Submit a Session Proposal

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

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

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

(a) Parallel session or town hall
1. Organize up to two sessions or have any other active role in up to two parallel sessions with the following restrictions* (see #2–#5)
2. Chairr† only one session, which can be a session they organized
3. Give a presentation in only one session, but not in a session for which they are serving as chair
4. Serve as a panelist in only one session, which could be in the same session in which they present
5. Serve as a discussant in only one session, but not in the same session in which they present or chair

(b) Roundtable leader
Lead one roundtable discussion

(c) Short course teacher
Teach one short course

Under (a), 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. However, the session’s organizer may serve as a presenter, discussant, panelist, or chair in that session, but not more than one of these roles.

For example, it is possible for the same person to do at most the following: organize one session, be the chair of the session he/she organizes and be the presenter in another session

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

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

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

* Because FDA participants are in high demand, these restrictions may be suspended for FDA participants to ensure FDA presence at the workshop, with approval from the workshop co-chairs.

The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is soliciting proposals for half-day statistical short courses. The content of the short course may involve topics relevant to workshop attendees, including statistical methods, quantitative and data science, career development, regulatory science, and drug development.

The short course proposal should include, but is not limited to, the following:

1. Course Title
2. Name(s) and Address(es) of Confirmed Instructor(s): Email and phone numbers should be included, as well. A contact person should be identified if there are multiple instructors.
3. Abstract: Provide an abstract. A brief course outline could also be included if the submitter thinks it would be helpful in evaluating the proposal.
4. Instructor(s) background: Provide a paragraph highlighting the instructor’s background and experience with the subject, including teaching experience and a short list of related publications, if relevant.

The selection process is competitive, as the venue can accommodate fewer than half the number of submissions we expect to receive. A Workshop Steering Committee sub-team may pre-approve a small number of courses based on the degree of current importance of their topics, their relevance to workshop attendees, and the quality and thoroughness of the abstracts and/or course outlines submitted. Some proposals may be dismissed if not relevant to the workshop or insufficient. However, the selection will largely be based on the ranking of proposals by vote of the full workshop organizing committee early in 2024.

The text portion of your submitted proposal should include a paragraph or two explaining the topic/concept, including a description of why this session would be relevant. Has this topic been presented at conferences before? If yes, why should this material be presented again? Proposals including 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 area.

Names of potential speakers should not be included in the proposal. Any names included in submissions will be stripped prior to voting and may affect the content of the submissions.

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.

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

An important step in maintaining the value of this workshop is additional organizers being assigned to aid every original session proposer to achieve a balance of speakers. This usually results in 3–4 session organizers, some from industry and some from the FDA. Because of these additional session organizers, the original session proposal can evolve while staying true to its specific topic.

The steering committee will sort the session proposals into topic areas and perform complete reviews. The committee may preselect a few outstanding proposals for the final program and reject session proposals not meeting the submission criteria. However, most of the session proposals will be selected via voting. The authors of the proposals up for voting and the preselected proposals will be contacted by the steering committee to participate in the voting. Voting will be done electronically, and only one vote per person will be permitted for any one proposal. The review and voting will follow a blinded process, and any names contained (e.g., organizer, chair, speakers, and panelist) in the submissions will be removed prior to distribution of proposals for voting.