Joint PSI, EFSPI & ASA BIOP Webinar: Estimands

PSI Introduction to Industry Training (ITIT) Course - 2025/2026

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.

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 Book Club Webinar: Atomic Habits - The Science of Getting Your Act Together

The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.

PSI Webinar: Methods and tools integrating clinical trial evidence with historical or real-world data, Bayesian borrowing, and causal inference

This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.

PSI Career Young Virtual Event (Q2 2025)

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: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance

This will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.

PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

One-day PSI/PHUSE Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

PSI Training Course: Pediatric Extrapolation

This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.

PSI Career Young Virtual Event (Q3 2025)

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/EFSPI Vaccines Statistics Workshop

The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.

PSI Career Young Virtual Event (Q4 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

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 (QS Technical Excellence and Program Strategy) Advisory Committee. 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).

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 (QS Technical Excellence and Program Strategy) Advisory Committee. 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).

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 (QS Technical Excellence and Program Strategy) Advisory Committee. 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).

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 (QS Technical Excellence and Program Strategy) Advisory Committee. 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).

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 (QS Technical Excellence and Program Strategy) Advisory Committee. 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).

Past PSI Events

On this page:

Conferences