Challenges in nanomedicine clinical translation

Abstract

New nanomedicine formulations and novel applications of nanomedicinal drugs are reported on an almost daily basis. While academic progress and societal promise continue to shoot for the stars, industrial acceptance and clinical translation are being looked at increasingly critically. We here discuss five key challenges that need to be considered when aiming to promote the clinical translation of nanomedicines. We take the perspective of the end-stage users and consequently address the developmental path in a top-down manner. We start off by addressing central and more general issues related to practical and clinical feasibility, followed by more specific preclinical, clinical, and pharmaceutical aspects that nanomedicinal product development entails. We believe that being more aware of the end user's perspective already early on in the nanomedicine development path will help to better oversee the efforts and investments needed, and to take optimally informed decisions with regard to market opportunities, target disease indication, clinical trial design, therapeutic endpoints, preclinical models, and formulation specifications. Critical reflections on and careful route planning in nanomedicine translation will help to promote the success of nanomedicinal drugs.

Drug Delivery (Nano)Platforms for Oral and Dental Applications: Tissue Regeneration, Infection Control, and Cancer Management

“…From this detailed analysis, few key parameters should be considered as reporters for formulation efficacy, in order to develop a robust quality control procedure necessary for NPs translation to clinics. [ 188 ]…”

Leveraging Immunotherapy with Nanomedicine

“…Several other outstanding issues including the immunonanotherapy efficacy, immune cells reaction to surface labeling, and immunonanotherapy translation toward clinic remain challenges that have to be prospectively addressed. In addition, the inherent limitations to NPs synthesis remain to be overcome, [ 195 ] such as the scale up of the NPs production to enable following the good manufacturing processes is required, or in depth toxicology, pharmacology, and biodistribution studies in the case the NPs are being separated from the immune cell during its circulation in the body.…”

Improving preclinical studies through replications

“…While such secondary outcomes might not be recorded in early experiments, replications are ideally suited to including these additional measures. Clinical biomarkers that are diagnostic for a disease in humans can provide information on the translational potential if collected also in replications in animal models ( Metselaar and Lammers, 2020 ; Volk et al, 2015 ). In this context, if an imaging method like MRI is used in the diagnosis of humans, the same method applied in animals can reveal whether physiological parameters and disease location are comparable.…”