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Technology Readiness Level for the R&D Streaming of Phytomedicines: Proposal of a Framework for Nonclinical Stages

DOI: 10.4236/ajps.2024.1512071, PP. 1113-1126

Keywords: Technology Readiness Level, Phytomedicines, Drug Development, Translational Research

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Abstract:

This study proposes the development of a system to classify phytomedicine projects by applying the technology readiness level (TRL). This strategy is gaining relevance in the field of health innovation because it promotes synergism between researchers and R&D managers working in this area. Nine TRLs were created for the development of herbal medicines by the authors, which is a group of experts in natural products, supported by pre-existing records on project management in the institutions to which they belong. The levels were determined by mirroring the bench-to-bedside development of synthetic drug pathways, in accordance with concepts of translational research. Each level was sectioned by disciplinary areas ruling pools of multiple activities, the achievements of which represent independent technologies. Short content deliveries (SCD) were empirically established at the end of each level as a requirement to enter the next technological stage. A TRL scale was constructed to classify the stages of phytomedicines development to reflect project maturity. Detailed descriptions of the first five nonclinical levels and their sublevels were provided. At the end of each level, the SCD served as an indicator of sufficiency to move on to the next stage. The TRL framework for developing phytomedicines provided an organized panel to clarify the independent technology generated in each stage. The integration of these technologies constitutes a valuable tool for institutions that foster pharmaceutical product development. The five initial levels of TRL considered here can contribute to accelerating innovation in R&D organizations dedicated to the development of plant-based products.

References

[1]  Kennedy, T. (1997) Managing the Drug Discovery/Development Interface. Drug Discovery Today, 2, 436-444.
https://doi.org/10.1016/s1359-6446(97)01099-4
[2]  Paul, D., Sanap, G., Shenoy, S., Kalyane, D., Kalia, K. and Tekade, R.K. (2021) Artificial Intelligence in Drug Discovery and Development. Drug Discovery Today, 26, 80-93.
https://doi.org/10.1016/j.drudis.2020.10.010
[3]  Hwang, S. (2019) Traditional Medicine, Modern Science and the Upgrading of the Local Pharmaceutical Industry: Endogenous Development of the Phytomedicine Innovation System in Korea. Innovation and Development, 10, 413-431.
https://doi.org/10.1080/2157930x.2019.1679953
[4]  Wagner, H. (2005) Natural Products Chemistry and Phytomedicine in the 21st Century: New Developments and Challenges. Pure and Applied Chemistry, 77, 1-6.
https://doi.org/10.1351/pac200577010001
[5]  Williamson, E. (2001) Synergy and Other Interactions in Phytomedicines. Phytomedicine, 8, 401-409.
https://doi.org/10.1078/0944-7113-00060
[6]  Pagani, E., Ropke, C.D., Soares, C.M., Perez, S.A.C., Benevides, P.J.C., Barbosa, B.S., et al. (2024) Technology Readiness Level Roadmap for Developing Innovative Herbal Medicinal Products. Pharmaceuticals, 17, Article 703.
https://doi.org/10.3390/ph17060703
[7]  Fishburn, C.S. (2013) Translational Research: The Changing Landscape of Drug Discovery. Drug Discovery Today, 18, 487-494.
https://doi.org/10.1016/j.drudis.2012.12.002
[8]  Clausing, D. and Holmes, M. (2010) Technology Readiness. Research-Technology Management, 53, 52-59.
https://doi.org/10.1080/08956308.2010.11657640
[9]  Bakke, K. (2017) Technology Readiness Levels Use and Understanding. MSc Thesis, University College South-East Norway.
https://openarchive.usn.no/usn-xmlui/bitstream/handle/11250/2452831/Master2017Bakke.pdf?sequence=1
[10]  Zerhouni, E.A. (2005) US Biomedical Research: Basic, Translational, and Clinical Sciences. JAMA, 294, 1352-1358.
https://doi.org/10.1001/jama.294.11.1352
[11]  Wehling, M. (2021) Principles of Translational Science in Medicine: From Bench to Bedside. 3rd Edition, Academic Press.
[12]  Sung, N.S., Crowley, W.F., Genel, M., Salber, P., Sandy, L., Sherwood, L.M., et al. (2003) Central Challenges Facing the National Clinical Research Enterprise. JAMA, 289, 1278-1287.
https://doi.org/10.1001/jama.289.10.1278
[13]  Guimarães, R. (2013) Pesquisa Translacional: Uma interpretação. Ciência & Saúde Coletiva, 18, 1731-1744.
https://doi.org/10.1590/s1413-81232013000600024
[14]  NIH (2020) A Decade of Discovery: The NIH Roadmap and Common Fund.
https://commonfund.nih.gov/sites/default/files/ADecadeofDiscoveryNIHRoadmapCF.pdf
[15]  Patwardhan, B. and Mashelkar, R.A. (2009) Traditional Medicine-Inspired Approaches to Drug Discovery: Can Ayurveda Show the Way Forward? Drug Discovery Today, 14, 804-811.
https://doi.org/10.1016/j.drudis.2009.05.009
[16]  De Oliveira, D.R., de Oliveira, A.C.D. and Marques, L.C. (2016) O estado regulatório dos fitoterápicos no Brasil: Um paralelo entre a legislação e o mercado farmacêutico (1995-2015). Vigilância Sanitária em Debate, 4, 139-148.
https://doi.org/10.22239/2317-269x.00806
[17]  Mankins, J.C. (1995) Technology Readiness Levels. A White Paper, Advanced Concepts Office, Office of Space Access and Technology, NASA.
[18]  Straub, J. (2015) In Search of Technology Readiness Level (TRL) 10. Aerospace Science and Technology, 46, 312-320.
https://doi.org/10.1016/j.ast.2015.07.007
[19]  Paternostro, A.G., Quintella, C.M. and Leite, H.J.D. (2020) Pesquisa Exploratória Comparativa entre Artigos e Patentes Sobre Maturidade (Prontidão) Tecnológica. Cadernos de Prospecção, 13, 1088-1112.
https://doi.org/10.9771/cp.v13i4.33176
[20]  de Meirelles Quintella, H.L.M. and Rocha, H.M. (2007) Nível de maturidade e comparação dos PDPs de produtos automotivos. Production, 17, 199-215.
https://doi.org/10.1590/s0103-65132007000100014
[21]  Gil, L., Andrade, M.H. and Costa, M.D.C. (2014) Os TRL (Technology Readiness Levels) como ferramenta na avaliação tecnológica. Revista Ingenium (Jan-Fev), 94-96.
http://hdl.handle.net/10400.9/2771
[22]  Savoini, A. and Tronchin, A. (2014) Definition of Technology Readiness Levels (TRL) and Application to Biomedical Field. In: Passamonti, S., Gustincich, S., Turnšek, T.L., Peterlin, B., Pišot, R. and Storici, P., Eds., Cross-Border Italy-Slovenia Biomedical Re-search: Are We Ready for Horizon 2020? Edizioni Università di Trieste, 421-424.
[23]  Souto, E.B., Silva, G.F., Dias-Ferreira, J., Zielinska, A., Ventura, F., Durazzo, A., et al. (2020) Nanopharmaceutics: Part II—Production Scales and Clinically Compliant Production Methods. Nanomaterials, 10, Article 455.
https://doi.org/10.3390/nano10030455
[24]  TIA (Technology Innovation Agency) (2021) Description of Technology Readiness Levels (TRL).
https://wwwold.tia.org.za/core/uploads/2019/12/TRL-1.pdf
[25]  Bazan, C. (2019) “From Lab Bench to Store Shelves:” A Translational Research & Development Framework for Linking University Science and Engineering Research to Commercial Outcomes. Journal of Engineering and Technology Management, 53, 1-18.
https://doi.org/10.1016/j.jengtecman.2019.05.001
[26]  Wagner, J., Dahlem, A.M., Hudson, L.D., Terry, S.F., Altman, R.B., Gilliland, C.T., et al. (2017) A Dynamic Map for Learning, Communicating, Navigating and Improving Therapeutic Development. Nature Reviews Drug Discovery, 17, 150.
https://doi.org/10.1038/nrd.2017.217
[27]  Gilliland, C.T., White, J., Gee, B., Kreeftmeijer-Vegter, R., Bietrix, F., Ussi, A.E., et al. (2019) The Fundamental Characteristics of a Translational Scientist. ACS Pharmacology & Translational Science, 2, 213-216.
https://doi.org/10.1021/acsptsci.9b00022
[28]  Velho, S.R.K., Simonetti, M.L., Souza, C.R.P.D. and Ikegami, M.Y. (2018) Nível de Maturidade Tecnológica: Uma sistemática para ordenar tecnologias. Parcerias Estratégicas (Brasília), 22, 119-140.
https://www.researchgate.net/publication/330170870
[29]  Pinheiro, A.A., Siani, A.C., de Fátima Guilhermino, J., de Oliveira Henriques, M.D.G.M. Quental, C.M. and Pizarro, A.P.B. (2006) Metodologia para gerenciar projetos de pesquisa e desenvolvimento com foco em produtos: Uma proposta. Revista de Administração Pública, 40, 457-478.
https://doi.org/10.1590/s0034-76122006000300007
[30]  Rogers, E.M., Takegami, S. and Yin, J. (2001) Lessons Learned about Technology Transfer. Technovation, 21, 253-261.
https://doi.org/10.1016/s0166-4972(00)00039-0
[31]  Webster, A. and Gardner, J. (2019) Aligning Technology and Institutional Readiness: The Adoption of Innovation. Technology Analysis & Strategic Management, 31, 1229-1241.
https://doi.org/10.1080/09537325.2019.1601694
[32]  Tao, L., Probert, D. and Phaal, R. (2009) Towards an Integrated Framework for Managing the Process of Innovation. R&D Management, 40, 19-30.
https://doi.org/10.1111/j.1467-9310.2009.00575.x
[33]  Hicks, B., Larsson, A., Culley, S. and Larsson, T. (2009) A Methodology for Evaluating Technology Readiness During Product Development. 17th International Conference on Engineering Design (ICED’09) Design Has Never Been This Cool, Stanford, 24-27 August 2009, 157-168.
http://urn.kb.se/resolve?urn=urn:nbn:se:bth-11260
[34]  Vahadane, S.S. and Clarke, A.P. (2021) A Theoretical Framework for Identifying Appropriate Marketing Approaches across the Product Development Life Cycle for Biomedical Science SMEs. Journal of Small Business and Enterprise Development, 29, 845-860.
https://doi.org/10.1108/jsbed-01-2021-0031
[35]  Barnes, M.L. and Brayley, R.E. (2006) Institutional Readiness and Grant Success among Public Recreation Agencies. Managing Leisure, 11, 139-150.
https://doi.org/10.1080/13606710600720739

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