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.

We are very glad to welcome Vicky Stahl and Maximilian Siebold back in our team. Vicky and Max already worked as student interns at Staburo earlier and will support our clients in the area of statistical programming. We are very happy to have you back in the team!

The statistical principles of equivalence trials and non-inferiority, as well as the special case bioequivalence, were presented. From a statistical perspective, being non-inferior or bioequivalent means to be only irrelevantly inferior or different, respectively. Based on this idea, the null hypotheses for non-inferiority or bioequivalence are shown.

The test decision, based on confidence intervals and the duality to the test problem, were discussed. A simple example of how to determine the acceptance range in a clinical trial was introduced. Problems with the constancy assumption and advances in standard of care were shown based on examples.

Further thoughts on populations, sample size and regulatory aspects as well as practical implementation in the protocol or statistical analysis plan were depicted.