CRED Understanding Clinical Development 2024

08/10/2024

Target product profile

• Defines the minimum / optimum requirements for a successful product vs a competitor (base case / stretch case)

• Multiple indications simultaneously or sequentially?

Definition of indication

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Acute vs chronic

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Mild vs moderate vs severe

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Monotherapy vs add-on therapy

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Medical setting

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1 st , 2 nd or 3 rd line therapy?

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Target product profile (continued)

Pharmacology

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• Time to onset of effect, duration of effect

Dosing regimen

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• Ideally once daily, more than twice daily may be uncompetitive

Clinical sub-groups

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• Paediatrics, elderly, organ impairment

Safety profile

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• Absolute and relative to competitors

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