From Breakthrough Science to IND-Ready Development
Strategic development support for novel therapeutics, from preclinical translation through IND readiness and clinical trials.
Who We Help
Supporting teams moving promising science toward IND-enabling development and early clinical translation, with senior scientists on every project.
Comprehensive Advisory Across Every Stage of Development
Regulatory Strategy & FDA Support
- IND Preparation & Submission Support
- FDA Meeting Preparation & Strategy
- Breakthrough Therapy Designation
- Fast Track & RMAT Applications
- Orphan Drug Designation
- Regulatory Pathway Assessment
Preclinical & Translational Science
- Study Design & Protocol Development
- Toxicology & Safety Assessment
- Biodistribution & PK/PD Studies
- Biomarker Strategy & Validation
- Proof-of-Concept Studies
- FDA-Aligned Development Plans
Manufacturing & CMC Excellence
- CMC Development Strategy
- Manufacturing Process Optimization
- Quality Control & Assurance
- Comparability Protocols
- Specifications Development
- Facility & Equipment Validation
Advanced Therapy Innovation
- Cell & Gene Therapy Pathways
- Base Editing & Prime Editing Programs
- RMAT Designation Support
- Long-term Follow-up Studies
- Vector Safety Assessments
- Personalized Medicine Strategies
Bioinformatics & Multi-Omics Analysis
- Bulk RNA-seq analysis
- Single-cell RNA-seq analysis
- Multi-omics integration
- NGS and tumor genomics
- Biomarker discovery
- Publication-ready figures and methods
Scientific Writing & Publication Support
- Manuscript writing and revision
- Responses to reviewer comments
- Abstracts and posters
- Publication planning
- Grant writing support
- Investor deck science sections
"Where others offer advice, we deliver execution."
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.
Our Approach
- Discovery AlignmentEvaluate preclinical data, define regulatory goals, and identify gaps.
- Translational MappingDesign FDA-aligned studies in cells and mouse models to generate robust data.
- Regulatory StrategyDevelop submission-ready documentation and regulatory communication plans.
- Clinical ExecutionSupport protocol design, biomarker planning, and study oversight to ensure IND continuity.
Latest from Our Blog
CellGene Nexus: Services & Client Insights
How consulting support shortens the path from discovery to clinic, how to reach the right experts, and how to judge client testimonials.
Read article →
In Vivo CAR-T in 2026: What It Means for Your IND and Regulatory
In vivo CAR-T is changing how cell therapies are made and regulated. Five questions every program should answer before IND submission.
Read article →FDA Just Opened a New Door for Individualized Gene Therapies
FDA's draft guidance introduces a plausible mechanism framework for individualized therapies in rare and ultra-rare disease.
Read article →Is Your Program Ready for Phase I/II?
The CellGene Nexus 2026 Phase I/II Readiness Checklist is a structured self-assessment for biomarker-driven oncology programs: 59 questions across eight domains, built to surface the gaps that most often delay early-phase programs.
Tell Us About Your Program
Preparing for an IND-enabling study, regulatory interaction, or early clinical development milestone? Tell us where your program stands and where you need support.
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.
- info@cellgenenexus.com
- +1 (346) 281-7094
- Houston, TX, USA