The ASA Biopharmaceutical Section recognizes the value of cross-community efforts in advancing statistical and regulatory science. To enable this, the executive committee encourages members to submit research topics that contribute to the goals of advancing the science, enabling innovation, and leveraging the expertise of the broad membership affiliations of the section. Members are encouraged to submit proposals to the Scientific Working Group Proposal Committee for review and if appropriate, subsequent consideration by the section executive committee. The proposal should be formal in nature, so that, if acceptable, it can be used as the basis of a scientific working group charter, and it should include at a minimum the following items as part of a submission (additional information beyond the bulleted items presented here is welcome):
- Topic and primary goal of the scientific working group
- Who is proposing it?
- Why is this an important topic to research (e.g. potential impact)?
- Why is this an appropriate topic for ASA Biopharm Section sponsorship?
- Are there any other known scientific working groups currently addressing this topic? If yes, what unique values will this SWG bring? If yes, please discuss potential opportunity for linkage to another group if other groups already exist. If “don’t know”, please state how you will follow-up to make sure there is not a redundancy in the statistical community.
- Estimate of the initial # of members for the working group, and if any non-statistician consultants will be part of the effort.
- How long will do you anticipate it will take the group to reach its goals?
- Who will chair/co-chair the group? Why is/are this chair (chair/co-chair) being proposed (e.g. qualifications)?
- Is financial support needed from BIOP?
- What will be the best avenues of communication to advertise the efforts, accomplishments, papers, presentations, etc. of this SWG.