Program - International Chinese Statistical Association

ICSA 2010 SYMPOSIUM KEYNOTE SPEECHES
Vitro Diagnostic Multivariate Index Assays (IVDMIAs) is also discussed. A second statistical challenge
is that of design: how can diagnostic tests and therapeutic products be co-developed. Statistical designs
that allow for adaptation or for the use of retrospective data in a scientifically valid manner are discussed.
Bayesian designs are also mentioned. A third statistical challenge is the analysis of data from such trials
and particularly the issues of multiplicity and of missing data. Several drug-diagnostic examples are
reviewed and a number of clinical trials are discussed. The implications for the future of individualized
medicine are enormous and it is clear that an interdisciplinary effort involving statistics, bioinformatics
and biology will be crucial in unlocking the promise of personalized medicine.
About the Speaker: Dr. Gregory Campbell is the Director of the Division of Biostatistics in the
Office of Surveillance and Biometrics (OSB) of Center for Devices and Radiological Health (CDRH) of
the Food and Drug Administration (FDA) since he came to FDA in 1995. With a B.S. in Mathematics
from the University of Dayton and M.S. in Mathematics from Michigan State University, he received a
Ph.D. in Mathematical Statistics from Florida State University. After serving on the faculty in the
Department of Statistics at Purdue University, he joined the National Institutes of Health, where he
became a tenured intramural research scientist, Acting Chief for the Laboratory of Statistical and
Mathematical Methodology, and Chief of the Analytical Biometrics Section. Dr. Campbell currently
leads a group of about 55 statisticians at the FDA that provides statistical support to CDRH as a whole
and, in particular, the statistical reviews of FDA’s pre-market device submissions. With the help of
statisticians in his Division, he pioneered the implementation in a regulatory environment of Bayesian
statistics (and more recently causal inference). His current research interests include the evaluation of
diagnostic tests especially using Receiver Operating Characteristic methodology as well as statistical
issues in clinical trials, with a more recent focus on microarrays. He serves as Associate Editor for
Statistics in Pharmaceutical Research and Journal of Biopharmaceutical Statistics. He has been the
recipient of the FDA’s Commendable Service Award, Award of Merit and Outstanding Service Award as
well as the CDRH Outstanding Scientific Award for Excellence in Analytical Science. He is a Fellow of
the American Statistical Association. He has been a member since 1998 of the Senior Biomedical
Research Service in the Department of Health and Human Services. He has served in leadership
positions for the Eastern North American Region of the International Biometric Society and on the Board
of Directors of the Society for Clinical Trials.
Banquet Keynote Speech: Statistics: a critical pharma--academic interface
Speaker: Dr. William W. Chin, Harvard Medical School
Location and Time: On Time Seafood Restaurant, Tuesday, June 22, 6:30 p.m.–9:00 p.m.
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