Vaccines SIG

Objectives

  • To create a professional platform for statisticians in the Pharmaceutical industry, Regulatory agencies and Public Health organizations working on the research and development of vaccines to understand how best to apply methodologies.
  • To keep up-to-date, discuss, apply and encourage relevant statistical and methodological developments. 
  • To encourage professional development. 
  • To organise (web)seminars and sessions in worldwide conferences on topics related to methodological developments in vaccines research.

Who we are

  • Holly Janes, Fred Hutchinson Cancer Research Center, USA.
  • An Vandebosch, Johnson & Johnson, Belgium
  • David Radley, Pfizer, USA.
  • Fabian Tibaldi, GlaxoSmithKline Vaccines, Belgium.
  • Frank Liu,Merck Sharp & Dohme corp., USA
  • Tsai-Lien Lin, FDA, USA.
  • Scott Patterson, Sanofi Pasteur, USA.
  • Fabrice Bailleux, Sanofi Pasteur, France
  • Larry Moulton, Johns Hopkins Bloomberg School of Public Health, USA

How to get in touch

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)

Latest News

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.

Upcoming Events

Invited vaccine session at

ISBS, Kyoto, Japan, August 26-30, 2019.

Statistical Issues and Methods for Vaccine Development

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:

  1. Holly Janes, Fred Hutch, Seattle, WA, USA,  “Potential HIV vaccine efficacy trial designs in the era of an expanding portfolio of non-vaccine HIV prevention strategies”
  2. Jing Jin, Sanofi, Beijing, China, “Immune correlates analysis of tetravalent dengue vaccine efficacy trials”
  3. Wenji Pu, GSK, Rockville, MD, USA, “Application of Bayesian Statistics in Vaccine Clinical Trials”
  4. Bart Spiessens, Janssen, Belgium, “Statistical challenges of an immune-bridging approach to assess clinical benefit as the basis for licensure of a prophylactic Ebola vaccine”

Discussant: Wenquan Wang, Sanofi Pasteur, Swiftwater, PA, USA.

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Upcoming Events

PSI New Starters Half-Day Networking Event

An opportunity to meet statisticians from across the pharmaceutical industry in a relaxed and informal setting. An exciting program of events and a chance to work in small groups on a data analysis challenge. Lunch provided.

A Non-PSI Event - Protecting confidentiality and privacy in clinical trial and medical data sets

We are increasingly living in a data driven world. Data are collected in many different ways for a variety of purposes. As such, concerns around protecting the privacy of individuals have increased in recent times.

A PSI Training Course - Practical Approaches to Designing Adaptive Clinical Trials

This hands-on course will provide a deep dive into 4 software packages used to design adaptive clinical trials. The course will start by providing a general overview of adaptive designs, explaining the different type of adaptations possible and the benefits of each design. Following this, participants will be given the opportunity to have a go at designing trials in R (using RPACTS), EAST, FACTS, and nQuery.

PSI Training Course - Bayesian Practical Course using R and SAS

This practical training course will give a deep dive into performing Bayesian analyses in R and SAS. It is aimed at statisticians who need to be able to conduct Bayesian analyses as part of their day to day work. By the end of the course participants will be able to conduct their own analyses.

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.

PSI Webinar - Statistical Operations Research

This webinar will address operational issues of paramount importance within the healthcare industry with a view to using statistics for the benefit of patients. In attending this webinar, you'll hear more about work being conducted to address some operational issues we face in the health care industrys e.g. patient rectuitment, drug supply and meeting NHS 18 week targets.

PSI Toxicology SIG Workshop

PSI Toxicology SIG workshop – 16th and 17th March 2020 The Toxicology SIG provides a forum for statisticians working in regulatory/investigative toxicology, as well as most other pre-clinical areas, to discuss issues and interact with one another. This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types. The afternoon of Day 1 will include a 4.5 hour Bayesian training course focused towards applications in toxicology/pre-clinical, provided by Prof. Dr. Katja Ickstadt and is included in the workshop fee. The cost will be £270 including VAT per delegate, inclusive of food and one night’s accommodation (and the training course). The workshop is being held at the Crowne Plaza Hotel, Heathrow. The agenda and topics that will be discussed are yet to be finalised, but please get in touch with gareth.thomas@covance.com if you have suggestions. Full details will be circulated in the coming weeks.

A PSI Training Course - R for SAS Users

This course is aimed at Statisticians and Programmers experienced in SAS, but little or no experience with R. An Introduction to R studio and the R language, statistical graphics, programming statistical models, simulations and more…

Non-proportional hazards and applications in immuno-oncology

Designs of clinical trials with time to event primary endpoints usually rely on hazards being constant over time. A major challenge in immuno-oncology is the delayed onset of benefit with such therapies and the presence of non-proportional hazards. The impact of this needs to be accounted for in sample size calculations, analysis methodology and reporting. At this meeting, we will examine possible strategies to handle such features, which may not be fully known when the trial is initiated.

Introduction To Industry Training Course 2020

The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies from October 2020 to July 2021 to learn about 6 topics from experts in their field. The ITIT course will have 6 sessions in continental Europe and 3 - 4 sessions in the UK. It promises to be a truly memorable course.

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