PMPS spoke with Tim Roberts, our Chief Commercial Officer, about the changing role of the contract development and manufacturing organisation and why an integrated approach can provide sponsors with greater flexibility, continuity and control across the product life cycle
The biopharmaceutical industry is navigating an increasingly complex environment. Sponsors are managing more specialised molecules, greater manufacturing complexity, pressure to accelerate development timelines, evolving regulatory expectations and a growing need to deliver patient-centric products at commercial scale. At the same time, supply-chain resilience, quality assurance, cost efficiency and speed to market have become strategic priorities.
Against this backdrop, the traditional model of engaging multiple specialist providers across development, manufacturing, packaging, device assembly and clinical supply can introduce additional complexity and risk.
PMPS: The biopharma industry is facing significant challenges today. What is driving the need for a different approach to outsourcing?
Tim Roberts (TR): The industry has always been complex, but the level of complexity sponsors are managing today is unprecedented. We are seeing increasingly sophisticated molecules, more challenging manufacturing requirements, shorter development timelines and greater expectations around the patient experience. At the same time, companies need to think much earlier about how a product will ultimately be manufactured, packaged, distributed and delivered to patients.
For sponsors, particularly emerging and virtual biopharma companies, this creates a significant strategic challenge. They need access to specialised expertise and infrastructure, but they also need to manage risk, timelines and capital very carefully. Importantly, the expectations can differ depending on the size and maturity of the sponsor.
Large pharma companies may be looking for committed capacity and the confidence that a contract development and manufacturing organisation (CDMO) can support
demand as a programme progresses and scales. Small and mid-sized biopharma companies, meanwhile, may need to demonstrate that they have a credible, audited supply chain and qualified vendors in place as they seek funding, licensing or strategic partnerships.
That means outsourcing decisions are increasingly becoming part of the broader business strategy, rather than simply a procurement exercise. Having the right manufacturing and supply-chain partners in place can provide not only operational confidence, but also evidence of programme readiness and scalability to potential investors or licensing partners.
This is where the role of the CDMO is changing. It is no longer simply about providing capacity. Sponsors are increasingly looking for an experienced strategic partner that can guide them in navigating the entire product journey from development through clinical supply and ultimately commercialisation, while helping them build a robust and credible supply chain.
An integrated CDMO can bring different disciplines together earlier, helping sponsors make better decisions at the right time rather than addressing challenges sequentially as the programme progresses. Ultimately, it is about creating a more predictable path from molecule to market, while giving sponsors the flexibility, capacity and supply-chain confidence they need at each stage of the journey.
PMPS: What does an ‘integrated CDMO’ actually mean in practice?
TR: Integration means much more than having a long list of capabilities. The real value comes from connecting those capabilities. For example, pharmaceutical development decisions can influence sterile fill-finish processes, which in turn can influence the choice of primary container. That container may ultimately need to be incorporated into a drug-device combination product, and that combination product then has implications for assembly, testing, packaging, labelling, clinical supply and commercial distribution.
If those decisions are made independently by different organisations, there is a risk that each part of the programme is optimised in isolation rather than for the product as a whole.
An integrated model allows those conversations to happen earlier. Development scientists can engage with manufacturing specialists; packaging design experts can work alongside device teams; and clinical supply and commercial considerations can be brought into the discussion before the programme reaches a critical transition point. The objective is not simply to offer more services. It is to create a seamless continuity between them.
PMPS: How can that integration reduce risk for sponsors?
TR: One of the biggest benefits is reducing the number of handoffs. Every technology transfer, supplier transition or change in manufacturing location creates an opportunity for valuable information to be lost, assumptions to be challenged or timelines to extend. That does not mean multiple suppliers cannot be successful, but coordinating a complex network of partners requires significant sponsor resources.
With an integrated CDMO, there is an opportunity to establish common technical understanding and programme ownership across multiple stages. Take the transition from a vial to a pre-filled syringe, for example. That is not simply a change in primary container. It involves formulation and compatibility considerations, container closure integrity, device functionality, process development, filling technology, inspection, assembly, packaging and ultimately the patient experience.
Bringing those disciplines together early allows the sponsor to understand the implications of the decision before
making the transition. That expert insight, continuous communication and holistic programme management can help avoid rework later in development. Ultimately, integration is about managing complexity before it becomes a problem.
PMPS: Does this become even more important as products move towards commercialisation?
TR: Absolutely. The transition from clinical development to commercial supply is one of the most important points in the product life cycle. A process that works at clinical scale does not automatically translate into an efficient, robust commercial operation.
Sponsors need to consider capacity, process capability, automation, supply-chain requirements, packaging, regulatory expectations and the ability to support future demand. This is where having a partner involved across multiple stages can be particularly valuable. The decisions made during development can be informed by an understanding of the eventual commercial requirements.
We increasingly see sponsors wanting to avoid the situation where a programme reaches late-stage development and then discovers that the commercial process, packaging configuration or device strategy requires significant redesign. The earlier you bring commercial thinking into development, the more options you have. That is a fundamental principle of good development strategy.
PMPS: Supply-chain resilience has also become a board-level issue. What role can an integrated CDMO play?
TR: The last few years have demonstrated that supply chains cannot be treated as an afterthought. Sponsors need to understand where their critical materials, manufacturing processes, packaging operations and distribution capabilities are located, and what happens if there is disruption at any point.
An integrated CDMO can provide greater visibility across that chain. It can also help sponsors think about resilience much earlier – whether that means capacity planning, geographic and regional network considerations, inventory strategies, packaging operations, cold-chain requirements or the ability to scale production as demand changes.
However, resilience is only as strong as the quality systems that underpin it. A robust quality foundation is essential to ensuring consistency, compliance and reliability across every stage of the product life cycle. When development, manufacturing, packaging and supply-chain operations are connected through a unified quality culture and harmonised quality systems, sponsors benefit from greater transparency, stronger oversight and reduced risk during technology transfer, scale-up and commercialisation.
In today’s regulatory environment, quality is not simply a compliance requirement; it is a critical enabler of supply continuity and business resilience.
The other important point is flexibility. Biopharma programmes do not always develop in a linear way. Clinical results can change demand forecasts, regulatory decisions can alter timelines and commercial uptake can be difficult to predict. Sponsors therefore need partners that can adapt with them rather than simply deliver against a fixed manufacturing plan.
Ultimately, the value of an integrated CDMO lies in its ability to combine a strong quality foundation with end-to-end operational visibility and expertise. From drug product development and manufacturing through to packaging and globally distributed supply networks, sponsors can build more agile, resilient and patient-focused supply chains that are better equipped to navigate uncertainty and support long-term commercial success.
PMPS: Does integration necessarily mean that sponsors should outsource everything to one provider?
TR: No, integration should not be confused with exclusivity. Sponsors will always have different programme requirements and may choose to work with multiple specialist vendors. The important question is how those partners are connected and where the critical interfaces exist.
What an integrated CDMO can provide is an alternative to managing every interface independently. Where a sponsor chooses to consolidate activities, there can be significant advantages in terms of communication, programme management, scientific continuity and accountability. But the right model ultimately depends on the product, the sponsor and the development strategy. Our role is to understand what the sponsor is trying to achieve and determine where we can create the greatest value.
PMPS: What should sponsors be looking for when evaluating an integrated CDMO?
TR: I would encourage sponsors to look beyond lists of capabilities. First, look at whether the organisation has genuine experience connecting development, manufacturing clinical supply and commercialisation. Secondly, understand how teams collaborate internally. Integration must exist operationally, not just on a website.
Sponsors should also look at scalability. Can the partner support the programme as it moves from early clinical development into late-stage manufacturing and commercial supply? Can it accommodate changes in format, volume or delivery technology?
And finally, consider the company culture and quality of the relationship. Complex programmes require transparency, open dialogue and proactive communication. Sponsors need a partner that will tell them when something is not working and help them find a solution, rather than simply executing
a statement of work. The best outsourcing relationships are collaborative. They are based on shared objectives rather than a transactional supplier-customer model.
PMPS: Looking ahead, how do you see the role of the CDMO evolving?
TR: I think the industry is moving towards a model where CDMOs become increasingly strategic participants in the development and commercialisation of medicines.
Sponsors are under pressure to move faster, but speed cannot come at the expense of quality, reliability or long-term scalability. The answer is not simply to add more suppliers or more activities. It is to create better connections between the different disciplines involved in bringing a life-changing therapy to patients.
At PCI, we see our role as helping sponsors navigate that complexity. That means bringing together pharmaceutical development, drug product manufacturing, sterile fill-finish, lyophilisation, drug-device combination products, clinical and commercial packaging in a way that supports the product life cycle from first in human to commercial market supply.
The real benefit of integration is ultimately very simple: fewer disconnects; better-informed decisions, and a clearer path from development to commercialisation. In today’s environment, that can make a meaningful difference – not only to the efficiency of a development programme, but to how quickly and reliably a medicine can reach the patients who need it.