Harmonised Non-Clinical Development Protocols

Unmet Need 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.

Value Proposition Define and develop a pre-competitive, harmonized,

validated, suite of non-clinical development assay protocols to support regulatory submissions

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

High-Level Implementation Timeline

Q4 - 14 Q1 - 15 Q4 - 15Q2 - 15

Workstream Start

Business Case

Funding Agreed

Project Funding Available NCD Template Library Service Available

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