The COVID-19 pandemic fundamentally changed pharmaceutical manufacturing approaches – demonstrating it’s possible to dramatically compress traditional timelines while maintaining quality standards.
At CDMO Live 2025, Fabrice Le Garrec, founder of the OSICS network, shared lessons learned from his experience during the unprecedented Lonza-Moderna vaccine manufacturing scale-up, where project management approaches were revolutionized to protect timelines when “timeline meant lives.”
Building on these experiences, Fabrice presented his “10 Commandments” for fast-tracking emergency drug manufacturing—practical strategies that pharmaceutical companies and CDMOs can implement to maintain this momentum in future crisis situations.
1. Have One Flexible Global Analytical Lab Service
Laboratory activities offer inherent flexibility and can be performed anywhere, making reactivity and repeatability the key priorities.
Work early to confirm capability and repeatability of all lab tests anywhere, ensuring consistent results regardless of location.
The optimal approach, Fabrice advises, is to build local labs with only the strictly necessary capabilities, whilst significantly buffering capacity with a global lab in a lower-cost country (LCC) that has substantial overcapacity.
This centralised approach ensures consistent analytical capabilities across all manufacturing sites while maintaining cost efficiency and rapid response times during emergencies.
2. Build a Specific Global Capability Centre and Recruitment Cell
Human resources represent one of the most significant bottlenecks in emergency manufacturing.
Dedicate two production lines early in the process to create a physical training facility for all new operations, technical, maintenance, and laboratory staff. This boot camp approach, running one-month intensive training cycles, rapidly builds capabilities.
Complement this with accelerated learning solutions to speed up knowledge transfer.
“When time is critical, your recruitment approach must be unconventional,” Fabrice advises. “Develop recruitment pools that tap both traditional and non-traditional sources to maximise the chances of attracting the right resources on time.”
Finally, assign an operational leader with direct responsibility for managing the entire recruitment machine to ensure accountability.
3. Create a PMO Network with Execution Power Over Functions
The critical success factor is to change the pyramid of powers. Establish a global network of Project Managers into one PMO with final authority to protect the planning and reporting directly to COO or CEO.
Functions heads provide the resources to execute the planning but cannot be the ones prioritising work. This fundamental shift in decision-making authority is essential for rapid progress.
Support these PMs with a team of Subject Matter Expert “flying squads” who can quickly address emerging risks or solve problems.
Fabrice emphasises that risks must be managed systematically through project teams reporting to the PMO, creating clear lines of authority and decision-making that transcend typical organisational boundaries.
4. Develop Processes Based on Standard Technologies, Consumables and Equipment
Changing points in any aspects of processing are pain points in Commissioning, Qualification and Validation (CQV). Avoid them or derisk them upfront.
Strict standardisation must become the rule so that Quality and Validation can be simplified through leveraging previous work when possible.
Fabrice strongly advocates implementing this standardisation as an organisational rule, which reduces the documentation burden, speeds up regulatory approvals, and ensures consistent quality across manufacturing sites.
5. Manage Change Controls with Highest Discipline
The change control process often becomes a major bottleneck during emergency manufacturing.
Put a cross-functional global and local team solely in charge of pushing and preparing Change Controls with sites and make them easier to handle whilst all the other activities are progressing.
“Change control management is where many fast-track projects falter,” Fabrice notes. “Use Lean practices for CC management to visualise progress and manage risks proactively with impact assessments and projections.”
6. Set Up a Central Documentation Control Tower
Documentation represents another critical path element that often delays manufacturing readiness.
Central control tower is the decision maker on documentation content and planning. Lean documentation creation processes and leverage digital/AI solutions to expedite the core of the work.
Create a centralised system for coordinating documentation flow, comparing capacity against forecasts for both writing and reviewing activities.
Fabrice recommends establishing local documentation SPOCs at each site to coordinate local execution and feedback loops, which can dramatically accelerate the documentation process.
7. Set Up a Specific and Dedicated Resources Planner
Resource forecasting becomes especially critical during emergency manufacturing.
Anticipate all resource needs based on standardised activity times scenario and make rough and fine forecast constantly. The resources planner is dedicated and working with each Project Manager.
Fabrice advises regularly revisiting assumptions and changes to project in order to establish an honest and realistic new picture.
Maintain “one set of eyes on the ball” constantly, anticipating hiring and upskilling of resources. Consider establishing 2 to 3 shifts for round-the-clock progress.
8. Establish One “Supplies & Consumables” Control Tower and PMO
Supply chain coordination across multiple manufacturing sites becomes essential during emergencies.
Implement full coordination of supplies and consumables stocks vs forecasts across sites. Provide status of stocks, release status and usage forecast to understand upcoming shortages.
Fabrice suggests setting up site synergies with allocation rules to ensure critical materials go where they’re most needed.
Structure both global and local coordination through typical PMO roles with local SPOCs who can monitor and report on inventory levels and upcoming requirements.
9. Set Up a CMO Coordination SPOC Based at the Critical Vendors’ Site
Contract Manufacturing Organisation (CMO) management often creates bottlenecks during accelerated manufacturing.
The SPOC ensures the full coordination of CMO requests flow and is the ultimate decision maker on vendor priorities (Activities forecasts) to avoid contradicting requests.
“Your CMOs become extensions of your team during emergencies,” Fabrice points out. “The SPOC works daily hand-in-hand with Vendor on Capacity/Capabilities needs at site to meet project requests and closing their gaps in full transparency.”
10. Focus on Deviations Management Optimisation to Reduce Burden
Quality deviations can quickly overwhelm resources during emergency manufacturing.
Set up deviation writers team dedicated to offload the operational teams on writing (only reviewing). Dedicated local teams work on Leaning deviations management and also optimise deviation writing from the start through one set of aligned expectations from QA.
Fabrice has seen significant improvements when organisations establish 2 to 3 shifts for deviation management to maintain continuous progress.
Taken together, these ten commandments together form a powerful framework for drug manufacturing that challenges traditional pharmaceutical approaches. By rethinking organisational structures, prioritising flexibility, and establishing dedicated coordination roles, manufacturers can achieve dramatic improvements in timelines without compromising quality—potentially saving countless lives whenever speed is of the essence.
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