A biopharmaceutical company was in the midst of bringing its first product to market with breakthrough therapy designation. The PDUFA date was fast approaching, and their small team needed guidance to steer them through the complicated access and reimbursement landscape.
To ensure broad access for their supportive care technology, a European-based medical device company looking to enter the US market sought guidance and support in understanding the US payer system and how to gain buy-in from US healthcare providers.
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.