Staburo @ R/Pharma 2021 Conference

Staburo participated in the R/Pharma 2021 Conference hosted by a committee existing of R practitioners from different companies, universities, and the FDA from the 2– 4 November. The conference took place online due to Covid19.

The conference provided an overview of new and upcoming R packages in the development of pharmaceuticals and discussed the challenges and opportunities of using R in the pharma industry. For example, the admiral package developed by Roche and gsk offers a consistent and CDISC compliant way to generate ADaM datasets in R. Furthermore, the GeneTonic package provides a Shiny application that makes it easier to analyze and visualize transcriptome data and results.

In addition to the usual discussions within the presentations there was also time to exchange views on all statistical and pharmaceutical topics throughout the conference. In this context, attention was also drawn to a statistical YouTube channel, which we would like to share with you.

We are looking forward to participating in next year’s conference where we can hopefully meet the speakers and attendees in real life!

Christmas Party 2021 @ Staburo

The Staburo Christmas Party followed the “tradition” of an online event for the second year in a row, but we made the best of the situation and had a very jolly time. As last year, the delivered food boxes contained a three-course menu, which was prepared by each participant after the year in review by Managing Director Dr. Josef Höfler.

The second highlight of the evening was an online crime game, with real actors! Some of the teams completed the challenge (solving a “Wine queen” kidnapping case), however the solution was quite difficult. The others unfortunately triggered a bomb which killed the “Wine queen” and destroyed most of the local wine production – not for the faint hearted!

As the last agenda item, we had a beer tasting with Managing Director Dr. Hannes Buchner. Each employee received a tasting set beforehand, including the famous hand crafted STABURATOR, plus Hacker-Pschorr Kellerbier, Giesinger Bräu Lemondrop and one Rammlerbräu Helles from former Staburoian Max Siebold!

We wish you relaxing Christmas holidays as well as health and happiness for the new year!

Update: results of MS Teams employee feedback poll in a word cloud below.

Staburo Sports Day

“The man who moves a mountain begins by carrying away small stones.” – Confucius

Overcoming the challenges of a pandemic can feel like trying to move a mountain, but on September 23rd we came together (with distance) as a group to move some stones. The Staburo Sports Day wasn’t just our way to replace the annual B2Run event, but a sorely needed reconnect with our colleagues.

Starting at the Kolumbusplatz we all made our way south along the Giesingerberg, guided all the way by the green and white of Staburo thanks to the adventurous work of Ulrike and Laura earlier that afternoon. Although summer was dwindling, we found ourselves catching up with our co-workers in the sunshine and enjoying the last of the green leaves along our route. We walked and ran our way towards Heilig-Kreuz-Kirche, passed the Grünwalder Stadion, and crossed the Isar at the Marienklause. The balloons that marked our way were collected enthusiastically all the while (no, not by the statisticians, by the kids!). Our route finished after 5 kilometres with Gabi (our well-defined endpoint) who greeted us with drinks and a smile. Finally, we ended our evening at the Asam Schlössl Biergarten with Brotzeit, drinks, and Kaiserscharrn.

Whether we’ll have a B2Run in 2022 remains to be seen, but what we know for certain is that Staburo can find a way to stay active and keep our ties strong.

Disclosure: FDA continues to take action on failure to submit required clinical trial information

Last month, the FDA sent out a 3rd notice of noncompliance for not submitted clinical trial results, for the first time to the primary investigator of an academic trial.
The previous notices, sent out in April and July of 2021, were related to trials from industry sponsors.
Trial sponsors risk a fine of up to $ 10,000 for noncompliance with US federal law.

The time to check your compliance with FDA’s disclosure regulations is now!

Staburo’s team of disclosure experts can provide exactly the advice and support you need: From checking general disclosure requirements of your studies, providing input to your trial protocols for disclosure readiness, to finally posting your study results in time on clinicaltrials.gov.

Get in touch with us – we are looking forward to working with you!

See: ClinicalTrials.gov – Notices of Noncompliance and Civil Money Penalty Actions