Patient Safety Physician in Therapeutic Area Inflammation

No two days are the same: 7 Questions with Veronika Kohlbrenner

Veronika Kohlbrenner, Patient Safety Physician in Therapeutic Area Inflammation, tells us how she is able to work across different levels of the drug development process, and how her role on an FDA advisory committee meant she was able to help get an important drug approved for patient treatment.

How long have you worked at Boehringer Ingelheim?

I’ve worked here for 25 years now, and I’ve spent the last eight of those years in Patient Safety and Pharmacovigilance.

What does a typical day look like for you?

There is no typical day! My work has been spread across two diverse areas: Post-Marketing safety surveillance, and Pre-clinical development projects. So, when it comes to Post-Marketing, I need to have my fingers continually on the pulse of incoming data, scrutinizing and analyzing information from different sources to ensure treatments continue to be safe and that the safety information of our drugs is up to date. In Pre-clinical work, I need to be inquisitive, using my medical knowledge to understand the inner workings of a novel compound, thinking creatively to figure out what data will be needed to explain potential mechanisms, and how this can be applied to patients.

Tell us the one thing you love most about your role?

I love the variety. As I mentioned, I’m able to work across different areas of the drug development process. I also get to work with so many people. On a daily basis, I’m speaking to toxicologists, pharmacologists, clinical operations colleagues… it’s very collaborative, and I’m able to stretch myself in ways I couldn’t in other departments.

How much impact do you have on patients’ lives?

I would say working in Patient Safety is as close as you can get to working in a clinical practice without actually working there. No two patient cases that are reported to us are the same – just as no two patients you would see as a physician are the same. For me, the main difference is the scale of the impact I get to have. I’m impacting tens of thousands of lives in my role. So, this is a big motivator for what I do.

Do you have any projects you are specifically proud of?

Yes. We were doing research into the viability of a drug to treat systemic sclerosis associated interstitial lung disease. The FDA called an advisory committee to talk about the background, efficacy, and safety of the drug – and I was honored to join the panel as the Lead Safety Spokesperson. I’d been working on the drug for three years while it was going through clinical trials, so it was wonderful to take it through to FDA approval. Pulling all the data into clinical trial reports, summarizing it effectively for submission, and presenting it back to the FDA...it was complex, but it was also a real privilege.

And what was the result of the project?

The drug was approved, and it’s now being used to treat patients. So that was incredibly rewarding. It’s been a long journey and a huge collaborative effort, so I feel proud that we have made a difference.

What’s next for Patient Safety?

Well, my favorite thing about working in Patient Safety is the diversity and challenge each and every day brings. So, I guess my answer to ‘what’s next?’ is ‘I don’t know’ – but that’s part of the joy of the job. The only certainty is that whatever we are working on, we are making a real, positive impact on the lives of patients.