The Road Ahead for Resilient Supply Chains

Industry leaders delve into the latest biopharma supply chain disruptions and provide insights into approaches that can help to reduce vulnerabilities and ensure greater resilience in the future.

From geopolitical tensions and shifting trade policies, to regulatory reforms and market-driven demands, the biopharma industry finds itself navigating a new era of evolving supply chain disruption. The very systems that once delivered global resilience have since become sources of vulnerability across the biopharma supply chain.

A stark wake up call for global pharmaceutical supply chains came in the form of the COVID-19 pandemic, which exposed vulnerabilities in essential medicines, ingredients, and device availability. Ever since the pandemic, the risks across supply chains have intensified due to geopolitical shifts, tariffs, changing trade agreements, and stricter regional regulations. Disrupted transport routes and an over-reliance on single-source dependencies — especially for APIs and critical materials — have further added to the global supply chain risks.

At the same time, the shift toward biologics and complex multi-modality therapies is raising the bar for manufacturing agility and specialist handling. Drug development timelines demand seamless tech transfers across continents and regulatory jurisdictions, with stringent expectations throughout the supply chain. The challenges have impacted biopharma significantly, resulting in the urgent need for highly coordinated, flexible, and regionally responsive supply chain solutions. Manufacturers and CDMOs must now go beyond cost and technical capability to deliver strategic resilience and adaptability in a rapidly evolving landscape.

In an effort to uncover more details about the challenges and opportunities facing both small-molecule and biologics’ supply chains and how business models are adapting to ensure greater supply chain resilience, industry leaders and innovators came together in two focused panel discussions, which formed part of the wider Endpoints Manufacturing Day 2025 event (1).

Small Molecule Panel: Building Strategic Resilience

The small molecule panel, which comprised four leaders; Steve Facer, SVP of Sales and Marketing at Adare Pharma Solutions; Teresa Pallotta, Vice President and Head of Small Molecule Sales at Curia; Owen Murray, CEO at Bend Bioscience; and Dan Peizer, VP Sales and Marketing at OFD Life Sciences, was hosted by Kurt Neilsen from Expert Insights Consulting. Kicking off the panel, all four panelists discussed the most underestimated risks to supply chain stability for the small molecule space.

While Pallotta noted there are many underestimated risks, the most pertinent threat in her opinion is the overreliance on single-site API sourcing, which is continuing to expose companies to vulnerability. Despite lessons learned, many supply chains remain overly concentrated — particularly in relation to single sourcing from intermediates to API — amplifying the chances of severe disruption if one site is compromised.

For Facer, tech tranfers of old products that often involve legacy dossiers is the biggest underestimated risk to supply chain stability. In such instances, there are often incomplete or outdated information in the legacy dossiers, which can result in delays and uncertainty during scale-up or site changes.

Following on, Murray remarked that, from an industry-wide lens, there is heavy dependency on placing everything into a protocol. “Certainly, we need protocols, but we need more conversations and a greater depth of understanding of what the science is behind affecting a successful tech transfer,” he said. It is a combination of understanding the qualitative and quantitative aspects of tech transfer and commercial manufacturing that ensures success, Murray added.

According to Peizer, there are two key challenges that his company frequently encounters in relation to supply chain stability risks. The first is avoidance of reliance on cold chain distribution, wherein companies are seeking out new solutions to improve the stability and preservation of their molecules so they don’t require costly cold chain storage/distribution, he explained. Simultaneously, Peizer continued, the other threat relates to how drug developers must contend with the increasing number of modalities, which is outpacing the tools that formulators have available to them for drug development.

Designing for Scale and Flexibility

When discussing potential bottlenecks that would be great to eliminate, Murray touches upon the issues surrounding handoffs between departments. “If you think about efficiency in general, and how organizations are constructed, they are typically done so department to department,” he remarked.

Dealing with this disparity between knowledge from department to department creates challenges for handoffs and can lead to supply chain problems, particularly for complex drug products, Murray noted. “Anytime there is the opportunity for a slip or dislocation between parties, that’s really where you trip yourself up,” he said.

Building on Murray’s point, Facer added that with larger clients you may also be dealing with tech transfers across different time zones in different sites. “Trying to pull that communication stream together in a timely fashion to make sure you get a methodical tech transfer is really key to ensure that you cut out bottlenecks and ensure you don’t have repeat double validations or double lots of method development,” she stated.

“Aside from cold chain, one of the things I’d eliminate is scalability,” asserted Peizer. Given the fact that for many of the new modalities being developed nowadays, APIs are extremely expensive and hard to acquire, meaning that it is more important than ever to have technologies that can scale processes easily, while also being sparing with the APIs, such as lyophilization, he specified.

Additionally, designing for scale must begin well before commercialization to prevent bottlenecks. Early planning ensures products are built with scalability in mind, supported by robust equipment and processes that allow a smooth transition from pilot to full production. This preparation helps companies maintain momentum, avoid duplicate validations, and reduce costly delays that often occur when scale-up is left too late.

“There is no point in having elegant chemistry if you don’t scale up properly and quickly,” exclaimed Pallotta, who noted that Curia is working hard to create solid and scalable processes.

Facer added, “plan for scale at Phase II and not wait till you're late in Phase III. That’s a surefire way to solidify your supply chain because you’re going to design your product so that you know that you’ve got a good equipment train, scalable goods, final formulation and drug and drug products.”

Driving Resilience Through Partnerships and Continuous Improvement

True resilience is built through deep customer understanding and sustained engagement. The panelists advocated for starting relationships early, even during discovery, and staying closely involved through development and supply. Tailoring services to client needs, offering flexible contracting models, and maintaining open lines of communication fosters trust and produces more agile responses to shifting requirements.

Murray summarized this point well: “I would encourage the industry to invest in meaningful partnerships, just recognizing that that is the quickest way to market and the quickest way to maintain market.”

Achieving resilience requires a continuous improvement mindset and seamless project management from tech transfer through commercial operations. The panel highlighted the importance of proactively managing legacy dossiers, updating regulatory documentation, and coordinating cross-functional teams to smooth tech transfer and eliminate knowledge silos.

The panel concluded that building strategic resilience in small molecule supply chains requires more than reactive fixes. Leaders agreed on four priorities, and their message was clear: resilience is a deliberate outcome of smart planning, flexible operations, and meaningful collaboration, positioning companies for long-term success in an unpredictable market.

Biologics Panel: Strengthening Through Localization and Technology

In a separate panel focusing on the supply chain for biologics experts detailed the shift toward modularity and regional manufacturing and highlighted the vital strategies necessary to meet increasingly complex demands (1). This panel comprised: Laurie Braxton, SVP at FUJIFILM Biotechnologies; Himanshu Gadgil, CEO at Enzene; and Sven Lee, Chief Commercial and Strategy Officer at Bionova Scientific; and was hosted by Elliott Berger, Board Director at Orientation Marketing.

The delicate nature of manufacturing biologic products requires complex supply chain needs, such as, liquid handling, cold chain logistics, and stringent quality controls. The panel discussed how the pandemic revealed the vulnerabilities of these requirements during the pandemic and exposed the heavy reliance on overseas manufacturing hubs.

“On reflection, I think that all of us learned a lot about supply chain resilience during COVID,” noted Braxton. “So, moving forward, to ensure uninterrupted supply, I think we have to make sure that we're diversifying and we're thinking about where we locate and making sure that it's not just for the short term, but it's also for long-term decision making.”

Concurring with Braxton, Gadgil remarked that the world has changed as a result of things like the pandemic and various conflicts that are occurring, which is also having an impact on manufacturing. “We are seeing a lot of localization happening in the U.S. and also across the rest of the world,” he said. “It’s more of a global trend, where people want to have access to local manufacturing so that countries can take care of their critical manufacturing needs if something like COVID happens again.”

As a result of this trend, many companies are investing heavily in modular, interconnected facility networks capable of supporting end-to-end biologics development and commercial manufacturing. Using FUJIFILM Biotechnologies as an example, Braxton highlighted the kojoX model, which is a modular approach with standardized equipment, processes, and procedures, as a way of providing manufacturing flexibility. The company has implemented the kojoX model across a large interconnected network of facilities in different geographical locations, enabling it to rapidly adapt to customer needs and supply disruptions, she specified.

Focusing on continuous manufacturing as a key technology for efficient and scalable biologics production, Gadgil shared how Enzene has scaled up continuous operations. “We now have continuous manufacturing operations at a commercial scale of 1000 liters bioreactor, which can give you 40 to 50 kilograms per batch,” he asserted. “The best part of it is the capital requirement for setting it up is significantly lower, almost 4, 5, or 6 times lower than what it would take to set up a conventional plant with the same output in terms of kilograms.”

Commercial Strategies: Proximity, Partnership, and Differentiation

From a commercial standpoint, localized biologics manufacturing resonates strongly with emerging biotech companies that seek proximity to manufacturing partners for faster, more flexible development. Within the U.S. alone, there are several hub areas where demand for support and services is increasing.

While Bionova is a smaller organization compared with others, Lee highlighted how it is focused on the U.S. market with plans to expand over the next few years. “What's unique about our organization is that we are currently U.S. focused, but we do have a huge Japanese conglomerate that really supports us,” he explained. “Right now, we are growing, and the scientists that we have both in Houston and in the Bay Area are a really good start to have some folks come to us very locally.”

To increase revenue, partnership and technology licensing will also become an essential strategic approach for biologics manufacturers while differentiating themselves in an increasingly competitive market. Through collaboration with likeminded organizations, biopharma companies can access innovative technologies that complement their existing capabilities without having to invest the time and resources required to develop everything in-house.

“One of the things that we're doing is partnering with organizations on their technologies as well because we clearly need to differentiate ourselves as we're growing and expanding,” Lee added. “If we can offer some other types of technologies that we could either develop or license, that's an approach that we're certainly going to look at.”

The Road Ahead

An overarching theme from both the small molecule and biologics panels was clear: no single organization can build resilient, agile supply chains alone. The increasingly complex biopharma environment demands collaborative ecosystems where CDMOs, sponsors, technology providers, and regulators pool expertise and resources to respond rapidly to disruptions and deliver tailored solutions.

Future-proof supply chains will rely on modularity, interconnected networks, and regionalized manufacturing models. Combined with cutting-edge technologies, these designs allow companies to scale capacity across geographies, improve accessibility, and accelerate patient access to potentially life-saving products. However, speed must not compromise quality. Advancing regulatory harmonization and maintaining rigorous standards are critical to ensure fast deployment does not threaten product integrity or patient safety.

Sustaining resilience will also require continued investment in skilled workforces capable of operating advanced and automated systems. At the same time, companies must balance redundancy with financial discipline — building flexible, risk-aware supply chain strategies that create genuine resilience rather than costly inefficiencies. With ongoing geopolitical uncertainty and global disruptions, this balance will remain a defining capability for the industry.

Reference

1. Endpoints. Battling Wildfires in Pharma Supply Chains: CDMO Leaders Weigh In. Panel discussions from Endpoints Manufacturing Day 2025, Aug. 6, 2025.