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

作　　者：Maria Dutra Behrens Anisia Darc Nascimento Brahim Sandra Aurora Chavez Pérez Paulo José Coelho Benevides Cristina Dislich Ropke Antonio Carlos Siani Maria Dutra Behrens;Anisia Darc Nascimento Brahim;Sandra Aurora Chavez Pérez;Paulo José Coelho Benevides;Cristina Dislich Ropke;Antonio Carlos Siani(Institute of Drug Technology, Fiocruz, Rio de Janeiro, Brazil;Fiocruz Mato Grosso do Sul, Jardim das Naes, Campo Grande, Brazil;Herbarium Laboratrio Botnico, Roa Grande, Colombo, Brazil)

机构地区：[1]Institute of Drug Technology, Fiocruz, Rio de Janeiro, Brazil [2]Fiocruz Mato Grosso do Sul, Jardim das Naes, Campo Grande, Brazil [3]Herbarium Laboratrio Botnico, Roa Grande, Colombo, Brazil

出　　处：《American Journal of Plant Sciences》2024年第12期1113-1126,共14页美国植物学期刊(英文)

摘　　要：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.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.

关 键 词：Technology Readiness Level PHYTOMEDICINES Drug Development Translational Research 

分 类 号：F42[经济管理—产业经济]