Staburo Wiesn-Workshop 2019

Staburo Wiesn-Workshop 2019

Staburo Wiesn-Workshop 2019

It is a very nice custom to have our Staburo statistics training session on the first Monday of the two-week Oktoberfest period. This year, the Staburo team had the chance to learn about our new R shiny App in the first presentation “OTTO – Demonstration and Methodology”. OTTO stands for Optimal Tool for Tracking of Outliers. Afterwards we heard a talk about “Sample Size Calculation in Time-to-Event Trials with Non-Proportional Hazards Using GESTATE”, presented by our new colleague Jasmin.

After lunch, there where two more Talks, one about “Optimal Plate Layout for Relative Potency Estimation – A Simulation Study” and the last one from our new employee Armin about “Subgroup identification by generalized Patient Rule Induction Method (PRIM)”.

As always, this was a great opportunity to share knowledge with the whole Staburo team, get the chance to get to know the team better and to exchange ideas afterwards.

The second important custom is to pay the Oktoberfest (or also called “Wiesn”) a visit, after the workshop. Once again, we had a wonderful time with our growing team and some long-time Staburo clients.

Everyone got home safely – with additional knowledge from the workshop and positive vibes from the Oktoberfest. We are already looking forward to the Staburo “Wiesn” Workshop 2020 and thank all participants for making this a great team event!

Data analysis, clinical biostatistics and more.

Staburo supported successful biosimilar development program

Staburo supported successful biosimilar development program

Staburo supported biosimilar development 

Together with Cinfa Biotech GmbH (now Mundipharma Biologics) and the University of Lucerne, Staburo recently published the first part of the results for a biosimilar which is used for preventing neutropenia, induced by chemotherapy (click here to read the whole article DOI: 10.1002/prp2.503). As part of the collaboration, Staburo Principal Statistician and Managing Director Josef Höfler supported the interdisciplinary team with biostatistics expertise, especially in PK/PD.

The team planned, conducted and analysed a single dose, randomized, double-blind, two-way crossover study and demonstrated the comparability for the two PK endpoints examined (area under the concentration curve from time zero to last measurable concentration and the maximum concentration). The PD comparability (area under the effect curve for absolute neutrophil count [ANC]) was demonstrated, as well. The team could show that there are clinically no differences between biosimilar and the originator with regard to immunogenicity and safety. The investigated drug was approved as biosimilar in Europe.

Data analysis, clinical biostatistics and more.