Module 3 - Strategic case studies in practice

7. ADDITIONAL CLAIMS

Essential Messages/ Claims

Commercial Value of Additional Claims

Promotion or Publication Only

Study Design Description/ Title

Essential Attributes for Registration

Competitor Data

Differential Competitive Advantages

Probability of Success/ Achievability

(Pharmacology, efficacy, safety or other) Japan Specific Claims

Incidence of Adverse Events (AEs)

Promotion

Existing data:

Increase Risk

At Launch

Post Launch

Decrease Risk

(Study Code To Be Determined)

Support Average Risk of Phase

Publication

At Launch

Claim is:

Post Launch

Achieved

Not Achieved

Safety / Tolerability Combination Therapy

Promotion

Existing data:

Incidence of AEs

Increase Risk

At Launch

Post Launch

Decrease Risk

Discontinuation Rate

Publication

Support Average Risk of Phase

At Launch

Post Launch

Claim is:

Achieved

Not Achieved

Essential Biomarker Claims Essential Messages/Claims (Pharmacology, efficacy, safety or other) (EU/USA)

Commercial Value of Additional Claims

Promotion or Publication Only

Target Measures Comparative Competitor Data/ Information

Differential Competitive Advantages

Probability of Success/ Achievability

Life Cycle Management

Pharmacology

Other Profiling Messages/Claims (Pharmacology, efficacy, safety, convenience, pharmacoeconomics)

Promotion or Publication Only

Target Measures

Comparative Competitor Data/ Information

Differential Competitive Advantages

Probability of Success/ Achievability