Advancing the Application of Next Generation Science to Make Safety Decisions

Maria Baltazar, Unilever’s Safety, Environmental and Regulatory Sciences, UK

Hosts: Fernando Remião / Félix Carvalho, Toxicology Lab, UCIBIO Porto

ZOOM link: https://ucibio.pt/l/GuestSeminars

Abstract:

Over the past two decades, our research has focused on developing and refining a tiered approach to risk assessment, ensuring the safety of consumers and the environment. Integrating New Approach Methodologies (NAMs) with Next Generation Risk Assessment (NGRA) poses significant challenges for complex toxicological endpoints like repeated dose systemic toxicity and developmental and reproductive toxicity (DART). A promising strategy involves deriving surrogate points of departure (PoD) from an in vitro battery designed to provide bioactivity measures that are protective of human health. The ‘context of use’ for this toolbox is defined as a low-tier approach for conducting systemic and DART toxicity risk assessments to achieve maximum protection of human health. The toolbox comprises physiologically-based kinetic (PBK) models to predict internal exposures and bioactivity NAMs designed to cover a broad range of toxicity modes of action.

This presentation will highlight key case studies demonstrating the practical application of non-animal methods for risk assessment. By leveraging these tools, we have identified a core systemic and DART toolbox, which we have been evaluating with a set of diverse chemistries, thereby building greater confidence in our methodologies. We will also showcase how higher tier tools, such as complex 3D liver models or primary renal cells, can reduce uncertainty and improve confidence in the risk assessment outcome. Collaborative engagement between academia, industry, and regulatory bodies will be essential to develop guidance and best practices for accelerating the validation and uptake of the best available science in regulatory frameworks.

Short Bio:

Maria Baltazar is currently Unilever’s Safety Science Capability Lead responsible for leading research teams developing new approach methodologies (NAMs) applied to next generation risk assessment for human and environmental safety since 2023. Maria received her Msc and PhD in Pharmaceutical Sciences from the Faculty of Pharmacy from the University of Porto in Portugal. While in Portugal, she was an invited Assistant Professor at the Advanced Institute of Health Sciences (Gandra, Portugal) where she lectured Food Toxicology Analysis in the BSc degree in Forensic and Criminal Sciences for two years. She joined Unilever in 2016 as a risk assessor in the skin allergy and immunology field and from 2018 she has led several research projects developing complex models for assessing inhalation and systemic toxicity, integrating in vitro 3D tissue models and computational tools.

Maria is a frequent invited speaker at international conferences and webinars and recipient of two awards from the Society of Toxicology Risk Assessment Specialty Section. She has been appointed as industry representative in international consortia (e.g., Texas A&M Tissue Chip Validation Consortium) and in trade associations, both Cosmetics Europe and the International Consortium on Cosmetic Safety. Maria’s research passion is to advance the application of non-animal methods for safety assessment and ultimate regulatory acceptance.