hypothetical scenarios and process modifications before experimentation. Insights gained early inform laterstage development, such as scale-up and commercial manufacturing, ensuring that processes remain robust, scalable, and cost-effective. The ability to offer full digital technology transfer and manufacturing capabilities from lab to plant beyond current MES and LIMS system is also opening a wide range of opportunities for acceleration and optimisation of manufacturing of pharmaceuticals. Toward a data-driven development paradigm in early phase The convergence of AI-enabled route scouting, HTE, model-based process optimization, solid form science and PBBM, is transforming small-molecule drug development. By adopting a data-driven, integrated approach, drug developers can accelerate timelines, mitigate risk, and improve long-term process reliability. This data/model driven scientific approach may appear counter intuitive in a field where speed and trials and error approaches have dominated for years. However, recent advances in early-phase tools and capabilities now make it possible to take a more insightful yet pragmatic approach to drug development, enabling faster progress by avoiding challenges such as poorly developed or convoluted processes and suboptimal solid-state selection. Early-phase decisions are no longer isolated tasks; they are interdependent steps that shape the efficiency and success of later development. Lonza’s tools and expertise empower biotech and pharmaceutical companies to adopt a “right-first-time” mindset, ensuring that every decision from solid form selection to scale-up is informed, strategic, and resilient. As the complexity of small molecules continues to grow, this integrated approach provides a competitive advantage, supporting faster access to life-saving therapies while optimizing costs and timelines. If you would like to learn more, join Francois Ricard’s presentation on Smarter Molecule Development: AIDriven Tools and Model-Based Approaches in EarlyPhase on Wednesday, October 29, 2025, from 2:30–2:55 PM (CET) in Hall 4.1 - 4.1L8, Manufacturing 5.0, or stop by our booth 5.1B76 to connect directly with our experts. or acid-reducing drug interactions. For example, in developing posaconazole ASDs, PBBM was used to predict in vivo performance, guiding formulation strategies and dosing regimens. Regulatory agencies increasingly recognize PBBM data in IND applications, underscoring the importance of these models in accelerating clinical readiness. Lonza is at the forefront of deploying PBBM modelling tools such as Gastro+ in the CDMO industry guiding our customers decision and derisking their assets by ensuring appropriate drug exposure. Strategic benefits for biotech and pharma Integrating AI-enabled route scouting, HTE, Design2Optimize™, solid form screening and PBBM tools provides a holistic, data-driven foundation for drug development in early phase and forms the first wave of a digital design and optimisation toolbox being built at Lonza to enable our customers’ drug to reach the market faster. Key benefits include: - De-risking early development: Identifying optimal routes, formulations, and process parameters early reduces the likelihood of delays during scale-up. - Accelerating timelines: Faster process optimization and predictive modeling shorten the path to IND submission and clinical trials. - Cost efficiency: By selecting commercially viable routes and formulations early, developers reduce potential losses from late-stage failures. - Investor confidence: Robust, data-backed processes demonstrate maturity and reliability to potential investors and partners. Looking beyond process chemistry With the remarkable growth in AI and predictive tools, Lonza’s integrated approach is being extended well beyond chemistry optimization. In the optimisation area, the combination of highthroughput screening combined with learning tools like D2O, Bayesian optimisation or AI are driving a paradigm shift towards self-optimising platform in process development. In the technology transfer and manufacturing areas, digital twins of synthetic processes already allow exploration of 22 Dr. FRANCOIS RICARD Executive Director, R&D Lonza Advanced Synthesis LONZA DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025
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