In biopharmaceutical development, speed-to-market pressures continue to intensify. The CDMO Live 2025 roundtable session, ‘Fast-Track to Market: Cutting Timelines Without Cutting Corners’ sponsored by Prasfarma.
Dr Marta Kijanka, Founder and Principal Consultant of MK Bio Consultancy B.V., brought together industry professionals to discuss key strategies for accelerating drug development timelines without sacrificing quality or increasing risk.
A central theme that emerged from the discussion was the importance of human alignment over technological solutions. Kijanka emphasised that, at the core of any successful fast-tracking approach, it is not just about having the best technology or the most sophisticated tools. Rather, it is about aligning teams and ensuring clear, effective communication throughout the process.
“It is people and alignment of the teams that is critical to get things done properly and fast,” she emphasised, capturing the essence of the session.
Key Barriers to Acceleration
Participants identified phase-inappropriate quality requirements—matching quality standards to development stage—as one of the most critical barriers to timeline acceleration. Many pharmaceutical executives shared their experiences with clients who requested stringent quality measures that were inconsistent with the phase of development they were in. For example, when working on early-stage clinical trials or preclinical formulations, there is no need to meet the rigorous quality standards expected in later stages like commercial production. However, clients often push for these higher standards, either due to lack of experience or the desire for a “fail-safe” approach. This mismatch results in unnecessary delays and can stretch project timelines far beyond what is needed for that stage of development.
One pharmaceutical executive described a scenario where clients insisted on high-quality controls during the early stages, which extended timelines and led to significant additional costs. This sentiment was echoed by another speaker, who noted that CMOs often face the dilemma of navigating between client expectations for excessive quality and the reality of phase-appropriate regulatory requirements.
Strategic Solutions for Timeline Reduction
Building on these governance foundations, participants explored practical strategies for timeline reduction, with clear governance structures emerging as fundamental to success.
Establishing Clear Governance Structures
Kijanka stressed the importance of clear governance structures from the outset of a project. Establishing these structures helps to delineate who has decision-making authority, especially when working in fast-paced environments. Without clear roles and responsibilities, projects can become bogged down by unnecessary debates or delays in decision-making, further extending timelines.
One speaker shared their experience of working with a client who did not have clear internal decision-making processes. This resulted in constant back-and-forth communication, with decisions being delayed or revisited multiple times, causing bottlenecks in the development timeline. Having clear authority lines ensures that the project can move forward smoothly and that decisions are made promptly.
Parallel Processing: Maximising Efficiency
Participants highlighted parallel processing as a major strategy for cutting timelines. One of the original questions raised was about identifying activities that could be conducted in parallel rather than sequentially to accelerate the overall timeline without compromising quality. Several participants shared insights into how they have successfully implemented parallel processing in their projects.
For example, a speaker from a large biopharmaceutical company mentioned that by overlapping preclinical studies with early clinical formulation work, they were able to fast-track their product development while ensuring both quality and safety. The key to success here, as emphasised during the conversation, is careful planning and coordination to ensure that the parallel activities do not introduce additional risks or delays.
A CDMO representative emphasised that parallel processing requires a deep understanding of the critical path—the sequence of activities that determine overall project duration. Identifying non-critical activities and handling them simultaneously can help significantly reduce time, but it requires a skilled team to ensure that risks are minimised during these overlapping activities.
Critical Path Management: Focused Resource Allocation
Critical path management emerged as another crucial topic during the roundtable discussion. One speaker from a CDMO shared their approach to identifying and focusing resources on the true critical path activities. This included engaging with CMC regulatory strategy (Chemistry, Manufacturing, and Controls) as early as possible, especially when the project aims for accelerated approval.
Focusing on the critical path means identifying the most crucial steps that must be completed to avoid delays. This includes not only manufacturing and testing but also regulatory submission timelines. Some speakers highlighted the importance of early engagement with regulatory authorities to streamline the approval process, ensuring that all required data is submitted in a timely manner. By focusing resources on the critical path, project teams can avoid wasting time on non-essential activities and can prioritise those actions that will have the most significant impact on meeting the target timeline.
An often overlooked yet critical factor influencing the overall project timeline is sourcing. Delays in the procurement and qualification of suppliers of e.g. excipients, the sourcing and testing of primary packaging materials, and the availability of key production components can significantly impact manufacturing activities. These sourcing elements, though frequently treated as logistical or operational details, often sit on or near the critical path, especially in accelerated development programmes. Integrating sourcing teams early into the project planning process is essential to avoid bottlenecks that can derail manufacturing schedules and eventually delay regulatory submissions. Close coordination with suppliers, proactive risk assessment, and built-in contingency strategies are all necessary to ensure timely material availability and maintain momentum along the critical path.
Partnership and Implementation Strategies
Beyond internal processes, the selection of external partners proved equally critical to timeline acceleration success.
Selecting the Right CDMO: A Key to Speed
When it comes to selecting a CDMO for projects where speed-to-market is a primary consideration, the discussion revealed that choosing the right partner is critical. Several participants noted that speed should not be the only criterion for CDMO selection. It’s also important to assess experience with similar products, flexibility, and the ability to scale quickly.
One speaker emphasised that when speed is a priority, selecting a CDMO that understands phase-appropriate requirements and has experience working with accelerated timelines is essential. A CDMO with a history of working on early-phase clinical trials or novel formulation technologies can provide more reliable timelines and mitigate risks associated with unfamiliar technologies.
In addition, communication and trust were cited as key components in a successful partnership. If a CDMO can work in lockstep with the client, understanding their needs and anticipating challenges, they can create a more collaborative and efficient development process. Trust and transparency allow both parties to make decisions more quickly and reduce the likelihood of unforeseen delays.
Phase-Appropriate Development Strategies
The importance of phase-appropriate development strategies cannot be overstated. By ensuring that each phase of development is managed according to its specific needs, companies can maintain a clear path to commercial readiness without wasting time or resources. One participant shared their experience with monoclonal antibody development, where they decided to focus less on process optimisation during early stages and instead pushed more activities into the post-approval phase. This allowed them to move the product to market in a record five years, much faster than the industry average of 8-12 years.
The approach of pushing activities into later stages has its risks, of course, such as the potential need for more change controls and adjustments post-approval. However, this strategy was successful due to the team’s deep experience and ability to assess the potential impacts of those decisions on both safety and quality. Understanding the regulatory environment and post-market requirements also played a significant role in this strategy’s success.
Risk Management Framework
Finally, the roundtable explored how to balance speed and risk, especially when making decisions to accelerate timelines. One of the most powerful tools shared was a simple decision-making framework based on three key factors: cost, time, and quality. This framework provides a quick and clear way to evaluate the impact of any decision, especially when faced with tight timelines.
One speaker reflected on the complexity of making decisions when resources are limited and deadlines are pressing. Risk management becomes more difficult when there’s pressure to reduce timelines, but it’s essential to ensure that any risk taken does not jeopardise the safety or efficacy of the product. Failing small, as discussed by one participant, can be a valuable approach to balancing speed and risk. By making smaller, calculated risks and accepting that some will fail, companies can test out different approaches without committing to large-scale changes that could cause major setbacks.
Conclusion
The roundtable demonstrated that successful timeline acceleration requires a holistic approach combining human factors with strategic planning. Whilst technology and processes provide the foundation, the differentiating factor lies in team alignment, clear decision-making authority, and partnerships built on trust and transparency. By implementing parallel processing strategies, focusing resources on critical path activities, and selecting experienced CDMO partners who understand phase-appropriate requirements, companies can achieve meaningful timeline reductions without compromising product quality or safety. Above all, fostering a culture of proactive risk management and collaborative decision-making ensures that projects progress smoothly whilst maintaining the rigorous standards required for market approval.
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