What is the reimbursement landscape and how do we plan for success?
Skysis has worked with many emerging and large pharmaceutical clients to support product launches from a market access perspective. This scope of work includes payer landscape assessments, site of care economics analysis, payer value proposition development, launch readiness strategy development, and launch execution support.
What are the gaps and opportunities in our payer value story?
A compound that demonstrates robust efficacy and a good safety profile in clinical development is likely to receive marketing approval by regulators. A compound’s efficacy and safety are measured against the primary and secondary endpoints included in registration trials. However, a compound’s regulatory approval does not guarantee payer reimbursement, especially in therapeutic categories that are tightly managed.
Where and how can we influence a patient’s journey from diagnosis to treatment?
Skysis has worked with many clients to assist in developing an understanding of the patient’s journey through a disease. Skysis’ commercial strategy experts also train clients on the methodology to complete robust patient journey assessments and determine how best to integrate relevant findings into overall brand strategy.
When should we begin commercial activities for a product in clinical development?
Clinical development-stage companies understand understand that foundational commercial activities must be contemporaneous with IND (investigational new drug) acceptance and commencement of the first clinical trial. These foundational commercial activities are important inputs into both the design of a mid- and late-stage clinical development program and the initial valuation of assets that have reached the clinical development stage.
How should we prioritize our investments in commercial assets and pipeline projects?
Skysis has worked with many clients who require assistance in prioritizing investment of commercial assets and pipeline projects. Skysis also assists clients with implementation of the process and methodology necessary for consistent future assessment.
When will our company reach cash flow breakeven?
Skysis has worked with clients who require an assessment of both the time and aggregate investment required until the company reaches cash flow breakeven. The scope of these financing assessments has included one or multiple compounds in mid-stage clinical development, with each asset having the potential for multiple indications.