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正在开发一种名为BICX 104的纳洛酮3个月皮下贮库颗粒制剂，用于 预防阿片类药物戒毒后阿片类药物依赖复发和预防生命- 威胁要服药过量我们正在进行临床前和临床研究，以支持BICX 104的批准。数据 管理目前集中在BioCorRx内，没有FAIR共享流程。数据和文件 重点关注FDA提交材料、内部报告、策略和假设的完善的结构 使项目成功。商业企业没有发布或公平分享数据的动机， 不分享药物开发数据的企业文化。有改进的余地，如果 系统可以由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。所有的HEAL获奖者将受益匪浅， 不同级别的此类数据和文件，我们建议改进或增加我们的流程和努力 实现公平共享。我们计划在BioCorRx开发和完善系统和策略， 数据和文档;保护商业敏感信息并启用概念验证FAIR数据 共享这些活动将涉及格式化、索引编制、编辑、创建模板和提供 不同的BioCorRx数据和文件。在这个项目中，我们的目标是开发实际的改进， 文件和数据如下所述和确定。该项目所模拟的进展可以作为一个 示范试点，我们将与RENCI/RTI和其他HEAL生态系统获奖者合作， 我们将在颁奖期间讨论如何在未来更广泛地实施这一点。大部分的治愈 获奖者是从事高度监管（FDA）项目的商业企业， 临床前IND和临床NDA使能活动。HEAL计划对阿片类药物危机的关注 提供了一个机会，使有价值的数据共享，可以是一个机会，以提高获奖者 不影响商业地位。可找到性：为了最好地服务于治愈获奖者， BioCorRx将根据1）FDA模块/章节，2） 药物开发阶段，3）适应症和4）产品类别。辅助功能：Convert BioCorRx data 和文件，以便访问。将开发模板、部分修订和SOP，以创建 创建文档和数据共享的系统。互操作性：数据和文档的转换， 通过使用通用格式的共享数据库进行共享，可确保互操作性和导入/导出 不同的程序和演示实用程序。可重用性： BioCorRx FAI数据可访问性。 BioCorRx将对生成的数据和文件应用公平原则。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。