5th OCTOBER, 2017
1st day: COURSE with special lecturers
11:00 – 12:00
1st Day Registration
12:00 – 13:00
Scientific factors in biosimilar product development
 László ENDRÉNYI,Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
13:00 – 14:00
Lunch break
14:00 – 17:40
Open issues in the assessment of bioequivalence and biosimilarity
 The course is lectured by:Helmut Schütz, Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies |
Main topics of the course:
- Unequal carry-over – “solved” in BE but still an Issue in Assessing Biosimilarity?
- Multi-Group and Multi-Site Studies. To pool or not to pool?
- Group-Sequential and Two-Stage Designs.
- Reference-scaling and Control of the Type I Error.
Schedule of the course:
14:00 – 15:00 | 1st part of COURSE
15:00 – 15:20 | Coffee break: refreshments & networking
15:20 – 16:20 | 2nd part of COURSE
16:20 – 16:40 | Coffee break: refreshments & networking
16:40 – 17:40 | 3rd part of COURSE
17:40 – 18:00
Discussion
6th OCTOBER, 2017
2nd day: SYMPOSIUM and ROUND TABLE SECTION
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
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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 |
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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:
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Regulatory perspective: Stephan LEHR, Biostatistician, Austrian Medicines and Medical Devices Agency, President, Viennese Section of IBS |
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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 |
