BioPhorum Connect

29:56

Beyond compliance: The behaviours that shape...

BioPhorum Connect ·

2026/09/30

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.

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34:40

Beyond inspection preparation: Embedding readiness...

BioPhorum Connect ·

2026/09/01

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.

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33:54

How better material decisions shape drug delivery...

BioPhorum Connect ·

2026/04/29

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

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40:25

Thinking outside the checkbox: Addressing...

BioPhorum Connect ·

2026/02/12

In this engaging episode of BioPhorm Connect, Soroosh Bagheriasl, Phorum Director at BioPhorum welcomes Kristen Booth, Senior Biocompatibility Scientist at AbbVie, for a deep discussion on biocompatibility in medical devices and combination products. Kristen shares her unique journey from animal science to medical device toxicology, explores the challenges of navigating ISO and USP standards, and reveals the complexities of supplier management. The conversation covers the evolving regulatory

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34:27

Advancing transformation with the QC lab of the...

BioPhorum Connect ·

2026/02/02

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

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39:54

From the surface up: Navigating biocompatibility...

BioPhorum Connect ·

2026/01/21

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

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29:51

Designing drug delivery devices: Prioritizing...

BioPhorum Connect ·

2025/12/09

Designing Drug Delivery Devices: Prioritizing Simplicity, Empathy, and Real Patient NeedsDescription / 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

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01:07:47

From Jet Engines to Heartbeats: Engineering the...

BioPhorum Connect ·

2025/10/17

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

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44:52

From Designing to Depending: A drug delivery journey

BioPhorum Connect ·

2025/10/16

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,

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25:48

Implementing AI systems

BioPhorum Connect ·

2025/07/24

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 managedIt's a risk-based

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06:40

Minimizing the Impact of Stability Testing on...

BioPhorum Connect ·

2025/07/15

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,

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37:11

Cybersecurity in biomanufacturing: Insights from...

BioPhorum Connect ·

2025/04/01

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

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14:35

Managing data as a product

BioPhorum Connect ·

2025/01/10

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 rolesExploring different data architecture strategies like data mesh and data fabricRealizing that a data product is more than just a dataset and what that means for ownership rolesVisualizing the lifecycle of a

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14:34

The DISCO playbook

BioPhorum Connect ·

2025/01/09

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

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12:12

Digital integration for external manufacturing: A...

BioPhorum Connect ·

2024/10/04

Rashitha Jayasekara, Director of Digital & Technology at GSK introduces the BioPhorum Digital Integration for Sponsor and Contract Organizations engagement pack. Intended to be used with partners who are prime candidates for digital integration, it covers, very briefly, some guiding principles and vision, the value proposition, ambition, mechanisms and next steps.Rashitha Jayasekara, Director of Digital & Technology at GSK

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41:25

Navigating Drug-Device Co-Development and...

BioPhorum Connect ·

2024/09/03

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

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41:40

AI's Role in Revolutionizing Product Development

BioPhorum Connect ·

2024/08/14

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,

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22:22

Navigating disruptions on the road to a resilient...

BioPhorum Connect ·

2024/08/07

In this podcast, we explore the latest advancements in the cell and gene therapy (CGT) supply chain, focusing on the newly released CGT outbound supply chain tool. We had the pleasure of speaking with two key contributors, Maria and Kelly, who shared their insights on the tool’s usability and its effectiveness in educating stakeholders about the complexities of the CGT supply chain.As the tool continues to evolve, Maria and Kelly also discuss the potential disruptions during therapy transportation

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21:00

MediPhorum Futures #1: Combination Products roundup...

BioPhorum Connect ·

2024/05/21

Join MediPhorum program manager, Victoria Ludlow, for a fireside chat with Susan Neadle, a recognized international Combination Products and Medical Device expert with >30 years industry experience. Networked, published, highly active in numerous industry groups with links to teaching institutions, Susan brings deep knowledge and genuine passion for sharing that knowledge with others, and has been involved across several MediPhorum collaborations including device specification setting for EPRs,

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13:27

The Future of the Inbound Supply Chain - Implementing...

BioPhorum Connect ·

2024/05/13

Global events such as the COVID-19 pandemic and geopolitical unrestacross the worldare putting immense pressure on the inbound supply chain. Therefore, BioPhorum Supply Resilience has identified end-to-end digitization as one of itsstrategicobjectives for the inbound supply strategy. The main goal is to enable a fully digitized supply chain that supports effective commerce, quality, and R&D data exchange with speed and accuracy.In this podcast, members of the BioPhorum Electronic Data Exchange

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