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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK