AGAH Workshop ‘Applied course Biostatistics’ on November 7-8, 2018 in Oberursel, Germany

Staburo Managing Directors Dr. Hannes Buchner and Josef Höfler will talk at the AGAH ‘Applied course Biostatistics’ workshop and will provide deeper insights into biostatistics in clinical trials.

The workshop will give the attendees an overview of relevant statistics aspects, like data structures, principles of descriptive statistics and also basic concepts of hypothesis testing. Furthermore, sample size estimation and statistical implications of study designs in phase I trials will be explained during the talks.

The workshop is targeted for project managers, investors and other participants, which are responsible for clinical pharmacology trials. There will be practical examples and scientific presentations, that help the attendees to facilitate the communication with their biostatistics colleagues or service providers, and to interpret the obtained clinical data in a professional way.

The two-day workshop contains an exciting program of lectures and exercises prepared for the participants. There will be presentations from Staburo Managing Directors Dr. Hannes Buchner and Josef Höfler on the second day of the workshop. We are looking forward to the event and to sharing our biostatistics expertise!

Check out the program here and register today!

Staburo’s statistical support in prospective oncology study

Staburo provided statistical support for a prospective study that was recently published in a poster of the LMU Haunersches Kinderspital. The poster describes a double-blinded trial with 26 children and adolescents with cancer, under chemotherapy, testing high-energy commercially available drinks. The rationale of this study was the fact that patients, especially children, under chemotherapy can sometimes not reach the required energy uptake, and nonetheless don´t like the available drinks and refuse them. The prospective study aimed to examine the taste preference of commercially available oral nutritional supplements in Germany. The result was that an energy drink with strawberry flavor and cacao were the best accepted drinks. A consequence of the findings in this study could be to enrich cacao with the unflavored supplement Energea P for a higher energy uptake.

Since the Staburo team not only possesses statistical, but also cinematic expertise, a continuation of the Staburo movie night was long overdue. After some lively discussions and several voting rounds on a Friday 13th, our team welcomed the weekend with pizza, cold drinks and the highly sophisticated horror comedy “Tucker and Dale versus Evil”. Thanks to all who took part and made it such fun – next time maybe with a real horror movie or the all-time favorite Coen brothers classic!

Presentation of biotech reports 2017/18 by vfa bio and BioM + overview of Staburo’s Data Analytics solutions

The vfa bio – the biotechnology advocacy group in the Association of Research-Based Pharmaceutical Companies – and BioM presented the current development of medical biotechnology in Germany and Bavaria at The Boston Consulting Group (BCG) office in Munich.

The surveys show an upward trend in medical biotechnology in Germany – Bavaria makes a clear contribution:

• Admission record: 23 new biopharmaceuticals in 2017, one of them “made in” Bavaria
• With 14,500 employees, Bavaria accounts for around one third of Germany’s 47,000 medical biotechnology employees
• Biopharmaceutical drug pipeline well filled
• Trend digitization is also evident in the new start-up companies

Further information can be found in the accompanying press release, in German.

What we have learned

Roland Stieger, Managing Director of Staburo, attended the event. Some of his conclusions from talks and discussions were:

• Biological drug development in Germany/Bavaria is sustainable and growing, if health politics provides friendly environment for new drug development
• Special positive location factor for Germany/Bavaria is salary, education and loyalty of employees (compared to e.g. USA, Asia)
• Local collaborations are preferred option for big companies, like Roche or Morphosys
• Big demand in Data Analytics in Healthcare – however very difficult to find expert support

If you also face these challenges in Data Analytics, we would like to offer our help. We currently have a team of 18 Data Scientists (mostly biostatisticians, mathematicians and related), who analyze data from healthcare projects on a daily basis. For sustainable growth, we also introduced the first biostatistics trainee program last year.

In Data Analytics, we don’t offer out-of-the-box services, but talk to our clients to learn about their challenges and then find tailor-made solutions for them, using state-of-the-art methods.

Data Analytics @ Staburo

Here we provide a short list of examples of our successful Data Analytics collaborations:

1. Non-Clinical Data Analytics

Statistical assessment of analytical similarity

• For tech transfers or production changes
• For biosimilars according to EMA / FDA guidelines

Design of experiments: input and recommendations

• Tuning of process parameter
• E.g. minimize production down-time

Stability testing

• Shelf life estimation by extrapolation
• Release specifications based on aging

Statistical process control

• Custom user interfaces for lab technicians
• Automation of statistical QC procedures
• Report generation for critical assessment

2. Translational Medicine & Biomarkers

• Phase I to phase III
• Agency interactions and submissions for top 20 pharma
• Various indications and biomarker types (e.g. Gene expression, Protein biomarkers, Genomics, Imaging)
• Purpose of biomarkers (e.g. Prognostic, predictive and diagnostic potential of biomarker, Pharmacodynamics, Safety)
• Study designs (e.g. Enrichment strategies, Adaptive designs)
• SAS and R (including interactive shiny apps)
• Identification of prognostic and predictive biomarkers (e.g. Penalized regression, Virtual twins, Cut-off detection)
• Multivariate data visualization (e.g. Principle component analysis, Partial least squares, Clustering)
• Stability assessment (e.g. Cross-validation, Bootstrapping)
• Signature identification

We would love to apply our experience to your project! Don’t hesitate to contact us, if you have any questions!

Team spirit, speed and strength. Qualities, which our clients normally value in biostatistics projects with us – we wanted to bring on the race track in the 2018 B2RUN in Munich.

The 6.1 km long was scheduled to take place in the Olympic Park, with the finish in the classic Olympic Stadium.

Unfortunately, a thunderstorm hit Munich, when we were about to start the race. After we got soaking wet and waited for over half an hour in the rain, the whole event was cancelled due to safety concerns. Ironically, the clouds cleared up directly after that but the decision was already made.

There was nothing left to do for us, but to discuss, if our team’s running times, i.e. 0:00h – from a statistics perspective – were our best results, or if we cannot count that…

After the B2RUN fail, we had dinner together at the restaurant Café Blücher in Munich, including the very French award ceremony for the World Cup Tippspiel, which was won with the closest possible margin by Josef Höfler. Despite the weather, it was a great event with a sporty team – next time maybe even with actual running!