Abstract

The field of health care is an important element of the economic and social life of every country in the world combining demographic, economic and epidemiological, ethical and social challenges. Spending on the development of new therapies has been increasing over the past two decades, and the amount of drugs approved by regulatory agencies has remained stable (FDA, 2023). Literature does not provide adequate knowledge about the reasons of the productivity drop that impacts the competitive advantage of the companies taking part in the project's race to the market (Schuhmacher et al., 2022), and it therefore seems crucial to analyse the factors determining high productivity of the pharmaceutical industry to adjust further actions ensuring the highest quality of health care systems, focusing on the wellbeing of the patient and the development of increasingly safer medicines. To address this need the author performed systematic literature review followed by structured interviews with 14 experts working globally in the field of drug development to determine productivity factors in drug discovery research and development projects, with the goal of answering questions related to which factors play a key role in the productivity of scientific organisations and the relationship between the factors, providing an insight into which parts of drug discovery ecosystem can increase a chance to address highly unmet medical needs of patients waiting for novel, safe and effective forms of treatment. As a result of the research 22 key productivity factors were defined and clustered into 4 categories: scientific, managerial, business, environmental and relations between the factors were discussed.

Keywords: drug discovery, drug development, innovation, productivity, R&D, project management

References

• Antonijevic, Z. (Ed.). (2015). Optimization of pharmaceutical R&D programs and portfolios. Design and investment strategy. Springer International Publishing AG.
• Berdigaliyev, N., & Aljofan, M. (2020). An overview of drug discovery and development. Future Medicinal Chemistry, 12(10). https://doi.org/10.4155/fmc-2019-0307
• Bode-Greuel, K., & Nickisch, K. (2008). Value-driven project and portfolio management in the pharmaceutical industry: Drug discovery versus drug development - Commonalities and differences in portfolio management practice. Journal of Commercial Biotechnology, 14(4), 307-325. https://link.springer.com/article/10.1057/jcb.2008.6#citeas
• Bukowski, H., & Gierczyński, J. (2019). Przełomowe innowacje farmaceutyczne - doświadczenia, rekomendacje, perspektywy. Instytut Innowacyjna Gospodarka dla INFARMA. https://www.infarma.pl/assets/files/raporty/raport_przelomowe_innowacje_farmaceutyczne.pdfzne.pdf (infarma.pl)
• Chen, J. L., Luo, X. Qiu, H., Mackey, V., Sun, L., & Ouyang, X. (2018). Drug discovery and drug marketing with the critical roles of modern administration. American Journal of Translational Research, 10(12), 4302-4312.
• Chung, T. D. Y., Terry, D. B., & Smith, L. H. (2015). In vitro and in vivo assessment of ADME and PK properties during lead selection and lead optimization - guidelines, benchmarks and rules of thumb. In S. Markossian, A. Grossman, K. Brimacombe, M. Arkin, D. Auld, C. Austin, J. Baell, T. D. Y. Chung, N. P. Coussens, J. L. Dahlin, V. Devanarayan, T. L. Foley, M. Glicksman, K. Gorshkov, J.V. Haas, M.D. Hall, S. Hoare, J. Inglese, P. W. Iversen. X. Xu (Eds.), Assay Guidance Manual [Internet]. The Assay Guidance Manual, National Library of Medicine.
• Cook, D., Brown, D., Alexander , R., March, R., Morgan, P., Satterthwaite,,G., & Pangalos, M. N. (2014). Lesson learned from the fate of Astra Zeneca's drug pipeline: a five-dimension framework. Nature Reviews Drug Discovery, 13(6), 419-431. https://doi.org/10.1038/nrd4309
• Czech, M. (2022). Leki. Od odkrycia do pacjenta. Wymiary zarządzania systemem. Polskie Wydawnictwo Ekonomiczne.
• DiMasi, J. A. (2000). New drug innovation and pharmaceutical industry structure: trends in the output of pharmaceutical firms. Drug Inform Journal, 34, 1169-1194. https://doi.org/10.1177/009286150003400425
• EvaluatePharma. (2018). World Preview 2018, Outlook to 2024 (11th ed.). https://www.evaluate.com/sites/default/files/media/download-files/WP2018.pdf
• EvaluatePharma. (2019). World Preview 2019, Outlook to 2024 (12th ed.). https://info.evaluate.com/rs/607-YGS-364/images/EvaluatePharma_World_Preview_2019.pdf
• FDA. (2018). The drug development process. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
• FDA. (2023). Novel drug approvals for 2022. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022
• Hingorani, A. D., Kuan, V., Finan, C. Kruger, F. A., Gaulton, A., Chopade, S., Sofat, R., MacAllister, R. J., Overington, J. P., Hemingway, H., Denaxas, S., Prieto, D., & Casas, J. P. (2019). Improving the odds of drug development success through human genomics: modelling study. Scientific Reports, 9, 18911. https://doi.org/10.1038/s41598-019-54849-w
• Kiriiri, G. K., Njogu P. M., & Mwangi, A. N. (2020). Exploring different approaches to improve the success of drug discovery and development projects: a review. Future Journal of Pharmaceutical Sciences, 6(27). https://doi.org/10.1186/s43094-020-00047-9
• Liberti, L., Breckenridge, A., Eichler, H. G., Peterson, R., McAuslane, N., & Walker, S. (2010). Expediting patients' access to medicines by improving the predictability of drug development and the regulatory approval process. Clinical Pharmacology & Therapeutics, 87(1), 27-31. https://doi.org/10.1038/clpt.2009.179
• Light, D. W. (2012). Pharmaceutical R&D. The Politics of Medicines (e-Encyclopaedia). https://haiweb.org/encyclopaedia/pharmaceutical-research-and-development/
• Mikulic, M. Total global pharmaceutical R&D spending 2014-2028, Statistica.com, October 2022.
• Mikulic, M. (2022). Worldwide generic prescription drug sales 2012-2026. https://www.statista.com/statistics/309411/global-total-generic-prescription-drug-revenue/
• Mingus, N. (2002). Alpha teach yourself project management in 24 hours. Alpha.
• Mullard, A. (2023, January 3). 2022 FDA approvals. Nature Reviews Drug Discovery, 22, 83-88. https://doi.org/10.1038/d41573-023-00001-3
• Ng, R. (2015). Drugs: From discovery to approval (3rd ed.). John Wiley & Sons Inc.
• Paul, S. M., Mytelka, S., Dunwiddie, Ch. T., Persinger, Ch. C., Munos, B. H., Lindborg, S. R., & Schacht, A. L. (2010). How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nature Reviews Drug Discovery, 9, 203-214 (2010). https://doi.org/10.1038/nrd3078
• Petro, Y., & Gardiner, P. (2015). An investigation of the influence of organizational design on project portfolio success, effectiveness and business efficiency for project-based organizations. International Journal of Project Management, 33(8), 1717-1729. https://doi.org/10.1016/j.ijproman.2015.08.004
• Project Management Institute. (2021). PMBOK guide. A guide to the Project Management Body of Knowledge (7th ed.).
• Poduri, R. (Ed.). (2021). Drug discovery and development, from targets and molecules to medicines. Springer.
• Rydzewski, R. (2008). Real world drug discovery. A chemist's guide to biotech and pharmaceutical research. Elsavier.
• Sagar, G. V. (2017). Pharmaceutical industrial management (2nd ed.). BSP Books Pvt. LTD.
• Schuhmacher, A., Gassmann, O., Hinder, M., & Kuss, M. (2021). The present and future of project management in pharmaceutical R&D. Drug Discovery Today, 26(1). https://doi.org/10.1016/j.drudis.2020.07.020
• Schuhmacher, A., Gassmann, O., Bieniok, D., Hinder, M., & Hartl, D. (2022). Open innovation: A paradigm shift in pharma R&D? Drug Discovery Today, 27(9), 2395-2405. https://doi.org/10.1016/j.drudis.2022.05.018
• Schuhmacher, A., Hinder M., & Gassmann O. (Eds.). (2016). Value creation in the pharmaceutical industry. Willey-VCH. https://doi.org/10.1002/cmdc.201700797
• Stalder, J. (2022). Project management for drug developers. CRC Press Inc.
• Tranfield, D., Denyer, D., & Smart, P. (2003). Towards a methodology for developing evidence-informed management knowledge by means of systematic review. British Journal Management, 14(3), 207-222. https://doi.org/10.1111/1467-8551.00375
• Wallmark, B. (2016). Success factors in drug discovery and development. Advances in Precision Medicine, 1(2), 1-5. http://dx.doi.org/10.18063/APM.2016.02.002
• Yeung, A. W. K., Atanasov, A. G., Sheridan, H., Klager, E., Eibensteiner, F., Völkl-Kernsock, S., Kletecka-Pulker, M., Willschke, H., Schaden, E. (2021). Open innovation in medical and pharmaceutical research: A literature landscape analysis. Frontiers in Pharmacology, 11. https://doi.org/10.3389/fphar.2020.587526
• Zurdo, J. (2013). Developability assessment as an early de-risking tool for biopharmaceutical development. Pharmaceutical Bioprocessing, 1(1), 29-50.