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.

The conversation dives deep into:

1. The shift from checklist-based testing to risk-based approaches under ISO 10993-1 and its connection to ISO 14971.
2. Challenges in global regulatory alignment, including differing requirements across FDA, EU, PMDA, and China.
3. The role of platform technologies in accelerating drug-device development and leveraging existing safety data.
4. Supplier engagement and material risk assessment—why early involvement of biocompatibility experts matters.
5. Training and cross-functional awareness—building company-wide understanding to flag changes that affect biocompatibility.
6. 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.

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.

1. 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.
2. Simplicity Over Complexity: Reliability and simplicity are more valuable to patients than flashy features, especially for those managing multiple therapies.
3. Challenges with Existing Therapies: Older, complex drug reconstitution processes persist due to regulatory grandfathering, leading to frequent user errors.
4. Engagement Myth: Debunking the idea that patients are excited about therapies, explaining that adherence is more about convenience than engagement.
5. 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.

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:

1. The origins and impact of the Living Heart Project
2. Building a fully functioning digital heart
3. Collaboration with the FDA and global regulators
4. The future of digital twins in drug development and personalised care

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.

It is based on the BioPhorum publication Implementing AI systems in regulated pharma environments and key takeaways include: 

1. The whole AI lifecycle needs to be managed 
2. It's a risk-based approach with risk management throughout 
3. Setting clear objectives and scope creates the essential focus for success 
4. For reliable AI, data needs to be really well managed 
5. Algorithm selection and model design needs discipline to create assurance 
6. Deployment is about thinking of the whole system, which could include many AIs 
7. Data drifts, so ongoing monitoring and evaluation is essential 
8. 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.

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:

1. Gael Debauve, Head of Gene Therapy Analytical Sciences at UCB
2. Madison Lee, Associate Director of CMC Program Management at Regeneron

Together, they discuss:

1. Why minimizing the impact of stability testing is critical for low-yield products
2. How the ASTM International guide expands the scope beyond gene therapies
3. The value of using a mock gene therapy product to quantify potential savings
4. Who in the industry will benefit most from this guidance
5. The 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.

Key topics discussed include:

1. The importance of IT and OT convergence for digital maturity and cybersecurity.
2. Practical steps for implementing cybersecurity frameworks and achieving consistency across organizations.
3. The impact of regulatory changes and validation challenges on cybersecurity practices.
4. 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:

1. Digital plant maturity model v3
2. IT vs OT
3. Tabletop exercise to improve incident response

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.

Also available is a public webinar 22 Jan 2025 by eight of the authors

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

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. 

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.

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

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.

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

Speakers - Dr Andrea Zobel

Senior Director Personalized Supply Chain

World Courier

The phrase was coined, regulatory partnership, not policing. Clare tells us more about what our members need from a regulatory perspective in order to accelerate progress.

Presented by: Sue Plant, Phorum Director, BioPhorum Regulatory CMC, Isabelle Lequeux, regulatory Lead, BioPhorum

As we launch BioPhorum Regulatory CMC, Sue Plant, the Phorum Director, and Isabelle Lequeux, Regulatory Lead tell us how investment in the new Phorum will continue to build regulatory as a capability that enables strategic innovation across the BioPhorum community. 

 The BioPhorum Regulatory Governance team of experts has been actively supporting the work of BioPhorum members for many years.  This team has now expanded to include more focus on external partnerships and thus has been rebranded as BioPhorum Regulatory Governance and External Partners, or in short REGx. The x represents the cross-phorum and external partnerships nature of the team. REGx will continue to support the technical workstreams in BioPhorum, ensuring the regulatory perspective is considered and embedded as teams innovate.

BioPhorum Regulatory CMC gives a dedicated space for regulatory to drive their own agenda and the vision of divergence to convergence.

Listen now, and get in touch if you want to be part of this collaboration. We welcome representation from all regions and those at the forefront of innovation. Contact sue.plant@biophorum .com, or visit the Phorum page here.

This conversation explores expectations about what can be achieved in the Digital Technology Roadmapping workstream. We hear from the members about the value and personal highlights they have taken from their involvement in the collaboration.

Calling all biomanufacturers, contract development/contract manufacturing organizations, are you curious about what long-range planning is and what the current status is within the biomanufacturing industry?

The BioPhorum Long Range Planning workstream team is keen to build a group that can define how we can prepare for the future and overcome the challenges that face this industry. In a global world, we want to avoid drug shortages due to a lack of planning and sharing. A way to prepare for the future is to combat known issues, such as the unknown future demand which is increased by a lack of connectivity and communication across the industry.

This podcast briefly discusses the benefits of combating these issues and how we can start to plan for the future, together.

Further resources:

BioPhorum’s Digital Plant Maturity Model

Dassault Systems white paper: The virtual twin experience of the pharmaceutical process

How can the biopharmaceutical industry move away from highly manual information exchange, and build seamless integration between sponsor companies, contract manufacturing organizations, and other vendors in an effort to optimize resources, create a common language and understanding, and help increase speed to market while also reducing costs?

In this podcast, Lesley talks about the needs and considerations of CGT supply chains and how they differ from traditional biopharmaceutical supply. She explores how important industry collaboration is and how we harness the expertise of our CGT Phorum to drive change.

Lesley Holt, BioPhorum Supply Chain to Patient Director, talks about the needs and considerations of a sustainable outbound supply chain. How can your company benefit from collaboration with BioPhorum?

Through conversations within pharma and biotech, Colm feels like we are trying to reinvent the wheel rather than learn from those who have trodden the path before. With one of the biggest sustainability challenges centered around supply chains, how does Ipsen hope to take value by collaborating in BioPhorum Sustainability?

Lesley Holt, BioPhorum Supply Chain to Patient Director, talks about data management and transparency, and the challenges this presents that affect biopharmaceutical logistics. What happens if the challenges are not addressed and what collaborations are expected across BioPhorum in order to tackle them?

Lesley Holt, BioPhorum Supply Chain to Patient Director, talks about the complexity of the global supply chain for biologics, the trends she sees emerging, and how this differs from what we see in the news about how the supply chain impacts everyday items. How can your company benefit from collaboration with BioPhorum?

In this podcast, Emmanuel Abate, Vice President Genomics and Cellular Research and Sustainability Executive Leader, Cytiva, talks about BioPhorum providing an excellent space to have facilitated discussions along the supply chain, allowing members to 'lift the curtains' on what they want to do better, and how they can do it jointly. Whilst the industry is traditionally secretive to protect IP, there are many common challenges they can work on together. One such challenge is the responsible use of single-use technology.

Lesley Holt, BioPhorum Supply Chain to Patient Director, discusses freight capacity and increased costs, complexity of supply chains for cell and gene therapy and direct to patient, and the benefits of collaboration on influencing regulations.

In this podcast, Christie McCarthy, Director of Sustainability at Corning Life Sciences, talks about being the conductor of a sustainability orchestra, building on from pockets of goodness, connecting the dots between employees and impact, and the importance of industry engagement.

Answering questions about why BioPhorum published the new technology vision and how this instructed a need for a strategic framework.

In this podcast, we hear from some of the lead authors from BioPhorum’sSmall Scale Models Workstream who contributed to the article Justifications of small scale models: an industry perspective to hear their thoughts on how it addresses the gap in industry alignment and regulatory practice. Prasad

Pathange, Director at Bayer, Kiran Andra, Development Scientist at Alexion Pharmaceuticals, Robert Luo, Scientific Director and Downstream Process Development at GlaxoSmithKline, and Joschka Buyel, Process and Knowledge Management Scientist at Bayer discuss what they think about the current situation and their thoughts for the future.

This is a very different way of working and a multi-company collaboration, comprising subject matter experts from 29 BioPhorum members, has shared case studies and discussed the practical factors that make remote inspections and audits effective. Learning from post-inspection feedback from inspectors has also been shared. This experience has been captured in Peer to peer practical guidance on remote inspections and audits.

In this podcast, a member of the collaboration, Søren Thuesen Pedersen, Senior Director of Quality Intelligence and External Affairs at Novo Nordisk, talks to Dawood Dassu, BioPhorum Fill Finish Lead.

In this podcast we talk to Phorum Lead, Bob Brooks and Matthew Neal, Account Manager and Facilitator from BioPhorum Supply Partner who talk about the impact of Covid-19 and how the pandemic is shaping in-bound supply chains for the future.

In this podcast we talk to Senthil Ramaswamy, Director of Cell and Gene Technologies R&D at Lonza; and Iara Cruz, Cell & Gene Therapy Site Manager at Roche, two of the authors from BioPhorum’s Cell & Gene Therapy Validation Workstream who contributed to the article CGT considerations when assigning responsibilities during a product transfer between a sponsor and a contract development manufacturing organization detailing these unique considerations within a CGT product transfer and validation; to gain an insight into the activity leading to the publication and what they see as the benefit of this work.