Keywords: nanomedicine, clinical trial
Summary:Nanomedicines have consistently shown their ability to improve therapeutic index in pre-clinical models particularly in cancer and the need to use nanomedicines is increasing with diversification of portfolios and requirement to deliver new modalities to access traditionally "non-druggable" target space. Gaining access to intracellular trafficking knowledge enables design of nanosystems for various modalities such as peptides, nucleic acid based drugs to either knock down or produce proteins or for gene editing Enabling exploitation of the CRISPR revolution accelerates the needs for better advanced drug delivery systems and more successful translation into the clinic and to patients .However the success rate of clinical translation of a number of nanomedicines in oncology has been poor historically and the advances beyond Phase 1 studies are limited This talk will provide a brief overview of where there has been successful translation of nanomedicines, highlight some newer emerging applications of nanomedicines that may transform growing areas of biology (e.g immunotherapies) and new modalities as well as focussing on the main reasons for attrition to date and learnings from them. These include poor translation to the clinic due to limited understanding of the disease and availability of poor disease models, challenges in scale up and manufacture and analytical characterisation that are required to ensure robust product quality and satisfy regulatory requirements. Growing understanding of robust and reproducible manufacturing and characterisation are key aspects that are still in their infancy but critical to establish early on, to enable a more rapid transition of successful concepts from the lab into the clinic.