NDA Group is thrilled to announce the expansion of their Advisory Board with the appointment of Marianne Scheel Fjording, Ph.D. Marianne is a highly experienced expert in regulated bioanalysis and immunogenicity, with an emphasis on bioanalytical method development and validation of advanced biologics. She has a wealth of experience in the development of gene and cell therapies, engineered proteins, therapeutic antibodies, and derivatives, as well as biosimilars.

Marianne, who holds a PhD in biochemistry from Copenhagen University, Denmark, is the founder and CEO of Biolyzr, a Copenhagen-based consultancy specializing in bioanalytical services. Prior to this, she held key positions of increasing responsibility in the industry, including SO of BioAgilytix and Scientific Director of translational sciences at Novo Nordisk.

Kurt Stoeckli, President of NDA Advisory Board, expressed his excitement about Marianne joining the team, stating that her deep expertise and extensive experience in modern bioanalysis are tremendous assets to the group. Her engagement will be crucial in helping global NDA clients shape their development and quality strategies for next-generation assets while remaining compliant with the latest regulatory requirements. Marianne's unique blend of profound knowledge, practical experience, and contextual judgment makes her a valuable addition to the NDA Advisory Board.

Marianne's expertise spans non-clinical and clinical drug development, including the supervision of projects following regulatory BMV guidelines and GLP/GCP regulations. She has developed and implemented bioanalytical strategies for a wide range of therapeutic modalities, including peptides, proteins, PEG-proteins, therapeutic monoclonal and multidomain antibodies, and ATMP's. Additionally, Marianne has significant experience in providing scientific input to GLP/GCP audits and has developed and implemented biomarker strategies for new therapeutic modalities, with a focus on decision-enabling strategies.

Over the years, Marianne has been the topic lead for PhRMA on the ICH M10 guidelines on bioanalytical method validation and study sample analysis. She was a Member of the Expert Working Group (EWG) for new ICH M10, ‘Bioanalytical method validation and study sample analysis’ working alongside FDA, EMA, Health Canada, Swiss Medic, Japan, China, and Anvisa regulatory authorities, as well as industry members from EfPIA and BIO.

NDA Group is delighted to have Marianne on board and looks forward to her contribution in advancing their mission to bring medicines to men, women and children all over the world without unnecessary delay.