Case study

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

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

We spoke to Andrew Goldman, Head of Business Continuity and Supply Chain Risk at Merck, and a long-standing member of BioPhorum’s Risk and Business Continuity Workstream, about his company’s approach to risk management and what it learned from the pandemic.

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

We had a robust business continuity management program before the pandemic. This is based on ISO 22301 and our plans might have a site or a product-family focus. For large sites, we look at risks across the end-to-end supply chain, from supplied materials and utilities downstream to our distribution and logistics network. We also do site-level disaster recovery and crisis management plans.

We were generally well prepared for COVID-19 as our business continuity plans drove resiliency by addressing potential failure modes, e.g., a workforce strike, a disrupted market for a raw material, a weather event, etc. We launched our program in 2012, so it had some maturity by the time the pandemic hit. This helped us be somewhat prepared for COVID-19 but, of course, there were many surprises.

How did you manage during the pandemic?

While our site-level business continuity plans were strong, we didn’t have corporate-wide pandemic plans. We had assumed, obviously incorrectly, that a pandemic might only happen in one region, so if we had a disruption event at one site, we knew we could flip the switch and use our network. But activating plans across 70+ manufacturing and distribution sites often at the same time was a different matter, and we found some of our plans weren’t easily executable at the corporate level.

A big topic of conversation was obviously around suppliers and raw materials. Our supply chain mapping exercises proved valuable because we could identify – especially in the early stages of the pandemic when it was seemingly isolated to China – which materials were coming from that region.

Many people in the risk world talk about qualifying second suppliers or alternative materials being crucial; they are, but we found that strong relationships with our suppliers were most important. For example, when we knew an event was happening, we could ask them which materials were coming from affected regions and get honest responses that helped us secure materials early.

Many mitigation actions in our business continuity plans built resiliency that we could use during COVID-19, such as increasing the inventories of higher-risk materials or purchasing more equipment to give us extra capacity.

Capacity was a major challenge during COVID-19 because we’re a supplier to the vaccine market, so we had a surge in demand for our products. But even customers not in that vaccine space were increasing their orders to create a buffer and mitigate their own risks. So we had extra demand and an initial reduction in capacity caused by local outbreaks, social distancing restrictions, etc. We didn’t anticipate that all our sites worldwide would be susceptible to infection and our biggest challenge during the initial stages of the pandemic was that our plans considered these issues happening separately, not simultaneously.

This is one of the problems with tabletop exercises, especially during a global pandemic, as there are so many variables. I would be amazed if any company had run a simulation with all the many variables that occurred.

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

For our future crisis management planning, we’ll incorporate those extra variables and do more simulations. We’re leveraging plans that go across sites, expanding our supply chain mapping activities, and gaining more understanding about what our suppliers are doing for crisis management. COVID-19 has also supercharged our reviews of our inventory levels.

A big corporate strategy is to expand our capacity within our sites and use dual manufacturing locations across regions. So we’ll build new plants on different continents to increase capacity and mitigate the risk of regional issues.

We’re also improving our focus on safety measures. For example, we had to reactively figure out things such as shift overlaps and disinfecting during the pandemic, but these have now become part of our standard operating procedures. For distribution and logistics, we’re investigating areas like alternative transportation lanes.

How has being part of the BioPhorum workstream helped you?

The main way has been to improve the open, two-way communications between customers and suppliers. It has helped our customers better understand our challenges and vice versa.

I get a lot from the interaction with our customers and see their concerns and how they manage us as a supplier – and I then take those learnings back upstream to our suppliers. This helps me be a better partner with our suppliers and helps me ask them questions to better understand what they have in place for risk management and crisis management.

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. 


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.


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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