2nd
A network of opportunities
The 2nd Edition of the Galileo Annual Meeting (GAM2), organized by Galileo Research (Pisa, Italy), brought together leaders from the pharmaceutical industry and regulatory affairs to discuss groundbreaking advancements in drug discovery, development, and evaluation, with a focus on addressing rare and complex diseases. The sessions covered diverse yet interconnected areas, ranging from cutting-edge metabolomics using Nuclear Magnetic Resonance (NMR) to the latest computational models that streamline drug design through artificial intelligence (AI). Additional topics included innovative Absorption, Distribution, Metabolism, and Excretion (ADME) assessment techniques, regulatory standards for preclinical studies, and evolving frameworks for Environmental Risk Assessment (ERA). Through case studies and expert presentations, the event highlighted how these new scientific methodologies and regulatory approaches are fast-tracking the development of safer, more effective treatments and advancing sustainable, patient-centered healthcare.
Prof. Claudio Luchinat explored the impact of NMR metabolomics on drug discovery by examining real-time metabolic changes.
Dr. Nedra Mekni discussed AI-driven models and their role in expediting drug design, with insights into the DeNovo model.
Dr. Emanuela Testai addressed New Approach Methodologies (NAMs) for ADME analysis, aimed at enhancing toxicological evaluations and reducing animal testing.
Dr. Maria Francesca Cometa highlighted the importance of preclinical regulations and Good Laboratory Practices (GLP) in ensuring drug safety and efficacy.
Dr. Federico Benetti examined BCS (Biopharmaceutics Classification System)-based biowaivers to simplify drug approvals.
Dr. Marco Rodda addressed Environmental Risk Assessment (ERA) and the challenges for pharmaceutical sustainability.
Dr. Paolo Baroldi presented new clinical paradigms in orphan disease treatments, along with updates on supporting regulations.
Dr. Silvia Trasciatti explored innovative strategies for drug repurposing to address unmet therapeutic needs.
