Expansion/Secondary Indications
Introduction
Many therapies have at least hypothetical benefits for multiple indications, or at least multiple subtypes of patients. Having a plan for how and when to expand beyond your initial indication will enable you to clearly and quantitatively communicate the full value of your efforts. “For instance, Humira (adalimumab) was first approved in 2002 for rheumatoid arthritis. Over the years it has obtained nine additional indications, including ankylosing spondylitis, Crohn’s disease, and plaque psoriasis”.
What
Identifying indications that are similar – most likely in the biological pathway(s) involved, and then prioritizing based on unmet need and likelihood of success (which is informed by understanding these new patients!) is the typical exercise. Many entrepreneurs want to list everything under the sun. Resist that urge. Self-critical and objective editing is a sign of sophistication and scientific rigor. Know where to draw the line!
When
Technically, this is an optional exercise, however, ignoring it will likely leave value on the table, and may rob patients of a beneficial therapy. Typically, some serious effort is made before talking with early investors.
Why
Having a plan for how and when to expand beyond your initial indication will enable you to clearly and quantitatively communicate the full value of your efforts.
Learning Goals
How to identify, prioritize, and communicate opportunities for expansion into additional indications.