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.

http://www.biologenkompass.de/business-development-manager/

The website biologenkompass.de published a story about our Business Development Manager Roland Stieger (in German).

The interview was done by Ulrike Herzog, who is one of the founders of biologenkompass.de. The goal of her team is to inform biologists with potential job opportunities after their Master’s degree or PhD thesis.

We are very happy to support them in their project and thank biologenkompass.de for the interview!

Staburo took part in the 2016 BIO Europe Conference in Cologne between 7 and 9 November.

The conference featured a wide range of interesting topics for statisticians in the pharmaceutical and healthcare industry, including health technology assessment, biomarkers in translational medicine and general trends in drug development.  Presenters from industry, academia and regulatory agencies shared their knowledge in talks and discussion rounds.

The most valuable feature of this conference was once again the partneringONE section, where we took the opportunity to meet potential partners face-to-face and learn about other their need in biostatistics. We will definitely be in Berlin for next years BIO Europe!

The incorporation of biomarkers into drug development becomes more and more important, as they provide essential information to find the right therapy at the right time for the right patient (“precision medicine”).

This talk provided an overview on the roles of prognostic and predictive biomarkers, with a particular focus on (semi-) quantitative markers based on Immunohistochemistry  (IHC). For their use in clinical practice, these biomarkers are often categorised via a cut-off value, as it conveniently divides patients into subgroups.

Different statistical models were discussed that identify subgroups of patients, who are most likely to benefit from a targeted therapy. Furthermore, it was illustrated that an analysis on the original scale of the biomarker is useful and necessary, as it provides insights on an individual patient level.