Staburo supported successful biosimilar development program

Staburo supported successful biosimilar development program

Staburo supported pegfilgrastim 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 Pelmeg, a pegfilgrastim 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 Pelmeg and the originator with regard to immunogenicity and safety. Pelmeg was approved as a pegfilgrastim biosimilar in Europe.

Data analysis, clinical biostatistics and more.

Staburo supported PD-L1 assay comparability study

Staburo supported PD-L1 assay comparability study

PD-L1 assay comparability study published

Staburo supported the evaluation of the first multicentric analytical comparability study of PD-L1 expression in urothelial bladder cancer using four clinically developed immunohistochemistry assays. Statistical analyses included the investigation of inter-assay differences using ANOVA and intra-class correlations and the concordance for clinically relevant cut-offs based on Fleiss‘ kappa.

The results suggest that all four currently clinically relevant assays are analytically similar for the evaluation of PD-L1-stained immune cells and three (SP263, 22C3, and 28-8) for PD-L1-stained tumor cells.

The paper, which was recently published in Virchows Archiv, can be downloaded here (Staburo’s Statistics contribution is mentioned in the Acknowledgments): https://rd.springer.com/article/10.1007%2Fs00428-019-02610-z

Data analysis, clinical biostatistics and more.

OTTO: an R Shiny App for Standardized Detection of Outliers in Bioassay Development

OTTO: an R Shiny App for Standardized Detection of Outliers in Bioassay Development

R Shiny App for Standardized Detection of Outliers in Bioassay Development

The availability of reliable and sensitive assays is an important building block in the production and quality control of biological products. In the development of such assays, unusual or erroneous measurement results need to be detected, but adjudication by human operators is often inconsistent or prone to bias.

To help overcome this challenge, a Shiny app for the statistical detection of such outliers is being developed at Staburo: the Optimal Tool for Tracking of Outliers (OTTO). Close collaboration with the end users throughout the development process ensures that the statistical outlier detection results are in good agreement with subject matter expert evaluations. In particular, a mixed method approach was chosen which significantly reduced false outlier detection rates, compared to conventional statistical methods.

Thanks to the capabilities of the R Shiny technology, the user interface is intuitive and well suited for everyday use in the lab. Features of the app include application of outlier tests, automatic curve refitting after removal of outliers, and report generation for documentation purposes.

Data analysis, clinical biostatistics and more.

Staburo @ B2Run2019

Staburo @ B2Run2019

Staburo @ B2Run2019 

Team spirit, speed and strength – this time in action! Staburo started again at this year’s B2Run, after the last one in 2018 was canceled due to safety concerns (click here for the story).

With best weather conditions, 30,000 participants from 1,500 Munich companies ran together to finish in the Olympic Stadium. The race track was 6.1km long and took us through the picturesque 1972 Olympic Park, which alone was worth the effort. Staburo was in the middle of the action, and once again no. 1 in the Biostatistics category, check this graph for our results:

Everyone finished safely (after being cheered on, by great Staburo fans before the finish line) and was greeted and congratulated by the rest of the team. Great achievement!

After some alcohol-free electrolytes, water and fruits, we walked to our beautiful location for dinner, the Italian restaurant “Ciao Francesco” with delicious food.

It was a great evening with sports, fun and dinner!

Data analysis, clinical biostatistics and more.

Staburo @ APF Statistics Leaders Meeting

Staburo @ APF Statistics Leaders Meeting

Staburo took part in the APF Statistics Leaders Meeting

Hosted by Boehringer Ingelheim Pharma GmbH & Co KG, Staburo Managing Director Josef Höfler attended the APF (Arbeitsgruppe Pharmazeutische Forschung) Statistics Leaders Meeting, to hear talks about current statistics topics that are relevant for all biostatisticians that work in the pharmaceutical industry.

The topics ranged from double programming / validation, APF talent support, the AIMS (African Institute of Mathematical Sciences), CDISC programming and data anonymisation.

We thank Boehringer Ingelheim for hosting this event and the APF for inviting us to such a top-class event! We are looking for the next APF (Arbeitsgruppe Pharmazeutische Forschung) Statistics Leaders Meeting!

 

Data analysis, clinical biostatistics and more.

New team member @ Staburo

New team member @ Staburo

New employee @ Staburo

 

We are very happy to welcome Dr. Yesilda Balavarca in our team. Yesilda joins Staburo with her work experience from Deutsches Krebsforschungszentrum (DKFZ) Heidelberg and her excellent education background from University of Hasselt and University of Göttingen. She supports our clients in the areas of biostatistics and statistical programming as a Senior Biostatistician. We are looking forward to a great collaboration!

Data analysis, clinical biostatistics and more.