Ildikó ARADI
Vice-Chair, Medicines for Europe, Biosimilar Medicines Group; Head of Clinical Development of Biologics, Gedeon Richter Plc.
Bernd JILMA
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna
Franz KÖNIG
Associate Professor, Section for Medical Statistics, Medical Unversity of Vienna
Stephan LEHR
Statistician, Austrian Medicines and Medical Devices Agency; President, Viennese Section of IBS
Júlia SINGER
Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics
SPEAKERS, LECTURERS, SPECIAL GUESTS (2018 OCT):
The World’s prominent biosimilar development experts have returned to Budapest in 2018 to the 3rd Annual Biosimilars Forum.
As in previous years, the programme of the event was supported and complemented by international bio- and nanosimilar development specialists from the fields of regulatory, academic and clinical research. Some specialists who accepted the invitation to participate at the 3rd Annual Biosimilars Forum:
Raj BAWA
President of Bawa Biotech LLC; Adjunct Professor at Rensselaer Polytechnic Institute, USA; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA
Marina A. DOBROVOLSKAIA
Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA
László ENDRÉNYI
Professor Emeritus from the University of Toronto, Canada; Former President of Canadian Society for Pharmaceutical Scientists, Canada
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
Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Hannover, Germany
Thomas JAKI
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK
Andrea LASLOP
European Regulatory Expert; Unit Head, Austrian Medicines and Medical Devices Agency, Austria
Philip PALLMANN
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK
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
János SZEBENI
Director of the Nanomedicine Research and Education Center of Semmelweis Medical University, Budapest, Hungary
Emmanuelle VINCENT
Head of Biostatistics and Data Management,
Fresenius-Kabi, Switzerland
Heike WOEHLING
Director Biostatistics for Biostatistics Biosimilars, Analytics group,
Novartis, Germany
Johanna MIELKE
Early Stage Research Fellow, IDEAS Innovative Training Network
Ildikó ARADI
OVice-Chair, Medicines for Europe, Biosimilar Medicines Group; Head of Clinical Development of Biologics, Gedeon Richter Plc., Hungary
Helmut SCHÜTZ
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria
SOME SPEAKERS FROM OUR PREVIOUS FORUMS
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, Canada
Bernd JILMA
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna, Austria
Andrea LASLOP
Unit Head, Austrian Medicines and Medical Devices Agency, Austria
Helmut SCHÜTZ
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria
János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Hungary
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.
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.
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.
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.
