BioPhorum Connect

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 innova...

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 ba...

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 impl...

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 in...

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...

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 under...

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 harne...

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...

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 ch...

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...

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...

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 facili...

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...

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 re...

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 Mod...

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 di...

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.