Staburo goes Bioinformatics!

We are very glad to welcome Dr. Janine Roy in our team. Janine is a bioinformatician by training, with an excellent education and broad working experience in the clinical, as well as the academic environment. She will support our clients in the areas of bioinformatics and precision medicine. Thanks to her joining our team, we can now get insights into the biomarker field from a different perspective and offer our clients even better solutions in their translational medicine challenges.
We are very happy and lucky to have you in our team and look forward to a great cooperation!

We are very glad to welcome Ningfu Sun in our Munich team. Ningfu supports us in biostatistics & statistical programming. With Ningfu, we win a team member with an excellent education, great biostatistics and programming skills and significant project experience. We are very happy about your support and are looking forward to a good and sustainable cooperation!

We invited clients, employees and friends to our summer party on 8 June 2018. There were many reasons to celebrate, such as the move to our new shiny office earlier this year, and the 10 years anniversary of our business plan seminar participation at unternehmerTUM. After all guests have been greeted by our Staburo “flower girl”, we had tasty summer drinks and juicy roast beef with shrimps. As a special highlight – our guests could taste custom made “red ale” beer, which was actually re-brewed at the summer party! Upon request, tastings can be arranged in six weeks, in Munich. At night, the band “Felix and the Machines” played wonderful live rock/indie/pop music and we were delighted to see almost everyone dance. We thank all our guests and helpers to make our Sommerfest a party to remember and we hope to repeat such an event, soon! After such a great evening, we might even wear our Hawaiian shirts again …

UPDATE *** JUL 26, 2018 +++ UPDATE:

Look at these beautiful babies, 6 weeks after our Sommerfest – don’t they look delicious? They are all little “Staburators”. Tastings can be arranged in our office! Just contact us!

Staburo poster presentation at PSI 2018

Staburo Managing Director Dr. Hannes Buchner will present the enhanced rank-preserving structural failure time method (eRPSFT), to adjust for treatment switching in 3-arm superiority trials. Meet Hannes personally at the PSI 2018 conference “Breaking Boundaries in Drug Development” from 3rd to 6th June 2018 in Amsterdam.

Introduction to the topic

Rapid progress in oncology and the according approvals of medications leads to fast and frequent change in the standard of care (SOC). Therefore, in trials with more than 2 arms, the comparison between investigational therapy (A) and former SOC (C), and the comparison between treatment (A) and alternative treatment therapy (B), the new SOC, are of interest. With new effective treatments, some of the patients will switch from treatment B or SOC therapy at some time point during the study period to treatment A. Treatment switching is not just an issue for economic evaluation. It is a problem for clinical and economic assessment.

Conclusions from our work

The enhanced RPSFT performed good with small bias for the calculations. Calculated confidence limits from the RPSFT model containing the true expected HR, for every comparison made. The uncorrected HR overestimates the true effect much more than the corrected HR. Only the confidence limits of the comparison of A vs. B in each scenario for the uncorrected HR contains the true expected HR, all other confidence limit exceed the HR. eRPSFT improves the estimation and should be used to adjust for treatment switching in 3-arm superiority trials.

If you are interested in Crossover Correction methods in Oncology, feel free to approach our colleague Hannes at PSI 2018 in Amsterdam or send us an email to info@staburo.com.

The Staburo Managing Directors Josef Hoefler and Roland Stieger had the opportunity to join the AGAH Annual Meeting in April 2018, here in Munich.

The conference focused on how to prevent or predict adverse drug reactions in early phase drug development. The major target organ systems were liver, kidney, CNS, cardiac function. Further sessions were dedicated to local tolerance and immunotoxicity.

The following questions were addressed in excellent expert talks and panel discussions.

• How can animal models and in vitro data help to estimate risk regarding human administration?
• How can kidney and liver function best be monitored in the settings of early phase trials?
• What do we need to know to assess potential CNS adverse drug reactions early on?
• What are the pathophysiological mechanisms leading to potential cardiac toxicity?
• What are the guidelines on non-clinical local tolerance testing?
• How to monitor immunotoxicity in novel immunological therapies?

The conference gave participants the opportunity to discuss these and additional questions with expert speakers, regulators and ethic committees members as well as colleagues from pharmaceutical industry, CRO and academia.

The meeting started with a one-day pre-conference workshop about basic terms and key concepts of pharmacovigilance with a strong focus on early phase drug development. This workshop offered an excellent preparation for the annual meeting for those who are not yet experts in the field.

Staburo participated in the conference and the networking opportunities and we were very happy to get to know new people in the field of clinical trials and to catch up with partners from client companies. Thank you for this great event in Munich!