Delivery science: Its increasing importance for the next generation of medicines

Abstract

The therapeutic landscape has diversified beyond traditional small molecules to encompass a plethora of different modalities including antibodies, peptides and nucleic acids as well as more complex small molecules. Increasingly heterofunctional molecules, targeted drug conjugates, including antibody drug conjugates, oligonucleotide drug conjugates and radionuclide conjugates, are being used to improve efficacy, reduce side effects and enable lower doses. These diverse modalities present distinct delivery needs. This perspective briefly reflects on the main drug modality classes, their delivery challenges and summarises the current delivery solutions and trends including amorphous solid dispersions, long acting injectables, approaches to high concentration subcutaneous delivery of biologics and lipid nanoparticles for delivery of mRNA. There is a continual drive for more patient centric formulations. We argue that this modality evolution heightens the importance of drug delivery as a core design parameter in discovery rather than as a downstream fix. Across modalities, targeted delivery remains pivotal to improve therapeutic index and to lower dose and environmental footprint. Translational success requires early collaboration among preclinical safety, CMC, clinical, and regulatory teams to define critical quality attributes and develop in vitro/in silico tools for predicting in vivo performance. Delivery science is positioned to play a leading role in enabling the next generation of medicines, accelerating translation, and improving patient outcomes.