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KEYNOTE SPEECHES ICSA 2010 SYMPOSIUM About the Speaker: Dr. William W. Chin was born in New York, and received his A.B. in chemistry summa cum laude from Columbia College and his medical degree from Harvard Medical School. He then completed a residency in internal medicine at the Beth Israel Hospital and a fellowship in endocrinology and metabolism at the Massachusetts General Hospital, Boston, Massachusetts. Dr. Chin served on the faculty of Harvard Medical School for 25 years and was professor of medicine, and professor of obstetrics, gynecology and reproductive biology at Harvard Medical School; investigator of the Howard Hughes Medical Institute; and chief of the division of genetics and senior physician at the Brigham and Women's Hospital, Boston. Dr. Chin then joined Eli Lilly and Company in 1999, and served most recently as senior vice president of discovery research and clinical investigation, with overall responsibilities for the therapeutic areas, chemistry, toxicology, ADME and early clinical development. He serves as a member of the company’s senior management council. He previously was vice president of discovery biology research and clinical investigation. In 2010, he returned to academia as the Executive Dean for Research and Professor of Medicine at Harvard Medical School. Dr. Chin is a world-renowned molecular endocrinologist who has pioneered the understanding of the mechanisms of nuclear receptor action with a focus on thyroid, estrogen, and other hormones, as well as various aspects of hormonal regulation of pituitary hormone gene expression. As the leader of the genetics program at the Brigham and Women's Hospital, he was responsible for the establishment of genomics, bioinformatics, and clinical genetics in the practice of medicine. He is author or co-author of more than 270 original papers, invited chapters or books, and he has served on numerous editorial boards and private and governmental review panels. He has received many accolades, including the Robert H. Williams Distinguished Leadership Award from the Endocrine Society, the Sidney H. Ingbar and Van Meter Awards from the American Thyroid Association, the Bowditch Award from the American Physiological Society, and the AFCR Young Investigator Award, and election to the American Society for Clinical Investigation and the American Association of Physicians. Dr. Chin has been a member of the board of scientific counselors of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), and chair of the NIH endocrinology study section. He has also provided leadership on the council of several key professional societies, including service as president of the American Thyroid Association and the Interurban Clinical Club. Dr. Chin is a member of the Board of Directors at the Indianapolis Museum of Art and the Indianapolis Prize [the largest monetary prize for wildlife conservation in the world] Jury. He has also been an overseer of the New England Conservatory of Music and a co-chair of Project Success, a science program for underprivileged secondary students in Boston. 38
ICSA 2010 SYMPOSIUM ROUND TABLE DISCUSSIONS ROUND TABLE DISCUSSIONS Round Table L1: Implementation Issues of Adaptive Design Clinical Trials Discussion Leader(s): Dr. Cyrus Mehta, Dr. Jason Connor Location and Time: Vision, Monday, June 21, 2010, 12:20 p.m.–1:20 p.m. Abstract: In this roundtable we discuss benefits and challenges of adaptive designs. Regulatory agencies are increasingly amenable to adaptive designs and Berry Consultants and Cytel both have extensive experience in working with pharmaceutical and medical device companies in designing adaptive clinical trials within the regulatory setting. This entails creating flexible, prospectively adaptive trials that also maintain statistical integrity. Depending upon the interests of participants we will discuss our experiences with adaptive designs, their benefits, the additional infrastructure they require, and our interactions with regulators (e.g. FDA, EMEA) regarding adaptive designs. About Discussion Leader(s): Dr. Cyrus Mehta was born in Bombay, India. He studied engineering at the Indian Institute of Technology, Bombay and obtained his Ph.D. from MIT in 1973. Dr. Mehta is President and co-founder of Cytel Corporation and Adjunct Professor of Biostatistics, Harvard University. Cytel is a leading provider of software and services for the design, interim monitoring and implementation of adaptive clinical trials. Dr. Mehta consults extensively with the biopharmaceutical industry on group sequential and adaptive design, offers workshops on these topics, and sits on several data monitoring committees for these types of clinical trials. He has led the development of the StatXact, LogXact and East software packages that are widely used in the biopharmaceutical industry and at academic research centers. He publishes his methodological research results in leading statistics journals and is a past co-winner of the George W. Snedecor Award from the American Statistical Association for the best paper in biometry. He was elected a Fellow of the American Statistical Association in 1995 and named the Mosteller Statistician of the Year by the Massachusetts Chapter of the American Statistical Association in 2000. In 2002, Dr. Mehta was named Outstanding Zoroastrian Entrepreneur by the World Zoroastrian Chamber of Commerce. Dr. Mehta is the Zoroastrian Chaplain at Harvard and MIT. Contact information: Cytel Inc. 675 Massachusetts Avenue, Cambridge, MA 02139, mehta@cytel.com, 617-661-2011, www.cytel.com. Dr. Jason Connor received his PhD in Statistics & Public Policy from Carnegie Mellon University and his BS in Biomedical Engineering from Texas A&M University. He is uniquely trained as a biomedical engineer and a Bayesian biostatistician. Dr. Connor has worked for Berry Consultants since 2006 designing Bayesian adaptive trials for clients from a wide range of pharmaceutical and medical device 39
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