The presentation materials of the professionally very fruitful 3rd Annual Biosimilars Forum are available to download, here are the links below to reach your copies:

© Copyrights: All of these presentation 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

Uni- and multivariate Bioequivalence of PK parameters

Lecturers of the Morning Course Session:

Thomas JAKI
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK

This presentation material is available only for those visitors who attended at the 1st-day course programme of the 3rd Biosimilars Forum.

Statistical aspects of equivalence testing for biosimilar studies: multiple, differently-scaled endpoints

The course is lectured by:
Ludwig A. HOTHORN,
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Germany

This presentation material is available only for those visitors who attended at the 1st-day course programme of the 3rd Biosimilars Forum.

26 OCT, 2018 | 2nd DAY SYMPOSIUM AND ROUND TABLE: Clinical Research and Regulatory

An update on development strategies of recently approved biosimilars in Europe

Johanna MIELKE,
Early Stage Research Fellow,
IDEAS Innovative Training Network

Presentation material
(.PDF, 674 KB)

Scientific Keynote Presentation:
Bioequivalence of highly variable drug products – an update

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

Presentation material
(.PDF, 1 410 KB)

Challenging issues in extrapolation of totality of evidence to pediatric indications in case of biosimilars

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

Presentation material
(.PDF, 1015 KB)

Regulatory Keynote Presentation:
The biosimilar concept revisited – is there a need for change?

Andrea LASLOP,
Unit Head,
Austrian Medicines and Medical Devices Agency

Presentation material
(.PDF, 1 432 KB)

Opportunities and limitations of a blinded sample size reassessment in biosimilars development

Emmanuelle VINCENT,
Head of Biostatistics and Data Management,

Presentation material
(.PDF, 584 KB)

Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian‐frequentist approach

Johanna MIELKE,
Early Stage Research Fellow,
IDEAS Innovative Training Network

Presentation material
(.PDF, 1 099 KB)

How the increase of assay sensitivity influences the immunogenicity

Director Biostatistics for Biostatistics Biosimilars, Analytics group,
Novartis, Germany

Presentation material
(.PDF,814 KB)

Animal models of immunogenicity and immune toxico-equivalence testing of nano-biopharmaceuticals

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

Presentation material
(.PDF, 4 080 KB)

27 OCT, 2018 | 3rd DAY SEMINAR in Nanomedicines

The Era of Biosimilars and Nanosimilars: Current Perspectives

President of Bawa Biotech LLC; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; Editor-in-Chief of the Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications, (CRC Press, 2016); USA

The immunological characterization of nanotechnology-formulated drugs

Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA

Presentation material
(.PDF, 5 746 KB)

Targeted Nanomedicine: State of Art and Future Developments

Professor of Targeted Nanomedicine at the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands

Presentation material
(.PDF, 7 710 KB)

Leaflet of the 3rd Annual Biosimilars Forum with Agenda

Leaflet of the Forum
(.PDF, 1.65 MB)

We had a successful and professionally fruitful event together in this year.
If you need more professional help or support regarding biosimilar drug development, do not hesitate to contact Accelsiors’ Biosimilar Research Team!