Science Translated from Lab to Clinic
Strategy translated from Vision to Results
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.
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.
Translational Science
Defining translational strategies from biomarker discovery to diagnostic development.
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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.
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Interim & Project Management
Acting as a scientific operations accelerator, I step in as project lead or interim manager for a bioanalytical program, a biomarker workstream or a lab build. I own the plan, the vendors and the deliverable, so your scientists can get on with the science.
25+
Years of 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
This is why I start biomarker work already during drug discovery and early development phases.
Biomarker decisions made in discovery are cheap. The same decisions made in Phase 2 are not. Early translational work shows which patients to select, which assay to trust and which readout will convince an investor, before the money is spent.
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. Provide feedback. Suggest a biomarker. Request an introductory call without obligation.