Event

Personalised Medicine: Statistics for Companion Diagnostics

PSI Webinar
Personalised Medicine: Statistics for Companion Diagnostics
Date for Webinar: Thursday 4th May. 2-3.30pm UK time

Personalised medicines - which are designed to treat particular groups of patients -  are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.

This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.

CLICK HERE TO VIEW THE FLYER

Speakers:

Meijuan Li, CDRH
Peter Cooper, Qiagen
Rachel Hodge, AstraZeneca

Abstracts:

Meijuan Li (CDRH)

Applications of personalized medicine are becoming increasingly prominent. A companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that FDA can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in drug-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. In this webinar, we will discuss statistical challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.

Peter Cooper (Qiagen)
Perspective from Diagnostic Company

 
Rachel Hodge (Astrazeneca)
Perspective/Case-study from Pharmaceutical Company

To access the recording, please visit the Video-on-Demand Library.

Upcoming Events

PSI VisSIG Wonderful Wednesdays

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.

PSI Book Club

PSI are starting a book club! We will be reading/discussing non-technical books relevant to our roles. Participants will be split into smaller groups to network with each other and practice exercises.

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

PSI Training Course: Use of Historical Data in Clinical Trials: An Evidence Synthesis Approach

In this short course, we will provide a statistical framework to incorporate external information into a trial. Bayesian Dynamic Borrowing designs based on the meta-analytic predictive (MAP) model will be detailed, and a practice session will be proposed with applications using the R package RBesT.

PSI Medical Statistics Careers Event

Our annual PSI Medical Statistics Careers Event, will be held online on Wednesday 2nd March 2022. The event will include a live online panel discussion and a virtual exhibition session.

Latest Jobs

(Senior/Principal) Clinical Data Scientist with focus on early Oncology Statistics (m/w/d)

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices.

Associate Director, Biostatistics, SARC

In this role you will consult in the design of complex and innovative studies and clinical trial programs as well as Leading DMC/DSMB processes.

Associate Director/Director (Supervisor), Statistical Science – Global Medical Affairs/Payer Biometrics

Biometrics at AstraZeneca provides the data that influences decisions on how we roll back the frontiers of science to bring life-changing medicines to the world. We are at the heart of design, decision making, analytics and interpretation.

Principal Biostatistician

Joining us as Principal Biostatistician you will be responsible for providing statistical support of global clinical development programs in neuroscience.