Medical Statistics Careers Event 2020
Our annual PSI Medical Statistics Careers Event, will be held at the De Montfort University in Leicester on Wednesday 4th March 2020.
If you have an interest in being involved in this SIG, or have an interesting case study or experience to share please contact Fabian Tibaldi (email: email@example.com)
Special issue of the Statistics in Biopharmaceutical Research dedicated to Vaccines and Biologics
The editorial board of the Statistics in Biopharmaceutical Research (SBR) journal plans to publish a special issue on Vaccines and Biologics. The special issue is motivated by the recognition that there are many unique statistical issues and challenges in vaccines and biologics development arising from the complex biological nature of these two classes of therapeutic products . The special issue seeks to publish high quality manuscripts focused on innovative approaches and reviews related to the statistical design, modeling and analysis of clinical and nonclinical studies of vaccines and biologics. Innovative statistical designs in clinical trials, statistical approaches to biosimilarity, especially as relating to regulatory considerations and reviews of the literature are especially welcome, although a broad range of statistical topics is anticipated.
Timelines and submission instructions for the special Vaccines and Biologics issue of the SBR:
1. The window for submission will be November 1, 2019 – June 30, 2019. Submissions are made through the SBR portal.
2. At the time of the submission of the manuscript, authors are asked to check the VB2019 selection box at Step 1 on the submission page, so the manuscript will be designated for the 2019 Vaccines and Biologics special issue.
3. Manuscripts will go through the standard SBR refereeing process.
4. Goal is to have a set of papers ready for publication in late 2020.
We appreciate your consideration and contributions to make the special issue of the SBR a showcase for cutting edge statistical methods and applications on vaccines and biologics.
Invited vaccine session at
Organizer: Frank Liu and Jie Chen
Chair: Frank Liu
Because of biological nature, there are many unique statistical issues and challenges in vaccine development. Some examples are: the rigorous safety requirement because vaccines are to be administrated to millions of healthy individuals; large studies needed to demonstrate efficacy due to low incidence rate of disease and strict requirement on a positive lower bound to show adequate efficacy; identifying and using biomarkers based on correlates of protection; dealing with uncertainty of event rates; and non-inferiority and lot consistency trials. In this session, speakers from industry and academia will talk about some of those unique features and challenges in design and analysis of vaccine trials, and share advances in statistical methods for handling the issues.
Invited speakers and tentative titles:
Discussant: Wenquan Wang, Sanofi Pasteur, Swiftwater, PA, USA.