© Copyrights: All of these presentation videos and materilas available this page and the content of these are owned by the authors of the lectures and are protected by copyright laws and international treaty provisions. Reproduction of any material on these lectures is only authorized for exclusive information for strictly personal and private use. Any reproduction and/or representation of all or part of the lectures, or any of the elements that compose it, on any media whatsoever, for any other purpose, including commercial, is expressly prohibited, unless the prior written authorization from the authors.
25 OCT, 2018 | 1st DAY: PK COURSES
MORNING COURSE SESSION: Uni- and multivariate Bioequivalence of PK parameters
1st Part of the course | 
48:42
Non-compartmental estimation of PK parameters
2nd Part of the course | 58:34
Univariate / Multiplicity and / Multivariate Bioequivalence
3rd Part of the course | 53:15
Multivariate Bioequivalence
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
AFTERNOON COURSE SESSION: Statistical aspects of equivalence testing for biosimilar studies: multiple, differently-scaled endpoints
1st Part of the course | 1:17:09
2nd Part of the course | 54:36
3rd Part of the course | 54:31
Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Germany
26 OCT, 2018 | 2nd DAY SYMPOSIUM AND ROUND TABLE: Clinical Research and Regulatory
Case Study | 33:25
An update on development strategies of recently approved biosimilars in Europe
Johanna MIELKE
Early Stage Research Fellow,
IDEAS Innovative Training Network
Early Stage Research Fellow,
IDEAS Innovative Training Network
Scientific Keynote Presentation | 1:04:35
Bioequivalence of highly variable drug products – an update
László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Co-author: László TÓTHFALUSI, Associate Professor, Semmelweis University
Presentation | 32:45
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
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
Regulatory Keynote Presentation | 43:22
The biosimilar concept revisited – is there a need for change?
Andrea LASLOP
Unit Head,
Austrian Medicines and Medical Devices Agency
Unit Head,
Austrian Medicines and Medical Devices Agency
Case Study | 24:29
Opportunities and limitations of a blinded sample size reassessment in biosimilars development
Emmanuelle VINCENT
Head of Biostatistics and Data Management,
Fresenius-Kabi
Head of Biostatistics and Data Management,
Fresenius-Kabi
Case Study | 26:03
Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian‐frequentist approach
Johanna MIELKE
Early Stage Research Fellow,
IDEAS Innovative Training Network
Early Stage Research Fellow,
IDEAS Innovative Training Network
Case Study | 25:40
How the increase of assay sensitivity influences the immunogenicity
Heike WOEHLING
Director Biostatistics for Biostatistics Biosimilars, Analytics group,
Novartis, Germany
Director Biostatistics for Biostatistics Biosimilars, Analytics group,
Novartis, Germany
Case Study | 47:47
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
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University
Discussion | 1:10:02
Round Table Session
Modarator:
Helmut SCHÜTZ
Owner at BEBAC – Consultancy Services
Helmut SCHÜTZ
Owner at BEBAC – Consultancy Services
27 OCT, 2018 | 3rd DAY SEMINAR in Nanomedicines
MORNING SEMINAR SESSION | 55:51
Part 1: The Era of Biosimilars and Nanosimilars: Current Perspectives
Raj BAWA
President of Bawa Biotech LLC; Adjunct Professor at Rensselaer Polytechnic Institute, USA; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA
President of Bawa Biotech LLC; Adjunct Professor at Rensselaer Polytechnic Institute, USA; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA
MORNING SEMINAR SESSION | 1:08:02
Part 2: The Era of Biosimilars and Nanosimilars: Current Perspectives
Raj BAWA
President of Bawa Biotech LLC; Adjunct Professor at Rensselaer Polytechnic Institute, USA; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA
President of Bawa Biotech LLC; Adjunct Professor at Rensselaer Polytechnic Institute, USA; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA
WebEx Presentation | 1:08:04
The immunological characterization of nanotechnology-formulated drugs
Marina A. DOBROVOLSKAIA
Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA
Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA
AFTERNOON SEMINAR | 1:09:30
Targeted Nanomedicine: State of Art and Future Developments
Gert STORM
Professor of Targeted Nanomedicine at the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands
Professor of Targeted Nanomedicine at the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands
