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!

Staburo goes Bioinformatics!

We are very glad to welcome Dr. Janine Roy in our team. Janine is a bioinformatician by training, with an excellent education and broad working experience in the clinical, as well as the academic environment. She will support our clients in the areas of bioinformatics and precision medicine. Thanks to her joining our team, we can now get insights into the biomarker field from a different perspective and offer our clients even better solutions in their translational medicine challenges.
We are very happy and lucky to have you in our team and look forward to a great cooperation!

We are very glad to welcome Ningfu Sun in our Munich team. Ningfu supports us in biostatistics & statistical programming. With Ningfu, we win a team member with an excellent education, great biostatistics and programming skills and significant project experience. We are very happy about your support and are looking forward to a good and sustainable cooperation!

We invited clients, employees and friends to our summer party on 8 June 2018. There were many reasons to celebrate, such as the move to our new shiny office earlier this year, and the 10 years anniversary of our business plan seminar participation at unternehmerTUM. After all guests have been greeted by our Staburo “flower girl”, we had tasty summer drinks and juicy roast beef with shrimps. As a special highlight – our guests could taste custom made “red ale” beer, which was actually re-brewed at the summer party! Upon request, tastings can be arranged in six weeks, in Munich. At night, the band “Felix and the Machines” played wonderful live rock/indie/pop music and we were delighted to see almost everyone dance. We thank all our guests and helpers to make our Sommerfest a party to remember and we hope to repeat such an event, soon! After such a great evening, we might even wear our Hawaiian shirts again …

UPDATE *** JUL 26, 2018 +++ UPDATE:

Look at these beautiful babies, 6 weeks after our Sommerfest – don’t they look delicious? They are all little “Staburators”. Tastings can be arranged in our office! Just contact us!

Staburo poster presentation at PSI 2018

Staburo Managing Director Dr. Hannes Buchner will present the enhanced rank-preserving structural failure time method (eRPSFT), to adjust for treatment switching in 3-arm superiority trials. Meet Hannes personally at the PSI 2018 conference “Breaking Boundaries in Drug Development” from 3rd to 6th June 2018 in Amsterdam.

Introduction to the topic

Rapid progress in oncology and the according approvals of medications leads to fast and frequent change in the standard of care (SOC). Therefore, in trials with more than 2 arms, the comparison between investigational therapy (A) and former SOC (C), and the comparison between treatment (A) and alternative treatment therapy (B), the new SOC, are of interest. With new effective treatments, some of the patients will switch from treatment B or SOC therapy at some time point during the study period to treatment A. Treatment switching is not just an issue for economic evaluation. It is a problem for clinical and economic assessment.

Conclusions from our work

The enhanced RPSFT performed good with small bias for the calculations. Calculated confidence limits from the RPSFT model containing the true expected HR, for every comparison made. The uncorrected HR overestimates the true effect much more than the corrected HR. Only the confidence limits of the comparison of A vs. B in each scenario for the uncorrected HR contains the true expected HR, all other confidence limit exceed the HR. eRPSFT improves the estimation and should be used to adjust for treatment switching in 3-arm superiority trials.

If you are interested in Crossover Correction methods in Oncology, feel free to approach our colleague Hannes at PSI 2018 in Amsterdam or send us an email to info@staburo.com.