Dr. Chuang-Stein, a Fellow of the American Statistical Association since 1998, is Head of the Statistical Research and Consulting Center at Pfizer. Dr. Chuang-Stein has 22 years of pharmaceutical industry experience. She serves on the editorial boards of Pharmaceutical Statistics, Drug Information Journal (DIJ), and Wiley Encyclopedia of Clinical Trials. Dr. Chuang-Stein, currently an Advisor for the Biostatistics and Data Management Technical Group of the Pharmaceutical Research and Manufacturers of America (PhRMA), was the Group's Chair for years 2003-2004. She continues to serve on several working groups under the auspices of PhRMA. She has over 100 publications, which include 2 books and several book chapters. Dr. Chuang-Stein has been an NIH Special Emphasis Panel member since 1996. She participated in the reviews of grant applications submitted to the National Institute of Allergy and Infectious Diseases, contributing to funding decisions at the national and the international levels.

Prof. D'Agostino is Professor of Mathematics/Statistics and Public Health at Boston University, Director of the Statistics and Consulting Unit and the Executive Director of the MA/PhD Program in Biostatistics at Boston University, Executive Director of Statistics and Data Management at Harvard Clinical Research Institute.

Prof. D'Agostino is a Fellow of the American Statistical Association and the Cardiovascular Epidemiology Council of the American Heart Association. He is a Special Government Employee to the United States' Food and Drug Administration and has been affiliated with the FDA's Center for Drugs Evaluation and Research since 1974 as an Expert Consultant to the Biometrics, Over-the-Counter Drugs, Oncology Drugs, Cardiovascular-Renal Drugs and Gastrointestinal Drugs Divisions. He is also a consultant to the Device Division. Further, he has served on a number of Advisory Committees and was the Chair of the Nonprescriptive Drugs Advisory Committee. He has twice been the recipient of the FDA's Commissioner's Special Citation (1981 and 1995).

Prof. D'Agostino has over 400 publications in peer reviewed journals and is a co-author/editor of eight books: Factor Analysis: An Applied Approach, Goodness-of-Fit Techniques, Mathematical Modeling: Applications in Emergency Health Services, Practical Engineering Statistics, Tutorials in Biostatistics (2 volumes), Introductory Applied Biostatistics and Pharmaceutical Statistics Using SAS.

Prof. D'Agostino has served on the editorial boards of the American Statistician, Journal of the American Statistical Association, Biostatistica, and Statistics in Medicine. Presently, he is an Editor of Statistics in Medicine, Associate Editor of American Journal of Epidemiology and on the editorial board of the Journal of Hypertension, Current Therapeutic Research and Health Services and Outcomes Research Methodology. He is also an Editor of the Wiley Encyclopedia of Clinical Trials.

Dr. Dmitrienko is Research Advisor, Global Statistical Sciences at Eli Lilly and Company. He has worked on early-stage clinical projects in a large number of therapeutic areas and currently serves in a consulting/advisory role with emphasis on innovative approaches in Phase I and Phase II development.

Dr. Dmitrienko has served on several PhRMA working groups (including the statistical QT working group, multiple endpoints expert team, adaptive dose-ranging studies working group and adaptive design working group). He has been actively involved in biostatistical research and authored over 40 papers on statistical sequential analysis, analysis of cardiac safety, multiple comparisons, group-sequential methods and clinical trials.

Dr. Dmitrienko is a co-author/editor of two books: Analysis of Clinical Trials Using SAS: A Practical Guide (written jointly with Geert Molenberghs, Christy Chuang-Stein and Walt Offen) and Pharmaceutical Statistics Using SAS: A Practical Guide (edited jointly with Christy Chuang-Stein and Ralph D'Agostino). He serves on the editorial board of the American Statistician, Statistics in Medicine and the Wiley Encyclopedia of Clinical Trials.

Dr. Ferber studied Mathematics in Stuttgart and Bochum (Germany). Before joining Sandoz Basle in 1984 he spent 10 years at the Medical School in Hannover and was involved in the analysis of the clinical electroencephalogram. At the same time he finished a doctoral thesis in Pattern Recognition at the Faculty of Electrical Engineering of Hannover Technical University.

Since 1990 he has been working as a Statistician with Sandoz, Innovex and later Novartis. He is currently Head of the Basle Neuroscience as well as the Infectious Diseases, Transplantation and Immunology Biostatistics Groups at Novartis. Since 2002 he has also been involved in cardiac safety and has been a member of the PhaRMA QT Statistical Experts Team and the QT ICH statistics group.

Dr. Scott Patterson is Senior Director, Vaccines and Infectious Disease at Wyeth Research and Development. He previously worked as Director of Statistical Science for Cardiovascular and Metabolism Medicine Development at GlaxoSmithKline Pharmaceuticals and Director for Clinical Pharmacology Statistics in Philadelphia at SmithKline Beecham.

He is an expert on the design and statistical analysis of cross-over and clinical pharmacology trials and coauthored the book Bioequivalence and Statistics in Clinical Pharmacology (written jointly with Byron Jones) published by CRC Press, Chapman & Hall. He is an editor for Pharmaceutical Statistics and is a cofounder and past chair of the Pharmacometrics and Biostatistics Section of the American Society of Clinical Pharmacology and Therapeutics. Scott has over 10 years of statistical consulting and collaborative experience in pharmaceutical research and development.

Dr. José Pinheiro is Director of Biostatistics in Clinical Development and Medical Affairs at Novartis Pharmaceuticals, where he has been since October 2001. He currently heads the Statistical Methodology Group in the U.S., which is responsible for internal consulting in biostatistics, leading various innovation projects (e.g., adaptive designs), training, and methodological development. He has been involved in the development and implementation of innovative statistical methods for early and late phase clinical trials across a wide range of therapeutic areas.

Dr. Pinheiro has served as a co-leader of the PhRMA PISC working group on Adaptive Dose Ranging Studies and participated in the PhRMA PISC working group on Adaptive Designs. He has been elected to the Biostatistics and Data Management Technical Group for the triennium 2007-2009. He was the co-chair for the 2006 ENAR meeting of the International Biometric Society, is currently a member of ENAR’s Regional Advisory Board (RAB), and has been elected Secretary of ENAR for the 2007-2009 triennium. He is an associated editor for the Biometrical Journal.

Dr. Pinheiro co-authored a book on the most widely used software in S-PLUS and R for mixed-effects models (Mixed Effects Models in S and S-Plus), six book chapters, and over 35 refereed papers.

Dr. Arne Ring leads the team of Phase I/IIa statistics at Boehringer Ingelheim Pharma, Germany. He received his Masters degree in mathematics and biochemistry, and his PhD in pharmacometrics. His major fields of interest are methodologies around QT interval assessment, bioequivalence, as well as on pharmacodynamic evaluations.

Dr. Frank Shen is Executive Director in Exploratory Development, Global Biometric Sciences at Bristol-Myers Squibb. He joined the pharmaceutical industry in 1989 and worked at Wyeth-Ayerst Research as a Research statistician until 1993. He then joined Biometrics Research group at Merck as a manager. Frank joined Bristol-Myers Squibb (BMS) in 1996 as Associate Director and has progressed with increasing responsibilities since then.

Dr. Shen has been named a Fellow of the American Statistical Association, and elected as the 2004 President of the International Chinese Statistical Association (ICSA). Frank is currently a member of the Clinical Leadership Committee (CLC) of PhRMA and chairs the Biostatistics and Data Management Technical Group under CLC that leads biometric interactions between pharmaceutical industry and the FDA.

Dr. Smith is Biostatistics Senior Manager at Amgen Inc. He currently works in Medical Sciences and his work focuses on early clinical development. He started working in the pharmaceutical industry in 1996 for Eli Lilly and Company. He spent nine years there focusing on clinical pharmacology and Phase 2 trials.

Dr. Smith's interests have focused on statistical methods to improve the quality of clinical pharmacology research. Some particular examples of Dr. Smith's interests include population pharmacokinetics and pharmacodynamics, design and analysis of thorough QT studies, analysis of dose proportionality, and bioequivalence.

Dr. Smith plays an active role with American Society of Clinical Pharmacology and Therapeutics. He is currently an associate editor for Clinical Pharmacology and Therapeutics.

Dr. Wiens is Director, Biometrics, at Gilead Sciences. Prior to joining Gilead, his career included positions at Myogen, Amgen, and Merck. He has been involved in clinical trials for many therapeutic areas including cardiovascular, oncology and infectious diseases. His research interests include noninferiority trials and multiple comparisons.

Dr. Wiens currently serves as Chair of the Biopharmaceutical Section of the American Statistical Association (2007). He also serves on the editorial board of Statistics in Biopharmaceutical Research.