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WIREs Nanomed Nanobiotechnol
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National Cancer Institute Alliance for nanotechnology in cancer—Catalyzing research and translation toward novel cancer diagnostics and therapeutics

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Abstract Nanotechnology has been a burgeoning research field, which is finding compelling applications in several practical areas of everyday life. It has provided novel, paradigm shifting solutions to medical problems and particularly to cancer. In order to accelerate integration of nanotechnology into cancer research and oncology, the National Cancer Institute (NCI) of the National Institutes of Health (NIH) established the NCI Alliance for Nanotechnology in Cancer program in 2005. This effort brought together scientists representing physical sciences, chemistry, and engineering working at the nanoscale with biologists and clinicians working on cancer to form a uniquely multidisciplinary cancer nanotechnology research community. The last 14 years of the program have produced a remarkable body of scientific discovery and demonstrated its utility to the development of practical cancer interventions. This paper takes stock of how the Alliance program influenced melding of disparate research disciplines into the field of nanomedicine and cancer nanotechnology, has been highly productive in the scientific arena, and produced a mechanism of seamless transfer of novel technologies developed in academia to the clinical and commercial space. This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine Therapeutic Approaches and Drug Discovery > Nanomedicine for Oncologic Disease Diagnostic Tools > in vivo Nanodiagnostics and Imaging
Breakdown of terminal degrees held by grant awardees. In total over the course of all three Phases, Alliance grants tend to include more investigators with clinical degrees than the pool of investigators funded through the general NIH NANO study section's cancer applications. This includes fraction of funded investigators who are MDs (gray bar) and fraction of funded investigators who hold dual degrees (MDs/PhDs, light blue bar)
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CCNE awards in three different Phases of the Alliance program. Solid blue represents grant awarded during Phase
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The U.S. government's funding trends in nanoscale science, engineering, and technology R&D since the inception of the National Nanotechnology Initiative (NNI). The funding for nanotechnology by 12 agencies of the U.S. government has maintained high levels since the inception of the NNI due to the 21st Century Nanotechnology Research and Development Act, signed into law in 2003. The agencies that have continued to maintain high levels for the last decade are the National Science Foundation, the Department of Energy, and the National Institutes of Health. (Source NNI Supplement to the President's 2019 Budget—https://www.nano.gov/2019budgetsupplement)
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Triangle of Medicine analysis. In this analysis, publications associated with a grant or set of grants are analyzed for the fractions of human, animal, and molecular/cellular research. In this case, the outside ring is representative of Alliance research, with about a quarter of the published research categorized as human (24%, blue section), slightly more than a quarter categorized as animal research (26%, orange section), and slightly less than half of Alliance research categorized as molecular/cellular research (44%, gray section). For comparison, we also analyzed the Triangle of Medicine research composition for all grants funded through the NIH NANO study section, represented in the inside ring. In the case of NIH NANO study section funded grants, only about 16% of published research included a human research component, with 22% animal research and 51% molecular/cellular research
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Alliance‐related patents. The Alliance program has funded many projects and platform technologies which have ultimately been commercialized and patented by the U.S. Patent and Trademark Office. The graph displays the total number of patents awarded to companies that were either direct spin off companies of Alliance research projects or companies that obtained the intellectual property to their technologies. The companies list does not represent the entire portfolio of companies that were spun‐off by Alliance investigators and is only a representative sample that covers the most directly related. Patent data was collected using the advanced search feature of Google Patents, where the name of the company was used as the assignee and a filter for US patents only was applied. Of note, not all of the patents listed in the figure came directly from projects funded by the Alliance, as the companies have extensive portfolios and have matured. Yet these companies, and their respective patents relative to Alliance‐related companies, are more directly applicable to the original research performed by Alliance investigators who either licensed to existing companies or established companies themselves
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The initial NCI funding and additional funding leveraged by funding to four Alliance CCNEs, which have been funded for all Phases of the program (California Institute of Technology, Northwestern University, Stanford University, and University of North Carolina at Chapel Hill). The graph represents the cumulative investment by NCI to these four CCNEs (gray solid line), the cumulative funds leveraged by these CCNEs from other public funding sources (blue solid line), and the cumulative total of both funds leveraged, and equity invested by companies that commercialized CCNE technologies (black solid line). For additional comparison, the cumulative investment by the NCI to all funded Alliance CCNEs, over all Phases, is also displayed (gray dashed line)
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Cumulative cancer clinical trials conducted for liposomal versus non‐liposomal nanoparticles over time. This graph displays clinical trials performed for liposomal delivery systems (solid orange bars—left axis) since the approval of Doxil in 1995. In comparison, all non‐liposomal nanoparticle cancer clinical trials are displayed as solid blue fill, corresponding right axis. The information was derived from clinicaltrials.gov based on the following keyword searches “Cancer and—liposomal, Caelyx, Myocet, Lipodox, Onivyde, Depocyt, Daunoxome, Marquibo, Vyxeos, or Mepact” and for non‐liposomal “Cancer and nanoparticle or nanotechnology.” The nab‐paclitaxel trials that were found were excluded from non‐liposomal trials count. The year on the horizontal axis corresponds to the initiation of the trial
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Modalities of Alliance‐funded projects over three different Phases of the program. These layered pie charts show the shift in modalities of Alliance‐funded projects over the last 15 years. The inner pie chart displays the fraction of total Alliance projects that focused on in vitro diagnostics, imaging, gene therapy, radiotherapy, immunotherapy, chemotherapy, and other during each period. While, the outer ring is color‐coded to emphasize the shift from a majority diagnostic (noted in blue) in Phase I to primarily therapeutic (noted in red) projects in Phase III. All other (materials characterization, for example) projects are noted in green
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Percent of the Alliance investigator authored publications that are cited by clinical papers—authored by Alliance and/or non‐Alliance investigators. This analysis was carried out using iTrans software from the National Institutes of Health—by program Phase and by grant type (Du, Li, Guo, & Tang, ). For comparison, this analysis was performed for grants originating from the NIH NANO study section over the period of time corresponding to all three Phases of the Alliance program. The figure displays that both CCNE and smaller Alliance grants tend to be cited more often in subsequent clinical papers when compared to grants originating from the NIH NANO study section
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NCI nanotechnology R01 applications versus all NCI R01 applications submitted. The graph highlights the changing level of investigator‐initiated R01 applications submitted in the last decade. Applications received and reviewed for nanotechnology (solid blue bars) in comparison with the total number of applications received and reviewed (solid gray bars) displays persistent increase in nanotechnology for cancer being researched by the biomedical research community. The proportion (black text percentiles) of nanotechnology applications to the total submitted highlights this increase. The data was obtained using an internal NIH grant database and contains information on both new and resubmitted grants. Nanotechnology submissions were identified using a search with the NIH RCDC (Research, Condition, and Disease Categorization) term of “nano”
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Publication focus of different Alliance investigators. The upper part of the graph represents investigators originating from non‐medical fields: physics, chemistry, engineering. As graph shows, prior to their involvement with the Alliance program (2001–2005, 1st, upper row of the graph), they published predominantly in non‐medical nanotechnology (indicated as “Nanotech” in red). Once they started to participate via Alliance program funded grants, their focus evolved, and their overall publication portfolio gradually shifted toward medical applications of nanotechnology (visualized by growing blue portion of the pie chart corresponding to “Biomedical” in 2nd upper row). Similarly (lower part of the graph), investigators, who traditionally researched cancer and medicine, began to involve more nanotechnologies in their work as demonstrated by the red portion (“Nanotech”) of the pie chart growing after their participation in the Alliance program
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Alliance published scientific output over the course of the program. The cumulative published research by Alliance investigators (dark blue solid bar) between 2005 and 2018. The data displayed is derived from literature search using NCBI's PubMed with Alliance‐specific grant identifiers for all Alliance publications. Grants included are all Centers of Cancer Nanotechnology Excellence (U54), single research projects (Cancer Nanotechnology Platform Partnership—U01 and Innovative Research in Cancer Nanotechnology—U/R01), Cancer Nanotechnology Training Centers (R25/T32), and Path‐to‐Independence Awards (K99/R00) funded under the NCI Alliance program
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Diagnostic Tools > In Vivo Nanodiagnostics and Imaging
Therapeutic Approaches and Drug Discovery > Nanomedicine for Oncologic Disease
Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine

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