SPEAKERS OF THE PREVIOUS ANNUAL BIOSIMILARS FORUMS (2016 | 2017 | 2018 | 2019)

Shein-Chung CHOW
Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, USA

László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists, Canada

Andrea LASLOP

Head of Scientific Office,
Austrian Medicines and Medical Devices Agency (AGES), Austria

Johanna MIELKE

Biostatistician,
Novartis Pharma AG, Germany
 

Bernd JILMA
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna, Austria
 

Franz KÖNIG
Associate Professor,
Section for Medical Statistics, Medical University of Vienna, Austria

Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency, former President of the Viennese Section of IBS, Austria

Júlia SINGER
Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics, Hungary

Vid STANULOVIC

Consultant,
Clinical Development and Pharmacovigilance, Hungary

Helmut SCHÜTZ
Owner at
BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria

Idikó ARADI
Head of Clinical Development of Biologics, Gedeon Richter Plc.,Vice-Chair, Medicines for Europe – European Biosimilars Group, Hungary

Péter ARÁNYI
Secretary,
Medical Research Council, Ethics Committee for Clinical Pharmacology, Hungary

László TÓTHFALUSI
Associate Professor,
Faculty of Pharmacology, Semmelweis Medical University, Hungary

Ina-Christine RONDAK
Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA, Germany

János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Professor at University of Miskolc, Dep. of Nanobiotechnology and the Regenerative Medicine, Institute of Theoretical Medicine, Hungary

Marina A. DOBROVOLSKAIA
Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA

Raj BAWA
President of Bawa Biotech LLC; Adjunct Professor at Rensselaer Polytechnic Institute, USA; Founding Director of American Society for Nanomedicine; USA

Ágnes GYURASICS
Hungarian member of EMA Committee for Human Medicinal Products (CHMP), and EMA Paediatric Committee (PDCO); Unit Head at National Institute of Pharmacy and Nutrition, Hungary

Thomas JAKI
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK

Philip PALLMANN
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK

Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Germany

Emmanuelle VINCENT
Head of Biostatistics and Data Management, Fresenius-Kabi, Switzerland

Heike WOEHLING
Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis, Germany

Gert STORM
Professor of Targeted Nanomedicine at the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands

Robert SCHALL
Professor, Statistical Consultation Unit, Department of Mathematical Statistics and Actuarial Science, University of the Free State, South Africa

Divan BURGER
Senior Lecturer, Department of Statistics, University of Pretoria,, South Africa

Arne RING
Professor of Statistics, University of the Free State, South Africa; Head of Biometrics and Statistical Programming, medac GmbH, Germany

Andreas BRANDT
Statistical assessor, Federal Institute for Drugs and Medical Devices (BfArM), Germany

ABOUT THE ORGANIZERS

The Annual Biosimilars Forum event series was founded in 2016 by two prestigious Central European scientific societies, the Viennese Section of the IBS and the Hungarian Society for Clinical Biostatistics in cooperation with the Accelsiors CRO Ltd., aimed at increasing effectiveness of clinical research and in order to provide even more effective support in sharing of recent scientific and practical knowledge for biosimilar development professionals and provide an opportunity for a constructive and open dialogue between regulatory professionals, clinical researchers, medical statisticians and pharmaceutical developers.

Viennese Section of the International Biometric Society
The Viennese Section of the International Biometric Society is part of the ROeS, the Austrian Swiss Region of the International Biometric Society (IBS). WBS is an independent, non-profit organization which provides a professional forum for discussions on how to apply statistical methods in biological and medical science.

Hungarian Society for Clinical Biostatistics
The Hungarian Society for Clinical Biostatistics is a national group of the International Society for Clinical Biostatistics (ISCB). One of its aims is to stimulate research of principles and methodologies used in the design and analysis of clinical trial.

Acccelsiors CRO Ltd.
Accelsiors – as a scientific driven CRO – has been a committed supporter of biosimilar drug development, many of their professionals were involved into biosimilar drug development from the early beginnings, guided and managed the first biosimilar drug development projects and professionally supporting clinical trials as well as registration in this innovative field and being active in the clinical research arena in the past two decades.