What does a “true strategic partnership” between sponsors and CDMOs look like in today’s environment?

Nathaniel Youndt, Vice President of Business Strategy and Program Management, Arranta Bio (now Recipharm Advanced Bio)

Pre-2023, biopharma strategic partnership models often meant monetarily large, multi-year deals between CDMOs and innovators. Today, strategic partnership can, on paper, still follow these criteria, but can also mean something much more nuanced. What we see now is that strategic partnership means establishing a core foundation of trust between sponsors and CDMOs, such that the relationship is not one of vendor–purchaser but two partners with a different set of shared risks and upsides working towards a common objective. Sometimes these include sharing more responsibilities than is typical in these relationships, and sometimes it simply means that both parties see a viable pathway to a long-term reward greater than the contract they may sign today. Every CDMO–customer relationship is important, but both CDMOs and innovators should approach their relationships with an awareness of end-goals and how CMC and commercialization plans support or do not support a more strategic partnership.

Kent Payne, Managing Director, Wilmington PharmaTech

As the disruptions and special requirements of the pandemic receded, our market has undergone significant change. The hype of new modalities settled into the realities of their safe delivery, and a wave of CDMO capacity investment is now online. Additionally, geopolitics, global supply chain issues, and regulatory changes are driving more change.

These developments have encouraged the adoption of closer, strategic partnerships between biopharma and contract research, development, and manufacturing organizations (CRDMOs); illuminating the increasing importance of outsourcing.

Now, there’s focus and action to deliver regional manufacturing; mitigating geopolitical, supply chain, and regulatory challenges. In turn, this is driving massive biopharma and CDMO investment in the United States, including multibillion-dollar commitments from large sponsors. While most of those needs will be fulfilled through standard “build and partner” models, more complex and increasingly sophisticated pipeline candidates require bespoke solutions.

This will mean those close partnerships will need to be forged earlier, at the design stage, because such complex programs require custom suites and processes, dedicated facilities, or a “factory-in-factory” approach. Curewell Capital partnered with Wilmington PharmaTech (WPT) to leverage WPT’s fully permitted, 54-acre, former DuPont–Merck campus in Delaware, where the CRDMO has the space, permissions, expertise, and financial backing to realize global biopharma’s need for U.S.-based capacity build outs. This type of partnership will become more common, to jump-start additional capacity needed to onshore production for U.S. patients.

Magdalena Pakuła, Global Head of Sales, Astrea Bioseparations

Today, a true strategic partnership between sponsors and CDMOs is much less about simply securing capacity and much more about working together early, sharing risk, and committing for the long term.

Before 2023, many relationships were transactional, driven by immediate capacity needs, pricing pressure, and short-term decisions. Now, sponsors are engaging CDMOs earlier in development to ensure processes are manufacturable, scalable, and supply chains are robust from the outset. We’re also seeing a clear shift toward fewer CDMO partners, but deeper relationships, often under multi-year, program-level agreements.

In the current environment, reliability, transparency, and supply chain resilience are just as important as technical capability. Strategic partners are expected to anticipate risk, align closely on forecasts and data, and scale alongside the program, not simply execute against a scope of work.

Ultimately, these partnerships are about reducing uncertainty across the life cycle, not just delivering capacity when it’s needed.

François Pedelaborde, Business Development Director, Clean Cells

In today’s environment, a “true strategic partnership” goes well beyond booking capacity or executing a scope of work. It is an operating model designed to mitigate unpredictability while protecting timelines, quality, and speed of decision.

Before 2023, many customer/CDMO relationships were optimized around predictable development plans: clearly staged tech transfers, sequential testing, and change control that could tolerate longer cycles. Since 2023, programs have been more agile. Risk tolerance is now lower, and schedules can move faster and more often. The differentiator is not only technical capability, but the ability to execute with minimal friction when priorities shift.

A strategic partnership includes three components in practice: first, shared planning in full transparency, highlighting critical steps, clear ownership (manufacturing, analytics, QA release), and agreed decision rules before the first batch. Second, an integrated documentation and data flow that reduces review loops and avoids reformatting between organizations. Third, true parallelism: aligning sampling strategies and analytics early so manufacturing, testing, and release move together, and not in a slow, linear sequence.

The best partnerships feel like one team across two organizations: transparent, proactive, and flexible to support the pressure and move in a solution-oriented mode, in order to provide continuity from early development through GMP release, without compromising on compliance or control.

Russell Miller, Vice President, Global Sales and Marketing, Enzene

A true strategic partnership is a relationship in which both parties benefit from a well-defined set of engagement parameters, including a commitment from both sides to the partnership’s long-term success. Such an arrangement should foster a greater commitment to long-term innovation, assure a steady flow of projects for the CDMO, and give the client priority access to premium services and technologies. In many cases, what is referred to as a strategic partnership is, in reality, a commitment to “preferred status” and is conditional upon that CDMO partner continuing to meet imperatives on cost, quality, on-time delivery, etc. Often, even when the CDMO meets these goals, it is considered as just one of several ‘tier-one’ providers and will be awarded more relevant outsourced projects. Because there is no guarantee of work or flow of projects, these arrangements are inherently not strategic in their nature. Instead, they define how client–service provider engagements are structured to support only the client’s strategic goals. To reap benefits from a “true” partnership, there must be a greater commitment to sharing risks and rewards than is typical, but the most significant benefits include genuine and substantial innovation, to the benefits of both sides.

Brian Eastwood, Head of Business Development & Strategic Relationships, Almac Pharma Services

A true strategic partnership between sponsors and CDMOs today goes far beyond traditional outsourcing. Pre 2023 models were largely transactional, centered on filling capacity gaps or executing predefined tasks. In contrast, today’s environment demands early scientific engagement, joint decision making, and an integrated approach to development and commercialization. CDMOs are now expected to serve as extensions of a sponsor’s technical teams, helping shape strategy and accelerating timelines through experience and deep expertise.

Transparency has also evolved dramatically. Where communication was once milestone based and reactive, modern partnerships rely on data sharing, regular touch points, and visibility across quality, scheduling, and supply chain operations. This level of transparency enables faster decisions and better portfolio management, making it a core differentiator for CDMOs in an increasingly complex global environment.

Furthermore, strategic partnerships now span the full product life cycle, not isolated stages. Sponsors expect CDMOs to support programs from early development through scale up and into commercial manufacturing, packaging and ongoing life cycle supply. This long term, innovation driven collaboration model stands in stark contrast to pre 2023 relationships, shifting the focus from delivering batches to co creating value throughout a product’s journey.

Finally, beyond operational integration, sponsors are increasingly seeking CDMOs capable of sustaining long term, multi year partnerships that evolve with program needs. A 3- to 5-year horizon enables both sides to invest in shared infrastructure, technology innovation, and continuous improvement initiatives that would be impractical in short term engagements. It also supports greater stability in forecasting, resource planning, and tech transfer orchestration — all of which reduce risk and strengthen supply resilience.

By committing to a long range collaboration model, CDMOs demonstrate not only capacity but true strategic intent, giving sponsors confidence that their partner will scale, adapt and grow with their pipeline over time.

Ricky Hopson, Group President, Clinical and Specialty Services, and Chief of Staff, Catalent

A true strategic partnership today looks markedly different from the transactional CDMO relationships that existed before 2023. In an environment defined by tighter funding, program prioritization, and heightened expectations around operational performance, sponsors now expect their CDMO partner to operate as an extension of their team.

 

Partnership with Catalent’s Clinical Supply business today is grounded in transparency, shared accountability, proactive collaboration, and contracting simplicity. Sponsors want greater flexibility in contracting structures and cleaner, more predictable pricing models that reduce friction, make budgeting easier, and allow them to adjust as programs evolve. Operational integration is deeper and more digitally enabled. Tools like our OneHub Portal give sponsors real time visibility into milestones, risks, and supply activity, creating transparency that simply didn’t exist in earlier models and allowing teams to jointly manage programs with more speed and confidence.

Beyond execution, sponsors expect innovation: better scenario planning, supply chain agility, digital visibility, and engineering support that reduces complexity and accelerates timelines, all capabilities within our toolbox.

Historically, relationships were largely capacity or purchase order driven with limited integration and planning. Today, value comes from simplified commercial models, transparent digital tools, and a CDMO that behaves like a strategic arm of the sponsor’s development and supply strategy, focused on achieving improved patient outcomes together.

Charles Evans, Ph.D., Senior Vice President of Pharmaceutical Development, MedPharm

A true strategic partnership in today’s biopharma world is built on knowledge, flexibility, collaboration, and end-to-end service, resulting in an environment where development philosophies are aligned and high-risk tech-transfers are mitigated. It combines the sponsor’s product vision with the CDMO’s scalable infrastructure, niche expertise, and operational efficiency, creating a relationship far more integrated than many pre-2023 models.

Since 2023, securing investment for early-stage assets has become more challenging. As a result, sponsors are prioritizing CDMOs who can genuinely add value. Those who do not may find out the hard way that doing it right the first time, although potentially more costly upfront, is often the more cost-effective option in the long run.

Credible CDMOs bring specialist skill sets and increased efficiency. Their ability to manage fluctuating workloads, evolving timelines, and shifting development priorities enables more efficient experimentation, smoother progression through the different development phases, and faster troubleshooting. However, not all CDMOs are true development organizations, and this should be scrutinized. Many can manufacture a final product, but fewer have the scientific knowledge to understand and develop a product that is optimized for both the drug and the patient, particularly in more complex areas of development.

Mat Minardi, Chief Scientific Officer, Sterling Pharma Solutions

Whereas price was previously a key metric within the sponsor’s decision-making process, greater importance is now being placed on developing long-term, strategic partnerships. Growing demand in the West, capacity constraints, and the need for niche experience, alongside supply chain uncertainty in the ever-changing geopolitical landscape, mean that CDMOs are in demand and have the opportunity to select partnerships with innovators that can create the most value for them.

Trust and transparency are key to developing strategic partnerships, and this goes both ways. There needs to be a commitment to openness and a willingness from both parties to develop a shared vision for the future. Ultimately, CDMOs and sponsors must recognize their mutual reliance upon one another to create life-changing impact for patients and the value that comes from sharing in success and establishing a relationship that benefits not just one, but both organizations.

In 2020, having long championed the benefits of developing true strategic partnerships, Sterling trademarked the term PDMO^®. This was to better reflect the way Sterling does business and recognize that, instead of a traditional contract development and manufacturing organization, customers need a partnership development and manufacturing organization.

Laura Mary, Director of Business Development, Adragos Pharma

In the current pharmaceutical landscape, a true strategic partnership between sponsors and CDMOs has transcended the traditional transactional boundaries that defined the pre-2023 era. While previous models often relied on a simple “win–win” philosophy focused on tactical execution and capacity sourcing, today’s environment demands a total integration of value chains. This evolution represents a shift toward a holistic collaboration where risk-sharing and profit-sharing are not just ideals but formal pillars of the business relationship. To achieve this, it is essential to move beyond the client-vendor dichotomy and operate as a single, unified team driven by a clearly established, common strategy.

This modern approach ensures that both parties are vertically aligned, sharing mutual targets and a deep commitment to the product’s long-term success. In this context, the CDMO becomes an extension of the sponsor’s own infrastructure, fostering a level of transparency and technical synergy that was rarely seen in the more fragmented models of the past. Ultimately, a strategic partnership today is about radical alignment. It is no longer enough to merely collaborate on projects; we must integrate our expertise and resources to navigate market complexities as a single entity, ensuring that every milestone achieved is a collective victory.

Megan Kuikstra, Program Manager, Grace

A true strategic partnership between sponsors and CDMOs is defined by seamless integration, transparency, and cross functional collaboration. At Grace, we act as a strategic extension of our sponsors’ teams — bringing world class scientific expertise, curiosity, and a solution oriented mindset to every stage of the project. Dedicated program teams, spanning analytical services, R&D, engineering, operations, and quality, work together to deliver proactive problem solving and consistent execution.

The program manager is foundational to this model, serving as the primary connection between Grace Fine Chemicals and the sponsor organization. With the increasing complexity of drug development and rising expectations for responsiveness, adaptability, and regulatory fluency, program managers help ensure projects move forward efficiently and with confidence by aligning technical strategy, facilitating clear communication, and driving issue resolution.

Our organizational model enables sponsors to have direct access to technical, R&D, business, and site leaders — strengthening trust and enabling more informed decision making. This close collaboration reflects our broader commitment to being a true strategic partner: this isn’t just a transactional relationship. By maintaining consistent teams and fostering long term relationships, we help biotech companies navigate complexity, support seamless tech transfer and scale up, and create lasting value.

Stefan Egli, Senior Vice President, Head of Strategic Accounts, Lonza

In today’s rapidly evolving biotech and pharmaceutical landscape, marked by an unpredictable geopolitical and economic climate, partnerships between drug developers and CDMOs have shifted from a transactional approach to a more long-term, collaborative partnership built on mutual investment and shared goals.

In the last few years, these partnerships are underscored by the need for a well-diversified global footprint, including significant capacity in the United States and a resilient supply chain strategy grounded in long-term planning and robust risk management. Operational flexibility has become increasingly important, enabling CDMOs to help drug developers shift their strategies due to evolving market demands.

Key elements of these partnerships include investment in capacity and end-to-end solutions from early development through commercial manufacturing and across modalities, helping drug developers mitigate disruptions and accelerate speed to market. For example, Lonza is investing in large-scale biomanufacturing, bioconjugation, and drug product manufacturing across its global network through customer collaborations.

CDMOs are also helping drug developers adhere to evolving regulatory requirements, which adds another layer of complexity to the drug development process, especially for early-stage companies. Additionally, adopting new technologies, such as real-time analytics, artificial intelligence, machine learning, and robotics, has further strengthened these collaborations by streamlining planning, increasing efficiency, and reducing both timelines and costs for developers.

Albert Rustullet, Ph.D., R&D Director, Barcelona – ESTEVE CDMO

Running our business in the COVID era required bringing the relationship with our sponsors to the next level. In a world where development speed was prioritized and communication was remote, trust and reliability with a CDMO partner proved to be of the greatest value for our sponsors.

For a CDMO with an excellent record as ours, we were able to discuss “speed-light approaches” to bring material to market, adapting the strategy and activities to the level of business risk the customer required, while always maintaining full quality assurance control. This level of alignment and flexibility is a key difference from many pre-2023 models, which were often more conservative and less adaptable.

This true strategic partnership made it possible, for example, to start a process performance qualification (PPQ) campaign only two months after project kick-off and to complete validation just six months later. Moreover, the project continued to grow to multiton-per-year volumes.

Once this trust-based relationship is established, the match between company cultures opens new synergies in subsequent projects. The collaboration can be periodically reviewed at a portfolio level, and new, sometimes unforeseen optimizations can be identified across areas, such as regulatory, quality and production. These improvements then apply to upcoming projects and prove beneficial for the growth of both companies.

Jongkyu Yoon, Vice President and Head of Project Management, Samsung Biologics

The industry is expanding beyond monoclonal antibodies (mAbs) toward antibody–drug conjugates (ADCs), bispecifics, and gene therapy vectors. This shift demands speed, flexibility, and operational agility from the entire value chain.

Before 2023, many CDMOs concentrated on large-scale capacity for mAbs, while a few operated at small scales for newer modalities. Relationships were largely transactional: sponsors placed orders, and CDMOs fulfilled them. Today, a strategic partnership integrates development, regulatory approval, capacity planning, and portfolio management. A joint roadmap addresses not only short-term demand but also long-term commercial supply that adapts to market fluctuations and demand uncertainties.

An effective partnership begins with due diligence that evaluates the CDMO’s technical expertise, quality systems, and track record. Cross-functional project managers, scientists, regulatory specialists, and supply chain experts foster transparency. A clear expansion strategy synchronizes with the sponsor’s commercial forecasts.

The CDMO’s role today is to anticipate the evolving pipeline for both clinical and commercial products, and to be an extension of the sponsor’s own capabilities.

Mark DaFonseca, Chief Commercial Officer, Lifecore Injectables CDMO

The strategic partnership model has evolved over the past three years and continues to progress in a positive direction. Historically, partnerships between CDMOs and sponsors were more tactical in nature — centered on standard agreed upon terms for supply and quality agreements, as well as predefined pricing structures and governance models. These relationships typically involved periodic project meetings supplemented by less frequent, executive level discussions that focused on overall relationship health and long term planning.

Where we have seen meaningful change — especially in areas facing global capacity constraints — is in the shift toward true strategic partnership. These newer models emphasize longer-term commitments and can include coinvestments in capital expenditures to support future growth needs. They also rely on more balanced terms that fairly distribute both risk and reward between the parties. This alignment enables greater cost transparency and fosters a shared approach to managing cost increases and decreases.

Partnerships can only succeed when both parties feel they are deriving value from the relationship. Achieving this requires openness and trust from both sides. That level of trust does not develop overnight. It grows from positive, early experiences working together and gradually elevates the relationship to a more strategic, collaborative level.

Tom Sellig, Chief Executive Officer, Adare Pharma Solutions

A true strategic partnership today means working with a CDMO that functions as an extension of your team, one that understands your program goals, communicates across functions, and supports cross-disciplinary collaboration.

Pre-2023 models often treated CDMOs as service providers executing a defined scope. Today’s environment, though, has been shaped by supply chain volatility, tariff pressures, and increasingly complex therapies. Sponsors need partners with global infrastructure, flexible operations, and a proactive, customer-focused mindset.

Central to this shift is the importance of integrated end-to-end capabilities. Working with a single CDMO from early formulation through commercial manufacturing and packaging ensures consistency, reduces handoff risks, and accelerates time to market.

Ultimately, the shift is from handoff-based relationships to deeply embedded collaboration where both parties are genuinely invested in the outcome. When your CDMO cares about your success as much as you do, that’s a true strategic partnership.

Maria Ebro Andreasen, Executive Vice President & Chief Strategy Officer, FUJIFILM Biotechnologies

In today’s CDMO landscape, strategic partnerships must extend well beyond transactional models that focus solely on contracted capacity. To provide real value, partnerships between innovators and manufacturers must be rooted in trust and transparency across all touchpoints. Here at FUJIFILM Biotechnologies, these partnerships are built on a people-first culture that fosters shared accountability at every level of the organization.

With increasingly complex biologics and accelerated timelines designed to meet high demand, it’s crucial that relationships between innovators and CDMOs are built on a foundation of trust and are operationally integrated. For example, at our new commercial-scale manufacturing site in Holly Springs, North Carolina, our customers are deeply connected to us — sitting alongside us at our facility, for faster and coordinated collaboration.

Cultural alignment is equally critical. High-performing CDMO relationships are built on mutual respect and shared core values, allowing partners to proactively identify risks and solve problems together. Innovators increasingly seek manufacturing partners that are willing to invest in advanced technologies and dedicate capacity to cultivate long-term, shared success together. That is what embodies Fujifilm’s “Partners for Life” commitment — putting people first to building enduring relationships that benefit customers and patients.

Ultimately, today’s strategic partnerships are defined by co-innovation, flexibility, and a shared commitment to patient impact. CDMOs that empower teams and prioritize operational excellence, while also allowing for inevitable shifts in pipeline demands, will be best positioned to help innovator companies navigate uncertainty and bring life-changing therapies to market faster and more reliably.

Kevin Li, MBA, Chief Marketing Officer, BioDuro

A true strategic partnership today is fundamentally more integrated and science-driven than in the past. With the rise of new modalities, such as peptides, antibody–drug conjugates (ADCs) and versatile x-any targeting moieties (XDCs), etc., and increasingly complex science, sponsors engage CDMOs much earlier — often at the discovery or translational stage — to access deep, specialized expertise and to shape development strategy together, rather than expecting that the CDMO simply executes predefined tasks.

Compared with pre-2023 models, today’s partnerships also reflect greater financial pressure. Sponsors expect CDMOs to help accelerate timelines while controlling costs, leading to more flexible commercial models, such as risk sharing, milestone-based payments, and adaptive scopes of work.

In addition, geopolitical uncertainty has elevated the importance of transparency and resilience. Strategic partners now proactively address supply chain risks, including raw material sourcing, dual supply strategies, and robust business continuity planning — identifying and mitigating risks early rather than reacting later.

Matt Hewitt, Ph.D., Vice President, CTO Manufacturing Business Division, Charles River Laboratories

When I think of a true strategic partnership, I think of a marriage to some degree. It’s something where communication is vital, and a lack thereof is where 100% of problems originate. The approach for both sides should be solution-oriented and to get to “yes” rather than looking to assign blame when challenges arise; this builds trust.

This is important because as programs move through clinical development and closer to commercial, any misalignment becomes magnified. This is why, as part of any program that comes into our CDMO sites, the first thing our teams look to do (other than build a good profession and hopefully a personal relationship) is to ensure a smooth technology transfer by rooting out any tribal knowledge and/or nuance to the manufacturing process and/or analytics.

These client/CDMO relationships have evolved over the past 2–3 years in that more programs are moving into the late-phase clinical and commercial stages. We see these relationships as long-term partnerships that evolve and because of that, CDMO capacity is not the only important element; capability and expertise come to the forefront. Our GMP facilities are world-class, but our teams’ expertise is what makes success possible.