Perspectives on the Future of Nanomedicine to Impact Patients: An Analysis of US Federal Funding and Interventional Clinical Trials.

The US and governments around the world, and companies, have made a considerable investment in nanomedicine, and there have been important discoveries. Nevertheless, there has been considerable debate as to whether the investment, both in money and in time, has been worth it. That question is not yet definitively answerable. However, investigators (and investors) might also wonder if the efforts in nanomedicine are likely to continue at the same pace as over the past decade. For this paper, an analysis was done by searching Medline, RePORT, the DOD (CDMRP), the NSF, and ClinicalTrials.gov. The major findings from the analysis are as follows: (1) The number of journal articles on the subject of nanomedicine continues to steadily rise and the areas "Drug Carriers" and "Drug Delivery Systems" are experiencing particularly rapid growth. (2) The level of funding from the Department of Health and Human Services (NIH and others) for indications other than cancer has been greater than that for cancer. (3) Funding for applications in HIV/AIDS has been strong. (4) Most of the cancers are being impacted. (5) The number of clinical trials are more highly focused in breast, skin, metastatic, and ovarian cancers, though the noncancer indications of pain and infections are also highly represented. The trials are primarily in Phases I and II, suggesting a long horizon before translating to a high impact on patients. (6) The vast majority of the clinical trials are for the evaluation of established nanomedicine formulations (liposomes and nab-paclitaxel/Abraxane) in combination with other therapies. Nevertheless, the number of clinical trials with other nanomedicine formulations has been increasing since 2009. Relatively few of the trials are for micelles or dendrimers. Taken as a whole, the analysis provides a picture that nanomedicine continues to be highly funded and highly studied but with few recent breakthroughs. Nanomedicine has yet to provide the "silver bullet" for therapy in cancer or other diseases, and it remains unclear whether it ever will.