Tammy Massie, FDA, and Carmen Mak, Schering-Plough
The 13th annual FDA/Industry Statistics Workshop is scheduled for September 23–25 at the Capital Hilton in Washington, DC. More than 600 statisticians from academia, industry, and government will gather for lively talks about topics of interest to all. The workshop will feature a day of short courses followed by two days of plenary and concurrent presentations, as well as luncheon discussions on a variety of topics.
Back by popular demand, the following eight short courses will offer practical solutions to real-life problems:
- Adaptive Design, taught by Martin Posch and Sue-Jane Wang
- Data Monitoring Committee, taught by Tom Fleming and Janet Wittes
- Analysis of Longitudinal Data with Missing Data, taught by Diane Fairclough
- Cox Regression in Practice, taught by Brenda Gillespie
- Special Topics in Survival Analysis, taught by Lee-Jen Wei
- Bayesian Adaptive Methods, taught by Peter F. Thall
- Benefits: Risk Assessment, taught by Scott R. Evans
- Bootstrap Methods and Permutation Tests, taught by Tim Hesterberg
Three plenary sessions will focus on regulatory and statistical issues in global harmonization, as well as future directions in safety analysis. Concurrent sessions will cover timely topics in adaptive designs, noninferiority trials, biomarkers, quality of clinical programs, designs of integrated safety and efficacy analysis plans, CMC issues, food safety, device trials, vaccine trials, and veterinary trials.
This year, the luncheon discussions will take place over two days and in a number of rooms, organized by topic. Boxed lunches will be served; workshop participants will be able to pre-select lunch when they register. This will allow participation to be available on a first-come, first-served basis (no pre-selection or sign-up necessary). In addition, roundtables will be smaller—including six to eight people each—to foster better discussion.
A block of rooms at the Capital Hilton has been reserved for workshop attendees. To receive the workshop rate, attendees must book their reservations by August 26. Up-to-date information, including the preliminary workshop programs and luncheon discussion topics, can be found here.
The FDA/Industry Statistics Workshop—sponsored by the Biopharmaceutical Section of the American Statistical Association, with cooperation from the Food and Drug Administration Statistical Association—is a unique forum for statisticians to network and discuss topics of mutual interest. The topics are always relevant and the discussions practical. The organizing committee looks forward to seeing you in September.
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