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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.

Designing Drug Delivery Devices: Prioritizing Simplicity, Empathy, and Real Patient Needs Description / Show notes: Andy discusses the importance of patient-centered design in drug delivery devices, emphasizing that simplicity, reliability, and empathy should guide innovation rather than adding unnecessary features. Andy shares insights from his experience in human factors and medical design, highlighting the challenges patients face with complex therapies and the need to design devices that fit seamlessly into their lives. The conversation covers the pitfalls of overcomplicated devices, the myth of patient engagement, and the tension between regulatory requirements and true user needs, with examples illustrating how usability can be compromised by commercial or regulatory pressures. Patient-Centered Design: Understanding real patient needs and lifestyles is crucial, and devices should be designed to minimize cognitive load and fit into daily routines.Simplicity Over Complexity: Reliability and simplicity are more valuable to patients than flashy features, especially for those managing multiple therapies.Challenges with Existing Therapies: Older, complex drug reconstitution processes persist due to regulatory grandfathering, leading to frequent user errors. Engagement Myth: Debunking the idea that patients are excited about therapies, explaining that adherence is more about convenience than engagement. Regulatory vs. User Needs: The discussion highlights how some device features are added to meet regulatory or commercial goals, not actual patient benefit, sometimes increasing complexity without improving usability.

In this episode of BioPhorum Connect, host Loic Bishop speaks with Dr. Steven Levine, Senior Director of Life Sciences and Healthcare at Dassault Systèmes and Executive Director of the Living Heart Project. They explore how engineering principles and digital twin technology are reshaping the future of medicine—from personalised treatment planning to regulatory-grade simulations. Steven shares his personal journey, including how his daughter's congenital heart condition and a brain tumour has inspired him to pioneer a new approach to medical modelling. Learn how the Living Heart Project grew from a bold idea into a global collaboration involving over 165 organisations, and how it’s now influencing how we run clinical trials, regulatory processes, and the development of digital organs. Topics include: The origins and impact of the Living Heart ProjectBuilding a fully functioning digital heartCollaboration with the FDA and global regulatorsThe future of digital twins in drug development and personalised care

Rick Wedge shares his personal and professional journey from developing medical devices to becoming a patient dependent on diabetes technology, following a total pancreatectomy and diagnosis of Type 3C diabetes. The discussion covers the challenges of managing diabetes, the importance of wearables and continuous glucose monitoring, and the impact of technology on quality of life. Rick reflects on how his experience as a patient has deepened his perspective on risk management and device design, emphasizing the real-world implications for patients. The episode also explores future improvements for diabetes devices and the value of patient-centric innovation.

This AI-generated conversation explores the challenges of implementing AI in pharma accurately, reliably and safely, particularly given the stringent requirements of good practice (GxP) regulations and the need to enhance trust among stakeholders, including regulatory authorities, healthcare professionals, and patients.    It is based on the BioPhorum publication Implementing AI systems in regulated pharma environments and key takeaways include:  The whole AI lifecycle needs to be managed It's a risk-based approach with risk management throughout Setting clear objectives and scope creates the essential focus for success For reliable AI, data needs to be really well managed Algorithm selection and model design needs discipline to create assurance Deployment is about thinking of the whole system, which could include many AIs Data drifts, so ongoing monitoring and evaluation is essential Change control includes a much bigger challenge of version management  You can also watch a 90-min webinar replay by nine of the (real-life) authors who illustrate each point from their experience.

In this episode of BioPhorum connect, we explore the newly published ASTM International standard guide 'Guide for Minimizing the impact of stability testing on batch yield of low yield biopharmaceutical products.' This guide, authored by BioPhorum members, builds on a foundational BioPhorum publication developed through collaboration among 12 companies in the Advanced Therapy Medicinal Products (ATMP) space, particularly focused on gene therapies. Simon Walker, Global Change Facilitator at BioPhorum, is joined by two key contributors to both the original BioPhorum deliverable and the ASTM guide: Gael Debauve, Head of Gene Therapy Analytical Sciences at UCBMadison Lee, Associate Director of CMC Program Management at Regeneron Together, they discuss: Why minimizing the impact of stability testing is critical for low-yield productsHow the ASTM International guide expands the scope beyond gene therapiesThe value of using a mock gene therapy product to quantify potential savingsWho in the industry will benefit most from this guidanceThe collaborative advantage of working through BioPhorum Whether you're in QC, QA, regulatory affairs, or CMC leadership, this episode offers valuable insights into improving efficiency and conserving product in early-stage development.

Join us for an insightful episode of the BioPhorum podcast, where we delve into the critical topic of cybersecurity in the biomanufacturing industry, which is now woven into the overall vision for digital maturity expressed in the Digital Plant Maturity Model. Hosted by Tim Horton, this episode features expert guests Anderson Goebel from Merck and Tom House from Rockwell Automation, who share their practical experiences and strategies for enhancing cybersecurity in their organizations.   Key topics discussed include: The importance of IT and OT convergence for digital maturity and cybersecurity.Practical steps for implementing cybersecurity frameworks and achieving consistency across organizations.The impact of regulatory changes and validation challenges on cybersecurity practices.The role of tabletop exercises in improving collaboration and risk management. Don't miss this opportunity to gain valuable insights and learn from industry leaders.   Check out the resources mentioned in the podcast: Digital plant maturity model v3IT vs OTTabletop exercise to improve incident response

Our AI-generated podcast explores the transformative concept of managing data as a product, and discusses how adopting a data product mindset can revolutionize digital transformation in the pharmaceutical industry.  Key takeaways include:  Understanding the importance of clear data ownership roles Exploring different data architecture strategies like data mesh and data fabric Realizing that a data product is more than just a dataset and what that means for ownership roles Visualizing the lifecycle of a data product and the responsibilities involved.

This AI-generated conversation reviews the recently-published Playbook for digital integration of sponsor and contract organizations (DISCO). With the rise of external manufacturing in the pharmaceutical supply chain, managing numerous partners has become complex. Digital transformation is essential for visibility and flexibility. Practitioners have shared their experiences and practical solutions for moving to digital partnerships. The podcast covers challenges, digital integration, stages of developing partnerships, and crafting collaboration agreements - with a big emphasis on the human factors. Also available is a public webinar 22 Jan 2025 by eight of the authors

In this episode, Soroosh and Soumen delve into the critical aspects of drug-device co-development, emphasizing the importance of early collaboration between teams to enhance patient safety and streamline processes. They discuss the vital role of biocompatibility testing, highlighting the need for early implementation to avoid delays and ensure regulatory compliance. The conversation also covers the complexities of regulatory challenges, including the variability in review processes across agencies like the FDA and EMA. Finally, Soumen introduces the concept of leveraging platform technology for biocompatibility testing, offering strategies for efficient integration in development programs. Tune in for valuable insights that can help navigate the intricacies of drug-device collaboration!

In this episode, we explore how AI is transforming product development and sustainability initiatives. Robin highlights the importance of leveraging company data throughout the product lifecycle to enhance decision-making and product development. We discuss AI's remarkable ability to synthesize extensive data sets, identify risks, and generate real-world evidence with unparalleled speed and precision. The potential of AI to streamline regulatory and quality documentation processes is also examined, envisioning a future where compliance is maintained effortlessly through automated updates. Soroosh and Robin address the challenges and benefits of data sharing for sustainability, emphasizing AI's role in analyzing sustainability data despite intellectual property and regulatory concerns. Finally, we delve into the future of AI in biopharma and medtech, advocating for a shift from traditional systems to process-oriented approaches, and exploring AI's potential to optimize critical documentation and business processes. Join us for an insightful discussion on the future of AI.