Skip to main content
Log in

Leveraging Research Failures to Accelerate Drug Discovery and Development

  • Research Article
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

Background

Research failures are one of the most significant costs associated with the estimated USD$2.6 billion price tag and 12-year time frame to bring a drug from discovery to market. The European Commission estimates that USD$20 billion are spent every year to develop innovations that have already developed elsewhere, highlighting the exorbitant cost of duplication. The competitive nature of the pharmaceutical industry is such that the voluntary sharing of information is not particularly forthcoming despite the highly publicized advantages of open science, open access, and open innovation. However, sharing research failures may be perceived as less competitively threatening because it is considered ‘useless’ to the party owning it, but highly valuable to the competition.

Method

A combination of existing legal tools and technology, such as trade secret protection, blockchain, and knowledge commons, may provide the necessary legal basis for a platform ecosystem that can incentivize and capture the value of sharing intellectual contributions (such as research failures), while protecting innovators against free-riding and unauthorized appropriation by third-parties.

Result

Not all intellectual efforts that contribute to the creation innovations can be protected by traditional forms of IP. If proprietary information necessary to create innovations cannot be adequately protected, innovators and researchers are likely to safeguard their interests at the expense of sharing.

Conclusion

A legally supported framework that proactively recognizes intellectual contributions by way of research failures, which can subsequently be translated into a revenue-sharing model, may lead to more openness, value creation, and overall acceleration of drug discovery and development.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. DiMasi JA, Grabowski HG, Hansen RA. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ. 2016;47:20–33.

    Article  Google Scholar 

  2. European Commission. Exploitation of IP for Industrial Innovation—final report, no. 213/PP/ENT/CIP/12/B/N04C03; 2015. p. 1–67.

  3. Bogers M, Chesbrough H, Moedas C. Open innovation: research, practices, and policies. Calif Manage Rev. 2018;60(2):5–16.

    Article  Google Scholar 

  4. Yu H. Bridging the translational gap: collaborative drug development and dispelling the stigma of commercialization. Drug Discov Today. 2016;21(2):299–305.

    Article  Google Scholar 

  5. Lilly Open Innovation Drug Discovery Program. https://openinnovation.lily.com. Accessed 9 Apr 2019.

  6. Innovative Medicines Initiative. https://www.imi.europa.eu. Accessed 9 Apr 2019.

  7. Wellcome Trust Open Research initiative. https://wellcomeopenresearch.org/. Accessed 9 Apr 2019.

  8. Yildirm O, Gottwald M, Schüler P, Michel M. Opportunities and challenges for drug development: public-private partnerships, adaptive designs and big data. Front Pharmacol. 2016;7:461.

    Google Scholar 

  9. Caroll GP, Srivastava S, Violini AS, Pineriro-Nunez MM, Vetman T. Measuring the effectiveness and impact of an open innovation platform. Drug Discov Today. 2017;22(5):776–85.

    Article  Google Scholar 

  10. Schuhmacher A, German P, Trill H, Gassmann O. Models for open innovation in the pharmaceutical industry. Drug Discov. Today. 2013;18(23):1133–7.

    Article  Google Scholar 

  11. Hunter J, Stephens S. Is open innovation the way forward for big pharma? Nat Rev Drug Discov. 2010;9:87–8.

    Article  CAS  Google Scholar 

  12. CARB-X Calls for New ‘Open Science’ Era in Antibacterial Innovation: Sharing Scientific Data Will Help Speed the Delivery of New Antibiotic and Other Life-Saving Products to Fight Superbugs. 2018. https://carb-x.org/carb-x-news/carb-x-calls-for-new-open-science-era-in-antibacterial-innovation-sharing-scientific-data-will-help-speed-the-delivery-of-new-antibiotics-and-other-life-saving-products-to-fight-sup/. Accessed 12 Jan 2019.

  13. United Nations Development Programme. Guidelines for pharmaceutical patent examination: examining pharmaceutical patents from a public health perspective; 2015. p. 1–48.

  14. Bentwich M. Changing the rules of the game: addressing the conflict between free access to scientific discovery and intellectual property rights. Nat Biotechnol. 2010;28:137–40.

    Article  CAS  Google Scholar 

  15. Organization for Economic Co-operation and Development. OECD’s principles and guidelines for access to research data from public funding (Paris). 2004.

  16. Medical Research Council UK. Data sharing policy. 2005. http://www.mrc.ac.uk/documents/pdf/mrc-data-sharing-policy/. Accessed 8 Feb 2019.

  17. European Parliament. Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure. 2016.

  18. Uniform Law Commission, United States Uniform Trade Secret Act, 14 ULA; 1985. §1.4.

  19. European Parliament. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.

  20. European Commission. European Open Science Cloud Declaration. 2017. https://ec.europa.eu/research/openscience/pdf/eosc_declaration.pdf. Accessed 21 Jan 2019.

  21. Ghosh S. How to build a commons: is intellectual property constrictive, facilitating, or irrelevant. In: Hess C, Ostrom E, editors. Understanding knowledge as a commons: from theory to practice. Cambridge: MIT Press; 2007. p. 209–45.

    Google Scholar 

  22. Frischmann BM, Madison MJ, Strandburg KJ. Governing knowledge commons. Oxford: Oxford University Press; 2014.

    Book  Google Scholar 

  23. Open Source Malaria. http://opensourcemalaria.org/. Accessed 21 Jan 2019.

  24. Vertinsky LS. Patents, partnerships, and pre-competitive collaboration myth in pharmaceutical innovation. Univ Calif Davis Law Rev. 2014;48:1509.

    Google Scholar 

  25. Tapscott D, Tapscott A. Blockchain revolution: how the technology behind Bitcoin is changing money, business, and the world. London: Penguin; 2016.

    Google Scholar 

  26. Werbach K. Trust, but verify: why the blockchain needs the law. Berkeley Technol Law J. 2018;33(2):487–550.

    Google Scholar 

  27. Forte P, Romano D, Schmid G. Beyond Bitcoin part I: a critical look at blockchain based systems. Cryptology ePrint Archive. 2015. p. 1–34

  28. de la Rosa JL, Torres-Padrosa V, el-Fakdi A, Gibovic D, Hornyák O, Maicher L, Miralles F. A survey of blockchain technologies for open innovation. In: 4rd Annual World Open Innovation Conf. WOIC. 2017. p. 14–15.

  29. Allen, D.W.E. Blockchain innovation commons. 2017. Retrieved from SSRN https://ssrn.com/abstract=2919170.

  30. European Commission. Staff Working Document on the free flow of data and emerging issue of the European data economy, SWD (2017) 2 final. 2017.

Download references

Acknowledgement

This research is supported by a Novo Nordisk Foundation grant for a Collaborative Research Programme (Grant Agreement Number NNF17SA0027784).

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Helen Yu.

Ethics declarations

Conflict of interest

There is no conflict of interest to disclose.

Research Involving Human and Animal Research

This article does not contain any studies with human or animal subjects performed by any of the authors.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Yu, H. Leveraging Research Failures to Accelerate Drug Discovery and Development. Ther Innov Regul Sci 54, 788–792 (2020). https://doi.org/10.1007/s43441-019-00005-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s43441-019-00005-5

Keywords

Navigation