This two-day series of events consists of a COURSE DAY with two professional lecture sessions (October 25th) and a SYMPOSIUM DAY (invited presentations, posters and round table session, scheduled for October 26th) comprising issues in biosimilar development with strong FOCUS ON Statistical and Regulatory Perspectives.
The event provides a detailed overview of current development issues of follow-on biologics and guidance for their handling. This unique forum will cover specific areas of controversy facing clinical development teams. The Annual Biosimilars Forum event series examines the actual challenges of biosimilar drug development with for research management, leadership and support teams working in and for biosimilars.
SCIENTIFIC PROGRAMME COMMITTEE
Vice-Chair, Medicines for Europe, Biosimilar Medicines Group; Head of Clinical Development of Biologics, Gedeon Richter Plc.
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna
Associate Professor, Section for Medical Statistics, Medical Unversity of Vienna
Statistician, Austrian Medicines and Medical Devices Agency; President, Viennese Section of IBS
Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics
As in previous years, the programme of the event will be supported and complemented by international specialists from the biosimilars and nanosimilars area. The agenda of the forum will continue to expand until October with internationally renowned experts. Some specialists who accepted the invitation to participate at the 3rd Annual Biosimilars Forum:
Marina A. DOBROVOLSKAIA
Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA
Professor Emeritus from the University of Toronto, Canada; Former President of Canadian Society for Pharmaceutical Scientists, Canada
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
Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Hannover, Germany
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK
European Regulatory Expert; Unit Head, Austrian Medicines and Medical Devices Agency, Austria
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria
Director of the Nanomedicine Research and Education Center of Semmelweis Medical University, Budapest, Hungary
Head of Biostatistics and Data Management,
Director Biostatistics for Biostatistics Biosimilars, Analytics group,
The list will be expanded soon
Tickets are available now with flexible terms. Please send us your registration as soon as possible because places are limited in number! WBS and ISCB members can attend the 2nd day symposium for free.
Register before 25th of MAY, and get up to 25% EARLY BIRD DISCOUNT from the ticket price!
Testing for the equivalence of the pharmacokinetic behaviour of compounds is an indispensable task in biosimilar and generic development. In many cases this is done on the basis of pharmacokinetic (PK) parameters that summarize how the compound is absorbed, distributed, metabolised and excreted.
In this course we will briefly discuss how different PK parameters can be estimated using a non-compartmental approach and then show how bioequivalence can be assessed on the basis of a single as well as multiple PK parameters.
The R packages PK and jocre will be presented.
- Multiple endpoints are common, and they are not necessarily equally distributed.
- Equivalence thresholds are, if ever, defined as ratios. Therefore, ratio-to-comparator tests and confidence intervals are needed.
- Commonly log-normal distribution is assumed. Alternatives for normal distribution (including variance heterogeneity) or any distribution (rank statistics) will be discussed. Claiming equivalence for multiple correlated endpoints is challenging.
- The pros and cons of multivariate tests and intersection-union tests are discussed.
- Sometimes bioassays with multiple biosimilars with respect to a single comparator are considered.
- The pros and cons of multiplicity adjustment will be discussed.
- The three topics will be explained by means of real data examples using CRAN packages.
EXCLUSIVE CONTENT – free video lecture series
Watch for free the presentations from the 2nd Biosimilars Forum
Sign up and watch all of the presentation videos recorded at the 2nd Biosimilars Forum for free. Progress your learning from the World’s prominent biosimilar drug development experts.
This video lecture series includes all of the professional courses & lectures delivered at the 2nd Biosimilars Forum relating to actual issues / challenges of follow-on biologics and guidance for their handling. The 1st lesson of the 3-part course about the ‘Open issues in the assessment of bioequivalence and biosimilarity’ lectured by Helmut SCHÜTZ is available now.
CALL FOR ABSTRACT SUBMISSIONS
This year the Scientific Programme Committee plans to organize a Contributed Papers section and a Poster section within the Forum.
The organizers are pleased to invite authors to submit abstracts for poster and oral symposium presentations to be delivered at the 3rd Annual Biosimilars Forum.
Email us your Abstract, participate at our 3rd event with your professional work!