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.

On 13 October 2016, managing directors and press officers of biotech, pharmaceutical and venture capital companies, as well as journalists, were meeting at the Faculty Club G2B of the IZB in Martinsried near Munich. There were three compact presentations held before a networking lunch:

• “Therapy advantage in cardiology through biotech” Dr. Stefan Kropff (Executive Medical Director, Amgen GmbH)
• “How to turn dust into stone with the help of bacteria”
  Martin Spitznagel (Managing Director, Dust Biosolutions)
• “New genomic methods for blood analysis:
  Liquid Biopsies” Dr. Rainer Schubbert (Head of Operations Applied Genomics,
  Eurofins Genomics)

For Staburo it was very exciting to see what is developed currently at the IZB in Munich, but also to learn about the successful history of several companies. As a specialised service provider for biostatistics solutions, it was also very interesting to meet current and potential clients in a relaxed atmosphere – we will definitely take part in more IZB events in the future!

The next Biotech Press Lounges will be on 16 February 2017, 11 May 2017 and 12 October 2017. Reservations can be made at marketing@izb-online.de.