DataSheet2_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科学与/或应用科学研究转化为可商业化健康技术的工具。本研究一方面展示本课题组开发一款搭载壳聚糖纳米技术、可抵御病毒、细菌与真菌的VESTA®面部呼吸器个人防护装备（Personal Protective Equipment, PPE）的转化路径，另一方面呈现转化健康研究应用于健康技术研发的完整流程。
方法：本研究将转化健康研究的理论-方法学流程应用于该呼吸器的研发（Research and Development, R&D）工作。该方法具有明确的阶段性特征，具体分为以下环节：T(0)——概念阶段、T(1)——临床前阶段、T(2)——临床试验阶段、T(3)——工业化规模生产阶段、T(4)——技术评估阶段。
结果：巴西利亚大学将转化健康研究流程应用于搭载壳聚糖纳米技术的二级颗粒物防护呼吸器（Particulate Filtering Facepiece class 2, PFF2）的研发与生产，仅用24个月便将研究构想转化为获得国家监管机构批准、可进行工业化规模生产的呼吸器。转化健康研究流程并非线性流程，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空间。
讨论：从研究启动初期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。国家工业部门的成熟度是将高校研究转化为市场化产品的关键，政府需在医疗体系采购中优先纳入此类产品。当前科学研究的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转化健康研究方法，仅用不到24个月便将一款新型个人防护装备的研究成果推向市场。