A First of its Kind Approval Changes the Way We Think About Access
The Challenge
A clinical-stage pharmaceutical company faced a unique barrier in bringing its first product to market—seeking pan-tumor approval based on a genetic marker, rather than a traditional approval based on cancer type. They subsequently sought recognition for the product across relevant clinical compendia.
The IP Solution
Our extensive experience shepherding dozens of products to market enabled us to develop a strategy unique to this product, opening access for patients to this practice-changing therapy. IP was critical in identifying how to make the best case for the product to the decision-makers at major guideline/compendia organizations.
Our well-established relationships with Key Opinion Leaders enabled us to gain insight through 1:1 engagement, as our meetings with leaders of compendia-developing organizations. IP’s talented team transformed this knowledge into action – providing medical writing assistance for compendia application submissions, planning and implementing an advisory board, and developing a publication strategy.
We engaged IP to help us identify KOLs in areas which our team didn’t have the level of comfort that we needed at the time, specifically Hematologists in Europe. Their execution was flawless.
The Results
Following FDA approval, the product was recognized across major clinical compendia for all approved indications, ensuring broad access for providers across the community and academic settings and ultimately for patients.
