Module 3 - Strategic case studies in practice

5. ESSENTIAL TARGET PRODUCT PROFILE CLAIMS

Essential Messages/ Claims

Description/ Title

Essential Attributes for Registration

Competitor Data

Differential Competitive Advantages

Probability of Success/ Achievability

Commercial Value of Additional Claims

Promotion or Publication Only

Study Design

(Pharmacology, efficacy, safety or other)

Phase II Efficacy

(Examples: Biomarker, Combo, Open Label, Basket, Adaptive)

Claim is:

Promotion

At Launch

Achieved

Post Launch

Not Achieved

Publication

At Launch

Post Launch

Phase II Safety

(Examples: SAD/MAD, DDI, PK, Food Effect, Special Populations)

Claim is:

Promotion

At Launch

Achieved

Post Launch

Not Achieved

Publication

At Launch

Post Launch

Phase III Efficacy

(Examples: Biomarker, Combo, Open Label, Basket, Adaptive)

Claim is:

Promotion

At Launch

Achieved

Post Launch

Not Achieved

Publication

At Launch

Post Launch

Phase III Safety

(Examples: SAD/MAD, DDI, PK, Food Effect, Special Populations)

Claim is:

Promotion

At Launch

Achieved

Post Launch

Not Achieved

Publication

At Launch

Post Launch