Tuesday, April 24
7:00–8:15 a.m.
Registration and Continental Breakfast (Amphitheater Foyer)
8:15–8:30 a.m.
Opening Remarks (Amphitheater)
Susan C. Winckler, President & CEO, FDLI
Geoffrey M. Levitt, Senior VP & Associate General Counsel, Regulatory & Policy, Pfizer, Inc. and Chair, FDLI
8:30–9:00 a.m.
Keynote Address (Amphitheater)
Margaret A. Hamburg, MD, Commissioner of Food and Drugs
Introduced by Geoffrey M. Levitt
9:00–10:00 a.m.
FDA Deputy Commissioners (Amphitheater)
As part of an effort to more accurately reflect the agency's responsibilities, subject matter expertise and mandates in an ever more complex world, FDA Commissioner Hamburg re-organized the Agency in mid-2011. The Commissioner divided the Agency's programs into four directorates that reflect the core functions and responsibilities of the Agency. Hear three Deputy Commissioners introduce their Directorates and discuss the challenges and opportunities they expect to address in the next year.
Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Stephen P. Spielberg, MD, Deputy Commissioner for Medical Products and Tobacco, FDA
Michael R. Taylor, Deputy Commissioner for Foods, FDA
Moderated by Susan C. Winckler
10:00–10:30 a.m.
Networking Break (Amphitheater Foyer)
10:30–11:50 a.m
Regulatory Science: Redefining FDA in 2012 (Amphitheater)
Since FDA launched its Strategic Plan for Regulatory Science in October 2010, stakeholders ranging from pharmaceutical companies to patient advocates to universities and venture capitalists have been working with FDA to successfully utilize the new program. But what, exactly, is the definition of regulatory science? And what has the new initiative accomplished? In this roundtable, you'll hear differing perspectives, including:
The impact of the new tools, standards, and approaches established to assess the safety, efficacy, quality, and performance of all FDA-regulated products;
- FDA "building arrangements" and what they mean;
- Avoiding perceived conflicts of interest;
- Challenges ahead and improvements that can be made to the regulatory science initiatives; and,
- Cooperative relationships between industry and FDA to promote regulatory science.
Vicki Seyfert-Margolis, PhD, Director, Office of Science and Innovation, Office of the Chief Scientist, OC, FDA
Kenneth L. Dretchen, PhD, Director of the Georgetown University Biosecurity Institute
Lance L. Shea, Partner, Fulbright & Jaworski L.L.P.
Moderated by Geoffrey M. Levitt
11:50 a.m.–12:10 p.m.
FDA Alumni Association Award Presentation (Amphitheater)
A lectureship named in honor of Dr. Harvey W. Wiley, the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of “Father of the Pure Food and Drugs Act” when it was enacted into law in 1906.
The 2012 Wiley Award Winner is Steve Usdin. Mr. Usdin has been Washington Editor of BioCentury since 1993, and has spent the past 20 years in Washington, DC covering political and policy issues affecting the life sciences sector. He also is the Senior Editor responsible for coverage of social issues involving biotechnology. His book, “Engineering Communism: How Two Americans Spied for Stalin and Founded the Soviet Silicon Valley,” was published in 2005 by Yale University Press. Mr. Usdin also hosts a TV show, “BioCentury This Week,” designed to help the public and policy makers “understand how politics, regulatory decisions, investor attitudes, bioethics and global competition will determine whether bioscience fulfills its social promise.” His show, the first of its kind to be broadcast on a network TV station and webcast around the world, has featured interviews with FDA leaders on cutting edge regulatory and public health issues.
12:10–1:30 p.m.
Lunch Address: FDA & Global Regulation (Atrium Ballroom)
Dara Corrigan, Associate Commissioner, Office of Regulatory Affairs, FDA
Daniel F. Shaw, Vice President and Deputy General Counsel, H.J. Heinz Company
Moderated by Luciano O. Ferreira, Regulatory Intelligence Manager, Latin America, GE Healthcare & Coordinator Professor, Pontifical Catholic University of São Paulo
1:30–3:00 p.m.
Concurrent Breakouts: FDA Product Center Directors
Representatives from each of FDA’s six product Centers will discuss the three most important developments from the last year and their three most important goals in 2012. You’ll hear directly from Center representatives, as well as food and drug law stakeholders responding to their presentations.
Center for Tobacco Products (CTP) (Hemisphere B)
Lawrence R. Deyton, MSPH, MD, Director, Center for Tobacco Products, FDA
James E. Dillard III., Senior Vice President, Altria Client Services, Inc.
Nancyellen Keane, Of Counsel, Troutman Sanders LLP
Matthew L. Myers, President, Campaign for Tobacco-Free Kids
Moderated by Mark S. Frankel, PhD, Director, Program on Scientific Responsibility, Human Rights and Law, AAAS
Center for Veterinary Medicine (CVM) (Oceanic B)
Bernadette M. Dunham, DVM, PhD, Director, Center for Veterinary Medicine, FDA
Edward J. Allera, Co-managing Shareholder, FDA/Biotech Chair, Buchanan Ingersoll & Rooney PC
R. Michael Herrman, Senior Division Counsel, Boehringer Ingelheim Vetmedica, Inc.
Roseann B. Termini, MEd, Professor, Widener University School of Law
Moderated by Jeannie M. Perron, DVM, Of Counsel, Covington & Burling LLP
Center for Food Safety and Applied Nutrition (CFSAN) (Meridian DE)
Daniel L. Engeljohn, PhD, Assistant Administrator, Office of Policy and Program Development, Food Safety and Inspection Service, USDA
Michael M. Landa, Director, Center for Food Safety and Applied Nutrition, FDA
Ann M. Boeckman, Chief Counsel, Food Law, Kraft Foods Global
Tony Corbo, Senior Lobbyist, Food & Water Watch
Frederick H. Degnan, Partner, King & Spalding
Moderated by Leslie T. Krasny, Partner, Keller and Heckman LLP
Center for Devices and Radiological Health (CDRH) (Hemisphere A)
William H. Maisel, MD, MPH, Deputy Director for Science, Office of the Center Director, Center for Devices
and Radiologic Health, FDA (as designated by Jeffrey Shuren, MD, Director, CDRH)
Jeffrey K. Shapiro, Director, Hyman, Phelps, & McNamara P.C.
Patricia B. Shrader, Senior Vice President, Corporate Regulatory and External Affairs, Medtronic, Inc. and Treasurer, FDLI
Timothy R. Wells, President, QualityHub,Inc
Diana Zuckerman, PhD, President, National Research Center for Women & Families, Cancer Prevention and Treatment Fund
Moderated by Daniel A. Kracov, Partner, Arnold & Porter LLP
Center for Biologics Evaluation and Research (CBER) (Polaris A)
Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA
Diane M. Maloney, Associate Director for Policy, CBER, FDA
Kay Holcombe, Senior Policy Advisor, Genzyme and Director, FDLI
Celia M. Witten, PhD, MD, Director, Office of Cellular, Tissue and Gene Therapies, CBER, FDA
Stephen Paul Mahinka, Partner, Morgan, Lewis & Bockius LLP
Moderated by Jordan K. Paradise, Associate Professor of Law, Seton Hall University School of Law
Center for Drug Evaluation and Research (CDER) (Polaris BC)
Douglas C. Throckmorton, MD, Deputy Center Director, Center for Drug Evaluation and Research, FDA
(as designated by Janet Woodcock, MD, Director, CDER)
Jonca C. Bull, MD, Novartis Pharmaceuticals Corporation
David M. Fox, Partner, Hogan Lovells
Robert A. Rhoades, Vice President, Quality & Compliance Consulting, Quintiles
Moderated by Michelle R. Mangrum, Managing Partner, Shook, Hardy & Bacon L.L.P
3:00–3:30 p.m.
Networking Break (Amphitheater Foyer)
3:30–5:00 p.m.
Concurrent Breakouts: Global Issues
What Every Medical Products Stakeholder Needs to Know about What’s Happening in China (Polaris BC)
For years, China has led the world’s emerging economies in both the global pharmaceutical and medical device businesses. Keeping current with regulation and business practices is essential for anyone interested in the Chinese market. In this session, experts in the Chinese pharmaceutical and medical device industries and foreign investment in the region will discuss what you need to know to successfully play in this space. This session will include discussion of:
- How product localization is changing the game;
- How newly issued Chinese GMPs affect the supply chain;
- Why developments in the Chinese regulatory regime are significantly affecting the life science industry in China; and,
- What price controls by National Development and Reform Commission (NDRC) of the People’s Republic of China mean for stakeholders.
Katherine Lu, Managing Director, China Healthcare Equity Research, Cowen and Company
Paul Neureiter, Senior Director for International Trade, Pfizer
Chen Yang, Partner, Sidley Austin LLP
Moderated by Joshua L. Berlin, Executive Editor & Director of Business Development, Elsevier Business Intelligence
Why Do FDA-Regulated Medical Product Companies Report Going Abroad to Develop New Products? (Hemisphere A)
Medical device and pharmaceutical manufacturers, government regulators, and other stakeholders are concerned about the growing trend of product development overseas. What factors in the U.S. regulatory approval process affect business development decisions? Explore how the medical product industry is increasingly:
- Weighing the benefits of increased regulatory scrutiny and potential cost to competitive edge and innovation;
- Assessing the effect on patients of the decision to go abroad to pursue approval of the newest medical technologies and treatments; and
- Exploring ways to make the FDA approval process more predictable and consistent.
Dorothy B. Abel, Biomedical Engineer, Office of Device Evaluation, Division of Cardiovascular Devices, Peripheral Vascular Devices Branch, CDRH, FDA
Andrew Farb, MD, Medical Officer, Office of Device Evaluation, Division of Cardiovascular Devices, CDRH, FDA
Sheila M. Hemeon-Heyer, RAC, President, Heyer Regulatory Solutions, LLC and Director, FDLI
Christopher-Paul Milne, DVM, Assistant Director of the Tufts Center for the Study of Drug Development, Tufts University
Gael D. Tisack, Vice President of Regulatory and Legal Affairs, Terumo Cardiovascular Systems
Andrew Van Haute, Associate General Counsel, AdvaMed
Moderated by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Emerging Markets for Dietary Supplements and Cosmetics: Key Compliance, Safety and Regulatory Issues (Meridian DE)
Dietary supplement and cosmetic manufacturers are increasingly seizing opportunities to produce and distribute product to emerging markets, especially China, India and Brazil. But with opportunity comes a raft of challenges, including GMP standards, supply chain integrity, import requirements and compliance with myriad regulatory schemes. In this session, you’ll find out:
- Where cosmetics and dietary supplement manufacturers are investing their resources internationally and the legal and regulatory obstacles they face;
- What supply chain and safety issues are integral to regulatory compliance globally; and
- The latest trends in international regulation of dietary supplements and cosmetics as food and/or drugs.
Daniel Fabricant, PhD, Director, Division of Dietary Supplement Programs, CFSAN, FDA
Rend Al-Mondhiry, Regulatory Counsel, Council for Responsible Nutrition
Francine Lamoriello, Executive Vice President, Global Strategies, Personal Care Products Council
Georgia C. Ravitz, Partner, Arent Fox LLC
Moderated by Mark Mansour, Partner, Akin Gump Strauss Hauer & Feld LLP
How FSMA Changed the Game on Imports (Polaris A)
Under the Food Safety Modernization Act (FSMA), FDA’s new import authority includes importer accountability, third-party accreditation, certification of high risk foods, voluntary qualifier importer programs and authority to deny entry into the country. Operating in a global market requires food manufacturers and processors to understand the evolving import and accreditation requirements to remain competitive at home and abroad. In this session you will learn:
- How FSMA requirements influence international trade and interaction with foreign regulators;
- How to develop and implement a foreign supplier verification program that is right for your business; and
- How to effectively resolve complex bilateral and multilateral trade and supply chain issues with foreign suppliers.
Benjamin L. England, President and CEO, FDAImports.com, LLC
Bruce A. Silverglade, Principal, Olsson Frank Weeda Terman Matz, PC
Christopher A. Waldrop, Director, Food Policy Institute, Consumer Federation of America
Moderated by Sarah Roller, Partner, Kelley Drye & Warren LLP
Antibiotic Use: Feed Animals and Antibiotic Resistance, A Global Challenge (Oceanic B)
Antibiotic resistance is a growing global problem. In January 2012, FDA partially banned certain extra-label uses of cephalosporins, a class of antimicrobial drugs and a critical component of human medicine. The action was applauded by some and challenged as insufficient by others. As the world’s food supply and trade of animal feed becomes increasingly globalized and antibiotic resistance permeates, what steps are the U.S., the European Union and other governing bodies taking? In this session, leaders in the field will:
- Analyze FDA’s regulation of animal drugs and collaboration with foreign regulatory agencies;
- Explore the international patterns of resistance and efforts to address the problem; and
- Examine response to antibiotic resistance by the meat industry.
Carlos Alvarez Antolinez, DVM, Minister Counselor, Food Safety, Health and Consumer Affairs, Delegation of the European Union
Betsy Booren, PhD, Director, Scientific Affairs, American Meat Institute
H. Scott Hurd, DVM, PhD, Associate Professor, Director, WHO Collaborating Center for Risk Assessment and Hazard Identification, Iowa State University
Jesse J. Sevcik, Director, Global Government Affairs, Elanco Animal Health, Eli Lilly & Company
Moderated by Suzanne M. O’Shea, Counsel, Faegre Baker Daniels LLP
Tobacco Research in a Post-Statute World (Hemisphere B)
This panel will engage experts on critical issues resulting from tobacco research being conducted after passage of the Tobacco Prevention and Control Act. These issues involve key regulatory and policy issues, including the pathways for different tobacco products and the continuing development of FDA’s role. In this session, the panel will consider:
- Concerns regarding industry funding of required research;
- Long-term options for a tobacco research infrastructure, including models such as the Health Effects Institute and the Hamner Institutes for Health Sciences;
- Research required for a modified risk tobacco product application, including the level of tobacco company oversight provided for industry-funded studies;
- FDA collaboration with external research entities, including those prescribed by the Institute of Medicine; and
- What companies can do now, including forming a company-sponsored oversight/advisory body and ensuring independence and credibility.
J. Ben Haas, Partner, Latham & Watkins LLP
Lars-Erik Rutqvist, MD, PhD, Senior Vice President Scientific Affairs, Swedish Match AB
Kathleen Stratton, PhD, Project Director, Innovate FDA, Pew Health Group
Moderated by James M. Solyst, Principal Consultant, ENVIRON
5:00–6:00 p.m.
Networking Reception (Amphitheater Foyer)