PROGRAMME OF THE 4th ANNUAL BIOSIMILARS FORUM (17-18 OCT, 2019)

This 2-day series of events consists of a professional COURSE DAY and a SYMPOSIUM DAY, comprising burning issues in Biosimilar development with a dedicated focus on the statistical and regulatory aspects of follow-on biologics.

During these two interactive days the forum ensures maximum knowledge transfer among professionals, regulators and leading subject matter experts in biosimilar development to exchange and elaborate on the best practices and debate the evolving landscape, pitfalls and current perspectives of biosimilars.

COURSE DAY

17 OCT, 2019

professional course in advanced biostatistics and robust methods in assessing biosimilarity, will be delivered by prominent biosimilar research expert scientists.

SYMPOSIUM DAY

18 OCT, 2019

professional presentations and round table sessions, focusing on statistical and regulatory perspectives in biosimilar development (presented by leading experts from the fields of regulatory, academic and clinical research).

 COURSE DAY PROGRAMME 17 OCT, 2019

Title of the short course:
  • Robust methods for assessment of average and scaled average bioequivalence
Presenters:

Robert SCHALL
Professor, Statistical Consultation Unit, Department of Mathematical Statistics and Actuarial Science, University of the Free State, South Africa

Co-author:
Divan BURGER
Senior Lecturer, Department of Statistics, University of Pretoria, South Africa

Summary of the course:

The short course presents robust methods for the assessment of both average and of scaled average bioequivalence, based on data from conventional cross-over studies and replicate design cross-over studies.

Initially, in an empirical study of a large number of average bioequivalence studies, the results of the
(i) classic,
(ii) conventional nonparametric and
(iii) Bayesian robust analyses are compared, and the need for robust analyses is discussed.

Thereafter, the classic and Bayesian robust methods are applied to a group of replicate design bioequivalence studies, and diagnostic plots and outlier diagnostics for such studies are presented. Robust analysis of replicate design bioequivalence data affects not only the estimation of the location parameters of the test and reference formulations, but also the within-reference scaling factor; a proposal is made for the appropriate handling of this matter.

The proposed Bayesian robust methodology is flexible with regard to study design (conventional cross-over, replicate design cross-over, parallel design) and with regard to the handling of outliers and skewness in the data.

Discover more about the Forum:
SYMPOSIUM DAY PROGRAMME

Join us for discovery, inspiration and meet leading biosimilar development experts at our Forum!

Advance Round tickets with 15% discount 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.