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: fabian.tibaldi@gsk.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.
Vaccines have been playing a critical role in public health through prevention of infectious diseases. An effective vaccine could prevent serious diseases, reduce disease burden on families and communities, or even eradicate diseases (e.g. smallpox). Vaccine research and development have been and will be important in this everchanging world. In developing new vaccines and managing life cycles of existing vaccines, new challenges keep emerging, and innovations are following.
As an integral part of the vaccine development, statisticians also come up with innovations in study designs and analysis methodologies. Speakers from academia, industry and government will share their experiences with some of the following innovations in solving challenges in vaccine development: biomarker assessment (correlates of risk and correlates of protection) especially for first-in-class vaccines; bridging of vaccine efficacy to new settings; multiplicity challenges in multivalent vaccines (multiple serotypes of a pathogen) or due to co-administration with routine vaccines that results in testing of many hypotheses to show non-inferiority of the routine vaccines with vs. without investigational vaccine; evaluation of effects for new serotypes added on top of an existing vaccine; real world data/evidence implementation (e.g. hybrid trial design); application of estimands in vaccine trials to address intercurrent events; and safety assessment/monitoring.
Chair: Josh Chen
Organizers: Frank, Lihan Yan (FDA CBER) and Wenquan Wang (Sanofi)
Potential speakers for the session include, to be confirmed
Dr. Peter Gilbert, Fred Hutch
Dr. Lihan Yan, CBER, FDA
Dr. Judy Pan, Sanofi Pasteur
Dr. Jianing Li, Merck & Co., Inc.
Invited vaccine session at
Organizer: Frank Liu and Jie Chen
Chair: Frank Liu
Abstract:
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.
