Staburo submitted comments on EMA’s draft guideline on multiplicity issues in clinical trials. Multiplicity issues arise in many areas of clinical development, including biosimilars  and translational medicine. The guideline is intended to provide guidance on how to deal with multiple comparison and control of type I error in the planning and statistical analysis of clinical trials.

Following our Strategy Workshop with Dr. Thilo Pfletschinger from 3DSE in May, we presented and discussed the results with all Staburo employees.

Our mission statement is a short statement of our organization’s purpose, identifying the scope of our operations. It includes information about our key market, our contribution to customers and our distinction from other biostatistics service providers.

Staburo’s mission statement:

• Staburo offers high-quality statistical services for pharmaceutical, CRO and biotech companies.
• We are a reliable and flexible partner for our clients.
• Staburo provides advanced statistical solutions, like cross-over correction, high-dimensional biomarker analysis and bayesian modeling.
• Working with leading pharma companies, we know how to successfully bring compounds to the patient.

Furthermore, we presented our Vision, Values, common Goals and a Strategy Map for the next five years.

Staburo provided statistical support for a biomarker study that was recently published in the Journal Lung Cancer. The manuscript describes a retrospective analysis to assess the ability of the VeriStrat serum protein test to predict clinical benefit with afatinib versus erlotinib (predictive effect), and the association of VeriStrat status with overall clinical outcomes (prognostic effect) in LUX-Lung 8.

Highlights of the publication

• Clinical utility of the VeriStrat serum protein test was assessed in LUX-Lung 8.
• Patients were classified as VeriStrat ‘Good’ (VS-G) or VeriStrat ‘Poor’ (VS-P).
• VS-G classification is associated with favorable survival outcomes versus VS-P.
• In VS-G patients, survival outcomes are superior with afatinib versus erlotinib.

The full publication can be read here: http://www.sciencedirect.com/science/article/pii/S016950021730329X

The Staburo team once again proved that it has endurance, power and a great finish. This time, for a change, not in biostatistics projects – but in the 2017 B2RUN Munich, alongside 30,000 other runners.

The race track was 6.1km long and took us through the picturesque 1972 Olympic Park, which alone was worth the hardship. We may not have been the fastest overall, but we claim to have finished as No. 1 in the biostatistics consulting category.

If other companies want to challenge this, please send us the exact data. One of our statistics experts will check it out – be aware that very fast outliers will not be analysed here.

After the B2RUN, we relaxed and had dinner together at the greek restaurant ‘Kalypso’ in Munich. Great weather, great event, great team!

With the support of Dr. Thilo Pfletschinger from 3DSE, we developed the company strategy for Staburo for the next five years. Before the workshop, all employees gave input to possible goals and the prospects of Staburo. The final strategy includes all our common goals and gives guidance, how to achieve them. Our clients profit from our support in biostatistics and statistical programming – now and in the future!