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.
Bridging discovery science and clinical success.
Regulatory Strategy & FDA Engagement
Preclinical & Translational Development
Preclinical & Translational Development
- IND Preparation & Submission Support
- FDA Meeting Preparation & Strategy
- Breakthrough Therapy Designation
- Fast Track & RMAT Applications
- Orphan Drug Designation
- Regulatory Pathway Assessment
Preclinical & Translational Development
Preclinical & Translational Development
Preclinical & Translational Development
- Study Design & Protocol Development
- Toxicology & Safety Assessment
- Biodistribution & PK/PD Studies
- Biomarker Strategy & Validation
- Proof-of-Concept Studies
- FDA-Aligned Development Plans
Clinical Development & Trial Design
Preclinical & Translational Development
Clinical Development & Trial Design
- Clinical Protocol Development
- Phase I-III Trial Design
- Patient Stratification Strategies
- Safety & Efficacy Endpoints
- Regulatory-Compliant Documentation
- Clinical Data Management
CMC & Manufacturing Strategy
CMC & Manufacturing Strategy
Clinical Development & Trial Design
- CMC Development Strategy
- Manufacturing Process Optimization
- Quality Control & Assurance
- Comparability Protocols
- Specifications Development
- Facility & Equipment Validation
Advanced Therapy Development
CMC & Manufacturing Strategy
Advanced Therapy Development
- Cell & Gene Therapy Pathways
- RMAT Designation Support
- Long-term Follow-up Studies
- Vector Safety Assessments
- Personalized Medicine Strategies
- Natural History Studies
Scientific Communications
CMC & Manufacturing Strategy
Advanced Therapy Development
- Regulatory Writing & Submissions
- Publication Strategy & Development
- Abstracts, Posters & Manuscripts
- Scientific Storytelling
- Grant Preparation Support
- Investigator Brochures
Why Choose CellGene Nexus?
Strategic science. Measurable impact. Real-world translation
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.
Positioning
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 Process
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.
Contact Us
Tell us about your program.
Share a brief overview of your program and timelines. We’ll respond with a suggested next step, whether that’s a Strategy Intensive or a deeper Navigator engagement.
Not sure which service fits? Briefly describe your program stage and main challenge. We’ll recommend a fit or point you in the right direction.
Email: info@cellgenenexus.com
Houston, TX, USA
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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