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Scaling a product from preclinical development through clinical phases and into commercial manufacturing is one of the most failure-prone transitions in the life sciences. Misaligned expectations, incomplete product knowledge, and poorly timed quality activities can quietly add months (or years!) to a program.
Our Nick Capman recently sat down with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, to unpack what actually goes wrong during these transitions and how sponsors and CDMOs can prevent it.
Jackie brings decades of experience leading quality and development across pharmaceutical drug products, medical devices, APIs, and biologics in multi-regulatory environments.
At Lifecore, a fully integrated CDMO with roughly 20 commercial SKUs approved in the U.S. and Europe, she oversees both Quality and Development Services, giving her a rare end-to-end view of how early decisions ripple forward into commercial reality.
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Jackie’s key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Over-engineering early—or under-engineering—is one of the most common mistakes. Jackie sees sponsors fall into two extremes. Some push for full analytical method validation or commercial-grade rigor during preclinical work, which adds unnecessary cost and effort. Others arrive without a clear understanding of their own design space, material variability, or critical product attributes. Both approaches create downstream risk when the product scales. The goal isn’t “more quality” early—it’s the right quality at the right time.
Knowledge transfer must be explicit, structured, and ongoing. Sponsors often assume the CDMO will “figure it out,” while CDMOs assume sponsors will share what they know. Jackie emphasizes the importance of clearly documenting what the sponsor and the CDMO know and what neither side yet knows. This includes sensitivities like light, oxygen, material variability, and processing effects—and documenting them early so they can be revisited and refined throughout the product lifecycle.
Design space is built through deliberate experimentation, not assumptions. Defining design space means actively testing the factors that can alter product performance. Jackie describes using approaches like Design of Experiments (DoE) to identify where “design cliffs” exist (points where small changes can destabilize the product ) and addressing them before scale introduces irreversible complexity
FMEA should become the living “encyclopedia” of the product. Jackie calls the FMEA one of the most critical knowledge documents a product can have. Rather than treating it as a one-time exercise, she describes using it as a living tool that evolves with new process knowledge, manufacturing experience, and complaints and CAPAs. Done well, the FMEA becomes a longitudinal record of how risk was identified, mitigated, and reassessed over time, supporting both quality decisions and regulatory confidence
Risk tools fail when the scope and teams aren’t defined. Over-engineering often happens when teams lose scope. Jackie emphasizes defining exactly what the risk assessment covers (e.g., bulk drug substance vs. fill-finish vs. packaging) and assembling the right cross-functional team (large enough to capture expertise, but small enough to stay focused).
Phase-appropriate QMS is not optional. It’s expected! Applying a full commercial QMS to preclinical work creates friction and inefficiency. Jackie explains that FDA and EU guidance both support phase-appropriate expectations, such as (1) sound—but not fully validated—methods early on, (2) increasing robustness through Phases 1–3, and (3) full commercial rigor only when it’s truly required. The key is documenting these expectations clearly in the QMS and ensuring teams are trained to apply them consistently.
EU and FDA expectations can diverge in ways that impact timelines. Failing to plan for these differences can lead to repeated work and delayed approvals. Jackie highlights several differences that frequently surprise sponsors:
EU requirements for more complete analytical methods earlier
Greater emphasis on hold studies in EU submissions
EU expectations for completed PPQ data, versus FDA acceptance of protocols
Stronger EU focus on documented design space and sterilization rationale
Communication—and documentation—are the real accelerators. Across the conversation, Jackie returns to a simple theme: open, structured communication prevents delays. Clear quality agreements, aligned expectations around review timelines, and regular live discussions reduce misinterpretation, frustration, and last-minute surprises. Documenting decisions as knowledge evolves ensures continuity even as teams or phases change
One thing to bring back to your team
Review how your organization defines and documents phase-appropriate expectations today. Ask:
Do we have a shared roadmap from preclinical to commercial?
Are risks and knowledge captured in living documents, or static ones?
Are sponsors and partners aligned on what “good enough” looks like at each phase?
Misalignment early is rarely visible, but it’s almost always expensive later.
Jackie Klecker is Executive Vice President of Quality and Development Services at Lifecore Biomedical. She has led quality systems and development programs across pharmaceutical, medical device, and API manufacturing for more than two decades, with deep experience in FDA 21 CFR 210, 211, and 820, ISO 13485, EU GMP, and ICH Q7 environments. Her background spans chemical engineering, process development, risk management, validation, and cross-functional leadership across multiple global manufacturing sites.
Connect with Jackie on LinkedIn here.
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