The information in this preliminary program will be updated periodically – this file is current as of June 1, 2007. For the most up-to-date content, click here. June 17-21, 2007|Atlanta, Georgia Don’t miss the Attend presentations event of the and case studies from more than year for the 1,000 speakers pharmaceutical and related Hear representatives from the FDA, EMEA industries! and other global regulatory agencies 27 tracks offered over 3½ days 35+ preconference tutorials Over 450 exhibitors Exhibit space is still available! 43rd Annual Meeting Georgia PROGRAM CHAIRPERSON World Congress Alberto Grignolo, PhD Center PAREXEL Consulting Program Chairperson umber 43 is finally here! And so are we all, ready to immerse ourselves fully into the Nenergy and substance of the 43rd Annual Meeting of DIA. Forty-three years after the 1st DIA Annual Meeting, the world is rather different – including Alberto Grignolo, PhD, is Corpor- that particular, specialized pharmaceutical world that DIA has mirrored and influenced for ate Vice President and General more than four decades. Through the yearly gathering of thousands of its members, DIA’s Manager of the Drug Development Annual Meeting has chronicled events of profound impact to the development of medicines; Consulting Practice in PAREXEL has offered a forum to innovators, critics, thought leaders, regulators and students of our Consulting. For the past fourteen field; has attracted an ever-expanding multinational constituency like a powerful magnet and years he has been responsible for has nurtured both learning and debate; has evolved into the must-attend event of the year PAREXEL’s regulatory services, for so many in our particular world. including worldwide drug devel- Welcome to Atlanta! Whether for the 1st time or the 43rd, you will reap the benefits of opment consulting and registra- tion strategies and submissions, the imagination, dedication and intellectual diversity of those who have labored to craft a regulatory compliance and clinical program of vast breadth and complexity to stimulate you, engage you, challenge you and quality assurance for pharmaceu- inform you. We were fortunate to receive more than twice as many session abstracts as we can accommodate in four days; as a result, we, the Program Committee, have selected the Alberto Grignolo, PhD ticals, biologics and medical devices. He leads a worldwide best of the best in our quest for relevance and excellence, and have designed an Annual staff of professional consultants and advises clients in the areas of Meeting that is timely, topical and transforming. drug development strategy, regulatory negotiation and best regu- Dr. Julie Gerberding, Director of the Atlanta-based Centers for Disease Control and Preven- latory practices. tion (CDC) will deliver the Keynote Address. Features this year include nearly 400 regular, Prior to joining PAREXEL, he served as President of FIDIA Pharma- plenary, and tutorial sessions with over 1,000 speakers, and our first multitrack plenary ceutical Corporation and held regulatory positions at SmithKline & session, Drug Safety Reform: Actions and Implications. More than 500 exhibitors will help French Laboratories. Having completed his undergraduate degree at expand our awareness of services and technologies relevant to the interests of DIA members Duke University, he earned his doctorate in Experimental Psychology everywhere. Across 27 Tracks, we have mapped for you such themes as Global Clinical Trials, from the University of North Carolina and conducted postdoctoral Critical Path, Personalized Medicine, and Adaptive Trials/Adaptive Methods to help you identify research in neuropharmacology at Duke University Medical Center. the sessions of greatest interest to you. And for the first time this year, to facilitate your personal scheduling, we have listed all sessions on a website (www.diahome.org) that allows Dr. Grignolo has been an active member of DIA since 1984, served you to click on specific sessions and download their titles, times and locations automatically on the board of DIA from 2000 until 2004, was the Chair of the to your Blackberry or PDA calendar! Throughout, the opportunities for making new friends Regulatory Track of the 2001, 2002 and 2003 DIA Annual Meetings and reconnecting with your established network will abound. and is an Instructor on the DIA Regulatory Training Faculty. He serves on the Graduate Faculty of the Massachusetts College of For the 43rd straight year, the content experts from industry, government and academia from Pharmacy and Health Sciences in Boston as an Adjunct Associate around the world and the phenomenal DIA staff have collaborated diligently to bring you a Professor. timely, relevant and diverse Annual Meeting program. The City of Atlanta, home of CNN, the CDC, the world’s busiest airport, the 1996 Summer Olympic Games, art, culture, glorious A native European who has also lived in Latin America and speaks peaches and innumerable attractions, welcomes you with warm Southern hospitality. four languages, Dr. Grignolo is a frequent speaker, instructor, and participant at international conferences, seminars, workshops and DIA 43rd in Atlanta – a prime number, a prime location! Welcome! courses on drug development, regulatory affairs and good clinical Alberto Grignolo, 2007 Annual Meeting Program Chairperson practice. TABLE OF CONTENTS Keynote Speakers 3 Program Committee DIA is pleased to announce two keynote speakers for the 43rd Annual Meeting Pleanary Session on Monday, June 18 in the Thomas B. Murphy Ballroom. They will 4 Roadmap to the Annual Meeting replace the originally scheduled speaker, Julie Gerberding. 6 Meeting Highlights: Multitrack Plenary Session, Expanded Networking Opportunities, and more Dr. James Canton is a renowned global futurist, social sci- 8 SIAC Events entist, author, and sought-after business advisor. For the past 9 Student Activities twenty-five years, he has been insightfully forecasting the impact 10 General Information of future trends and innovations on business, customers and society. Dr. Canton is Chairman and CEO of the Institute for 12 Getting around Atlanta Global Futures, an internationally-recognized San Francisco- 13 Meeting Schedule by Day and Time based think tank he founded in 1990, to help clients better antic- 24 Meeting Schedule by Interest Area ipate the future. Dr. Canton advises Fortune 1000 corporations Session Descriptions and governments worldwide. A highly sought-after public speak- 36 Saturday, June 16 – Monday, June 18 er, Dr. Canton has spoken to thousands of organizations on five 57 Tuesday, June 19 continents. He is noted for his unique and entertaining ability to blend fascinating forecasts 85 Wednesday, June 20 of trends and breakthroughs that will shape the future. Successful Meetings Magazine named 113 Thursday, June 21 him as one of the top presenters in the nation. 123 Tutorial Instructors 125 Award Winners In January 2006, Bradley A. Perkins, MD, MBA, was 130 Poster Presentations: Students and Professionals named the Acting Chief, Office of Strategy and Innovation (OSI), 132 Speaker Index Office of the Director, Centers for Disease Control and Prevention (CDC). Dr. Perkins has served as the Deputy Director for OSI since 144 Speaker Disclosure Statements May 2004. He joined CDC in 1989 as an Epidemic Intelligence 151 Exhibitor Services Guide Service Officer and has served in such capacities as Chief of the 153 List of Exhibitors Meningitis and Special Pathogens Branch and Associate Director 159 Exhibit Hall Floor Plan for Bioterrorism in the Division of Bacterial and Mycotic Diseases 160 Summaries of Exhibitors’ Services and, most recently, as Deputy Director of the Office of Strategy and Innovation. 2007 Annual Meeting Program Committee ACADEMIC HEALTH CENTERS eCLINICAL PROJECT MANAGEMENT /FINANCE Stanley A. Edlavitch, PhD, MA Charles Jaffe, MD, PhD Martin D. Hynes, III, PhD University of Missouri-Kansas City, USA HL7, USA Eli Lilly and Company, USA Melvyn Greberman, MD, MS, MPH John Sun, PhD, MBA Public Health Resources, LLC, USA GOOD CLINICAL PRACTICES sanofi-aventis, USA Michael R. Hamrell, PhD ADVERTISING MORIAH Consultants, USA PUBLIC POLICY / LAW John C. Marlow, MD Neal Collins, MD Beat E. Widler, PhD Advanstar Communications, Inc., USA Pfizer Inc, USA Roche Products Ltd., UK Peter H. Rheinstein, MD, JD, MS John F. Kamp, JD, PhD IMPACT OF MEDICAL PRODUCTS AND Severn Health Solutions, USA Coalition for Healthcare Communication, USA THERAPIES Wayne L. Pines C. Daniel Mullins, PhD REGULATORY AFFAIRS APCO Worldwide, USA University of Maryland School of Pharmacy, USA Ian Laws GlaxoSmithKline Pharmaceuticals, UK BIOTECHNOLOGY INFORMATION TECHNOLOGY Craig A. Metz, PhD Joy A. Cavagnaro, PhD Paul A. Bleicher, MD, PhD GlaxoSmithKline, USA Access BIO, USA Phase Forward, USA Robert A. Paarlberg, MS Bernard D. “Barney” King, MD, MBA Barbara E. Tardiff, MD, MBA, MS UCB, Inc., USA Macnas Consulting International, USA Merck & Co., Inc., USA Lynne M. Tracey Srinivas Vangala P&G Pharmaceuticals, Inc., USA CHEMISTRY, MANUFACTURING, AND Forest Research Institute, USA CONTROLS / GOOD MANUFACTURING R&D STRATEGY PRACTICES INVESTIGATOR SITES Kenneth I. Kaitin, PhD Chi-wan Chen, PhD Karen E. Woodin, PhD Tufts Center for the Study of Drug FDA, USA JKK Consulting LLC, USA Development, Tufts University, USA Charles P. Hoiberg, PhD STATISTICS Pfizer Inc, USA MARKETING AND SALES Douglas A. Reagan Jerald S. Schindler, DrPH Merck Research Laboratories, USA CLINICAL DATA MANAGEMENT iMetrikus,