The Situation
On average, manufacturers spend >$125MM over three years leading up to launch, yet 66% of drugs don’t meet launch expectations. An unpredictable landscape, coupled with inevitable industry pressures, is forcing manufacturers to seek a more complete commercialization approach with less risk and
more value.
EVERSANA partnered with a UK-based molecular diagnostic firm to commercialize their first test in the US market. Using our innovative EVERSANA COMPLETETM Commercialization model, our partner was able to mitigate risk and combat curveballs that they would otherwise have been unable to predict when launching their product.
The Solution
We applied our risk management methodology that revealed two key risks:
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- Lack of demonstrated clinical utility which required another study and
- Lack of US lab operations.
Our team quickly worked with the partner to shift launch timelines, prioritize workstreams and reorganize budgets. EVERSANA also brought on a consultant to identify labs to partner with and establish US lab operations.
The Results
Our team helped design the partner’s clinical utility program and engage with the FDA and potential customers to inform the best path forward.
Employing a single team with one shared goal enabled our partner to overcome external pressures and mitigate risk.