Develop and Commercialize the Bayesian Dose-Response Modeling System and Services

开发贝叶斯剂量反应建模系统和服务并将其商业化

• 批准号: 10081313
• 负责人: Kan Shao
• 金额: $ 97.25万
• 依托单位: KS AND ASSOCIATES, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081313
• 关键词: Address; Adoption; Adverse effects; Advocate; Benchmarking; Biological Models; Businesses; Chemical Exposure; Chemicals; Communities; Computer software; Confidence Intervals; Data; Data Reporting; Dependence; Development; Dose; Dreams; Educational workshop; Employment; Epidemiology; European; Evaluation; Food Safety; Foundations; Genomics; Goals; Government; Government Agencies; Health; Indiana; Industry; Knowledge; Libraries; Literature; Methodology; Methods; Modeling; No-Observed-Adverse-Effect Level; Online Systems; Phase; Process; Public Health; Research; Risk Assessment; Safety; Services; Small Business Technology Transfer Research; Solid; Standardization; Statutes and Laws; Stream; System; Testing; Toxic effect; Toxicology; Training; Uncertainty; United States Environmental Protection Agency; Universities; authority; base; commercialization; design; experimental study; improved; programs; prototype; research and development; response; skills; success; tool

PROJECT SUMMARY Chemical risk assessment is widely applied in industries and regulatory agencies as an important tool to evaluate chemical toxicity in support of chemical registration, safety evaluation, and exposure limitation development. One of the most notable improvements in dose-response assessment - a required quantitative step in risk assessment - is the development of benchmark dose (BMD) methodology to better utilize toxicological information to facilitate toxicity evaluation of chemicals. Although the BMD method has been advocated by the US Environmental Protection Agency (EPA) and European Food Safety Authority (EFSA) for its scientific advantages (such as less dependency on the design of experiments and more plausible interpretation on uncertainty) for years, the employment of the method in practical risk assessment has been significantly hindered by a few important limitations, one of which is the lack of a reliable modeling system to support consistent practice of BMD modeling across different sectors. Therefore, based on the Bayesian benchmark dose modeling system (BBMD) prototype successfully built in Phase I of the STTR project, the objective of Phase II is to further the development of the BBMD system to meet more diverse needs in dose- response assessment and to enlarge the user base of the system as an essential component for commercialization. The rational is that, given relatively limited practical implementation of BMD modeling for dose-response assessment in industry and some government agencies, demonstrating and improving the utility of the BMD method rather than sophisticating the methodology are more appropriate at the current stage to enhance the acceptance of BMD method and then create business opportunities for the company. To accomplish this objective, three specific aims will be pursued: (1) develop a Bayesian BMD modeling approach with software for typical epidemiological dose-response data; (2) develop a Bayesian BMD modeling approach with software for high-throughput dose-response data; (3) upgrade the BBMD to a data computation and management system to perform, store, and distribute BMD analyses approved by a panel of experts. The success of the project will fill multiple gaps that hamper the large-scale adoption of BMD methodology in industry and government. Meanwhile, Dream Tech will increase the influence of the BBMD system and build up user base through an array of channels to commercialize the dose-response modeling platform and services in support of chemical risk assessment.

项目概要 化学品风险评估作为重要工具被广泛应用于行业和监管机构。 评估化学毒性以支持化学品注册、安全评估和暴露限制 发展。剂量反应评估最显着的改进之一是所需的定量 风险评估的步骤 - 是开发基准剂量 (BMD) 方法以更好地利用 毒理学信息，以促进化学品的毒性评估。尽管 BMD 方法已 美国环境保护署（EPA）和欧洲食品安全局（EFSA）倡导 它的科学优势（例如对实验设计的依赖性较小，并且更合理） 不确定性的解释）多年来，该方法在实际风险评估中的应用 受到一些重要限制的严重阻碍，其中之一是缺乏可靠的建模系统 支持不同部门 BMD 建模的一致实践。因此，基于贝叶斯 STTR项目一期成功构建基准剂量建模系统（BBMD）原型， 第二阶段的目标是进一步开发 BBMD 系统，以满足剂量方面更多样化的需求 响应评估并扩大系统的用户基础，将其作为 商业化。理由是，鉴于 BMD 建模的实际实施相对有限 工业界和一些政府机构的剂量反应评估，展示并改进了 在现阶段，BMD方法的实用性比方法论的复杂性更合适 提升BMD方法的接受度，进而为公司创造商机。到 为了实现这一目标，将追求三个具体目标：（1）开发贝叶斯 BMD 建模方法 带有典型流行病学剂量反应数据的软件； (2) 开发贝叶斯 BMD 建模方法 具有高通量剂量反应数据软件； (3) 将BBMD升级为数据计算 管理系统，用于执行、存储和分发经专家小组批准的 BMD 分析。这 该项目的成功将填补阻碍 BMD 方法大规模采用的多项空白 行业和政府。同时，梦想科技将扩大BBMD系统的影响力，打造 通过一系列渠道扩大用户群，将剂量反应建模平台商业化， 支持化学品风险评估的服务。