Agenda of the 3rd Biosimilars Forum – 25 OCT 2018

AGENDA OF THE 3rd ANNUAL BIOSIMILARS FORUM (OCT, 2018)

At this 3-day series of events we focused on the most actual issues and challenges in bio- and nanosimilar drug development with a strong focus on STATISTICAL and REGULATORY perspectives.

COURSE DAY

25 OCT, 2018

with 2 professional course sessions on statistical and pharmacokinetical aspects of biosimilarity assessment (delivered by prominent biosimilar research expert scientists).

SYMPOSIUM DAY

26 OCT, 2018

with invited professional presentations, posters and round table session, was focusing on statistical and regulatory perspectives in bio- and nanosimilar development (presented by leading experts from the fields of regulatory, academic and clinical research).

SEMINAR DAY in Nanomedicines

27 OCT, 2018

NEW IN 2018: the 3rd-day programme consisted of professional Seminar sessions regarding current perspectives of bio- and nanosimilar drug development (it was lectured by special international experts from the field of nanotechnology-formulated drug research).

1st COURSE DAY AGENDA

2nd SYMPOSIUM DAY AGENDA

3rd SEMINAR DAY AGENDA

25th OCTOBER, 2018

1st day: COURSES with special lecturers

8:30 – 9:00

1st Day Registration

9:00 – 12:30

MORNING COURSE SESSION:
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

Philip PALLMANN
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK

Abstract of the course:

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.

Schedule of the course:

9:00 – 10:00 | 1st part of COURSE

10:00 – 10:20 | Coffee break: refreshments & networking

10:20 – 11:20 | 2nd part of COURSE

11:20 – 11:40 | Coffee break: refreshments & networking

11:40 – 12:30 | 3rd part of COURSE

12:30 – 14:00

Lunch break

14:00 – 17:30

AFTERNOON COURSE SESSION:
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

Abstract of the course:

Preclinical biosimilar assays consider both bioequivalence (PK) and equivalence (surrogate therapeutic endpoints)
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.

Schedule of the course:

14:00 – 15:00 | 1st part of COURSE

15:00 – 15:20 | Coffee break: refreshments & networking

15:20 – 16:20 | 2nd part of COURSE

16:20 – 16:40 | Coffee break: refreshments & networking

16:40 – 17:30 | 3rd part of COURSE

17:30 – 18:00