PSI EIWG Webinar: PIONEERing estimands in Clinical Research (Session 1)

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.

Speaker	Biography
Melanie Wright Novartis	Melanie Wright is a Biostatistics Global Group Head at Novartis Pharma AG. She has an MSc in Biometry from University of Reading (UK) and started working in the pharmaceutical industry in 1996. Despite her background in statistics, Melanie describes herself as “an experienced drug developer with a focus on structured quantitative decision making”. Melanie has been leading many activities as part of the estimand workstream at Novartis for the last 3 years and from last year became involved in the EFSPI/EFPIA estimand working group.
Sue McKendrick PPD	Sue McKendrick is an Associate Statistical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991, she graduated with an M.Sc. in Biometry from University of Reading, UK and has been a Chartered Statistician since 1998. Sue has over 25 years’ experience of statistical consultancy across drug development in both CRO and pharma companies, including collaborating with clinical colleagues on protocol development.
Nanco Hefting Lundbeck	Nanco Hefting is Chief Scientific Specialist in the Clinical Research – Psychiatry department at H. Lundbeck A/S, Copenhagen, Denmark. He has a Master of Science in pharmacy and pharmacist education from the University of Groningen, NL, 1991 and has worked since as a clinical scientist and clinical lead in Clinical Pharmacology and Clinical Development in various companies. Nanco has been involved in the EFSPI/EFPIA estimand working group and is Co-Chair of the EIWG.
Rikke Agesen Novo Nordisk	Rikke Mette Agesen is a Senior International Medical Manager in Global Development at Novo Nordisk. She graduated as a Medical Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke holds a PhD and a Postdoctoral position in Type 1 diabetes and hypoglycaemia. With a physician’s perspective Rikke represents Novo Nordisk in the EFPIA/EFSPI estimand implementation working group (EIWG).
Helle Lynggaard Novo Nordisk	Helle Lynggaard is a Principal Statistician in Global Development at Novo Nordisk. She obtained her MSc from the University of Aalborg in 1994 and her PhD in 2005 from the University of Copenhagen. She has worked with Novo Nordisk since 1994 in different statistical roles including being a Project Statistician. Since 2015 she has been working in a cross-project biostatistics department that provides support to statisticians in the clinical projects. Helle is a key driver in implementing estimands in Novo Nordisk studies, and is a member of the EFPIA/EFSPI estimand implementation working group (EIWG).

Speaker	Biography
Melanie Wright Novartis	Melanie Wright is a Biostatistics Global Group Head at Novartis Pharma AG. She has an MSc in Biometry from University of Reading (UK) and started working in the pharmaceutical industry in 1996. Despite her background in statistics, Melanie describes herself as “an experienced drug developer with a focus on structured quantitative decision making”. Melanie has been leading many activities as part of the estimand workstream at Novartis for the last 3 years and from last year became involved in the EFSPI/EFPIA estimand working group.
Sue McKendrick PPD	Sue McKendrick is an Associate Statistical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991, she graduated with an M.Sc. in Biometry from University of Reading, UK and has been a Chartered Statistician since 1998. Sue has over 25 years’ experience of statistical consultancy across drug development in both CRO and pharma companies, including collaborating with clinical colleagues on protocol development.
Nanco Hefting Lundbeck	Nanco Hefting is Chief Scientific Specialist in the Clinical Research – Psychiatry department at H. Lundbeck A/S, Copenhagen, Denmark. He has a Master of Science in pharmacy and pharmacist education from the University of Groningen, NL, 1991 and has worked since as a clinical scientist and clinical lead in Clinical Pharmacology and Clinical Development in various companies. Nanco has been involved in the EFSPI/EFPIA estimand working group and is Co-Chair of the EIWG.
Rikke Agesen Novo Nordisk	Rikke Mette Agesen is a Senior International Medical Manager in Global Development at Novo Nordisk. She graduated as a Medical Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke holds a PhD and a Postdoctoral position in Type 1 diabetes and hypoglycaemia. With a physician’s perspective Rikke represents Novo Nordisk in the EFPIA/EFSPI estimand implementation working group (EIWG).
Helle Lynggaard Novo Nordisk	Helle Lynggaard is a Principal Statistician in Global Development at Novo Nordisk. She obtained her MSc from the University of Aalborg in 1994 and her PhD in 2005 from the University of Copenhagen. She has worked with Novo Nordisk since 1994 in different statistical roles including being a Project Statistician. Since 2015 she has been working in a cross-project biostatistics department that provides support to statisticians in the clinical projects. Helle is a key driver in implementing estimands in Novo Nordisk studies, and is a member of the EFPIA/EFSPI estimand implementation working group (EIWG).

Speaker	Biography
Melanie Wright Novartis	Melanie Wright is a Biostatistics Global Group Head at Novartis Pharma AG. She has an MSc in Biometry from University of Reading (UK) and started working in the pharmaceutical industry in 1996. Despite her background in statistics, Melanie describes herself as “an experienced drug developer with a focus on structured quantitative decision making”. Melanie has been leading many activities as part of the estimand workstream at Novartis for the last 3 years and from last year became involved in the EFSPI/EFPIA estimand working group.
Sue McKendrick PPD	Sue McKendrick is an Associate Statistical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991, she graduated with an M.Sc. in Biometry from University of Reading, UK and has been a Chartered Statistician since 1998. Sue has over 25 years’ experience of statistical consultancy across drug development in both CRO and pharma companies, including collaborating with clinical colleagues on protocol development.
Nanco Hefting Lundbeck	Nanco Hefting is Chief Scientific Specialist in the Clinical Research – Psychiatry department at H. Lundbeck A/S, Copenhagen, Denmark. He has a Master of Science in pharmacy and pharmacist education from the University of Groningen, NL, 1991 and has worked since as a clinical scientist and clinical lead in Clinical Pharmacology and Clinical Development in various companies. Nanco has been involved in the EFSPI/EFPIA estimand working group and is Co-Chair of the EIWG.
Rikke Agesen Novo Nordisk	Rikke Mette Agesen is a Senior International Medical Manager in Global Development at Novo Nordisk. She graduated as a Medical Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke holds a PhD and a Postdoctoral position in Type 1 diabetes and hypoglycaemia. With a physician’s perspective Rikke represents Novo Nordisk in the EFPIA/EFSPI estimand implementation working group (EIWG).
Helle Lynggaard Novo Nordisk	Helle Lynggaard is a Principal Statistician in Global Development at Novo Nordisk. She obtained her MSc from the University of Aalborg in 1994 and her PhD in 2005 from the University of Copenhagen. She has worked with Novo Nordisk since 1994 in different statistical roles including being a Project Statistician. Since 2015 she has been working in a cross-project biostatistics department that provides support to statisticians in the clinical projects. Helle is a key driver in implementing estimands in Novo Nordisk studies, and is a member of the EFPIA/EFSPI estimand implementation working group (EIWG).

Speaker	Biography
Melanie Wright Novartis	Melanie Wright is a Biostatistics Global Group Head at Novartis Pharma AG. She has an MSc in Biometry from University of Reading (UK) and started working in the pharmaceutical industry in 1996. Despite her background in statistics, Melanie describes herself as “an experienced drug developer with a focus on structured quantitative decision making”. Melanie has been leading many activities as part of the estimand workstream at Novartis for the last 3 years and from last year became involved in the EFSPI/EFPIA estimand working group.
Sue McKendrick PPD	Sue McKendrick is an Associate Statistical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991, she graduated with an M.Sc. in Biometry from University of Reading, UK and has been a Chartered Statistician since 1998. Sue has over 25 years’ experience of statistical consultancy across drug development in both CRO and pharma companies, including collaborating with clinical colleagues on protocol development.
Nanco Hefting Lundbeck	Nanco Hefting is Chief Scientific Specialist in the Clinical Research – Psychiatry department at H. Lundbeck A/S, Copenhagen, Denmark. He has a Master of Science in pharmacy and pharmacist education from the University of Groningen, NL, 1991 and has worked since as a clinical scientist and clinical lead in Clinical Pharmacology and Clinical Development in various companies. Nanco has been involved in the EFSPI/EFPIA estimand working group and is Co-Chair of the EIWG.
Rikke Agesen Novo Nordisk	Rikke Mette Agesen is a Senior International Medical Manager in Global Development at Novo Nordisk. She graduated as a Medical Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke holds a PhD and a Postdoctoral position in Type 1 diabetes and hypoglycaemia. With a physician’s perspective Rikke represents Novo Nordisk in the EFPIA/EFSPI estimand implementation working group (EIWG).
Helle Lynggaard Novo Nordisk	Helle Lynggaard is a Principal Statistician in Global Development at Novo Nordisk. She obtained her MSc from the University of Aalborg in 1994 and her PhD in 2005 from the University of Copenhagen. She has worked with Novo Nordisk since 1994 in different statistical roles including being a Project Statistician. Since 2015 she has been working in a cross-project biostatistics department that provides support to statisticians in the clinical projects. Helle is a key driver in implementing estimands in Novo Nordisk studies, and is a member of the EFPIA/EFSPI estimand implementation working group (EIWG).

Speaker	Biography
Melanie Wright Novartis	Melanie Wright is a Biostatistics Global Group Head at Novartis Pharma AG. She has an MSc in Biometry from University of Reading (UK) and started working in the pharmaceutical industry in 1996. Despite her background in statistics, Melanie describes herself as “an experienced drug developer with a focus on structured quantitative decision making”. Melanie has been leading many activities as part of the estimand workstream at Novartis for the last 3 years and from last year became involved in the EFSPI/EFPIA estimand working group.
Sue McKendrick PPD	Sue McKendrick is an Associate Statistical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991, she graduated with an M.Sc. in Biometry from University of Reading, UK and has been a Chartered Statistician since 1998. Sue has over 25 years’ experience of statistical consultancy across drug development in both CRO and pharma companies, including collaborating with clinical colleagues on protocol development.
Nanco Hefting Lundbeck	Nanco Hefting is Chief Scientific Specialist in the Clinical Research – Psychiatry department at H. Lundbeck A/S, Copenhagen, Denmark. He has a Master of Science in pharmacy and pharmacist education from the University of Groningen, NL, 1991 and has worked since as a clinical scientist and clinical lead in Clinical Pharmacology and Clinical Development in various companies. Nanco has been involved in the EFSPI/EFPIA estimand working group and is Co-Chair of the EIWG.
Rikke Agesen Novo Nordisk	Rikke Mette Agesen is a Senior International Medical Manager in Global Development at Novo Nordisk. She graduated as a Medical Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke holds a PhD and a Postdoctoral position in Type 1 diabetes and hypoglycaemia. With a physician’s perspective Rikke represents Novo Nordisk in the EFPIA/EFSPI estimand implementation working group (EIWG).
Helle Lynggaard Novo Nordisk	Helle Lynggaard is a Principal Statistician in Global Development at Novo Nordisk. She obtained her MSc from the University of Aalborg in 1994 and her PhD in 2005 from the University of Copenhagen. She has worked with Novo Nordisk since 1994 in different statistical roles including being a Project Statistician. Since 2015 she has been working in a cross-project biostatistics department that provides support to statisticians in the clinical projects. Helle is a key driver in implementing estimands in Novo Nordisk studies, and is a member of the EFPIA/EFSPI estimand implementation working group (EIWG).

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