Commercialization
There's no question that commercialization has become far more than "feet on the street."
The key components of commercialization and launch have changed significantly in an era of heightened safety awareness as has the need to support appropriate use of products in the care delivery process. So-called "fair balance statements" are no longer sufficient to help clinicians make informed benefit-risk decisions with patients.
Instead, clinicians now expect transparent communication about product risks and clear advice on how to effectively mitigate those risks. This requires that brand teams:
- Understand and map the clinical care process
- Define parameters of appropriate use
- Design tools collaboratively with clinicians to support appropriate use
- Design a REMS (if necessary)
Identifying behaviors, office procedures and tools that drive successful use and mitigate risks is critical to addressing the gap between trials and reality and optimizing product uptake. Identifying best practices enables clinicians, patients and payers to more readily access the benefits and minimize the risks of your product.
Risk mitigation can easily make the difference between a product that never reaches full potential and early adoption of a therapy. As product labeling becomes guidance for clinical practice, you're charged with reducing the uncertainty associated with its use, to maximize the clinical effectiveness that supports commercial success.