Program - International Chinese Statistical Association

ICSA 2010 SYMPOSIUM ROUND TABLE DISCUSSIONS
journals. He has extensive experience in NDA/BLA submissions and FDA interactions, with rich
knowledge in new drug application process and regulatory procedures. He is a member of American
Statistical Association, Drug Information Association, ICSA and SAPA.
Contact information: Brightech International, tomx@brightech-intl.com, 908-790-8888,
www.brightech-intl.com.
Round Table L3: Monitoring Safety During Drug Development
Discussion Leader(s): Dr. Brenda Crowe
Location and Time: Vision, Monday, June 21, 2010, 12:20 p.m.–1:20 p.m.
Abstract: The Safety Planning Evaluation and Reporting Team (SPERT) formed in 2006 by the
Pharmaceutical Research and Manufacturers of America includes industry biostatisticians,
epidemiologists, and safety physicians, as well as representatives from the FDA. Our goal was to
recommend an industry standard for safety planning, data collection, evaluation and reporting. The scope
included new product development programs, from first-in-human studies through planning of postapproval
period. In 2009 SPERT published a manuscript with several important ideas. A chief
recommendation was that sponsors should create a Program Safety Analysis Plan (PSAP) early in
development. We also gave recommendations for the planning of repeated, cumulative meta-analyses of
the safety data obtained from the studies conducted in the development program. These included clear
definitions of adverse events of special interest and standardization of many aspects of data collection and
study design. In this lunch session we will discuss the SPERT recommendations and issues such as ways
that companies can prepare for a potential regulatory expectation that PSAPs will be performed, timing of
PSAPs, analyses that can impact preparedness for a regulatory filing/submission and any other related
topics that arise.
About Discussion Leader(s): Dr. Brenda Crowe is a Research Advisor at Eli Lilly and
Company, where she has worked since obtaining a PhD in Statistics from the University of Toronto in
1997. She has designed and analyzed many clinical trials and observational studies. She currently
provides statistical expertise to Lilly’s Global Patient Safety division. She is a co-chair of the Safety
Planning, Evaluation and Reporting Team (SPERT), a cross-company group whose goal is recommend an
industry standard for safety planning, data collection, evaluation and reporting.
Contact information: Eli Lilly And Company, Lilly Corporate Center, Indianapolis, IN 46285,
bjcrowe@lilly.com, 317-276-3529.
Round Table L4: Biopharmeutical Statistics and Biostatistics Development in China
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