harmonised non-clinical development protocols
DESCRIPTION
High-Level Implementation Timeline. Business Case. Unmet Need. Value Proposition. Harmonised Non-Clinical Development Protocols. - PowerPoint PPT PresentationTRANSCRIPT
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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