European Statistical Forum - Relatori

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 SSI Business Operations Excellence Senior Lead at UCB Biosciences GmbH. 

Lisa has over 20 years of experience in the clinical research industry. In her current role, Lisa is responsible for the management of the biostatistics team including the development professional growth, supervision of the quality of deliverables and outputs, as well as the management of processes for biostatistical activities to ensure they are up-to-date and aligned with the business need and regulatory requirements. Lisa’s areas of expertise include DSMB support, submission studies, integrated summaries, writing Statistical Analysis Plans and contributing to Clinical Study Reports. She has worked in a variety of therapeutic areas and has particular expertise in respiratory, cardiovascular, infectious diseases and oncology. She is a committee member of ESF (European Statistical Forum) and is also a member of several associations including PSI (Statisticians in the Pharmaceutical Industry) and EFSPI (European Federation of Statisticians of the Pharmaceutical Industry). Lisa has been a contributing author on scientific articles in cardiology, diabetes and oncology.

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 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.

Bruno has 25 years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. He holds various positions in Europe and in USA. Bruno joined UCB Pharma in 2007 as Director of Exploratory Statistics. Bruno is also since 2000 Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and Statistics. He is also a USP Expert, member of the Committee of Experts in Statistics since 2010. Bruno has authored or co-authored more than 100 publications and co-edited one book in applied Bayesian statistics.

Vaiva Deltuvaite-Thomas, PhD, is Research Statistician at International Drug Development Institute, IDDI. Her research focuses on Generalized Pairwise Comparisons based methods in multivariate data analysis, with or without missingness/censoring.
After 15 years working as a Community Pharmacist in Lithuania, Belgium, Ireland, and France, the need to understand and explain increasing amounts of drug and treatment related information, and more importantly misinformation, has led Vaiva to joining and completing the Master program in biostatistics, followed by a PhD research, at Hasselt University (Belgium).

Biography available soon

Frank has started in the biostatistics group at Boehringer Ingelheim in 2007. Initially, he worked as a project statistician in oncology, immunology and biosimilars. In 2016 he became one of the founding members of the methodology group at Boehringer-Ingelheim and served this team as the Head of Methodology Statistics from 2018. In 2021 he became the Head of Therapeutic Area and Methodology (TAM) Statistics. This group of data scientists is supporting clinical development teams regarding TA strategy, statistical methodology, statistical approaches to biomarker, pharmacokinetic and real-world evidence analyses as well as randomization and unblinding. Frank is also interested in agile methods and efficient organizational structures. He is passionate about collaborating across industry and with academia, in particular regarding the detection and promotion of data science talents via internships and thesis opportunities. Frank holds a PhD in statistics from Ulm University and MScs in mathematics and business mathematics from UW Milwaukee and Ulm University, respectively.

Andrew P. Grieve is a Statistical Research Fellow in the Centre of Excellence in Statistical Innovation at UCB Pharma. He is a former Chair of PSI (Statisticians in the Pharmaceutical Industry) and a past-President of the Royal Statistical Society. He has over 45 years of experience as a biostatistician working in the pharmaceutical industry and academia. He has been active in the majority of areas of pharmaceutical R&D in which statistical methods and statisticians are intimately involved including drug discovery, pre-clinical toxicology, pharmaceutical development, pharmacokinetics and pharmacodynamics, phase I-IV of clinical development, manufacturing, health economics and clinical operations. His statistical research has been primarily concerned with the implementation of Bayesian ideas and techniques. Latterly he has concentrated on the design and implementation of Bayesian adaptive trials, and the Probability of Success (PoS) of studies and drug development programs. He has published over 140 articles and is the author of two. He has been an invited speaker at national and international conferences on over 300 occasions.

Rob is a partner at Consilium, a consultancy partnership between Rob Hemmings and Tomas Salmonson, both long-standing contributors to the EU regulatory network.  Consilium supports companies in the design of clinical development programmes, the design, analysis and interpretation of clinical trials, regulatory strategy and regulatory interactions.

Previously Rob worked at AstraZeneca and then for 19 years at the Medicines and Healthcare products Regulatory Agency, heading the group of medical statisticians and pharmacokineticists.  Rob is a statistician by background and was co-opted as a member of EMA’s CHMP for expertise in medical statistics and epidemiology.  Over 11 years at CHMP, Rob served as was Rapporteur for multiple products and was widely engaged across both scientific and policy aspects of the committee’s work.  Rob also chaired the CHMP’s Scientific Advice Working Party for 8 years and also chaired EMA expert groups on Biostatistics, Modelling and Simulation and Extrapolation.  Rob has co-authored multiple regulatory guidance documents, including those related to estimands, subgroups, use of conditional marketing authorisation, development of fixed-dose combinations, extrapolation, missing data and adaptive designs and continues to work on any and all aspects of evidence generation in respect of medicine’s development.

Cornelia Kunz is currently working as a methodology statistician at Boehringer Ingelheim (BI). After completing her PhD at the Institute of Medical Biometry and Informatics at the University of Heidelberg, Cornelia moved to the UK where she continued her research at Warwick Medical School. She then became a lecturer at Lancaster University’s Maths and Stats department while also receiving the MRC Career Development Award in Biostatistics. Her research interest lies in adaptive and group sequential designs as well as in multiple testing problems.

Biography available soon