Marianne Scheel Fjording

Marianne Scheel Fjording, MSc, PhD, is the CEO and founder of Biolyzr, an independent consultant company specializing in bioanalysis excellence. The consultancy covers all aspects of bioanalytical activities, including bioanalytical strategy, project scoping and management, audits, compliance as well as CRO selection and monitoring.

Prior to founding Biolyzr, Marianne was Scientific Director at Novo Nordisk and Scientific Officer and Executive Director at BioAgilytix (both Copenhagen, Denmark), where she worked with regulated bioanalytical assay validation. Her experience is within large molecules and immunoassays. Marianne was a member of the Expert working group (EWG) for the newly implemented ICH M10 guideline as a representative for PhRMA.

Marianne has been active in the EBF as a member and part of the steering committee and the organizing committee for workshops and annual symposiums.

Marianne has a Master of Science degree in biochemistry from Copenhagen University (Denmark), a PhD in intracellular signaling and more than 25 years of experience within pharmaceutical companies.

What three things would you take if you were stranded on a desert island?

  • My family
  • A good book
  • Sunscreen

If you weren’t a bioanalyst, what would you be?

  • Gardener growing tomatoes

What is your favorite city?

  • Rome

Why have you decided to become a Zone Leader?

I love to share my passion and experience about the complex world of regulated bioanalytical strategies. With all the new modalities in drug development, this is an exciting journey.


Journal articles from Bioanalysis

Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy

How the bioanalytical scientist plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum

Feedback from the EBF – Focus Workshop: bringing assay validation and analysis of biomarkers into practice

Recommendations on qPCR/ddPCR assay validation by GCC

Recommendations on ELISpot assay validation by the GCC

EBF recommendation on practical management of critical reagents for PK ligand-binding assays

Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective

Toward decision-based acceptance criteria for Bioanalytical Method Validation: a proposal for discussion from the European Bioanalysis Forum

Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum

Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles

Co-medication and interference testing in bioanalysis: a European Bioanalysis Forum recommendation

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays)

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)

Tiered approach into practice: scientific validation for chromatography-based assays in early development – a recommendation from the European Bioanalysis Forum

Feedback from the European Bioanalysis Forum Workshop: taking tiered approach to the next level