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Scientific innovation is just one dimension of building a cell and gene therapy organization. Another (less discussed) dimension is about creating systems that can absorb change, learn from failure, and maintain focus on the patient even when the path forward is uncertain.
Our Nick Capman recently sat down with Nelly Viseux, Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, to learn what it takes to build and lead resilient organizations in one of biotech’s most complex modalities.
Nelly brings over 20 years of biotechnology experience, having worked at large companies including Shire, Biogen, and Baxter before transitioning to the startup world. She switched to the CGT space over a decade ago and has been deeply immersed in the field ever since.
At Regeneron, she joined as an executive leader to support the establishment and growth of the Regeneron Cell Medicines unit following the acquisition of 2seventy bio’s early clinical pipeline. She leads a cross-functional technical organization bridging Research and Clinical Development for autologous cell therapy programs—a 100-FTE CMC-focused organization spanning development, manufacturing, quality, and innovation.
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Nelly's key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Organizational resilience means adaptability (the capacity to absorb and anticipate change). Cell and gene therapy is biologically complex, fast-evolving, and highly competitive. Nelly says a great way to functionally define resilience is building an organization that can continue developing products and sustain its mission even when pipelines change or products fail. This requires clear communication with regulatory agencies, operational control, and acceptance that scientific outcomes remain inherently uncertain.
Integrity, transparency, and accountability are the cultural foundation. These have to be lived throughout the organization. Transparency of information, issues, and priorities empowers teams to make decisions without excessive escalation. Nelly describes a biotech organization as a living organism, a dynamic environment where empowerment is the driving principle.
Balance innovation and execution through intentional structure. There’s inherent tension between innovation and execution in any biotech, whether a startup or an established corporation. Nelly addresses this by separating functions: development groups handle “blue sky” innovation and necessary development work, while operational teams focus solely on execution. The key is an “intentional innovation crossover”—consciously deciding when innovation is ready to be implemented into the manufacturing suite, accepting the associated risk, and generating the data needed to engage regulatory agencies.
Build manufacturing as an ecosystem with tiered communication. Nelly’s facility integrates manufacturing, quality control, and quality organization, leveraging expertise from facility and IT groups across the broader company. A tiered escalation system ensures day-to-day empowerment while maintaining visibility for larger issues. Rapid response teams address critical situations—essential when turnaround time is crucial and patients are waiting.
Learning is embedded into operations. Every batch, every operation is followed by a review to learn and improve. Regular reporting on metrics and improvements keeps the organization focused on continuous advancement. On the development side, a matrix structure with functional heads gates innovation decisions, while CMC teams coordinate what capabilities can be applied to incoming projects.
Document your assumptions to manage risk effectively. Risk management in cell and gene therapy spans scientific, regulatory, operational, and financial domains. The key is knowing—and documenting—the assumptions behind your decisions. When you revisit those decisions later, you’ll understand your starting point, which risks you accepted, and how to adapt. Scientific and clinical risk is the hardest to control; efficacy outcomes remain uncertain despite best efforts in construct design and translation.
Talent strategy starts with alignment between what you promise and what people experience. Onboarding should be smooth, and the experience should match what was sold during the recruiting process. Cultivating the workforce means providing real opportunities for growth (training, conferences, and external learning). Cell and gene therapy evolves too quickly for teams to rely solely on internal knowledge development. When hiring, know your non-negotiables (like aseptic technique for manufacturing roles), but be willing to train on modality-specific skills.
Failure isn’t personal—it’s usually process! Psychological safety comes from demonstrating values through action: integrity, accountability, transparency, and authenticity. Regular touchpoints and open surveys give people channels to voice concerns. When failures occur, the focus should be on understanding how the organization got there and what can be learned, not on blaming individuals. Root cause analysis should identify system and process improvements.
Data governance and AI start with consolidating what you have. In autologous cell therapy, you deal with small clinical datasets but can generate substantial data across the product lifecycle, from patient cells through modification and reinfusion. Mining data comprehensively across this lifecycle can reveal insights invisible when viewed in isolation. Dashboards, data lakes, and workflow automation are enabling more real-time decision-making, though the industry still has work to do.
Start with the end in mind for quality and compliance. Commercially, the regulatory expectations are known. Cell and gene therapy has approved products now. There are standards to meet! The question is how to prepare during Phase 1 for later-stage requirements. This includes strategic decisions about manufacturing approach: traditional CDMO partnerships versus more innovative, enclosed, robotic technologies. Each choice involves different assumptions, risks, and regulatory conversations.
Data is the common language for alignment. Across scientists, regulatory agencies, investors, and commercial stakeholders, everything comes down to data. Scientific understanding and excellence provide the foundation for productive discussions. Type C meetings with regulatory agencies allow for early exploration of novel approaches. Cross-functional scientific discussions help surface explanations and interpretations that might otherwise be missed.
Managing burnout requires recognizing that everyone is a leader. In autologous cell therapy, manufacturing and QC teams literally hold patient lives in their hands—the patient is waiting for that specific product. This creates tremendous commitment but also tremendous pressure. Leaders must model vulnerability and authenticity, speak from their own experience, and make space for priorities outside work. It’s about pacing for sprints, recognizing limits, and calling for help when needed.
One thing to bring back to your team
Consider how your organization structures the relationship between innovation and execution. Ask:
Is there a clear separation between development/innovation activities and operational execution?
Do you have defined gates for when innovation is ready to be implemented?
Are assumptions documented so decisions can be revisited effectively?
Does your culture treat failure as a process problem rather than a personal one?
The most resilient organizations aren’t those that avoid disruption—they’re the ones designed to absorb and learn from it.
Nelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, where she leads a 100-person CMC-focused organization supporting autologous cell therapy programs. She joined Regeneron to help establish and grow the Cell Medicines unit following the acquisition of 2seventy bio's early clinical pipeline. With over 20 years of biotechnology experience spanning large pharmaceutical companies (Shire, Biogen, Baxter) and startups, Nelly has worked across modalities including cell and gene therapies, biologics, and immunomodulatory nanoparticles.
Her accomplishments include building and operationalizing a Phase 1 cell therapy manufacturing facility that achieved 100% cGMP success and first IND submission within two years. She holds a Ph.D. in Biochemistry and Molecular Biology from the University of Lille 1 Sciences and Technology and a Regulatory Affairs Certificate from RAPS. Nelly is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy, and is regularly invited to speak at international conferences on clinical manufacturing and development innovation in cell therapies.
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