COURSE DAY
25 OCT, 2018
with 2 professional course sessions on statistical and pharmacokinetical aspects of biosimilarity assessment (delivered by prominent biosimilar research expert scientists).
SYMPOSIUM DAY
26 OCT, 2018
with invited professional presentations, posters and round table session, was focusing on statistical and regulatory perspectives in bio- and nanosimilar development (presented by leading experts from the fields of regulatory, academic and clinical research).
SEMINAR DAY in Nanomedicines
27 OCT, 2018
NEW IN 2018: the 3rd-day programme consisted of professional Seminar sessions regarding current perspectives of bio- and nanosimilar drug development (it was lectured by special international experts from the field of nanotechnology-formulated drug research).
1st COURSE DAY AGENDA
2nd SYMPOSIUM DAY AGENDA
26th OCTOBER, 2018
2nd day: SYMPOSIUM and ROUND TABLE SECTION
9:00 – 9:30
2nd Day Registration (for those attending only day 2)
9:30 – 9:50
An update on development strategies of recently approved biosimilars in Europe
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9:50 – 10:30
Scientific Keynote Presentation:
Bioequivalence of highly variable drug products – an update
 László ENDRÉNYI,Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists |
 Co-author: László TÓTHFALUSI,Associate Professor, Faculty of Pharmacology, Semmelweis Medical University |
10:30 – 10:50
Challenging issues in extrapolation of totality of evidence to pediatric indications in case of biosimilars
 Ágnes GYURASICS,Hungarian member of EMA Committee for Human Medicinal Products (CHMP), and EMA Paediatric Committee (PDCO); Unit Head at National Institute of Pharmacy and Nutrition, Hungary |
10:50 – 11:10
Coffee break: refreshments & networking
11:10 – 11:50
Regulatory Keynote Presentation:
The biosimilar concept revisited – is there a need for change?
 Andrea LASLOP,Unit Head, Austrian Medicines and Medical Devices Agency |
11:50 – 12:10
Opportunities and limitations of a blinded sample size reassessment in biosimilars development
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Emmanuelle VINCENT, Head of Biostatistics and Data Management, Fresenius-Kabi |
12:10 – 12:40
Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian‐frequentist approach
 Johanna MIELKE,Early Stage Research Fellow, IDEAS Innovative Training Network |
12:40 – 14:00
Lunch Break
14:00 – 14:40
Animal models of immunogenicity and immune toxico-equivalence testing of nano-biopharmaceuticals
 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 |
14:40 – 15:10
How the increase of assay sensitivity influences the immunogenicity
 Heike WOEHLING,Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis, Germany |
15:10 – 15:30
Coffee break: refreshments & networking
15:30 – 17:30
Round table discussion:
Moderator:
 Helmut SCHÜTZ,Owner BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies |
Discussants:
 Regulatory perspective: Andrea LASLOP,Unit Head, Austrian Medicines and Medical Devices Agency |
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Industry perspective: Heike WOEHLING, Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis |
Panel members:
 Ildikó ARADI ,Head of Clinical Development of Biologics, Gedeon Richter Plc., Vice-Chair, Medicines for Europe – European Biosimilars Group |
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Ágnes GYURASICS, Hungarian member of EMA Committee for Human Medicinal Products (CHMP), and EMA Paediatric Committee (PDCO); Unit Head at National Institute of Pharmacy and Nutrition |
 Júlia SINGER,Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics |
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Emmanuelle VINCENT, Head of Biostatistics and Data Management, Fresenius-Kabi, Switzerland |
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Johanna MIELKE, Early Stage Research Fellow, IDEAS Innovative Training Network |
2nd SYMPOSIUM DAY AGENDA
