Staburo @ BVMA Symposium 2022 in Munich

Staburo @ BVMA Symposium 2022 in Munich

Staburo @ BVMA Symposium 2022 in Munich

Staburo took part in the BVMA symposium on 25 November 2022, at the Westin Grand Hotel, here in Munich. This year it was the 30. BVMA symposium and for this anniversary the get-together took place the evening before at the SEA LIFE aquarium in Munich.

This year’s topic was: “New approaches in clinical research – Europe moves together”. The symposium presentations and discussions covered the areas of regulatory, decentralized clinical trials, first experiences in the area of CTR/CTIS and as well innovation and digitalisation within clinical research.

We were very happy to learn more about current changes in regulations and updates in the CRO market – thanks to the excellent networking sessions! Congratulation to the BVMA for the organisation of this great event and thank you for the invitation! We are already looking forward to next year’s BVMA symposium.

The BVMA represents the interests of its German CRO members. BVMA members maintain a lively exchange of information on topics that important to the German CRO industry, e.g. on questions of liability and insurance, education and training, quality requirements and trends in the pharmaceutical and CRO industry.

Data analysis, clinical biostatistics and more.

Meet the Management – Stefan Bentink – Director Data Science and Diagnostics

Meet the Management – Stefan Bentink – Director Data Science and Diagnostics

Meet the Management – Stefan Bentink – Director Data Science and Diagnostics

Since our team grew substantially, we searched, appointed, and enabled a bigger management team at Staburo, consisting of two heads (of departments) and six directors (focus on data science topics). We want to give them a chance to talk about themselves and their passion! Therefore, we publish a mini news series about the management team members and will continue with our Director Data Science and Diagnostics, Stefan Bentink.

Who are you?

My name is Stefan Bentink, and I am Director Data Science and Diagnostics. I received my PhD in Bioinformatics from FU Berlin, and my scientific background is in the field of diagnosis and classification of disease, based on genomics data using bioinformatics and machine learning methodology.

Tell us something about your area of expertise.

Throughout my entire career – in academia, biotech, and the pharma industry – I have been developing and employing data analysis and modeling strategies, to mine biomedical research data in order to gain scientific insights and to translate these insights into real world diagnostic applications.

What are your goals for your role?

The nature of statistical analysis tasks in the context of diagnostic assay development can be diverse. Innovation is driven by new scientific insights often discovered during retrospective and exploratory analyses of complex and high-dimensional biomedical data sets. The situation changes further down the research and development chain, when the goal is to market a new diagnostic product. The freedom to operate and explore becomes limited by the constrains of regulation and the need for prospective study planning.

One of my tasks as Director Data Science and Diagnostics is to facilitate the exchange between Staburo experts in bioinformatics, biomarker research, and biostatistics. In this interdisciplinary work environment, we learn from each other to provide customers with the best possible support, during all stages of the development of medical devices and diagnostic assays.

What motivates you as an individual?

I’m thrilled by interdisciplinary biomedical research and development questions! On the one hand, these projects require a lot of communication and exchange between experts from different fields. On the other hand, there is a challenge in the underlying data science or statistical questions. This is what I love about my job, the balance between interaction with people and the focus on solving the analysis puzzle behind the data!

Data analysis, clinical biostatistics and more.

Staburo @ BIO-Europe 2022 in Leipzig

Staburo @ BIO-Europe 2022 in Leipzig

Staburo @ BIO-Europe 2022 in Leipzig

Staburo’s Managing Director Roland Stieger joined the BIO-Europe last week and enjoyed the great networking opportunities of this partnering conference with approx. 4800 delegates!

In addition to several one-on-one meetings, in which Roland discussed data science challenges of potential partners, there were panel discussions, e.g. about changes in Health Technology Assessment in Europe with Florian Diwischek (Novartis) and Fabian Berkemeier (IGES).

Roland also attended the well organized official BIO-Europe evening receptions, where it was nice to catch up with known and introduced colleagues, all from the (bio)pharmaceutical industry. Thanks to EBD for this great conference and see you next year in our hometown Munich!

Data analysis, clinical biostatistics and more.

Meet the Management – Katrin Frank – Head of Business Unit

Meet the Management – Katrin Frank – Head of Business Unit

Meet the Management – Katrin Frank – Head of Business Unit

Since our team grew substantially, we searched, appointed, and enabled a bigger management team at Staburo, consisting of two heads (of departments) and six directors (focus on data science topics). We want to give them a chance to talk about themselves and their passion! Therefore, we publish a mini news series about the management team members and will continue with our Head of Business Unit, Katrin Frank.

Who are you?

Hi, my name is Katrin Frank, Head of Business Unit.
My university background is in international business and cultural studies. I’m with Staburo for more than 7 years now and supporting the growth of Staburo, especially from business perspective. Since 2021, I’m heading the business unit and my special focus is on finance and human resources.

Tell us something about your area of expertise

My dedication is to steadily improve and develop the organizational backbone of Staburo, optimizing processes and be one step ahead of Staburo’s growth.

As part of the management team, I create an environment at Staburo, in which everybody likes to work and can evolve in their personal development and augment their strength. This atmosphere aims to facilitate the collaboration within and across teams.

What are your goals for your role?

Advancing, professionalizing, and creating sustainable structures are my passion!

My goals are to further enhance the profile of the business unit and give it a more precise identity to be ready for the next steps!

Data analysis, clinical biostatistics and more.

Team event Oktoberfest 2022

Team event Oktoberfest 2022

Staburo @ Oktoberfest 2022

It is a very nice Staburo tradition to go to the traditional Munich Oktoberfest together. The last two years the “Wiesn” was cancelled but this year it took part again and we decided to go and had a reservation for the Bräurosl tent!

Once again, we had a wonderful time with our growing team and long-time Staburo clients. It was great fun to come together again at the Oktoberfest to celebrate, dance and sing together.

Everyone got home safely – with good vibes from the event and some funny pictures and experiences. We are already looking forward to the Staburo “Wiesn” 2023 and thank all participants for making this a great team event!

Data analysis, clinical biostatistics and more.

Estimands online workshop

Estimands online workshop

Staburo estimands online workshop

The gold standard for evaluating medical interventions is a randomised clinical trial with statistical analysis based on the intention-to-treat population. However, even if a randomised clinical trial is well planned, post-randomisation events occur and affect or even challenge the interpretation and validity of the study results.

In November 2019, ICH published an addendum to the ICH E9 guideline to address such problems by the so called “Estimand Framework”. This framework aims to ensure an alignment of trial objectives, study design, data collection, and choice of statistical analysis methods – at the stage of protocol writing.

The interactive workshop is designed for all stakeholders of a clinical study and will include many active training elements (50:50 ratio of theory vs. training)! You will be trained on all topics of the estimand framework. We will present and discuss examples from various study phases and different medical indications. After this hands-on training you will be confident in developing and writing estimands for study protocols.

After the great interest in the estimands workshop last year, we are happy to offer it again! The course will take place on 10 + 11 October 2022. The course will be held in English. You can find more details here.

For questions and registration please contact academy@staburo.de.

Data analysis, clinical biostatistics and more.