Program - International Chinese Statistical Association

ICSA 2010 SYMPOSIUM ROUND TABLE DISCUSSIONS
Round Table L5: Effective Communications Between Industry and FDA
Discussion Leader(s): Dr. Suktae Choi, Dr. James Hung
Location and Time: Vision, Monday, June 21, 2010, 12:20 p.m.–1:20 p.m.
Abstract: Effective communication between pharmaceutical companies and regulatory agencies,
such as the Food and Drug Administration (FDA), is a key factor in the process of drug development and
also for regulatory reviewers. Communication is done by many ways including briefing documents, faceto-face
or telecom meetings, and written communications (e.g. fax and email). Recently, the role of
statistical methodology in clinical trials has increased greatly. Thus, communication between statisticians
in the pharmaceutical industry and those at the FDA has become more important. Many statisticians in the
pharmaceutical industry are eager to exchange ideas with statisticians at the FDA. However, appropriate
ways of communication are not obvious. During this lunch meeting, each participant will share examples
and perspectives on communication between the pharmaceutical industry and the FDA.
About Discussion Leader(s): Dr. Suktae Choi has 12 years experience in the clinical trial area
beginning with his employment as a project statistician of Organon, Inc. In 2000, he moved into Center
for Drug Evaluation and Research, US FDA as Mathematical Statistician. During 7+ years with the FDA,
he reviewed many clinical trials in analgesic, arthritis, ophthalmic, and anti-viral area submitted for
approval of drug indication. He joined Eli-Lilly and Company in 2007 as Sr. Research Scientist, and
currently leader of Byetta statistics group. The research areas that he is interested in are multivariate
survival analyses, multiple comparisons, and missing data imputations. He published statistical articles in
statistics and medical journals and presented in public. He received Master’s degree of Statistics from
Michigan State University, and also received Ph.D. degree of Statistics from Rutgers University in 1998.
Contact information: Eli Lilly and Company, Lilly Corporate Center Indianapolis, IN 46285,
CHOI_SUKTAE@LILLY.COM, 317-655-9104.
Dr. James Hung is presently Director of Division of Biometrics I, Office of Biostatistics, Office of
Translational Sciences, Center for Drug Evaluation and Research, US FDA. The division provides
services for Division of Cardiovascular and Renal Products, Division of Neurology Products and Division
of Psychiatry Products. During his 20+ year tenure with FDA, he reviewed many large
mortality/morbidity clinical trials in cardiovascular and renal disease areas. He published articles in
Biometrics, Statistics in Medicine, Controlled Clinical Trials, Biometrical Journal, Journal of
Biopharmaceutical Statistics. His research areas include factorial design clinical trials, utility of p-value
distribution, adaptive design/analysis in clinical trials, and non-inferiority trials, multi-regional clinical
trials. Dr. Hung received two FDA/CDER Scientific Achievement Awards and many other awards for the
recognition of his scientific contributions to the US FDA. He gave many invited talks, lectures or short
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