How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development.

Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why documenting your assumptions is critical to managing risk, and what it really takes to maintain resilience when you're literally holding patient lives in your hands.

A few of Nelly's key takeaways:

Resilience is adaptability—build organizations that absorb and anticipate change rather than resist it
Separate innovation from execution with intentional gates for when new approaches are ready to implement
Document your assumptions so you can revisit decisions effectively when circumstances change
Failure is a process problem, not a personal one—root cause analysis should improve systems, not assign blame
Data is the common language that aligns scientists, regulators, and stakeholders
Everyone is a leader in cell therapy—manufacturing and QC teams hold patient lives in their hands

About Nelly Viseux

Nelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, leading a 100-person organization supporting autologous cell therapy programs. She has over 20 years of biotechnology experience spanning large pharma (Shire, Biogen, Baxter) and startups, working across cell and gene therapies, biologics, and nanoparticles. Her accomplishments include building 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 University of Lille and is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy.

About The FDA Group

The FDA Group helps life science organizations rapidly access the industry’s best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/

Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux

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