPHS is the Director of the Division of Scientific Investigations, Office of Compliance, in the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). Piro to this appointment, Dr. Ball was Branch Chief of the Good Clinical Practice II, Division of Scientific Investigations (DSI). She joined FDA as a medical officer in the Center for Biologics Evaluation (CBER), Office of Vaccines Research and Review. Previously, Dr. Ball worked at the Office of Human Research Protections in the U.S. Department of Health and Human Services (HHS), where she coordinated compliance investigations, participated in inspections of institutions and institutional review boards (IRBs) and worked on children’s research issues. Since coming to DSI/CDER, she has directed and participated in FDA Clinical Investigator, Sponsor and IRB inspections. Dr. Ball completed a fellowship in Pediatric Infectious Diseases at the Walter Reed Army Medical Center. She is board certified in pediatrics and has practiced in Subic Bay, Republic of the Philippines, and in private practice in Maryland. She is currently on the staff of the National Naval Medical Center. Dr. Ball received her M.D. from Georgetown University School of Medicine.

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J. SCOTT BALLENGER is a Partner in the law firm of Latham & Watkins, Washington, D.C. He focuses on appellate and Supreme Court litigation, with an emphasis on constitutional law. He has been the principal author of the merits briefing in five Supreme Court cases: including the winning briefs for the University of Michigan Law School in its affirmative action case Grutter v. Bollinger, 539 U.S. 306 (2003) and for Arthur Andersen in its successful effort to get Andersen's conviction for obstruction of justice overturned, Arthur Andersen LLP v. United States, 544 U.S. 696 (2005). Mr. Ballenger has drafted dozens of amicus curiae briefs, petitions for certiorari, or briefs in opposition to certiorari in the Supreme Court, and many other briefs on constitutional or other complex legal issues in the lower federal courts. In the lawsuit against the Food and Drug Administration, Abigail Alliance v. von Eschenbach, 445 F. 3d 470 (2006), he recently convinced the D.C. Circuit to recognize a new constitutional right of access to experimental drugs for terminally ill patients. He has also extended his United States v. Microsoft experience with complex trial litigation by working on several trial teams in both state and federal court, including Latham's successful defense of Oracle Corporation against the Justice Department, in US v. Oracle Corp., 2004 WL 2006847 (N.D.Ca. 2004). Prior to joining Latham & Watkins, he served as a law clerk to the Hon. J. Clifford Wallace of the United States Court of Appeals for the Ninth Circuit and as a law clerk to the Hon. Antonin Scalia, Associate Justice of the United States Supreme Court. He served as Senior Counsel to Assistant Attorney General Joel Klein in the Antitrust Division of the Department of Justice, where he worked on David Boies’s trial staff and briefing team for the Division’s landmark monopolization case United States v. Microsoft. Mr. Ballenger received his B.A. and J.D. from the University of Virginia.

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LISA BARCLAY is an Associate in the law firm of Zuckerman Spaeder LLP, Washington, D.C. She practices in the areas of complex civil litigation, food and drug law, and professional ethics. She has represented a variety of clients, including non-profit groups, generic pharmaceutical companies, and individual attorneys and law firms. She frequently works with clients on matters involving professional ethics, counseling lawyers and law firms on ethics requirements and compliance. Prior to joining Zuckerman Spaeder, she clerked for Senior Judge William B. Bryant, U.S. District Court for the District of Columbia, and practiced civil litigation in the Washington, D.C. office of Weil, Gotshal & Manges, LLP. Previously, she worked in the Office of the Policy at the Food and Drug Administration (FDA). Ms. Barclay received her B.A. from The George Washington University and her J.D. from Georgetown University Law Center.

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DAN BARRETO is currently the International Vice President of current good manufacturing practices (cGMP) Compliance, Janssen Pharmaceutical NV, a position created as part of a global focus to bring the Food and Drug Administration (FDA) expertise to European and worldwide facilities within the Janssen Pharmaceutica network of manufacturing sites. His responsibilities include providing strategic and technical guidance on good manufacturing practices, implementation of systems and processes in accordance with current FDA expectations, training and education to production and quality assurance personnel, and performing as a senior advisor to senior management on strategic quality and compliance issues. He has extensive international experience, both as an FDA investigator and executive within the pharmaceutical sector performing compliance assessments, lecturing, training and coordinating key cGMP projects in Europe, the U.S., India and China. Prior to joining Janssen, he worked with Celitech Pharmaceuticals in Rochester, NY as the Senior Manager of cGMP Compliance. Mr. Barreto’s career began when he joined FDA as a Laboratory Analyst and Drug/Device Investigator in the San Juan District, and Supervisory Investigator in the New Orleans and Kansas City Districts.

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ELONA BAUM is Director, Regulatory Policy and Strategy at Genentech, Inc.  In this capacity, Ms. Baum is responsible for identifying policy and regulatory trends relevant to the company, evaluating their potential impact, and managing various projects of strategic value to Genentech. Prior to her current position, Ms. Baum was an Associate General Counsel in Genentech’s Legal Department.  During her 10 year tenure there, she handled key acquisitions for Genentech, served as a Director and Secretary for a Spanish subsidiary, and counseled clients on a broad array of issues ranging from clinical trial practice, cGMP compliance,  FDA inspections, real estate and environmental, health and safety compliance.  Ms. Baum received her B.A. in economics from the University of California, Los Angeles, and her J.D. from the University of San Francisco School of Law in 1989. She was selected and served as an extern for Justice Arguelles, California Supreme Court.

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MINNIE V. BAYLOR-HENRY is currently the Vice President for Global Regulatory Affairs – OTC, McNeil Consumer Healthcare, a Johnson & Johnson Company.  She currently serves as a member of the Leadership Board for McNeil.  Prior to joining McNeil, Ms. Baylor-Henry worked for another J&J company, Johnson & Johnson Pharmaceutical Research & Development (“PRD”).  As a Senior Director, Regulatory Affairs at J&J PRD, she was responsible for the regulatory oversight for promotional activities at several J&J Companies.  Before joining J&J in July 1999, Ms. Baylor-Henry served as the Director of the Division of Drug Marketing, Advertising, and Communications (“DDMAC”) from 1995-1999.  Before becoming DDMAC’s Director, she had worked as a Regulatory Review Officer and Branch Chief.  Ms. Baylor-Henry is a pharmacist and an attorney.  She received her pharmacy degree from Howard University’s College of Pharmacy and her law degree from Catholic University’s Columbus School of Law.

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DONALD O. BEERS is a Partner in Arnold & Porter and has his office in Washington, D.C. He served in the Office of Chief Counsel of the Food and Drug Administration (FDA) for ten years, participating in both litigation and regulatory proceedings involving drugs for human use, medical devices, foods and food additives, cosmetics, and veterinary drugs. When he left FDA he held the titles of Associate Chief Counsel for Drugs and Associate Chief Counsel for Enforcement. Since entering private practice, Mr. Beers has been active in representing and counseling drug, medical device and food manufacturers on FDA regulatory issues and related matters, including product life-cycle management, competitive issues, fraud and abuse, pricing, reimbursement, FDA regulatory compliance matters and FDA-related patent law issues. The sixth edition of his book, Generic and Innovator Drugs: A Guide to FDA Approval Requirements, focuses on issues raised by the 1984 Drug Price Competition and Patent Term Restoration Act, was published in 2004.  Mr. Beers received his B.A. from Dartmouth College and his J.D. from  Columbia Law School.

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ALAN R. BENNETT is a Partner with the Washington, D.C. law firm of Ropes & Gray, LLP where he serves as outside counsel to a number of pharmaceutical and medical device firms. Mr. Bennett has spoken often and written extensively on food and drug law issues. He has been involved in many significant legislative and regulatory initiatives affecting the Food and Drug Administration (FDA). He is a recognized authority on issues involving drug approvals, pharmaceutical marketing and promotion, the Hatch-Waxman Act and biological products. Prior to entering private practice, Mr. Bennett was Legislative Assistant to the late Senator Jacob Javits and Counsel to the Senate Governmental Affairs Committee, where he concentrated on a wide variety of health regulatory matters, consumer protection and administrative law issues. Previously, he served in the Office of the General Counsel of FDA where he was a trial lawyer and legal advisor to several FDA bureaus. Mr. Bennett is a graduate of the University of Connecticut and received his law degree from Columbia University.

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LINDA D. BENTLEY is a member in the Corporate Section and Life Sciences Practice Group in the law firm of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C. (Mintz Levin) in Boston, MA. She has experience representing pharmaceutical, biotechnology and medical device manufacturers on the regulatory and reimbursement status of particular products and procedures and on strategic pathways for bringing new products to market. She has counseled clients on compliance with the Federal Food, Drug and Cosmetic Act (FDCA) and related matters such as clinical trial agreements, arrangements with third-party contractors, labeling and advertising, and the regulatory issues relating to a range of in vitro diagnostic products. She performs regulatory due diligence for initial public offerings (IPOs) and other financings and counsels clients on disclosure of product information. Previously, she served as Director of Regulatory Affairs at New England Nuclear/Dupont Medical Products, where she established and implemented the company’s Food and Drug Administration (FDA) policy and was responsible for obtaining marketing approval for new products in the U.S., Canada and other countries. She is a member of various associations and is a former Director of the Massachusetts Medical Device Industries Council (MassMEDIC) and a Director of MedTech IGNITE, a MassMEDIC program for medical device entrepreneurs. She also is a member of the Advisory Board of BNA, Inc.'s Pharmaceutical Law & Industry Report. Ms. Bentley received her B.S. from Simmons College and her J.D. from Boston College.

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ASHLEY B. BOAM currently serves as Acting Deputy Director for Science and Review Policy in the Office of Device Evaluation at FDA's Center for Devices and Radiological Health.  As acting Deputy Director for ODE, Ms. Boam provides oversight of premarket review policies and procedures, including the review of RFDs for combination products; acts as liaison to the Office of Compliance and Office of Science and Engineering Laboratories; and provides oversight for the 513g and ODE guidance programs.  Ms. Boam joined FDA in 1993 as a scientific reviewer in the Division of Ophthalmic and ENT Devices.  In 2002, she joined the Division of Cardiovascular Devices as Chief of the Interventional Cardiology Devices Branch.  Products reviewed by the branch include drug-eluting stents, embolic protection devices, cardiac occluders, and other devices associated with coronary percutaneous interventional procedures.  Ms. Boam earned her B.S.E and M.S.B.E. in biomedical engineering from Tulane University and the University of Alabama at Birmingham, respectively.

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ROBERT E. BRACKETT, PhD, is Senior Vice President and Chief Science and Regulatory Officer at Grocery Manufacturers Association (GMA) in Washington, D.C. He oversees all of the association’s scientific and regulatory activity, including the operation of its in-house food safety laboratory. Prior to joining GMA, he served in various positions within the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN), eventually attaining the position of Center Director. He provided 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. Previously, he served as a Professor of Food Science and Technology in the Center for Food Safety at the University of Georgia where he was an active researcher in the area of food microbiology, specializing in microbiological safety of foods. Dr. Brackett has also served on the faculty of North Carolina State University where he held the title of Extension Food Safety Specialist and Assistant Professor. He has served elected leadership positions in several professional associations and is a Fellow of the American Academy of Microbiology and the International Association of Food Protection. He is the recipient of numerous professional awards and serves on the Advisory Boards of the National Center for Food Protection and Defense, and the National Center for Food Safety and Technology. Dr. Brackett received his B.S. in bacteriology and his M.S. and Ph.D. in food microbiology, all from the University of Wisconsin-Madison.

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FREDERICK H. BRANDING, RPh, JD, is a Partner with the law firm of Reed Smith in Chicago, IL. He is a registered pharmacist and has extensive experience in pharmaceutical, food, drug, medical device, and cosmetic regulatory compliance and enforcement issues. His experience includes assisting medical products manufacturers in responding to government inspections, warning letters, investigations, and litigation. He has represented individuals and corporations in various government enforcement actions, including seizures, injunctions and prosecutions, as well as private litigation between businesses. Prior to joining Reed Smith, Mr. Branding was a Partner with the law firm of McGuireWoods LLP in Chicago, IL. He was part of the firm’s Health Law Group. Mr. Branding is a former Chief of the Civil Division of the United States Attorney’s Office for the Northern District of Illinois and Chief of the Psychotropic Drugs Unit of the United Nations International Narcotics Control Board in Vienna, Austria. While at the U.S. Department of Justice, he twice received the Food Drug Administration Commissioner’s Special Citation for outstanding contributions in the field of food and drug law enforcement. He is the author of a several publications and been a speaker and presenter at numerous meetings and conferences. Mr. Branding received his pharmacy and biology degrees from Drake University and his J.D. from Illinois Institute of Technology Chicago-Kent College of Law.

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NANCY L. BUC is a Partner in the law firm of Buc & Beardsley in Washington, D.C. She served as General Counsel for the Food and Drug Administration from 1980-1981. During an earlier period of government service, she served as Attorney-Advisor to the Chairman of the Federal Trade Commission and Assistant Director of that agency’s Bureau of Consumer Protection. A member of the Institute of Medicine’s Committee on Contraceptive Research and Development, she was also a member of the National Institutes of Health’s Recombinant DNA Advisory Committee and its Consensus Panel on Effective Medical Treatment of Herion Addiction. Ms. Buc served as a member of the Office of Technology Assessment’s Advisory Committee on New Developments in Biotechnology and its panel on Government Policies and Pharmaceutical Research and Development. She was also a member of the American Bar Association Antitrust Law Section’s Special Committee to Study the Federal Trade Commission and is a member of FDLI’s Advisory Board. Ms. Buc is an Adjunct Professor of Law at Georgetown University Law Center. She is a Director of the National Partnership for Women and Families, and was formerly a director of Agritope, Inc. Ms. Buc is a graduate of Brown University and the University of Virginia School of Law. She holds an honorary doctor of laws from Brown and is a Trustee of Brown.

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GLENN N. BYRD, MBA, RAC, is Director of Regulatory Affairs, Advertising and Promotion at Medimmune. 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 B.S. in Aerospace and Ocean Engineering from Virginia Tech, his RAC from the Regulatory Affairs Professionals Society and his M.B.A. from Hood College.

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ELIZABETH J. CAMPBELL is Vice President of EAS Consulting Group, LLC. She provides regulatory advice and training to the food and dietary supplement industry, particularly on labeling. Ms. Campbell began consulting in 1999, after a 35-year career with FDA.  She has considerable expertise in the regulation of food products, having served as a division director in the Office of Food Labeling in the Center for Food Safety and Applied Nutrition (CFSAN), and most recently as Acting Director of the Office of Food Labeling. Ms. Campbell played a key role in writing the Nutrition Labeling and Education Act (NLEA) regulations in the early 1990s and then had major responsibility for implementing those regulations. She also helped develop current FDA policies on claims under the Dietary Supplement Health and Education Act and the FDA Modernization Act of 1997.. Ms. Campbell also served nearly ten years as a chemist in FDA’s New Orleans and Atlanta Districts prior to transferring to Washington DC in 1972.  Ms. Campbell received her B.S. in chemistry from Louisiana State University.

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GAIL H. CASSELL, PhD is Vice President of Scientific Affairs and Distinguished Lilly Research Scholar for Infections Diseases at Eli Lilly and Company in Indianapolis, Indiana.  She is the former Charles H. McCauley Professor and Chairman of the Department of Microbiology at the University of Alabama Schools of Medicine and Dentistry at Birmingham.  Prior to this she also served as the President of the American Society for Microbiology.  She was a member of the National Institutes of Health Director’s Advisory Committee and a member of the Advisory Council of the National Institute of Allergy and Infections Diseases of NIH.  Dr. Cassell is currently a member of the Science Board of FDA’s Advisory Committee to the Commissioner.  She is a member of the U.S.-Japan Cooperative Medical Science Program, where she is responsible for advising the respective governments on joint research agendas.  Dr. Cassell is also currently a member of the Executive Committee of the Board of Visitors of Columbia University School of Medicine, a member of the Board of Directors of the Burroughs Wellcome Fund, and the Advisory Council of the School of Nursing of Johns Hopkins.  She has served on several editorial boards of scientific journals, has authored over 250 articles and book chapters, and has received national and international awards and an honorary degree for her research in infectious diseases.  Dr. Cassell received her B.S. from the University of Alabama in Tuscaloosa and her Ph.D. in Microbiology from the University of Alabama at Birmingham.

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CARL H. COLEMAN is the Director of Health Law and Policy at Seton Hall Law School and a Professor of Law. He was awarded the Andrea Catania Fellowship for Excellence in Teaching in 2007. For the 2006-2007 academic year, Professor Coleman served as Bioethics and Law Adviser at the World Health Organization in Geneva, Switzerland. He has participated in numerous governmental and bar association committees, including as a member of the New York State Attorney General’s Commission on Quality of Care at the End of Life and as co-chair of the Committee on Ethical Issues in the Provision of Health Care of the New York State Bar Association. He is a member of the Institutional Review Board at Seton Hall University and previously served as a member of the Institutional Review Board at the University of Medicine and Dentistry of New Jersey. He is a member of the steering committee of the Family Decisions Coalition. After law school, Professor Coleman served as law clerk to Chief Judge James L. Oakes of the U.S. Court of Appeals for the Second Circuit. He then worked as a litigation associate at Leventhal Slade & Krantz in New York City. Later he was appointed Counsel to the New York State Task Force on Life and the Law and was made Executive Director of the Task Force in 1995. He has published numerous books, articles and book chapters. Professor Coleman received his received his A.M. in East Asian Studies from Harvard, his B.S.F.S., cum laude, from Georgetown University’s School of Foreign Service and his J.D., magna cum laude, from Harvard Law School, where he served as Supervising Editor of the Harvard Law Review.

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CARMEN M. COLLAZO, PhD, is a Primary Review Scientist in the Office of Vaccines Research and Review (OVRR) in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) and is the Regulatory Project Officer for CBER’s Vaccine Safety Team (VST). She is responsible for the regulatory review process for viral vaccine pre-submissions, Investigational New Drug submissions and Biological License Applications, some of which are related to seasonal and pandemic influenza vaccines, and she serves as the agency liaison for manufacturers of those submissions. She works with the VST co-chairs, organizes and leads VST meetings and actions and interacts with government agencies concerned with vaccine safety issues such as the Centers for Disease Control and Prevention (CDC) and the National Vaccine Program Office at the Department of Health and Human Services. Dr. Collazo received her B.S. in Industrial Microbiology from the University of Puerto Rico, her Ph.D. in Molecular Genetics and Microbiology from the State University of New York, and her post-doctoral training in Immunobiology at the Laboratory of Parasitic Diseases, NIAID, National Institutes of Health.

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RICHARD M. COOPER is a Partner in the Washington, D.C. law firm of Williams & Connolly. 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 National Academy of Sciences and the Congressional Office of Technology Assessment as Chairman of the Editorial Board of the Food and Drug Cosmetic Law Journal, and has been a member of the American Law Institute. Mr. Cooper edited the FDLI book, Food and Drug Law (1991), and co-edited the FDLI book, Fundamentals of Law and Regulation (1997). He was previously Chief Counsel of FDA from 1977-1979. 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. He also did legal work 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. Mr. Cooper received his B.A. summa cum laude from Haverford College, his B.A., First Class with Congratulations, from Oxford University, and a J.D. summa cum laude from Harvard Law School.

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DENNIS R. CRYER, MD, FAHA is Chief Medical Officer for CryerHealth, LLC, Washington, D.C. He is responsible for providing medical and scientific guidance to all programs at CryerHealth, a strategy and public affairs firm serving the breadth of the healthcare community in the U.S. and internationally. Most recently, he served as external liaison across therapeutic areas and products for Bristol-Myers Squibb. Dr. Cryer began his medical career at the Children’s Hospital of Philadelphia in the area of human genetics and metabolism and subsequently spent 20 years in varied positions across both research and development and commercial divisions of Bristol-Myers Squibb. He led the medical development for Bristol-Myers Squibb’s –pravastatin (Pravachol(r)) and metformin (Glucophage(r)). Dr. Cryer received his degrees from Johns Hopkins and the Albert Einstein College of Medicine.

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BRIAN R. DALEY is a Partner in the Canadian law firm of Ogilvy Renault in Montreal, Canada. His practice is in all areas of intellectual property law, including patents, trademarks and litigation at the trial, appellate and Supreme Court level. He has particular expertise in litigation relating to pharmaceutical patents and regulatory matters involving pharmaceuticals. He has also advised on the applicability of language legislation to companies doing business in Quebec and judicial review of matters under federal jurisdiction. Mr. Daley is a member of the Canadian Bar Association, the Intellectual Property Institute of Canada (IPIC), and its Montreal Informals Committee, the American Intellectual Property Law Association (AIPLA), the International Association for the Protection of Industrial Property (AIPPI) and the Professional Engineers of Ontario. He is a Professional Engineer. He received his LL.B./B.C.L. from McGill University, his M.A.Sc. from the Technical University of Nova Scotia, and his B.Eng., Mechanical Engineering from Memorial University.

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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 is 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 B.S. in Political Science from the University of California, Berkeley, and her J.D. from the Catholic University of America.

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TOM DILENGE is Vice President and General Counsel of the Biotechnology Industry Organization (BIO). Previously, he was Acting General Counsel and Deputy General Counsel. Prior to joining BIO, Mr. DiLenge served as the Chief Counsel and Policy Director for the House Homeland Security Committee and previously served as a Senior Counsel for the House Energy and Commerce Committee. On the Hill, he was a leading expert in the area of public health emergency preparedness. Prior to working on Capitol Hill, Mr. DiLenge worked at the Washington, D.C. office of the law firm Mayer, Brown, Rowe and Maw. He participated in a sophisticated general and appellate commercial litigation practice. He represented a host of publicly traded and privately held corporation and worked closely with in-house corporate counsel on antitrust issues and investigations.  Mr. DiLenge graduated summa cum laude from Fordham University and graduated with honors from the University of Virginia School of Law.

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BRIAN J. DONATO is a Principal in the law firm of Hyman, Phelps & McNamara. He manages their Irvine, California office. His practice includes providing information about various legal issues related to the Federal Food, Drug and Cosmetic Act (FDCA) and the Food and Drug Administration’s (FDA’s) regulations, and similar laws and regulations of the state of California. Previously, Mr. Donato practiced law in firms he founded in Virginia and Florida. He served as General District Court Judge for Albemarle County, VA and was Chief Judge for all of the General District Courts in the Sixteenth Judicial District of Virginia. He was appointed to the position of Lecturer at the University of Virginia Law School and has been a faculty member at the University’s Annual trial Advocacy Institute since 1982. He is the recipient of an FDA Commissioner’s Special Citation for his work in helping FDA communicate with members of the regulated industries. He is also the recipient of awards from FDLI, RAPs and The Orange Count Regulatory Affairs Discussion Group. In January 2001, he received The William J. Brennan, Jr. Award from the University of Virginia School of Law for his efforts in teaching trial tactics and techniques at the law school’s annual Trial Advocacy Institute. He is the author of a number of papers and articles on federal and state regulatory law issues and has made numerous presentations to a variety of trade associations about various regulatory issues affecting their membership. Mr. Donato is a graduate of Manhattan College and the University of Virginia School of Law.

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MELVIN S. DROZEN is a Partner in the Washington, D.C. law firm of Keller and Heckman. He provides advice to clients on a broad spectrum of FDA, FTC, USDA, and EPA 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 B.A. from Georgetown University and his J.D. from Brooklyn Law School.

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BERNADETTE DUNHAM, DVM, PhD was appointed Director of the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) in January 2008. Prior to becoming Director, she was Deputy Director of CVM. Dr. Dunham also served as the Director of CVM's Office of Minor Use and Minor Species (OMUMS). She came to CVM as Deputy Director of CVM’s Office of New Animal Drug Evaluation (ONADE). She is an Adjunct Professor in the Department of Biomedical Sciences and Pathobiology at the Virginia-Maryland Regional College of Veterinary Medicine. She lectures on a variety of topics from emerging issues and opportunities in veterinary medicine to the role of consensus building in policy development. Dr. Dunham received her D.V.M. from the Ontario Veterinary College, the University of Guelph, Ontario, Canada and she received her Ph.D in Cardiovascular Physiology from Boston University.

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JARILYN DUPONT is Director of Regulatory Policy, Office of Policy, Planning and Preparedness, Office of the Commissioner with the Food and Drug Administration (FDA). Prior to joining the Office of Policy she worked in the FDA Office of Legislation in several positions including Division Director and Senior Legislative Counsel. During her tenure with FDA, she has been detailed to the Office of Chief Counsel as a staff attorney and the Office of Crisis Management as Acting Director. Her previous experience includes working for Congress as a counsel for the House Judiciary Committee on Intellectual Property and Judicial Administration and as legislative counsel/analyst for a Member of the House of Representatives. She has experience in private practice as well as state and local legislative and administrative experience. She received a B.A., cum laude from the University of Texas and her J.D. from Southern Methodist University School of Law.

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MARK E. DuVAL is President of DuVal & Associates, PA, in Minneapolis, MN, where he counsels pharmaceutical, medical device, biotech, food, and nutritional supplement companies. Mr. DuVal’s practice also includes combination products. He regularly advises clients in all areas of Food and Drug Administration (FDA) laws and regulations, from product development to post-marketing responsibilities. He specializes in counseling on sales and marketing programs. Previously, Mr. DuVal was an in-house FDA, Anti-Kickback, and False Claims Act expert for Medtronic business units and their lawyers, and before that, he was Division Counsel for 3M Pharmaceuticals and Drug Delivery Systems businesses. He is on the Board of Directors for the Food and Drug Law Institute (FDLI) and the Minnesota BioBusiness Alliance. He also serves on the Editorial Advisory Board of the Medical Device Compliance Report. Mr. DuVal received his B.S. in public administration from St. Cloud State University and his J.D. from William Mitchell College of Law in St. Paul, MN.

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DANIEL R. DWYER is a Partner in the law firm of Kleinfeld, Kaplan and Becker, LLP in Washington, D.C. Mr. Dwyer’s practice is concentrated on the regulation of pharmaceuticals, food, dietary supplements, medical devices, cosmetics, and related medical and consumer products. Mr. Dwyer is an adjunct professor of food and drug law at George Mason University Law School and is a frequent writer and speaker on FDA topics. Most recently, he spoke on medical device reclassification and co-authored a chapter on “Regulation of Dietary Supplements” in the Food and Drug Law Institute’s Practical Guide to Food and Drug Law and Regulation. Mr. Dwyer is a graduate of Georgetown University Law Center in Washington, D.C., and is admitted to practice in the District of Columbia and Maryland.

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HAMILTON P. FOX, III (PHIL) is a Partner in the Washington, D.C. office of Sutherland Asbill & Brennan LLP. His practice emphasizes white-collar criminal defense work (trial and appellate) and civil trials and appeals in various courts. In addition, he represents lawyers in the disciplinary process and advises lawyers and law firms on ethical issues. He also advises corporations with respect to the implications of the sentencing guidelines and compliance programs applicable to organizations. Mr. Fox previously served as Associate Special Counsel to the House Committee on Standards of Official Conduct. He was appointed by the Court of Appeals to serve as a Member of the Board of Professional Responsibility in 1989. He was Chair of the Board of Professional Responsibility from January 1994 until August 1996 and a Member and Chair of the D.C. Circuit’s Committee on Admissions and Grievances from 1996-2002. He is recognized in The Best Lawyers in America, 2005-2006, in Commercial Litigation and White-Collar Criminal Defense. Mr. Fox clerked in the United States Court of Appeals for the First Circuit for Judge Frank M. Coffin and then in the Supreme Court of the United States for Justices Stanley F. Reed and Lewis F. Powell, Jr. He began his practice as a federal prosecutor in the United States Attorney’s Office for the District of Columbia. This appointment was briefly interrupted when he worked as an assistant special prosecutor for the Watergate Special Prosecution Force. After the United States Attorney’s Office, he joined the Organized Crime and Racketeering Section of the United States Department of Justice where he was the Deputy Chief of that Section. Mr. Fox received his B. A., with honors, from the University of Virginia, Phi Beta Kappa, and his LL.B. from Yale Law School where he was Article and Book Review Editor for the Yale Law Journal.

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HOPE S. FREIWALD is a partner in Dechert’s mass tort and products liability group. She has represented numerous drug and device companies in mass tort cases across the country involving nutritional supplements, pain medications, lipid-lowering agents, blood derivatives, acne medication, anti-hypertensives, and latex gloves. Most recently, Hope has served as part of GlaxoSmithKline’s national Baycol defense team, where she has headed GSK’s expert development efforts and also been responsible for coordinating GSK’s defense of several thousand cases filed in the Philadelphia Court of Common Pleas. She was co-trial counsel for GSK in a Baycol personal injury case that settled after jury selection on terms highly favorable to defendants. Hope regularly counsels in mass tort/product liability risk reduction, particularly focusing on issues created by labeling and marketing practices, co-promotion and in-licensing agreements, and emerging injury and liability theories. She also has worked extensively on pre-litigation dispute resolution including resolution of putative mass tort claims in Europe. She has advised clients appearing before government review panels with regard to their perspective medications and advised them in lobbying efforts concerning compensation fund legislation. Hope is a graduate of Brown University (A.B., magna cum laude, 1986) and Columbia Law School (J.D., 1990). After law school, she clerked for the Honorable Jan E. DuBois, of the United States District Court for the Eastern District of Pennsylvania. Hope is a member of the Defense Research Institute.

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JONATHAN C. GOLDSMITH, MD is the Deputy Director, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), the Food and Drug Administration (FDA). He spent over 20 years in academic medicine performing research, teaching, and patient care at four schools of medicine.  His last appointment was at the University of Southern California as a Professor of Pediatrics and Medicine at Children’s Hospital in Los Angeles where he directed the Children’s AIDS Center and the Region IX Hemophilia Program funded by Health Resources and Services Administration (HRSA) and the Centers for Disease Control and Prevention (CDC).  After leaving academic medicine, he held upper management positions at two biopharmaceutical corporations that developed plasma derivatives for the U.S. market and was the Medical Director and Interim President of the Immune Deficiency Foundation in Towson, MD. During his career, he has been designated a Fellow of the American College of Physicians and has been a member of the American Society of Hematology and other hematology societies.  He also served as a board member of the National Hemophilia Foundation and as a member of the Blood Products Advisory Committee, CBER.

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JESSE L. GOODMAN, MD, MPH is Director of the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). He is responsible for overseeing a broad range of medical, public health and policy activities. Dr. Goodman is active in a wide variety of clinical and public health issues including 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 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 M.D. at Albert Einstein; he did his residency and Fellowship training at the Hospital of the University of Pennsylvania and at 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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R. KENNETH GORDON is a Partner in the law firm of Baker & McKenzie LLP in Dallas, TX. He serves as Head of his Firm’s U.S. Health Law Practice Group and the Firm’s North American Pharma & Healthcare Industry Group. He is also a member of the Steering Committee for the Firm’s Global Pharmacy & Healthcare Industry Group. His areas of practice are General Corporate. He has significant experience with a wide variety of issues facing healthcare providers and others involved in the healthcare industry. For example, he regularly works with both the laws and the practical considerations involved with strategic planning and Board matters for healthcare providers and entities; fraud and abuse and Stark Law compliance, investigations, and defense before intermediaries and carriers as well as the Office of Inspector General and the Justice Department; Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security; pharmaceutical regulation; medical staff relations; healthcare mergers and acquisitions; and managed care organizations. Mr. Gordon has numerous Professional and Association Memberships. He is a frequent speaker and has written articles and book chapters for a variety of organizations. He also provides training services on compliance with fraud and abuse, HIPAA privacy and security and other laws. Mr. Gordon received his B.S., cum laude, from Tufts University, his M.B.A. from Kellogg Graduate School of Management and his J.D. from Northwestern University School of Law.

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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 A.B. from Indiana University and his J.D. from Indiana University School of Law at Indianapolis.

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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 D.C. Super Lawyers, March 2007 edition; and in the Washingtonian magazine, as one of the top FDA lawyers. Mr. Heller received his B.A. and J.D. from the University of Wisconsin.

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CRAIG W. HENRY, PhD is Senior Vice President and Chief Operating Officer for Scientific and Regulatory Affairs, Grocery Manufacturers Association (GMA) in Washington, D.C. He is responsible for setting strategy and providing senior leadership, staff management, program direction, and financial control to the scientific and regulatory activities of the Association. This includes oversight of the Center for Technical and Laboratory Services and the Center for Northwest Seafood, the Office of Food Safety programs, regulatory affairs, and the Food Products Association Research and Education Foundation. Prior to joining FPA, he was Vice President of Quality and Food Safety with Koch Foods of Mississippi, LLC. Dr. Henry has published numerous articles in scientific journals. He is a member of the American Association of Avian Pathologists and the U.S. Poultry Science Association, where he has served as a member of the Committee on Drugs and Chemicals and he served a term as Chairman. Dr. Henry received his M.S. in Poultry Science from Clemson University, his B.Sc. in Agriculture from the University of Delaware, and his Ph.D. in Animal Science from Auburn University.

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WILLIAM A. HERMAN is the Deputy Director of the Office of Science and Engineering Laboratories in the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH). He is responsible for developing the strategic scientific directions for this group, and for maintaining an anticipatory perspective for scientific support of the Center’s regulatory programs. He is the primary technology forecaster for CDRH. He has served on advisory and grant review panels for the National Science Foundation, the National Academy of Sciences, the National Institutes of Health, and the Department of Defense. He is named in Who’s Who in Science and Engineering.

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GREGORY M. HOCKEL, PhD is Executive Vice President, Regulatory Affairs at PharmaNet, Inc. His responsibilities include Regulatory Operations, Document Management & Publishing, Global Safety & Pharmacovigilance, Medical Writing, and Clinical Trial Supply Management. He joined PharmaNet, Inc. in 1999 and established its Washington, D.C. office and the PharmaNet Consulting Group. Dr. Hockel left the contract research organization arena to work in the biotechnology field, first with British Biotech and subsequently Guilford Pharmaceuticals. In 1989, Dr. Hockel joined G.H. Besselaar Associates and took on increasing levels of responsibility which included Food and Drug Administration (FDA) liaison activities and the management of the Drug Safety Monitoring, GCP Auditing, and Clinical Trial Supply Management groups. His career in the pharmaceutical industry began when he joined the Department of Metabolic Diseases at Pfizer Central Research, supervising the drug discovery efforts in the renal and gastrointestinal laboratories. Later he joined the Regulatory Affairs department at Pfizer, where he was responsible for the Pfizer's cardiovascular drug development regulatory effort. Dr. Hockel received his B.A. in Biology from California State University at Long Beach, his Ph.D. in Physiology from Indiana University School of Medicine, and his M.B.A. from Rensselaer Polytechnic Institute.

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HOWARD M. HOFFMANN is a Partner and Senior Trial Attorney and Appellate Attorney with the law firm of Duane Morris LLP in Chicago. He practices commercial litigation, regulatory law, and white collar criminal defense in federal and state courts throughout the United States. He has over twenty years experience representing compounding pharmacies and trade associations in matters involving the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA) state pharmacy boards, and law enforcement agencies before federal and state appellate, trial and administrative courts. Mr. Hoffman successfully argued before the United States Supreme Court on behalf of compounding pharmacies Thompson v. Western States, the First Amendment case that established that bans on advertising compounding pharmacy drugs was unconstitutional. He is a former Assistant United States Attorney with the U.S. Attorney’s office for the Northern District of Illinois-Chicago, where he served as Deputy United States Attorney, Chief of the Criminal Division and Chief of the Tax Division. He is a frequent lecturer on healthcare advocacy and criminal practice at trade associations and bar associations. Mr. Hoffmann is a graduate of Loyola University and the Chicago-Kent College of Law.

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PETER BARTON HUTT is a Partner in the Washington, D.C. law firm of Covington & Burling specializing in food and drug law. He teaches a full course on food and drug law at Harvard Law School during winter term and has taught the same course at Stanford Law School during spring term. From 1971 to 1975 he was Chief Counsel for the Food and Drug Administration. Mr. Hutt is a member of the Institute of Medicine of the National Academy of Sciences, and serves on a wide variety of academic and scientific advisory boards and on the Board of Directors of venture capital startup companies. He was named by The Washingtonian magazine as one of Washington’s 50 best lawyers and as one of Washington’s 100 most influential people, by the National Law Journal as one of the 40 best health care lawyers in the United States, and by European Counsel as the best FDA regulatory specialist in Washington, D.C. Mr. Hutt received his B.A. magna cum laude from Yale University, his LL.B. from Harvard University, and his LL.M. from New York University.

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GORDON S. JEPSON is a Partner in the law firm of Deeth Williams Wall LLP in Toronto, Canada.  His practice includes advising on regulatory clearance for drugs, medical devices, foods, cosmetics, dietary supplements and natural health products, and advertising relating to these types of products. He also practices patent, trademark and industrial design law.  He appears before the Federal Court of Canada in matters arising from these areas of law.  Mr. Jepson received his undergraduate degree from the Royal Military College of Canada in 1986.  After four years of overseas military service, he went on to obtain a Masters in English from Queen's University in Kingston, Ontario, in 1991, and an LL.B. from the University of Windsor in 1994.  He was called to the Ontario Bar in 1996, and is a registered trademark agent.

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RADY A. JOHNSON, II is Senior Vice President and Associate General Counsel at Pfizer Inc. He is Chief of the Legal Division’s Global Products & Regulatory Law practice group. Prior to joining Pfizer, he was associated with the Washington, D.C. law firm of Hogan & Hartson. At Hogan & Hartson, he was a member of the firm’s extensive Food and Drug Law practice group. He was a Certified Public Accountant with Arthur Anderson in Washington for several years prior to entering law school. Mr. Johnson received his B.S. in Accounting from the University of Richmond and received his J.D. from Georgetown University.

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DAVID P. JONES is General Counsel of Intervet Inc. in Millsboro, DE. His responsibilities include advising Intervet on all legal matters before the company, including regulatory, commercial, and transactional issues. He previously served as Counsel for C.R. Bard, Inc. Mr. Jones received his B.A. from Louisiana State University and his J.D. from Duke University School of Law.

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LINDA M. KATZ, M.D., M.P.H., is the Director of the Office of Cosmetics and Colors (OCAC), in the Food and Drug Administration’s (FDA’s) Center of Foods and Applied Nutrition (CFSAN) and the Interim Chief Medical Officer for CFSAN.  She establishes the priorities and missions of OCAC focusing on cosmetic safety, compliance, certification of color additives and research such as nanotechnology, phototoxicity and percutaneous absorption, and addresses safety and medical concerns for CFSAN regulated products.  She is the agency’s liaison for nanotechnology issues pertaining to food and cosmetics.  Dr. Katz is a member of the FDA Nanotechnology Task Force and other FDA nanotechnology working groups, as well as being an active member of CFSAN’s Leadership Board, and other CFSAN and FDA management committees.  She has had numerous presentations and publications, including those related to nanotechnology regarding cosmetics and foods issues, and other specific cosmetic topics.  Prior to assuming leadership of OCAC, she held positions in FDA’s Center for Drug Evaluation and Research (CDER) as Deputy Director for the Division of Over-the-Counter Drug Products, Deputy Director for the Division of Dermatologic and Dental Drug Products, and Team Leader and Acting Director for the Pilot Drug Evaluation Staff. Dr. Katz received her B.A. in Biology from the University of Pennsylvania, her M.P.H. in Epidemiology from the University of Michigan School of Public Health, and her M.D. from the University of Connecticut.  She completed her internship and residency in Internal Medicine, and fellowship in Rheumatology at the George Washington University Medical Center, in Washington, D.C.

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SARAH A. KLEIN, JD, MA is Staff Attorney with the Food Safety Program for the Center for Science in the Public Interest (CSPI). She represents CSPI in the regulatory arena, commenting to the Department of Agriculture (USDA) and the Food and Drug Administration (FDA) on issues relating to food safety programs, including risk-based inspection, imported food and irradiated food labeling, among others. She is also leading CSPI’s campaign for restaurant ratings, encouraging states and local governments to standardize and publicize restaurant inspection scores. Prior to joining CSPI, Ms. Klein was an Assistant Attorney General with the District of Columbia Office of the Attorney General. In that capacity, she drafted consumer protection legislation that is now law in the District. She has also worked with U.S. PIRG on consumer protection issues, and the National Whistleblower Center on whistleblower law. Ms. Klein received her Bachelor’s degree from Boston University, her J.D. from George Washington University and her Master’s Degree in Public Communications from American University.

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EDWARD L. KORWEK, PhD, JD is a Partner in the law firm of Hogan & Hartson L.L.P. in Washington, D.C. As a former scientist, he has a special expertise in modern biotechnology-derived products, particularly drugs, including biologics. For over twenty-five years Dr. Korwek has practiced in the Food and Drug Administration (FDA) area. His practice in the drug area involves providing advice on all aspects of FDA regulation of human over-the-counter (OTC) and prescription drugs, including antibiotics, insulin, and biological drugs. Specific areas of his drug practice include advising on Orphan Drug Act considerations. He has worked on various issues related to nearly all offices within the Center for Drugs and nearly all divisions within the Center for Biologics. He also works on Drug Enforcement Agency (DEA) matters pertaining to controlled substances. Dr. Korwek provides regulatory advice on not-approvable letters, export requirements, new drug applications, investigational new drugs, and product license application submissions, and FDA procedures. He also provides guidance on OTC monograph and switch issues and on drug advertising. He has been on numerous governmental advisory committees pertaining to the subject of biotechnology and is a member of the Editorial Advisory Board of the Biotechnology Law Report and the Journal of Biotechnology in Healthcare. He is a former member of the Board of Directors of the Food and Drug Law Institute (FDLI) and a member of the Drug Information Association, and the Regulatory Affairs Professionals Society. He is also a member of several legal and scientific associations. Dr. Korwek received his Ph.D. in biochemistry from the University of Pittsburgh and his J.D., cum laude, from Duquesne University Law School.

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LISA LAYMAN is Associate Vice President for Government Affairs and Policy at the Generic Pharmaceutical Association (GPhA).  Prior to joining GPhA, Ms. Layman was a senior policy advisor to U.S. Senator Debbie Stabenow.  In that role, she developed and implemented legislative strategies focusing on Medicare, prescription drugs, health information technology and insurance.  Prior to this, Ms. Layman worked on health care issues for U.S. Senators Bob Graham, Richard Bryan and John Chafee.  She also held analyst positions with the National Academy of Social Insurance and the Congressional Budget Office.  Ms. Layman received her B.A. in biology from Macalester College and her master’s degree in Public Health and Public Policy from the University of California–Berkeley.

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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 over 4,075 advertising cases over the past 34 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 B.A. from New York University and her J.D. from Brooklyn Law School.

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BEVERLY H. LORELL, MD (Bev) is the Senior Medical and Policy Advisor with the law firm of King & Spalding’s Food and Drug Administration (FDA)/Healthcare Practice Group in Washington, D.C. She specializes in the areas of clinical trial design of studies for drugs, devices and biologics; review of pre-market submissions; recalls; and assessment of matters involving a risk to health. She also specializes in the area of physician and industry relations and the development of independent scientific panels to advise health industries. Dr. Lorell is an internationally recognized clinical and basic science investigator with experience in multi-center clinical trials and preclinical proof-of-concept translational science. Prior to joining King & Spalding, she served as Vice President and global Chief Medical and Technology Officer at Guidant Corporation. Her responsibilities included evaluating emerging technologies and attendant regulatory challenges, determining product development priorities, and influencing clinical research strategies. She participated in the firm’s board for business development. Previously, Dr. Lorell was Professor of Medicine at Harvard University where she served the federal government in multiple roles. She has served in national leadership positions in professional societies. She continues to be an active invited lecturer at national professional meetings, as well as Harvard Law School and Harvard Medical School and is the author of numerous publications. Dr. Lorell graduated from Stanford University and received her M.D. and Residency in Internal Medicine from Stanford University Medical School. She received her advanced training as a Fellow in Cardiovascular Medicine at Harvard University.

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STEPHEN PAUL MAHINKA is a Partner in the Washington, D.C. office of Morgan Lewis. He is the chair of the firm’s Life Sciences Interdisciplinary Practice Group and a member of both the the FDA/Healthcare and Antitrust Regulation Practices. In the FDA/healthcare regulation area, he focuses on regulatory and compliance matters related to the FDA-regulated product lifecycle, including the development, acquisition, licensing, approval, distribution, marketing and pricing of prescription and over-the-counter drugs, food additives and packaging, dietary supplements and other products regulated and enforced by FDA, Federal Trade Commission, Department of Justice, and State Attorneys General; biotechnology regulation; Hatch-Waxman matters; and healthcare regulatory and enforcement matters of the Centers for Medicare and Medicaid Services. He has published numerous articles on FDA/healthcare regulation and competition matters, including FDA and antitrust issues in pharmaceutical industry protection of market exclusivity, competitive consequences of the new Medicare Act on the pharmaceutical industry, risk management strategies throughout the FDA-regulated product lifecycle, antitrust issues in pharmaceutical product licensing, and the effects of potential FDA approval of generic biologics. Mr. Mahinka received his undergraduate degree from The Johns Hopkins University, Phi Beta Kappa, and his law degree from the Harvard Law School where he was executive editor of the Harvard International Law Journal.

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MARK MANSOUR is a partner with Foley & Lardner LLP, where he is a member of the Public Affairs Practice and the Food, Nanotechnology and International Business Industry Teams. He also works with pharmaceutical and regulatory teams in establishing and maintaining intellectual property protection and securing regulatory approvals in emerging Asian markets and the Middle East. Mr. Mansour's practice focuses on national and international food, drug, cosmetic and consumer product regulation, as well as regulatory and public policy issues relating to nutrition, dietary supplements, food additives, pharmaceuticals, agribusiness, biotechnology, "biopharming" and nanotechnology. Mr. Mansour has had a heavy public policy and governmental and intergovernmental component to his practice since his early professional career as a senior staff member in the United States House of Representatives. Mr. Mansour is recognized as a pioneer in the development of strategies to open markets and address non-tariff barriers to trade affecting the international regulation of food, food additives and ingredients, dietary supplements, nutritional foods, pharmaceuticals, biotechnology, nanotechnology and a variety of other consumer products. Mr. Mansour received his B.S, Phi Beta Kappa, in foreign service from the Georgetown University School of Foreign Service, his M.A. in international affairs and public policy from Harvard University, and his J.D. from the Georgetown University Law Center.

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GERALD F. MASOUDI serves as the Chief Counsel for the Food and Drug Administration (FDA). He previously served as Deputy Assistant Attorney General in charge of International, Policy and Appellate Matters in the Antitrust Division at the U.S. Department of Justice. From 2004-2005, he served as Principal Deputy Chief Counsel and for a time he served as Acting Chief Counsel both for the FDA. Before joining FDA, he was a Partner at Kirkland & Ellis LLP. He also clerked for Judge Frank H. Easterbrook of the U.S. Court of Appeals for the Seventh Circuit. Mr. Masoudi earned his bachelor's degree in Economics from Amherst College and received his law degree, with high honors, from the University of Chicago Law School, where he was an editor of the Law Review.

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KATE DUFFY MAZAN is an attorney in private practice in McLean, VA. She is the founding member of The Clinical Technology Transfer Group (CTTG), a law firm specializing in technology transfer and regulatory compliance in the clinical setting. For the past 7 years, Ms. Mazan has practiced exclusively in the area of food and drug law with an emphasis on the regulation of clinical research. In private practice, she has assisted a variety of companies and institutions in complying with federal and state laws and regulations governing the conduct of clinical trials. Ms. Mazan has extensive experience in the negotiation of clinical trial agreements and the regulatory review of clinical research practices. Prior to entering private practice, Ms. Mazan worked at the National Cancer Institute (NCI) within the National Institutes of Health (NIH) where she managed the intellectual property portfolio of NCI’s Natural Products Branch, negotiating CRADAs and international agreements with countries in Africa, Central and South America, and the Pacific Rim. She began her career at NIH as Chief of NCI’s Cancer Information Service (CIS), a nationwide network of cancer information and education programs located at major cancer centers across the country. In that capacity, she was responsible for developing a training program on the conduct of clinical trials to assist information specialists explain clinical research to patients and the public. Ms. Mazan holds a law degree from the Columbus School of Law at the Catholic University of America, Washington, D.C., a Master of Science in Public Health Administration from the University of Massachusetts, Amherst, and an A.B. from Stonehill College, North Easton, Massachusetts. She is admitted to practice law in Virginia, Maryland, and the District of Columbia.

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MADELEINE M. McDONOUGH is a Partner in the law firm of Shook, Hardy & Bacon, Kansas City, MO. She concentrates her practice primarily on the defense of pharmaceutical and medical device manufacturers. She serves as national and regional counsel for pharmaceutical manufacturers for a wide range of different products. She has represented clients in the chemical, agribusiness, food, telecommunications, and energy industries. She has extensive experience in successfully resolving class actions, multidistrict litigation, mass torts, and other complex litigation. Ms. McDonough has represented corporations and individuals in product liability, toxic tort, personal injury and commercial matters. She regularly counsels clients on preventative litigation strategies and creative and efficient resolution of claims and threatened litigation. She has also counseled food processors and pharmaceutical manufacturers required to comply with Food and Drug Administration (FDA) regulations, ranging from bovine spongiform encephalopathy (BSE) prevention to facility inspections and recalls. She has authored articles and frequently speaks at national and local conferences on complex litigation issues, electronic discovery, negotiation, mediation, trial practice and other case resolution techniques. Before her legal career, she worked as a clinical pharmacist in a large university teaching hospital and brings her pharmaceutical background to her representation of pharmaceutical and medical device manufacturers in product liability, regulatory and related legal issues. Ms. McDonough received her B.S. from the University of Missouri-Kansas City School of Pharmacy and her J.D. from the University of Kansas School of Law.

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WILLIAM A. McGRATH is a Partner in the Washington, D.C. office of Wiley Rein & Fielding LLP. Mr. McGrath counsels clients on federal and state regulatory and liability issues in the development, safety, advertising, and marketing of drugs, medical devices, food and beverages, nutritional supplements, cosmetics, and consumer products. He represents clients before the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), U.S. Consumer Product Safety Commission (CPSC), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), state agencies, and state and federal courts. Mr. McGrath counsels pharmaceutical, food and nutritional supplement manufacturers and distributors on all phases of FDA, state and local regulatory requirements. Additionally, he counsels pharmaceutical, medical device, food, beverage, and consumer product manufacturers on developing constitutional and statutory defenses in product liability litigation and works with medical product manufacturers, healthcare organizations, and others on liability reform issues. Mr. McGrath represents pharmaceutical and consumer product manufacturers in litigation challenging federal and state regulatory actions and in product liability litigation. Previously, he was a law clerk for the Honorable William T. Prince, U.S. Magistrate Judge, in the U.S. District Court for the Eastern District of Virginia. Mr. McGrath serves on the Editorial Board of the Food & Drug Law Institute's Update magazine. He received a B.F.A. from Southern Methodist University and his J.D. from The Marshall-Wythe School of Law, The College of William & Mary.

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JUDITH K. MERITZ is a Partner in the Health Law Practice Group at Blank Rome LLP. 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). Ms. Meritz served as Assistant General Counsel for the American Red Cross (ARC) and was responsible for regulatory affairs. She served as the Chief Counsel to the BioMedical services group and provided guidance to the other ARC units 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. Her responsibilities included providing counsel to domestic and international business divisions regarding all aspects of regulatory affairs and governmental compliance. She oversaw quality control, quality assurance, product labeling, product and facility registrations, complaint handling, recalls, facility audits, safety and environmental compliance groups. Former positions include Director of Regulatory Affairs and Regulatory Counsel for Henry Schein, Inc. and Assistant Regional Counsel for the EPA. 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 served as Chair for FDLI’s Law Journal Editorial Advisory Board, serves on the Dean’s Advisory Council, serves as Alumni Chapter President of the School of Public Affairs at American University, Washington, DC and serves on various other boards. Ms. Meritz received her B.A. 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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DANIEL MERON is the General Counsel of the Department of Health and Human Services. Mr. Meron was sworn in on August 31, 2006. Mr. Meron graduated magna cum laude from Harvard College in 1986, with a major in Government. Mr. Meron graduated magna cum laude from Harvard Law School in 1992, where he served as co-chair of the articles office of the Harvard Law Review and was a winner and oralist of the Ames moot court competition. Mr. Meron also has a Ph.D., a.b.d., in Social Thought from the University of Chicago. Following graduation from law school, Mr. Meron clerked for the Hon. Laurence H. Silberman of the United States Court of Appeals for the District of Columbia Circuit and for the Hon. Anthony M. Kennedy of the United States Supreme Court.

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ELAINE C. MESSA is Vice President of Medical Device/Quality Systems with Quintiles Consulting. Based in southern California, she works with clients in the pharmaceutical, medical device, and biotechnology industries to develop quality assurance, manufacturing, and regulatory strategies for compliance with Food and Drug Administration (FDA) regulations. She conducts regulatory gap analysis at client sites, assists with the development and implementation of quality systems, and develops and implements corrective action plans to address deficiencies identified by regulatory agencies. Ms. Messa also provides training in the areas of management responsibility and inspectional preparedness. In addition to her client responsibilities she manages the efforts of the nationwide staff of Senior Quality System Associates in the Medical Device/Quality Systems service group. She joined Quintiles Consulting following a thirty year career with FDA. Most recently, Ms. Messa was the Director of FDA’s Los Angeles District, a district responsible for the largest import operations and medical device workload in the U.S. During her tenure at FDA she successfully established an industry grassroots group and developed technical joint training efforts with local regulatory associations. She chaired the ORA/CDRH Medical Device Field Committee and participated in the development and implementation of the Medical Device Mutual Recognition Agreement (MRA annex), Medical Device Initiative, Warning Letter Pilot, and Quality Systems Inspection Technique (QSIT). She is the President of Orange County Regulatory Affairs (OCRA) and a member of several trade organizations. Ms. Messa received her B.A. in political science from the University of Pittsburgh.

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THOMAS MILLER,CEO, Workflow and Solutions, Siemens Healthcare (formerly Siemens Medical Solutions). Thomas Miller's areas of expertise include medical physics and information technology, combined with his passion for transforming how we approach disease – prediction, prevention, diagnosis, and treatment.  A 20-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 leading the U.S. sales and service organization. Mr. Miller holds a B.S. 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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PAULA A. MONOPOLI is a Professor of Law at the University of Maryland School of Law and the Founding Director of its Women, Leadership & Equality Program. The program is the first of its kind at an American law school. The goal of the program is to train women law students in the professional skills necessary to survive, thrive and assume leadership in law practice and the legal profession. She practiced law at Hawkins Delafield & Wood, Holland & Knight and Hill & Barlow prior to entering academia. Professor Monopoli teaches Property, Trusts & Estates and a seminar in Gender and Leadership. She is a frequent speaker and author on the intersection of gender and the law. She recently published Gender and Constitutional Design in the Yale Law Journal. She is an elected member of the American Law Institute and she was the 2004 Outstanding Professor of the Year at Maryland.  Professor Monopoli received a B.A, cum laude, from Yale College and her J.D. from the University of Virginia School of Law.

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TOM NAGLE is a co-founder of Statler Nagle LLC, a marketing consulting firm with specialized expertise in issues and industry campaigns. He has been a marketing leader and innovator for many years. He has worked in advertising agencies, marketing research firms, and most recently, as the head of Marketing for the International Dairy Foods Association (IDFA), he was the senior strategic and operational manager of the iconic national "Got Milk/Milk Mustache" campaign. Among his key achievements were shifting this historic campaign from an "awareness only" advertising and PR program to a fully integrated sales driving marketing effort. He also led the launch of the first national integrated campaign to promote the "weight loss" benefits of milk consumption. Prior to joining IDFA, he worked in a number of advertising agencies, as both a senior account manager and as a brand planner. He worked on such categories as fast food, healthcare, insurance, online services, retail house wares, banking and financial services, and cable television systems. He has frequently lectured at colleges and universities, served on various boards and been the recipient of numerous national awards for both marketing creativity and effectiveness. Mr. Nagle received his bachelor’s degree in Journalism and Business Management from the University of Maryland.

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ROBERT B. NICHOLAS is a Partner in the Washington, D.C. 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 ABA and as an Editor of the Biotechnology Law Journal. Mr. Nicholas received his A.B. from St. Lawrence University in 1966, and his J.D. from Boston University in 1969.

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