In this episode of BioPhorum Connect, Loic Bishop sits down with returning guest Soumen Das, Delivery Systems Qualification Lead at Takeda, to explore the evolving world of biocompatibility in drug-device combination products. Soumen shares his journey from academic research in chemistry and biochemistry to leading biocompatibility strategies for global pharmaceutical delivery systems.
The conversation dives deep into:
- The shift from checklist-based testing to risk-based approaches under ISO 10993-1 and its connection to ISO 14971.
- Challenges in global regulatory alignment, including differing requirements across FDA, EU, PMDA, and China.
- The role of platform technologies in accelerating drug-device development and leveraging existing safety data.
- Supplier engagement and material risk assessment—why early involvement of biocompatibility experts matters.
- Training and cross-functional awareness—building company-wide understanding to flag changes that affect biocompatibility.
- Whether you’re a biocompatibility professional, regulatory strategist, or simply curious about how patient safety is ensured in complex delivery systems, this episode offers practical insights and forward-looking perspectives.
