Case study

Lessons learned during the pandemic and how BioPhorum’s Risk and Business Continuity Management helped: Amgen’s approach to risk management

BioPhorum’s Risk management in the biologic industry supply chain: a best practice guide was published in November 2020 to encourage industry to review its approach to risk management and to validate, refine, and improve current company practices.

We spoke to Melinda McCants, Senior Resiliency Officer at Amgen, and a long-standing member of BioPhorum’s Risk and Business Continuity Workstream, about her company’s approach to risk management and what it learned from the pandemic.

Amgen

How did you manage risk and business continuity before COVID-19?

After the earthquakes and tsunami in Japan in 2011, we put a huge effort into understanding our supply base and building a risk management program. But when I started in 2017, I realized that while we had a good tool on paper, we didn’t have a process for what we would do in a disruption event. So, we documented the steps to follow, mapped our supply chain, and started working with our suppliers to define the actions needed. It meant we were in good shape when Hurricane Maria struck Puerto Rico in September 2017.

How did you manage during the pandemic?

At the start, we ran scenarios for China, Asia, and Australia and did some proactive ordering before the pandemic worsened. This significantly increased our safety stocks of materials. We also researched when a vaccine would be produced, the materials that would be pulled into the program, and how this might affect us. Then we added details of any at-risk materials to monitor to our monitoring process.

We also started collaborating more with our suppliers to understand how they were being impacted. We asked them to complete weekly surveys to input into our COVID-19 Tracker report on the materials potentially at risk. Once lockdown hit, we established monthly intelligence reporting and used Smartsheets to collate everything into a COVID-19 one-stop-shop for materials. At the same time, our global risk network held virtual weekly meetings with all our sites to understand how we were operating, potential supplier disruptions, etc.

What was successful for us was using our relationships with key suppliers to prioritize orders. We also improved our connections with secondary suppliers – we all recognized we didn’t want to order excess materials, as this was not sustainable. So, we used ‘control towers’ to look across our company to see who needed materials and whether we had them elsewhere so they could be transferred. And if a supplier told us, it was being impacted by rated orders or had limited capacity, we implemented centralized ordering

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.

How has being part of the BioPhorum workstream helped you?

BioPhorum’s work in this area has been important. When the first best practice guide was published on LinkedIn, it got thousands of ‘likes,’ which meant people had started understanding what needed to be done. There has been a real mindset shift.

Building relationships and sharing information in the workstream has been great and several of our suppliers participate in BioPhorum, so I have been able to benchmark what they are doing. For example, the contract for one of our tools was up for renewal last year, and I could leverage my BioPhorum contacts to understand what tools they used, what worked, what did not work, as an example.

I’m sure BioPhorum’s guidance will become industry standards. It gives you a platform to build on and lets you focus on key suppliers without asking them hundreds of questions. It says if you’re at point X, then do these actions; if you’re at point Y, do these. That’s very helpful for those just starting their programs as some third-party tools sell you the world, and it’s easy to get overwhelmed. The BioPhorum best practice guides do a great good job of suggesting that you start small and build things up.

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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