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

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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.