Overview

This book explores how artificial intelligence is transforming the pharmaceutical industry and examines the legal challenges arising from its integration into every stage of the drug lifecycle. From target identification, molecular design, and clinical development to regulatory approval, manufacturing, and pharmacovigilance, the volume provides a comprehensive legal framework for understanding what the author terms algoraceutics, the growing convergence of artificial intelligence and pharmaceutical innovation.  Combining insights from information technology law, pharmaceutical regulation, civil liability, intellectual property, competition law, and data governance, the book explains how contemporary AI systems, including machine learning models, generative AI, digital twins, and autonomous research platforms, are reshaping drug discovery and development. It analyzes the opportunities created by these technologies alongside their legal implications, including questions of inventorship, product liability, algorithmic transparency, explainability, patient protection, and access to data.  Particular attention is devoted to the European regulatory framework, including the AI Act, the Product Liability Directive, the Data Act, the European Health Data Space, and the evolving guidance of the European Medicines Agency and the U.S. Food and Drug Administration. The book further examines cutting-edge issues such as AI-assisted pharmaceutical inventions, digital twins and in silico clinical trials, algorithmic decision-making in research, and the role of explainability techniques such as SHAP and LIME in regulatory and judicial proceedings.  Written from an international perspective and grounded in both legal doctrine and regulatory practice, this timely work serves as an authoritative guide for academics, legal practitioners, regulators, and professionals working at the intersection of law, artificial intelligence, biotechnology, and the life sciences. It offers a rigorous yet accessible analysis of one of the most significant technological transformations shaping the future of healthcare and pharmaceutical innovation.

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9783032385369

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Author Information

Gianluca Rotino is a senior legal advisor with twenty years of executive and consulting experience at the intersection of law, life sciences, and artificial intelligence. He holds a Master’s degree in Law from the University of Milan and is affiliated with its Information Society Law Center (ISLC). His training—in addition to numerous advanced courses in corporate (criminal and civil) liability and the legal and forensic aspects of cybersecurity—combines advanced programs in artificial intelligence at the University of Oxford (Saïd Business School) with specialized studies in drug discovery, development, and commercialization at UC San Diego (Skaggs School of Pharmacy) and in GDPR, clinical trials, and medical devices at the Scuola Superiore Sant’Anna in Pisa. For nearly a decade, he served as Chief Strategy and Innovation Officer and Board Director of a NASDAQ-listed clinical-stage biotech company operating a proprietary AI-driven target-discovery platform, where he defined the legal framework for AI applications in drug discovery and clinical trials. He currently advises clients in various highly regulated sectors, including pharmaceutical, biotech, finance, and ICT, on the AI Act, cybersecurity and resilience (NIS2, CRA, CSA, etc.), MDR, DORA, and GDPR compliance through CCLEX Associated Law Firm in Milan, where he serves as Director of the Compliance Department.

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