The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association.
Each year, the conference lasts two days, with invited sessions co-chaired by statisticians from industry, academia, and the FDA. In addition, short courses on related topics are offered the day prior to the workshop.
The method of planning and organizing the ASA Biopharmaceutical Section Regulatory-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 achieved attendance of more than 850 statisticians in 2019, it 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 result is the most relevant conference for statistical practitioners in the biopharmaceutical arena.
A successful ASA Biopharmaceutical Section Regulatory-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 until February of the following year. The meeting frequency is approximately every other week. It may intensify in January–February, 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. This 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 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 participate in the grass-roots organizing meeting held online in mid-February. A steering committee facilitates the categorizing of session proposals into statistical topics. This steering committee may preselect a few highly valued session topics for the workshop program and remove session proposals not meeting the submission criteria. Most of the program is then the result of selection by online voting and scoring by the steering committee. The final program results in approved sessions of the highest quality.