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Precision Nanomedicine

The official journal of CLINAM

About the Journal: Precision Nanomedicine (PRNANO) is a peer-reviewed, not-for-profit, international society journal to promote all practical, rational, and progressive aspects of theory and practice of nanomedicine, from basic research through translational and clinical aspects including commercialization.

PRNANO provides an open access forum with reliable content and quick turnaround time.

We invite authors to submit both original, as well as replication studies. Discussions of negative results are also welcome if they move the field forward.  Papers are published continuously then organized into quarterly issues.

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PRNANO is digitally distributed by a scientists-owned non-profit publisher: Andover House Inc, 138 River Rd, Andover, Massachusetts, 01810, USA.

 ISSN: 2639-9431 (online)

Nanoparticle-Encapsulated Doxorubicin Demonstrates Superior Tumor Cell Kill in Triple Negative Breast Cancer Subtypes Intrinsically Resistant to Doxorubicin
- Krausz AE, Adler BL, Makdisi J, Schairer D, Rosen J, Landriscina A, Navati M, Alfieri A, Friedman JM, Nosanchuk JD, Rodriguez-Gabin A, Ye KQ, McDaid HM, Friedman AJ.
Liposomal formulation of polyacrylate-peptide conjugate as a new vaccine candidate against cervical cancer
- Khongkow M, Liu TY, Bartlett S, Hussein WM, Nevagi R, Jia ZF, Monteiro MJ, Wells J, Ruktanonchai UR, Skwarczynski M, Toth I.
Specific Molecular Recognition as a Strategy to Delineate Tumor Margin Using Topically Applied Fluorescence Embedded Nanoparticles
- Barton S, Li B, Siuta M, Janve VA, Song J, Holt CM, Tomono T, Ukawa M, Kumagai H, Tobita E, Wilson K, Sakuma S, Pham W.
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Improving Innovation in Nano-Healthcare Funding

Opinion

Author:

Affiliation:

  • ENATRANS<TecMinho < Campus de Azurém < Universidade do Minho – Guimarães, Portugal

Submitted: January 3, 2018; Accepted: January 8, 2018

License

Introduction and Discussion

European countries have invested heavily in Nanomedicine over the last decade, however the output has been much reduced by a lack of knowledge of how to innovate in a heavily regulated setting [1, 2]. This development failing is not unique to nanomedicine but is there to differing extents across most open innovation healthcare projects.

The healthcare value of this public funding has been shrunk by the beneficiaries’ lack of understanding of development - not knowledge of research [3, 4]. Public funding systems assume this development knowledge is understood by both scientists and peer review funders - neither is true and it reduces funding to an expensive lottery (Figure 1). Successful translation requires a detailed understanding of the path through and beyond the clinic to the market, with a quantifiable value to patients, companies, innovators, tax payers and funders. Healthcare is rightly a highly-regulated sector with a slow and extremely expensive development process; it is not an area to enter lightly unless you have development knowledge and a strong Unique Selling Proposition (USP). In any specific therapeutic area - unlike most business areas - there is only a market for a few products, due to the development costs. Development processes and their milestones are not obscure, but it does require effort to learn and practice them, and these essential skills are not taught at present. There are early plans to teach healthcare product development in some European countries, but these are at a pilot or low level at present.

Universities’ philosophy is to create globally competitive research centres; however, they very rarely train students or recruit lecturers with a background in development science or thinking. Their staff, in due course, inevitably view healthcare from their narrow research perspective when invited to peer review (de facto “applied”) projects. There is a big opportunity here for European Science to encompass development science(s) but this change from the status quo lacks motivation? Without high level political encouragement, the situation will continue to help a minority, and not the stakeholders that matter.

The consequences of this research-focused culture are that many applied projects at inception start with a very low chance of success, from a development and patient perspective; again, not surprisingly, many such projects are publicly funded at a serious level by “expert” academic peer reviewers. If you want to build a house do you employ an experienced builder or an expert in cement technology?

Figure 1 The lack of development know-how leads to a lottery in healthcare funding.

The ground rules for development have been published and are freely available [3, 4]. The industry development milestones and relevant gatekeeping questions are openly used by ENATRANS5, an EC funded translation advisory service, as it evaluates and supports innovation in academia and industry. Some of the problems seen by ENATRANS can be solved by training on how to showcase projects to an industrial audience. This requires joined up thinking, and a clear presentation, demonstrating the advantages of their chosen approach compared with a competitor. There are many opportunities for a strong technology transfer office to advise on translation, but this rarely happens.

ENATRANS has seen exceptional developable projects, but the majority are industry-benchmarked as very early research, and often lack the industrial metrics for acceptance into development. Whilst ENATRANS’s main role was envisaged as assisting in the preclinical stage, it has de facto assumed an educational role, as well in helping at ideation, clearly signalling an unmet need. Some projects reach ENATRANS without funding and others have been funded substantially, without addressing development metrics such as “freedom to operate”. It has been said that researchers in nanomedicine are unable to address industrial norms in the R to D transition - however in the author’s experience - researchers CAN acquire these skills even to a high level quite quickly if it makes a funding difference.

The current culture helps academics, but does not make Europe more competitive, nor does it help taxpayers or patients. Cultural change is difficult, but this is truly a win-win-win opportunity for researchers as their eyes and careers can be opened to the real world and the difficult challenges in healthcare, including the “blue sky” ones. Incremental or derivative research is the fall-back of the research community, but in comparison to radical innovation, it leads to a product concept with a lower USP. A step change in creativity is required for radical innovation, but if successful will have a stronger USP. Such a step change led to the birth of Biologicals - such innovation is rare but repeatable.

The lever for change lies crucially in the hands of funders, as they fund and direct scientists either to healthcare research or development. Funding should not be automatic through R to D, because the transition from research to development requires informed debate and high-quality data and is a very challenging milestone. Researchers often say they are developing a new drug, when they are in fact doing research – funders also use the terms (R or D) interchangeably - an unfortunate consequence of their academic training. A simple test is if you don’t know actually what you are developing - you are in research. Both terms should be used appropriately and remember, development is not reversible due to its expensive resource requirements. Development costs are so high and time-consuming, that it permits only a handful of drugs, to be marketed for any indication. Development also necessitates a knowledge not only of current competitors, but of future markets – a good USP is everything.

Whilst a research-based model works well for research, it needs to be expanded to make it more appropriate for healthcare development. It is a seriously flaw to start a research project with no knowledge of the ultimate development requirements.

Conclusion

The areas for improvement are:

  • Knowledgeable peer review to select the most promising research and development healthcare topics for funding.
  • A process for development scientists / entrepreneurs to train researchers/students.
  • A more pro-active, informed role for “Technology” Transfer Officers/Business Development officers.
  • Learning Communication skills for entry into development. A shift from technologies to products with commercial or societal value.

References

[1]

M. Eaton, "Nanomedicine: Industry-wise research," Nature Materials, vol. 6, no. 4, pp. 251-253, 1 April 2007.

[2]

M. A. Eaton, "Improving the translation in Europe of nanomedicines (a.k.a. drug delivery) from academia to industry," Journal of Controlled Release, vol. 164, no. 3, pp. 370-337, 28 December 2012.

[3]

E. H. Chang, J. B. Harford, M. A. Eaton, P. M. Boisseau, A. Dube, R. S. H. Hayeshi and D. S. Lee, "Nanomedicine: Past, present and future - A global perspective," Biochemical and Biophysical Research Communications, vol. 468, no. 3, pp. 511-517, 18 December 2015.

[4]

M. A. Eaton, L. Levy and O. M. Fontaine, "Delivering Nanomedicines to Patients: A Practical Guide," Nanomedicine: Nanotechnology, Biology and Medicine, vol. 11, no. 4, pp. 983-992, May 2015.

[5]

"ENATRANS - Enabling Nanomedicine Translation," [Online]. Available: http://www.enatrans.eu/public. [Accessed 1 February 2018].

Quote as: Eaton, M. Improving Innovation in Nano-Healthcare Funding. Prec. Nanomed. 2018 Apr; 1(1):15-17. DOI: 10.29016/180108.1

Download PDF Views: 315     Downloads: 103

Editor-in-Chief Lajos P. Balogh PhD

Clinical Editor Kenneth KY Wong, MD, PhD
Christoph Alexiou, MD

Associate Editors Marina A. Dobrovolskaia, PhD
Marianna Földvári, D.Pharm.Sci., PhD
Adam Friedman, MD
Marc F. Hansen, PhD
Rodney Hill, PhD
Manzoor Koyakutty, PhD
Gregory M. Lanza, MD, PhD
Dong Soo Lee, MD, PhD
Yuri L. Lyubchenko, PhD, DSc
S. Moein Moghimi, PhD
Bert Müller, PhD
Lily Yang, MD, PhD

Honorary Board Yechezkel (Chezy) Barenholz PhD
Michelle Bradbury MD, PhD
Mike Eaton, PhD
Omid C. Farokhzad, MD
Peixuan Guo, PhD
Patrick Hunziker, MD
CN Lee, MD
Beat Löffler, MA, MD h.c.
Donald A. Tomalia, PhD
Yuliang Zhao, PhD

Editorial Board Fatemah Atyabi, PhD
Roy Bicknell PhD
Massimo Bottini, PhD
Siu-Wai Chan, Ph.D.
Daxiang Cui, PhD
Mohamed E.H. ElSayed
Elias Fattal, PhD
Robert A. Freitas Jr. PhD
Howard E. Gendelman, MD
Gershon Golomb, PhD
África González-Fernández MD, PhD
Dean Ho, Ph.D.
Varvara Karagkiozaki M.D., MSc
Barbara Klajnert-Maculewicz, Ph.D., D.Sc.
Silke Krol, PhD
Claus-Michael Lehr PhD
Zifu Li, PhD
Yoav Livney, PhD
Wan-Liang Lu, PhD
Donald Mager, Pharm.D, PhD
Guangjun Nie, PhD
Andrew Owen PhD
Dan Peer PhD
Christine Pham, MD
Wellington Pham, PhD
David Pozo Perez PhD
Adriele Prina-Mello, PhD
Kun Qian, PhD
Vittoria Raffa, PhD
Eder Lilia Romero, PhD
Dmitri Simberg, PhD
Simó Schwartz Jr, MD. PhD
Youqing Shen, PhD
Eliana B. Souto, PhD
János Szebeni, MD, PhD
Istvan Toth, PhD DSc FRACI FQA
Subbu S. Venkatraman PhD
Yuri Volkov, MD
Gayle E. Woloschak, PhD