Case study

Addressing industry issues: the value of collaborative learning through BioPhorum

There are many technical benefits to BioPhorum membership, such as developing best practice tools, creating leading-edge solutions, and influencing regulators. But there is also the softer side of being in a learning environment and understanding that you’re not alone when tackling common issues.

We spoke to Sonia Schwantes, Director of Product Management at NewAge Industries, about how membership has helped her learn about end users, the value of sharing experiences, and why it is important to have the courage to ask questions.

New Age Industries logo

What’s your history with BioPhorum?

I first became involved with BioPhorum when I started at NewAge a little over two years ago. I took over as the point of contact after the Director of NPD left the position. At first, I wasn’t sure exactly what this entailed as being a supplier means we’re often further away from the end user, so it’s sometimes unclear how we can participate.

However, I soon caught up and it’s been a great experience as I love hearing the perspectives of end users. This can be quite humbling as it’s easy to assume you know what’s going on, only to find that you don’t. Many things can differ in how an end user approaches things, so hearing those different perspectives is important and can help us improve too.

How has BioPhorum helped your learning?

It’s been great to further understand the layer between us and the end user through BioPhorum discussions because I can see that everyone is also learning like us. Again, it’s easy to assume that the big players have all the answers because of their size and experience. But BioPhorum has shown me that we all wrestle with the same questions and dilemmas and have something to teach one another.

Once you realize this, you can bring value simply by having the courage to ask questions. You can help each other by talking about your experiences and they can do the same Eventually, everyone improves.

There’s only so much we can pick up from courses and webinars or, if you’re lucky, visits to customers, which can be incredibly helpful in understanding the complexity of our industry. But if you can’t do those things, it can be difficult to learn as you may only see small pieces of the bigger picture.

The great thing about BioPhorum is that we’re all in the same room. Everyone brings their expertise, so asking questions and listening to discussions gives you a good perspective on a process. Everyone shares their experience of what’s worked for them and what hasn’t. Or they give pointers for things to look into or recommend things to try. This is one of the things I enjoy most about the collaborative process.

It’s been great to further understand the layer between us and the end user through BioPhorum discussions because I can see that everyone is also learning like us. Again, it’s easy to assume that the big players have all the answers because of their size and experience. But BioPhorum has shown me that we all wrestle with the same questions and dilemmas and have something to teach one another.

How are you doing things differently as a result of what you’ve learned?

We now see risk very differently than before COVID-19. What was often seen only as a localized, single risk is now being routinely viewed and assessed for its potential to become a global risk with lasting ripple effects.

For example, we have tried hard to improve our indirect communication. Before COVID-19, we used emails, and it was all ‘push’ communication. Now, we have a much better two-way communication process and use online tools such as a Smartsheet hub, which has become our team channel. If there’s an event that may impact us, we post a message on the channel and people can ask questions if they don’t see an answer.

Originally, there was a lot of focus on the sub-tier visibility of our suppliers, but COVID-19 showed us what’s more valuable is our relationships with our main suppliers and their relationships with their suppliers. While it is helpful to understand some sub-tier information, it is important to ensure the effort is focused on the high-risk materials. For materials that are easily procured the investment in subtier is not needed.

We also found that the reality for pharma is that we will always have a lot of single-source materials as it’s just not financially viable to have second sources because our volumes aren’t big enough.

Have you used AskBioPhorum?

Yes. I like that everyone can submit questions, which means I can see what issues people are grappling with and how others have tried to make things work. I always learn a lot from reading through questions and responses. It’s just really fascinating.

Occasionally, if an issue impacts us, I’ll put together a summary for internal circulation based on AskBioPhorum conversations because they’re things my colleagues should understand, such as end-user perspectives of what they need, want, or are looking for. So, let’s take advantage of that insight. AskBioPhorum gives us more awareness of current issues, especially regulatory ones.

We can see the issues concerning others and pointers to resources that we may not have ourselves. It’s been helpful to make sure we understand where industry is going so we can address issues before they become something major. Usually, we’ve asked ourselves the questions but have never been able to answer them because we don’t know a solution or don’t have the connections to find one.

It’s nice to feel you’re part of a joint team trying to address industry issues. It makes you feel that you’re not alone out there.

And in terms of giving back, we’ve been able to get more people involved with BioPhorum and have them be part of some workstreams. This is really helpful for senior management as the upward feedback lets them understand the potential issues that our sales or quality people might see every day.

Have you adopted any BioPhorum best practices or new approaches?

We’re doing more of this now. We’re taking the supply change notification best practice guidance and template and adapting it for our processes to ensure we cover more of the things BioPhorum addresses. And we’re definitely looking at the business continuity best practice guide, which we’re starting to address in much more detail than before.

We’re also looking at some of the BioPhorum tools available, such as the single-use user requirements or user specification toolkit, and seeing how we can apply them from a supplier perspective.

And in terms of giving back, we’ve been able to get more people involved with BioPhorum and have them be part of some workstreams. This is really helpful for senior management as the upward feedback lets them understand the potential issues that our sales or quality people might see every day.

The other advantage of having staff involved in workstreams is that the facilitators do a great job of taking high-quality notes or recordings. So, if I can’t make a meeting because my schedule gets crazy sometimes, I know I can still stay up-to-date on discussions and progress by reading the meeting notes. These also help our international peers who may find time differences hard to always attend meetings or calls. They can access the recordings or notes, so they can still have a good idea of what’s going on in the industry, even if they can’t always participate as much as they’d like.

Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges.To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory-CMC

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

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Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more
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