General Information

How the Workshop Is Organized

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 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 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 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.

Details on the Session Approval Process

Organizers submitting similar proposals may be contacted prior to the organizing meeting about possibly merging their ideas into one proposal. Organizers may choose to keep their session proposals separate, but combining sessions with other session organizers may increase the chance of one of them being selected. Note that steering committee members may also submit session proposals but not for topic areas that they are responsible for reviewing.

An important step in maintaining the value of this workshop is that additional organizers are assigned to aid every original session proposer to achieve a balance of speakers. Usually this results in 3-4 session organizers, some of which are from industry and some from the FDA. Because of these additional session organizers, the original session proposal can be expected to evolve somewhat but will still stay true to its specific topic.

A few proposals will be selected as back-up sessions to be included in the final program only if other approved sessions do not come together. Prospective speakers should be notified if their session is a back-up and thus could be canceled.

Guide for Writing Session Proposal

Session Criteria: The text portion of your submitted proposal should include the following: a paragraph or two explaining the topic/concept including a description of why this session would be relevant and important. Has this topic been presented in conferences before? If yes, why should this material be presented again? Proposals that include novel and important information, especially if not previously presented at this workshop, will be given a higher priority for acceptance. Often, several proposals are submitted for popular topic areas, e.g., adaptive designs and oncology. Make your session proposal stand out by describing how it would be different from others in the same general topic.

Names of potential speakers may be included in the proposal even though they need not be contacted. If speakers are contacted about the possibility of speaking, it should be made clear to those contacted that the session has not yet been finalized or accepted; the additional session organizers assigned for the session at the organizing meeting may have suggestions that will result in a more balanced session. So the finalization of the speaker list will be a group effort and prospective speakers should be informed of this.

Please note that a person cannot be both a chair/organizer and a speaker/discussant in the same session. Proposals submitted not following this guideline will still be considered and may be accepted with the expectation that the final session will follow this guideline.

Voting at the Organizing Meeting

After the Steering Committee has sorted the session proposals into topic areas and performed a first round of reviews, the proposals chosen as finalists will be presented at the organizing meeting. The Steering Committee may preselect a few outstanding proposals for the final program and may remove session proposals not meeting the submission criteria. However, the majority of the session proposals will be selected via voting at the organizing meeting.

Only those present at the organizing meeting will vote. Each attendee will be allowed to vote for their 10 favorite session proposals and only one vote per person is permitted for any one proposal.

Tips and Participation Guidelines

When inviting speakers for your session, please keep in mind that parallel sessions are only 75 minutes in length (plenary are 90 minutes). Please plan for no more than 3 speakers for a parallel session, 2 speakers plus a discussant or 2 speakers plus a small panel.

To encourage a wide and diverse set of presenters, the following restrictions will apply. These should be communicated to speakers so that they do not inadvertently accept too many invitations.

Each individual may do any or all of the following activities labeled (a), (b) or (c):

(a) Parallel sessions
1. Organize up to 2 sessions or have any other active role (see below #2-5) in up to 2 parallel sessions:
2. Chair† 1 session and this can be a session they organized
3. Give a presentation in 1 session but not in a session for which they are serving as chair
4. Serve as a panelist in 1 session and this could be in the same session in which they present
5. Serve as a discussant in 1 session but not in the same session in which they present or chair

(b) Roundtable leader
Lead 1 round table luncheon discussion

(c) Short course teacher
Teach 1 short course

Under (a) please note that a person cannot hold multiple roles within one session. For example, one person cannot serve as both the chair and a speaker in the same session. Neither can a person be a discussant and a speaker in the same session. The session's organizer may serve as a presenter, discussant, panelist, or chair in that session, but not more than one of these roles..

The chair is responsible for keeping time for each presentation, for introducing the speakers, and for starting and ending the session on time.

For example, it is possible for the same person to do at most the following: organize 1 session, be the chair of that session he/she organizes and be the presenter in another session, lead 1 roundtable, and teach one short course.

Plenary session: Being a speaker or panelist of a plenary session is considered as a being invited, and therefore exempted from the rules above and it can be done in addition to any of the roles in (a), (b) and (c).

Diversity: To ensure diversity of speakers' affiliation, every session must have at least 1 presenter from industry, and one from the FDA. A speaker from academia is ideal but not required for all sessions. If 2 or more speakers/panelists are from industry, they must be from different companies.

Every session should have 2 organizers from industry/academia and 2 from the FDA. The organizers, the Chair and speakers from industry must not be all from the same company within the same session. One organizer and one speaker or one organizer and the chair of the session can be from the same company within a session.