Date: Thursday 5th November 2020 Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST) Speakers:John Scott(FDA), Andreas Brandt (BfArM), Vladimir Dragalin(JNJ) andEvgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia. What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
Registration
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
Experience with proposals submitted to FDA and EMA on implementation of Estimands
How the estimands framework facilitates interaction with clinicians in different therapeutic areas
Common problems where the Estimands framework can help advance research
Where further discussions and research is required, and particularly where industry and regulators can collaborate
Issues related to alignment between different estimators to a given estimand
Special considerations of estimand framework in COVID-19 vaccine trials
Speaker Details
Speaker
Biography
John Scott
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics.
Andreas Brandt
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology.
Vlad Dragalin
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QSTechnical Excellence and Program Strategy) AdvisoryCommittee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
Evgeny Degtyarev
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).
Date: Thursday 5th November 2020 Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST) Speakers:John Scott(FDA), Andreas Brandt (BfArM), Vladimir Dragalin(JNJ) andEvgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia. What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
Registration
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
Experience with proposals submitted to FDA and EMA on implementation of Estimands
How the estimands framework facilitates interaction with clinicians in different therapeutic areas
Common problems where the Estimands framework can help advance research
Where further discussions and research is required, and particularly where industry and regulators can collaborate
Issues related to alignment between different estimators to a given estimand
Special considerations of estimand framework in COVID-19 vaccine trials
Speaker Details
Speaker
Biography
John Scott
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics.
Andreas Brandt
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology.
Vlad Dragalin
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QSTechnical Excellence and Program Strategy) AdvisoryCommittee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
Evgeny Degtyarev
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).
Date: Thursday 5th November 2020 Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST) Speakers:John Scott(FDA), Andreas Brandt (BfArM), Vladimir Dragalin(JNJ) andEvgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia. What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
Registration
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
Experience with proposals submitted to FDA and EMA on implementation of Estimands
How the estimands framework facilitates interaction with clinicians in different therapeutic areas
Common problems where the Estimands framework can help advance research
Where further discussions and research is required, and particularly where industry and regulators can collaborate
Issues related to alignment between different estimators to a given estimand
Special considerations of estimand framework in COVID-19 vaccine trials
Speaker Details
Speaker
Biography
John Scott
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics.
Andreas Brandt
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology.
Vlad Dragalin
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QSTechnical Excellence and Program Strategy) AdvisoryCommittee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
Evgeny Degtyarev
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).
Date: Thursday 5th November 2020 Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST) Speakers:John Scott(FDA), Andreas Brandt (BfArM), Vladimir Dragalin(JNJ) andEvgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia. What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
Registration
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
Experience with proposals submitted to FDA and EMA on implementation of Estimands
How the estimands framework facilitates interaction with clinicians in different therapeutic areas
Common problems where the Estimands framework can help advance research
Where further discussions and research is required, and particularly where industry and regulators can collaborate
Issues related to alignment between different estimators to a given estimand
Special considerations of estimand framework in COVID-19 vaccine trials
Speaker Details
Speaker
Biography
John Scott
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics.
Andreas Brandt
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology.
Vlad Dragalin
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QSTechnical Excellence and Program Strategy) AdvisoryCommittee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
Evgeny Degtyarev
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).
Date: Thursday 5th November 2020 Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST) Speakers:John Scott(FDA), Andreas Brandt (BfArM), Vladimir Dragalin(JNJ) andEvgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia. What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
Registration
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
Experience with proposals submitted to FDA and EMA on implementation of Estimands
How the estimands framework facilitates interaction with clinicians in different therapeutic areas
Common problems where the Estimands framework can help advance research
Where further discussions and research is required, and particularly where industry and regulators can collaborate
Issues related to alignment between different estimators to a given estimand
Special considerations of estimand framework in COVID-19 vaccine trials
Speaker Details
Speaker
Biography
John Scott
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics.
Andreas Brandt
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology.
Vlad Dragalin
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QSTechnical Excellence and Program Strategy) AdvisoryCommittee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
Evgeny Degtyarev
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).
Date: Thursday 5th November 2020 Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST) Speakers:John Scott(FDA), Andreas Brandt (BfArM), Vladimir Dragalin(JNJ) andEvgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia. What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
Registration
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Overview
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
Experience with proposals submitted to FDA and EMA on implementation of Estimands
How the estimands framework facilitates interaction with clinicians in different therapeutic areas
Common problems where the Estimands framework can help advance research
Where further discussions and research is required, and particularly where industry and regulators can collaborate
Issues related to alignment between different estimators to a given estimand
Special considerations of estimand framework in COVID-19 vaccine trials
Speaker Details
Speaker
Biography
John Scott
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics.
Andreas Brandt
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology.
Vlad Dragalin
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QSTechnical Excellence and Program Strategy) AdvisoryCommittee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
Evgeny Degtyarev
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).
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