What is your/your company current role in TransBioLine?
I am one of several Pfizer colleagues involved in TransBioLine, and I co-lead Work Package 5 (WP5), drug-induced nervous system injury (DINI) with Klemens Ruprecht from Charite. I took this role on in the spring of 2023, following the retirement of my predecessor, Chris Somps. Chris did an amazing job of leading the team toward qualification of novel DINI biomarkers, and my goal is to get us across the finish line.
What have you found the most challenging/interesting during the Project?
The formal biomarker qualification process was new to me as I joined the team, so I’ve had to quickly come up to speed on what we need to assemble a qualification plan in terms of data and strategy, and regulatory components.
What has been your/your company greatest achievement during the Project?
My proudest achievement to date is the submission of our DINI Qualification Plan to the FDA and EMA. These documents themselves were a huge amount of work, but they represent the culimination of years worth of work by the team. A year from now, I will hopefully be able to upgrade this answer to say that my greatest achievement is achieving full qualification of the first biomarker of DINI.
What you consider will be the major impact of TransBioLine on the society / biomedical research area?
TransBioLine is an excellent example of an industry-academic partnership in which scientists are working together across companies and institutions to tackle a common goal of developing and qualifying novel drug safety biomarkers. I have no doubt that at least some of these biomarkers will end up being used in future clinical trials, enabling companies to more safely bring new medicines to patients.
