CRED Understanding Clinical Development 2024

08/10/2024

Additional Considerations

⚫ Formulation – Ph 2 to Ph 3

⚫ Unlikely to have the final commercial formulation for Ph 2

⚫ Additional studies may be required to bridge the Phase 2 formulation to Phase 3 (pre filled syringe vs autoinjector) ⚫ Patient Reported Outcomes (PRO)

⚫ Use Ph 2 to develop a PRO tool to validate and use in Ph 3

Robust FDA guidance

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Limited EU guidance

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⚫ Qualification advice/Qualification procedure

⚫ Important factor during both regulatory and HTA assessment ⚫ Biomarker Strategy (IVDR)

⚫ Enhanced efficacy in a sub-set of the population

Companion Diagnostic

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The Organisation for Professionals in Regulatory Affairs

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Study Design Consideration

The Organisation for Professionals in Regulatory Affairs

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