Challenges in Clinical Translation of Musculoskeletal Drug Delivery Systems

The burden of musculoskeletal-related diseases has increased globally due to an unhealthy lifestyle and an aging population. Advanced drug delivery systems such as hydrogel, nano/microparticles, and 3D-printed scaffolds are potential candidates for the treatment of damaged and degenerative musculoskeletal tissues. During the development of such drug delivery systems, biomaterials play a crucial role in improving the therapeutic efficacy of small drug molecules and other kinds of drugs, such as nucleic acid and protein. However, successful clinical translation is still difficult as every level of clinical translation faces a number of challenges. By understanding these challenges, one can determine the future success of the drug delivery system from bench to bedside. In this chapter, we will discuss key issues limiting the translation of drug delivery systems. These issues mainly involve biological challenges, regulatory approvals, and large-scale manufacturing. These factors impose major hurdles in the commercialization of these products and hence need to be addressed.