CellGene Nexus
CellGene Nexus
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Is your startup truly ready for the FDA?
  • Home
  • About
  • Our Team
  • Services
  • Insights
  • Contact Us
Is your startup truly ready for the FDA?

Our Scientific Consulting

Oncology Spinouts

Academic Partnerships

Oncology Spinouts

Streamlined an early-phase oncology spinout’s IND-enabling workflow, reducing time-to-submission by 40% and improving FDA alignment through biomarker-driven study design.

Gene Therapy

Academic Partnerships

Oncology Spinouts

Designed a dual-AAV preclinical plan and biomarker roadmap that supported seamless IND preparation for a gene therapy startup.

Academic Partnerships

Academic Partnerships

Academic Partnerships

Converted exploratory mouse model data into a GLP-aware regulatory study package adopted by a partnering CRO.

Guiding You from Discovery to IND.

Key Insights in Early-Stage Science

Key Insights in Early-Stage Science

Key Insights in Early-Stage Science

From discovery to IND: 7 avoidable mistakes in early-stage oncology and gene therapy programs.

Mention “IND guide” when you contact us and we’ll walk you through the core checklist live.

Partnering for Progress

Key Insights in Early-Stage Science

Key Insights in Early-Stage Science

We partner with accelerators, incubators, and investor groups to deliver workshops and strategy sessions on IND readiness.

To explore a session for your portfolio or program, get in touch via the contact form.

Pioneering Cell & Gene Tech

Coming soon: CellGene IND Navigator™ -  a proprietary framework to assess and accelerate IND readiness across preclinical and regulatory milestones.

Discover Our Solutions

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