SPEAKERS AND LECTURERS

The program of the event will be supported and complemented by several international experts. The final agenda and the list of lectures and speakers of the event is currently under preparation, the complete list will be available soon. Some specialists who have already accepted our invitation to participate in the 2nd Annual Biosimilars Forum:

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

Title of lecture:

Scientific factors in biosimilar product development

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

Title of course:

Open issues in the assessment of bioequivalence and biosimilarity

Andrea LASLOP
Unit Head,

Austrian Medicines and Medical Devices Agency

Title of keynote presentation:

12 years of biosimilars in Europe:
What is the exposure and response in our learning curve?

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

Title of lecture:

Investigating PK/PD in the steep ascending part of the dose response curve

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

Title of lecture:

Statistical considerations in the biosimilarity assessment of quality attributes

Johanna MIELKE

Biostatistician,
Novartis Pharma AG
 

Title of lecture:

Clinical trials for biosimilars in Europe: an updated systematic comparison of the
clinical development programs

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

Title of lecture:

Regulatory perspective on comparison of quality attributes in drug development

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

Title of lecture:

Immune side effects of biologicals and nanomedicines: unsolved issues in bio- and nanosimilar development

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

Title of lecture:

Algorithms for evaluating reference scaled average bioequivalence: Power, bias and consumer risk

(co-author and lecturer: László Endrényi)

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 of 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 International Society for Clinical Biostatistics (ISCB), and it was founded to stimulate research into the principles and methodology used in the design and analysis of clinical research and to increase the relevance of statistical theory to the real world of clinical medicine.

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.