This summary page about the events is available in:

UPCOMING EVENT (Q4 of 2019):


Based on the success of our last years’ events, we have started to prepare our next, 4th Annual Biosimilars Forum, will be held in autumn of 2019 in Budapest.

Next forum will cover actual issues and specific areas of debate facing clinical development teams for biosimilars with a strong focus on statistical and regulatory perspectives. As in previous years, the program of the event will be supported and complemented by international subject experts from the biosimilars and nanomedicines area. The detailed program will be available soon, until then we recommend you read more about our previous forums below!

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

TESTIMONIALS

  • Bring the Regulators and Producer Companies together into one room is an excellent idea and a beautiful concept.

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

  • I think it’s very nicely covers the whole biosimilar development process… Broader roles could benefit from this conference!

    –Ildikó ARADI | Head of Clinical Development of Biologics, Gedeon Richter Plc.

  • These conferences are extremely useful, they provide discussions in many problems and issues. I hope very much that the series will continue …

    –László ENDRÉNYI | Professor Emeritus of Pharmacology and Biostatistics, University of Toronto

  • The Organizers really done a very good job trying to put together such a conference where we can exchange an idea regarding the regulatory approval process and also on some actual issues in the biosimilar drug development process.

    –Shein-Chung CHOW | Professor, Duke University School of Medicine

  • These meetings, where experts are coming together from the same or different countries bring something new: collaborations, new knowledge, so this is very precious.

    –János SZEBENI | Director of the Nanomedicine Research and Education Center at Semmelweis University

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 ENDRÉNYI
Professor 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 SCHÜTZ
Owner at
BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies
(Lecturer of the 2nd Annual Biosimilars Forum, 2017)

VIDEO 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 Accelsiors - The scientific driven CRO‘ Biosimilar Reserach experts!

Take advantage from Accelsiors’
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.
Let us to accelerate your biosimilar program by sharing with you our proficiency, experience and tailored service capabilities! Connect with us by filling out this contact form or click on the link below to reach more information about how we can support your pipeline.

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.