AGENDA

This two-day series of events consists of a COURSE DAY (October 5th) and a professional SYMPOSIUM DAY (invited presentations and round table session, scheduled for October 6th) regarding hot topics related to the development of biosimilars with strong FOCUS ON Statistical and Regulatory Perspectives.

9:00 – 9:30 

2nd Day Registration (for those attending only day 2)

9:30 – 10:00

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

Johanna MIELKE,
Biostatistician,
Novartis Pharma AG

10:00 – 10:30

Algorithms for evaluating reference scaled average bioequivalence: power, bias and consumer risk
László TÓTHFALUSI,
Associate Professor,
Faculty of Pharmacology, Semmelweis Medical University, Budapest
László ENDRÉNYI,
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists

10:30 – 11:00

Investigating PK/PD in the steep ascending part of the dose response curve
Bernd JILMA,
Vice Chair,
Department Clinical Pharmacology, Medical University of Vienna

11:00 – 11:30

Coffee Break

11:30 – 12:20

1st Keynote lecture: 12 years of biosimilars in Europe: what’s the exposure and response in our learning curve?
Andrea LASLOP,
Unit Head,
Austrian Medicines and Medical Devices Agency

12:20 – 12:50

Regulatory perspective on comparison of quality attributes in drug development
Ina-Christine RONDAK,
Biostatistician,
Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA
Stephan LEHR,
Biostatistician, Austrian Medicines and Medical Devices Agency,
President, Viennese Section of IBS

12:50 – 13:45

Lunch Break

13:45 – 14:25

2nd Keynote lecture: Immune side effects of biologicals and nanomedicines: unsolved issues in bio- and nanosimilar 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

14:25 – 14:45

Coffee Break

14:45 – 16:45

Round table discussion:
Moderator:
Júlia SINGER,
Chief Scientific Officer, Accelsiors CRO Ltd.;
President, Hungarian Society for Clinical Biostatistics
Discussants:
Regulatory perspective: Stephan LEHR,
Biostatistician, Austrian Medicines and Medical Devices Agency,
President, Viennese Section of IBS
Industry perspective: Heike WÖHLING,
Head of Biostatistics,
Sandoz Biopharmaceuticals
Panel members:
Ildikó ARADI ,
Head of Clinical Development of Biologics, Gedeon Richter Plc.,
Vice-Chair, European Generic medicines Association – European Biosimilars Group
Bernd JILMA,
Vice Chair,
Department Clinical Pharmacology, Medical University of Vienna
Franz KÖNIG,
Associate Professor,
Medical Unversity of Vienna, Section for Medical Statistics
Andrea LASLOP,
Unit Head,
Austrian Medicines and Medical Devices Agency
Johanna MIELKE,
Biostatistician,
Novartis Pharma AG
Vid STANULOVIC,
Consultant,
Clinical Development and Pharmacovigilance