If there’s one constant in drug development today, it’s that the pressure of speed to clinic is only ever increasing. The sheer growth of small biotechs and mid-sized pharma companies entering the field has reshaped expectations of contract development and manufacturing organizations (CDMOs). Over the past decade, 32% of innovative drug approvals were sponsored by emerging biotech companies, suggesting that they are more willing and more able to take on the risks of innovation than big pharma. To do this, biotech teams need to be lean but ambitious, their molecules promising yet complex, and their timelines ambitious. 

Flexibility and agility are everything. Biotechs need CDMOs to be nimble on their feet, to think creatively, and to truly act as an extension of their team.

The key elements are to build the culture, capability, and processes for fast, collaborative problem-solving, especially in the middle of early development where unknowns inevitably emerge. The reality is that projects fail, or succeed, in how quickly challenges are solved together.

Biotech Strategies Have Evolved and CDMOs Must Evolve with Them

Over the past ten years, there has been a real shift in the way products are developed by biotechs. Years ago, it was quick to clinic, demonstrate that the desired clinical exposure is visible, and the product would then be sold off as an asset. However, that isn’t the case anymore. Biotechs now have a vision of going right from early-stage development all the way through to late stage. Therefore, when biotechs are going through CDMO selection, they want to know that they’re going to work with a team that can deliver it all the way through.

Biotechs now want partners who can deliver from the very early days through to late development. We share that vision, and we plan for it from the start. Quick to clinic matters, but quick to clinic with a path to scale matters more. CDMOs need to help map that path, so momentum doesn’t stall after the first study.

That changes how programs are designed. It isn’t enough to solely target Phase I; CDMOs need to build for scalability. Early on, there needs to be a plan for manufacturability, process trains that can expand, and decisions that won’t become bottlenecks later.

For Upperton, that’s the most inspiring part of the work: seeing teams bring their science to patients and knowing we helped along that journey.

What Partnership Looks Like in Practice

In a typical scenario, a biotech team arrives with a promising molecule and an aggressive timeline to first-in-human. The science is strong, the formulation window is tight, and the timeline is challenging.

CDMOs then convene a cross functional team, R&D formulators, analytical scientists, GMP manufacturing leads, and regulatory specialists. At Upperton, a senior leader joins the core project team from day one, not for optics but for speed and unparalleled decision-making experience. Their involvement brings strategic oversight and the authority to resolve challenges quickly, avoiding delays that often occur in siloed environments. By embedding leadership early, CDMOs can create a culture of accountability and agility, enabling seamless transitions from development to scale-up and ultimately to commercial manufacturing.

At this stage, simply questioning “what are the biggest risks to achieving a robust clinical prototype?” can support CDMOs along the development pathway. This involves pressure testing excipient selections based on product performance, product viability, and robustness. This is followed by aligning analytical methods with release needs and using the technical batch to flush out any remaining hidden risks and to give an early indication of product stability. 

By the time we hit the technical batch, it feels like muscle memory. Everyone knows the plan, the handoffs, and the failure modes we’ve already mitigated.

The clinical run then becomes execution, not experimentation. And because we made Phase I decisions with Phase II/III in mind, the scale up conversation starts clean, with fewer engineering cycles and less risk of revalidation.

Where Projects Win or Lose: R&D to GMP Transition

One critical moment where drug development consistently gets riskier, is the transfer from R&D into GMP manufacturing. This transition represents a fundamental shift from exploratory, small-scale processes to highly controlled, validated operations governed by stringent regulatory requirements. Any gaps in technology transfer at this stage such as incomplete process characterization, inadequate scalability assessments, or insufficient documentation, can lead to batch failures, compliance issues, and costly delays. 

As a formulator, I’ve seen firsthand how easy it is for knowledge to evaporate when departments operate in silos. When R&D and GMP don’t move as one, knowledge gets lost, timelines slip, and risk creeps into the clinical product.

Aspects that can help with this include working with a CDMO that operates all on one-site and ensuring there is a consistent project manager across the entire project. Multiple handovers increase risk and can potentially lead to delays.

CDMO Selection as a Critical Business Choice

Early phase development is full of challenges, and biotechs need to be able to trust that their CDMO team is going to be able to respond quickly, come up with ideas enthusiastically and be able to navigate the shift to the clinic and beyond. Whilst choosing a partner that has specialized capability and experts is undeniably important, looking beyond that to the wider capabilities of the business are equally as important. Factors such as consistent project management, flexibility in scaling, and a proven track record of adapting to evolving requirements can make a significant difference in project success. A CDMO that combines scientific excellence with operational agility ensures smoother progress, reduces risk, and ultimately accelerates timelines. This structure supports the balance between sponsor and CDMO, wherein biotechs focus on innovation whilst their CDMO manages complexity.

Ultimately, the CDMO is the team that is going to take a project all the way to market. They will provide support throughout all the highs and lows of early and late phase development and manufacturing. The precise expertise needed will need to pivot and change as the project develops. Therefore, building a positive relationship with the whole CDMO organization is essential. This approach ensures that when new challenges arise, the right specialists can be engaged quickly and effectively. A strong, collaborative partnership is characterized by open communication, trust, and flexibility. By investing in these relationships early, sponsors gain access to a broader pool of knowledge and resources, reducing delays and mitigating risks. Ultimately, a well-connected team within the CDMO can accelerate problem-solving and drive project success.

The advice that I would give to any biotech is to pick a team where you feel like you’re a high priority in the organization, where you get to know the leadership team, and have a very technical project team that is also enthusiastic and passionate about your product.

Final Thoughts

The CDMO market is crowded and capable, but capability alone doesn’t guarantee outcomes. What matters, especially for smaller biotech and midsized pharma, is a partner who can move quickly, think critically and creatively, and collaborate deeply. Speed and agility are essential when timelines are tight and funding windows narrow, but they must be paired with strategic insight and problem-solving. A CDMO that understands the nuances of your molecule, anticipates challenges, and adapts proactively can make the difference between meeting milestones and missing opportunities. Successful partnership is about shared accountability, transparent communication, and a commitment to innovation. In an environment where every decision has an impact on cost, quality, and time to market, choosing a CDMO that acts as an extension of your team is vital.

Nikki Whitfield is CEO of Upperton Pharma Solutions, a Nottingham-based CDMO specializing in formulation development and clinical trial manufacturing across a broad range of dosage forms, including oral solids, liquids, semi-solids, and inhalation products. She brings more than 35 years of technical and operational leadership experience developing drug products for small- and mid-sized biotech and pharmaceutical companies, with senior and executive roles spanning emerging biotech, large pharma, and CDMOs.