We wish all our partners and future partners, all our employees and future employees, and all their families a wonderful Christmas and a great start in 2017. Staburo will continue to support you with experienced biostatisticians and statistical programmers next year and in the years to come!

This talk provided insight into the system of the AMNOG and the hurdles which have to be overcome in the assessment of a benefit, with focus on the statistical needs. In particular, the process at the German authorities “Gemeinsamer Bundesausschuss” (G-BA) and “Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen” (IQWiG) should be outlined.
On the basis of an example of a medicinal product, which has completed the process, the different steps of the evaluation, according to the early benefit assessment were illustrated and discussed. Further examples display the problems which need to be solved with the use of statistical methods (e.g. subgroup analysis or meta-analysis).

This year’s Staburo Christmas party took place in the Barschule München, where we learned very much about famous Cocktails, its variants and how to produce them.

We started the course with (single-)blinded sensorical testing of different alcoholic analytes, by smelling only. The best of us could get about half of the samples right, which showed a lot of training potential here.

Then, Matthias Knorr, the owner of the Barschule explained about Gin and Rum and we could – this time unblinded – taste the differences between the brands and production styles.

This was followed by a very active bottle juggling – or flair bartending – show in the training room of the school, where we could also practice some tricks.

In the last session, Matthias showed us how to produce tasty drinks – we even made a Lebkuchen (gingerbread) cocktail!

Staburo took part in the APF workshop on 25 November 2016 in Berlin. This year, the APF has been invited by Parexel International GmbH.

The APF is a German pharmaceutical research working group for statisticians in the pharmaceutical and healthcare industry, academia and regulatory agencies. The APF is also a part of the international biometric society.

The day before, on 24 November 2016, we attended the get-together at the Schnitzelei in Berlin. It was a great opportunity to meet other statisticians.

The speakers from industry and regulatory agencies gave a great update and overview about estimands and prediction of disease progression. They also shared their knowledge in very interesting discussion rounds afterwards.

Big thank you to the great organisation of this event.

Staburo took part in this year’s BVMA symposium on 25 November 2016, at the Sheraton München Arabellapark Hotel, here in Munich.

The BVMA represents the interests of the German CROs. The member companies maintain a lively exchange of information on all topics which are of particular importance to the CRO branch, e.g. on

• Questions of liability and insurance
• Education and training
• Quality requirements and
• Trends in the pharmaceutical and CRO industry

In this talk, important aspects of pharmacokinetics (PK) and pharmacodynamics (PD) were presented. Four elements of PK (ADME) were discussed in detail. Biopharmaceutical classification system (BCS), 2-compartment distribution model, destructive and conjugative reactions and the elimination phase of drugs were discussed for ADME trials. Some PK parameters were also listed and described. The second part of this talk was about pharmacodynamics, where the onset, duration and mechanism of actions were presented. In addition, some PD concepts such as ED50, efficacy and potency were discussed.