Date: Wednesday 25th November 2020 Time: 14:00 - 15:00 GMT Speakers: Graham Healey (Oncimmune) and Dea Putri (Janssen)
Who is this event intended for? Anybody involved in the development and deployment of biomarkers in pharmaceutical or diagnostic areas.
What is the benefit of attending? To gain an appreciation of the range of issues at the non-clinical end.
Registration
You can now register for this event. Registration will close at 12:00 on 24th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
The deployment of biomarkers in drug development and diagnostics has many challenges ranging from analytical validation, in vivo study design, to the translation to human utility and financial considerations. In this Webinar focus will be given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way will be discussed.
Speakers
Speaker: Graham Healey
Biography: Graham has 40 years experience in supporting R&D in the pharmaceutical and diagnostics industries, particularly in the areas of discovery, toxicology, assay validation and clinical trials. After graduating in Zoology from Imperial College, he then converted to full-time statistics via the MSc Biometry course at Reading. After a year lecturing at Bunda Agricultural College deep in the Malawian bush, he joined the biotech division of G.D.Searle UK, working on interferon and aspartame. Next came six years at Searle's R&D site in Belgium followed by 16 years as Head of Statistics at HLS in UK, working in a vast array of preclinical, toxicology and clinical areas. He is currently Chief Statistician at Oncimmune Ltd, involved in all stages of the commercialisation of blood tests for the early detection of cancer, from laboratory bench to doctor’s surgery. In his spare time his main passions are classical music and insects.
Speaker: Dea Putri
Biography: Right after graduating from her master study in biostatistics at Hasselt University, Belgium, Dea directly joined the discovery statistics at Janssen Pharmaceutica in 2015 as biostatistician. In this role, Dea closely collaborates with other statisticians as well as scientist from different therapeutic area to provide solutions from day to day business needs to a more specific cases which need tailor-made analysis. Dea is building her expertise in high dimensional data integration on pre-clinical as well as clinical studies. At the moment, Dea is also finishing her doctoral school at Hasselt University under supervision of Prof. Ziv Shkedy and Prof. Luc Bijnens with research topic related to statistical method development for the design and statistical analysis of high dimensional data integration.
Date: Wednesday 25th November 2020 Time: 14:00 - 15:00 GMT Speakers: Graham Healey (Oncimmune) and Dea Putri (Janssen)
Who is this event intended for? Anybody involved in the development and deployment of biomarkers in pharmaceutical or diagnostic areas.
What is the benefit of attending? To gain an appreciation of the range of issues at the non-clinical end.
Registration
You can now register for this event. Registration will close at 12:00 on 24th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
The deployment of biomarkers in drug development and diagnostics has many challenges ranging from analytical validation, in vivo study design, to the translation to human utility and financial considerations. In this Webinar focus will be given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way will be discussed.
Speakers
Speaker: Graham Healey
Biography: Graham has 40 years experience in supporting R&D in the pharmaceutical and diagnostics industries, particularly in the areas of discovery, toxicology, assay validation and clinical trials. After graduating in Zoology from Imperial College, he then converted to full-time statistics via the MSc Biometry course at Reading. After a year lecturing at Bunda Agricultural College deep in the Malawian bush, he joined the biotech division of G.D.Searle UK, working on interferon and aspartame. Next came six years at Searle's R&D site in Belgium followed by 16 years as Head of Statistics at HLS in UK, working in a vast array of preclinical, toxicology and clinical areas. He is currently Chief Statistician at Oncimmune Ltd, involved in all stages of the commercialisation of blood tests for the early detection of cancer, from laboratory bench to doctor’s surgery. In his spare time his main passions are classical music and insects.
Speaker: Dea Putri
Biography: Right after graduating from her master study in biostatistics at Hasselt University, Belgium, Dea directly joined the discovery statistics at Janssen Pharmaceutica in 2015 as biostatistician. In this role, Dea closely collaborates with other statisticians as well as scientist from different therapeutic area to provide solutions from day to day business needs to a more specific cases which need tailor-made analysis. Dea is building her expertise in high dimensional data integration on pre-clinical as well as clinical studies. At the moment, Dea is also finishing her doctoral school at Hasselt University under supervision of Prof. Ziv Shkedy and Prof. Luc Bijnens with research topic related to statistical method development for the design and statistical analysis of high dimensional data integration.
Date: Wednesday 25th November 2020 Time: 14:00 - 15:00 GMT Speakers: Graham Healey (Oncimmune) and Dea Putri (Janssen)
Who is this event intended for? Anybody involved in the development and deployment of biomarkers in pharmaceutical or diagnostic areas.
What is the benefit of attending? To gain an appreciation of the range of issues at the non-clinical end.
Registration
You can now register for this event. Registration will close at 12:00 on 24th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
The deployment of biomarkers in drug development and diagnostics has many challenges ranging from analytical validation, in vivo study design, to the translation to human utility and financial considerations. In this Webinar focus will be given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way will be discussed.
Speakers
Speaker: Graham Healey
Biography: Graham has 40 years experience in supporting R&D in the pharmaceutical and diagnostics industries, particularly in the areas of discovery, toxicology, assay validation and clinical trials. After graduating in Zoology from Imperial College, he then converted to full-time statistics via the MSc Biometry course at Reading. After a year lecturing at Bunda Agricultural College deep in the Malawian bush, he joined the biotech division of G.D.Searle UK, working on interferon and aspartame. Next came six years at Searle's R&D site in Belgium followed by 16 years as Head of Statistics at HLS in UK, working in a vast array of preclinical, toxicology and clinical areas. He is currently Chief Statistician at Oncimmune Ltd, involved in all stages of the commercialisation of blood tests for the early detection of cancer, from laboratory bench to doctor’s surgery. In his spare time his main passions are classical music and insects.
Speaker: Dea Putri
Biography: Right after graduating from her master study in biostatistics at Hasselt University, Belgium, Dea directly joined the discovery statistics at Janssen Pharmaceutica in 2015 as biostatistician. In this role, Dea closely collaborates with other statisticians as well as scientist from different therapeutic area to provide solutions from day to day business needs to a more specific cases which need tailor-made analysis. Dea is building her expertise in high dimensional data integration on pre-clinical as well as clinical studies. At the moment, Dea is also finishing her doctoral school at Hasselt University under supervision of Prof. Ziv Shkedy and Prof. Luc Bijnens with research topic related to statistical method development for the design and statistical analysis of high dimensional data integration.
Date: Wednesday 25th November 2020 Time: 14:00 - 15:00 GMT Speakers: Graham Healey (Oncimmune) and Dea Putri (Janssen)
Who is this event intended for? Anybody involved in the development and deployment of biomarkers in pharmaceutical or diagnostic areas.
What is the benefit of attending? To gain an appreciation of the range of issues at the non-clinical end.
Registration
You can now register for this event. Registration will close at 12:00 on 24th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
The deployment of biomarkers in drug development and diagnostics has many challenges ranging from analytical validation, in vivo study design, to the translation to human utility and financial considerations. In this Webinar focus will be given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way will be discussed.
Speakers
Speaker: Graham Healey
Biography: Graham has 40 years experience in supporting R&D in the pharmaceutical and diagnostics industries, particularly in the areas of discovery, toxicology, assay validation and clinical trials. After graduating in Zoology from Imperial College, he then converted to full-time statistics via the MSc Biometry course at Reading. After a year lecturing at Bunda Agricultural College deep in the Malawian bush, he joined the biotech division of G.D.Searle UK, working on interferon and aspartame. Next came six years at Searle's R&D site in Belgium followed by 16 years as Head of Statistics at HLS in UK, working in a vast array of preclinical, toxicology and clinical areas. He is currently Chief Statistician at Oncimmune Ltd, involved in all stages of the commercialisation of blood tests for the early detection of cancer, from laboratory bench to doctor’s surgery. In his spare time his main passions are classical music and insects.
Speaker: Dea Putri
Biography: Right after graduating from her master study in biostatistics at Hasselt University, Belgium, Dea directly joined the discovery statistics at Janssen Pharmaceutica in 2015 as biostatistician. In this role, Dea closely collaborates with other statisticians as well as scientist from different therapeutic area to provide solutions from day to day business needs to a more specific cases which need tailor-made analysis. Dea is building her expertise in high dimensional data integration on pre-clinical as well as clinical studies. At the moment, Dea is also finishing her doctoral school at Hasselt University under supervision of Prof. Ziv Shkedy and Prof. Luc Bijnens with research topic related to statistical method development for the design and statistical analysis of high dimensional data integration.
Date: Wednesday 25th November 2020 Time: 14:00 - 15:00 GMT Speakers: Graham Healey (Oncimmune) and Dea Putri (Janssen)
Who is this event intended for? Anybody involved in the development and deployment of biomarkers in pharmaceutical or diagnostic areas.
What is the benefit of attending? To gain an appreciation of the range of issues at the non-clinical end.
Registration
You can now register for this event. Registration will close at 12:00 on 24th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
The deployment of biomarkers in drug development and diagnostics has many challenges ranging from analytical validation, in vivo study design, to the translation to human utility and financial considerations. In this Webinar focus will be given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way will be discussed.
Speakers
Speaker: Graham Healey
Biography: Graham has 40 years experience in supporting R&D in the pharmaceutical and diagnostics industries, particularly in the areas of discovery, toxicology, assay validation and clinical trials. After graduating in Zoology from Imperial College, he then converted to full-time statistics via the MSc Biometry course at Reading. After a year lecturing at Bunda Agricultural College deep in the Malawian bush, he joined the biotech division of G.D.Searle UK, working on interferon and aspartame. Next came six years at Searle's R&D site in Belgium followed by 16 years as Head of Statistics at HLS in UK, working in a vast array of preclinical, toxicology and clinical areas. He is currently Chief Statistician at Oncimmune Ltd, involved in all stages of the commercialisation of blood tests for the early detection of cancer, from laboratory bench to doctor’s surgery. In his spare time his main passions are classical music and insects.
Speaker: Dea Putri
Biography: Right after graduating from her master study in biostatistics at Hasselt University, Belgium, Dea directly joined the discovery statistics at Janssen Pharmaceutica in 2015 as biostatistician. In this role, Dea closely collaborates with other statisticians as well as scientist from different therapeutic area to provide solutions from day to day business needs to a more specific cases which need tailor-made analysis. Dea is building her expertise in high dimensional data integration on pre-clinical as well as clinical studies. At the moment, Dea is also finishing her doctoral school at Hasselt University under supervision of Prof. Ziv Shkedy and Prof. Luc Bijnens with research topic related to statistical method development for the design and statistical analysis of high dimensional data integration.
Date: Wednesday 25th November 2020 Time: 14:00 - 15:00 GMT Speakers: Graham Healey (Oncimmune) and Dea Putri (Janssen)
Who is this event intended for? Anybody involved in the development and deployment of biomarkers in pharmaceutical or diagnostic areas.
What is the benefit of attending? To gain an appreciation of the range of issues at the non-clinical end.
Registration
You can now register for this event. Registration will close at 12:00 on 24th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
The deployment of biomarkers in drug development and diagnostics has many challenges ranging from analytical validation, in vivo study design, to the translation to human utility and financial considerations. In this Webinar focus will be given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way will be discussed.
Speakers
Speaker: Graham Healey
Biography: Graham has 40 years experience in supporting R&D in the pharmaceutical and diagnostics industries, particularly in the areas of discovery, toxicology, assay validation and clinical trials. After graduating in Zoology from Imperial College, he then converted to full-time statistics via the MSc Biometry course at Reading. After a year lecturing at Bunda Agricultural College deep in the Malawian bush, he joined the biotech division of G.D.Searle UK, working on interferon and aspartame. Next came six years at Searle's R&D site in Belgium followed by 16 years as Head of Statistics at HLS in UK, working in a vast array of preclinical, toxicology and clinical areas. He is currently Chief Statistician at Oncimmune Ltd, involved in all stages of the commercialisation of blood tests for the early detection of cancer, from laboratory bench to doctor’s surgery. In his spare time his main passions are classical music and insects.
Speaker: Dea Putri
Biography: Right after graduating from her master study in biostatistics at Hasselt University, Belgium, Dea directly joined the discovery statistics at Janssen Pharmaceutica in 2015 as biostatistician. In this role, Dea closely collaborates with other statisticians as well as scientist from different therapeutic area to provide solutions from day to day business needs to a more specific cases which need tailor-made analysis. Dea is building her expertise in high dimensional data integration on pre-clinical as well as clinical studies. At the moment, Dea is also finishing her doctoral school at Hasselt University under supervision of Prof. Ziv Shkedy and Prof. Luc Bijnens with research topic related to statistical method development for the design and statistical analysis of high dimensional data integration.
Upcoming Events
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