Date: Thursday 12th January 2023 Time: 15:00-16:30 GMT | 10:00-11:30 EST
Overview
The DIA Statistics and Data Science Virtual Journal Club are pleased to announce a joint webinar with the Statisticians in the Pharmaceutical Industry (PSI) journal club. The title is Biomarker Adaptive Designs. The webinar will be held on Dec. 16th 12:00-1:30pm EST (4:00-5.30pm GMT). Dr. Shufang Liu (Astellas Pharma Inc.) and Dr. Weidong Zhang (Jounce Therapeutics) will present their recent publications and Dr. Sue-Jane Wang (FDA) will the discussant.
1. An Adaptive Biomarker Basket Design in Phase II Oncology
Shufang Liu, Kentaro Takeda, Alan Rong Pharmaceutical Statistics. 2022; 1-15
2. Statistical and Operational Considerations for 2 Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker Selected Populations in Oncology Confirmatory Trials Weidong Zhang, Sunhee Ro et al
Therapeutic Innovations & Regulatory Science. 2022; 56: 552-560
Date: Thursday 12th January 2023 Time: 15:00-16:30 GMT | 10:00-11:30 EST
Overview
The DIA Statistics and Data Science Virtual Journal Club are pleased to announce a joint webinar with the Statisticians in the Pharmaceutical Industry (PSI) journal club. The title is Biomarker Adaptive Designs. The webinar will be held on Dec. 16th 12:00-1:30pm EST (4:00-5.30pm GMT). Dr. Shufang Liu (Astellas Pharma Inc.) and Dr. Weidong Zhang (Jounce Therapeutics) will present their recent publications and Dr. Sue-Jane Wang (FDA) will the discussant.
1. An Adaptive Biomarker Basket Design in Phase II Oncology
Shufang Liu, Kentaro Takeda, Alan Rong Pharmaceutical Statistics. 2022; 1-15
2. Statistical and Operational Considerations for 2 Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker Selected Populations in Oncology Confirmatory Trials Weidong Zhang, Sunhee Ro et al
Therapeutic Innovations & Regulatory Science. 2022; 56: 552-560
Date: Thursday 12th January 2023 Time: 15:00-16:30 GMT | 10:00-11:30 EST
Overview
The DIA Statistics and Data Science Virtual Journal Club are pleased to announce a joint webinar with the Statisticians in the Pharmaceutical Industry (PSI) journal club. The title is Biomarker Adaptive Designs. The webinar will be held on Dec. 16th 12:00-1:30pm EST (4:00-5.30pm GMT). Dr. Shufang Liu (Astellas Pharma Inc.) and Dr. Weidong Zhang (Jounce Therapeutics) will present their recent publications and Dr. Sue-Jane Wang (FDA) will the discussant.
1. An Adaptive Biomarker Basket Design in Phase II Oncology
Shufang Liu, Kentaro Takeda, Alan Rong Pharmaceutical Statistics. 2022; 1-15
2. Statistical and Operational Considerations for 2 Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker Selected Populations in Oncology Confirmatory Trials Weidong Zhang, Sunhee Ro et al
Therapeutic Innovations & Regulatory Science. 2022; 56: 552-560
Date: Thursday 12th January 2023 Time: 15:00-16:30 GMT | 10:00-11:30 EST
Overview
The DIA Statistics and Data Science Virtual Journal Club are pleased to announce a joint webinar with the Statisticians in the Pharmaceutical Industry (PSI) journal club. The title is Biomarker Adaptive Designs. The webinar will be held on Dec. 16th 12:00-1:30pm EST (4:00-5.30pm GMT). Dr. Shufang Liu (Astellas Pharma Inc.) and Dr. Weidong Zhang (Jounce Therapeutics) will present their recent publications and Dr. Sue-Jane Wang (FDA) will the discussant.
1. An Adaptive Biomarker Basket Design in Phase II Oncology
Shufang Liu, Kentaro Takeda, Alan Rong Pharmaceutical Statistics. 2022; 1-15
2. Statistical and Operational Considerations for 2 Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker Selected Populations in Oncology Confirmatory Trials Weidong Zhang, Sunhee Ro et al
Therapeutic Innovations & Regulatory Science. 2022; 56: 552-560
Date: Thursday 12th January 2023 Time: 15:00-16:30 GMT | 10:00-11:30 EST
Overview
The DIA Statistics and Data Science Virtual Journal Club are pleased to announce a joint webinar with the Statisticians in the Pharmaceutical Industry (PSI) journal club. The title is Biomarker Adaptive Designs. The webinar will be held on Dec. 16th 12:00-1:30pm EST (4:00-5.30pm GMT). Dr. Shufang Liu (Astellas Pharma Inc.) and Dr. Weidong Zhang (Jounce Therapeutics) will present their recent publications and Dr. Sue-Jane Wang (FDA) will the discussant.
1. An Adaptive Biomarker Basket Design in Phase II Oncology
Shufang Liu, Kentaro Takeda, Alan Rong Pharmaceutical Statistics. 2022; 1-15
2. Statistical and Operational Considerations for 2 Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker Selected Populations in Oncology Confirmatory Trials Weidong Zhang, Sunhee Ro et al
Therapeutic Innovations & Regulatory Science. 2022; 56: 552-560
Date: Thursday 12th January 2023 Time: 15:00-16:30 GMT | 10:00-11:30 EST
Overview
The DIA Statistics and Data Science Virtual Journal Club are pleased to announce a joint webinar with the Statisticians in the Pharmaceutical Industry (PSI) journal club. The title is Biomarker Adaptive Designs. The webinar will be held on Dec. 16th 12:00-1:30pm EST (4:00-5.30pm GMT). Dr. Shufang Liu (Astellas Pharma Inc.) and Dr. Weidong Zhang (Jounce Therapeutics) will present their recent publications and Dr. Sue-Jane Wang (FDA) will the discussant.
1. An Adaptive Biomarker Basket Design in Phase II Oncology
Shufang Liu, Kentaro Takeda, Alan Rong Pharmaceutical Statistics. 2022; 1-15
2. Statistical and Operational Considerations for 2 Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker Selected Populations in Oncology Confirmatory Trials Weidong Zhang, Sunhee Ro et al
Therapeutic Innovations & Regulatory Science. 2022; 56: 552-560
Discussant: Dr. Sue-Jane Wang
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