Please click here to view the slides from Dr Norisuke Kawai.
Please click here to view the slides from Dr Dejun Tang
Please click here to hear the audio from Dr Dejun Tang
PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
Please click here to view the slides from Dr Norisuke Kawai.
Please click here to view the slides from Dr Dejun Tang
Please click here to hear the audio from Dr Dejun Tang
PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
Please click here to view the slides from Dr Norisuke Kawai.
Please click here to view the slides from Dr Dejun Tang
Please click here to hear the audio from Dr Dejun Tang
PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
Please click here to view the slides from Dr Norisuke Kawai.
Please click here to view the slides from Dr Dejun Tang
Please click here to hear the audio from Dr Dejun Tang
PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
Please click here to view the slides from Dr Norisuke Kawai.
Please click here to view the slides from Dr Dejun Tang
Please click here to hear the audio from Dr Dejun Tang
PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
Please click here to view the slides from Dr Norisuke Kawai.
Please click here to view the slides from Dr Dejun Tang
Please click here to hear the audio from Dr Dejun Tang
PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
We will do our best to discuss them at the webinar.
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.
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.
PSI Training Course: Regulatory Guidelines for Statisticians
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.
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