BioPhorum Connect

16:43

Delivering a Cell and Gene Therapy Outbound Supply...

BioPhorum Connect ·

2024/01/31

The CGT Supply Chain team has collaboratively created a high-level pathway that differentiates between autologous, allogeneic, and genetherapies 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

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25:43

The value of Digital solutions for Drug Delivery and...

BioPhorum Connect ·

2023/11/30

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

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07:14

A round-up of what is ahead on the Senior BioPhorum...

BioPhorum Connect ·

2023/09/11

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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08:10

The implementation of Annex 1 and beyond - how...

BioPhorum Connect ·

2023/08/23

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?

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09:44

Digital maturity unlocked: digital strategy and...

BioPhorum Connect ·

2023/08/22

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,

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10:01

BioPhorum Council - An update on the key outputs from...

BioPhorum Connect ·

2023/07/31

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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20:16

Bringing drugs to market earlier with greater patient...

BioPhorum Connect ·

2023/07/14

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

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15:32

Moving the industry toward a sustainable inbound...

BioPhorum Connect ·

2023/06/26

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

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11:01

The key topics discussed by senior leaders at the...

BioPhorum Connect ·

2023/06/21

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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09:40

What is Senior BioPhorum Connect

BioPhorum Connect ·

2023/05/04

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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11:06

The next step in building regulatory as a capability...

BioPhorum Connect ·

2023/04/02

Broadcast date: Mon, Apr 3, 2023 Presented by: Sue Plant, Phorum Director, BioPhorum Regulatory CMC, Isabelle Lequeux, regulatory Lead, BioPhorumAs we launch BioPhorumRegulatory CMC,Sue Plant, the PhorumDirector, andIsabelle Lequeux, Regulatory Lead tell us how investment in the new Phorumwill continue to build regulatory as a capability that enables strategic innovation across the BioPhorumcommunity.The BioPhorum Regulatory Governance team of experts has been actively supporting the work of

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08:14

Takeda details how a BioPhorum paper was cited in...

BioPhorum Connect ·

2023/03/30

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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10:45

Connect the value of BioPhorum to your corporate...

BioPhorum Connect ·

2023/03/28

Clare Simpson, BioPhorum’sClient Service Director, tells us how members can connect the value of BioPhorumto theiroverall corporate strategy,helping you to understand what the opportunitiesare, and how best to use the resources available to you for maximum benefit.

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25:47

Digital technology roadmap - the story so far

BioPhorum Connect ·

2023/03/02

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

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05:14

The Annual BioPhorum - welcoming champions of the...

BioPhorum Connect ·

2023/02/10

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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07:12

Achieve a best-in-class supply chain through...

BioPhorum Connect ·

2023/01/30

Ciera Clayton, BioPhorum Global Change Facilitator talks to Hélène Pora, VP Technical Communication and Regulatory Strategy, PALL Corporation, and Benjamin Jequier, Supply Chain Director, TakedaCalling all biomanufacturers, contract development/contract manufacturing organizations, are you curious about what long-range planning is and what the current statusis within the biomanufacturing industry?The BioPhorumLong RangePlanning workstream team iskeento build a group that can define how we can

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13:33

Taking back increased value to your organization

BioPhorum Connect ·

2023/01/27

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 contactingclare.simpson@biophorum.com

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26:53

Virtual twins for biomanufacturing

BioPhorum Connect ·

2022/10/03

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

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15:12

In conversation with Bristol Myers Squibb on...

BioPhorum Connect ·

2022/09/23

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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08:19

Needs and considerations of CGT supply chains

BioPhorum Connect ·

2022/09/01

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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