Advisory Board Member

Dr Marianne Scheel Fjording

 

Marianne has 25 years’ experience in the pharmaceutical industry, a thought leader expert in regulated bioanalysis including pharmacokinetic, biomarker and immunogenicity assays. A former expert member of the EWG for the newly implemented ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis.

Marianne has extensive experience in designing and executing regulatory strategies for bioanalytical methods covering both large and small molecules as well as ATMP/CGT.

Key areas of expertise
  • Comprehensive knowledge of regulatory requirements and procedures for bioanalysis
  • Strategy for validation of bioanalytical methods for the support of quantitative pharmacokinetic assessment of (new) drug development candidates
  • Strategy for study sample bioanalysis for regulatory decision and submission
  • Biomarker-guided assay development strategies / regulatory requirement of biomarker assays by applying context-of-use
  • Biomarker-guided development strategies supporting clinical trials for application of biomarkers as target engagement, proof-of-mechanism and precision medicine
  • Immunogenicity assays strategy for regulatory submissions
  • Bioanalytical assay strategy in support of potency demonstration and dose finding of ATMP/CGT’s
 
Before NDA 

Marianne held positions in several major pharma companies and a global CRO, working closely with regulatory authorities on several continents, thus knowing the industry from all sides. The roles were of increasing responsibility in project planning & management, outsourcing, consultancy, and strategic work related to regulated bioanalysis.

She has a Master of Science and a PhD degree in biochemistry from Copenhagen University, Denmark

Recent Publications 

Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy.
Bioanalysis. 2022 Jul;14(13):911-917

Recommendations on ELISpot assay validation by the GCC.Recommendations on ELISpot assay validation by the GCC.
Bioanalysis. 2022 Feb;14(4):187-193.

EBF recommendation on practical management of critical reagents for PK ligandbinding assays Bioanalysis. 2018 Oct 1;10(19):1557-1565.

Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles. Bioanalysis. 2018 Feb;10(4):197-204. ·

 

 

Dr Marianne Scheel Fjording

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