Harmonised Non-Clinical Development Protocols

1. 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