MCP-Mod (Multiple Comparisons & Modelling) is a popular statistical methodology for model-based design and analysis of dose finding studies. This webinar will describe the theory behind MCP-Mod (plus extensions), and how to implement it within available software. Pantelis Vlachos (Cytel) will provide a brief introduction to the methodology and illustrate the MCP-MoD capabilities in EAST 6.5. Saswati Saha (Inserm, Aix-Marseille University) will discuss new variations and alternatives to MCP-Mod and show how to implement them in R. Neal Thomas (Pfizer) will present further technical details of MCP-Mod by evaluating the method using results from least squares linear model theory.

Our next journal club is the inaugural PhD webinar, where we will share 4 topics with you from 4 PhD students. Our format will be slightly changed, with each student presenting for 10 minutes, followed by 5 minutes of discussion.

In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.

PSI are pleased to announce that the countdown to the 2019 Conference has begun! The theme for the conference is “Data Driven Decision Making in Medical Research”. The 2019 PSI Conference will take place at the Queen Elizabeth II Centre (QEII), London, from 2nd to 5th June 2019.

Based on the MHRA experience from hundreds of scientific advice meetings with industry and contributions to CHMP scientific advice, this one-day course will provide valuable insights to the most talked about methodological challenges facing applicants.

The in vivo Pig-a gene mutation assay is based on the endogenous X-linked Pig-a gene (phosphatidylinositol N-acetylglucosaminyltransferase, subunit A).

The course will focus on the practical implementation of the background and practicalities of Bayesian design, analysis and reporting and will not go into deep statistical methodology or software coding. Examples and practical exercises are used throughout to aid understanding and interaction. References will be to give the attendee links to the statistical formulae and other reading.

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 2019 to July 2020 to learn about 6 topics from experts in their field. The ITIT course will have 3 sessions in continental Europe and 3 sessions in the UK. It promises to be a truly memorable course.