Past PSI Events

Conferences

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Date: Thursday 2nd December 2021
Time: 15:00 - 17:00 GMT
Speakers: Ivan Chan and Stephen Senn

Who is this event intended for? The event is intended for statisticians working on COVID 19 challenges in vaccine and non-vaccine studies.

Overview

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Registration

You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.

Speaker Details

Speaker

Biography

Abstract

Ivanedit
Ivan S. F. Chan, Ph.D.
VP, Head of Hematology Biostatistics, Global Biometrics & Data and Sciences, Bristol Myers Squibb

 

Dr. Ivan S.F. Chan has more than 25 years of experience in the pharmaceutical industry. He is VP and Head of Hematology Biostatistics, Global Biometrics & Data Sciences at Bristol Myers Squibb. Previously, Ivan was VP and Head of Statistical Sciences at AbbVie. Prior to that, Ivan was Executive Director at Merck Research Laboratories where he led the global statistical support for vaccines and early oncology. He had worked with US government and World Health Organization on developing several novel vaccines, including varicella, herpes zoster, HPV and Ebola vaccines. Ivan is the 2021 recipient of the Deming Lecturer Award from the American Statistical Association (ASA) for his outstanding contributions to vaccine development.

Ivan received his B.S. in Statistics from the Chinese University of Hong Kong and Ph.D. in Biostatistics from the University of Minnesota. He is an elected Fellow of the American Statistical Association and an elected Fellow of the Society for Clinical Trials (SCT). He currently serves as Executive Director of the International Society for Biopharmaceutical Statistics and Chair of Development Committee for SCT. Ivan has previously served as the President of the International Chinese Statistical Association and the Program Chair of the ASA Biopharmaceutical Section. He has 80+ publications in statistical and clinical journals.

Introduction to Statistical Methods and Challenges in Vaccine Development.

Vaccines have long been recognized as one of the greatest achievements in public health. Through mass immunization, smallpox was eradicated globally in 1979 and polio was eliminated in the Americas in 1994. In the fight against the COVID-19 pandemic, several vaccines have been successfully developed in record time thanks to incredible scientific innovation and public-private partnership. A new vaccine must pass high bars of safety and efficacy to justify the risk benefit of potential mass immunization. In this presentation, we will first introduce the concept of immunity and explain how vaccine works in stimulating immune responses and protecting people from diseases. Then we will give an overview of the statistical methods commonly used in assessing vaccine’s efficacy and safety. In addition, we will discuss a few special challenges in developing vaccines and give examples of statistical innovation that have helped accelerate the development of novel vaccines.

 

Stephenedit
Stephen Senn, PhD.
Statistical Consultant, Edinburgh, Scotland, United Kingdom

Originally from Switzerland, Stephen Senn was head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health in Luxembourg, 2011-2018, Professor of Statistics at the University of Glasgow, from 2003 to 2011, and Professor of Pharmaceutical and Health Statistics at University College London from 1995-2003. He has also worked in the Swiss pharmaceutical industry, as a lecturer and senior lecture in Dundee and for the National Health Service in England. He is the author of the monographs Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007), Dicing with Death (2003) and over 300 scientific publications. In 2001 Stephen Senn was the first recipient of the George C Challis award for Biostatistics of the University of Florida, in 2008 he gave the Bradford Hill lecture of the London School of Hygiene and Tropical Medicine and in 2009 was awarded the Bradford Hill Medal of the Royal Statistical Society. In 2017 he gave the Fisher Memorial Lecture. He is a Fellow of the Royal Society of Edinburgh and an honorary life member of Statisticians in the Pharmaceutical Industry (PSI) and the International Society for Clinical Biostatistics. He is an honorary professor at the University of Sheffield and the University of Edinburgh. He retired in 2018 but is still researching and consulting in statistics.

Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes.

The response to the COVID-19 crisis by various vaccine developers has been extraordinary, both in terms of speed of response and the delivered efficacy of the vaccines. It has also raised some fascinating issues of design, analysis and interpretation. I shall consider some of these issues, taking as my example, five vaccine programmes: Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, Novavax, and J&J Janssen paying particular attention to the first two. Among matters covered will be concurrent control, efficient design, issues of measurement raised by two-shot vaccines and implications for roll-out, and the surprising effectiveness of simple analyses. Differences between the five development programmes as they affect statistics will be covered but some essential similarities will also be discussed.

A key issue is the difference between causal and predictive inference, a matter that has become important due to the emergence of new viral variants on the one hand and (of necessity) limited follow-up in the clinical trials that were conducted.

 

Scientific Meetings

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Date: Thursday 2nd December 2021
Time: 15:00 - 17:00 GMT
Speakers: Ivan Chan and Stephen Senn

Who is this event intended for? The event is intended for statisticians working on COVID 19 challenges in vaccine and non-vaccine studies.

Overview

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Registration

You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.

Speaker Details

Speaker

Biography

Abstract

Ivanedit
Ivan S. F. Chan, Ph.D.
VP, Head of Hematology Biostatistics, Global Biometrics & Data and Sciences, Bristol Myers Squibb

 

Dr. Ivan S.F. Chan has more than 25 years of experience in the pharmaceutical industry. He is VP and Head of Hematology Biostatistics, Global Biometrics & Data Sciences at Bristol Myers Squibb. Previously, Ivan was VP and Head of Statistical Sciences at AbbVie. Prior to that, Ivan was Executive Director at Merck Research Laboratories where he led the global statistical support for vaccines and early oncology. He had worked with US government and World Health Organization on developing several novel vaccines, including varicella, herpes zoster, HPV and Ebola vaccines. Ivan is the 2021 recipient of the Deming Lecturer Award from the American Statistical Association (ASA) for his outstanding contributions to vaccine development.

Ivan received his B.S. in Statistics from the Chinese University of Hong Kong and Ph.D. in Biostatistics from the University of Minnesota. He is an elected Fellow of the American Statistical Association and an elected Fellow of the Society for Clinical Trials (SCT). He currently serves as Executive Director of the International Society for Biopharmaceutical Statistics and Chair of Development Committee for SCT. Ivan has previously served as the President of the International Chinese Statistical Association and the Program Chair of the ASA Biopharmaceutical Section. He has 80+ publications in statistical and clinical journals.

Introduction to Statistical Methods and Challenges in Vaccine Development.

Vaccines have long been recognized as one of the greatest achievements in public health. Through mass immunization, smallpox was eradicated globally in 1979 and polio was eliminated in the Americas in 1994. In the fight against the COVID-19 pandemic, several vaccines have been successfully developed in record time thanks to incredible scientific innovation and public-private partnership. A new vaccine must pass high bars of safety and efficacy to justify the risk benefit of potential mass immunization. In this presentation, we will first introduce the concept of immunity and explain how vaccine works in stimulating immune responses and protecting people from diseases. Then we will give an overview of the statistical methods commonly used in assessing vaccine’s efficacy and safety. In addition, we will discuss a few special challenges in developing vaccines and give examples of statistical innovation that have helped accelerate the development of novel vaccines.

 

Stephenedit
Stephen Senn, PhD.
Statistical Consultant, Edinburgh, Scotland, United Kingdom

Originally from Switzerland, Stephen Senn was head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health in Luxembourg, 2011-2018, Professor of Statistics at the University of Glasgow, from 2003 to 2011, and Professor of Pharmaceutical and Health Statistics at University College London from 1995-2003. He has also worked in the Swiss pharmaceutical industry, as a lecturer and senior lecture in Dundee and for the National Health Service in England. He is the author of the monographs Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007), Dicing with Death (2003) and over 300 scientific publications. In 2001 Stephen Senn was the first recipient of the George C Challis award for Biostatistics of the University of Florida, in 2008 he gave the Bradford Hill lecture of the London School of Hygiene and Tropical Medicine and in 2009 was awarded the Bradford Hill Medal of the Royal Statistical Society. In 2017 he gave the Fisher Memorial Lecture. He is a Fellow of the Royal Society of Edinburgh and an honorary life member of Statisticians in the Pharmaceutical Industry (PSI) and the International Society for Clinical Biostatistics. He is an honorary professor at the University of Sheffield and the University of Edinburgh. He retired in 2018 but is still researching and consulting in statistics.

Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes.

The response to the COVID-19 crisis by various vaccine developers has been extraordinary, both in terms of speed of response and the delivered efficacy of the vaccines. It has also raised some fascinating issues of design, analysis and interpretation. I shall consider some of these issues, taking as my example, five vaccine programmes: Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, Novavax, and J&J Janssen paying particular attention to the first two. Among matters covered will be concurrent control, efficient design, issues of measurement raised by two-shot vaccines and implications for roll-out, and the surprising effectiveness of simple analyses. Differences between the five development programmes as they affect statistics will be covered but some essential similarities will also be discussed.

A key issue is the difference between causal and predictive inference, a matter that has become important due to the emergence of new viral variants on the one hand and (of necessity) limited follow-up in the clinical trials that were conducted.

 

Training Courses

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Date: Thursday 2nd December 2021
Time: 15:00 - 17:00 GMT
Speakers: Ivan Chan and Stephen Senn

Who is this event intended for? The event is intended for statisticians working on COVID 19 challenges in vaccine and non-vaccine studies.

Overview

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Registration

You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.

Speaker Details

Speaker

Biography

Abstract

Ivanedit
Ivan S. F. Chan, Ph.D.
VP, Head of Hematology Biostatistics, Global Biometrics & Data and Sciences, Bristol Myers Squibb

 

Dr. Ivan S.F. Chan has more than 25 years of experience in the pharmaceutical industry. He is VP and Head of Hematology Biostatistics, Global Biometrics & Data Sciences at Bristol Myers Squibb. Previously, Ivan was VP and Head of Statistical Sciences at AbbVie. Prior to that, Ivan was Executive Director at Merck Research Laboratories where he led the global statistical support for vaccines and early oncology. He had worked with US government and World Health Organization on developing several novel vaccines, including varicella, herpes zoster, HPV and Ebola vaccines. Ivan is the 2021 recipient of the Deming Lecturer Award from the American Statistical Association (ASA) for his outstanding contributions to vaccine development.

Ivan received his B.S. in Statistics from the Chinese University of Hong Kong and Ph.D. in Biostatistics from the University of Minnesota. He is an elected Fellow of the American Statistical Association and an elected Fellow of the Society for Clinical Trials (SCT). He currently serves as Executive Director of the International Society for Biopharmaceutical Statistics and Chair of Development Committee for SCT. Ivan has previously served as the President of the International Chinese Statistical Association and the Program Chair of the ASA Biopharmaceutical Section. He has 80+ publications in statistical and clinical journals.

Introduction to Statistical Methods and Challenges in Vaccine Development.

Vaccines have long been recognized as one of the greatest achievements in public health. Through mass immunization, smallpox was eradicated globally in 1979 and polio was eliminated in the Americas in 1994. In the fight against the COVID-19 pandemic, several vaccines have been successfully developed in record time thanks to incredible scientific innovation and public-private partnership. A new vaccine must pass high bars of safety and efficacy to justify the risk benefit of potential mass immunization. In this presentation, we will first introduce the concept of immunity and explain how vaccine works in stimulating immune responses and protecting people from diseases. Then we will give an overview of the statistical methods commonly used in assessing vaccine’s efficacy and safety. In addition, we will discuss a few special challenges in developing vaccines and give examples of statistical innovation that have helped accelerate the development of novel vaccines.

 

Stephenedit
Stephen Senn, PhD.
Statistical Consultant, Edinburgh, Scotland, United Kingdom

Originally from Switzerland, Stephen Senn was head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health in Luxembourg, 2011-2018, Professor of Statistics at the University of Glasgow, from 2003 to 2011, and Professor of Pharmaceutical and Health Statistics at University College London from 1995-2003. He has also worked in the Swiss pharmaceutical industry, as a lecturer and senior lecture in Dundee and for the National Health Service in England. He is the author of the monographs Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007), Dicing with Death (2003) and over 300 scientific publications. In 2001 Stephen Senn was the first recipient of the George C Challis award for Biostatistics of the University of Florida, in 2008 he gave the Bradford Hill lecture of the London School of Hygiene and Tropical Medicine and in 2009 was awarded the Bradford Hill Medal of the Royal Statistical Society. In 2017 he gave the Fisher Memorial Lecture. He is a Fellow of the Royal Society of Edinburgh and an honorary life member of Statisticians in the Pharmaceutical Industry (PSI) and the International Society for Clinical Biostatistics. He is an honorary professor at the University of Sheffield and the University of Edinburgh. He retired in 2018 but is still researching and consulting in statistics.

Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes.

The response to the COVID-19 crisis by various vaccine developers has been extraordinary, both in terms of speed of response and the delivered efficacy of the vaccines. It has also raised some fascinating issues of design, analysis and interpretation. I shall consider some of these issues, taking as my example, five vaccine programmes: Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, Novavax, and J&J Janssen paying particular attention to the first two. Among matters covered will be concurrent control, efficient design, issues of measurement raised by two-shot vaccines and implications for roll-out, and the surprising effectiveness of simple analyses. Differences between the five development programmes as they affect statistics will be covered but some essential similarities will also be discussed.

A key issue is the difference between causal and predictive inference, a matter that has become important due to the emergence of new viral variants on the one hand and (of necessity) limited follow-up in the clinical trials that were conducted.

 

Journal Club

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Date: Thursday 2nd December 2021
Time: 15:00 - 17:00 GMT
Speakers: Ivan Chan and Stephen Senn

Who is this event intended for? The event is intended for statisticians working on COVID 19 challenges in vaccine and non-vaccine studies.

Overview

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Registration

You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.

Speaker Details

Speaker

Biography

Abstract

Ivanedit
Ivan S. F. Chan, Ph.D.
VP, Head of Hematology Biostatistics, Global Biometrics & Data and Sciences, Bristol Myers Squibb

 

Dr. Ivan S.F. Chan has more than 25 years of experience in the pharmaceutical industry. He is VP and Head of Hematology Biostatistics, Global Biometrics & Data Sciences at Bristol Myers Squibb. Previously, Ivan was VP and Head of Statistical Sciences at AbbVie. Prior to that, Ivan was Executive Director at Merck Research Laboratories where he led the global statistical support for vaccines and early oncology. He had worked with US government and World Health Organization on developing several novel vaccines, including varicella, herpes zoster, HPV and Ebola vaccines. Ivan is the 2021 recipient of the Deming Lecturer Award from the American Statistical Association (ASA) for his outstanding contributions to vaccine development.

Ivan received his B.S. in Statistics from the Chinese University of Hong Kong and Ph.D. in Biostatistics from the University of Minnesota. He is an elected Fellow of the American Statistical Association and an elected Fellow of the Society for Clinical Trials (SCT). He currently serves as Executive Director of the International Society for Biopharmaceutical Statistics and Chair of Development Committee for SCT. Ivan has previously served as the President of the International Chinese Statistical Association and the Program Chair of the ASA Biopharmaceutical Section. He has 80+ publications in statistical and clinical journals.

Introduction to Statistical Methods and Challenges in Vaccine Development.

Vaccines have long been recognized as one of the greatest achievements in public health. Through mass immunization, smallpox was eradicated globally in 1979 and polio was eliminated in the Americas in 1994. In the fight against the COVID-19 pandemic, several vaccines have been successfully developed in record time thanks to incredible scientific innovation and public-private partnership. A new vaccine must pass high bars of safety and efficacy to justify the risk benefit of potential mass immunization. In this presentation, we will first introduce the concept of immunity and explain how vaccine works in stimulating immune responses and protecting people from diseases. Then we will give an overview of the statistical methods commonly used in assessing vaccine’s efficacy and safety. In addition, we will discuss a few special challenges in developing vaccines and give examples of statistical innovation that have helped accelerate the development of novel vaccines.

 

Stephenedit
Stephen Senn, PhD.
Statistical Consultant, Edinburgh, Scotland, United Kingdom

Originally from Switzerland, Stephen Senn was head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health in Luxembourg, 2011-2018, Professor of Statistics at the University of Glasgow, from 2003 to 2011, and Professor of Pharmaceutical and Health Statistics at University College London from 1995-2003. He has also worked in the Swiss pharmaceutical industry, as a lecturer and senior lecture in Dundee and for the National Health Service in England. He is the author of the monographs Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007), Dicing with Death (2003) and over 300 scientific publications. In 2001 Stephen Senn was the first recipient of the George C Challis award for Biostatistics of the University of Florida, in 2008 he gave the Bradford Hill lecture of the London School of Hygiene and Tropical Medicine and in 2009 was awarded the Bradford Hill Medal of the Royal Statistical Society. In 2017 he gave the Fisher Memorial Lecture. He is a Fellow of the Royal Society of Edinburgh and an honorary life member of Statisticians in the Pharmaceutical Industry (PSI) and the International Society for Clinical Biostatistics. He is an honorary professor at the University of Sheffield and the University of Edinburgh. He retired in 2018 but is still researching and consulting in statistics.

Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes.

The response to the COVID-19 crisis by various vaccine developers has been extraordinary, both in terms of speed of response and the delivered efficacy of the vaccines. It has also raised some fascinating issues of design, analysis and interpretation. I shall consider some of these issues, taking as my example, five vaccine programmes: Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, Novavax, and J&J Janssen paying particular attention to the first two. Among matters covered will be concurrent control, efficient design, issues of measurement raised by two-shot vaccines and implications for roll-out, and the surprising effectiveness of simple analyses. Differences between the five development programmes as they affect statistics will be covered but some essential similarities will also be discussed.

A key issue is the difference between causal and predictive inference, a matter that has become important due to the emergence of new viral variants on the one hand and (of necessity) limited follow-up in the clinical trials that were conducted.

 

Webinars

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Date: Thursday 2nd December 2021
Time: 15:00 - 17:00 GMT
Speakers: Ivan Chan and Stephen Senn

Who is this event intended for? The event is intended for statisticians working on COVID 19 challenges in vaccine and non-vaccine studies.

Overview

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Registration

You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.

Speaker Details

Speaker

Biography

Abstract

Ivanedit
Ivan S. F. Chan, Ph.D.
VP, Head of Hematology Biostatistics, Global Biometrics & Data and Sciences, Bristol Myers Squibb

 

Dr. Ivan S.F. Chan has more than 25 years of experience in the pharmaceutical industry. He is VP and Head of Hematology Biostatistics, Global Biometrics & Data Sciences at Bristol Myers Squibb. Previously, Ivan was VP and Head of Statistical Sciences at AbbVie. Prior to that, Ivan was Executive Director at Merck Research Laboratories where he led the global statistical support for vaccines and early oncology. He had worked with US government and World Health Organization on developing several novel vaccines, including varicella, herpes zoster, HPV and Ebola vaccines. Ivan is the 2021 recipient of the Deming Lecturer Award from the American Statistical Association (ASA) for his outstanding contributions to vaccine development.

Ivan received his B.S. in Statistics from the Chinese University of Hong Kong and Ph.D. in Biostatistics from the University of Minnesota. He is an elected Fellow of the American Statistical Association and an elected Fellow of the Society for Clinical Trials (SCT). He currently serves as Executive Director of the International Society for Biopharmaceutical Statistics and Chair of Development Committee for SCT. Ivan has previously served as the President of the International Chinese Statistical Association and the Program Chair of the ASA Biopharmaceutical Section. He has 80+ publications in statistical and clinical journals.

Introduction to Statistical Methods and Challenges in Vaccine Development.

Vaccines have long been recognized as one of the greatest achievements in public health. Through mass immunization, smallpox was eradicated globally in 1979 and polio was eliminated in the Americas in 1994. In the fight against the COVID-19 pandemic, several vaccines have been successfully developed in record time thanks to incredible scientific innovation and public-private partnership. A new vaccine must pass high bars of safety and efficacy to justify the risk benefit of potential mass immunization. In this presentation, we will first introduce the concept of immunity and explain how vaccine works in stimulating immune responses and protecting people from diseases. Then we will give an overview of the statistical methods commonly used in assessing vaccine’s efficacy and safety. In addition, we will discuss a few special challenges in developing vaccines and give examples of statistical innovation that have helped accelerate the development of novel vaccines.

 

Stephenedit
Stephen Senn, PhD.
Statistical Consultant, Edinburgh, Scotland, United Kingdom

Originally from Switzerland, Stephen Senn was head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health in Luxembourg, 2011-2018, Professor of Statistics at the University of Glasgow, from 2003 to 2011, and Professor of Pharmaceutical and Health Statistics at University College London from 1995-2003. He has also worked in the Swiss pharmaceutical industry, as a lecturer and senior lecture in Dundee and for the National Health Service in England. He is the author of the monographs Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007), Dicing with Death (2003) and over 300 scientific publications. In 2001 Stephen Senn was the first recipient of the George C Challis award for Biostatistics of the University of Florida, in 2008 he gave the Bradford Hill lecture of the London School of Hygiene and Tropical Medicine and in 2009 was awarded the Bradford Hill Medal of the Royal Statistical Society. In 2017 he gave the Fisher Memorial Lecture. He is a Fellow of the Royal Society of Edinburgh and an honorary life member of Statisticians in the Pharmaceutical Industry (PSI) and the International Society for Clinical Biostatistics. He is an honorary professor at the University of Sheffield and the University of Edinburgh. He retired in 2018 but is still researching and consulting in statistics.

Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes.

The response to the COVID-19 crisis by various vaccine developers has been extraordinary, both in terms of speed of response and the delivered efficacy of the vaccines. It has also raised some fascinating issues of design, analysis and interpretation. I shall consider some of these issues, taking as my example, five vaccine programmes: Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, Novavax, and J&J Janssen paying particular attention to the first two. Among matters covered will be concurrent control, efficient design, issues of measurement raised by two-shot vaccines and implications for roll-out, and the surprising effectiveness of simple analyses. Differences between the five development programmes as they affect statistics will be covered but some essential similarities will also be discussed.

A key issue is the difference between causal and predictive inference, a matter that has become important due to the emergence of new viral variants on the one hand and (of necessity) limited follow-up in the clinical trials that were conducted.

 

Careers Meetings

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Date: Thursday 2nd December 2021
Time: 15:00 - 17:00 GMT
Speakers: Ivan Chan and Stephen Senn

Who is this event intended for? The event is intended for statisticians working on COVID 19 challenges in vaccine and non-vaccine studies.

Overview

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

Registration

You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.

Speaker Details

Speaker

Biography

Abstract

Ivanedit
Ivan S. F. Chan, Ph.D.
VP, Head of Hematology Biostatistics, Global Biometrics & Data and Sciences, Bristol Myers Squibb

 

Dr. Ivan S.F. Chan has more than 25 years of experience in the pharmaceutical industry. He is VP and Head of Hematology Biostatistics, Global Biometrics & Data Sciences at Bristol Myers Squibb. Previously, Ivan was VP and Head of Statistical Sciences at AbbVie. Prior to that, Ivan was Executive Director at Merck Research Laboratories where he led the global statistical support for vaccines and early oncology. He had worked with US government and World Health Organization on developing several novel vaccines, including varicella, herpes zoster, HPV and Ebola vaccines. Ivan is the 2021 recipient of the Deming Lecturer Award from the American Statistical Association (ASA) for his outstanding contributions to vaccine development.

Ivan received his B.S. in Statistics from the Chinese University of Hong Kong and Ph.D. in Biostatistics from the University of Minnesota. He is an elected Fellow of the American Statistical Association and an elected Fellow of the Society for Clinical Trials (SCT). He currently serves as Executive Director of the International Society for Biopharmaceutical Statistics and Chair of Development Committee for SCT. Ivan has previously served as the President of the International Chinese Statistical Association and the Program Chair of the ASA Biopharmaceutical Section. He has 80+ publications in statistical and clinical journals.

Introduction to Statistical Methods and Challenges in Vaccine Development.

Vaccines have long been recognized as one of the greatest achievements in public health. Through mass immunization, smallpox was eradicated globally in 1979 and polio was eliminated in the Americas in 1994. In the fight against the COVID-19 pandemic, several vaccines have been successfully developed in record time thanks to incredible scientific innovation and public-private partnership. A new vaccine must pass high bars of safety and efficacy to justify the risk benefit of potential mass immunization. In this presentation, we will first introduce the concept of immunity and explain how vaccine works in stimulating immune responses and protecting people from diseases. Then we will give an overview of the statistical methods commonly used in assessing vaccine’s efficacy and safety. In addition, we will discuss a few special challenges in developing vaccines and give examples of statistical innovation that have helped accelerate the development of novel vaccines.

 

Stephenedit
Stephen Senn, PhD.
Statistical Consultant, Edinburgh, Scotland, United Kingdom

Originally from Switzerland, Stephen Senn was head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health in Luxembourg, 2011-2018, Professor of Statistics at the University of Glasgow, from 2003 to 2011, and Professor of Pharmaceutical and Health Statistics at University College London from 1995-2003. He has also worked in the Swiss pharmaceutical industry, as a lecturer and senior lecture in Dundee and for the National Health Service in England. He is the author of the monographs Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007), Dicing with Death (2003) and over 300 scientific publications. In 2001 Stephen Senn was the first recipient of the George C Challis award for Biostatistics of the University of Florida, in 2008 he gave the Bradford Hill lecture of the London School of Hygiene and Tropical Medicine and in 2009 was awarded the Bradford Hill Medal of the Royal Statistical Society. In 2017 he gave the Fisher Memorial Lecture. He is a Fellow of the Royal Society of Edinburgh and an honorary life member of Statisticians in the Pharmaceutical Industry (PSI) and the International Society for Clinical Biostatistics. He is an honorary professor at the University of Sheffield and the University of Edinburgh. He retired in 2018 but is still researching and consulting in statistics.

Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes.

The response to the COVID-19 crisis by various vaccine developers has been extraordinary, both in terms of speed of response and the delivered efficacy of the vaccines. It has also raised some fascinating issues of design, analysis and interpretation. I shall consider some of these issues, taking as my example, five vaccine programmes: Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, Novavax, and J&J Janssen paying particular attention to the first two. Among matters covered will be concurrent control, efficient design, issues of measurement raised by two-shot vaccines and implications for roll-out, and the surprising effectiveness of simple analyses. Differences between the five development programmes as they affect statistics will be covered but some essential similarities will also be discussed.

A key issue is the difference between causal and predictive inference, a matter that has become important due to the emergence of new viral variants on the one hand and (of necessity) limited follow-up in the clinical trials that were conducted.

 

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