BioPhorum Connect

This episode aligns with BioPhorum's Quality Community by exploring how human behaviours, communication, leadership, and quality culture influence inspection outcomes. The discussion supports BioPhorum's focus on advancing quality excellence, strengthening inspection readiness, and sharing practical approaches that help organisations move beyond compliance to achieve sustainable performance.

This podcast is connected to BioPhorum's Quality Community and builds on discussions within the Inspection Body Intelligence workstream. The episode explores industry challenges related to inspection readiness, regulatory expectations, quality culture, and continuous compliance, while sharing practical insights and lessons learned that support BioPhorum's mission of enabling collaboration and best practice across the biopharmaceutical industry.

In this episode of BioPhorum Connect, Loic Bishop is joined by Lucas Pianagonda, a materials science expert in sustainable plastics, to explore how sustainability can be embedded into the design and material selection of drug delivery devices. The discussion covers key pressures driving change in biopharma, practical challenges in redesigning established devices, and where meaningful sustainability gains can realistically be made—spanning eco-design, material trade-offs, lifecycle assessment, and emerging trends such as mass balance plastics and AI-enabled material selection.

In this BioPhorum Connect episode, Charlotte Scutt, Global Change Facilitator at BioPhorum, hosts a strategic conversation with senior authors Laura Mahoney (Pfizer) and Steven Muller (Bristol Myers Squibb) to explore the collaborative development and purpose of the 'Manifesto: Digital technology-based capabilities for the quality control (QC) lab of the future 2.0', published in July 2025.
Rather than offering a fixed solution, the manifesto provides a structured vision and practical considerations for QC labs navigating digital transformation. The speakers reflect on industry-wide challenges such as fragmented systems, manual workflows, and limited automation, and how the manifesto—now aligned with the 'Digital plant maturity model (DPMM 3.0)'—helps organizations build strong data foundations, foster collaboration and make informed decisions to advance digital maturity.
Listeners are encouraged to use the manifesto as a strategic blueprint, share it across teams and join the ongoing BioPhorum conversations shaping the future of QC labs.

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.