Module 6

02/10/2024

Regulatory Team: strategic partners to the Brand Team Identify the potential opportunity to expand the brand and advise/guide the team

• Obtain agency scientific advice on unknowns/gaps in development program, post authorisation plans including PAES/PASS and potential regulatory commitments. • Advise on post-approval data requirements for expanding TPP • Realistic expectations for label (maximum efficacy, minimum safety). How target label fits in context of current treatment landscape (with input from key stakeholders) • Competitive intel & research: any past precedent, EPARs, clinical study reports, SmPCs • Ensuring relevant new or developing clinical guidelines are followed and advise cross functional teams

Opportunity!

Benefits

Challenges

What needs to be done

What can be done

Increased revenue

Balance of potential investment to make vs revenue and post-approval study commitments. Resource intensive: how much do you want to dedicate to lifecycle efforts? Defending and maintaining orphan designation status without losing it R/B re-evaluated by agency and price may be re-evaluated by payors. Regulators and payors will scrutinize the level of data and improvement.

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IP rewards: additional +1 RDP for new indications approved within first 8 years of MAA.

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Improved efficacy, side effect/tolerability profile, more convenient to patients

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File licence extension application

Brand perception - scope of indication

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Additional support pricing & reimbursement

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

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Learning Outcomes: recap

Key considerations in maintaining and extending brand awareness

The input of the regulatory representative in shaping a successful product through to life-cycle management

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

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