biophorum connect by BioPhorum

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 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 landscape, the importance of harmonizing industry practices, and the drive toward platform approaches for drug delivery devices. With anecdotes, practical advice, and a touch of horror movie fun, this episode offers valuable...

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.

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.

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

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.

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.

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. 

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.'

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.

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. 

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.

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.

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.

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.

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.

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, quality, and R&D data exchange with speed and accuracy. 

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. 

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.

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 visibility and is a key element in digital strategy and network-wide digital progression.

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 industry is working to achieve greater patient centricity with direct to patient shipments, accelerating the clinical trial process and ultimately allowing drugs to come to market earlier, for the benefit of all.

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 serves. How does BioPhorum Supply Partner enable its members to work together on identifying ways to meet the challenge?

Following a successful meeting with senior leaders in Copenhagen, Clare tells us that the biggest theme of the week was a discussion about regulatory partnerships.

Clare tells us about the variety of topics that are explored by our senior leaders who come together to openly discuss trends, and challenges while learning how the BioPhorum teams are addressing them. It is a chance for leaders to catch-up on the work that their SMEs are doing across the BioPhorum community

Broadcast date: Mon, Apr 3, 2023

Catherine Wyatt, Phorum Director at BioPhorum talks to Philippe Baumgartner, Head of CMC for Biologics, and Stephanie Robichaud, Program Manager for the Cell Bank Centre of Excellence, from Takeda about how they were able to successfully cite a recent BioPhorum paper A risk-based scientific approach to qualify replenishment working cell banks, an industry view to demonstrate to the FDA that its bank was like-for-like to the currently approved working cell bank.

Clare Simpson, BioPhorum’s Client Service Director, tells us how members can connect the value of BioPhorum to their overall corporate strategy, helping you to understand what the opportunities are, and how best to use the resources available to you for maximum benefit.

How do different roles interact with data? How do we keep pace with the developing tools that will help us do our jobs? One future focus is on digital technology transfer. With a need to supply products to patients faster, we need to improve our digital tech transfer in order to minimize manual activity as well as reduce data re-entry. How does BioPhorum help in creating standards that can be implemented at industry level?

Clare Simpson, Client Service Director gives us a brief outline of why you should attend this exclusive networking event, being held in Copenhagen from 9-11 May 2023. With a focus on regulatory partnerships, make sure you take advantage of this unique opportunity to have some open and robust conversations with your senior-level industry peers.

Ciera Clayton, BioPhorum Global Change Facilitator talks to Hélène Pora, VP Technical Communication and Regulatory Strategy, PALL Corporation, and Benjamin Jequier, Supply Chain Director, Takeda

Clare Simpson, Client Service Director, talks us through the concept of BioPhorum Council. What initiated the idea, and what opportunities will it provide? How will the Council feed into the work being advanced at the phorum and workstream level and who should be participating? Listen now to learn about this exciting launch, and then get in touch by contacting clare.simpson@biophorum.com

In this interview, Kim Wilson, Dassault Systèmes, explains the concepts of digital and virtual twins, and applies that first to the growing challenge of manufacturing cell and gene therapies efficiently and at scale. She considers the broader aspects of optimizing the supply chain, and how twins go much further than a CAD model when considering a new facility design. Twins have the potential to transform tech transfer, combination product design, and the industry’s whole understanding and approach to sustainability. So how can biomanufacturers get started – how does this relate to BioPhorum’s Digital Plant Maturity Model? Why has it not happened already? What are the obstacles and what are the main benefits to go for?

What practical use could digital twins have in biopharmaceutical manufacturing? Talking with Kim Wilson, Dassault Systèmes, David Wallace draws on her expertise to show the opportunity and benefits of using virtual twins to optimize the supply chain, facility design, technology transfer, combination products, and sustainability.

In this podcast, BioPhorum talks to Brian and Brent about the future of collaboration across biopharmaceutical supply chains.

Within the growth area of cell and gene therapy (CGT), exciting new therapies are being developed, bringing with them new challenges and opportunities for the outbound supply chain.

BioPhorum members recognize the need to transform the performance of the global supply chain for biologics, and so a team of subject matter experts from across multiple companies is shaping a program of cross-industry collaboration to address topics ranging from capacity constraints, increased costs, and alignment on quality expectations of the outbound supply chain.

Colm Murphy came to the biopharmaceutical industry from the food industry, which has been dealing with farm-to-fork sustainability challenges for over a decade.

BioPhorum members recognize the need to transform the performance of the global supply chain for biologics, and so a team of subject matter experts from across multiple companies is shaping a program of cross-industry collaboration to address topics ranging from capacity constraints, increased costs, and alignment on quality expectations of the outbound supply chain.

BioPhorum members recognize the need to transform the performance of the global supply chain for biologics, and so a team of subject matter experts from across multiple companies is shaping a program of cross-industry collaboration to address topics ranging from capacity constraints, increased costs, and alignment on quality expectations of the outbound supply chain.

Cytiva's sustainability plan is a strategic intention to ensure that its policies, processes and collaborations across the value chain reflect its commitment to integrate sustainability throughout the business.

BioPhorum members recognize the need to transform the performance of the global supply chain for biologics, and so a team of subject matter experts from across multiple companies are shaping a program of cross-industry collaboration to address topics ranging from capacity constraints, increased costs, and alignment on quality expectations of the outbound supply chain.

Sustainability for many organizations is mission-critical and materials science group Corning is making great progress. Most recently, using guidance developed by the Science Based Targets initiative (SBTi) and in alignment with a 1.5°C future scenario, two more goals were added to their list of climate commitments: reduce Scope 1 and 2 greenhouse gas (GHG) emissions by 30% (absolute basis) and relevant Scope 3 emissions by 17.5% (absolute basis) by 2028 compared to a 2021 baseline.

Bob Brooks, BioPhorum Supply Partner Lead and Clare Simpson, BioPhorum Technology Roadmapping Lead share their thoughts on the recent focus on a new strategy.

Tara Cox, Head of Device Quality and Regulatory Compliance at Takeda talks us through the updated EU MDR regulation, the drivers that instructed the update and the biggest changes that will impact the biopharmaceutical industry. How is BioPhorum helping to address the challenges that are anticipated in supporting the products?

In this podcast, we talk to Kelsey Hill, Life Sciences Marketing Manager, Emerson, Jean-Luc Gerling, Solution Manager, Merck, and Gene Tung, Executive Director, MSD about the concept of plug-and-play, its testing and adoption in the biopharmaceutical industry, and how the current global pandemic has changed the approach.​

Small-scale models and their qualification are important steps of biopharmaceutical process development, characterization, and validation. Despite being required by regulatory bodies, there is no guidance on current best practices and companies use many different qualification approaches throughout the industry.

In normal conditions, regulatory inspections and audits are conducted on-site, however, travel and social restrictions due to the Covid-19 pandemic have forced regulatory inspections and audits of affiliates to be conducted remotely.

The impact of the Covid-19 pandemic has been far-reaching, not least on the industry’s in-bound supply chain.

The process of transferring a product from a developer to a contract development and manufacturing organization and executing a successful validation campaign is a well-established process. However, due to numerous unique aspects required for a cell and gene therapy (CGT) product manufacture, there are a variety of unique or different considerations required during a transfer and validation campaign within CGT. Therefore, although transferring a product is ‘routine’, there is a risk that these CGT considerations are overlooked if treated as a ‘normal’ process.