Harmonised Non-Clinical Development Protocols
This project aims to create a harmonized, validated library of non-clinical development protocols to support the pharmaceutical industry. By unifying pre-clinical testing standards and reducing redundancy across companies, we can save time, decrease costs, and improve quality. The estimated value of implementing this initiative is yet to be determined, but with access to a web-based, quality-controlled library, industry stakeholders will streamline their regulatory submissions. Funding for the project has been agreed upon, with a projected shared cost of ~$xxx,xxx.
Harmonised Non-Clinical Development Protocols
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Presentation Transcript
High-Level Implementation Timeline Business Case Unmet Need Value Proposition Harmonised Non-Clinical Development Protocols • Projected Shared Project Costs ~$xxx,xxx[Project Analyst, meetings, socialisation, PoC service implementation, RFP construction, publication and shared-risk funding] • Estimated value for the industry of implementing this project is TBD • Access to a web-based, searchable library of quality-controlled, validated, non-clinical development protocols will save time, decrease costs and increase quality • Before an investigational compound can be evaluated in humans, it needs to undergo pre-clinical testing. • Pre-clinical tests must be conducted according to regulatory guidelines and under GLP conditions. • Currently, each pharmaceutical company establishes its own pre-clinical testing protocols and validates them to show they are fit-for-purpose • Much time and money is expended across the pharmaceutical industry by NCD functions replicating the protocol creation and validation efforts of other pharmaceutical companies. • Define and develop a pre-competitive, harmonized, validated, suite of non-clinical development assay protocols to support regulatory submissions Workstream Start Project Funding Available NCD Template Library Service Available 1 Q4 - 14 Q1 - 15 Q2 - 15 Q4 - 15 Funding Agreed
