BioPhorum Connect

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, 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...

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 inv...

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...

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: 

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:

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:

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: 

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...

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...

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 to...

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...

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 Sart...

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...

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...

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.

Sp...

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.

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.

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

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...

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?

This conversation explores expectations about what can be achieved in the Digital Technology Roadmapping workstream. We hear from the members about the value...

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

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 la...

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 n...

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.

Kim 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 f...

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

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?

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.

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.

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.

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?

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.

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?

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.

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?<...

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.

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...

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.

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...

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.

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.

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.

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 d...

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

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

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 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 Al...

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.

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...

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

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.

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.

In this podcast we talk to Senthil Ramaswamy, Director of Cell and Gene Technologies R&D at L...