Science Translated from Lab to Clinic
Your next milestone depends on data you do not have yet. I help drug development teams in start up, biotech and pharmac companies decide what to measure, how to measure it, and whether the result is good enough to move forward.
Stefan Kostense, PhD, provides expert guidance for Translational Science, Biomarkers & Bioanalysis. Partner with Science in Translation to rapidly advance your drug development projects through expert consultancy and interim leadership combining science with strategy.
Strategy translated from Vision to Results
Translational Science
Defining translational strategies from biomarker discovery to diagnostic development.
Regulated Bioanalysis
Assay development, validation and bioanalysis that hold up to regulatory scrutiny and to your own go/no-go criteria..
Fit for Purpose Quality
ISO 9001 to G(C)LP quality system implementation, matching the developmental phase of your organisation.
Interim & Project Management
Acting as a scientific operations accelerator, building high-performing teams and generate the reliable data that drives the right decisions about promising drug candidates and increases the probability of success in drug development.
25+
Years Industry Experience
15+
Drug development programs supported
5
G(C)LP inspections passed
Biomarkers more than double clinical success rates*
I help you:
- Identify high-impact biomarkers early
- Validate assays and endpoints for regulatory success
- Integrate translational data to attract partners/funding
Therefore biomarkers should be identified and developed already during discovery and early development.
In the early stages of drug development, a robust translational strategy ensures that opportunities for biomarker discovery and co-development are identified early, enabling data-driven decision making throughout the program. By integrating translational science from the outset, development risks can be identified and mitigated before they lead to costly delays or program termination.
For biotech in early drug discovery this means faster decisions, less risk, higher NPV and stronger investors confidence.
As programs progress into clinical development, I help teams implement and operationalize their translational strategy through biomarker-driven decision making, assay development, and data integration. This approach supports patient selection, demonstrates target engagement and mechanism of action, informs dose selection, and generates the evidence needed to make critical development decisions. Ultimately, a well-executed translational strategy increases the probability of clinical success and accelerates the path toward regulatory approval.
Contact Stefan
Ask a question. Request an introductory call. Provide feedback. Suggest a biomarker. Without obligation