Stefan Kostense, PhD
Scientific Operations Accelerator | Translational Science & Bioanalysis Consultant | Interim Leader in Drug Development
With 25 years of experience across biotech, pharma, and CRO environments, I help drug development teams in start-up and established companies reach critical milestones. Faster and with confidence. Trained as an immunologist I developed deep expertise in assay development and validation, bioanalysis, and biomarker science. I act as a scientific operations accelerator: stepping in as strategic advisor, project lead, or interim manager to build 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.
Science in Translation: Science translated from lab to clinic.
Strategy translated from vision to results.
Career Highlights
Director of Drug Discovery &
Biomarkers
Charles River Laboratories
P&L revenues & OI, scientific strategy & capabilities, business development & marketing
Director of Biomarker Sciences
Janssen Prevention Center,
Johnson & Johnson
Biomarker & IVD strategy, prospective screening studies & clinical trials, cross functional project management, CRO management.
Director of Clinical Immunology
Janssen Vaccines
Departmental management (35 FTE, technicians, scientists, managers and project leaders), clinical Immunology strategy, regulatory & compliance, R&D governance.
GLP Manager / Associate Director Clinical Assays, Crucell
Departmental management (15 FTE), bioanalysis, regulatory & compliance, assay development & validation, CRO management.
Major Achievements
Result Orientation:
Finished my PhD program within the 4 years of funding.
Change Management:
Converted my research team into a GLP compliant development team.
Quality:
Established a GLP/GCLP compliant laboratory (250 m²), endorsed in 5 consecutive inspections.
Collaboration:
Co-authored the European Industry perspective on unwanted immunogenicity testing.
Leadership:
My Biomarker team scored 15% higher than the divisional score in the Janssen employee engagement survey.
Innovation:
First prize in a Janssen IP competition.
Business Acumen:
Received the Charles River Business Impact Award for engaging scientists in business development activities when revenues declined.
Perseverance:
Can do a forward loop in windsurfing.
Recommendations
"His strong sense of ownership, attention to detail and commitment ensured that projects were delivered successfully and in time."
"Stefan’s team “ran like a clock.” They consistently delivered high-quality results, even when working on regulated bioanalytical activities that were on the critical path"
"His experience and expertise would be highly beneficial for companies making their first steps towards a quality system, approaching their first clinical study and building bioanalytical capabilities."
"Stefan knows how to combine his strong scientific background, especially in the field of biomarkers, with an ability to apply this operationally."
" Any team that needs a biomarker strategy, and translated into actionable results would do well to work with him."
Key publications
Discovery of prognostic and treatment predictive biomarkers in T1D..
Challenges of Immunogenicity assays for vaccines
Fit-for-purpose strategy for risk-based immunogenicity testing..
Preclinical models used for immunogenicity prediction...
Plasma tau, NfL and amyloid-β levels and risk of dementia..
Quantifying adenovirus-neutralizing antibodies...
Validation of the RFFIT for rabies virus-NAbs in clinical samples