BioPhorum Connect

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 sustainabilit...

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...

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 convers...

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, high...

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...

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...

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 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...

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 thei...

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 ...

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...

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 th...

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 precis...

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 co...

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...

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 b...

Global events such as the COVID-19 pandemic and geopolitical unrest across the world are putting immense pressure on the inbound supply chain. Therefore, BioPhorum Supply Resilience has identified end-to-end digitization as one of its strategic objectives for the inbound supply strategy. The main goal is to enable a fully digitized supply chain that supports effective commerce,...

The CGT Supply Chain team has collaboratively created a high-level pathway that differentiates between autologous, allogeneic, and gene therapies and the logistics pathway they follow.  Two of the subject matter experts, Alyssa Palmer, Global Value Stream Strategy at Roche, and Maria Rende, Process Technology Expert – Cell Therapy at Sartorius Stedim, who worked on the pathway, talk abou...

In this episode, we take a look at some of the challenges that are encountered when trying to introduce digital to drug delivery devices, where the value and opportunities lie for digital, and what the future might hold for digital in combination devices. Mark describes what could be a typical trajectory when considering adding a digital element to a drug delivery device, introducing where challen...

Senior BioPhorum Connect gives our senior leaders a window into what is happening across the Phorums they sponsor. Clare tells us what they can expect to hear about in the second half of this year. From the World Health Organization's Pandemic Preparedness Program to our most recent roadmaps, these easy-to-access meetings are the platforms by which to keep informed.

The update to Annex 1 is perhaps the biggest change to the manufacture of sterile medicinal products in recent times and possibly the most important topic for many in the biomanufacturing industry now. How has BioPhorum helped to prepare its members for the new regulations?

The Digital Plant Maturity Model (DPMM) is a strategic framework guiding industries through five digital maturity levels, aligning shop floor to senior management with clear targets and information. It's industry-tailored for simplicity, adopted by companies like Merck through top-down decisions, fostering a common language for digital alignment. Industry-built and peer-reviewed, the DPMM offers v...

With discussions around strategy and working together with the agencies and legislators to make sure the industry voice is heard on all the raft of changes we expect to see around materials of concern and new modality regulations, what has been the key focus of the last six months, and what are the critical pathways that will shape the program going forward?

With the FDA calling for greater patient diversity in clinical trials, and the industry’s need to include patients in clinical trials no matter where they are located, how can direct to patient shipment help in addressing diversity and inclusion? What are the greatest challenges that direct to patient shipments face both in terms of data privacy and regulations? Andrea tells us about how the indus...

We have to adjust some of our manufacturing industry's production processes to take account of changes that we see in the acceptability of different materials. These materials of concern are those that have been identified to have a negative environmental impact, as well as a negative impact on human health. Bob tells us what this means for the future of the supply chain, and the patients it serve...