Building Agile Pharmaceutical Programs That Stand Strong Amid Global Health Uncertainty

As global health threats continue to evolve rapidly, pharmaceutical leaders face mounting pressure to design development programs that can withstand volatility. From pandemics to geopolitical unrest and climate-related disruptions, resilience is a strategic requirement.

Traditionally, pharmaceutical programs have been built on the assumption of a relatively stable world: predictable supply chains, regulatory timelines, and patient demand. Recent years have revealed how fragile that model can be.

The Covid-19 pandemic showed how quickly a promising program can be derailed by external instability. These experiences revealed a need to shift the planning mindset. To prevent this in the future, leaders must ask essential questions from the start:

• What risks could disrupt this program in the short or long term?
• How can we proactively plan for unforeseen changes?
• Are our systems designed to pivot when needed?

In working on pandemic preparedness and emerging virus initiatives, it became clear how mission-critical it is to embed resilience into strategy from day one. For example, during an outbreak response in East Africa, program leaders had to rapidly adapt clinical and regulatory strategies in collaboration with international and local health authorities. The ability to pivot trial designs and supply chains under pressure ensured that patient needs were not compromised despite instability on the ground.

Building agile pharmaceutical programs through scenario planning and risk analysis

Resilience in drug development comes from deliberate design. Here is a three-part framework that leaders can use to make programs more adaptive and future-ready.

1. Use scenario planning to prepare for multiple possible futures

Scenario planning helps model different futures, not to predict them, but to prepare for them. In pharmaceutical settings, this may include:

• Regulatory uncertainty
• Emerging competitor products
• Supply chain failures
• Changes in public health policy
  

Structured scenario exercises help uncover hidden vulnerabilities and force strategic flexibility. This process should be iterative, not annual. Assumptions should be revisited regularly as milestones and external signals shift.

During recent global health crises, scenario planning proved essential. Cross-functional groups worked across clinical, regulatory, and supply chain functions to stress-test multiple futures: potential surges in global demand, sudden trial-site shutdowns, and accelerated regulatory pathways. When certain geographies became inaccessible due to lockdowns, contingency sites were activated and patient recruitment diversified globally. This type of proactive planning shaved months off timelines and allowed critical therapies to reach patients sooner.

2. Integrate comprehensive risk analysis early in program design

While clinical and regulatory risks should be top of mind, building true resilience requires a broader scope of risk analysis. Programs should also assess:

• Workforce and talent risks
• Geopolitical exposure
• Financial dependency on single markets
• Supplier concentration
  

Both quantitative models and qualitative workshops are critical. Engaging cross-functional contributors in identifying potential risks encourages ownership and surfaces blind spots early.

3. Design flexible systems and governance from the start

Flexibility cannot be reactive. It must be embedded into program operations, contracts, and timelines. Examples include:

• Adaptive clinical trial models
• Modular manufacturing plans
• Vendor diversification strategies
• Pre-approved contingency budgets
  

Flexible governance frameworks also allow program leaders to make quick decisions when priorities shift. Building in agility helps preserve momentum when timelines or assumptions change unexpectedly.

Real-world preparedness programs have shown the value of flexibility in innovation. For instance, some therapies initially designed for one infectious disease were able to be redirected and evaluated for new pathogens because of early investments in preclinical work and adaptable regulatory scaffolding. Similarly, respiratory preparedness programs highlight how investments in regional trials, diversified clinical partnerships, and real-time data infrastructure can accelerate development when demand surges.

In antiviral preparedness efforts, some development programs were deliberately designed to allow rapid protocol adaptation across multiple respiratory pathogens. This approach meant that when new viral variants emerged, data could be leveraged across indications with minimal delays, providing regulators and public health agencies with a faster decision-making pathway.

These examples demonstrate the payoff of designing with optionality and preparedness in mind. Agility must be part of the DNA of a program.

How to embed resilience in portfolio management and decision-making

Resilience should extend beyond individual programs to the entire pipeline. Portfolio management must shift from a purely ROI-driven model to one that accounts for adaptability, interdependence, and environmental volatility.

Key strategies include:

• Conducting resilience audits – Review each program’s capacity for flexibility, scenario planning depth, and risk diversification.
  Mapping cross-portfolio dependencies – Many organizations unknowingly rely on shared vendors, talent, or regulators. Understanding these dependencies helps prevent cascading failures.
• Developing cross-functional talent plans –  A resilient portfolio requires a resilient workforce. Cross-train staff, document institutional knowledge, and build systems that reduce dependence on any one individual.
• Creating space for strategic foresight and innovation –  Encourage program contributors to surface uncertainties and test assumptions. Cultures that reward foresight will be better equipped to adapt.
  

In one antiviral portfolio, governance forums initially focused heavily on ROI and speed to market. By embedding foresight reviews and structured “what if” discussions, program leaders began surfacing risks earlier and developing mitigation strategies proactively. This shift allowed resourcing and regulatory engagement to be adjusted in advance, strengthening long-term program durability.

As we navigate a more unpredictable and interconnected world, the pharmaceutical industry must embrace resilience as a core design principle. Programs that anticipate disruption and integrate flexibility from the start are more likely to succeed and deliver value to patients faster.

Resilient program design is not just about managing crises. It is about building systems that evolve, improve, and seize opportunity through uncertainty.

The key takeaway from years of preparedness and antiviral development is this: resilience pays dividends beyond crisis response. It builds trust with regulators, accelerates decision-making, and, most importantly, ensures patients receive life-saving treatments when they need them most. The programs that endure are those built for the uncertainties we cannot yet see.

Photo: inkoly, Getty Images

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