Unmet Need, Safety, Efficacy, Compliance, Costs

Introduction

What does your patient need? A survival benefit? Pain management? Fewer wrinkles? This is the unmet need, the goal, and the primary endpoint. Be specific, objective, and self-critical. How does your therapy stack up vs. everything else in the development pipeline?

What

Define the unmet need in terms of safety and efficacy. Typically, there is a minimum safety threshold that is acceptable (which varies widely between indications and class of intervention, e.g. a cancer therapy has a different minimum safety threshold than a pediatric vaccine), and value is typically driven by efficacy improvements. There may be other dimensions of unmet need, e.g. compliance, ease of use, or costs.

When

If you’ve really understood your patient, you’ve understood the standard of care they currently receive. Now is the time to project into the future to determine how the many competitive efforts may derail or supersede your own.

Why

If you’re unaware of the competition, you don’t know the goal, you can’t respond and react to competitive pressures, and you’ll most certainly make errors during development. Investors will demand a sober assessment of competition.

Learning Goals

Become familiar with basic competitive analysis in therapeutics.