Introduzione

In 2020 the revision of ICHE9 has become effective in the ICH regions.
Beyond the immediate operational consequences in terms of study documentation development, it has become clearer and clearer that the introduction of the Estimand framework may require methodological solutions which were not common practice in drug development when the revised guidance was released.

In this context, causal inference, or the problem of causality in general, has received a lot of attention in recent years. It appears to provide a suitable methodological framework for tackling some of these challenges.

Five years after its edition dedicated to Estimands, the European Statistical Forum returns to this topic intending to understand the deeper implications of the introduction of the ICHE9 (R1) guidance in terms of how the traditional approach of statistical inference may be affected in its fundamentals of sample size, testing, and estimation by the arrival of causal inference.

The conference will focus, among others, on the following areas:

  • Regulatory perspective on study design development based on causal inference methods
  • Operational implementation of causal inference methods
  • Novel approaches based on causal inference methodologies
  • Real case studies and practical approaches

Scientific Board
Jens-Otto Andreas - Project Lead Statistician at UCB Biosciences GmbH
Lisa Comarella - Director Biostatistics at CROS NT
Giacomo Mordenti - Head of Biostatistics & Data Management Europe at Daiichi Sankyo Europe GmbH
Marc Vandemeulebroecke - Global Group Head for Dermatology at Novartis Biostatistics

Who should attend?
The conference is addressed to statisticians, pharmacometricians, physicians, regulators, academia and other experts interested in the field belonging to: Pharmaceutical, and Biotechnology companies, CROs, Universities/Hospitals, Academic Research.

Programma

We’re working on the programme.
More details available soon

Relatori
Jens-Otto Andreas
Info Scientific Board

Jens-Otto Andreas

Project Lead Statistician at UCB Biosciences GmbH
Jens-Otto received a diploma in Mathematics in 1993. In 1994 he started his career in Biostatistics at Grünenthal GmbH in Aachen. Here he worked in several therapeutical areas like gynecology and pain. Later on he became a specialist in the Phase 1 area. In 2005 he started to UCB (legacy Schwarz Pharma) as a Project Biostatistician in Phase 1. With the restructuring at UCB in 2008 Jens-Otto became the Head EU Biostatistics supervising Biostatisticians located in Monheim (Germany) and Brussels. Since 2016 he is also the Head of the East Asia Biostatistics of UCB. UCB’s key indications are CNS and immunology. From 2017 to 2019  Jens-Otto was the Head of Statistical Sciences – Bone & New Diseases at UCB Biosciences GmbH. Currently Jens-Otto is holding the position of a Project Lead Statistician at UCB Biosciences GmbH. 
Lisa Comarella
Info Scientific Board

Lisa Comarella

Director Biostatistics at CROS NT
Lisa Comarella joined CROS NT in 2000 as a Statistician and Data Manager. In the past 19 years, she has developed a career in CROS NT as a Principal Statistician and since 2010 has been managing the team of biostatisticians as Director of Biostatistics. In her role as head of the department, Lisa is responsible for the management of statistics resources, supervision of the quality of deliverables, and contributing to complex and strategic projects as statistical lead. Lisa holds a Master’s degree in Statistics and Demographic Sciences from the University of Padua in Italy. She is a scientific committee chair for ESF – the European Statistical Forum, she is a member of associations of statisticians in Europe (PSI, EFSPI).
Giacomo Mordenti
Info Scientific Board

Giacomo Mordenti

Head of Biostatistics & Data Management Europe at Daiichi Sankyo Europe GmbH
After the degree in statistical sciences from the University of Florence (1998), Giacomo stared his career in drug development in Menarini where he was exposed to different therapeutic areas and development phases. In 2007 he moved to Geneva to join Merck Serono, where he led a biostatistical team dedicated to early development in oncology. In 2013 Giacomo joined Grunenthal as global head of Biostatistics. In 2016 he moved to medical device industry in Livanova as Global Head of Data Management and Statistics. In 2020 he joined Daiichi-Sankyo as Head of Biostatistcs and Data Management Europe. Since 2011 he is part of the scientific board of European Statistical Forum; since 2013 he is part of the European Statistical Leader group of EFSPI. His main research interests are in the field of Bayesian statistics, adaptive design and applications of data science techniques to drug development.
Marc Vandemeulebroecke
Info Scientific Board

Marc Vandemeulebroecke

Global Group Head for Dermatology at Novartis Biostatistics
Marc Vandemeulebroecke joined Novartis in 2006, coming from Schering AG in Berlin. He has been supporting development programs in early and late phase development across various disease areas (incl. Neuroscience, Gastrointestinal, Parasitology, Cardio-metabolic, Immunology, Transplant and Hepatology) as statistician and pharmacometrician. Currently he is Global Group Head for Dermatology. Marc holds a maîtrise in mathematics from the University Paris XI, a diploma in mathematics from the University of Münster, a PhD in mathematical statistics from the University of Magdeburg, and an MSc in PKPD modeling from the University of Manchester. He received the Gustav-Adolf-Lienert award from the German Region of the International Biometric Society (IBS) for his PhD thesis, which focused on adaptive designs. He co-authored various scientific publications and one R package and is Associate Editor of Pharmaceutical Statistics. Marc’s current interests include statistical graphics and machine learning.
Training

Pre-Conference Training: 15 November 2021 – Online
Stay tuned for the forthcoming updates!

Contatti

Valeria Quintily
Project & Scientific Manager
valeria.quintily@lsacademy.com
+39.329.4683329

Ilaria Butta
Events & Training Executive
ilaria.butta@lsacademy.com
+39.379.1492960


Quote di iscrizione

Registrations will open soon. Stay tuned!

Edizioni Passate
2020
Data Science and the Rise of New Analytical Techniques. The Evolution of the Clinical Development Paradigm and Biostatistics
2019
Statistical Methodology for the Assessment and Analysis of Risk and Safety Data in Clinical Development
2018
Innovative Clinical Trial Designs
2017
Statistical Methods for Rare Diseases and Special Populations
2016
Estimand and Missing Value
2015
Applications of Statistical Methodology in Early Drug Development
Acquista

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<p style="text-align: center;"><span>Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.</span><br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>

Virtual conference with presentations, slots for Q&A and discussion among delegates.
LS Academy will provide the link to join the conference some days before.

<p style="text-align: center;"><span>Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.</span><br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>