Submit a Proposal

When inviting speakers for your session, please keep in mind that parallel sessions are only 75 minutes in length (plenaries are 90 minutes). Please 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 wide and 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 individual may do any or all of the following activities labeled (a), (b), or (c):

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

(b) Roundtable Leader
Lead one roundtable luncheon 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.

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

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

Plenary Session: Being a speaker or panelist of a plenary session is considered as 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’ affiliation, every session must have at least one presenter from industry and one from the FDA. A 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.

Every session should have two organizers from industry/academia and two from the FDA. The organizer, chair, and speakers from industry must not be 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.

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 and important. Has this topic been presented at 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. 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.

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 also may submit session proposals, but not for topic areas 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. 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 somewhat, while staying true to its specific topic.

After the steering committee has sorted the session proposals into topic areas and performed a first round of reviews, the authors of the proposals chosen as finalists will be contacted by the steering committee for voting. The steering committee may preselect a few outstanding proposals for the final program and remove session proposals not meeting the submission criteria. However, the majority of the session proposals will be selected via voting. Voting will be done electronically, and only one vote per person is permitted for any one proposal.