MSc in Pharmacy and MSc in R+D+i of New Drugs at the University Of Navarra (Pamplona, Spain), with doctorate course in Design, Synthesis and Evaluation of New drugs, in Pharmaceutical and Organic Chemistry. In addition, she has an MBA from the San Pablo CEU University of Madrid (Spain), where she improved her management and business development skills.
She began working in CROs 15 years ago, first in the field of Clinical Trials to later in 2006 move to the Pre-clinical field starting to work in Biobide, after a training period working with zebrafish in the Salk Institute of California. During those years she had various positions in Biobide, from Quality, Safety and Environment Director, to I.P. R&D or Business Development, leading to generate a deep understanding of the zebrafish alternative animal model, and improving management skills been part of the Board of Directors.
Moving the Needle on New Approach Methods (NAMs) in Predictive Toxicology and Risk Assessment: Integrating Methods Towards Regulatory Acceptance
Achieving regulatory acceptance of New Approach Methods (NAMs) is critical to advancing predictive toxicology and reducing reliance on traditional animal models. At Biobide, we have developed and qualified the zebrafish developmental defects assay following the ICH S5(R3) guideline, demonstrating data robustness, reproducibility, and regulatory relevance, even to complement or substitute animal studies for regulatory purposes. Our assay evaluated 32 reference compounds, achieving Accuracy: 89.66%, Sensitivity: 88.46% and Specificity and Repeatability: 100%
These results were obtained through three blinded biological replicates, with teratogenic classification based on LC50/EC50-derived Teratogenic Index (TI a 2). Benchmark Concentration (BMC) values showed strong correlation with mammalian LOAEL Cmax data, reinforcing the zebrafish model's translational value. Bioavailability studies further refined inconclusive results, highlighting the importance of internal exposure metrics. In parallel, Biobide's ecotoxicity and endocrine disruption platforms—based on OECD guidelines and transgenic zebrafish lines—enable high-throughput screening of environmental and pharmaceutical compounds. These assays integrate morphological, molecular (RT-qPCR), and fluorescence endpoints, offering mechanistic insights into estrogenic and thyroid pathway disruption. Our work underscores the need for high-quality, reproducible data to support regulatory confidence in NAMs. The zebrafish model provides a whole-organism vertebrate system that bridges in vitro and mammalian testing, aligning with 3Rs principles and international guidelines. This presentation will share qualification and validation data, regulatory alignment strategies, and a tiered testing framework to accelerate NAMs' adoption in risk assessment.