Joint PSI/EFSPI Vaccine SIG Webinar: Statistical and Mechanistic Models for Correlates of Protection
This webinar will explore two different approaches to Correlates of Protection in vaccine development.
Chair and Discussant: Christine Fletcher, Amgen
Discussant: Andy Grieve, Aptiv Solutions
Speaker: Sara Hughes, GSK
Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach
Co-authors: Karen Wells, Paul McSorley and Andrew Freeman;
Pharmaceutical Statistics, Volume 13, Issue 3, Pages 179-183, May/June 2014
Abstract | Paper+ | Slides
Speaker: Kert Viele, Berry Consultants
Use of historical control data for assessing treatment effects in clinical trials
Co-authors: Scott Berry, Beat Neuenschwander, Billy Amzal, Fang Chen, Nathan Enas, Brian Hobbs, Joseph G. Ibrahim, Nelson Kinnersley, Stacy Lindborg, Sandrine Micallef, Satrajit Roychoudhury and Laura Thompson;
Pharmaceutical Statistics, Volume 13, Issue 1, Pages 41–54, January/February 2014
Abstract
| Paper+ | Slides
+ Papers available to view from 10th July 2014 to 7th August 2014.
For a flier advertising the event, please click here.
This webinar will explore two different approaches to Correlates of Protection in vaccine development.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.