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Submit a Session Proposal

Parallel Session, Short Course, and Town Hall Proposal Submissions – CLOSED
November 17 – December 21, 2020

This year, up to 10 half-day short courses will be available at the workshop, though full-day short courses may be considered.


Workshop Guidelines

When inviting speakers for your session, please keep in mind that parallel sessions are only 75 minutes in length (plenary 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 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 #2–#5) in up to two parallel sessions
2. Chair† one session, which 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, which could 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 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, lead one roundtable, and teach one short course.

† 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 exempted 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 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.

Short Course Proposals Submission Guidelines

The ASA 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 and a brief course outline could be included if the submitter feels 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 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 its topic, its relevance to workshop attendees, and the quality and thoroughness of the abstract and/or course outline submitted. Some proposals may be dismissed if not relevant to the workshop or the proposal is insufficient. However, the selection will largely be based on the ranking of proposals by vote of the full workshop Organizing Committee early in 2021.

Tips for Writing a Proposal

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 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.

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.

Parallel Session Approval Process and Voting

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.

The steering committee will sort the session proposals into topic areas and perform a first round of reviews. They may preselect a few outstanding proposals for the final program and remove 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 is permitted for any one proposal.

Parallel Session Topic Categories
Bayesian Methods in Clinical Trials   Master Protocols
Big Data (including machine learning, AI, digital health)   Missing Data
Biomarkers (PK/PD, prognostic, predictive, etc.)   Modeling and Simulation (e.g., microsimulation, causal inference, covariate adjustment)
Chemistry, Manufacturing, and Controls   Multiplicity (subgroup analysis, etc.)
Complex and Innovative Study Designs (adaptive design, pragmatic trials, etc.)   Noninferiority, Bioequivalence, and Biosimilars
COVID-19 (treatment, vaccine, diagnostic, medical device, impact on trials, etc.)   Oncology
Decision Analysis (go/no-go, benefit-risk, patient preference, etc.)   Other
Development of Gene Therapies   Precision Medicine
Diagnostics and Medical Devices   Real-World Evidence
DSMB/Interim Analysis/Advisory Committee   Safety
Early-Phase/Pre-Clinical Trials   Small Populations (rare disease, orphan drug, pediatric, etc.)
Endpoints (novel, surrogate, composite, etc.)   Statistical Leadership and Effective Communication
Estimands   Time-to-Event Analysis
Evidence Synthesis (meta-analysis, historical control, etc.)   Vaccines
Innovations in Animal Drug Development    
Townhall Sessions

A townhall is a parallel session encompassing a topic of broad interest in which a substantial portion of time is allotted to audience participation in a relaxed and informal atmosphere. These sessions were created in response to roundtable luncheon topics being too popular to accommodate their demand. The townhall option permits a large number of people to participate.

Typically, a townhall is in a panel format. Panelists first give brief remarks about the topic and then answer questions by the audience in an open forum. A good moderator is necessary for a successful townhall.

A townhall proposal competes with other parallel session proposals for acceptance onto the program. Because it is a parallel session, a townhall is assigned to one of the timeslots allotted to parallel sessions.

Key Dates

    Attend

  • June 15, 2021
    Conference Early Registration Opens
  • August 16, 2021
    Early Conference Registration Closes
  • August 30, 2021
    Housing Deadline
  • September 2, 2021
    Registration Cancellation Deadline
  • September 21, 2021 – September 23, 2021
    2020 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
  • Program Participants

  • April 16, 2021 – May 20, 2021
    Invited Abstract Submission Open for Accepted Parallel Sessions
  • May 25, 2021 – June 10, 2021
    Session Editing
  • July 7, 2021 – August 25, 2021
    Abstract Editing
  • July 16, 2021
    Speaker/Participant Registration Deadline
  • August 23, 2021
    Short Course materials due from Instructors