Paving the way for translational relevance in advanced therapies in Brazil: conference report from SBINT 2025.
Abstract
The 2nd Symposium on Pharmaceutical Bioengineering and Nanobiotechnology Applied to Advanced Therapies (SBINT 2025) was held in Goiânia, Brazil, under the theme "Challenges in preclinical evaluation: paving the way to translational relevance of advanced therapies." The meeting brought together approximately 150 participants from academia, industry, clinical institutions and regulatory agencies to discuss scientific, technological and regulatory barriers shaping advanced therapy medicinal products (ATMPs) in Brazil. Keynote lectures addressed human-relevant bioengineered platforms, organ-on-a-chip and microphysiological systems, regenerative biomaterials, extracellular vesicle-based therapies, nanobiotechnology-enabled nucleic acid delivery, clustered regularly interspaced short palindromic repeats (CRISPR)-based genome and epigenome editing, and the Brazilian regulatory framework for ATMPs. The discussions highlighted the need for predictive preclinical models capable of capturing human-specific mechanisms, as conventional animal models may have limited translational value for personalized cell, gene and tissue-engineered products. Regulatory and roundtable sessions emphasized risk-based assessment, Good Manufacturing Practice-compatible infrastructure, product characterization, traceability, and the development of national biotechnological raw materials, analytical services and vector production capacity. Overall, SBINT 2025 underscored Brazil's scientific maturity and structural bottlenecks in regenerative medicine, highlighting the importance of coordinated action among academia, industry, clinical centers, regulators and funding agencies to support ATMP translation in Latin America.
