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

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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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