Formulation Development Gap Assessment for An In-licensed Program: A Case Study

08:50 - 09:25

Complex due diligence activities often overshadow potential scientific challenges associated with an in-licensed program.  To successfully transition a product in-house, a cross-functional team of subject matter experts, in addition to the due diligence team members, should be engaged in a timely manner to identify development gaps, and assess the time and resources required for a successful product transition and an ultimate launch.  This presentation highlights a formulation-specific case study and the challenges that are scientifically being remedied.

Nazila Miller, Director, Drug Product Development , Takeda