Pre-Clinical SIG (previously TOX SIG)

Core Committee (L-R): Fetene Tekle (Janssen), Gareth Thomas (former member and chair), Bernd Igl (Boehringer Ingelheim), Eloisa Brook (chair, GlaxoSmithKline), Jim Saul (Covance) and Phillip Jarvis (Novartis). Luc Essermeant (Sanofi) and Ezgi Tanriver-Ayder (GlaxoSmithKline) have also recently joined the team.

Objectives

To provide a forum to discuss and advance statistical topics related to Research, Discovery (including efficacy models), Regulatory and Investigative Toxicology/Safety Assessment and to promote the involvement of Statisticians in these areas.

Who we are

Our membership consists of statisticians at CROs, pharmaceutical companies and academia who are working in areas such as:

- Discovery

- Good statistical practice in in-vitro, ex-vivo and in-vivo assay development

- Reproducibility and Translation from pre-clinical to clinical

- Toxicogenomics

- Genetic Toxicology
- Acute Toxicology
- General Toxicology

- Eco-Toxicology
- Toxicokinetics
- DMPK / Pharmacokinetics
- ECG
- Immuno Toxicology
- Histopathology
- Pharmacology
- Developmental and Reproductive Toxicology

- Carcinogenicity

We discuss diverse topics ranging from Dog Telemetry data analysis to Decision Trees, from Bayesian methods to dealing with irate study directors, and now have a list of over 50 affiliates on our e-mail distribution list.

Find out more in our video overview:

Upcoming Events

The PSI Pre-clinical Special Interest Group have a series of regular FREE webinars dealing with statistical topics faced in pre-clinical and related fields. The presentations will run for an hour, with approximately 45 min presentation and a Q&A session in the remaining time. See section below for details of this year’s webinars.

PSI Pre-Clinical workshop is back! This year it will be run virtually, including a training course on Bayesian Statistics for Preclinical Research: New Opportunities.

The workshop will be on Wednesday 21^st September and Thursday 22^nd September 2022 with a training course given by Bruno Boulanger and Brad Carlin from PharmaLex along with presentations on applications of Bayesian methodology given by Marie Miossec from IT&M stat focusing on Bayesian tumor volume analysis with BRMS R package and Helena Geys from Janssen focusing on Bayesian Generalized Frailty Model for Comet Assays.

Key topics covered by the course include:

Define the question and the research objective
Strategies for determining, using, and checking robustness of prior distributions
Replacing experiment-based decisions in favor of project-based decision
Use of informed control groups and unbalanced designs
Design of the overall project, integrating the potential sources of irreproducibility in advance
Progress under uncertainty, adoption of adaptive designs
Designing experiments using Bayesian assurance, rather than power
Understand risks and predictive probability of success to meet the objective
Bayesian incorporation of real world evidence (RWE)
Examples of Bayesian programming using R/STAN/BUGS and SAS

Please note that this event will take place online via Zoom, and has a limited number of places available. For more information and to register for this workshop, please follow this link: PSI Pre-Clinical SIG Workshop 2022 (psiweb.org)

Preclinical SIG

Workshop

We are planning to hold our 10th and first fully virtual 1.5 day workshop on 21/22 September, 2022.

Date	Title	Presenter
21/22 Sept	Workshop including a training course and presentations on the application of Bayesian Methods in Preclinical Environment	Bruno Boulanger, PharmaLex Bradley Carlin, PharmaLex Marie Miossec, IT&M Stats Helena Geys, Janssen	For more information and to register please click here

Webinars

The PSI Pre-Clinical Special Interest Group seminars for 2022 are as follows:

Date	Title	Presenter
12 April	Optimal Experimental Design in Preclinical Dose Response Studies	Dr. Tim Holland-Letz, DKFZ	To access the video on demand, please click here
21 June	Regression to the mean, dilution and bridging studies illustrated in R	Dr. Bernard Francq, GSK	To access the video on demand, please click here
4 October	Therioepistemology: Rethinking how we conduct animal-based experimentation	Dr. Brianna Gaskill, Novartis	To access the video on demand, please click here

How to get in touch

Please email us with any questions or comments and if you would like to join our mailing list.

Upcoming Events

PSI VisSIG Wonderful Wednesday Webinar Series (2023)

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 EIWG Webinar: Proposing Estimands from Different Perspectives

The webinar will build on the concepts and case studies previously discussed. A case study in heart failure will be presented from the perspective of multiple stakeholders.

Apprentice Statistician

As an Apprentice Statistician, you will work as a statistician on clinical trials under supervision, whilst also completing off-the-job training through the University of Strathclyde. You will receive an MSc-equivalent qualification in Medical Statistics.

Head of Hepatology/Gastrointestinal (GI)/ Renal Disease Area Clinical Statistics

This Head of Hepatology/Gastrointestinal (GI)/ Renal Disease Area Clinical Statistics role has a portfolio leadership for groups of statisticians aligned with specific business areas.