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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.
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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.
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Saknas det avsnitt?
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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
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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.
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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?
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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 Zobel
Senior Director Personalized Supply Chain
World Courier
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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?
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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.
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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
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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 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.
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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.
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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.
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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 and personal highlights they have taken from their involvement in the collaboration.
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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.
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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 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.
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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 [email protected]
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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?
Further resources:
BioPhorum’s Digital Plant Maturity Model
Dassault Systems white paper: The virtual twin experience of the pharmaceutical process
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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?
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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.
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