Challenges And Strategies In Anti-cancer Nanomedicine Development: An Industry Perspective
Authors: Jennifer I. Harea, Twan Lammers, Marianne B. Ashforde, Sanyogitta Puri, Gert Storm, Simon T. Barry
Abstract:
Transforming anti-cancer nanomedicines from pre-clinical proof of concept to demonstrating their therapeutic value in clinical settings presents significant challenges. However, by leveraging advancements in drug delivery technologies, we can draw valuable lessons from other areas of oncology drug development. These lessons emphasize the importance of patient stratification and target-driven design, which have led to improved outcomes for patients. To effectively develop nanomedicines, we must integrate the patient and disease into our development strategies from the very beginning.
The success of small molecule targeted therapies has been greatly enhanced through the adoption of specific decision-making frameworks, such as AstraZeneca's 5R principle. This principle emphasizes the importance of the right target/efficacy, right tissue/exposure, right safety, right patient, and right commercial potential. By investing appropriately and fostering collaborations to generate a robust evidence platform supporting clinical applications, a similar framework can be established to enhance the translation and performance of nanomedicines.
Addressing these challenges and improving the cost-effectiveness of nanomedicine development and translation requires several key actions. Firstly, we need to gain a better understanding of the heterogeneity of clinical cancers and the biological factors that influence the behavior of nanomedicines within patient tumors. Secondly, we should shift from formulation-driven research to disease-driven development, placing greater emphasis on the specific characteristics of the disease being targeted. Thirdly, it is crucial to implement more relevant animal models and testing protocols that better mimic human conditions. Finally, the pre-selection of patients most likely to respond to nanomedicine therapies is essential for achieving success.
Overcoming these challenges is imperative to advance the development and translation of nanomedicines, ultimately leading to the establishment of superior therapies for patients.
Keywords
Nanomedicine; EPR effect; Clinical translation; Pre-clinical models; Industry; Companion diagnostics; Patient pre-selection.
Citation: Jennifer I. Harea, Twan Lammers, Marianne B. Ashforde, Sanyogitta Puri, Gert Storm, Simon T. Barry Challenges And Strategies In Anti-cancer Nanomedicine Development: An Industry Perspective doi:10.1016/j.addr.2016.04.025
Received: 24 February 2016, Revised: 20 April 2016, Accepted: 21 April 2016, Available online: 29 April 2016
Copyright: © 2016 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Acknowledgements
This work was financially supported by AstraZeneca. The authors kindly acknowledge Dr. Colin Howes for helpful comments and discussions. The European Research Council is gratefully acknowledged for financial support (ERC Starting Grant 309495 (NeoNaNo) and proof-of-concept grant 680882 (CONQUEST); both to TL).
