End-to-end advisory from discovery to IND
CellGene Nexus provides senior-level regulatory, scientific, and data expertise across six integrated service pillars — designed to move cell and gene therapy programs from preclinical data to FDA submission with speed and precision.
Regulatory Strategy & FDA Support
Navigate the FDA with confidence — not guesswork.Regulatory missteps are the single most common cause of IND delays. Our team brings direct FDA engagement experience and a deep understanding of CBER's current expectations for cell and gene therapy programs. We work alongside your team from the earliest stages to build a regulatory strategy that is defensible, efficient, and aligned with your clinical and commercial goals.
Services included
- IND Preparation & Submission Support
- FDA Meeting Preparation & Strategy
- Breakthrough Therapy Designation
- Fast Track & RMAT Applications
- Orphan Drug Designation
- Regulatory Pathway Assessment
Who this is for
- Biotech startups preparing their first IND submission
- Programs seeking Breakthrough Therapy, Fast Track, or RMAT designation
- Teams that have received a clinical hold or FDA deficiency letter
- Founders preparing for a pre-IND meeting with CBER
What you get
- A clear, written regulatory pathway with milestone dates
- A pre-IND meeting package that maximizes FDA engagement
- Designation applications that strengthen your program's profile
- Reduced risk of clinical holds and submission deficiencies
Preclinical & Translational Science
Build the preclinical package the FDA expects to see.A strong IND rests on a rigorous, well-documented preclinical foundation. We help you design studies that generate the right data — not just any data — and translate your scientific findings into a coherent narrative that supports your clinical hypothesis and satisfies FDA reviewers. Our team has hands-on experience designing and interpreting studies for CAR-T, TCR-T, and gene-edited cell therapy programs.
Services included
- Study Design & Protocol Development
- Toxicology & Safety Assessment
- Biodistribution & PK/PD Studies
- Biomarker Strategy & Validation
- Proof-of-Concept Studies
- FDA-Aligned Development Plans
Who this is for
- Programs with promising in vitro data that need to move into in vivo models
- Teams designing toxicology and safety packages for IND submission
- Founders who need to identify and close preclinical data gaps before a pre-IND meeting
- Programs developing biomarker strategies for early clinical trials
What you get
- An FDA-aligned preclinical development plan with clear study sequencing
- Toxicology and safety data packages that meet CBER expectations
- Biomarker strategies that support both regulatory and clinical objectives
- A preclinical narrative that translates seamlessly into your IND
Manufacturing & CMC Excellence
CMC is where most early-stage programs lose time. We help you get it right.The Chemistry, Manufacturing, and Controls section is consistently the most technically demanding part of an IND submission — and the most common source of FDA deficiencies for cell therapy programs. We provide hands-on CMC strategy and documentation support, working directly with your manufacturing team or CDMO to ensure your processes, controls, and specifications meet current FDA expectations.
Services included
- CMC Development Strategy
- Manufacturing Process Optimization
- Quality Control & Assurance
- Comparability Protocols
- Specifications Development
- Facility & Equipment Validation
Who this is for
- Programs transitioning from research-grade to GMP manufacturing
- Teams working with a CDMO who need independent CMC oversight
- Founders preparing the CMC section of their first IND
- Programs that have received CMC-related FDA deficiency letters
What you get
- A CMC development strategy aligned with your IND timeline
- Manufacturing process documentation that meets GMP standards
- Specifications and release criteria that satisfy FDA reviewers
- A comparability framework for post-IND manufacturing changes
Advanced Therapy Innovation
Purpose-built expertise for the most complex modalities in medicine.Cell and gene therapies operate under a distinct regulatory framework — one that is still evolving. Our team has direct experience with RMAT designation, long-term follow-up requirements, vector safety assessments, and the specialized regulatory pathways that apply to CAR-T, TCR-T, gene-edited cells, and other advanced therapy medicinal products. That includes next-generation editing platforms such as base editing and prime editing, where off-target analysis and editing-outcome characterization shape what the FDA expects to see. We help you navigate the complexity without slowing your program down.
Services included
- Cell & Gene Therapy Pathways
- Base Editing & Prime Editing Programs
- RMAT Designation Support
- Long-term Follow-up Studies
- Vector Safety Assessments
- Personalized Medicine Strategies
- Natural History Studies
Who this is for
- CAR-T and TCR-T programs approaching IND submission
- Gene-edited cell therapy programs navigating RMAT designation
- Base editing and prime editing programs planning off-target and genotoxicity assessments
- Teams designing long-term follow-up protocols for FDA compliance
- Founders developing natural history studies to support rare disease designations
What you get
- RMAT designation applications grounded in current FDA guidance
- Off-target and editing-outcome characterization plans for base- and prime-edited products
- Long-term follow-up protocols that satisfy CBER requirements
- Vector safety assessment packages aligned with FDA expectations
- Specialized regulatory strategies for rare and ultra-rare indications
Bioinformatics & Multi-Omics Analysis
We turn sequencing data into clear biology, publication-ready figures, and answers to your next experimental question.Genomic and multi-omics data is only as valuable as your ability to interpret it. Our bioinformatics team works directly with academic labs, core-facility users, and biotech teams to transform raw sequencing data into rigorous, reproducible analyses — from bulk RNA-seq to single-cell profiling to multi-omics integration. Every deliverable is documented, reproducible, and ready to support your next grant, publication, or regulatory filing.
Services included
- Bulk RNA-seq: QC, differential expression, pathway and gene set analysis
- Single-cell RNA-seq: clustering, cell type annotation, trajectories, cell-cell communication
- Multi-omics integration across transcriptomics, epigenomics, and proteomics
- NGS and tumor genomics: variant calling, annotation, and biomarker discovery
- Analysis of mouse model and patient-derived samples
- Reproducible code, figures, and a methods section ready for your manuscript
Who this is for
- Academic labs and core-facility users with sequencing data and a question to answer
- Biotech teams needing publication-quality figures and a methods section
- Programs integrating transcriptomics, epigenomics, and proteomics datasets
- Teams performing tumor genomics or patient-derived sample analysis
What you get
- An analysis report with publication-quality figures
- Processed data with fully documented, reproducible code
- Biomarker candidates and pathway insights ready for follow-up experiments
- A methods section ready for your manuscript or regulatory submission
Scientific Writing & Publication Support
We help your work get published, presented, and funded.Strong science deserves strong writing. Our team brings more than 300 peer-reviewed publications and multiple journal editorial roles in oncology and cell biology to every engagement. Whether you are preparing a manuscript for a high-impact journal, responding to reviewer comments, or building a grant application, we work alongside your team to produce submission-ready documents that communicate your science with clarity and precision.
Services included
- Manuscript writing, editing, and revision for peer-reviewed journals
- Responses to reviewer comments
- Conference abstracts and posters (ASCO, AACR, ASH, SITC, ASGCT)
- Publication planning across a program
- Grant writing support (NIH, CPRIT, SBIR/STTR)
- Science sections for investor pitch decks
Who this is for
- Labs and companies with results ready to share, or deadlines coming up
- Teams preparing manuscripts for peer-reviewed journals in oncology or cell biology
- Programs submitting NIH, CPRIT, or SBIR/STTR grant applications
- Founders who need science sections for investor pitch decks
What you get
- Submission-ready manuscript drafts, figures, and formatted files for your target journal
- Polished responses to reviewer comments that strengthen your submission
- Conference abstracts and posters formatted for ASCO, AACR, ASH, SITC, or ASGCT
- Grant applications and science sections that communicate your program's value
How we work with you
Every engagement begins with a Discovery Call — a focused conversation to understand your program, identify your most pressing gaps, and determine where we can add the most value.
Discovery Call
A 45-minute conversation to understand your program stage, regulatory history, and most urgent needs. No charge, no obligation.
Gap Assessment
We review your existing data, documentation, and regulatory history to identify the gaps that pose the greatest risk to your IND timeline.
Engagement Design
We propose a focused, value-based engagement scoped to your specific needs — not a retainer for work you do not need.
Execution & Delivery
Senior-level experts work directly on your program. You get clear deliverables, defined timelines, and direct access to the people doing the work.
Ready to discuss your program?
Book a Discovery Call with our team. We will review your current stage, identify your most critical gaps, and tell you honestly where we can help.
Book a Discovery Call