Past PSI Events

Conferences

PSI Webinar: How to use prior knowledge and still give new data a chance?

Time: 15:00 - 17:00 UK time

The paper to be presented appeared earlier this year in Pharmaceutical Statistics (Weber, Hemmings, Koch, 17, 329-341) and is motivated by the opportunities and challenges for using Bayesian methods with informative priors to support drug development and licencing when only a small pool of patients is available, as in the case of rare diseases and paediatric population. With a small study population, meeting the expected level of evidence required for regulatory approval can be challenging. The specific focus of the paper is on the use of data‐based priors in the decision-making process of paediatric extrapolation, and results are presented comparing different frequentist and Bayesian meta-analytic methods for combining adult and paediatric data.

In this webinar, the authors will present their paper, followed by discussion on: 

 - Scientific rationale for borrowing existing data to make inference about drug effects under different settings: rare diseases, extrapolation and use of historical controls.

 - Other methods for combining historical and prospective data beyond standard meta-analytic approaches (e.g., robust MAP priors). 

 - Ways in which the Bayesian strategy could be supplemented or adapted to enable the independent contribution of the new trial data to be formally quantified and assessed. 

We are pleased to announce that the meeting will be chaired by Byron Jones (Novartis)

Presenters: 

 Kristina Weber
Kristina Weber (Institute for Biostatistics, Hannover Medical School) 

Kristina Weber is since 2014 a research associate at the Institute of Biostatistics, Hannover Medical School. Her research interests are in the development of efficient and effective research strategies in limited populations. Her PhD thesis focuses on the application of Bayesian methods in paediatric and rare diseases extrapolation concepts. She has joined Roche in November 2018.
 Rob Hemmings Rob Hemmings (MHRA)

Rob has been with the Licensing Division within MHRA for approaching 19 years, has been a co-opted member of CHMP for 11 years; chair of the EMA’s SAWP for the past 8 years; first chair and then member of the EMA’s BSWP since its inception.
 Armin Koch

Armin Koch (Institute for Biostatistics, Hannover Medical School)

Professor Armin Koch studied mathematics and chemistry at Heidelberg University, has been a research assistant at the German Centre for the Research on Cancer (DKFZ) between 1984 and 1991. Thereafter he has been an employee at the Institute of Medical Biometry at Heidelberg University until in 1999 when he joined the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. From 2001 to 2008 he was head of the unit „Biostatistics and Experimental Design“. Since 2008 he is Director of the Institute for Biostatistics at Hannover Medical School. Prof. Koch is a member of the Scientific Advice Working Party (SAWP) and the Biostatistics working party (BSWP) at the European Medicines Agency (EMA) and has been a member of the International Council for Harmonisation ICH-E17 working group.

 

Discussants:

 Nicky Best Nicky Best (GSK) (on behalf of the EFSPI/PSI Historical Data SIG)

Nicky Best was an academic statistician for 20 years, starting out at the Medical Research Council Biostatistics Unit in Cambridge, UK before moving to Imperial College London, where she was professor of Statistics and Epidemiology. Her research interests focused around the development and application of Bayesian methods in health and social science, and she is a co-developer of the BUGS Bayesian software package. In 2014 she moved to GlaxoSmithKline (GSK), where she is Head of the Advanced Biostatistics and Data Analytics group. She was awarded the RSS/PSI award for Statistical Excellence in the Pharmaceutical Industry in 2015 for her leading role in implementing expert prior elicitation methods and statistical assurance calculations to improve decision making in clinical development at GSK, and the RSS Bradford Hill Medal in 2018 for her contributions to the exposition and application of Bayesian methods to clinical trials, cost-effectiveness, epidemiology and drug development programmes.
 Lisa LaVange Lisa LaVange (University of North Carolina, Chapel Hill)

Lisa LaVange, PhD, is Professor and Associate Chair of Biostatistics, Gillings School of Global Public Health, UNC-CH.  She is also director of the department’s Collaborative Studies Coordinating Center.  From 2011 to 2017, Dr. LaVange led the Office of Biostatistics, CDER, FDA, where she directed over 200 statisticians involved in the development and application of statistical methodology for drug regulation.  Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry.  Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and is the 2018 ASA President. 

 

 

 
 Registration
 PSI Member  Free
 Non-member  £20 (plus VAT) 

Registration has now closed.

Scientific Meetings

PSI Webinar: How to use prior knowledge and still give new data a chance?

Time: 15:00 - 17:00 UK time

The paper to be presented appeared earlier this year in Pharmaceutical Statistics (Weber, Hemmings, Koch, 17, 329-341) and is motivated by the opportunities and challenges for using Bayesian methods with informative priors to support drug development and licencing when only a small pool of patients is available, as in the case of rare diseases and paediatric population. With a small study population, meeting the expected level of evidence required for regulatory approval can be challenging. The specific focus of the paper is on the use of data‐based priors in the decision-making process of paediatric extrapolation, and results are presented comparing different frequentist and Bayesian meta-analytic methods for combining adult and paediatric data.

In this webinar, the authors will present their paper, followed by discussion on: 

 - Scientific rationale for borrowing existing data to make inference about drug effects under different settings: rare diseases, extrapolation and use of historical controls.

 - Other methods for combining historical and prospective data beyond standard meta-analytic approaches (e.g., robust MAP priors). 

 - Ways in which the Bayesian strategy could be supplemented or adapted to enable the independent contribution of the new trial data to be formally quantified and assessed. 

We are pleased to announce that the meeting will be chaired by Byron Jones (Novartis)

Presenters: 

 Kristina Weber
Kristina Weber (Institute for Biostatistics, Hannover Medical School) 

Kristina Weber is since 2014 a research associate at the Institute of Biostatistics, Hannover Medical School. Her research interests are in the development of efficient and effective research strategies in limited populations. Her PhD thesis focuses on the application of Bayesian methods in paediatric and rare diseases extrapolation concepts. She has joined Roche in November 2018.
 Rob Hemmings Rob Hemmings (MHRA)

Rob has been with the Licensing Division within MHRA for approaching 19 years, has been a co-opted member of CHMP for 11 years; chair of the EMA’s SAWP for the past 8 years; first chair and then member of the EMA’s BSWP since its inception.
 Armin Koch

Armin Koch (Institute for Biostatistics, Hannover Medical School)

Professor Armin Koch studied mathematics and chemistry at Heidelberg University, has been a research assistant at the German Centre for the Research on Cancer (DKFZ) between 1984 and 1991. Thereafter he has been an employee at the Institute of Medical Biometry at Heidelberg University until in 1999 when he joined the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. From 2001 to 2008 he was head of the unit „Biostatistics and Experimental Design“. Since 2008 he is Director of the Institute for Biostatistics at Hannover Medical School. Prof. Koch is a member of the Scientific Advice Working Party (SAWP) and the Biostatistics working party (BSWP) at the European Medicines Agency (EMA) and has been a member of the International Council for Harmonisation ICH-E17 working group.

 

Discussants:

 Nicky Best Nicky Best (GSK) (on behalf of the EFSPI/PSI Historical Data SIG)

Nicky Best was an academic statistician for 20 years, starting out at the Medical Research Council Biostatistics Unit in Cambridge, UK before moving to Imperial College London, where she was professor of Statistics and Epidemiology. Her research interests focused around the development and application of Bayesian methods in health and social science, and she is a co-developer of the BUGS Bayesian software package. In 2014 she moved to GlaxoSmithKline (GSK), where she is Head of the Advanced Biostatistics and Data Analytics group. She was awarded the RSS/PSI award for Statistical Excellence in the Pharmaceutical Industry in 2015 for her leading role in implementing expert prior elicitation methods and statistical assurance calculations to improve decision making in clinical development at GSK, and the RSS Bradford Hill Medal in 2018 for her contributions to the exposition and application of Bayesian methods to clinical trials, cost-effectiveness, epidemiology and drug development programmes.
 Lisa LaVange Lisa LaVange (University of North Carolina, Chapel Hill)

Lisa LaVange, PhD, is Professor and Associate Chair of Biostatistics, Gillings School of Global Public Health, UNC-CH.  She is also director of the department’s Collaborative Studies Coordinating Center.  From 2011 to 2017, Dr. LaVange led the Office of Biostatistics, CDER, FDA, where she directed over 200 statisticians involved in the development and application of statistical methodology for drug regulation.  Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry.  Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and is the 2018 ASA President. 

 

 

 
 Registration
 PSI Member  Free
 Non-member  £20 (plus VAT) 

Registration has now closed.

Training Courses

PSI Webinar: How to use prior knowledge and still give new data a chance?

Time: 15:00 - 17:00 UK time

The paper to be presented appeared earlier this year in Pharmaceutical Statistics (Weber, Hemmings, Koch, 17, 329-341) and is motivated by the opportunities and challenges for using Bayesian methods with informative priors to support drug development and licencing when only a small pool of patients is available, as in the case of rare diseases and paediatric population. With a small study population, meeting the expected level of evidence required for regulatory approval can be challenging. The specific focus of the paper is on the use of data‐based priors in the decision-making process of paediatric extrapolation, and results are presented comparing different frequentist and Bayesian meta-analytic methods for combining adult and paediatric data.

In this webinar, the authors will present their paper, followed by discussion on: 

 - Scientific rationale for borrowing existing data to make inference about drug effects under different settings: rare diseases, extrapolation and use of historical controls.

 - Other methods for combining historical and prospective data beyond standard meta-analytic approaches (e.g., robust MAP priors). 

 - Ways in which the Bayesian strategy could be supplemented or adapted to enable the independent contribution of the new trial data to be formally quantified and assessed. 

We are pleased to announce that the meeting will be chaired by Byron Jones (Novartis)

Presenters: 

 Kristina Weber
Kristina Weber (Institute for Biostatistics, Hannover Medical School) 

Kristina Weber is since 2014 a research associate at the Institute of Biostatistics, Hannover Medical School. Her research interests are in the development of efficient and effective research strategies in limited populations. Her PhD thesis focuses on the application of Bayesian methods in paediatric and rare diseases extrapolation concepts. She has joined Roche in November 2018.
 Rob Hemmings Rob Hemmings (MHRA)

Rob has been with the Licensing Division within MHRA for approaching 19 years, has been a co-opted member of CHMP for 11 years; chair of the EMA’s SAWP for the past 8 years; first chair and then member of the EMA’s BSWP since its inception.
 Armin Koch

Armin Koch (Institute for Biostatistics, Hannover Medical School)

Professor Armin Koch studied mathematics and chemistry at Heidelberg University, has been a research assistant at the German Centre for the Research on Cancer (DKFZ) between 1984 and 1991. Thereafter he has been an employee at the Institute of Medical Biometry at Heidelberg University until in 1999 when he joined the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. From 2001 to 2008 he was head of the unit „Biostatistics and Experimental Design“. Since 2008 he is Director of the Institute for Biostatistics at Hannover Medical School. Prof. Koch is a member of the Scientific Advice Working Party (SAWP) and the Biostatistics working party (BSWP) at the European Medicines Agency (EMA) and has been a member of the International Council for Harmonisation ICH-E17 working group.

 

Discussants:

 Nicky Best Nicky Best (GSK) (on behalf of the EFSPI/PSI Historical Data SIG)

Nicky Best was an academic statistician for 20 years, starting out at the Medical Research Council Biostatistics Unit in Cambridge, UK before moving to Imperial College London, where she was professor of Statistics and Epidemiology. Her research interests focused around the development and application of Bayesian methods in health and social science, and she is a co-developer of the BUGS Bayesian software package. In 2014 she moved to GlaxoSmithKline (GSK), where she is Head of the Advanced Biostatistics and Data Analytics group. She was awarded the RSS/PSI award for Statistical Excellence in the Pharmaceutical Industry in 2015 for her leading role in implementing expert prior elicitation methods and statistical assurance calculations to improve decision making in clinical development at GSK, and the RSS Bradford Hill Medal in 2018 for her contributions to the exposition and application of Bayesian methods to clinical trials, cost-effectiveness, epidemiology and drug development programmes.
 Lisa LaVange Lisa LaVange (University of North Carolina, Chapel Hill)

Lisa LaVange, PhD, is Professor and Associate Chair of Biostatistics, Gillings School of Global Public Health, UNC-CH.  She is also director of the department’s Collaborative Studies Coordinating Center.  From 2011 to 2017, Dr. LaVange led the Office of Biostatistics, CDER, FDA, where she directed over 200 statisticians involved in the development and application of statistical methodology for drug regulation.  Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry.  Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and is the 2018 ASA President. 

 

 

 
 Registration
 PSI Member  Free
 Non-member  £20 (plus VAT) 

Registration has now closed.

Journal Club

PSI Webinar: How to use prior knowledge and still give new data a chance?

Time: 15:00 - 17:00 UK time

The paper to be presented appeared earlier this year in Pharmaceutical Statistics (Weber, Hemmings, Koch, 17, 329-341) and is motivated by the opportunities and challenges for using Bayesian methods with informative priors to support drug development and licencing when only a small pool of patients is available, as in the case of rare diseases and paediatric population. With a small study population, meeting the expected level of evidence required for regulatory approval can be challenging. The specific focus of the paper is on the use of data‐based priors in the decision-making process of paediatric extrapolation, and results are presented comparing different frequentist and Bayesian meta-analytic methods for combining adult and paediatric data.

In this webinar, the authors will present their paper, followed by discussion on: 

 - Scientific rationale for borrowing existing data to make inference about drug effects under different settings: rare diseases, extrapolation and use of historical controls.

 - Other methods for combining historical and prospective data beyond standard meta-analytic approaches (e.g., robust MAP priors). 

 - Ways in which the Bayesian strategy could be supplemented or adapted to enable the independent contribution of the new trial data to be formally quantified and assessed. 

We are pleased to announce that the meeting will be chaired by Byron Jones (Novartis)

Presenters: 

 Kristina Weber
Kristina Weber (Institute for Biostatistics, Hannover Medical School) 

Kristina Weber is since 2014 a research associate at the Institute of Biostatistics, Hannover Medical School. Her research interests are in the development of efficient and effective research strategies in limited populations. Her PhD thesis focuses on the application of Bayesian methods in paediatric and rare diseases extrapolation concepts. She has joined Roche in November 2018.
 Rob Hemmings Rob Hemmings (MHRA)

Rob has been with the Licensing Division within MHRA for approaching 19 years, has been a co-opted member of CHMP for 11 years; chair of the EMA’s SAWP for the past 8 years; first chair and then member of the EMA’s BSWP since its inception.
 Armin Koch

Armin Koch (Institute for Biostatistics, Hannover Medical School)

Professor Armin Koch studied mathematics and chemistry at Heidelberg University, has been a research assistant at the German Centre for the Research on Cancer (DKFZ) between 1984 and 1991. Thereafter he has been an employee at the Institute of Medical Biometry at Heidelberg University until in 1999 when he joined the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. From 2001 to 2008 he was head of the unit „Biostatistics and Experimental Design“. Since 2008 he is Director of the Institute for Biostatistics at Hannover Medical School. Prof. Koch is a member of the Scientific Advice Working Party (SAWP) and the Biostatistics working party (BSWP) at the European Medicines Agency (EMA) and has been a member of the International Council for Harmonisation ICH-E17 working group.

 

Discussants:

 Nicky Best Nicky Best (GSK) (on behalf of the EFSPI/PSI Historical Data SIG)

Nicky Best was an academic statistician for 20 years, starting out at the Medical Research Council Biostatistics Unit in Cambridge, UK before moving to Imperial College London, where she was professor of Statistics and Epidemiology. Her research interests focused around the development and application of Bayesian methods in health and social science, and she is a co-developer of the BUGS Bayesian software package. In 2014 she moved to GlaxoSmithKline (GSK), where she is Head of the Advanced Biostatistics and Data Analytics group. She was awarded the RSS/PSI award for Statistical Excellence in the Pharmaceutical Industry in 2015 for her leading role in implementing expert prior elicitation methods and statistical assurance calculations to improve decision making in clinical development at GSK, and the RSS Bradford Hill Medal in 2018 for her contributions to the exposition and application of Bayesian methods to clinical trials, cost-effectiveness, epidemiology and drug development programmes.
 Lisa LaVange Lisa LaVange (University of North Carolina, Chapel Hill)

Lisa LaVange, PhD, is Professor and Associate Chair of Biostatistics, Gillings School of Global Public Health, UNC-CH.  She is also director of the department’s Collaborative Studies Coordinating Center.  From 2011 to 2017, Dr. LaVange led the Office of Biostatistics, CDER, FDA, where she directed over 200 statisticians involved in the development and application of statistical methodology for drug regulation.  Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry.  Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and is the 2018 ASA President. 

 

 

 
 Registration
 PSI Member  Free
 Non-member  £20 (plus VAT) 

Registration has now closed.

Webinars

PSI Webinar: How to use prior knowledge and still give new data a chance?

Time: 15:00 - 17:00 UK time

The paper to be presented appeared earlier this year in Pharmaceutical Statistics (Weber, Hemmings, Koch, 17, 329-341) and is motivated by the opportunities and challenges for using Bayesian methods with informative priors to support drug development and licencing when only a small pool of patients is available, as in the case of rare diseases and paediatric population. With a small study population, meeting the expected level of evidence required for regulatory approval can be challenging. The specific focus of the paper is on the use of data‐based priors in the decision-making process of paediatric extrapolation, and results are presented comparing different frequentist and Bayesian meta-analytic methods for combining adult and paediatric data.

In this webinar, the authors will present their paper, followed by discussion on: 

 - Scientific rationale for borrowing existing data to make inference about drug effects under different settings: rare diseases, extrapolation and use of historical controls.

 - Other methods for combining historical and prospective data beyond standard meta-analytic approaches (e.g., robust MAP priors). 

 - Ways in which the Bayesian strategy could be supplemented or adapted to enable the independent contribution of the new trial data to be formally quantified and assessed. 

We are pleased to announce that the meeting will be chaired by Byron Jones (Novartis)

Presenters: 

 Kristina Weber
Kristina Weber (Institute for Biostatistics, Hannover Medical School) 

Kristina Weber is since 2014 a research associate at the Institute of Biostatistics, Hannover Medical School. Her research interests are in the development of efficient and effective research strategies in limited populations. Her PhD thesis focuses on the application of Bayesian methods in paediatric and rare diseases extrapolation concepts. She has joined Roche in November 2018.
 Rob Hemmings Rob Hemmings (MHRA)

Rob has been with the Licensing Division within MHRA for approaching 19 years, has been a co-opted member of CHMP for 11 years; chair of the EMA’s SAWP for the past 8 years; first chair and then member of the EMA’s BSWP since its inception.
 Armin Koch

Armin Koch (Institute for Biostatistics, Hannover Medical School)

Professor Armin Koch studied mathematics and chemistry at Heidelberg University, has been a research assistant at the German Centre for the Research on Cancer (DKFZ) between 1984 and 1991. Thereafter he has been an employee at the Institute of Medical Biometry at Heidelberg University until in 1999 when he joined the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. From 2001 to 2008 he was head of the unit „Biostatistics and Experimental Design“. Since 2008 he is Director of the Institute for Biostatistics at Hannover Medical School. Prof. Koch is a member of the Scientific Advice Working Party (SAWP) and the Biostatistics working party (BSWP) at the European Medicines Agency (EMA) and has been a member of the International Council for Harmonisation ICH-E17 working group.

 

Discussants:

 Nicky Best Nicky Best (GSK) (on behalf of the EFSPI/PSI Historical Data SIG)

Nicky Best was an academic statistician for 20 years, starting out at the Medical Research Council Biostatistics Unit in Cambridge, UK before moving to Imperial College London, where she was professor of Statistics and Epidemiology. Her research interests focused around the development and application of Bayesian methods in health and social science, and she is a co-developer of the BUGS Bayesian software package. In 2014 she moved to GlaxoSmithKline (GSK), where she is Head of the Advanced Biostatistics and Data Analytics group. She was awarded the RSS/PSI award for Statistical Excellence in the Pharmaceutical Industry in 2015 for her leading role in implementing expert prior elicitation methods and statistical assurance calculations to improve decision making in clinical development at GSK, and the RSS Bradford Hill Medal in 2018 for her contributions to the exposition and application of Bayesian methods to clinical trials, cost-effectiveness, epidemiology and drug development programmes.
 Lisa LaVange Lisa LaVange (University of North Carolina, Chapel Hill)

Lisa LaVange, PhD, is Professor and Associate Chair of Biostatistics, Gillings School of Global Public Health, UNC-CH.  She is also director of the department’s Collaborative Studies Coordinating Center.  From 2011 to 2017, Dr. LaVange led the Office of Biostatistics, CDER, FDA, where she directed over 200 statisticians involved in the development and application of statistical methodology for drug regulation.  Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry.  Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and is the 2018 ASA President. 

 

 

 
 Registration
 PSI Member  Free
 Non-member  £20 (plus VAT) 

Registration has now closed.

Careers Meetings

PSI Webinar: How to use prior knowledge and still give new data a chance?

Time: 15:00 - 17:00 UK time

The paper to be presented appeared earlier this year in Pharmaceutical Statistics (Weber, Hemmings, Koch, 17, 329-341) and is motivated by the opportunities and challenges for using Bayesian methods with informative priors to support drug development and licencing when only a small pool of patients is available, as in the case of rare diseases and paediatric population. With a small study population, meeting the expected level of evidence required for regulatory approval can be challenging. The specific focus of the paper is on the use of data‐based priors in the decision-making process of paediatric extrapolation, and results are presented comparing different frequentist and Bayesian meta-analytic methods for combining adult and paediatric data.

In this webinar, the authors will present their paper, followed by discussion on: 

 - Scientific rationale for borrowing existing data to make inference about drug effects under different settings: rare diseases, extrapolation and use of historical controls.

 - Other methods for combining historical and prospective data beyond standard meta-analytic approaches (e.g., robust MAP priors). 

 - Ways in which the Bayesian strategy could be supplemented or adapted to enable the independent contribution of the new trial data to be formally quantified and assessed. 

We are pleased to announce that the meeting will be chaired by Byron Jones (Novartis)

Presenters: 

 Kristina Weber
Kristina Weber (Institute for Biostatistics, Hannover Medical School) 

Kristina Weber is since 2014 a research associate at the Institute of Biostatistics, Hannover Medical School. Her research interests are in the development of efficient and effective research strategies in limited populations. Her PhD thesis focuses on the application of Bayesian methods in paediatric and rare diseases extrapolation concepts. She has joined Roche in November 2018.
 Rob Hemmings Rob Hemmings (MHRA)

Rob has been with the Licensing Division within MHRA for approaching 19 years, has been a co-opted member of CHMP for 11 years; chair of the EMA’s SAWP for the past 8 years; first chair and then member of the EMA’s BSWP since its inception.
 Armin Koch

Armin Koch (Institute for Biostatistics, Hannover Medical School)

Professor Armin Koch studied mathematics and chemistry at Heidelberg University, has been a research assistant at the German Centre for the Research on Cancer (DKFZ) between 1984 and 1991. Thereafter he has been an employee at the Institute of Medical Biometry at Heidelberg University until in 1999 when he joined the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. From 2001 to 2008 he was head of the unit „Biostatistics and Experimental Design“. Since 2008 he is Director of the Institute for Biostatistics at Hannover Medical School. Prof. Koch is a member of the Scientific Advice Working Party (SAWP) and the Biostatistics working party (BSWP) at the European Medicines Agency (EMA) and has been a member of the International Council for Harmonisation ICH-E17 working group.

 

Discussants:

 Nicky Best Nicky Best (GSK) (on behalf of the EFSPI/PSI Historical Data SIG)

Nicky Best was an academic statistician for 20 years, starting out at the Medical Research Council Biostatistics Unit in Cambridge, UK before moving to Imperial College London, where she was professor of Statistics and Epidemiology. Her research interests focused around the development and application of Bayesian methods in health and social science, and she is a co-developer of the BUGS Bayesian software package. In 2014 she moved to GlaxoSmithKline (GSK), where she is Head of the Advanced Biostatistics and Data Analytics group. She was awarded the RSS/PSI award for Statistical Excellence in the Pharmaceutical Industry in 2015 for her leading role in implementing expert prior elicitation methods and statistical assurance calculations to improve decision making in clinical development at GSK, and the RSS Bradford Hill Medal in 2018 for her contributions to the exposition and application of Bayesian methods to clinical trials, cost-effectiveness, epidemiology and drug development programmes.
 Lisa LaVange Lisa LaVange (University of North Carolina, Chapel Hill)

Lisa LaVange, PhD, is Professor and Associate Chair of Biostatistics, Gillings School of Global Public Health, UNC-CH.  She is also director of the department’s Collaborative Studies Coordinating Center.  From 2011 to 2017, Dr. LaVange led the Office of Biostatistics, CDER, FDA, where she directed over 200 statisticians involved in the development and application of statistical methodology for drug regulation.  Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry.  Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and is the 2018 ASA President. 

 

 

 
 Registration
 PSI Member  Free
 Non-member  £20 (plus VAT) 

Registration has now closed.

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.

AIMS SIG - Open-Source Lunch Bites

Topic: R Package Basics. Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.

PSI Mentoring 2026

Date: Ongoing 6 month cycle beginning late April/early May 2026 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.

PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence

If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event! Haven’t read the book yet? Pick up a copy today and join us. Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.

PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities

This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation. The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication. The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication. The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.