Development of a 3-month implantable depot pellet of Naltrexone for the treatment of Opioid Use Disorder.

开发用于治疗阿片类药物使用障碍的 3 个月植入式纳曲酮储库颗粒。

• 批准号: 10552495
• 负责人: Andrew Peter Mallon
• 金额: $ 9.94万
• 依托单位: BIOCORRX, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10552495
• 关键词: Adopted; Award; Classification; Clinical; Clinical Research; Collaborations; Data; Development; Ecosystem; Ensure; FAIR principles; Formulation; Future; Life; Modeling; Naltrexone; Ontology; Opiate Addiction; Organizational Culture; Overdose; Pharmacologic Substance; Positioning Attribute; Prevention; Process; Publishing; Reporting; Structure; System; Testing; base; data format; data management; data sharing; disorder later incidence prevention; improved; indexing; interoperability; member; opioid epidemic; opioid use disorder; opioid withdrawal; pragmatic implementation; pre-clinical; preclinical study; programs; shared database; subcutaneous; success

BioCorRx is developing a 3-month subcutaneous depot pellet formulation of naltrexone called BICX104 for the prevention of relapse to opioid dependence, following opioid detoxification and the prevention of life- threatening overdose. We are undertaking preclinical and clinical studies to support approval of BICX104. Data management is currently centralized within BioCorRx without FAIR sharing processes. Data and documents are focused upon the structuring of FDA submissions, internal reports, strategy and refinement of hypotheses to enable project success. Commercial ventures are not incentivized to publish or FAIR share data and there is a corporate culture of not sharing pharmaceutical development data. There is room for improvement if a system can be developed by BioCorRx to enable standard formatting, FAIR sharing and collaboration whilst protecting commercially sensitive information. All HEAL awardees would benefit greatly by having access to different levels of such data and documents and we propose to improve or augment our processes and efforts to enable FAIR sharing. We plan to develop and refine systems and strategies at BioCorRx that will format data and documents; protect commercially sensitive information and enable proof of concept FAIR data sharing. These activities will involve formatting, indexing, redacting, creating templates and making available different BioCorRx data and documents. During this project we aim to develop practical improvements to document and data as described and identified below. Advances modeled by this project could serve as an exemplary pilot, and we will collaborate with RENCI/RTI and other HEAL ecosystem awardees during the award period to discuss how this could be more broadly implemented in future. The majority of HEAL awardees are commercial ventures that are working on highly regulated (FDA) projects encompassing preclinical IND- and clinical NDA-enabling activities. The focus of the HEAL program on the opioid crisis provides an opportunity to enable valuable data sharing that can be an opportunity to enhance awardee success without compromising commercial positions. Findability: In order to serve HEAL awardees best, BioCorRx will develop a common system of classification and ontology based upon 1) FDA Module/Section, 2) pharmaceutical development stage, 3) indication and 4) product class. Accessibility: Convert BioCorRx data and documents to enable access. Templates, partial redactions and SOPs will be developed to create a system for creating documents and data for sharing. Interoperability: Conversion of data and documents for sharing through shared databases using common formats that can ensure interoperability and import/export with different programs and demonstrate utility. Reusable: Practical implementation and testing of the BioCorRx FAI data accessibility. BioCorRx will apply FAIR principles to data and documents generated. Subsequently, our proof of concept project can help build a practical model for other awardees and ecosystem members to adopt and access.

BioCorRx 正在开发一种为期 3 个月的纳曲酮皮下储库颗粒制剂，称为 BICX104，用于 预防阿片类药物戒毒后阿片类药物依赖复发以及预防生命- 威胁服药过量。我们正在进行临床前和临床研究以支持 BICX104 的批准。数据 管理目前集中在 BioCorRx 内，没有公平的共享流程。数据和文件 专注于 FDA 提交材料、内部报告、策略和假设的完善的结构 使项目取得成功。商业企业没有动力发布或公平共享数据，并且存在 不共享药品开发数据的企业文化。如果有的话，还有改进的余地 系统可由 BioCorRx 开发，以实现标准格式、公平共享和协作，同时 保护商业敏感信息。所有 HEAL 获奖者都将受益匪浅 不同级别的此类数据和文件，我们建议改进或增强我们的流程和工作 启用公平共享。我们计划在 BioCorRx 开发和完善系统和策略，以格式化 数据和文件；保护商业敏感信息并启用概念验证 FAIR 数据 分享。这些活动将涉及格式化、索引、编辑、创建模板和提供 不同的 BioCorRx 数据和文档。在这个项目中，我们的目标是开发实用的改进 如下所述和确定的文件和数据。该项目所模拟的进步可以作为 模范试点，我们将在试验期间与 RENCI/RTI 和其他 HEAL 生态系统获奖者合作 授予期讨论如何在未来更广泛地实施这一点。大多数治愈 获奖者是致力于高度监管（FDA）项目的商业企业，包括 临床前 IND 和临床 NDA 支持活动。 HEAL 计划的重点是阿片类药物危机 提供了实现有价值的数据共享的机会，这可以成为增强获奖者的机会 在不损害商业地位的情况下取得成功。可查找性：为了最好地为 HEAL 获奖者提供服务， BioCorRx 将开发一个基于 1) FDA 模块/部分，2) 的通用分类和本体系统 药物开发阶段，3）适应症和4）产品类别。辅助功能：转换 BioCorRx 数据 以及允许访问的文档。将开发模板、部分修订和 SOP 以创建 用于创建共享文档和数据的系统。互操作性：数据和文档的转换 使用通用格式通过共享数据库进行共享，可确保互操作性和导入/导出 与不同的程序并展示实用性。可重用：实际实施和测试 BioCorRx FAI 数据可访问性。 BioCorRx 将对生成的数据和文档应用公平原则。随后，我们的概念验证 项目可以帮助建立一个实用的模型，供其他获奖者和生态系统成员采用和访问。