Speaker Biographies
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EDWARD ABRAHAMS, PhD is the Executive Director of the Personalized Medicine Coalition (PMC), a non-profit group that works to spread the understanding and adoption of personalized medicine to patients. Prior to joining PMC, he was the Executive Director of the Pennsylvania Biotechnology Association, where he led a successful effort toward Pennsylvania’s $200 million investment in commercializing biotechnology in the state. Previous to this, Dr. Abrahams was the Assistant Vice President for Federal Relations at the University of Pennsylvania, and also held a senior administrative position at Brown University. Additionally, he spent seven years working for the U.S. Congress, which included a position as legislative assistant to Senator Lloyd Bentsen, as an economist for the Joint Economic Committee under Representative Lee Hamilton and as a AAAS Congressional Fellow for the House Committee on the Interior.
DAVID WILLIAM KENNEDY ACHESON, MD, FRCP is the Managing Director, Food and Import Safety Practice for Leavitt Partners. He assists clients in entering new markets, enhancing the value of their products, navigating dynamic regulatory and reimbursement systems and improving health conditions around the world. Previously, Dr. Acheson served as the Associate Commissioner for Foods, in the Office of Food Protection, Office of the Commissioner, Food and Drug Administration (FDA) where he provided advice and counsel to the Commissioner on strategic and substantive food safety and food defense matters and worked with individual FDA product centers, as well as the Office of Regulatory Affairs to coordinate FDA’s food safety and defense assignments and commitments. As a Center for Food Safety and Applied Nutrition (CFSAN) office director before joining FDA, 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. He also served as the former 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, serving 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.
ANTHONY P. ALBINO, PhD is Vice President for Public Health Affairs for Vector Group Ltd., Senior Vice President for Public Health Affairs at Vector Tobacco Inc, and President and CEO of Vector Research LLC. His focus is on developing biological and molecular strategies of disease development as a prelude to reducing the disease risks associated with long-term smoking. Dr. Albino has over thirty-five years of broad experience in basic and clinical cancer research, and public health in both the academic and corporate environments. He is an expert in the field of tumor biology, author of over 135 research articles and book chapters, and the recipient of eight patents in the areas relevant to cancer identification, diagnosis, treatment, and initiation. After completing a post-doctoral fellowship, he joined the staff of the Memorial Sloan-Kettering Cancer Center in New York where his research focused on the molecular and genetic analysis of a wide range of human cancers. In 1997, Dr. Albino became Director of Research at the American Health Foundation in NY, the premier National Cancer Institute-Designated Cancer Center devoted to cancer prevention strategies and the elucidation of the biochemical, biological and societal impact of chronic tobacco usage. In 1999, he assumed the additional role of Deputy Director of the American Health Foundation Cancer Center. In 2001, Dr. Albino joined Vector Group as Vice-President for Public Health Affairs to applying his experience in the fields of cancer research and public health towards elucidating how tobacco usage causes disease and developing innovative ways to reduce the known toxicity of tobacco products. In his career, Dr. Albino has served as Scientific Consultant for several major medical establishments, and as a member or chairperson of numerous national and international cancer funding review committees, including the National Cancer Institute and the New York State Department of Health. He is also a former member of the Commission for a Healthy New York, a blue-ribbon panel of experts in the field of tobacco control, science, health promotion, and community intervention that guided the Health Commissioner of New York State. Dr. Albino is or has been a member of a range of scientific and medical societies, Associate Editor of several scientific journals, reviewer for numerous national and international scientific journals, and invited speaker at many national and international scientific symposia. Of relevant note, Dr. Albino, in compliance with Good Clinical Practices and under an Investigational New Drug Application (IND) from the FDA, successfully led a team that assessed the efficacy of a nicotine-free cigarette as a smoking cessation device in a randomized, multi-center study. He received a BA in biology from Hunter College and a PhD from Cornell University with a focus in RNA tumor viruses.
ALBERTO ALEMANNO, Senior Advisor for International Affairs/Codex Manager, CFSAN, FDA
Biogrpahy coming soon
SCOTT D. BALLIN is a tobacco and health policy consultant in Washington, DC and has spent more than 25 years involved in issues related to tobacco and health. He has worked on a spectrum of issues ranging from labeling reforms on cigarettes and smokeless tobacco products, FDA regulation of tobacco, excise tax increases, clean indoor air laws and tobacco agriculture reforms. For more than 10 years he served as the American Heart Association's Vice President for Public Policy and Legislative Counsel, and as a Steering Committee member and two-time Chairman of the Coalition on Smoking OR Health which was the first truly active national coalition in the tobacco movement. Recently, he served on (and continues to serve on) the Steering Committee of the Alliance for Health Economic and Agriculture Development (AHEAD), an informal organization committed to bringing parties together in order to discuss controversial issues, remove barriers, foster constructive dialogue and look for new opportunities to find common ground. He is a graduate of Georgetown University's School of Foreign Service and has a law degree from George Mason University.
STEPHANIE BATLINER is Chairperson of the Generic Animal Drug Alliance (GADA), an independent professional trade organization that represents the interests of generic animal health companies before Federal regulatory agencies and Congress. Member companies are focused on the development, approval and marketing of high quality generic drugs for livestock and pets. Ms. Batliner also serves as Director, Regulatory Affairs for Teva Animal Health, Inc. She has over 15 years of experience in the animal pharmaceutical industry. She received her BS in Animal Science from the University of Missouri.
ERIC M. BLUMBERG is the Deputy Chief Counsel for Litigation in the Office of the Chief Counsel, FDA. He oversees all litigation relating to enforcement of the statutes administered by FDA and all defensive litigation arising out of FDA programs, and assists the agency in its rapidly expanding enforcement initiatives. He has been with the Office of the Chief Counsel since 1970 and has played a leading role in the litigation of many important trial and appeal cases, including FDA’s first prosecution of a pharmaceutical company for failing to report adverse drug reactions. Mr. Blumberg received his BA from Washington and Lee University and his JD from Georgetown University Law Center.
JOHN W. BODE is a Principal with the Washington, DC law firm of Olsson Frank Weeda Terman Bode Matz PC. He held three Presidential appointments at the U.S. Department of Agriculture (USDA) before joining the firm in 1989. His practice is concentrated in government relations. As Assistant Secretary for Food and Consumer Services, Mr. Bode was responsible for almost half of the USDA budget and, as a Director of the Commodity Credit Corporation, was heavily involved in commodity issues. Mr. Bode testified on behalf of the Reagan and Bush Administrations over seventy times. Before joining USDA in 1981, he was on the staff of the U.S. Senate Committee on Agriculture, Nutrition and Forestry for two years. Mr. Bode also served on the staff of then-Governor of Oklahoma, David L. Boren, and as a court clerk. Mr. Bode received his BA from the University of Oklahoma and his JD from George Mason University School of Law.
SHELDON T. BRADSHAW is a Partner and Co-chair, Food and Drug Practice 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 U.S. 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.
JENNIFER L. BRAGG is a Partner with the law firm of Skadden, Arps, Slate, Meagher & Flom in Washington, DC. She provides FDA compliance counseling to numerous pharmaceutical and medical device clients. Often, she has managed this work in the context of other litigation in which companies are engaged, which requires a strategy that both resolves the regulatory issues and minimizes litigation risks. She also provides strategic litigation assistance to companies who are the subject of civil and criminal governmental inquiries and she has been responsible for managing the FDA and Drug Enforcement Administration (DEA) components of complex products liability litigation. Previously, Ms. Bragg served in the Chief Counsel’s Office at FDA as Associate Counsel for Criminal Enforcement. During her tenure at FDA, Ms. Bragg was responsible for directing all aspects of the investigation and prosecution of complex criminal cases. She acted as liaison between the Office of Chief Counsel and the Office of Criminal Investigations, and helped make policy determinations about issues facing the agency in the criminal arena. Ms. Bragg received her BA in Journalism from the University of Maryland and her law degree from the University of Maryland School of Law, where she graduated with honors.
MARK S. BROWN is a Partner in King & Spalding’s FDA & Life Sciences Practice in Washington, DC. He advises clients on various FDA regulatory compliance issues, including factory inspections, criminal investigations, recalls, labeling, advertising and promotion issues, and on strategies for obtaining FDA approval and clearance. He has negotiated several agreements with FDA and the U.S. Department of Justice to settle civil and criminal enforcement actions. Mr. Brown also has extensive experience in FDA compliance and product approval issues that arise in products liability litigation involving drugs and devices, and advertising disputes between competing companies. Prior to joining King & Spalding in 1994, Mr. Brown served for five years as an Associate Chief Counsel in FDA’s Office of the General Counsel where he represented FDA in both civil and criminal enforcement litigation. During his tenure at FDA, he became the agency’s chief litigator in device enforcement actions, particularly in the area of FDA’s current Good Manufacturing Practice (GMP) regulations. He represented FDA in several complex and comprehensive GMP-based enforcement actions undertaken against medical device manufacturers. Mr. Brown received his AB from the University of Michigan and his JD from St. Louis University.
NANCY L. BUC is a Partner in the law firm of Buc & Beardsley, LLP in Washington, DC. She served as General Counsel for the U.S. Food and Drug Administration (FDA) from 1980 to 1981. During an earlier period of government service, she served as Attorney-Advisor to the Chairman of the Federal Trade Commission (FTC) and Assistant Director of that agency's Bureau of Consumer Protection. She was a member of the Life Science Research Office’s (LSRO’s) Reduced Risk Tobacco Products Core Committee and was also a member of the Institute of Medicine's Committee on Contraceptive Research and Development and its Committee on National Institute on Drug Abuse (NIDA) Medications Development. Ms. Buc was also a member of the National Institutes of Health’s Recombinant DNA Advisory Committee and its Consensus Panel on Effective Medical Treatment of Heroin Addiction. She 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 FTC, and is the Immediate Past Chair of the Food and Drug Law Institute’s Board of Directors. She is a Director of Dynavax Technologies Corporation, and was formerly a Director of Agritope, Inc. and the National Partnership for Women and Families. She has been an Adjunct Professor of Law (Food and Drug Law) at Georgetown University Law Center. She is a graduate of Brown University and the University of Virginia School of Law. Ms. Buc holds an honorary doctor of laws from Brown and is a Trustee Emerita of Brown.
DAVID S. BUCKLES, PhD is the Director of the Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH, FDA. His responsibilities include overseeing every aspect of the handling of medical device adverse event reports (MDRs) including data entry and quality control as well as adverse event analyses. He has been with FDA in various capacities since 2003. Prior to joining FDA, Dr. Buckles worked in the cardiovascular medical device industry as Chief Scientist and Chief Technology Officer, serving also in regulatory affairs and quality assurance roles. From 1985 to 1995, he was a researcher, faculty member and health care provider at the Children’s Hospital, Medical University of South Carolina (MUSC), working in the field of congenital heart disease. He is a Fellow of the American College of Cardiology and a member of the Heart Rhythm Society. Dr. Buckles received a BS in chemistry from the University of Texas at Austin and a PhD in biomedical systems science from MUSC.
GLENN N. BYRD, MBA, RAC is the 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. Previous to this, Mr. Byrd served as the Chief of the Advertising and Promotional Labeling Branch (APLB) in 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. He also served 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 MBA from Hood College.
ANDREW M. CAPLAN is an Attorney in the Ethics Division, Office of the General Counsel, U.S. Department of Health and Human Services (HHS), where he serves as the Ethics Counsel for the Food and Drug Administration (FDA). Mr. Caplan provides advice to FDA employees on the full range of federal ethics laws, including post-employment restrictions, financial conflicts of interest and outside activities. He has been part of the HHS Office of the General Counsel since 1997. Previously, he was an ethics counsel at the U.S. Department of Commerce, and was a commissioned officer in the U.S. Navy Judge Advocate General’s Corps. Mr. Caplan received his JD from Emory University School of Law and his BA from Brandeis University.
DAVID E. CHADWICK, PhD, RAC is a Regulatory Scientist in the Regulatory Affairs Department of Cook, Inc., a healthcare device development company. He focuses on regulatory strategy for emerging and marketed products within the company as well as regulatory submissions/compliance. Dr. Chadwick has over 25 years of experience in the medical device industry in various areas, such as basic research and development, clinical research and regulatory affairs/quality assurance. He also has experience in the product areas of dermatology, in vitro diagnostics, urology, cardiology, drug delivery and electrosurgery. Prior to his work in regulatory affairs, he spent a number of years in research and development functions as well as the management of clinical trials. Dr. Chadwick received a BS in biology from Albright College and a PhD in anatomy and cell biology from the School of Medicine, University of Pittsburgh.
MICHAEL A. CHAPPELL is the Acting Associate Commissioner for Regulatory Affairs and Deputy Associate Commissioner for Field Operations in FDA’s Office of Regulatory Affairs. He is head of a 4,000-person staff spanning five regional offices that are responsible for imports, inspections and enforcement policy. Previously, Mr. Chappell served as director of the Dallas District where he was responsible for all FDA domestic field activities in Texas, Oklahoma and Arkansas. He was also a supervisory consumer safety officer in the Atlanta District and a director of investigations for the Florida District, where he managed all field investigational programs for the district and one of the largest import operations in FDA’s Southeast Region. Mr. Chappell started his FDA career as a consumer safety officer in Nashville. He later became the resident in charge of the Memphis Resident Post of the Nashville District, where he was responsible for new emphasis programs for the field force in medical devices, biologics, and bioresearch. Mr. Chappell is a graduate of the University of Alabama.
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, the National Research Council and the Congressional Office of Technology Assessment. He also served as Chairman of the Editorial Board of the Food and Drug Law Journal and 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 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 BA, First Class with Congratulations from Oxford University and a JD, summa cum laude, from Harvard Law School.
E. STEWART CRUMPLER is a Principal Consultant with Quintiles Consulting. In this role, he assists domestic and international companies in the medical device, pharmaceutical, biologics, and biotechnology industries to develop strategies for quality assurance and regulatory compliance. Before his position at Quintiles, Mr. Crumpler was an Assistant Vice President for five years at Wyeth Pharmaceuticals, where he served as the quality system champion for computer systems compliance and directed the corporation’s Part 11 compliance strategy for electronic records, electronic signatures and computer validation. Prior to his position at Wyeth, Mr. Crumpler held a variety of management and compliance roles during his 28-year career at the Food and Drug Administration. As the Software Expert for the Office of Compliance, Center for Devices and Radiological Health (CDRH), he advised the medical device industry regarding application of FDA’s device software policy and led development of FDA’s guidance on software validation. He also planned and directed the strategy for implementation of FDA’s first medical device performance standard for electrode lead wires and patient cables, and was a member of the FDA Design Control Inspection Strategy Team during implementation of the Quality System Regulation. Mr. Crumpler is a senior member of the American Society for Quality and an ASQ Certified Software Quality Engineer. He earned his BS in physics and his MS in public health, both from the University of North Carolina.
FRED H. DEGNAN is a Partner in King & Spalding’s Washington office where since 1988 he has specialized in food and drug law and handled a wide array of food safety, labeling, and biotechnology issues. His prior eleven and one half year legal career in Food and Drug Administration’s (FDA’s) Office of Chief Counsel (where he served as Associate Chief Counsel for Foods, Associate Chief Counsel for Veterinary Medicine, and Associate Chief Counsel for Enforcement) included extensive experience with food and drug issues, including food safety, nutrition and health, infant formula, labeling, good manufacturing practice, new drugs, new animal drugs, and the use of risk assessment in the regulation of the safety of food ingredients. He also had substantial FDA litigation and enforcement experience in federal courts. He received the agency’s highest awards. Since 1989, in addition to his responsibilities at King & Spalding, Mr. Degnan has taught food and drug law at the Catholic University of America’s Columbus School of Law where he serves as a “Distinguished Lecturer.” He has published and lectured extensively on FDA-related issues and is the author of the book, FDA’s Creative Application of the Law: Not Merely a Collection of Words (2nd Edition), a consideration of FDA’s implementation of its statutory authority to adapt to the practical demands of modern regulation. In 2002, he received the FDLI Distinguished Leadership Award for his contributions to the food and drug community. Mr. Degnan has consistently been named in independently conducted surveys as among the top lawyers, and specifically top food and drug lawyers, nationwide (Chambers, USA, 2007, 2008, 2009) and in Washington, DC (Washingtonian Magazine “Best” Lawyers, 2004, 2007, 2009; Law & Politics, Washington, DC “Super Lawyers” 2007, 2008, 2009, 2010). Mr. Degnan received his undergraduate degree, cum laude, from the College of the Holy Cross, Worcester, Massachusetts and his law degree from Georgetown
University, Washington, DC.
CRAIG A. DeLARGE is the Associate Director of eMarketing & Relationship Marketing at Novo Nordisk, Inc. In his over 20 years in marketing & management, Mr. DeLarge has worked in marketing research, promotions & media management, business development, brand management, knowledge management, eMarketing, relationship marketing and team/organizational leadership roles for Johnson & Johnson, Communications Media, Inc., a start-up media consultancy, GlaxoSmithKline and Novo Nordisk. He has also taught & lectured at Philadelphia University and Chestnut Hill College on marketing, consumer behavior, communications, marketing research, sales, leadership, organizational storytelling and visual literacy. In addition, he has authored on the topics of management storytelling, knowledge networking, pharma/healthcare relationship marketing, social media and virtual worlds. Mr. DeLarge received his BS in Marketing from Philadelphia University and his MBA in Design Management from the University of Westminster in London.
LAWRENCE R. DEYTON, MSPH, MD became the first Director of the Center for Tobacco Products at the Food and Drug Administration (FDA) in September 2009. The goals of the center include reducing youth tobacco use, promoting public understanding of the contents and consequences of use of tobacco products and reducing the toll of tobacco-related diseases, disability and death. Before joining FDA, Dr. Deyton worked for the Department of Veterans Affairs, first serving as director of the AIDS Service and then establishing VA’s Public Health Strategic Health Care Group. He later became Chief Public Health and Environmental Hazards Officer, where he revitalized the VA’s smoking and tobacco use cessation programs, causing an 11 percent drop in tobacco use among veterans enrolled in the program. Prior to his VA work, Dr. Deyton served for 11 years in leadership roles at the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). He also founded the Whitman Walker Clinic, a community-based AIDS service organization in Washington, DC. Dr. Deyton is a graduate of Kansas University, the Harvard School of Public Health and the George Washington University School of Medicine.
GARY D. DOLCH, PhD is Senior Vice President, Quality & Regulatory Affairs at C.R. Bard, Inc., a medical technology developer and manufacturer based in Murray Hill, New Jersey. Prior to joining Bard, he was Executive Vice President, Quality, Regulatory, and Operational Excellence for Cardinal Health. Before Cardinal, Dr. Dolch served as Senior Vice President, Quality and Regulatory Affairs for the American Red Cross. He was also Vice President of Operations and Quality Assurance for the Knoll Pharmaceutical Division of BASF. Earlier in his 30-year career in healthcare, he worked in Quality Assurance and Regulatory Affairs with American Home Products, Genentech Inc. and Boehringer Ingelheim Pharmaceuticals. Dr. Dolch received a BS in Chemistry from Ursinus College, an MS in Chemistry from Fairleigh Dickinson University and a PhD in Medicinal Chemistry from Purdue University.
DIANE E. DORMAN is Vice President for Public Policy for the National Organization for Rare Disorders (NORD). She leads NORD efforts in its relationship with the federal government and Congress. Since joining NORD in October 2000, Ms. Dorman has been instrumental in the passage of the Rare Diseases Act (P.L. 107-281), and the Rare Diseases Orphan Product Development Act (P.L. 107-281). She was also influential in the introduction of House Concurrent Resolution 147, commemorating the 20th Anniversary of the Orphan Drug Act. In addition of these activities, she is responsible for ensuring that patients continue to have access to life-saving orphan therapies through Medicare, Medicaid and private insurance. Ms. Dorman serves as NORD’s primary liaison to the Food and Drug Administration (FDA), the National Institutes of Health, and the Center for Medicare and Medicare Services, as well as the pharmaceutical and biotechnology industry. On behalf of NORD and Coalitions in which NORD participates, Ms. Dorman leads education and outreach programs to gain policymaker support for increased research into rare diseases and greater development of orphan products. She develops and maintains relationships with other healthcare voluntary agencies and patient groups. Ms. Dorman provides technical assistance and legislative analysis to NORD’s member agencies on government-related matters, as well as the training of staff and volunteers of member organizations. She serves on the Board of Directors of the FDA Alliance, and was recently elected Vice President. She is one of the founding members of the Alliance for Drug Safety and Access, and was also appointed to the Membership Committee of the U.S. Pharmacopeia.
RYAN DRANT is a General Partner for New Enterprise Associates (NEA), a venture capital firm in the IT and healthcare sectors. He specializes in healthcare investments in the specialty pharma, medical device and healthcare IT sectors. He is a board member of a number of organizations, including BENU, Carticept Medical, Concentric Medical and ExploraMed III, among others. Before joining NEA, Mr. Drant was with the Health Care Investment Banking Group of Alex. Brown & Sons in San Francisco. Prior to this, he worked in the San Francisco office of Arthur Anderson & Co. He received a BA from Stanford University.
BENJAMIN L. ENGLAND is an Attorney and the Founder of Benjamin L. England & Associates, LLC and FDAImports.com, LLC. A 17-year veteran of the Food and Drug Administration (FDA), Mr. England focuses his practice on preparing for, managing, and responding to FDA inspections, food, dietary supplement, and cosmetic labeling and dietary supplement labeling and advertising compliance under FDA and FTC regulations, among other areas. His FDA experience includes guiding responses to FDA and U.S. Department of Agriculture (USDA) inspection and enforcement actions, defending against FDA and Customs criminal investigations, inquiries, and prosecutions and assisting clients in leveraging their risk management programs for food, medical device or drug distribution against FDA and Customs import clearance processes to obtain more rapid cargo clearance. While at FDA, he served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs and also as an FDA Consumer Safety Officer, Compliance Officer, and Senior Special Agent with the Office of Criminal Investigations. Mr. England received his BA in biological sciences from the University of Maryland and his JD, summa cum laude, from the University of Miami School of Law, where he was a member of the Order of the Coif and the University of Miami Law Review.
MARY KOELBEL ENGLE is the Associate Director for Advertising Practices, Bureau of Consumer Protection at the Federal Trade Commission (FTC). The FTC is a federal law enforcement agency charged with enforcing the nation's antitrust and consumer protection laws. The Division of Advertising Practices is responsible for regulating national advertising matters, including claims about food, over-the-counter (OTC) drugs, dietary supplements, alcohol, tobacco and Internet services. The Division also enforces the Children’s Online Privacy Protection Act. Ms. Engle joined the FTC as a staff attorney and has served as Assistant to the Director of the Bureau of Consumer Protection, attorney advisor to a Commissioner, and Assistant Director of the Divisions of Enforcement and Advertising Practices. She also served as the Project Director of the FTC’s Study of the Marketing of Violent Entertainment to Children. Prior to joining the FTC, she practiced law with a firm in Washington, DC. Ms. Engle received her AB from Harvard University and her JD from the University of Virginia School of Law.
ANDREW C. FISH is Senior Vice President of Legal and Government Affairs, General Counsel, and Secretary for the Consumer Healthcare Products Association (CHPA), the trade association representing the leading manufacturers of over-the-counter medicines and dietary supplements. In this position, he oversees government relations and legal affairs. Prior to joining CHPA, Mr. Fish directed federal government relations for the American Cancer Society. He has also worked in the U.S. Senate and in private legal practice, and served as Assistant Secretary of Agriculture for Congressional and Intergovernmental Affairs during the Clinton Administration. Mr. Fish is a graduate of Yale University and Stanford Law School, and is a member of the bar in Virginia and the District of Columbia.
KEITH J. FLANAGAN is Health Counsel to Ranking Member Enzi on the U.S. Senate Committee on Health, Education, Labor and Pensions. He previously practiced corporate law at Sonnenschein Nath & Rosenthal LLP. Before this position, Mr. Flanagan served as Assistant Legal Counsel with the Illinois Office of Banks and Real Estate within the agency's Bureau of Banks and Trust Companies, where he provided legal support and assistance by conducting research and responding to legal issues raised by agency personnel and representatives of Illinois' banking industry. Prior to this position, he served as Assistant Legal Counsel to the Illinois Comptroller, providing legal advice concerning financial institutions, technology and electronic commerce matters. Mr. Flanagan earned a BA from Colgate and a JD from the University of Southern California.
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.
ELIZABETH R. FORMINARD is Vice President of Law at Ethicon, Inc. In this position, she is responsible for legal support to the U.S. activities of the Ethicon franchise, a global medical device company with five business units and products including medical devices and biosurgicals. Prior to joining Ethicon in 2008, Ms. Forminard was Vice President of Law at Consumer Health Care, a position she held following the acquisition of Pfizer Inc. by Johnson & Johnson in 2006. At Pfizer, she held numerous positions including head of the U.S. Legal Regulatory function for Pfizer’s Consumer business and lead counsel to the consumer business in Australia/New Zealand. Prior to joining Pfizer, she was an associate at the law firm of Weil, Gotshal & Manges LLP. Ms. Forminard earned her BA from Cornell University and her JD from the University of Pennsylvania Law School. She was Editor in Chief of the Comparative Labor Law Journal and Founding Editor of the University of Pennsylvania Journal of Labor and Employment Law.
JEFFREY K. FRANCER is Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he provides advice and advocacy on FDA regulatory and policy matters. He counsels the association and member companies on a wide range of issues relating to the regulation of drugs and biological products, including: drug approval and postmarketing requirements, product labeling and promotion, direct-to-consumer advertising, clinical trials, and current Good Manufacturing Practice (cGMP). Mr. Francer also advises and participates in the committees that draft PhRMA’s Code on Interactions with Healthcare Professionals (the PhRMA Code), its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results and its Guiding Principles on DTC Advertising. Previously, he served as Associate Chief Counsel of the Food and Drug Administration from 2003-2005 where he advised agency leaders on a wide range of issues involving the regulation of drugs and biologics including clinical investigation and emergency use of medical products, enforcement matters and legislative matters. Immediately prior to joining PhRMA, Mr. Francer served as Associate General Counsel and U.S. Compliance Officer of Biogen Idec, Inc. At Biogen Idec, he was the primary in-house counsel on FDA issues, fraud and abuse, and patient privacy. He was also responsible for overseeing the U.S. and corporate compliance program. Mr. Francer received his AB in Public Policy and Economics from Brown University, his MPP from Harvard University and his JD from the University of Virginia.
MARK S. FRANKEL, PhD is the Director of the Scientific Freedom, Responsibility and Law Program at the American Association for the Advancement of Science (AAAS), where he develops and manages the Association's activities related to professional ethics, science and society, and science and law. At AAAS, he has directed projects on research integrity and scientific misconduct; human enhancement; the ethical and legal implications of genetic testing; the ethical and policy implications of human stem cell research and inheritable genetic modification; bioethics consulting for industry; and the implications of advances in neuroscience research for the legal system. Dr. Frankel is a former member of the Board of Directors of the National Patient Safety Foundation and currently serves on the Boards of the Food and Drug Law Institute and the Center for Law, Science and Innovation at Arizona State University. He is on the planning committee for the 2010 NNI Capstone Workshop on Risk Management Methods & Societal, Ethical, and Legal Implications of Nanotechnology, and is a member of the Science and Ethics Advisory Group of F. Hoffmann-La Roche, a pharmaceutical company based in Switzerland. Dr. Frankel is on the editorial boards of Science and Engineering Ethics, Ethics & Behavior, Professional Ethics and the Journal of Empirical Research on Human Research Ethics. He is editor of AAAS’s quarterly publication, Professional Ethics Report, and a Fellow of AAAS. He serves as Staff Officer to the AAAS-ABA National Conference of Lawyers and Scientists, a joint committee with the ABA’s Section of Science & Technology Law. Dr. Frankel received a BA in political science from Emory University and a PhD in political science (with a concentration in science policy) from George Washington University.
JESSE L. GOODMAN, MD, MPH is Chief Scientist and Deputy Commissioner for
Science and Public Health, OC, FDA and is a key advisor to the Commissioner
on scientific, medical and public health issues. Previously, 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. 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 called human
granulocytic ehrlichiosis (HGE) and subsequently characterized fundamental
events involved in infection of leukocytes, including its cellular receptor.
Dr. Goodman 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 was elected 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 UCLA, where he was also Chief Medical Resident, and is
Board Certified in Internal Medicine, Oncology and Infectious Diseases. Dr.
Goodman received his MPH from the University of Minnesota.
LEWIS A. GROSSMAN, PhD is Professor of Law and Associate Dean for Scholarship at the American University Washington College of Law (WCL). He is also Of Counsel with the food and drug group at Covington & Burling LLP. He joined the faculty of Washington College of Law in 1997 and became Professor of Law in 2003 and Associate Dean for Scholarship in 2008. He teaches, writes, and lectures in the areas of food and drug law, civil procedure and American legal history. Prior to joining the faculty of WCL, he was an Associate at Covington & Burling, and before that was clerk for Chief Judge Abner Mikva, U.S. Court of Appeals, DC Circuit. Dr. Grossman is coauthor (with Peter Barton Hutt and Richard A. Merrill) of Food and Drug Law: Cases and Materials 3d ed. (Foundation Press, 2007). He is a member of the National Academies’ Institute of Medicine (IOM) Committee for Review of FDA’s Role in Ensuring Safe Food and was a legal consultant for the IOM Committee on the Framework for Evaluating the Safety of Dietary Supplements. He earned his BA, summa cum laude, from Yale University and his JD, magna cum laude, from Harvard Law School. Dr. Grossman received his PhD in History from Yale University, where he earned the George Washington Egleston Prize for Best Dissertation in American History.
MARLENE E. HAFFNER, MD, MPH is the CEO of Haffner Associates, LLC, a firm dedicated to the strategy, development and policy of drug development with a special emphasis on rare diseases and the products that treat them. Before establishing her own company, she was Executive Director, Global Regulatory Policy and Intelligence at Amgen, Inc. Prior to that, Dr. Haffner served as Director of the Office of Orphan Products Development (OOPD) of the Food and Drug Administration (FDA) for 20 years. As OOPD Director she was responsible for the leadership and management of the FDA orphan products development program, the first Orphan Products program in the world. She is well known as an expert in orphan drug development and is a sought after speaker and consultant in that area of regulatory science. In addition to her consulting activities, Dr. Haffner is Adjunct Professor, Department of Preventive Medicine and Biometrics, and Clinical Professor, Department of Medicine, at the F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland. She served in the United States Public Health Service (USPHS) for 36 years, beginning her career with the Indian Health Service in Gallup, New Mexico. Dr. Haffner has received many awards for her work in drug development including The Outstanding Contributions to Pharmaceutical Medicine Award from the American Academy of Pharmaceutical Physicians, and in May 2009, the Woodrow Wilson Award for Outstanding Government Service from the Johns Hopkins University. She received her MD from the George Washington University School of Medicine where she then interned in Internal Medicine. She received further training in internal medicine, dermatology and hematology at the Presbyterian Hospital, New York and at the Albert Einstein College of Medicine, New York. She received an MPH from the Johns Hopkins University Bloomberg School of Public Health.
RALPH F. HALL is a Distinguished Visiting Practitioner & Professor at the University of Minnesota Law School and is also of Counsel in the law firm of Baker & Daniels in Indianapolis, Indiana. 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.
MARGARET A. HAMBURG, MD is serving as the 21st Commissioner of Food and Drugs. Before joining FDA, Dr. Hamburg served as Senior Scientist for Nuclear Threat Initiative. The Nuclear Threat Initiative is a foundation dedicated to reducing the threat to public safety from nuclear, chemical and biological weapons. She began as Vice President for Biological Programs for the Initiative in 2001. Dr. Hamburg advocated broad reforms in public health infrastructure and policy, from local health departments to the national agency, in order to meet the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu. In 1994, Dr. Hamburg was elected to the membership in the Institute of Medicine (IOM). Three years later, she accepted the position of Assistant Secretary for Policy and Evaluation in the U.S. Department of Health and Human Services (HHS). In 1990, Dr. Hamburg joined the New York City Department of Health and Mental Hygiene as Deputy Health Commissioner and within a year was promoted to Commissioner, a position she held until 1997. During her tenure, she was widely praised for her initiatives, decisive leadership and significant public health measures she carried out despite severe budget constraints and while holding academic positions at Columbia University School of Public Health and Cornell University Medical College. Dr. Hamburg's accomplishments as New York's top public health official included improved services for women and children, needle-exchange programs to reduce the spread of HIV (the AIDS virus), and the initiation of the first public health bio-terrorism defense program in the nation. Her most celebrated achievement, however, was curbing the spread of tuberculosis. In the 1990s, TB resurged as a major public health threat, largely because many patients did not complete the full course of the treatment and the disease became resistant to standard drugs. Dr. Hamburg confronted the problem by sending healthcare workers to patients’ homes and taking other steps to make sure they completed the drug regimen. Dr. Hamburg graduated from Harvard Medical School, and completed her residency in internal medicine at what is now New York Presbyterian Hospital-Weill Cornell Medical Center, one of the top-ten hospitals in the nation. She conducted research on neuroscience at Rockefeller University in New York, studied neuropharmacology at the National Institute of Mental Health on the National Institutes of Health (NIH) campus in Bethesda, MD, and later focused on AIDS research as Assistant Director of the National Institute of Allergy and Infectious Diseases.
JERROLD J. HEINDEL, PhD is a Health Science Administrator at the National Institute of Environmental Health Sciences, National Institutes of Health (NIH). His recent work has involved the promotion of research into endocrine disruptors and their health effects. Dr. Heindel has also worked as the coordinator and director of the NIEHS Small Business Innovation Research/Small Business Technology Transfer grant and contract program. In addition, he is the scientific program administrator for the NIEHS Reproductive and Developmental Toxicology/Disease, Endocrine Toxicology/Disease (including endocrine disruptors) and Development of Alternative Toxicity Testing Assays research programs. Dr. Heindel is the author, coauthor, editor and coeditor of numerous professional publications. He received his PhD in biological chemistry from the University of Michigan.
MARK A. HELLER is a Partner in the law firm of Goodwin Procter LLP in Washington, DC and 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.
SHEILA M. HEMEON-HEYER, JD, RAC is Vice President, Global Regulatory Affairs with Boston Scientific Corporation (BSC). She provides leadership to the global regulatory affairs function with responsibility for compliance with worldwide product approval and recertification regulations. She sits on the BSC Operating Committee, as well as the management boards for the Clinical and Quality functions. Ms. Hemeon-Heyer began her regulatory career at the Food and Drug Administration (FDA), where she was a Scientific Reviewer in the Division of General Neurological and Restorative Devices, Center for Devices and Radiological Health (CDRH), and was responsible for reviewing 510(k), premarket approval application (PMA) and investigational device exemption (IDE) applications. After leaving FDA, Ms. Hemeon-Heyer provided regulatory, clinical and quality consulting services to the medical device industry, specializing in developing regulatory strategies, interacting with FDA, securing domestic and international product approvals, and managing complex projects across the medical product lifecycle. Ms. Hemeon-Heyer received her BS in Biomedical Engineering from Boston University, her MS in Biomechanics from the University of Massachusetts at Amherst, and her JD from Western New England College School of Law. She is Regulatory Affairs Certified (RAC).
MICHAEL H. HINCKLE is a Partner in the law firm of K&L Gates LLP in Washington, DC where he serves in the food and drug practice. He focuses on counseling corporations and individuals on all aspects of Food and Drug Administration (FDA) regulatory and corporate matters. He works primarily in the areas of pharmaceutical, medical device, and tobacco product regulation as well as related corporate transactional activities. Previously, Mr. Hinckle served as Vice President and General Counsel of Synthon Pharmaceuticals, Inc. where he led the legal, regulatory and compliance efforts in the company’s generic and specialty brands, as well as advising on employment, product liability, litigation, real estate and general corporate matters. He also played a significant role in drafting the pediatric “carve out” provision of the “Best Pharmaceuticals for Children Act” and the “Greater Access to Affordable Pharmaceuticals Act” that was passed by the U.S. Senate. Mr. Hinckle holds a BS in Biology, cum laude, from Radford University, and a JD, with honors, from The George Washington University Law School.
DAVID J. HOROWITZ is Deputy General Counsel at the U.S. Department of Health and Human Services. Prior to this, he served as the Assistant Commissioner for Policy and led the Office of Policy in the Office of the Commissioner at the Food and Drug Administration (FDA). Mr. Horowitz 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). 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. Mr. Horowitz earned a BA in Public Policy from Brown University and a JD from the University of Virginia.
LINDA R. HORTON is a Partner at the Washington, DC office of Hogan & Hartson LLP. She counsels clients on requirements of the EU regulatory authorities, the Food and Drug Administration (FDA) and other agencies in a range of fields, including pharmaceutical, medical device, animal health, food and cosmetic industries. Ms. Horton joined the firm in early 2002 after many years in FDA legislative, legal and international leadership positions. Most recently, she was Advisor to the Acting Deputy Commissioner and, before that, Director of International Policy. In the latter positions, she led FDA harmonization, agreement, and trade activities, represented the U.S. Government at international meetings, and advised other countries drafting food and drug legislation. Ms. Horton served eighteen years in the Office of the FDA Chief Counsel as a trial attorney, a medical device counselor, and, for fourteen years, Deputy Chief Counsel for Regulations and Hearings. She started at FDA as its first Management Intern and worked her way up to Chief of the Legislative Services Branch while attending law school. Ms. Horton is a frequent speaker at FDLI meetings, author of several FDLI publications, and a former member of its Academic Oversight Committee. In 1999, she was the first recipient of FDLI's Distinguished Service and Leadership Award. Also, she was a charter member of the Editorial Advisory Board of the Food, Drug and Cosmetic Law Journal and chaired the Board for two years. In the 1980s, Ms. Horton taught an advanced administrative law course at George Washington Law School and also taught International Food, Drug, and Medical Device law at Georgetown Law School. Ms. Horton received her BA from the University of Kentucky, her JD from George Washington University Law School and her LLM in international and comparative law from Georgetown Law School.
WILLIAM K. HUBBARD is the Leader of The Coalition for a Stronger FDA. Previously, he was the Senior Associate Commissioner for Policy and Planning, Office of the Commissioner, Food and Drug Administration (FDA). He advised the Commissioner on agency policy, coordinated the development of the agency’s rulemaking and oversaw the planning and evaluation functions of FDA. Mr. Hubbard began his career in Federal service in the U.S. House of Representatives, serving as a higher education specialist at the Department of Education. After serving one year at the Environmental Protection Agency, he joined FDA as a program analyst, where he worked in FDA’s Office of the Commissioner in various capacities (as well as serving in the Office of the Secretary of Health and Human Services (HHS)). He received numerous FDA awards for outstanding performance, as well as the Presidential Award for Design Excellence, the Secretary’s Award for Excellence in Public Service, the HHS Distinguished Service Award and the Presidential Executive Rank Award (twice). Mr. Hubbard received his BA in history and American studies from the University of North Carolina, Chapel Hill and his MA in Public Administration from American University. He is currently retired in North Carolina.
KATHY L. HUDSON, PhD is Chief of Staff, Office of the Director, National Institutes of Health (NIH). She is also the founder and Director of the Genetics and Public Policy Center and is an Associate Professor in the Berman Bioethics Institute, Institute of Genetic Medicine, Department of Pediatrics at The Johns Hopkins University. Dr. Hudson founded the Center to fill an important niche in science policy and to focus on public policy issues raised by advances in human genetics. Her special interest include the scientific, legal, ethical and social issues related to human reproductive genetic technologies, genetic testing, gene transfer and human cloning. Dr. Hudson serves on a number of advisory boards, has published articles and is a frequent speaker on issues related to biotechnology, genetics, and public policy. Before founding the Center, Dr. Hudson was the Assistant Director of the National Human Genome Research Institute (NHGRI) and was responsible for communications, legislation, planning and education activities. She provided leadership in public policy, genetic technology and public affairs issues and spearheaded efforts to prevent genetic discrimination. Previously, she served as a senior policy analyst in the Department of Health and Human Services and worked on Capitol Hill. Dr. Hudson received her PhD in Molecular Biology from the University of California at Berkeley, her MS in Microbiology from the University of Chicago, and her BA in Biology from Carleton College.
WILLIAM M. JANSSEN is an Assistant Professor of Law at the Charleston School of Law in Charleston, South Carolina. He teaches courses in civil procedure, products liability and first amendment law. He has published and spoken widely on pharmaceutical and medical device law. Before his appointment to the faculty in Charleston, he was a Litigation Partner in Saul Ewing's Philadelphia office, where he was principally engaged in pharmaceutical and medical device tort defense work. He also served as Chairman of the Saul Life Sciences Group, and was a member of the firm’s governing Executive Committee. Mr. Janssen is an invited member of the International Association of Defense Counsel and a member of the Food & Drug Law Institute. He was “AV”-rated by Martindale-Hubbell, three times selected as a Pennsylvania “Super Lawyer” and named a “Key Author” by West Publishing. After law school, he clerked for a federal district judge in Philadelphia and a federal court of appeals judge in Pittsburgh. Mr. Janssen received his BA, magna cum laude, from Saint Joseph's University in Philadelphia and his JD from the Washington College of Law at American University.
GAIL H. JAVITT, JD, MPH is Counsel in the Food and Drug Regulatory practice of Sidley Austin LLP in Washington, DC. She is also a Research Scientist in the Berman Institute of Bioethics at Johns Hopkins University. Previously, she served as the Law and Policy Director at the Genetics and Public Policy Center where she was responsible for developing policy options to guide the development and use of reproductive technologies and led an initiative to improve oversight of genetic testing quality. Ms. Javitt also served as an Adjunct Professor of Law at the University of Maryland School of Law, where she has taught Food and Drug Law and Genetics and Law, and at the Johns Hopkins School of Public Health, where she co-taught Health Law and Regulation. She was a Greenwall Fellow in Bioethics and Health Policy at Johns Hopkins and Georgetown Universities. She also served as an Associate at Covington & Burling in Washington, DC specializing in FDA regulatory issues. Ms. Javitt was a law clerk to the Honorable Gary L. Taylor, U.S. District Court, Central District of California. She has written on a variety of science regulatory and legal issues on topics including direct-to-consumer advertising of genetic testing and FDA regulation of biotechnology. Ms. Javitt holds a BA, magna cum laude, Phi Beta Kappa, from Columbia College, a JD, cum laude, from Harvard Law School and an MPH from Johns Hopkins University.
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 LLB from the University of Windsor in 1994. He was called to the Ontario Bar in 1996, and is a registered trademark agent.
KATHLEEN R. JOHNSON is an Attorney in the Office of the General Counsel at the Federal Trade Commission (FTC), where she provides advice and counsel primarily on government ethics and conflicts issues. She also provides advice and counsel on attorney professional conduct issues and FTC rulemakings, civil penalties and Congressional legislation impacting the Commission. Ms. Johnson has six years of legal experience that includes both litigation and counseling and is licensed to practice in both California and New York. She is a graduate of Columbia University School of Law where, among other things, she was Staff Editor of the Columbia-VLA Journal of Law and the Arts. She is also a graduate of Stanford University, where she majored in English.
SUZANNE L. KIANI is a Senior Scientist in Pharma Technical Regulatory at Genentech, Inc. in San Francisco. She is responsible for developing regulatory strategies for Genentech’s combination products and leading global initiatives concerning policy and development of combination products for the Pharma group. Ms. Kiani has over 10 years of experience in the field of combination products, which include working on pulmonary delivery devices, orthopedic implants, hemostatic products and drug-eluting stents. Currently, she is working on injectable delivery of therapeutic proteins, monoclonal antibodies and antibody-drug conjugates at Genentech. She is an expert on ISO/TC 84 and is a member of the Combination Product Coalition, PDA Combination Product Task Force, AAPS and AdvaMed. Ms. Kiani received a BA in Chemistry from Scripps College and a MS in Drug Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy.
RICHARD M. KLEIN is the HIV/AIDS Program Director with the Office of Special Health Issues, OC, FDA. He serves as the primary interface between the agency and the HIV/AIDS patient and advocate communities. He works extensively with outside communities and within the agency’s scientific offices to address issues and concerns of the affected community in a variety of areas, including drug access, product safety, and clinical trial design. He also ensures that patient communities are represented in approval and policy decisions, and at FDA advisory committee meetings related to HIV/AIDS and other serious and life-threatening illnesses. Mr. Klein has worked in various capacities with FDA for more than 30 years. Immediately prior to becoming the HIV/AIDS Program Director, he was involved in Human Subject Protection policy development for the agency, working closely with other federal agencies and the Department of Health and Human Services to ensure consistent and meaningful policy for the protection of human subjects of biomedical research. He is a member of the FDA institutional review board, participating in the ethical review of research conducted by the agency.
KENNETH K. KLEINHENZ is Vice President of Regulatory Affairs and Quality Assurance at Cytori Therapeutics, Inc. Previously, he served as the Technical Director for IFM Manufacturing, as Chief Microbiologist for Becton Dickenson and as Manager of Quality Assurance and Regulatory Affairs at Pacific Pharmaceuticals. Mr. Kleinhenz is a veteran of the United States Navy and served as a Clinical Microbiologist for six years at the Naval Hospital in San Diego. He received his BS in Microbiology at the University of California, San Diego and his MBA in Technology Management at the University of Phoenix.
DEMETRIOS L. KOUZOUKAS is Of Counsel in the law firm of Covington & Burling LLP in Washington, DC. He is a member of the firm’s Health Care, Food & Drug and Election & Political Law Practice groups. Prior to joining Covington & Burling, he served as Principal Associate Deputy Secretary of the U.S. Department of Health and Human Services (HHS), where he focused on Medicare & Medicaid reimbursement, food and drug regulation and health information technology. He oversaw the programs and operations of numerous agencies, including the Centers for Medicare and Medicaid Services and the Food and Drug Administration, among others. While at HHS, Mr. Kouzoukas also served as Deputy General Counsel, where he helped lead a nationwide law office of over 400 attorneys and was responsible for legal advice with regard to public health issues for the Agency for Healthcare Research and Quality, National Institutes of Health, Centers for Disease Control and Prevention, and other agencies. He is a graduate of George Washington University and received his JD from the University of Illinois College of Law.
DANIEL A. KRACOV is a Partner in the law firm of Arnold & Porter LLP in Washington, DC where he chairs 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.
ARETA L. KUPCHYK is a Partner with Reed Smith LLP 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) 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, pharmacogenomics and drug codevelopment with in vitro diagnostics (IVDs), 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.
RACHEL G. LATTIMORE is a Partner at the law firm of Arent Fox LLP in Washington, DC. Her practice focuses on biotechnology and extends to broader environmental and food safety issues, including food marketing and safety, nanotechnology and pesticide regulation issues. Her work includes representation of large and small technology providers, as well as industry groups serving these companies. Her clients include developers of biotechnology-derived agricultural traits, as well as companies developing therapeutic proteins for pharmaceutical and industrial use. Ms. Lattimore’s litigation experience includes administrative and federal court challenges on behalf of the regulated community, including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the National Environmental Policy Act (NEPA) and the Administrative Procedure Act (APA). She chairs Arent Fox’s Emerging Technology Subcommittee within the Life Sciences group and has advised clients, written and lectured on the regulation of nanotechnology. Ms. Lattimore is a graduate of Duke University School of Law and received her undergraduate degree from the University of North Carolina at Chapel Hill.
MARK B. LEAHEY is the President & CEO for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents research-driven medical technology companies. Mr. Leahey's responsibilities include advocating on behalf of the entrepreneurial sector of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and other federal and state agencies. He has lobbied for a more reasonable user fee for smaller companies and worked to open access to the hospital marketplace by challenging the exclusionary and anti-competitive nature of certain large group purchasing organizations (GPOs), as well as helped to ensure that medical device technologies are reimbursed adequately. Mr. Leahey currently sits on the Medical Devices Committee for the Food and Drug Law Institute (FDLI) and the Editorial Advisory Board of Medical Product Outsourcing. He is a member of the Massachusetts Bar and a graduate of Georgetown University, the Georgetown Law Center and Georgetown’s McDonough School of Business.
LEE H. LEICHTER is the President of P/L Biomedical. He provides assistance with Regulatory, Quality, project and business issues regarding combination medical products, medical devices and drug delivery systems in the U.S., Europe and Canada. Mr. Leichter served as Vice President of RA/QA for GeNO, LLC for two years, where he was responsible for developing and implementing Regulatory and Quality Strategy, submissions, interactions and systems for a complex combination product regulated as a drug. He has also served as a consultant for both large pharmaceutical, biotechnology and medical device companies as well as smaller start-up ones. Mr. Leichter received his BA in Social Science from the State University of New York at Stony Brook and his MBA in Finance/Entrepreneurial Studies from Florida Gulf Coast University.
RICHARD J. LEIGHTON is a Partner in the law firm of Keller and Heckman LLP in Washington, DC, where he is the senior litigator. He is a trial and appellate lawyer as well as a commercial arbitrator and mediator. He has a national practice representing business and trade association clients before federal and state courts, regulatory and self-regulatory bodies, legislative committees, and alternative dispute resolution forums. Mr. Leighton is frequently involved in food, drug, environmental and contract issues, especially those related to advertising, labeling, promotion, trademarks and franchising. He has been named by Washingtonian Magazine as one of the "50 Best Lawyers" in Washington and has authored many publications. He is a program leader at the National Institute for Trial Advocacy, former President of the Federal American Inn of Court, former Chairman of the ADR Committee of the International Trademark Association, and former Chairman of the Adjudication Committee of the Administrative Conference of the United States. Mr. Leighton received his BA from Pennsylvania State University and his JD from American University.
ANDREW LOH is a Partner at the law firm of Borden Ladner Gervais LLP in Vancouver, Canada. He also serves as the Regional Leader of the firm’s Biotech and Pharmaceutical practice group and the Health Care Institutions and Services practice group. Mr. Loh advises pharmaceutical, biotechnology, medical device and bioinformatics companies as well as importers, distributors, clinical trial companies, research institutions and hospitals on commercialization of medical technology and health regulatory compliance matters. Prior to practicing law, he worked in the microbiology department of a private laboratory in Vancouver before moving to Toronto, where he worked as the Coordinator of Development and Systems Supervisor of the fundraising office of the Toronto Hospital. He then joined a private software company where he designed, developed and provided training and technical support for fundraising software used by fundraising organizations worldwide. Mr. Loh was later recruited to work in the Research Computing Department of the Toronto Hospital where he developed clinical database software for medical researchers in Radiology, Gynecology and Pathology, as well as inventory and cost management software for the O.R. and Pharmacy departments of the Hospital. Mr. Low earned a Bachelor of Science degree in Microbiology and law degrees from Ontario and Michigan.
WILLIAM C. MacFARLAND is the Deputy Director II in the Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA. Previously, he served as the branch chief for the Orthopedics, Anesthesiology and Physical Medicine Devices Branch (OPMADB) within the FDA CDRH Office of Compliance, where he was responsible for overseeing the branch’s review of PMA and HDE Manufacturing Sections, Establishment Inspection Reports, recall classifications and compliance cases. In 1998, Mr. MacFarland joined Angiosonics, Inc. of Morrisville, NC as Director of Regulatory Affairs. Before joining Angiosonics, he worked in CDRH’s Office of Device Evaluation as a reviewer in the Division of Cardiovascular, Respiratory and Neurological devices. In 1999, he returned to the Washington area and joined Quintiles Consulting. Mr. MacFarland received his MBA from the University of Maryland, his MS in Biomedical Engineering from Case Western Reserve University and his BS in Electrical Engineering from Clarkson University. Currently he maintains a Professional Engineers license in Maryland and is an ASQ Certified Quality Engineer, Certified Biomedical Auditor, Certified Software Quality Engineer and Certified Six Sigma Black Belt.
ANNE V. MAHER is a Partner in the law firm of Kleinfeld Kaplan & Becker LLP (KKB) in Washington, DC. She specializes in the needs of Food and Drug Administration (FDA)-regulated companies and related entities. She counsels clients on food, drug, dietary supplement and cosmetic advertising issues and requirements and represents clients in investigations and advertising challenges. She also frequently speaks at industry and association meetings involving advertising law and policy. Before joining KKB, Ms. Maher was the Assistant Director for Advertising Practices Division in the Federal Trade Commission’s (FTC) Bureau of Consumer Protection, where she supervised law enforcement investigations and industry outreach. Prior to her appointment as Assistant Director, she served in the Office of the Director, Bureau of Consumer Protection and as Attorney Advisor to an FTC Commissioner as well as a staff attorney. Ms. Maher was the FTC’s designated liaison with FDA and the U.S. Department of Agriculture, and worked closely with the staff of both agencies on a wide range of projects and regulatory actions. She directed the development of FTC’s 1994 Food Advertising Enforcement Policy Statement, and was integral in the creation of FTC’s 1998 Dietary Supplement Advertising Guide, as well as the 1999 Report to Congress on Self-Regulation in the Alcohol Industry. She is a recipient of the Federal Trade Commission’s Award for Distinguished Service. Ms. Maher received her BA from Boston University and her JD from Northeastern University School of Law.
STEPHEN PAUL MAHINKA is a Partner in the Washington, DC office of Morgan Lewis & Bockius LLP. He is the Chair of the firm’s interdisciplinary Life Sciences Practice. Mr. Mahinka is the founder of the firm’s FDA/Healthcare Regulation Practice and a former head of its Antitrust Practice. In the FDA/healthcare area, he focuses on regulatory, transactional and compliance matters throughout the product lifecycle, including the acquisition, licensing, approval, distribution and pricing of prescription and over-the-counter (OTC) drugs, food additives, biologics and medical devices; Federal Trade Commission (FTC), Department of Justice (DOJ), and state investigations; and the Centers for Medicare and Medicaid Services (CMS) healthcare regulatory matters. He has substantial experience with life sciences transactions, including collaboration and licensing agreements. His antitrust practice focuses on counseling and litigation concerning mergers and joint ventures, pricing and price discrimination, marketing and distribution, consumer protection issues as well as the application of the antitrust laws to regulate industries. Following law school, he was law clerk to the Chief Justice of the Massachusetts Appeals Court. He has published numerous articles on FDA/healthcare and competition matters in the United State, European Union and Japan, is co-author of the FDA/healthcare regulatory due diligence chapter of Aspatore Books’ Life Sciences Mergers and Acquisitions and he is a former editor of the Food and Drug Law Journal. Mr. Mahinka received his undergraduate degree from Johns Hopkins University, Phi Beta Kappa, where he has also been a Trustee of the University, and he received his law degree from Harvard Law School where he was executive editor of the Harvard International Law Journal.
DIANE M. MALONEY is the Associate Director for Policy in the Center for Biologics Evaluation and Research (CBER), FDA. Ms. Maloney oversees CBER’s policy formulation and development as well as the center's regulations and guidance development. She is also responsible for representing the center on numerous cross-cutting agency and departmental initiatives. Prior to joining 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.
WILLIAM A. McCONAGHA is a Fellow, Majority Staff, Committee on Health, Education, Labor, and Pensions, U.S. Senate. Previously, he worked in FDA's Office of Chief Counsel (OCC), where he spent the first five years of his tenure working on enforcement litigation, in addition to serving as a senior member of the OCC drugs team. He also worked directly with the agency's Office of Criminal Investigations from 1996 to 2000. Mr. McConagha’s areas of expertise include Internet drug sales, over-the-counter drugs, pharmacy compounding, radiopharmaceuticals, the Prescription Drug Marketing Act, current good manufacturing practice, import/export issues, dietary supplements and drug enforcement matters. Prior to joining FDA, Mr. McConagha worked for two years as an attorney with the Office of the Public Defender for the State of Maryland.
JENNIFER C. McENTIRE, PhD is a Research Scientist and Manager of Science and Technology Projects with the Institute of Food Technologists. She is responsible for all of IFT’s technical grant and contract work. A food microbiologist by training, she also currently leads contract work in the areas of food safety and defense. Dr. McEntire also supports IFT’s outreach initiatives, promoting food science as a career. She has authored or co-authored several peer reviewed publications, a book chapter, and has presented her work nationally and internationally. She is also a member of the International Association for Food Protection and the Phi Tau Sigma Honor Society for Food Science. Dr. McEntire received her BS with Distinction in Agriculture (majoring in Food Science) from the University of Delaware. She conducted her doctoral work in the Department of Food Science at Rutgers University as a USDA National Needs Fellow in Food Safety, which provided the opportunity to complete an internship at the National Food Processors Association (now GMA), and serve as a Visiting Scientist at the Center for Food Safety and Applied Nutrition at FDA.
M. ELIZABETH McKENZIE, PhD is Director, U.S. Regulatory Affairs, Veterinary Research and Development at Pfizer Animal Health, Pfizer Inc. Her responsibilities include post-approval supplements for veterinary pharmaceuticals and review of advertising and promotional materials for veterinary pharmaceuticals. She has over 22 years of experience in veterinary product development and various regulatory activities in the U.S. and international markets. Dr. McKenzie received her BA in Biology from Hendrix College and her MS and PhD degrees in various aspects of parasitology from the University of Georgia.
RICHARD A. MERRILL is a Daniel Caplin Professor of Law Emeritus at the University of Virginia School of Law and a Retired Senior of Counsel with the firm of Covington & Burling LLP. From 1980-1988 he served as Dean of the University of Virginia School of Law. Previously, he served as Chief Counsel to the Food and Drug Administration (FDA) from 1975-1977, where he received the FDA Award of Merit in 1976 and the FDA Commissioner’s Special Citation in 1977 and again in 1991 for his work on the Institute of Medicine study of nutrition labeling. Mr. Merrill has been a member of the Virginia law faculty since 1969 and previously practiced food and drug law with Covington & Burling, where he has been of counsel since 1991. He is the author of many articles on food and drug law and administrative law and is a co-author of Administrative Law: The American Public Law System as well as Food and Drug Law: Cases and Materials. Mr. Merrill is a former Rhodes scholar and was editor-in-chief of the Columbia Law Review. He served as law clerk to Judge Carl McGowan of the U.S. Court of Appeals for the D.C. Circuit after graduation, and was a consultant to the Office of Technology Assessment of the U.S. Congress, the White House Office of Science and Technology Policy, and the Environmental Protection Agency. Mr. Merrill received an AB from Columbia University, a BA and MA from Oxford University and an LLB from Columbia University School of Law.
VIRGIL MILLER is a Professional Staff Member for the Committee on Energy and Commerce in the U.S. House of Representatives, working directly with Chairman Emeritus John Dingell. As health policy advisor to Rep. Dingell, his
responsibilities include developing strategy for health initiatives, drafting
legislation and monitoring key health proposals before the Committee. Mr.
Miller's legislative portfolio includes health care reform, Food and Drug
Administration (FDA) reform and Medicare/Medicaid policy, in addition to
other key health policy issues. During the 110th Congress, his portfolio
included food and medical product safety, cosmetics, tobacco, biologics, and
health disparities. Mr. Miller was instrumental in securing passage of the
Family Smoking Prevention and Tobacco Control Act, which granted FDA
authority to regulate tobacco products, as well as the Food and Drug
Administration Amendments Act of 2007. He has also been instrumental in
drafting legislation aimed at protecting the nation's medical product and
food supply, including the Food Safety Enhancement Act of 2009. Prior to his
current position, he served as a Congressional Black Caucus Foundation Louis
Stokes Urban Health Policy Fellow in the office of U.S. Representative
Edolphus Towns (D-NY). Mr. Miller received a BS in Biology and a Master of
Public Health from Florida A&M University.
COLLEEN M. MOCKBEE, RPh is Senior Director, GRA-US Oncology at Eli Lilly and Company. She specializes in the field of regulatory oncology drug development and is knowledgeable in U.S. policy, regulations, and regulatory precedent. In her 10-plus years of drug development experience, Dr. Mockbee has prepared teams for FDA and advisory committee meetings and has successfully registered new indications for commercial products. Previously, she served as a pharmacist in the Veteran’s Administration hospital and clinics and was also a sales representative for Merck & Co.
MICHAEL C. MORTON is the Senior Director for Global Regulatory Affairs at Medtronic, Inc. In this position, he leads a council of senior regulatory leaders across the corporation, and provides strategic guidance and support to the business units. Before joining Medtronic, Mr. Morton worked with CarboMedics, Inc., W.L. Gore and Associates, Alcon, Inc. and Sorin Group. He has over 20 years of experience in regulatory affairs and has been recognized as a Fellow by the Regulatory Affairs Professional Society. He also served as the industry representative to the FDA Circulatory System Devices Advisory Panel from 2001 to 2005. Mr. Morton currently chairs the Advanced Medical Technology Association (AdvaMed) PMA Working Group, and is the AdvaMed representative to Study Group 1 (Premarket Issues) of the Global Harmonization Task Force.
MEGAN MOYNAHAN is the Network Leader for the Cardiac Electrophysiology and Monitoring Devices Network, Center for Devices and Radiological Health (CDRH), FDA. She is responsible for coordinating the Center’s premarket, post-market, enforcement, science, and communication activities for pacemakers, defibrillators, cardiac ablation systems, and cardiac monitoring systems. Before becoming Network Leader, Ms. Moynahan served as Chief of the Pacing Defibrillators and Leads Branch in the Center’s Office of Device Evaluation. Prior to this, she was a scientific reviewer in the Division of Cardiovascular Devices. A biomedical engineer by training, she has been a regular speaker in recent years at the Heart Rhythm Society annual meeting and has served as an FDA representative to both the American Heart Association Emergency Cardiovascular Care committee and the NCDR National ICD Registry. Ms. Moynahan has a BS (from Johns Hopkins University) and MS (from Case Western Reserve University) in Biomedical Engineering.
JANE MUNCKE, PhD is the Environmental Risk Assessment Specialist for Emhart Glass SA, a supplier company for the glass packaging industry based in Cham, Switzerland. Dr. Muncke specializes in environmental toxicology and has worked on removing endocrine disrupters and other pollutants out of the waste water stream, as well as testing for hormonally active substances in rivers and lakes. She is currently interested in the presence of endocrine disrupting chemicals in common food packaging. Dr. Muncke received her MSC and PhD from the Swiss Federal Institute of Technology (ETH) in Zurich.
MATTHEW L. MYERS, JD is President of the Campaign for Tobacco-Free Kids, a leader in the fight to reduce tobacco use and its devastating consequences in the United States and around the world. Over the last 25 years, Mr. Myers has participated in virtually every major national tobacco-related legislative effort and has worked with state tobacco prevention advocates and officials around the country. Before joining the Campaign, Mr. Myers worked at the Federal Trade Commission in the Division of Advertising Practices and was responsible for the agency’s tobacco-related activity. In 1989, Mr. Myers received the prestigious Surgeon General’s Medallion from Dr. C. Everett Koop for contributions to the public health of the nation. In 1996, he received the Smokefree America Award as the lawyer who had made the greatest contribution to tobacco-control efforts in the United States. Mr. Myers participated in the negotiations that led to an unprecedented agreement between the tobacco industry and the states in 1997. He then served as one of the leading spokespersons for public health in the debate that followed in Congress and worked with Senator John McCain on his 1998 comprehensive tobacco legislation. He was honored with the Jacob K. Javits Award in 1998 for his contributions to public health. In 1999, Mr. Myers was asked to serve on the first advisory committee established to advise the Director General of the World Health Organization on tobacco issues. In 2004, the Harvard School of Public Health bestowed the prestigious Julius B. Richmond award on Mr. Myers for his work as an advocate in preventing tobacco industry marketing to children. On October 26, 2007, the American Cancer Society honored Mr. Myers with its highest award, The Medal of Honor, for his work in the fight against cancer and childhood tobacco addiction. He holds a BA from Tufts University and a JD from the University of Michigan Law School, where he was awarded the Order of the Coif and served on the staff of the Journal of Law Reform.
NANCY BRADISH MYERS is the Founder and President of Catalyst Healthcare Consulting, Inc. Ms. Myers advises manufacturers, trade associations and patient advocacy organizations on regulatory and health policy matters. Previously, she served as special assistant and senior strategic advisor in FDA’s Office of the Commissioner. In the private sector, she served as Special Counsel for Science Policy for the Pharmaceutical Research and Manufacturers of America (PhRMA) and vice presidential-level political healthcare analyst for Lehman Brothers, among other positions. Ms. Myers is also a founding member and Vice President of the Alliance for a Stronger FDA, as well as a board member of the FDA Alumni Association. She received her BS from Duke University and her juris doctor degree from Temple University School of Law.
STEVEN M. NIEDELMAN is a Senior Consultant to the Health Care and Product Risk Management Groups at Crowell & Moring LLP in Washington, DC. He specializes in regulatory, enforcement and policy matters involving industries regulated by the Food and Drug Administration (FDA) and provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and foods industries to assure conformance to the requirements of the Federal Food, Drug and Cosmetic Act. 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. He retired from FDA 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 he 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 BA in Biology and Chemistry from the College of Emporia in Kansas.
PATRICK C. O’BRIEN, PharmD is a Partner with the law firm of O’Brien Gould PLLC in Washington, DC. He specializes in providing fraud compliance advice, conducts internal investigations and facilitates administrative proceedings. He has over 15 years experience as an attorney and over 20 years of experience in the healthcare field. Dr. O’Brien has worked for the federal government, as a commercial litigator in a large firm, and as in-house counsel for one of the world’s largest healthcare products companies. Prior to co-founding O’Brien Gould, he served as Vice President of Law for Johnson & Johnson’s biotechnology commercial operating company, Centocor Ortho Biotech. As in-house counsel, he conducted and oversaw internal company investigations, provided advice concerning compliance with laws administered by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), as well as general fraud & abuse laws. Dr. O’Brien previously served as regulatory counsel to the Division of Drug Marketing, Advertising, and Communications (DDMAC), Center for Drug Evaluation and Research (CDER), FDA. Before commencing law practice, he was a clinical pharmacist with the Arizona Poison and Drug Information Center in Tucson, AZ. He began his healthcare career working as a field paramedic. Dr. O’Brien received his PharmD from the University of Arizona College of Pharmacy and his JD from the University of Arizona College of Law.
WAYNE W. OLIVER is the Vice President of the Center for Health Transformation (CHT). He leads the center’s Health Justice and Right to Know projects and also works on CHT’s Georgia Project. Previously, Mr. Oliver served as the lead lobbyist and chief spokesperson for the Georgia Pharmacy Association, and was also the Managing Editor of the Georgia Pharmacy Journal. He was recently appointed to the Georgia Commission on Men’s Health by Governor Sonny Perdue. Mr. Oliver is the author of hundreds of articles on a range of issues, including rural healthcare, professional liability, diabetes care and management, healthcare reform, Medicaid and healthcare financing. He is also a member of numerous law organizations, including the American Society of Law, the Georgia Chamber of Commerce and the American Society of Association Executives, among others. Mr. Oliver received a dual BA in Political Science and Speech and Communications from Mercer University and also has a law degree.
STUART M. PAPE is the Managing Partner and a member of the Executive and Management Committees of the Washington, DC law firm of Patton Boggs LLP. He specializes in assisting clients in obtaining approval of new food ingredients, pharmaceuticals and medical devices as well as advising on labeling and advertising of regulated products, assisting in enforcement proceedings initiated by regulatory bodies and lobbying in connection with legislative consideration of statutory changes to the laws governing FDA-regulated products. Mr. Pape’s practice involves appearances before the Food and Drug Administration (FDA), the U.S. Department of Agriculture, the Federal Trade Commission, the Consumer Product Safety Commission, the Bureau of Alcohol, Tobacco, and Firearms, and numerous other federal and state regulatory bodies as well as the U.S. Congress. Before joining the firm, he served in various positions in the Office of the Chief Counsel at FDA including as Associate Chief Counsel for Food. From 1978-1979 Mr. Pape served as Executive Assistant to FDA Commissioner Donald Kennedy. In 1978 he received the FDA Commendable Service Award. He is also the author of numerous articles on food and drug law and serves on the Advisory Board of World Food Regulation Review and on the Editorial Advisory Board of Guide to U.S. Food Labeling Law. Mr. Pape is a graduate of the University of Virginia and received his JD from the University of Virginia School of Law.
MARY K. PENDERGAST, JD, LLM is the President of Pendergast Consulting in Washington, DC. Prior to forming her own consulting business, she served as Executive Vice President, Government Affairs at Elan Corporation, where she was involved in significant regulatory, strategic and government issues. Previously, Ms. Pendergast was Deputy Commissioner and Senior Advisor to the Commissioner at the Food and Drug Administration (FDA) where she spearheaded the agency's efforts to modify its regulation of emerging scientific areas such as biotechnology, cellular and tissue-based therapies, xenotransplantation, genetic testing and acute care research. She also served as an Associate Chief Counsel for Enforcement at FDA and as an attorney in the Office of the General Counsel, Department of Health and Human Services (HHS). Ms. Pendergast received her BA from Northwestern University, her LLM degree from Yale Law School and her JD summa cum laude from the University of Iowa College of Law.
PHILIP J. PHILLIPS, MBA is the President of Phillips Consulting Group, LLC in McHenry, Maryland. Previously, Mr. Phillips served as 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) and 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. Mr. Phillips also 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.
WILLIAM J. PIGNATO is Global Head of Regulatory Affairs for Novartis Molecular Diagnostics. He currently leads the diagnostic regulatory program at Novartis’ newly formed diagnostic business unit, which is focused on employing a variety of innovative molecular technologies to help personalize diagnosis and treatment. Previously, he worked at Genentech, Inc, leading the regulatory effort specific to the company’s companion diagnostic initiative. Mr. Pignato was also the founder of W.J. Pignato & Associates, a Boston consulting firm specializing in regulatory affairs that focused on diagnostics, medical devices and the biotech industry. He brings 24 years of regulatory diagnostic experience in bringing products to market. Prior positions include Vice President of Regulatory Affairs for EXACT Sciences Corp., an applied genomics company focused on the early detection of colorectal cancer and Vice President of Regulatory Affairs for Valeo Medical. He has also held senior regulatory positions at Bayer Diagnostics, Chiron and Ciba-Corning Diagnostics. Mr. Pignato has been active in numerous FDA/Industry cooperative activities regarding regulatory policy impacting diagnostic devices. He is a Northeastern University undergraduate in environmental engineering and graduate studies from Tufts University.
MERCY O. QUAGRAINE, PhD is a Biologist in the Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), FDA. She currently co-chairs the “USAN for cell therapies” working group in OCTGT, which developed a nomenclature scheme for providing non-proprietary names for cell therapy products, and continues to vet ballots for USAN (United States Adopted Names) names. Her specialty area of review is hematopoietic stem cells, including cord blood. Dr. Quagraine received her PhD from the University of Illinois at Chicago College of Medicine, Department of Pharmacology.
SARA RADCLIFFE is Vice President for Science and Regulatory Affairs at Biotechnology Industry Organization (BIO). She is responsible for developing and implementing strategic BIO responses to scientific and regulatory issues that affect the ability of BIO’s healthcare-focused companies to research and develop products and bring them to the market. Prior to joining BIO, Ms. Radcliffe served as Senior Director, Biologics & Biotechnology, and Assistant Vice-President, Preclinical Drug Safety Evaluation, at the Pharmaceutical Research and Manufacturers of America (PhRMA), where she staffed the PhRMA Vaccines CEOs Committee and the PhRMA Emergency Preparedness Task Force. She was also a Research and Development Policy Analyst for the Alliance and Technology Group at SmithKline Beecham Pharmaceuticals. In addition, she worked in New Zealand for the Core Services Committee of the New Zealand Ministry of Health, and also in community health in Canada. Ms. Radcliffe received her Master’s of Public Health and a Master’s in Philosophy from Johns Hopkins University.
PAUL RAND is the President of the Word of Mouth Marketing Association (WOMMA), a nonprofit organization that works to advance the discipline of offline and online word of mouth marketing. Prior to this, he served as a Partner, Executive Committee member and the Global Chief Development and Innovation Office for Ketchum, a public relations firm. He also worked as the Director of Ketchum’s Global Technology Practice and Managing Director for its Midwest operations. In addition, Mr. Rand was the founder and CEO of Corporate Technology Communications (CTC), which was acquired by CTC. He spent 10 years as an adjunct faculty member at DePaul University’s Kellstadt Graduate School of Business and is currently serving as an executive member of the Dean’s Advisory Council. Mr. Rand was twice named to BtoB Magazine’s “Top 100 Marketers” and has been featured and/or quoted in outlets such as The Wall Street Journal, The New York Times, Business Week, National Public Radio and The Chicago Tribune, among others.
JOHN B. REISS, PhD is a Partner in the law firm of Saul Ewing LLP in Philadelphia, PA. He 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; FDA 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 hospitals, 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 to1979, 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 also 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 in St. Louis and his JD from Temple University School of Law.
MARGARET F. RILEY is a Professor at the University of Virginia School of Law. She teaches food and drug law, health law, animal law, bioethics, regulation of clinical research and public health law. She also has a secondary appointment in the Department of Public Health Sciences at UVA’s School of Medicine. Ms. Riley has written and presented extensively about biomedical research, genetics, reproductive technologies, stem cell research, animal biotechnology, health disparities and chronic disease. She serves as chair of UVA's Embryonic Stem Cell Research Oversight Committee and as legal advisor to the Health Sciences Institutional Review Board, which is responsible for reviewing all human subject research at UVA involving medically invasive procedures. Previously, Ms. Riley was an associate with Pepper Hamilton & Scheetz in Philadelphia, where she worked primarily in complex securities, commercial and mass tort litigation. Prior to that position, she was a litigation associate with Rogers & Wells in New York. Riley received her law degree from Columbia University and her BA from Duke University.
JED E. ROSE, PhD is the Director of the Duke Center for Nicotine and Smoking Cessation Research and a Professor in the Department of Psychiatry and Behavioral Sciences at Duke University Medical Center. He led the first studies of transdermal nicotine administration in the early 1980’s, which helped initiate the development of commercial nicotine skin patches as an anti-smoking treatment. Dr. Rose’s current research involves applying brain imaging methodologies, including positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) to identify brain substrates underlying craving and addiction. Previously, he served in UCLA's Department of Psychiatry. He is widely published and holds numerous patents to various smoking cessation aids. Dr. Rose received his BA in physics from the University of California, Berkeley and his PhD from the University of California, San Diego.
SHAMIM RUFF is the Oncology Therapeutic Area Head, Global Regulatory Affairs at Amgen, Inc. She is responsible for directing the development of regulatory strategy and organizational structure to ensure global product registration and lifecycle management. She is a member of the Therapeutic Area Steering Committee as well as a member of the Regulatory Senior Management Team. Prior to joining Amgen, Ms. Ruff was with Abbott Laboratories in Chicago, where she was the Global Regulatory Therapy Area Head for Oncology, which encompassed all aspects of the regulatory process from early development to commercialization (from discovery candidate selection, INDs/CTAs, to post licensure). She was also with Astrazeneca for eleven years where she worked in a number of therapeutic areas including Oncology, CV and Anesthesiology, and was the global lead for a number of successful global regulatory filings. Ms. Ruff also has direct experience working as the regulatory lead for FDA Advisory Committee meetings. Earlier in her career, she briefly worked at Janssen Pharmaceuticals, Medisense UK Inc. and Fisons Pharmaceuticals (now Sanofi Aventis). Ms. Ruff has a degree in Chemistry and Biology and a Master of Science degree in Analytical Chemistry and Instrumentation. She is a Chartered Chemist and a member of the Royal Society of Chemistry.
MARC J. SCHEINESON is a Partner in the Washington, DC office of Alston & Bird LLP, where he heads the firm’s Food and Drug Law Practice. He has practiced food and drug law, healthcare law, and administrative law for over 25 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 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 and advertising and promotion law. He also advises on the FDA regulatory aspects of healthcare transactions and is a frequent speaker in industry forums. Mr. Scheineson 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.
DANIEL G. SCHULTZ, MD is Senior Vice President, Medical Devices and Combination Products of Greenleaf Health LLC, a Washington, DC-based healthcare consulting firm. Previously, he served as Director of the Center for Devices & Radiological Health (CDRH) at the Food & Drug Administration (FDA) from 2004 to 2009, where he led the development, implementation and evaluation of regulatory policies concerning medical devices and radiation-emitting products. Prior to this, Dr. Schultz served in CDRH’s Office of Device Evaluation, first as a medical officer, then a Division Director, then the Office’s Deputy Director and finally the Director. Previously, he entered the Commissioned Corps of the U.S. Public Health Service (PHS) and served in the PHS Indian Health Service as a hospital clinical director and a surgical resident. He was appointed Chief of Surgery at the Indian Health Service Hospital in Santa Fe, New Mexico. Dr. Schultz received his BA in Political Science from City College of New York and his MD from the University of Pittsburgh. He is Board-certified in Surgery and Family Practice.
WILLIAM B. SCHULTZ is a Partner in the law firm of Zuckerman Spaeder LLP in Washington, DC, where he represents clients in court and at the Food and Drug Administration (FDA). While at Zuckerman Spaeder, he represented the Campaign for Tobacco Free Kids in the Congressional consideration of tobacco legislation. Prior to joining Zuckerman Spaeder, Mr. Schultz held the position of Deputy Assistant Attorney General, Civil Division, U.S. Department of Justice, where he supervised the Civil Division’s Appellate Litigation section and the Department’s lawsuit against the tobacco industry. He also served as Deputy Commissioner for Policy at FDA (1994-1998) where, among other things, he oversaw the Agency's development of its tobacco regulation and represented the agency in negotiations regarding the 1998 tobacco legislation. Prior to serving at FDA, Mr. Schultz was Counsel for the Subcommittee on Health and the Environment, U.S. House of Representatives, Committee on Energy and Commerce (1990-1994), where he staffed the Committee's tobacco hearings regarding the FDA's regulation of tobacco. From 1976-90, Mr. Schultz was an attorney at Public Citizen Litigation Group, where he brought lawsuits against federal agencies, including FDA. He also served as a law clerk to U.S. District Judge William B. Bryant and for 10 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 School of Law.
FRANCIS J. SERBAROLI is a Shareholder in the Health and FDA Business department at the law firm of Greenberg Traurig in New York City. He has nearly 30 years of experience in the healthcare industry working with health insurers and managed care plans, hospitals, nursing homes, clinics, ambulatory surgery centers and home health agencies, clinical laboratories, renal dialysis providers, faculty practice plans, pharmaceutical companies and medical device and equipment manufacturers. Mr. Serbaroli handles a wide range of corporate, regulatory, compliance, reimbursement, corporate governance, bankruptcy and litigation matters and advises clients in connection with the prohibitions on the corporate practice of medicine and fee-splitting, as well as Medicare and Medicaid fraud and abuse matters. He also has three years of government experience as an Assistant Attorney General in New York and writes a regular health law column for the New York Law Journal. Mr. Serbaroli received his JD from Fordham University School of Law and his BA from Fordham University.
JORDI SERRATOSA, PhD is the European Food Safety Authority Liaison Officer in the Office of International Programs, OC, FDA. His responsibilities cover risk assessment work in food safety, nutrition and plant and animal health. Since 2003 he has been the Head of the Animal Health and Welfare Unit with the European Food Safety Authority (EFSA) and he is currently in Washington, DC at FDA working to increase collaboration on scientific risk assessment activities in the area of food safety between the E.U. and U.S. Previously, Dr. Serratosa was Associate Professor in Veterinary and Food Legislation at the Autonomous University of Barcelona. He also worked for the private sector for 10 years as Technical Director of Rhone Merieux as well as International Business Director in feed additives at Co Lucta, and he joined the European Commission in Brussels in 1998. Dr. Serratosa also served as Principal Administrator with DG SANCO for Legislation on Veterinary Aspects of Public Health for animal products, where he focused on issues such as hormones, residue plans applicable to E.U. member states and other countries exporting products to E.U., and 4 Community Reference Laboratories. Dr. Serratosa received PhDs from the University of Hannover in Germany and the University of Barcelona.
VICKI SEYFERT-MARGOLIS, PhD is an Advisor to FDA Chief Scientist Jesse Goodman, with a focus on bioinformatics. Previously, she served as Chief Scientific Officer at Immune Tolerance Network (ITN), a non-profit consortium of researchers seeking new treatments for diseases of the immune system. At ITN, she oversaw the development of 10 core facilities and construction of a primer library of 1,000 genes that may be involved in establishing and maintaining immunologic tolerance. Dr. Seyfert-Margolis was also an Adjunct Associate Professor with the Department of Medicine at the University of California San Francisco. Prior to this, she served as Director of the Office of Innovative Scientific Research Technologies at the National Institute of Allergy and Infectious Diseases at NIH, where she worked to integrate emerging technologies into existing immunology and infectious disease programs. Dr. Seyfert-Margolis completed her PhD in immunology at the University of Pennsylvania’s School of Medicine.
MARJORIE A. SHAPIRO, PhD is Chief of the Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, Biotechnology Products Office, CDER, FDA. Her responsibilities include the review and supervision of reviews of monoclonal antibody quality information submitted to the FDA in INDs, BLAs, NDAs and PMAs. Dr. Shapiro also directs a research program aimed toward understanding the molecular and epigenetic mechanisms in the development of the antibody repertoire, the diversity generated under artificial selection conditions (phage display) relative to natural selection conditions (hybridomas) and the usage of specific antibody sequences in different B cell subsets. She received her BA in biology from the University of Rochester and her PhD in immunology from the University of Pennsylvania.
JEREMY SHARP, Professional Staff Member, Subcommittee on Children and Families, HELP Committee, U.S. Senate
Biography coming soon
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.
DEBORAH M. SHELTON is a Partner with law firm of Sheppard, Mulllin, Richter & Hampton, LLP in Washington, DC. She concentrates her practice in the area of Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) law, with particular emphasis on drugs, biological products and medical devices. Ms. Shelton counsels clients in all phases of product development, from clinical trials to post-marketing requirements. Her work includes counseling clients on a broad range of marketing applications, including full and abbreviated New Drug Applications and medical device Premarket Approval Applications Notifications and 510(k) Notifications, reviewing and evaluating labeling and advertising claims, conducting due diligence audits of potential acquisition targets of drug and device companies and defending against various types of enforcement actions taken by the government. Ms. Shelton counsels pharmaceutical companies on various issues arising under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, including patent listing and certification requirements, patent and non-patent market exclusivities and patent-term extensions, and has represented drug companies in patent and antitrust litigation involving these issues. She also counsels clients on, and has written and spoken about, the rapidly evolving issue of “follow-on biologics” and the issues involved with developing an abbreviated approval process for biologics. She has participated in numerous agency rulemaking and adjudicatory proceedings before FDA and the DEA. Ms. Shelton received her JD, with honors, from the University of Maryland Law School where she served as Associate Editor of the Maryland Law Review.
JEFFREY E. SHUREN, MD, JD is the Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). He previously served as Acting Center Director. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including Acting Deputy Commissioner for Policy, Planning, and Budget; Associate Commissioner for Policy and Planning; Special Counsel to the Principal Deputy Commissioner; Assistant Commissioner for Policy; and Medical Officer in the Office of Policy.Dr. Shuren is board certified in Neurology and served as an Assistant Professor of Neurology at the University of Cincinnati. In 1998, Dr. Shuren joined FDA as a Medical Officer in the Office of Policy. In 2001, he became the Director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services. Dr. Shuren returned to FDA as the Assistant Commissioner for Policy in 2003, and assumed his current position in 2008. He received both his BS and MD degrees from Northwestern University under its Honors Program in Medical Edcuation.and his JD from the University of Michigan.
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.
ALAN SLOBODIN is the Chief Oversight Counsel, Minority Staff, Committee on Energy and Commerce, U.S. House of Representatives. 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.
MERTON V. SMITH, PhD is the Special Assistant for International Activities in the Office of the Director, Center for Veterinary Medicine (CVM), U.S. Food and Drug Administration (FDA). He represents FDA and CVM in several international harmonization organizations, including as the FDA Delegate to the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). Prior to this, he worked in the Office of International Programs, Office of the FDA Commissioner, where he held a number of positions including being the Africa and Near East Desk Officer, the Americas Desk Officer, the Multilateral Programs Desk Officer, the International Harmonization and Trade Affairs Desk Officer, and the Associate Director for International Agreements. Dr. Smith was detailed to the Office of the U.S. Trade Representative (USTR) in the Executive Office of the President assisting in finalizing both the North American Free Trade Agreement (NAFTA) and the Uruguay Round of Multilateral Trade Negotiations, the latter establishing the World Trade Organization (WTO). At USTR he was Special Assistant for Health and Safety and served to advise the Assistant U.S. Trade Representative for Environment and Natural Resources on sanitary and phytosanitary (SPS) measures and technical barriers to trade, among other issues. From 1975-1984 Dr. Smith worked in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) in a number of technical and regulatory positions. He has published a number of technical and regulatory articles and has received numerous awards while at FDA, including twice receiving the agency’s highest award―the FDA Award of Merit. His early career was spent as a chemist and inspector working at the Virginia Department of Agriculture and Commerce in Richmond, where he completed research in the area of foodborne infections and intoxications. Dr. Smith received his BA in liberal arts from the University of Virginia, his MS and PhD in microbiology and food sciences from Virginia Polytechnic Institute and State University, and his JD from Columbus School of Law at the Catholic University of America.
KATHRYN E. STEIN, PhD is Senior Vice President for Product Development & Regulatory Affairs at MacroGenics Inc. in Rockville, Maryland. Prior to joining MacroGenics, she was the Director of the Division of Monoclonal Antibodies (DMA), Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research (CBER) and Acting Chief, Laboratory of Molecular and Developmental Immunology, DMA from 1992-2002. She joined CBER in 1980 as a Senior Staff Fellow and became a Senior Investigator in 1985 and Chief of the Laboratory of Molecular and Developmental Biology in the Division of Bacterial Products in 1991. Dr. Stein has over 22 years of experience at the FDA, having worked on all regulatory aspects of therapeutic proteins and monoclonal antibodies and was a leader in policy development at FDA for these products. Most of the marketed monoclonal antibodies were approved under her leadership. She maintained an active research lab at the FDA and played a significant role in the review and approval of the Hib conjugate vaccines. Dr. Stein received a National Research Service Award from the National Institutes of Health (NIH) for post-doctoral studies at Harvard with Dr. Harvey Cantor and at the NIH with Dr. William Paul prior to her joining CBER. She received her BA in Chemistry from Bard College in Annandale-on-Hudson, New York and her PhD in Microbiology and Immunology from the Albert Einstein College of Medicine of Yeshiva University.
ROY J. STURGEON, PhD is President of Lachman Consultants in Westbury, NY. He provides leadership and subject matter expertise for the assessment, analysis, planning, implementation and verification of compliance programs and corrective action plans. He also develops manufacturing strategies, resolves technical manufacturing issues and assesses and resolves pharmacovigilance, vaccine/biological product strategies and production. Prior to joining LCS, Dr. Sturgeon held a number of high level executive positions in both consulting groups and major global pharmaceutical companies including Wyeth and Merck. He is also an expert in crisis management, having handled product withdrawals and Class II, III recalls, and has also served as a Corporate Crisis Manager. Dr. Sturgeon received his BSP in Pharmacy and his PhD in Pharmaceutical Sciences and Analytical Chemistry from the University of Florida. He also received a CBE in Business from Northeastern University.
THEODORE M. SULLIVAN is a Senior Attorney at Buchanan Ingersoll & Rooney PC’s Washington, DC office and is a member of the firm's Corporate Finance Group and Food and Drug Section. He counsels clients subject to Food and Drug Administration (FDA) regulations and advises them in over-the-counter drug regulation, drug exclusivity issues, food and dietary supplement labeling and advertising and import detention of FDA-regulated products. In the drug and medical device area, Mr. Sullivan has experience in both pre- and post-approval issues. He has worked closely with clients in guiding new drugs and medical devices through the FDA's approval processes, and has assisted clients resolving conflicts with the agency regarding approved products. In addition to FDA regulatory practice, he has also counseled clients on the regulation of perishable agricultural commodities by the United States Department of Agriculture and North American Free Trade Agreement (NAFTA) country of origin rules. Mr. Sullivan previously served as legal counsel for an international medical device company, where he worked to launch the opening of a subsidiary in the United States, obtained pre-market approval for injectable medical devices, and advised the company on FDA-related advertising, labeling, import/export and manufacturing issues. Before practicing law, he was an FDA biologist at the National Center for Food Safety and Technology, where he conducted research into methods for detection of food-borne pathogens and toxins. Mr. Sullivan received his BS in biological sciences from George Mason University and his JD with honors from the Chicago-Kent College of Law.
STEPHEN F. SUNDLOF, DVM, PhD is the Director of the Center for Food Safety and Applied Nutrition (CFSAN) at 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. From 1994 to 2008, he served 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.
JAMES E. SWAUGER, PhD is Vice President, Regulatory Oversight at R.J. Reynolds Tobacco Company. His current responsibilities are focused on preparing the company to achieve and maintain compliance with the provisions of the Smoking Prevention and Tobacco Control Act. He has held several positions at R.J. Reynolds Tobacco over a period of 17 years, managing Scientific Affairs, Regulatory Affairs and Regulatory Compliance functions. Dr. Swauger is a member of the Society of Toxicology and the Society of Risk Analysis. He earned his BS in Toxicology from Northeastern University and his PhD in Toxicology from the Johns Hopkins School of Public Health.
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 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.
ROSEANN B. TERMINI is a Professor at Widener University School of Law in Pennsylvania and Delaware as well as the University of Georgia School of Pharmacy. She has extensive experience in food and drug law and has both presented and published a broad array of specialized food and drug law topics including ethics and corporate accountability. Ms. Termini just published comprehensive new editions of Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements 4th ed. with a separate CD and separate Training Manual (2010). Recently, Ms. Termini addressed FDA Enforcement at the Health Law Institute and was a featured speaker at FDA about product classification and safety issues. Other presentations include claims, dietary supplements, duty to warn, preemption, medical device regulation, direct to consumer promotion, tobacco and risk assessment. She authored monthly periodicals specifically pertaining to food and drug law regulations. Ms. Termini is a contributing author, served on the RxMD advisory board and is a founding board member of the Center for Pharmaceutical Health Services Research. She has authored numerous articles primarily focusing on specialized issues involving safety, stem cells, globalization, labeling claims, dietary supplements and pharmaceutical law. Further, she has written about the environment, constitutional issues and plain English drafting and was the first recipient of the Statewide PA Bar Association Plain English Clarity Award. Other expertise entails an appellate law clerkship and the sole corporate counsel for an FDA regulated company and a regulatory affairs attorney. As senior deputy attorney general, Office of Attorney General, Ms. Termini successfully litigated and prosecuted numerous cases at the trial and appellate levels. Ms. Termini initiated the inaugural online food and drug law courses at Widener University Law School and was the first to teach food and drug law online for the University of Georgia School of Pharmacy. Other online expertise includes Johns Hopkins, St. Joseph’s, Drexel and on-ground food and drug at Penn State-Dickinson Law. She also taught the Legal Environment of Business-Ecommerce. Besides her professional association committee appointments which include Ethics and Professional Responsibility, Medical and Health Law, Legal Services and Plain English, she was appointed to chair an FDLI committee. She is also a member of the Central Atlantic Association of Food and Drug Law Officials and was appointed to serve on the President’s Council of Immaculata University.
BRADLEY MERRILL THOMPSON is a Partner in the law firm of Epstein Becker & Green, P.C. There he counsels medical device and drug companies on a wide range of 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 Law School and Columbia Law School, served as and also serves as Co-Chair of the Food & Drug Law Committee of the Administrative Law Section of the American Bar Association. 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. He 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. 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.
JAYNE T. TUNG, DVM is a small animal emergency clinician at the Frederick Emergency Animal Hospital in Frederick, Maryland. She is also an independent equine practitioner. Previously, Dr. Tung served in FDA’s Center for Veterinary Medicine in the Office of New Animal Drug Approval, Office of Generic Animal Drugs and Office of Surveillance and Compliance. Prior to joining the FDA, she served as a small animal emergency clinician in the Metropolitan Emergency Animal Hospital in Rockville, Maryland. Dr. Tung received a BS in Marketing from the University of Maryland and a DVM from Michigan State University College of Veterinary Medicine.
RALPH S. TYLER is Chief Counsel to the Food and Drug Administration (FDA). Prior to joining FDA, he served as the Maryland Insurance Commissioner. During Mr. Tyler’s 35-plus years as a lawyer, he has served as Counsel to the Governor of Maryland, Baltimore City Solicitor and Maryland Deputy Attorney General, as well as a Partner in the law firm of Hogan & Hartson, LLP. His legal practice has focused on both civil litigation and administrative law. Mr. Tyler received his BA from the University of Illinois, his JD from Case Western Reserve University and his LLM from Harvard University.
MICHAEL T. VAN KOEVERING, PhD is the Director of Regulatory Surveillance and Compliance at Elanco Animal Health, a marketing company that works to promote products that improve animal health and protein production. He directs all responsibilities relating to the approval of promotional advertising and labeling, post-approval labeling and other areas of regulatory product support. Dr. Van Koevering has had over 15 years of experience within the feed and animal health industry. He worked extensively with both cattle and swine customers in the area of technical consulting, and since joining the Elanco Regulatory Affairs team in 2007, now works across all food and companion animal brands. Dr. Van Koevering received his BS from the University of Wisconsin-River Falls, his MS from Iowa State University, his PhD from Oklahoma State University and his MBA from the University of Nebraska-Omaha.
FREDERICK S. vom SAAL, PhD is a Curators' Professor of Biology, Division of Biological Sciences at the University of Missouri – Columbia. The focus of his research is on abnormal development of reproductive organs and metabolic processes due to exposure during fetal life to estrogenic chemicals in plastic. In addition, he is helping to conduct numerous collaborative projects relating environmental chemicals with diseases in humans. Dr. vom Saal has published over 160 articles on his research and has testified at hearings in the U.S. Senate and House of Representatives, numerous State legislative bodies, the EU Parliament, and at regulatory agency hearings in the U.S., Germany and Japan. He has served on editorial boards of a number of scientific journals and on the National Academy of Sciences Committee on Hormonally Active Agents in the Environment. He is also an elected fellow of the American Association for the Advancement of Science. After serving as a Peace Corps volunteer in Somalia and Kenya, Dr. vom Saal received his PhD in neuroscience from the University of Rutgers. His postdoctoral training was in reproductive physiology at the University of Texas at Austin.
SHEILA D. WALCOFF is a Partner in the law firm of McDermott Will & Emery LLP in Washington, DC. She focuses her practice on personalized medicine and other federal regulatory and science policy matters and counsels a broad range of clients, including pharmaceutical and biotechnology companies, specialized laboratories, science and technology start-ups, and associations/coalitions on policy, government affairs advocacy, business strategy and communications. Ms. Walcoff has significant federal health policy, communications, legislative/regulatory and management experience. She served as counselor to the secretary of the U.S. Department of Health and Human Services (HHS), where she advised the HHS secretary, the White House and other government agencies on all science and public health policy, management, communications and budget matters, including personalized medicine, follow-on biologics, amendments to the Food Drug and Cosmetic Act and food safety. She served the administration as the principal policy liaison managing the four public health and science operating divisions of HHS: the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and Agency for Healthcare Research and Quality (AHRQ). Ms. Walcoff also developed and directed major HHS and administration initiatives, including personalized health care, genomics and information technology, prevention, World Trade Center responder health care and HIV/AIDS initiatives. Prior to this, she served as associate commissioner for external relations at FDA, where she provided policy and communications counsel to the FDA commissioner and other senior government officials, among other duties. Ms. Walcoff received her JD from Georgetown University Law Center and her BA from Minot State University.
JEFFREY N. WASSERSTEIN is a Shareholder for the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC. He specializes in healthcare fraud and abuse and health privacy issues as well as general food and drug law. Mr. Wasserstein primarily focuses on counseling pharmaceutical and medical device companies on compliance issues. Before joining Hyman, he practiced at Sidley & Austin in Washington, DC. Previous to this, he clerked for the Honorable Samuel A. Alito, Jr. of the US Court of Appeals and the Honorable Allyne R. Ross, U.S. District Judge for the Eastern District of New York. Mr. Wasserstein is a graduate of Columbia University School of Law and has BAs from Columbia University and the Jewish Theological Seminary.
JOHN B. WEINER is an Associate Director for the Policy & Product Classification Office, Office of Combination Products, OC, FDA. In this position, he classifies and assigns therapeutic products for regulation and ensures that regulation is consistent and timely. He also works with legal issues as well as a wide range of scientific and policy considerations. Mr. Weiner also served as Associate Chief Counsel at FDA for four years. Prior to this, he served as an Associate at Beveridge & Diamond, P.C. for four years before joining Ropes & Gray LLP, where he spent two years. Mr. Weiner earned his undergraduate degree from Princeton University and his JD from Columbia University School of Law.
MICHAEL J. WERNER is a Partner with the law firm of Holland & Knight LLP in Washington, DC. He focuses on issues affecting biotechnology and pharmaceutical companies, researchers and research institutions, physicians and patients. His specific areas of expertise include FDA drug/biologic regulations, FDA and NIH oversight of clinical trials, approval and marketing of orphan drugs, and stem cell research and regulation of cell therapy and regenerative medicine products, among other areas. Prior to joining Holland & Knight, Mr. Werner founded and served as president of The Werner Group, which provides lobbying, regulatory, and bioethics consulting services for biotechnology and pharmaceutical companies, physicians, health plans, investors and patient advocacy groups. Previous to this, he was chief of policy for the Biotechnology Industry Organization (BIO) where he was responsible for issues affecting biotech companies, including drug evaluation and review by FDA, CMS policies and reimbursement, Medicare, and other issues. Mr. Werner has also served as senior healthcare advisor to U.S. Senate Majority Leader George Mitchell and senior advisor to Maryland Governor William Donald Schaefer. He received his BA from the University of Michigan and his JD from George Washington University Law School.
SUSAN C. WINCKLER, RPh, JD is the President and Chief Executive Officer of the Food and Drug Law Institute (FDLI). FDLI is nonprofit 501(c)(3) organization committed to providing high-quality education and a neutral forum for the generation of ideas and discussion of food and drug law and public policy. Immediately prior to joining FDLI, Ms. Winckler served as Managing Director, Medical Products Practice, at Leavitt Partners. Founded by former U.S. Health and Human Services (HHS) Secretary and EPA Administrator Michael O.
Leavitt, the partnership advises senior executive teams in the practice areas of health, environment and trade. Ms. Winckler retains a limited affiliation with Leavitt Partners as a Senior Advisor. From January 2007 to June 2009, she served as the Chief of the Staff for the U.S. Food and Drug Administration (FDA) within HHS. In that capacity, she provided integrated policy analysis and strategic consultation to the Commissioner and senior FDA officials on significant agency issues and programs. Ms. Winckler also led the operations of the Office of Legislation (until April 2009), the Office of External Relations, Office of Public Affairs, and Office of the Executive Secretariat. Prior to joining FDA, Ms. Winckler was the Vice President for Policy and Communications and Staff Counsel for the American Pharmacists Association (APhA). Ms. Winckler served as the primary spokesperson for APhA during media interviews, and was APhA’s senior lobbyist. Previous positions with the Association include Group Director of Policy and Advocacy, Director of Policy and Legislation, Director of Practice Affairs, and Manager of Special Projects. Prior to joining APhA, Ms. Winckler directed the implementation of the Iowa Medicaid Drug Prior Authorization Program for the Unisys Company, and worked for the Iowa Pharmacists Association (now the Iowa Pharmacy Association) and a community pharmacy in Iowa. Ms. Winckler is a graduate of the University of Iowa College of Pharmacy and the Georgetown University Law Center, magna cum laude. She is a licensed pharmacist in Iowa and admitted to the bar in the Commonwealth of Virginia.
JANET WOODCOCK, MD is the Director of the Center for Drug Evaluation and Research (CDER) at 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.
DONALD L. ZINK, PhD is the Director, Senior Science Advisor Staff, Office of the Center Director, CFSAN, FDA. He has worked in the food safety and quality assurance industry for 25 years. Previously, he was the Director of Food Safety at Nestle USA. Prior to joining Nestle, he served as Manager of Process Microbiology at the Campbell Soup Company, where he focused on refrigerated food safety. Dr. Zink also served as an Assistant Professor in the College of Veterinary Medicine at Texas A&M University, and as an Assistant Professor of Microbiology and Immunology at the University of Arizona. His academic research interests centered on the genetic and biochemical basis of bacterial virulence. He has been involved in numerous professional scientific organizations and advisory committees, and currently serves as a member of the National Advisory Committee on Microbiological Criteria for Foods. Dr. Zink is a graduate of Texas A&M University where he earned a PhD in Biochemistry and Biophysics.