Here is some further background information about the content and the presenters:
The emerging and merging fields of benefit-risk and health technology assessments
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies.
Aboutthepresenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.
Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation.
Aboutthepresenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.
Here is some further background information about the content and the presenters:
The emerging and merging fields of benefit-risk and health technology assessments
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies.
Aboutthepresenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.
Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation.
Aboutthepresenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.
Here is some further background information about the content and the presenters:
The emerging and merging fields of benefit-risk and health technology assessments
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies.
Aboutthepresenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.
Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation.
Aboutthepresenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.
Here is some further background information about the content and the presenters:
The emerging and merging fields of benefit-risk and health technology assessments
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies.
Aboutthepresenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.
Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation.
Aboutthepresenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.
Here is some further background information about the content and the presenters:
The emerging and merging fields of benefit-risk and health technology assessments
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies.
Aboutthepresenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.
Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation.
Aboutthepresenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.
Here is some further background information about the content and the presenters:
The emerging and merging fields of benefit-risk and health technology assessments
Abstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often seen as purely regulatory activities, while health technology assessments (HTA) consider a wider range of aspects, but mainly concentrate on economic evaluations. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those directly involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or BRA in regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initiatives focusing on methodologies, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies.
Aboutthepresenter: Jason (Jixian) Wang is a principle statistician at Celgene, with over 25 years of experiences as statistician in a number of areas in pharmaceutical statistics, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several years before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions, with a number of successful NDA submissions to the FDA/EMEA . Since 2014, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling, real world evidence generation and causal inference, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology), modeling and simulation and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA, and is a coordinator for the EFSPI joint working group for benefit-risk assessment and HTA.
Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices
Abstract: The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe two real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations (i.e subgroup identifications, endpoint selection with important clinical impacts, uncertainty quantification, risk mitigation etc.) for a full benefit-risk evaluation.
Aboutthepresenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research, risk-benefit modeling, comparative effectiveness research, evidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessment of Medicines, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HTA. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IMI PROTECT, QSPI Benefit-Risk Working Group and CIOMS X working group on "Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P program on benefit-risk assessment of medicines.
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