New Medicines Design, Development and Commercialization in the Era of AI

The escalating demand for innovative therapies and increasing chronic disease incidence pose significant challenges to the pharmaceutical industry. Regulatory bodies are prioritizing more cost-effective, sustainable solutions with greater transparency. In response, AstraZeneca is evolving its strategies to prioritize speed, sustainability, and cost-effectiveness, while maintaining quality and patient safety. We are leveraging advancements in data-centric science, digital twin technology, and AI, including generative AI, to expedite clinical trials and streamline drug development. Our digital transformation is rooted in a profound understanding of drug substance and product, clinical supply chain planning, and manufacturing. This shift is facilitated by data, novel business processes, and human skills. We are entering a new era of digital innovations, where our pharmaceutical development expertise is strengthened by tools like generative AI and deep understanding of various scientific disciplines. This paper provides an overview of our activities and methodology for digital innovations relevant to pharmaceutical technology and development. It delves into the Drug Development Holistic Digital Twin concept, aimed at transforming our work methods, productivity, and innovation, and concludes with an update on progress and future plans.