Broad toxicology profiling takes traditionally place at the interface between discovery and development when a potential drug candidate is selected. However, it would be both time- and cost-wise better if mechanism (target)-related toxicity and compound-chemistry related toxicity is addressed earlier, when discussions on novel drug targets take place and compound series are identified and optimized. As the traditional in-vivo and in-vitro toxicity testing is rather low-throughput, they can’t be used in these early stages of the drug discovery process. Therefore a paradigm shift in toxicity testing needs to take place to move to high-throughput cell-based assays to reveal key pathways and proteins linked with toxicity end points. I will present some explorations and case studies where both transcriptional profiling and imaging techniques are explored to flag early potential toxicity issues already during the drug development process where the findings could still influence the final candidate selection.
About the Presenter: Bie Verbist
Bie Verbiststudied medicinal chemistry at KU Leuven, Belgium and finished PhD in 2005 on the design and synthesis of potential β‐turn mimetics in the group of Prof.Dr.G.Hoornaert. Following this, she started as a post-doc at Johnson & Johnson Pharmaceutical Research and Development in Beerse, Belgium where she was involved in the design, synthesis and validation of new biological entities within the therapeutic areas pain and internal medicine, for three years. Afterwards, she went back to university to follow a one-year MaNaMa in statistical data analysis. In 2011, after a short period of working as a scientific collaborator at Ghent University on qPCR data, she started a second PhD to search for low-frequency variants in viral populations using Illumina deep sequencing technologies under supervision of Prof.Dr. O. Thas and in close collaboration with Johnson & Johnson Pharmaceutical Research and Development in Beerse, Belgium. In 2014, Bie joined Johnson & Johnson as a Principal Biostatistician in the non-clinical statistics department to support oncology projects within discovery with a focus on omics data analysis.
An opportunity to meet statisticians from across the pharmaceutical industry in a relaxed and informal setting. An exciting program of events and a chance to work in small groups on a data analysis challenge. Lunch provided.
A Non-PSI Event - Protecting confidentiality and privacy in clinical trial and medical data sets
We are increasingly living in a data driven world. Data are collected in many different ways for a variety of purposes. As such, concerns around protecting the privacy of individuals have increased in recent times.
A PSI Training Course - Practical Approaches to Designing Adaptive Clinical Trials
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The course will start by providing a general overview of adaptive designs, explaining the different type of adaptations possible and the benefits of each design. Following this, participants will be given the opportunity to have a go at designing trials in R (using RPACTS), EAST, FACTS, and nQuery.
PSI Training Course - Bayesian Practical Course using R and SAS
This practical training course will give a deep dive into performing Bayesian analyses in R and SAS. It is aimed at statisticians who need to be able to conduct Bayesian analyses as part of their day to day work. By the end of the course participants will be able to conduct their own analyses.
This webinar will address operational issues of paramount importance within the healthcare industry with a view to using statistics for the benefit of patients. In attending this webinar, you'll hear more about work being conducted to address some operational issues we face in the health care industrys e.g. patient rectuitment, drug supply and meeting NHS 18 week targets.
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The Toxicology SIG provides a forum for statisticians working in regulatory/investigative toxicology, as well as most other pre-clinical areas, to discuss issues and interact with one another.
This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.
The afternoon of Day 1 will include a 4.5 hour Bayesian training course focused towards applications in toxicology/pre-clinical, provided by Prof. Dr. Katja Ickstadt and is included in the workshop fee.
The cost will be £270 including VAT per delegate, inclusive of food and one night’s accommodation (and the training course). The workshop is being held at the Crowne Plaza Hotel, Heathrow.
The agenda and topics that will be discussed are yet to be finalised, but please get in touch with firstname.lastname@example.org if you have suggestions. Full details will be circulated in the coming weeks.
This course is aimed at Statisticians and Programmers experienced in SAS, but little or no experience with R.
An Introduction to R studio and the R language, statistical graphics, programming statistical models, simulations and more…
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