A translational framework to DELIVER nanomedicines to the clinic

doi:10.1038/s41565-024-01754-7

Review

. 2024 Sep 6.

doi: 10.1038/s41565-024-01754-7. Online ahead of print.

A translational framework to DELIVER nanomedicines to the clinic

Paul Joyce¹, Christine J Allen², María José Alonso^{3

4}, Marianne Ashford⁵, Michelle S Bradbury⁶, Matthieu Germain⁷, Maria Kavallaris^{8

9}, Robert Langer^{10

11}, Twan Lammers^{12

13}, Maria Teresa Peracchia¹⁴, Amirali Popat¹⁵, Clive A Prestidge¹⁶, Cristianne J F Rijcken¹⁷, Bruno Sarmento^{18

19}, Ruth B Schmid²⁰, Avi Schroeder²¹, Santhni Subramaniam¹⁶, Chelsea R Thorn²², Kathryn A Whitehead²³, Chun-Xia Zhao^{24

25}, Hélder A Santos^{26

27

28}

Affiliations

¹ Centre for Pharmaceutical Innovation, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia. paul.joyce@unisa.edu.au.
² Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
³ Center for Research in Molecular Medicine and Chronic Diseases (CIMUS), IDIS Research Institute, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.
⁴ Department of Pharmacology, Pharmacy and Pharmaceutical Technology, School of Pharmacy, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.
⁵ Advanced Drug Delivery, Pharmaceutical Sciences, R&D, AstraZeneca, Macclesfield, UK.
⁶ Molecular Imaging Innovations Institute, Department of Radiology, Weill Cornell Medical College, New York, NY, USA.
⁷ Curadigm, Nanobiotix, Paris, France.
⁸ Children's Cancer Institute, Lowy Cancer Research Centre, School of Clinical Medicine, Faculty of Medicine and Health UNSW, Sydney, New South Wales, Australia.
⁹ UNSW Australian Centre for Nanomedicine, Faculty of Engineering, University of New South Wales (UNSW), Sydney, New South Wales, Australia.
¹⁰ Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA.
¹¹ Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA.
¹² Department of Nanomedicine and Theranostics, Institute for Experimental Molecular Imaging (ExMI), RWTH Aachen University Hospital, Aachen, Germany.
¹³ Mildred Scheel School of Oncology (MSSO), Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIOABCD), RWTH Aachen University Hospital, Aachen, Germany.
¹⁴ mRNA Center of Excellence, Sanofi R&D, Marcy l'Etoile, France.
¹⁵ School of Pharmacy, The University of Queensland, Woolloongabba, Queensland, Australia.
¹⁶ Centre for Pharmaceutical Innovation, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
¹⁷ Cristal Therapeutics, Maastricht, The Netherlands.
¹⁸ IiS - Institute for Research and Innovation in Health (i3S), University of Porto, Porto, Portugal.
¹⁹ INEB - Institute for Biomedical Engineering, University of Porto, Porto, Portugal.
²⁰ Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
²¹ The Louis Family Laboratory for Targeted Drug Delivery and Personalized Medicine Technologies, Department of Chemical Engineering, Technion - Israel Institute of Technology, Haifa, Israel.
²² BioTherapeutics Pharmaceutical Sciences, Pfizer, Andover, MA, USA.
²³ Department of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA.
²⁴ School of Chemical Engineering, Faculty of Sciences, Engineering and Technology, University of Adelaide, Adelaide, South Australia, Australia.
²⁵ Australian Institute for Bioengineering and Nanotechnology, The University of Queensland, St Lucia, Queensland, Australia.
²⁶ Department of Biomaterials and Biomedical Technology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. h.a.santos@umcg.nl.
²⁷ The Personalized Medicine Research Institute (PRECISION), University Medical Center Groningen, Groningen, The Netherlands. h.a.santos@umcg.nl.
²⁸ Drug Research Program, Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland. h.a.santos@umcg.nl.

PMID: 39242807
DOI: 10.1038/s41565-024-01754-7

Review

A translational framework to DELIVER nanomedicines to the clinic

Paul Joyce et al. Nat Nanotechnol. 2024.

. 2024 Sep 6.

doi: 10.1038/s41565-024-01754-7. Online ahead of print.

Authors

Affiliations

¹ Centre for Pharmaceutical Innovation, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia. paul.joyce@unisa.edu.au.
² Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
³ Center for Research in Molecular Medicine and Chronic Diseases (CIMUS), IDIS Research Institute, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.
⁴ Department of Pharmacology, Pharmacy and Pharmaceutical Technology, School of Pharmacy, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.
⁵ Advanced Drug Delivery, Pharmaceutical Sciences, R&D, AstraZeneca, Macclesfield, UK.
⁶ Molecular Imaging Innovations Institute, Department of Radiology, Weill Cornell Medical College, New York, NY, USA.
⁷ Curadigm, Nanobiotix, Paris, France.
⁸ Children's Cancer Institute, Lowy Cancer Research Centre, School of Clinical Medicine, Faculty of Medicine and Health UNSW, Sydney, New South Wales, Australia.
⁹ UNSW Australian Centre for Nanomedicine, Faculty of Engineering, University of New South Wales (UNSW), Sydney, New South Wales, Australia.
¹⁰ Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA.
¹¹ Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA.
¹² Department of Nanomedicine and Theranostics, Institute for Experimental Molecular Imaging (ExMI), RWTH Aachen University Hospital, Aachen, Germany.
¹³ Mildred Scheel School of Oncology (MSSO), Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIOABCD), RWTH Aachen University Hospital, Aachen, Germany.
¹⁴ mRNA Center of Excellence, Sanofi R&D, Marcy l'Etoile, France.
¹⁵ School of Pharmacy, The University of Queensland, Woolloongabba, Queensland, Australia.
¹⁶ Centre for Pharmaceutical Innovation, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
¹⁷ Cristal Therapeutics, Maastricht, The Netherlands.
¹⁸ IiS - Institute for Research and Innovation in Health (i3S), University of Porto, Porto, Portugal.
¹⁹ INEB - Institute for Biomedical Engineering, University of Porto, Porto, Portugal.
²⁰ Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
²¹ The Louis Family Laboratory for Targeted Drug Delivery and Personalized Medicine Technologies, Department of Chemical Engineering, Technion - Israel Institute of Technology, Haifa, Israel.
²² BioTherapeutics Pharmaceutical Sciences, Pfizer, Andover, MA, USA.
²³ Department of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA.
²⁴ School of Chemical Engineering, Faculty of Sciences, Engineering and Technology, University of Adelaide, Adelaide, South Australia, Australia.
²⁵ Australian Institute for Bioengineering and Nanotechnology, The University of Queensland, St Lucia, Queensland, Australia.
²⁶ Department of Biomaterials and Biomedical Technology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. h.a.santos@umcg.nl.
²⁷ The Personalized Medicine Research Institute (PRECISION), University Medical Center Groningen, Groningen, The Netherlands. h.a.santos@umcg.nl.
²⁸ Drug Research Program, Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland. h.a.santos@umcg.nl.

PMID: 39242807
DOI: 10.1038/s41565-024-01754-7

Abstract

Nanomedicines have created a paradigm shift in healthcare. Yet fundamental barriers still exist that prevent or delay the clinical translation of nanomedicines. Critical hurdles inhibiting clinical success include poor understanding of nanomedicines' physicochemical properties, limited exposure in the cell or tissue of interest, poor reproducibility of preclinical outcomes in clinical trials, and biocompatibility concerns. Barriers that delay translation include industrial scale-up or scale-down and good manufacturing practices, funding and navigating the regulatory environment. Here we propose the DELIVER framework comprising the core principles to be realized during preclinical development to promote clinical investigation of nanomedicines. The proposed framework comes with design, experimental, manufacturing, preclinical, clinical, regulatory and business considerations, which we recommend investigators to carefully review during early-stage nanomedicine design and development to mitigate risk and enable timely clinical success. By reducing development time and clinical trial failure, it is envisaged that this framework will help accelerate the clinical translation and maximize the impact of nanomedicines.

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References

1. Park, K. The beginning of the end of the nanomedicine hype. J. Control. Release 305, 221–222 (2019). - PubMed - DOI
1. Bhatia, S. N., Chen, X., Dobrovolskaia, M. A. & Lammers, T. Cancer nanomedicine. Nat. Rev. Cancer 22, 550–556 (2022). - PubMed - PMC - DOI
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1. Leong, H. S. et al. On the issue of transparency and reproducibility in nanomedicine. Nat. Nanotechnol. 14, 629–635 (2019). - PubMed - PMC - DOI
1. Lammers, T. et al. Cancer nanomedicine: is targeting our target? Nat. Rev. Mater. 1, 16069 (2016). - PubMed - PMC - DOI

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[1] Park, K. The beginning of the end of the nanomedicine hype. J. Control. Release 305, 221–222 (2019). - PubMed - DOI

[2] Park, K. The beginning of the end of the nanomedicine hype. J. Control. Release 305, 221–222 (2019). - PubMed - DOI

[3] Bhatia, S. N., Chen, X., Dobrovolskaia, M. A. & Lammers, T. Cancer nanomedicine. Nat. Rev. Cancer 22, 550–556 (2022). - PubMed - PMC - DOI

[4] Bhatia, S. N., Chen, X., Dobrovolskaia, M. A. & Lammers, T. Cancer nanomedicine. Nat. Rev. Cancer 22, 550–556 (2022). - PubMed - PMC - DOI

[5] Youn, Y. S. & Bae, Y. H. Perspectives on the past, present, and future of cancer nanomedicine. Adv. Drug Deliv. Rev. 130, 3–11 (2018). - PubMed - DOI

[6] Youn, Y. S. & Bae, Y. H. Perspectives on the past, present, and future of cancer nanomedicine. Adv. Drug Deliv. Rev. 130, 3–11 (2018). - PubMed - DOI

[7] Leong, H. S. et al. On the issue of transparency and reproducibility in nanomedicine. Nat. Nanotechnol. 14, 629–635 (2019). - PubMed - PMC - DOI

[8] Leong, H. S. et al. On the issue of transparency and reproducibility in nanomedicine. Nat. Nanotechnol. 14, 629–635 (2019). - PubMed - PMC - DOI

[9] Lammers, T. et al. Cancer nanomedicine: is targeting our target? Nat. Rev. Mater. 1, 16069 (2016). - PubMed - PMC - DOI

[10] Lammers, T. et al. Cancer nanomedicine: is targeting our target? Nat. Rev. Mater. 1, 16069 (2016). - PubMed - PMC - DOI

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A translational framework to DELIVER nanomedicines to the clinic

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A translational framework to DELIVER nanomedicines to the clinic

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