CALL FOR ABSTRACT SUBMISSIONS

This year the Scientific Programme Committee plans to organize a Contributed Papers section and a Poster section within the Forum. Abstract proposals for both sessions are awaited, deadline: 10 September 2018. Suggested topics may include: problems related to quality analysis, multiple endpoints in biosimilar studies, the choice of equivalence margins, subgroup analysis, interchangeability, switchability. However, other topics are also welcome.

ABOUT THE EVENT SERIES
The Annual Biosimilars Forum event series examines the actual challenges of biosimilar drug development for research management, leadership and support teams working in and for biosimilar drug development. The event provides a detailed overview of current development issues of follow-on biologics and guidance for their handling.
This year’s event will cover important issues and specific areas of debate facing clinical development teams specialized in biosimilar development with a strong focus on statistical and regulatory perspectives. As in previous years, the program of the event will be supported and complemented by leading experts from the fields of regulatory, academic and clinical research.

SCIENTIFIC PROGRAMME COMMITTEE

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

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

SHORT AGENDA

This two-day series of events consists of a COURSE DAY with two professional lecture sessions (October 25th) and a SYMPOSIUM DAY (invited presentations, posters and round table session, scheduled for October 26th) comprising issues in biosimilar development with strong FOCUS ON Statistical and Regulatory Perspectives.

25th October, 2018 | COURSES with special lecturers

26th October, 2018 | SYMPOSIUM and ROUND TABLE

SPEAKERS AND LECTURERS

As in previous years, the program of the event will be supported and complemented by international specialists from the biosimilars and nanosimilars area. The programme of the event will continue to expand until October with internationally renowned subject experts. Some specialists who accepted the invitation to participate at the 3rd Annual Biosimilars Forum:



László ENDRÉNYI
Professor Emeritus from the University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists


Andrea LASLOP
European Regulatory Expert; Unit Head, Austrian Medicines and Medical Devices Agency


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


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


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


János SZEBENI
Director of the Nanomedicine Research and Education Center of Semmelweis Medical University, Budapest

MORE SPEAKERS
COMING SOON


Tickets are available now with flexible terms. Please send us your registration as soon as possible because places are limited in number! WBS and ISCB members can attend the 2nd day symposium for free.

Registration deadline: 15th October, 2018

1st day COURSES with special lecturers

MORNING COURSE SESSION

Uni- and multivariate Bioequivalence of
PK parameters

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

In cooperation with: Phillip PALLMANN
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK

AFTERNOON COURSE SESSION

Preclinical biosimilar assays consider both bioequivalence (PK) and equivalence (surrogate therapeutic endpoints)

Lecturer of the Afternoon Course Session:

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

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

The detailed programme of the event will be available soon, until then we recommend you read more about our previous forums!

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 two 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

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 and 2nd Annual Biosimilars Forum, 2016 – 2017)

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 Annual Biosimilars Forum, 2017)

Andrea LASLOP
European Regulatory Expert, Unit Head, Austrian Medicines and Medical Devices Agency
(Speaker of the 1st and 2nd Annual Biosimilars Forum, 2016-2017)

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.

Learn more about the previous events! Click on the links below and take a look at short video interviews with the key lecturers, photo galleries and account of experiences articles of our events.

IMAGE GALLERY | Annual Biosimilars Forums


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.