PHARMACEUTICALS
Figure 2- Phase-specific & multi-phase integration results
also highlighted the impact of time savings. In oncology trials, even a onemonth delay in Phase III can translate to $ 8 million in lost revenue due to deferred market entry and shortened exclusivity periods.
The findings also reinforce the compounding value of continuity. When integration is sustained across multiple phases, the combined operational efficiencies and reduced transition costs can yield even greater financial returns than single-phase improvements alone. Programmes that maintained integration from Phase II into Phase III, for example, saw eNPV gains climb significantly compared to those that adopted the model for a single phase.
Focusing integration in later phases
Although integrated strategies can be applied at any point in development, the data suggests that Phase III offers the greatest opportunity to realise measurable value. At this stage, assets are typically de-risked, having passed key clinical and regulatory hurdles. Programmes are larger and more complex, with higher resource investment and higher stakes.
Streamlining execution during Phase III can prevent costly setbacks and accelerate readiness for commercialisation and earlier market entry. The Tufts team also found that the ROI of late-phase integration held steady across a range of assumptions, reinforcing the robustness of these benefits.
This stage of development also involves a broader range of stakeholders, from regulatory bodies and supply chain teams to commercial strategists. A unified model allows for more consistent communication and decision-making, which in turn helps sponsors respond faster to late-stage data and regulatory feedback.
Laying the foundation earlier
While later-stage programmes show the largest returns, the decisions made in Phase I can set the tone for future performance. Selecting a scalable partner, harmonising data systems, and aligning supply and regulatory planning early on can reduce downstream issues and bottlenecks and create continuity as programmes advance.
Early integration can also help sponsors avoid delays related to technology transfer, contract renegotiations and documentation gaps. These issues may not appear critical at the outset but can become major roadblocks as development progresses and operational needs increase.
Additionally, unified early-phase planning can enable more responsive scenario modeling, allowing sponsors to plan for multiple development paths based on emerging trial results. This kind of flexibility is increasingly valuable in oncology and other therapeutic areas where biomarker data and adaptive trial designs are changing how programmes evolve.
Strategic implications for developers
For biotechs and large pharma alike, the study provides a framework for evaluating when integrated outsourcing might make strategic and financial sense. Emerging companies may benefit from the operational support and cohesive oversight that a single-partner model provides, especially when internal resources are limited. Larger organisations managing diverse pipelines may find integration across CMC supply and clinical studies useful in improving efficiency, visibility and flexibility to make justin-time decisions.
Sponsors may also consider integration as a risk mitigation strategy. In today’ s environment, marked by geopolitical uncertainty, evolving regulatory expectations and complex trial logistics, fewer handoffs and more centralised accountability can help prevent gaps in execution that jeopardise timelines or quality.
By grounding its findings in the operational structure of Accelerator Drug Development, the Tufts analysis adds real-world context to the modelling, demonstrating how integrated execution can be implemented and measured in practice.
Looking ahead
There is no one-size-fits-all approach to outsourcing in drug development. Every programme has its own requirements, and some projects may still benefit from engaging with multiple specialised vendors. But the findings from Tufts suggest that integration, when applied strategically, can yield tangible gains.
In a landscape defined by high costs, compressed timelines and growing demand for innovation, the ability to manage clinical development holistically is no longer just an operational advantage. It is becoming a financial imperative and opportunity to accelerate commercialisation by reducing time to market. ●
*- Accelerator Drug Development is a trademark of Thermo Fisher
J j
Erin Morton
DIRECTOR, COMMUNICATIONS
THERMO FISHER erin. morton @ thermofisher. com www. thermofisher. com
16 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981