Module 6

02/10/2024

Disease Area Strategy Define the brand: pre-licence and pre-launch: several questions to resolve !

Unmet Medical Need

Product’s Mechanism of Action

Disease / condition: is it rare, genetic?

•

What is the new drug?

•

• Target population (prevalence, epidemiology data)?, • How are patients diagnosed and treated today (SOC)? • Is there a severity disease spectrum? • What is the patients prognosis and quality of life • How could patients be treated differently /followed up? • Is there a current standard of care? • What indication can we achieve? • What can we actually achieve in the label, (e.g. oral kinase inhibitor vs syk inhibitor, moderate to severe) • What can be supported by the generated data? • What is scientifically appropriate and meaningful? • Research into all the available clinical guidelines for designing studies in the disease area.

• How does the new drug work? Is it novel, complex, what is the mechanistic pathway? • Would it be short term or long-term treatment • Preventive or treatment? • Where does it fit in the care pathway? • How will the drug be delivered? • Is the drug safe and effective and will the drug be able to work in clinical practice? • Alignment of scientific, commercial and regulatory. • Start laying out the scientific groundwork. • What must be achieved to make the drug marketable; improved efficacy, safety, tolerability, new treatment option, superior claims, better than gold standard. • Develop a ‘Target Product Profile’ (TPP). • You do not want to change messaging mid pre-launch Cross-functional Strategic Alignment

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

11

Value Proposition Defining the brand

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

12

6