Cell Therapy Consulting: Our Expert Team
A Team Built for Regulatory Excellence
PhD scientists, certified project managers, government mentors, venture advisors, and active cancer researchers come together as a consulting firm united by one mission: accelerating the FDA approval process to get your cell therapy to patients faster.
Dr. Abhijit Chakraborty, Ph.D, PMP; Founder & CEO
The Rare Combination of Scientific Depth & Execution
Abhijit founded CellGene Nexus, a consulting firm specializing in cell therapy, to address a recurring gap in the Texas biotech ecosystem: early-stage oncology and cell/gene therapy programs that showcase breakthrough science but lack a clear path to FDA approval. As a PhD scientist and certified Project Management Professional, Abhijit offers a unique blend of rigorous scientific judgment and disciplined execution that few regulatory consultants can match.
His approach is direct and senior-level: every engagement is personally led by Abhijit, ensuring there are no junior hand-offs and no vague advice. Clients benefit from a precise gap analysis, a prioritized remediation plan, and structured milestone tracking from the initial call to IND submission. Programs that collaborate with Abhijit always understand their progress at every stage of development.
Rooted in the Houston/TMC ecosystem, the world's largest medical center, Abhijit connects clients to a network of trusted CROs, CDMOs, and translational partners while maintaining a reach that is scalable nationwide.
Dr. Dhriti Roy, Ph.D. MBA; Chief Regulatory & Strategy Advisor · MedTech Mentor · VC Limited Partner (LP)
Regulatory Thought Leader at the Intersection of Science, Policy & Capital
Dr. Roy is a regulatory thought leader whose influence spans government, academia, and venture capital—a rare profile that makes her uniquely valuable to early-stage healthcare founders, especially in the cell therapy sector, as they navigate complex FDA approval and market access challenges. As a U.S. Department of Commerce MedTech Mentor, she advises founders and investors directly on FDA readiness, regulatory risk, and scalable execution strategies.
At Oxford, she serves as a life sciences platform leader, contributing regulatory and operational judgment to some of the most promising early-stage healthcare innovations emerging from the UK and European ecosystems. Her work at Oxford bridges the gap between academic discovery and commercialization—the same gap that the consulting firm, CellGene Nexus, was built to close in the U.S.
As a limited partner in select venture capital firms, Dr. Roy brings an investor's perspective to regulatory strategy, understanding not just what the FDA requires, but also what de-risked regulatory milestones mean for fundraising, valuation, and long-term program viability. Her advisory role at CellGene Nexus ensures that clients benefit from regulatory guidance that aligns with both scientific rigor and capital market realities.
Dr. Faisal Aziz, Ph.D ; Scientific Director · Drug Discovery · T-Cell · Immunotherapy
Translational Oncology Scientist Bridging Molecular Discovery & Therapeutic Innovation
Dr. Faisal Aziz is a Scientist at the Hormel Institute, University of Minnesota, one of the nation's leading cancer research centers. His work sits at the intersection of drug discovery, nucleotide metabolism, T-cell immunotherapy, and cancer biology; this combination of expertise is particularly relevant to the next generation of cell therapy programs supported by CellGene Nexus, a prominent consulting firm in the field.
His research is distinguished by a deep focus on the molecular mechanisms underlying gastric and inflammation-associated cancers. By integrating structural biology, immunology, and translational disease models, Dr. Aziz aims to uncover therapeutic pathways and identify novel disease biomarkers. These discoveries can significantly inform drug development strategies and facilitate FDA approval processes. His expertise in protein structure function analysis, enzymology, and animal model development provides CellGene Nexus clients with rigorous preclinical scientific guidance rooted in active, published research.
An accomplished scholar, Dr. Aziz has authored numerous peer-reviewed publications and actively contributes to the scientific community as a manuscript reviewer and editorial board member for several international biomedical journals. His perspective spans oncology, infectious disease therapeutics, and molecular medicine, offering CellGene Nexus clients scientific advisory support that is current, credible, and deeply grounded in translational research practice.
Why Our Team Is Different
Expert Guidance
Our consulting firm specializes in MedTech, including cell therapy, and has a deep understanding of the regulatory landscapes required for FDA approval. We offer clients the expert guidance needed to navigate these challenges, focusing on delivering actionable advice backed by scientific evidence.
Government & Academic Credibility
With a U.S. Department of Commerce mentor and an Oxford platform leader on the advisory team, CellGene Nexus operates as a consulting firm that specializes in cell therapy, carrying a level of institutional credibility that signals trust to investors and the FDA alike.
Investor-Aligned Regulatory Strategy
Dr. Roy's venture capital experience means that regulatory milestones are structured to de-risk your cell therapy program for fundraising — not just for FDA approval. This approach demonstrates how science and capital strategy can work together, enhancing the value of a consulting firm in this space.
PMP Project Discipline
Abhijit's Project Management Professional certification means your IND timeline for cell therapy is managed with the rigor of a structured project, ensuring clear milestones, accountability, and no surprises as we navigate the path to FDA approval through our consulting firm.
Active Research-Not Just Consulting
Dr. Aziz actively publishes at the Hormel Institute, University of Minnesota, bringing a preclinical strategy informed by ongoing work in cell therapy rather than insights from someone who left the bench years ago. This hands-on experience supports his consulting firm in guiding clients through the complexities of gaining FDA approval.
T-Cell & Immunotherapy Depth
With Dr. Chakraborty and Dr. Aziz's expertise in T-cell immunotherapy, nucleotide metabolism, and biomarker discovery, CellGene Nexus serves as a consulting firm that provides scientific advisory support, directly enhancing cell therapy development and facilitating FDA approval for CAR-T and cell therapy IND packages.