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

This 2-day series of events consisted 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 ensured 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

a professional course in advanced biostatistics and robust methods in assessing biosimilarity (delivered by prominent biosimilar research expert academic 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

SYMPOSIUM DAY PROGRAMME 18 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.

Course Agenda

 13:00 – 14:00 | 1st day Registration

14:00 – 15:00 | 1st PART
  1. Objectives
  2. Rationale
  1. Potential Need for Robust Methodology
  2. Approach: Bayesian Framework / t-Distribution
  1. Average Bioequivalence
  1. Statistical Model
  2. Types of Outlier
  3. Robust Methodology

15:00 – 15:20 | Coffee Break

15:20 – 16:40 | 2nd PART
  1. Empirical Study
  1. Data Pool
  2. Need for Robust Methodology
    1. Degrees of Freedom
    2. Shift in Point and Interval Estimates
    3. Relative Confidence Interval Widths
  3. Method Comparison: Agreement between Methods
  1. Simulation study: Confidence Interval Coverage / Power
  1. Scaled Average Bioequivalence
  1. Statistical Model
  2. Types of Outlier
  3. Outlier plots
  4. Robust Methodology

16:40 – 17:00 | Coffee Break

17:00 – 18:00 | 3rd PART
  1. Empirical Study
  1. Data Pool
  2. Need for Robust Methodology: Confidence Intervals and Degrees of Freedom
  1. Method Comparison: Agreement Between Methods
  2. Simulation study: Confidence interval coverage / Power
  1. Discussion / Summary

Discover more about the Forum:
SYMPOSIUM DAY PROGRAMME