Faster Paths from Lab to Life
Expert guidance for novel therapeutics. We transform science into FDA approval.
Faster Paths from Lab to Life
Expert guidance for novel therapeutics. We transform science into FDA approval.
Connecting Science & Real-World Impact.
Regulatory Success & FDA Support
Preclinical & Translational Insights
Preclinical & Translational Insights
- IND Preparation & Submission Support
- FDA Meeting Preparation & Strategy
- Breakthrough Therapy Designation
- Fast Track & RMAT Applications
- Orphan Drug Designation
- Regulatory Pathway Assessment
Preclinical & Translational Insights
Preclinical & Translational Insights
Preclinical & Translational Insights
- Study Design & Protocol Development
- Toxicology & Safety Assessment
- Biodistribution & PK/PD Studies
- Biomarker Strategy & Validation
- Proof-of-Concept Studies
- FDA-Aligned Development Plans
Clinical Strategies & Trials
Preclinical & Translational Insights
Manufacturing & CMC Excellence
- Clinical Protocol Development
- Phase I-III Trial Design
- Patient Stratification Strategies
- Safety & Efficacy Endpoints
- Regulatory-Compliant Documentation
- Clinical Data Management
Manufacturing & CMC Excellence
Innovate with Advanced Therapies
Manufacturing & CMC Excellence
- CMC Development Strategy
- Manufacturing Process Optimization
- Quality Control & Assurance
- Comparability Protocols
- Specifications Development
- Facility & Equipment Validation
Innovate with Advanced Therapies
Innovate with Advanced Therapies
Innovate with Advanced Therapies
- Cell & Gene Therapy Pathways
- RMAT Designation Support
- Long-term Follow-up Studies
- Vector Safety Assessments
- Personalized Medicine Strategies
- Natural History Studies
Scientific Publishing & Outreach
Innovate with Advanced Therapies
Innovate with Advanced Therapies
- Regulatory Writing & Submissions
- Publication Strategy & Development
- Abstracts, Posters & Manuscripts
- Scientific Storytelling
- Grant Preparation Support
- Investigator Brochures
Why Select CellGene Nexus?
Impactful Science, Real Results
We are the only consulting firm in Texas focused exclusively on early-stage oncology and gene therapy translation bridging academic discovery and IND readiness. Our team merges scientific, translational, and regulatory insight into one cohesive solution.
Our Philosophy
- Fast, founder-to-founder collaboration that delivers clarity in days, not months.
- Senior-level expertise on every project.
- Value-based, outcome-driven engagements designed for IND success.
- End-to-end alignment between discovery and clinical execution.
Our Edge
Texas-first, nationally scalable. We anchor in the Houston/TMC ecosystem and extend through partnerships with CROs, accelerators, and translational networks.
Where others offer advice, we deliver execution.
Our Approach
Clarity, compliance, and collaboration at every stage of translation.
- Discovery Alignment: Evaluate preclinical data, define regulatory goals, and identify gaps.
- Translational Mapping: Design FDA-aligned studies in cells and mouse models to generate robust data.
- Regulatory Strategy: Develop submission-ready documentation and regulatory communication plans.
- Clinical Execution: Support protocol design, biomarker planning, and study oversight to ensure IND continuity.
This framework advances every program toward FDA submission efficiently and confidently.
Download our 2026 Pre-IND Readiness Checklist to identify critical gaps in your oncology or cell therapy program before your next regulatory milestone.
Get Your 2026 Readiness Checklist (pdf)
DownloadGet in Touch
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Email: info@cellgenenexus.com
Houston, TX, USA
Business Hours
Mon | 09:00 am – 05:00 pm | |
Tue | 09:00 am – 05:00 pm | |
Wed | 09:00 am – 05:00 pm | |
Thu | 09:00 am – 05:00 pm | |
Fri | 09:00 am – 05:00 pm | |
Sat | Closed | |
Sun | Closed |
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