PSI Pre-Clinical SIG Webinar: Update from the Carcinogenicity working group

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

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 Webinar: Drug Development in Women's Health

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.

PSI Webinar: Surrogacy

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.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

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.

Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

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.

PSI Career Young Virtual Event (Q2 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI EIWG Webinar: Estimands framework in action, the Alzheimer's disease case

The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.

PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations

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.

PSI Career Young Virtual Event (Q3 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

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.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Speaker	Biography
Steven Bailey Pfizer	Steven Bailey has been supporting Preclinical Drug Safety for 37 years, initially at Wyeth, and more recently at Pfizer. He has provided statistical support and consulting to all areas of drug safety studies, but has particular expertise in carcinogenicity, developmental and reproductive toxicology, juvenile animal studies, and behavioral testing. Steve is a member of a number of Health and Environmental Science Institute (HESI) and International Consortium on Innovation and Quality in the Pharmaceutical Industry (IQ) cross-industry work teams. He has contributed to 2 books on analysis of preclinical animal studies, and has numerous articles to his credit. Steve received a BS in Mathematics and a MS in Statistics from Carnegie-Mellon University. In 2011, Steve was one of the first statisticians in the country to be certified as an 'Accredited Professional Statistician' (PStat) with the American Statistical Association. He is a member of the American Statistical Association and the Teratology Society.

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