DataSheet5_Translational pathway of a novel PFF2 respirator with chitosan nanotechnology: from the concept to the practical applications.PDF

Introduction:Translational Health Research (THR) is a tool aimed at assisting in the transformation of basic and/or applied scientific research into a health technology ready for commercialization. The aim of this study is to present the translational pathway in wich our research group developed a Personal Protective Equipment (PPE) called VESTA® Facial Respirator with chitosan nanotechnology for protection against viruses, bacteria, and fungi. The aim of this study is to present the process of THR applied to a health technology research.
Methods:The theoretical-methodological process of THR was applied to the Research and Development (R&D) of the respirator. This method is characterized by subsequent phases, as follow: T (0)—Concept, T (1) Pre-Clinical, T (2) Clinical, T (3) Industrial Scale Production, and T (4) Characterized by subsequent phases, as follow: Technological Evaluation.
Results:Applying the THR process in the development and production of the Particulate Filtering Facepiece class 2 (PFF2) respirator with chitosan nanotechnology, University of Brasilia was able to transform the research idea into a respirator approved by the National Regulatory Agency for industrial-scale production within 24 months. The THR process is not a linear action; this flexibility allows essential activities for transforming research into a marketable product.
Discussion:The integration among various stakeholders right from the genesis of research is a driving force for the effective utilization of results. The maturity of the country’s industrial sector is crucial for converting university research into a marketable product, and governments need to prioritize these products in healthcare system incorporations. The academic culture of scientific research needs to intensify the technological transfer phase of its inventions. Conclusion: In less than 24 months, the University of Brasilia translated research on a new PPE into the market by applying the THR method.

引言：转化健康研究（Translational Health Research, THR）是一类用于辅助将基础与应用科学研究转化为可商业化健康技术的工具。本研究旨在展示本团队开发一款搭载壳聚糖纳米技术、可抵御病毒、细菌与真菌的个人防护装备（Personal Protective Equipment, PPE）——VESTA®面部呼吸器的转化路径，并阐述应用于健康技术研究的THR流程。
方法：本研究将转化健康研究的理论-方法论流程应用于该呼吸器的研发（Research and Development, R&D）工作。该方法包含以下依次推进的阶段：T(0) 概念阶段、T(1) 临床前阶段、T(2) 临床阶段、T(3) 工业化大规模生产阶段以及T(4) 技术评估阶段。
结果：通过将THR流程应用于搭载壳聚糖纳米技术的二级颗粒物过滤面罩（Particulate Filtering Facepiece class 2, PFF2）呼吸器的开发与生产，巴西利亚大学得以在24个月内将该研究构想转化为获得国家监管机构批准、可进行工业化大规模生产的呼吸器。THR流程并非线性流程，其灵活性为将研究转化为可市场化产品提供了必要的活动支撑。
讨论：从研究初始阶段便整合各类利益相关方，是高效利用研究成果的核心驱动力。一国工业体系的成熟度对于将高校研究转化为可市场化产品至关重要，各国政府应在医疗体系采购中优先纳入此类产品。当前科研学术文化需强化其发明成果的技术转化环节。
结论：巴西利亚大学通过应用THR方法，在不到24个月的时间内将一款新型个人防护装备的研究成果推向了市场。