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A translational framework to DELIVER nanomedicines to the clinic

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From Nature Nanotechnology

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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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Fig. 1: The DELIVER framework for translating nanomedicines to the clinic.

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Acknowledgements

P.J. gratefully acknowledges the financial and other support of Cancer Council SA’s Beat Cancer Project (MCR2282) on behalf of its donors and the State Government of South Australia through the Department of Health and Wellbeing, and The Hospital Research Foundation through their EMCR Fellowship funding (2022-CF-EMCR-004-25314). M.J.A. gratefully acknowledges support by the ISCIII thorough AES 2020, award number AC20/00028 and within the framework of EuroNanoMed III and the Ministry of Sciences, Innovation and Universities AEI/PID2020-119368RB-I00. M.K. acknowledges funding support from the National Health and Medical Research Council (NHMRC) Investigator Grant (2016464), the NHMRC Synergy Grant (2019056), a Cancer Council New South Wales Project (2020797), a Tour de Cure (CG-001-FYE2023) and a Neuroblastoma Australia Grant. T.L. gratefully acknowledges support by the European Research Council (ERC: CoG Meta-Targeting (864121) and PoC PRIME (101138100), the German Federal Ministry of Research and Education (BMBF: PP-TNBC) and the German Research Foundation (DFG: RTG2735, SFB1066, LA2937/4-1, KFO5011). C.-X.Z. acknowledges the support from the Australian National Health and Medical Research Council Investigator project of Australia (APP2008698). H.A.S. acknowledges the Research Council of Finland (grant number 331151) and the University Medical Center Groningen Research Funds.

Author information

Authors and Affiliations

  1. Centre for Pharmaceutical Innovation, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia

    Paul Joyce, Clive A. Prestidge & Santhni Subramaniam

  2. Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada

    Christine J. Allen

  3. Center for Research in Molecular Medicine and Chronic Diseases (CIMUS), IDIS Research Institute, Universidade de Santiago de Compostela, Santiago de Compostela, Spain

    María José Alonso

  4. Department of Pharmacology, Pharmacy and Pharmaceutical Technology, School of Pharmacy, Universidade de Santiago de Compostela, Santiago de Compostela, Spain

    María José Alonso

  5. Advanced Drug Delivery, Pharmaceutical Sciences, R&D, AstraZeneca, Macclesfield, UK

    Marianne Ashford

  6. Molecular Imaging Innovations Institute, Department of Radiology, Weill Cornell Medical College, New York, NY, USA

    Michelle S. Bradbury

  7. Curadigm, Nanobiotix, Paris, France

    Matthieu Germain

  8. Children’s Cancer Institute, Lowy Cancer Research Centre, School of Clinical Medicine, Faculty of Medicine and Health UNSW, Sydney, New South Wales, Australia

    Maria Kavallaris

  9. UNSW Australian Centre for Nanomedicine, Faculty of Engineering, University of New South Wales (UNSW), Sydney, New South Wales, Australia

    Maria Kavallaris

  10. Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA

    Robert Langer

  11. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA

    Robert Langer

  12. Department of Nanomedicine and Theranostics, Institute for Experimental Molecular Imaging (ExMI), RWTH Aachen University Hospital, Aachen, Germany

    Twan Lammers

  13. Mildred Scheel School of Oncology (MSSO), Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIOABCD), RWTH Aachen University Hospital, Aachen, Germany

    Twan Lammers

  14. mRNA Center of Excellence, Sanofi R&D, Marcy l’Etoile, France

    Maria Teresa Peracchia

  15. School of Pharmacy, The University of Queensland, Woolloongabba, Queensland, Australia

    Amirali Popat

  16. Cristal Therapeutics, Maastricht, The Netherlands

    Cristianne J. F. Rijcken

  17. IiS - Institute for Research and Innovation in Health (i3S), University of Porto, Porto, Portugal

    Bruno Sarmento

  18. INEB - Institute for Biomedical Engineering, University of Porto, Porto, Portugal

    Bruno Sarmento

  19. Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway

    Ruth B. Schmid

  20. The Louis Family Laboratory for Targeted Drug Delivery and Personalized Medicine Technologies, Department of Chemical Engineering, Technion – Israel Institute of Technology, Haifa, Israel

    Avi Schroeder

  21. BioTherapeutics Pharmaceutical Sciences, Pfizer, Andover, MA, USA

    Chelsea R. Thorn

  22. Department of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA

    Kathryn A. Whitehead

  23. School of Chemical Engineering, Faculty of Sciences, Engineering and Technology, University of Adelaide, Adelaide, South Australia, Australia

    Chun-Xia Zhao

  24. Australian Institute for Bioengineering and Nanotechnology, The University of Queensland, St Lucia, Queensland, Australia

    Chun-Xia Zhao

  25. Department of Biomaterials and Biomedical Technology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

    Hélder A. Santos

  26. The Personalized Medicine Research Institute (PRECISION), University Medical Center Groningen, Groningen, The Netherlands

    Hélder A. Santos

  27. Drug Research Program, Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland

    Hélder A. Santos

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  1. Paul Joyce
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  2. Christine J. Allen
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  3. María José Alonso
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  4. Marianne Ashford
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  5. Michelle S. Bradbury
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  6. Matthieu Germain
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  7. Maria Kavallaris
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  8. Robert Langer
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  9. Twan Lammers
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  10. Maria Teresa Peracchia
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  14. Bruno Sarmento
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  15. Ruth B. Schmid
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Contributions

All authors contributed extensively to the work presented in this paper. P.J. conceived the work and prepared the paper. P.J. and H.A.S. supervised the project, collating the expert advice from the co-authors. C.J.A., M.J.A., M.A., M.S.B., M.G., M.K., R.L., T.L., M.T.P., A.P., C.A.P., C.J.F.R., B.S., R.B.S., A.S., S.S., C.R.T., K.A.W., C.-X.Z. and H.A.S. analysed the framework, provided critical expertise and conceptual advice across the various elements of nanomedicine development, and edited the paper.

Corresponding authors

Correspondence to Paul Joyce or Hélder A. Santos.

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Competing interests

M.J.A. is a co-founder of Libera Bio. M.A. is an employee and shareholder of AstraZeneca. M.B. is a co-founder of Elucida Oncology, Inc, and serves on their scientific advisory board. M.G. is an employee of Curadigm, a subsidiary company of Nanobiotix. He is co-inventor of patent applications related to NBTXR3 product (Nanobiotix) described in this article. R.L. is a co-founder of Moderna and serves on its board. For a list of entities with which R.L. is, or has been recently involved, compensated or uncompensated, see https://www.dropbox.com/scl/fi/xjq5dbrj8pufx53035zdf/RL-COI-2024.pdf?rlkey=fwv336uoepiaiyg4e7jz5t4zo&dl=0. T.L. is a co-founder of SonoMAC GmbH, and serves on the scientific advisory board of BiOrion Technologies BV, Sense Biopharma and Cristal Therapeutics. M.T.P. is a Sanofi employee and may hold shares and/or stock options in the company. C.J.F.R. is a consultant to and shareholder of Cristal Delivery BV and CEO of Liberates. C.R.T. is an employee of Pfizer Inc. K.A.W. is an inventor on several patents related to mRNA delivery systems, is an SAB member of Rampart Bioscience, EnterX Bio and Poseida Therapeutics, and is a shareholder of Poseida Therapeutics.

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Nature Nanotechnology thanks Roey Elnathan and Betty Kim for their contribution to the peer review of this work.

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Joyce, P., Allen, C.J., Alonso, M.J. et al. A translational framework to DELIVER nanomedicines to the clinic. Nat. Nanotechnol. (2024). https://doi.org/10.1038/s41565-024-01754-7

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