BioPhorum Connect

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 RegeneronTogether, 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 BioPhorumWhether 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.

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 and how addressing these in future updates is crucial for building greater resilience.Creating this tool is just one of the many benefits of collaboration within the CGT Supply Chain workstream. We invite biomanufacturing and logistics industry representatives to join us for discussions, idea-sharing, and insights from top subject matter experts. Let’s work together to shape the future of CGT supply chains! Get in touch by emailing scott.clayton@biophorum.com and for more information about BioPhorum Supply Chain to Patient, visit our homepage.Download the tool here.

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

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, Risk Management and Global Regulatory programs. Join us as she gives an industry update across developments across these three key topics. 

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. In this podcast, members of the BioPhorum Electronic Data Exchange (EDE) workstream discuss the reasons why digitization is becoming more relevant than ever, the crucial factors and considerations when implementing EDE, and how one can start the journey towards digitization.

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 about their experience working in the team, the process of creating the pathway, and what they feel are the key benefits to participation. Speakers: Alyssa Palmer, Global Value Stream Strategy at Roche, Maria Rende, Process Technology Expert – Cell Therapy at Sartorius Stedim, Antoinette Levett, Associate Account Manager, Supply Chain to Patient

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 challenges might present themselves along a hypothetical timeline, contrasting with what might be a typical timeline for any pharmaceutical product. The reality of constantly evolving apps, boards, and software is very different from that of a 'regular' drug or biologic. The value - to patients, health care providers, industry, and many other stakeholders is also a critical aspect of including digital in drug delivery devices. Mark goes on to describe the pros and cons associated with connected devices: the management of personal and clinical data, and the value that data can realise in enhancing patient experiences and optimising treatment and its outcomes. Mark also touches upon connected devices failures and their implications, and cites some of the key successes seen in this space to date with insulin delivery, and ways in which we can perhaps extend that success to other therapeutic areas. Mark speaks so fluently about this topic that you'll be left wanting more. Let us know if you want a sequel.

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.In this podcast, Yves Berthouzoz, a member of the BioPhorum IT, Digital and Data leadership team discusses his role in the development of the recent DPMM refresh, how Merck has adopted the tool, and the benefits of using it to assess your plant and global network manufacturing maturity level. Download the assessment tool, accompanying paper, and best practice guide here: Digital Plant Maturity Model V3 - BioPhorum Operations Group

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.Speakers - Dr Andrea ZobelSenior Director Personalized Supply ChainWorld Courier