Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies

In: Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004–.
[updated ].


Setting up drug discovery and development programs in academic, non-profit and other life science research companies requires careful planning. This chapter contains guidelines to develop therapeutic hypotheses, target and pathway validation, proof of concept criteria and generalized cost analyses at various stages of early drug discovery. Various decision points in developing a New Chemical Entity (NCE), description of the exploratory Investigational New Drug (IND) and orphan drug designation, drug repurposing and drug delivery technologies are also described and geared toward those who intend to develop new drug discovery and development programs.

Note: The estimates and discussions below are modeled for an oncology drug New Molecular Entity (NME) and repurposed drugs. For other disease indications these estimates might be significantly higher or lower.

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