Denise Steckel, Head of Clinical Collaboration at Genentech, advocated for clinical collaborations with external companies because even though many big biopharma companies already have extensive pipelines, they may run out of combinations. Through collaborations, researchers can explore more combinations with a focus on the mechanisms of action, and which combination therapies could help patients. This has potential across several therapeutic areas especially in oncology, where combining two or more medicines is the norm.
Steckel likened data to currency: the generated data is considered the bread and butter of these combination studies. Roche can either provide or receive drugs for these studies and the resulting data is shared with the collaborating company.
Roche establishes clinical collaborations to explore innovative drug combinations. It is critical to determine which combinations work most successfully for the patient.  These partnerships typically last between two and seven years. The Industry Clinical Collaborations (ICC) team at Roche is dedicated to managing these collaborations, handling everything from initial agreements to the final study close.
There was a growing demand for a consistent approach to initial agreements, including master agreements, supply agreements, quality agreements, and safety agreements. So, the ICC team checks that these agreements are consistent and clear to ensure that progressing to the next study phase runs smoothly.
Combining two investigational medicinal products (IMPs) or novel/novel combinations presents an exciting opportunity for scientists. Yet compared to combining marketed drugs, combining IMPs brings additional challenges. For example, combining two IMPs raises extra regulatory barriers. The regulatory agreements for novel/novel combinations are more complex and go beyond standard agreements. From a safety standpoint, with no data on the combinations with similar modes of action and limited exposure to the drugs in monotherapy, safety checks are paramount. Steckel also mentioned that companies combining IMPs must consider QC/QA.
To assist with these challenges, the ICC team works closely with their collaborators to plan things such as manufacturing drug availability. This requires understanding the supply chain, managing small batch productions, and coordinating the packaging and labelling of the product. Steckel added that if there is a change in manufacturing site or formulation processes, these changes must be filed. Overall, consistent checking in, mutual understanding, and monitoring are crucial to ensuring compliance between the ICC team and their collaborators.