Staburo participated in the APF meeting on 24 November 2017 in Freiburg. This year, the APF was hosted by Roche. Speakers from pharmaceutical industry, academia and regulatory agencies discussed important topics on estimands, safety and Health Technlogy Assessment.

The APF (Arbeitsgruppe Pharmazeutische Forschung) is a German pharmaceutical research working group for statisticians in the pharmaceutical and healthcare industry, academia and regulatory agencies. The APF is part of the International Biometric Society.

We also attended the get-together on 23 November 2017 at the restaurant Großer Meyerhof. It was a great opportunity to meet other statisticians.

Big steps for Staburo in 2017

Last year was very successful for our company. Our major milestones were:

• Strategy workshop with Mission & Vision for 2022
• Further internationalization with additional US, EU and UK projects
• New big pharma & new biomarker project
• Four new employees during 2017 + several interns
• Goals for net sales and FTEs achieved
• Moving to a new, bigger office space

We thank our employees and clients, who helped us, to make all of this happen!

We wish all partners and future partners, our employees, and their families a wonderful Christmas and a great start in 2018.

Staburo will continue to support you with experienced biostatisticians and statistical programmers next year and in the years to come! Thank you!

The 2nd Annual Biosimilars Forum was hosted in Budapest in October 2017. Clinicians, statisticians and regulatory representatives from around the world gathered here, to share with each other their perspectives on this hot topic of research, in lectures and informal discussions. The professional lectures of the event reflected the challenges in this special and complex field of drug development.

Use Staburo’s expertise with biosimilars

Staburo is already supporting several biosimilars companies in the development of their biosimilar drugs. We are involved in the stability and similarity testing at an analytical level, according to the latest draft FDA guidelines and EMA reflection paper. Besides this, we bring our statistical knowledge into the companies for innovative study designs and plan state-of-the-art statistical analyses that are key for bringing biosimilars to the market as fast as possible.

Staburo took part in the WiMa17 Congress at the University Ulm. The WiMa Congress is a networking forum for companies and students from a mathematics, finance, IT, and biometry background.

At the WiMa Congress, companies have the opportunity to present themselves, get in contact with their possible future employees and have personal interview sessions with them. Furthermore, there are different presentations on very interesting topics, during the entire day. Staburo provided insights into crossover correction methods in oncology, as well as an overview on other offered services and the work of biostatisticians and statistical programmers in clinical research. A current employee, who studied medical biometry at Ulm University also shared a short personal testimonial about her start at Staburo.

A big thank you for inviting us and for the great organisation of this event. We will definitely come back next year!

Imagine we had a cure for cancer, but patients don’t receive it?

This sounds very disturbing, but it can happen to the most effective drugs, if Crossover Correction is not taken into account.

To share our profound expertise on this topic, our Head of Biostatistics Dr. Hannes Buchner gave a presentation on “Introduction to Crossover Correction Methods in Oncology” at Roche.

In randomized controlled clinical trials, patients are divided into a treatment and a control group, in order to measure the effectiveness of a new drug. In Oncology studies, patients may receive additional anti-cancer drugs during the study – planned or unplanned – and can change treatment groups (crossover, cross-in), if disease progression makes this necessary.

This allows a good estimate of progression-free survival (PFS) in most cases, but not of the clinically more important overall survival (OS) outcome.

While drug approval by FDA or EMA can also be achieved without a significant OS effect (as long as PFS and other efficacy measures indicate drug efficacy), Health Technology Assessment benefit analyses often only value OS results.

As a consequence, correction methods such as RPSFT (Rank Preserving Structural Failure Time), IPE (Iterative Parameter Estimation), IPCW (Inverse Probability Censoring Weights), and IPTW (Inverse Probability of Treatment Weights), which were presented in this talk, are becoming very, very important, to reach an acceptable price for innovative new medicines.

Without Crossover Correction methods, e.g. with a simple ITT analysis, the effectiveness of a drug cannot be properly estimated, if crossover occurs. The timing of crossover can influence the progression of the patient’s condition and also its survival times.

The consequences for the well-being of affected patients can be devastating, since the wrong choice of the method or the ignorance of crossover implications in Oncology trials, can lead – in the worst case – to the non-admission of extremely effective medications.

At Staburo, we support our international clients in Crossover Correction method application, to prevent cases of very effective drugs not reaching the market and the patient. Our goal is to become the first point of contact on this topic, worldwide.