Session Proposals

How the Workshop Is Organized

The method of planning and organizing the ASA Biopharmaceutical Section FDA-Industry Statistics Workshop is unique from other conferences as it has a more "grass-roots" style. The workshop was originally a meeting for FDA statisticians that later expanded to include all statisticians interested in statistical practices for all areas regulated by the FDA. Although the workshop has achieved attendance by over 800 statisticians in 2011, it still maintains the same grass-roots approach for its planning. By bringing both FDA and industry speakers into each session, the highly valued original intent of the conference is maintained. The value is enhanced further when academic speakers can be engaged as well as speakers from other regulatory agencies. The end result is the most relevant conference for statistical practitioners in the biopharmaceutical arena.

A successful ASA Biopharmaceutical FDA-Industry Statistics workshop relies heavily on careful planning and hard-working volunteers. The selected Steering Committee members are expected to participate in meetings starting with the kick-off meeting held at the current year workshop (in September) and continuing with teleconferences till February of the following year. The meeting frequency is approximately every other week. It may intensify in January-February time frame depending on the necessary activities in preparation of the face-to-face organizing meeting in February. Several subcommittees will be formed to handle different tasks and support the two co-Chairs, and could involve additional meetings within each subcommittee. In addition, the steering committee members are expected to review session proposals.

Selection of steering committee members is based on a series of factors, including but not limited to the following: balance between affiliations (FDA and industry), balance of levels of experience in similar volunteering and organizational work at this or other conferences/workshops/short courses, broad representation across companies (for industry representatives), variety of areas of interest and technical expertise (CMC, clinical, preclinical, early and late development of drugs, devices, etc.), and strong commitment, including active participation and attendance at steering committee meetings, to do the best for the workshop.

All are welcome to submit a session proposal and are welcome to attend the grass-roots organizing meeting held each year in late January or early February. A steering committee facilitates the organizing meeting by categorizing session proposals into statistical topics. This steering committee may preselect a few highly valued session topics for the workshop program and may remove session proposals not meeting the submission criteria. The majority of the program is then the result of selection by those attending the organizing meeting. The final program results in approved session of the highest quality, that are the most important and most novel.