Current Trends and Challenges in the Clinical Translation of Nanoparticulate Nanomedicines: Pathways for Translational Development and Commercialization

Abstract

The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effective dose, and/or reduce the risk of systemic side effects. In order to move a NNM from the bench to the bedside, several experimental challenges need to be addressed. This review will discuss the current trends and challenges in the clinical translation of NNMs as well as the potential pathways for translational development and commercialization. Key issues related to the clinical development of NNMs will be covered, including biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), government regulations, and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of NNMs on the market, irrelevant of whether they are therapeutically beneficial or not.

Nanomedicine Fight against Antibacterial Resistance: An Overview of the Recent Pharmaceutical Innovations

“…The main challenges related to the clinical translation are biological issues, safety, biocompatibility, intellectual property (IP), laws and regulations, and overall cost-effectiveness compared to traditional therapies [233], (Figure 3). These obstacles limit the usage of nanoparticles in the present markets regardless of their effectiveness [234]. Many issues should be considered during the clinical translation of nanomedicine.…”

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“…Even several formulations of liposomal and polymeric NPs earned the FDA‐approved and introduced in the market (Shi et al, ; Svenson, ). However, there are several key obstacles and challenges which are related to the clinical and translational development of targeted NPs in nanomedicine, such as lack of clear regulatory guidelines that are specific to targeted NPs, limited understanding of the biological stability of targeted NPs in human body and serum, and limited knowledge about NPs biocompatibility and biodegradability (Hua, De Matos, Metselaar, & Storm, ; Svenson, ). On the other hand, there is some incoordination between members of the investment community in conceptual understanding of the nanomedicine and scientific research recognize that has very low understanding about business expertise to develop commercial product in nanomedicine.…”

Analysis of costs and strategies for using academic research in a private dental college to develop commercially viable products

“…Material costs, also called 'external costs', is often a significant portion of capital required to run a trials-to-commercialization study 10,11,15,28,29 . It includes procurement, purification, manufacturing and packaging costs of a product along with any additional expenses incurred towards achieving regulatory approval and patenting 15,29 . In R&D, around 30% of the budget is spent on product development whereas the remainder is on clinical trials 8,9,11,12,15 .…”

“…The material costs were 35 to 44% of the total capital for the three products identified for commercialization. However, it is difficult to compare these values with benchmarks from earlier studies as all material costs are factored into the final pricing of the material and end up in a clinical trial as "per-patient" or "per-site" costs 15,27,29,30 ; one study 15 reported that the 'clinical procedure costs' consumed about 22.32% of the overall costs. Most of the projects in this study procured materials either in bulk or small batches which made it easy for us to calculate material costs via invoicing.…”