Thirteen Early Stage Researchers (ESRs) were recruited into the InPharma European Industrial Doctorate network to undertake industrially based PhD programmes. These programmes are broadly focused on developing a fully integrated, animal-free, end-to-end modelling approach to oral drug product development. Each ESR completed a unique intersectoral training plan, gaining experience in both industry and academia. As of March 2025, six ESRs have successfully been awarded PhDs, while the remaining seven are on track to submit their PhD theses in 2025. All ESRs received training in computational formulation design, bio-predictive in vitro testing, and physiologically based pharmacokinetic modelling, with specific training tailored to the individual needs of each ESR project. Additionally, all ESRs underwent a transferable skills training programme to build proficiency in essential research and industry disciplines, including professional skills and entrepreneurship, inspiring them to become trailblazers in industrial drug product development.
This research strategy is reflected in two research work packages (WPs), with key achievements in the project summarized as follows:
WP1 is dedicated to advancing computational tools for developing oral drug formulations. The two primary research objectives are: (1) Investigating novel mechanistic and data-driven algorithms to support the formulation design of poorly soluble drugs, and (2) Using these algorithms to select drug-excipient mixtures for optimal excipient selection for a given drug. Collectively, ESR research in WP1 has led to significant formulation innovations, enabled by diverse computational approaches. These achievements span multiple formulation platform technologies, including co-crystals (ESR1), solid dispersions (ESR6), deep eutectic solvents (ESR5), co-milling (ESR3), and lipid-based formulations (ESR2, ESR4). Various formulations have been thoroughly characterized on a physicochemical basis, successfully linking with WP2 for further biopharmaceutical analysis, including in vitro testing and physiologically based pharmacokinetic modelling.
WP2 focuses on developing animal-free assessment methods for predicting formulation performance in patients. This is achieved by developing in vitro methodologies that are bio-predictive of enabling formulations under clinically relevant conditions, as well as developing in silico models for predicting drug concentration profiles in patients after oral administration. Highlights of WP2 include progress in establishing the animal-free ‘rDCS approach’ to predicting formulation strategy (ESR7), novel in vitro methods for evaluating bio-enabled formulations (ESR8, ESR9, ESR11, ESR12 & ESR13), and advancing in silico approaches to replace allometric scaling from animal studies with virtual trials (ESR8, ESR10, ESR11 & ESR12).
