From Small Data to Big Data, from
RCT to RWE, the Impact of Statistics

September 23–25, 2019
Washington Marriott Wardman Park

Workshop Information

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 2017, 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.

Key Dates

    Attend

  • June 10, 2019
    Conference Registration Opens
  • August 12, 2019
    Advance Conference Registration Closes
  • August 26, 2019
    Hotel Reservations Deadline
  • September 3, 2019
    Registration Cancellation Deadline
  • September 23, 2019 – September 25, 2019
    2018 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
  • Program Participants

  • April 15, 2019 – May 17, 2019
    Invited Abstract Submission Open for Accepted Parallel Sessions
  • August 23, 2019
    Short Course materials due from Instructors