13 August 2026 | Thursday | Expert Opinion | By Russell Thomas, Chief Scientific Officer at Symeres and Axxam, and Paul O’Shea, Managing Director at Exemplify BioPharma
Drug development is inherently uncertain, with scientific discoveries, manufacturing challenges, regulatory expectations and commercial priorities capable of reshaping a program at any stage. Rather than attempting to eliminate uncertainty, biotech companies can build resilience by identifying risks early, making evidence-based decisions and creating development strategies that can evolve as new information emerges. In this feature insight, Russell Thomas, Chief Scientific Officer at Symeres and Axxam, and Paul O’Shea, Managing Director at Exemplify BioPharma, explore how organizations can balance structured planning with the flexibility needed to navigate an increasingly complex development landscape.
Drug development is an exercise in managing uncertainty. Every program begins with a strategy based on the best available scientific evidence and commercial assumptions, but scientific discoveries, manufacturing challenges, evolving regulatory expectations and changing commercial priorities mean no development plan remains unchanged. Rather than trying to eliminate uncertainty, successful organizations build strategies that can adapt as new evidence emerges while maintaining program momentum.
Being nimble, or adaptable, to a program's needs requires more than careful planning. It depends on identifying technical risks early, making evidence-based decisions throughout development and creating organizational structures that support collaboration and informed decision-making across disciplines.
In this article, we explore how combining early risk identification, evidence-driven decision-making and organizational flexibility will ensure biotech companies build development strategies that remain effective in the face of scientific and operational uncertainty.
Planning is essential, but uncertainty is inevitable
Planning remains fundamental to successful drug development. Without clear objectives, coordinated activities and realistic timelines, programs quickly lose direction. The added value of a risk-based development plan lies in providing a flexible framework to enable informed decisions as new evidence emerges.
Every development strategy is built on assumptions. Teams select synthetic routes, analytical methods, formulations and manufacturing approaches using the best information available at the time. These decisions enable programs to progress, but they are based on knowledge that is being acquired in real time.
This is one of the defining characteristics of drug development. Unlike commercial manufacturing, which relies on well-established and predictable processes, development is inherently experimental. Every stage is designed to answer scientific questions, and the results cannot always be anticipated. Scientific findings, manufacturing challenges, regulatory expectations and commercial priorities all have the potential to reshape a program as it progresses.
Successful organizations treat development plans as flexible, working frameworks rather than fixed roadmaps. Their objective is to ensure the plan continues to reflect the program’s evolving scientific understanding. When evidence changes, the strategy will evolve alongside it.
Accepting uncertainty is therefore what makes planning effective. The challenge is designing development strategies that can adapt to changing circumstances while maintaining momentum. Understanding where uncertainty exists and how best to manage it is the balancing act that requires expertise to deliver the best outcomes.
Building plans around uncertainty
Recognizing that uncertainty is inevitable is only the first step. The greater challenge is designing development strategies that can accommodate changing technical and commercial circumstances without disrupting program momentum.
This requires a shift in thinking. Rather than assuming uncertainty can be eliminated through increasingly detailed planning, successful organizations seek to understand where uncertainty exists, which risks matter most and how their programs can respond when new evidence emerges. Building flexibility into the development planning process means ensuring a suitable support and organizational culture structure is in place, enabling better decision-making throughout the development lifecycle.
The transition from discovery into development is one of the most influential stages of any program. At this point, a molecule may have demonstrated promising biological activity, while many aspects of its pharmaceutical profile remain only partially understood. Questions surrounding manufacturability, formulation, analytical methods and process scalability may still be unanswered, yet decisions made during this stage can shape the entire downstream program.
To address this uncertainty, organizations are increasingly using comprehensive developability assessments to evaluate how readily a candidate can progress through development and ultimately reach commercial manufacture.
A robust developability assessment considers factors including:
These assessments identify potential challenges early and distinguish between manageable technical risks and issues that warrant further investigation. For example, recognizing likely formulation or manufacturing constraints while multiple options remain available allows teams to investigate solutions before they become critical bottlenecks. This provides a stronger scientific foundation for future decisions and enables development strategies to adapt more effectively as new evidence emerges.
Traditional development plans are typically organized around activities. Teams identify the work that needs to be completed, estimate timelines and sequence those tasks into an integrated program plan. While this remains an essential part of effective project management, activity lists alone rarely provide a complete picture of program readiness.
A risk-based approach shifts the emphasis from completing tasks to generating the knowledge required to support confident decisions.
Traditional project plans typically ask teams to:
A risk-based strategy instead asks:
This changes how progress is measured. Rather than assuming every activity will proceed exactly as planned, development teams continually assess whether sufficient evidence has been generated to support the program’s next major decision. Experiments are designed such that they reduce uncertainty and increase confidence in future choices.
By identifying potential technical and development risks early, this approach helps teams address issues before they become costly bottlenecks later in the program. This is particularly valuable for emerging biotechnology companies, where scientific progress is closely linked to commercial milestones such as investor commitments or grant funding. An avoidable development delay that appears relatively modest from a technical perspective can have far-reaching consequences, for example, preventing a program from reaching a critical inflection point on schedule or budget.
Building flexibility into a development strategy does not mean every aspect of a program should remain open to change. Clinical manufacturing slots, toxicology studies, regulatory submissions, investor commitments and externally funded deliverables often create genuinely immovable milestones. The challenge is understanding where flexibility creates value and where it does not.
Instead of treating every deadline as equally important, experienced development teams identify the program’s true critical path and focus their efforts on protecting those activities. Supporting workstreams can then adapt without compromising overall progress.
This often requires looking beyond individual deliverables to understand the broader objective. A biotechnology company may initially require 100 grams of material within a defined timeframe, but further discussion may reveal that downstream studies can begin with substantially less. Delivering 20 grams initially, followed by additional batches as manufacturing progresses, allows critical studies to start while the remaining material is produced.
Although the manufacturing strategy has changed, the program continues to move forward because the underlying objective has not. This type of flexibility requires scientific judgment rather than rigid adherence to predefined deliverables, but it often prevents relatively small technical challenges from becoming program-wide delays.
Drug development exists to generate new knowledge. Every experiment provides additional information about a molecule, its behavior or the suitability of a particular development strategy. The challenge is deciding when new findings should simply refine existing plans and when they justify a more fundamental change in direction.
Not every unexpected result requires a strategic pivot. Equally, organizations that become reluctant to revisit earlier decisions risk allowing relatively minor technical issues uncovered at that time to develop into much larger problems later in development. Scientific judgment therefore becomes just as important as project management.
Teams that have supported numerous programs are able to recognize patterns that individual datasets cannot reveal. An unexpected process trend may resemble issues encountered during previous scale-up activities, while an analytical observation may indicate a broader formulation challenge rather than an isolated laboratory anomaly.
Project managers provide the structure needed to coordinate increasingly complex programs, but scientists determine whether the emerging evidence continues to support the current strategy. The strongest development organizations ensure these perspectives work together, allowing programs to evolve in response to robust scientific evidence without losing overall direction.
These four principles shift development planning away from trying to predict every outcome and toward creating programs that can respond intelligently as new evidence emerges. Instead of resisting uncertainty, organizations build strategies that use it to make better decisions at every stage of development.
Organizational structure determines whether flexibility is possible
Even the best development strategy can only be as adaptable as the organization delivering it. While scientific uncertainty is unavoidable, many delays arise from the way programs are coordinated rather than from the science itself. As biotechnology companies increasingly rely on specialist partners for chemistry, formulation, analytical development and manufacturing, organizational complexity has become just as important as technical complexity.
To maintain program momentum, organizations need structures that enable rapid, informed decision-making. This typically involves:
When expertise is housed within a single integrated organization, information can flow more easily across functions, enabling faster, more efficient decision-making than is typically possible across multiple partners. Organizations that share scientific knowledge across disciplines and make decisions in the context of the wider program are also better positioned to adapt as new evidence emerges and maintain overall development momentum.
Building organizations that become stronger through uncertainty
Resilient development strategies require an organization to adapt when new evidence emerges without compromising on project pace. This starts with recognizing that development plans are living frameworks rather than fixed roadmaps. Building this resilience depends on creating an organizational culture that empowers teams to challenge assumptions, revisit earlier decisions and adapt as new scientific evidence emerges, without viewing changes in direction as a sign of failure. Governance processes should support evidence-based decision-making rather than adherence to predetermined timelines.
As development becomes increasingly multidisciplinary, collaboration is becoming even more important. Chemistry, formulation, analytical development, manufacturing and regulatory teams all generate information that shapes program strategy. Organizations that integrate these disciplines are better equipped to understand the wider implications of technical decisions and resolve challenges before they affect downstream activities.
Emerging technologies, including predictive modeling and advanced data analysis, will continue to improve planning and provide greater confidence in decision-making. However, advances in AI and machine learning will complement rather than replace scientific judgment. Experienced teams remain essential for interpreting complex data and determining when programs need to adapt. Resilient organizations are defined by their ability to respond to uncertainty quickly and collaboratively.
Designing future strategies to evolve with the science
Reality is that no program reaches the clinic without encountering unexpected scientific findings, manufacturing challenges or changing commercial priorities. These challenges are an inevitable consequence of developing innovative medicines, not evidence that planning has failed. The organizations that consistently navigate complexity recognize that planning and flexibility are complementary rather than opposing concepts. Robust planning provides the structure needed to coordinate increasingly sophisticated programs, while scientific agility ensures those plans remain aligned with reality as new evidence emerges.
Resilient development strategies are built on a simple principle: decisions can and should change as knowledge evolves. By investing early in understanding technical risk, focusing on developability, identifying where flexibility will have the greatest value and fostering collaborative partnerships that support informed decision-making, biotech companies can maintain program momentum even as circumstances change. In an industry where uncertainty is a way of life, long-term success depends on organizations being capable of making better decisions every time the original development plan is challenged.
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