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The goal of the Annual Biosimilars Forum
In cooperation with two prestigious international scientific institute partners, the Viennese Section of the IBS and the Hungarian Society for Clinical Biostatistics, Accelsiors CRO launched the Annual Biosimilars Forum professional event series in order to provide even more effective support in sharing of recent scientific and practical knowledge for professionals who are working in and for biosimilar drug development. The event series provides an opportunity for a constructive and open dialogue on hot development topics between regulatory professionals, clinical researchers, medical scientists, statisticians and pharmaceutical developers.
SOME PROFESSIONAL LECTURES FROM PREVIOUS EVENTS
At the Annual Biosimilars Forum event series, clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this key topic of research. Some topics of the last three year’s forums included:
2016 OCT: 1st Annual Biosimilars Forum | Lecture examples:
Design and analysis of biosimilar studies
(3-part course)
Shein-Chung CHOW
Professor, Duke University School of Medicine
Interchangeability of biological drug products
László ENDRÉNYI
Professor Emeritus, University of Toronto (co-author: László TÓTHFALUSI, Associate Professor, Semmelweis Medical University)
The regulator’s view on the totality of evidence for biosimilars
Andrea LASLOP
Unit Head, Austrian Medicines and Medical Devices Agency
Biosimilar development – a statistical assessor’s perspective
Stephan LEHR
President, Viennese Section of IBS; Biostatistician, Austrian Medicines and Medical Devices Agency
2017 OCT: 2nd Annual Biosimilars Forum | Lecture examples:
Scientific factors in biosimilar product development
László ENDRÉNYI
Professor Emeritus of University of Toronto
Open issues in the assessment of bioequivalence and biosimilarity
Helmut Schütz
Owner at BEBAC – Consultancy Services
Immune side effects of biologicals and nanomedicines
János SZEBENI
Director of the Nanomedicine Research and Education Center at Semmelweis University
Regulatory keynote lecture: 12 years of biosimilars in Europe
Andrea LASLOP
Unit Head, Austrian Medicines and Medical Devices Agency
2018 OCT: 3rd Annual Biosimilars Forum | Lecture examples:
The Era of Biosimilars and Nanosimilars: Current Perspectives
Raj BAWA
Founding Director of American Society for Nanomedicine
Uni- and multivariate Bioequivalence of PK parameters
Thomas JAKI: Professor of Statistics, Lancaster University
& Philip PALLMANN: Deputy Director RDCS, Cardiff University
The biosimilar concept revisited – is there a need for change?
Andrea LASLOP
Unit Head, Austrian Medicines and Medical Devices Agency
How the increase of assay sensitivity influences the immunogenicity
Heike WÖHLING,
Director Biostatistics for Biostatistics Biosimilars, Novartis
2019 OCT.: 4th Annual Biosimilars Forum | Topic examples:
Robust methods for assessment of average and scaled average bioequivalence
Robert SCHALL
Professor, University of the Free State
Dival BURGER
Senior Lecturer, University of Pretoria
Balaam’s Design Revisited
Julia SINGER
Chief Scientific Officer, Accelsiors CRO Ltd.;
President, Hungarian Society for Clinical Biostatistics
Measuring switchability using observational data
László TÓTHFALUSI
Associate Professor, Semmelweis Medical University
Co-author: László ENDRÉNYI
Professor Emeritus, University of Toronto
Challenge the Regulator!
Extended Regulatory Panel Discussion and Q&A type of interaction
with the participation of Regulators from around Europe
TESTIMONIALS
SOME INTERNATIONAL BIOSIMILAR EXPERT SPEAKERS FROM OUR PREVIOUS FORUMS
Shein-Chung CHOW
Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine
(Lecturer of the 1st Annual Biosimilars Forum, 2016)
László ENDRÉNYIProfessor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists
(Lecturer of the 1st, 2nd and 3rd Annual Biosimilars Forum, 2016 – 2017 – 2018)
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
(Speaker of the 2nd and 3rd Annual Biosimilars Forum, 2017 – 2018)
Andrea LASLOP
European Regulatory Expert, Unit Head, Austrian Medicines and Medical Devices Agency
(Speaker of the 1st, 2nd and 3rd Annual Biosimilars Forum, 2016 – 2017 – 2018)
Bernd JILMA
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna
(Speaker of the 1st and 2nd Annual Biosimilars Forum, 2016 – 2017)
Helmut SCHÜTZVIDEO HIGHLIGHTS
Please watch this short videos with the key lecturers and the organizers of the previous forums summarizing their thoughts about the topic and sharing their experiences, or click on the links below and take a look at some short video interviews with the key speakers of our previous events.
IMAGE GALLERY | Annual Biosimilars Forums
Feel free to ask 
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expertise and 2 decades of experiences
in biosimilar clinical trials.
Biosimilar development is one of the main specialties of Accelsiors CRO. Our professionals were among the first pioneers in the biosimilars field, supporting biosimilar development programs from 1996 with the first biosimilar, somatotropin.
Accelsiors’ dedicated Biosimilar Research Team can support you in every aspect of clinical and nonclinical development of your biosimilar compound from the concept through pre-clinical development to successful conduct of Phase III registration trials.
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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.
