ProgramSpeakers. Kate Beardsley, J.D. Principal, Beardsley Law, PLLC. Sheldon Bradshaw, J.D. Partner, Hunton & Williams LLP

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1 Kate C. Beardsley is an FDA lawyer in Washington, D.C. who represents generic drug companies in matters related to Hatch-Waxman, regulatory approvals, and compliance. Her practice includes providing strategic and legal advice, and she regularly represents clients in front of the FDA, both at the Office of Chief Counsel and at the Center for Drug Evaluation and Research. She previously worked for the federal government as the Deputy Director of the United States Regulatory Counsel. She is a founding partner of the law firm of Buc and Beardsley, and, prior to that, was associated with the law firm of Weil, Gotshal and Manges. Ms. Beardsley received her B.A. from Smith College and her J.D. from Emory School of Law, where she was an editor of the Law Review. Kate Beardsley, J.D. Principal, Beardsley Law, PLLC Sheldon Bradshaw is co-chair of the food and drug practice group at the law firm Hunton & Williams, LLP. His practice focuses on providing legal and regulatory assistance to both small growth companies and large multinational corporations regarding products regulated by the Food and Drug Administration. Prior to joining Hunton & Williams, Mr. Bradshaw served as Chief Counsel at the U.S. Food and Drug Administration (FDA) from 2005 to As Chief Counsel, he was responsible for providing legal advice to the FDA s senior leadership including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers 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. In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA. Prior to his service at the FDA, Mr. Bradshaw held several senior positions at the U.S. Department of Justice where he, among other things, provided advice to FDA and testified before Congress on matters under the FDA s jurisdiction. At Hunton & Williams, he advises clients in the same areas in which he worked while Chief Counsel of FDA. Sheldon Bradshaw, J.D. Partner, Hunton & Williams LLP Aaron (Ronny) Gal is the Senior Research Analyst covering the specialty pharmaceutical industry at Sanford C. Bernstein, providing research and investment insights on specialty and generic pharmaceutical stocks to institutional clients around the world. His work is recognized in third-party surveys, including those conducted by Institutional Investor and Greenwich Associates. Prior to joining Bernstein, Mr. Gal spearheaded Canon s business development in life sciences. He also spent six years with the Boston Consulting Group, advising clients in the pharmaceutical and healthcare delivery sectors. Mr. Gal was awarded a Ph.D. from the Massachusetts Institute of Technology and holds a B.Sc. from Emory University. Ronny Gal, Ph.D. Senior Analyst, Sanford C. Bernstein & Co.

2 Scott Gottlieb, M.D. is a practicing physician and Resident Fellow at the American Enterprise Institute. From , Dr. Gottlieb served as FDA Deputy Commissioner for Medical and Scientific Affairs and before that, from , as a senior advisor to the FDA Commissioner and as the FDA s Director of Medical Policy Development. He left the FDA in the spring of 2004 to work on implementation of the new Medicare Drug Benefit as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services. Dr. Gottlieb is an editorial board member of the journal Value Based Cancer Care, the Food and Drug Law Institute s Policy Forum, and is a member of the board of advisers of Cancer Commons. He writes a regular column for The Wall Street Journal. Dr. Gottlieb is a member of the policy boards to the Society of Hospitalist Medicine and the Leukemia and Lymphoma Society and serves as a director to public and private life science and healthcare services companies. Dr. Gottlieb is a Clinical Assistant Professor at the New York University School of Medicine. He completed a residency in internal medicine at Mount Sinai Hospital in New York and is a graduate of the Mount Sinai School of Medicine and of Wesleyan University, in Middletown, Connecticut, where he studied Economics. Scott Gottlieb, M.D. Resident Fellow, American Enterprise Institute, Former Deputy Commissioner, Food and Drug Administration Gordon Johnston has more than 25 years of experience in the pharmaceutical industry, beginning with the U.S. Public Health Service, where he served in a number of pharmacist and health care management positions. In 1987, he was assigned to the Food and Drug Administration (FDA) and, in 1994, was promoted to Deputy Director of the FDA s Office of Generic Drugs (OGD). During his tenure at the federal agency, Mr. Johnston was a key member of the FDA team that developed and put into practice the regulations implementing the Hatch-Waxman amendments. While at the FDA, Mr. Johnston interfaced with a number of foreign governments on generic drug regulatory standards. Following his retirement from the FDA in 1999, Mr. Johnston served as a consultant to the pharmaceutical industry and, more recently, as the Vice President for Regulatory Science for the Generic Pharmaceutical Association from 2003 to Mr. Johnston now serves as an expert consultant to the pharmaceutical industry. He also has spoken at numerous national and international meetings on regulatory and technical issues related to generic drugs. Gordon Johnston, R.Ph., M.S. Principal, Gordon Johnston Regulatory Consultants, LLC Doug Long is Vice President of Industry Relations at IMS Health, the world s largest pharmaceutical information company. Mr. Long, who has been with IMS Health since 1989, focuses on securing data for all existing and new databases supported by IMS Health, managing supplier, manufacturer and association relationships, and developing information for data partners. He has considerable experience with, and unique perspective on, the changing U.S. and global health care marketplace and pharmaceutical distribution. Doug Long Vice President, Industry Relations, IMS Health

3 Anthony Mauro is the president of Mylan North America, overseeing all business operations in that region. Throughout his 18 year tenure at Mylan, Mauro has held roles of increasing responsibility, including president of Mylan Pharmaceuticals Inc., chief operating officer for Mylan Pharmaceuticals ULC in Canada, vice president of North America Strategic Development and vice president of North America Sales. In 2013, Mauro was elected to serve a second term as chairman of the board of directors for the Generic Pharmaceutical Association (GPhA). Previously, Mauro served two consecutive terms as GPhA s vice chairman. Mauro earned a bachelor s degree in business administration, with a specialization in finance, and a master s degree in business administration from West Virginia University, where he is a member of the Graduate School of Business and Economics Visiting Committee. Tony Mauro President, Mylan North America Marcie McClintic Coates is Vice President and head of global regulatory affairs at Mylan where she oversees the global regulatory affairs function responsible for obtaining the approval and maintenance of new and existing products from health authorities around the world to ensure patient access to Mylan s high quality portfolio of medicines. Marcie also has served on various industry task forces and working groups, and was a member of the GDUFA negotiating team where she played a leading role, together with industry participants and the U.S. Food and Drug Administration, in developing, negotiating, and reaching consensus for passage of the landmark generic drug user fee program in 2012, along with key provisions of the Food and Drug Administration Safety and Innovation Act. Marcie began her career at Mylan in the Legal department, where she held several roles of increasing responsibility. Prior to her current role, Marcie served as vice president and chief of staff in the Office of the CEO where she provided strategic counsel and operational support to Mylan s CEO and leadership teams. She earned a Master of Business Administration from West Virginia University and a Juris Doctor from the West Virginia College of Law, where she was editor in chief of the West Virginia Law Review. Marcie also earned a bachelor s degree in business management from Wittenberg University. Marcie McClintic Coates, J.D. VP and Head of Global Regulatory Affairs, Mylan Inc. Andrea Miller is Senior Vice President and head of Mylan s Global Complex Products Operations. In this role, Miller is a key contributor to the company s efforts to continue expanding the use of generic drugs, especially those that are difficult to develop or manufacture or that have high hurdles to entry in the marketplace. Throughout her 25- year career at Mylan, Miller has held roles of increasing responsibility within the company s Research and Development, Clinical/Medical and Regulatory Affairs areas, and she has led its Global Regulatory Affairs and Drug Safety teams. In her participation with the growth of the generic drug industry since its infancy, Miller has supported and managed the development of abbreviated new drug applications and new drug applications. Miller earned a Bachelor of Science degree in pharmacy and Doctor of Jurisprudence from West Virginia University. Andrea Miller. J.D. Senior Vice President, Head, Global Complex Products Operations, Mylan, Inc.

4 Thomas Moore President, Hospira USA Thomas G. Moore serves as President of Hospira USA and is responsible for developing strategy, delivering growth and attaining market leadership for Hospira products and services in the United States. Hospira is the world s leading provider of injectable drugs and infusion technologies. Dr. Moore has 29 years of executive experience in the pharmaceutical industry. He has a distinguished track record of leadership excellence at both Abbott and Hospira where he served as President of Global Pharmaceuticals, Vice President and General Manager of Specialty Pharmaceuticals and other executive positions. Prior to his career in the pharmaceutical industry, Tom was a director of pharmacy and materials management at a California hospital. Tom received his bachelor of science degree in microbiology at Loyola University in Los Angeles and his doctor of pharmacy degree from the University of Southern California. Tom is a member of the American Society of Health System Pharmacists, the International Pharmaceutical Licensing Group, and currently serves as a trustee on The Rosalind Franklin University of Medicine and Science board. Tom is a leading global expert on the pharmaceutical business and is often asked to address industry issues to Congress and other national groups. Ralph G. Neas President and CEO, GPhA Ralph G. Neas is the President and CEO of the Generic Pharmaceutical Association (GPhA). Prior to joining GPhA, he was the President and CEO of the National Coalition on Health Care (NCHC), a nonpartisan centrist coalition of more than eighty national organizations. For more than 30 years, Neas focused principally on civil rights, civil liberties, health and consumer issues, serving as the Executive Director of the nonpartisan Leadership Conference on Civil Rights (the nation s oldest and largest coalition), as President and CEO of the nonpartisan People For the American Way, and as a chief counsel in the U.S. Senate, first to Senator Edward W. Brooke (R-MA) and then to Senator Dave Durenberger (R-MN). Neas earned his B.A. from the University of Notre Dame and his J.D. from the University of Chicago Law School. Neas has also taught at the University of Chicago Law School, Georgetown University Law Center, and Harvard s Kennedy School of Government. Allan Oberman became President & CEO of Teva Americas Generics in November 2012, after serving as the head of the North America Generics division. Prior to his role in the Americas, he served as President of Teva EMIA, where he had responsibility for Eastern Europe, Middle East, Israel and Africa. Allan joined Teva in 2000 as the President and CEO of Novopharm, which is now Teva Canada. While at Teva Canada, he led the transition of the company from a family-owned business to that of a successful subsidiary of Teva, ultimately regaining the Canadian generic market leadership position. Allan also served as the Chief Operating Officer of the Teva International Group. Before joining Teva, he was President of Best Foods Canada Inc. Allan holds an MBA from Schulich School of Business, York University and a B.A. from University of Western Ontario. He also served as Chairman of the Canadian Generic Pharmaceutical Association (CGPA) from Allan Oberman President and CEO, Teva Americas Generics

5 As the director of A.T. Kearney s Global Business Policy Council, Erik Peterson advises the world s top CEOs and business-minded thought leaders. Prior to joining A.T. Kearney, he served as senior vice president at the Center for Strategic and International Studies (CSIS) and as director of research at Kissinger Associates. The author of numerous publications, Peterson is now completing a book on global strategic trends and their effects on governance structures in societies across the world. His other writings include Race to the Future (The Age, November 20, 2009) and The World is Dry (SAISphere, May 2008). Peterson currently serves on several advisory boards and judging panels, including the Center for Global Business Studies at Pennsylvania State University, the Center for the Study of the Presidency and Congress, and the Gerald R. Ford Foundation prize in national security reporting. Peterson received his MBA from the Wharton School at the University of Pennsylvania, his M.A. from the Johns Hopkins University School of Advanced International Studies (SAIS), and his B.A. from Colby College. Erik Peterson, M.A. Director, A.T. Kearney s Global Business Policy Council Robert Pollock recently retired from Lachman Consultants as Executive Vice President and is currently Senior Advisor and Outside Director to the Board at Lachman where he provides support and counsel to the Lachman regulatory team and other Lachman practice areas and also provides regulatory services for the industry. Formerly, Mr. Pollock was the Acting Deputy Director of the Office of Generic Drugs (OGD), Center for Drug Evaluation and Research, Food and Drug Administration. Bob was in the generic drugs program shortly after the passage of the Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Act). Prior to transferring to the FDA in 1985, he held various field and headquarters assignments with the Health Resources and Services Administration of the Public Health Service. He retired from the PHS in January 1995 with over 20 years of service at the rank of Captain. Mr. Pollock received his B.S. degree in pharmacy and his M.S degree in pharmacy administration at the University of Rhode Island where he studied as a Fellow of the American Foundation for Pharmaceutical Education. Mr. Pollock has numerous publications and presents extensively on the drug approval process as well as issues regarding strategic alliances. Robert Pollock, R.Ph., M.S. Senior Advisor and Member of the Board, Lachman Consultant Services, Inc. Dr. Carlos Sattler is Vice President, Clinical Development and Medical Affairs at Sandoz, where he leads efforts to develop Sandoz s biosimilars pipeline and biosimilars medical and scientific strategy. He joined Sandoz from Merck & Co., Inc. where he served in various clinical research and medical affairs roles, with a focus on the development and commercialization of the company s human papillomavirus vaccine. Dr. Sattler is a pediatrician with subspecialty training in pediatric infectious diseases. Carlos Sattler, M.D. Vice President, Clinical Development & Medical Affairs, Sandoz, Inc.

6 Randall Stanicky Managing Director, Equity Research, RBC Capital Markets Randall is currently Managing Director, RBC Capital Markets and lead analyst of the specialty and generic pharmaceuticals research team in New York. He has more than 14 years of experience covering several healthcare sectors on both the buy and sell-side, most recently at Canaccord Genuity and Goldman Sachs. Prior to becoming a sell-side analyst, Randall followed healthcare stocks on the buy side at Citigroup Global Asset Management. He has been recognized by several external surveys, including Institutional Investor and StarMine, among others. He is a regular Wall Street speaker at international conferences and is a regular contributor to mainstream print, radio and TV media, presenting his views on the industry. Randall received a bachelor s degree in commerce from the University of British Columbia and he is a CFA charterholder. Randall is also a Board Member of TherapeuticsMD. Kathleen Uhl, M.D. currently serves as the Acting Director for the Office of Generic Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA). This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs). Its mission is to ensure, through a scientific and regulatory process, that generic drugs are safe and effective for the American public. Dr. Uhl began her career with FDA as a medical officer in the Office of Clinical Pharmacology and has served in numerous positions at FDA, including five years as the Assistant Commissioner for Women s Health and the Director of FDA s Office of Women s Health and, more recently, as the Deputy Director of the Office of Medical Policy in the Center for Drug Evaluation and Research. She received her undergraduate degree from Temple University and her medical degree from the Medical College of Pennsylvania, with subsequent fellowship training in medical research and clinical pharmacology at the Uniformed Services University in Bethesda, MD. She has been an active member of numerous working groups in the FDA and serves on the Editorial Board for Clinical Pharmacology and Therapeutics. She retains faculty appointments as Professor in Family Medicine and Internal Medicine at the Uniformed Services University and is a retired officer of the U.S. Public Health Service Commissioned Corps. Kathleen Uhl, M.D. Office Director (Acting), Office of Generic Drugs, U.S. Food and Drug Administration Jeff joined Apotex, Canada s largest generic pharmaceutical company, in 1993 and, over the last 20 years, he has held various progressive positions within the Marketing and Sales Division, including time spent working in the retail pharmacy sector. He currently holds the position of President, Apotex Corp., North America and is responsible for all Canadian and U.S. Commercial operations within the Apotex Group of companies reporting to the CEO. Jeff is a member of the Apotex Executive Operating Committee, Apotex s highest level management committee, that is mandated to provide direction for all aspects of the business. His other leadership role is to motivate and inspire others to achieve strategic corporate objectives to meet targeted corporate growth. Since 2008, Jeff has been an active Executive Member of the Canadian Generic Pharmaceutical Association (CGPA) and Vice Chairman since From , he served on the board for the Canadian Sports Hall of Fame, making contributions in building networks and partnerships. In 2009, he was appointed to the Board for The Center for Healthcare Supply Chain Research in the U.S. that serves as the knowledge partner of the Healthcare Distribution Management Association. In September 2011, he was named Vice Chair and assumed the role of Chairman in November In January 2012, Jeff was elected to the Board of the Generic Pharmaceutical Association. He is also on the Board of Directors for TruLeaf Sustainable Agriculture, Nova Scotia, Canada and he was Jeff Watson recently named Chairman of the Board. President, Apotex Corp., North America

7 Craig A. Wheeler joined Momenta Pharmaceuticals, Inc. as Chief Executive Officer in September Momenta Pharmaceuticals is a biotechnology company specializing in the detailed characterization and engineering of complex drugs. Momenta is applying its technology to create technology-enabled generic versions of complex drug products, develop improved versions of existing drugs, and discover novel drugs and new biological processes. He also serves as a member of the Company s board of directors. Craig Wheeler President & CEO, Momenta Pharmaceuticals, Inc.