About CellTC

Built by scientists. Trusted by institutions.

CellTC was founded by cell therapy researchers who recognized a critical gap: programs failing not from lack of science, but from lack of strategic clarity. We bridge that gap.

40+Peer-reviewed publications in cell therapy
15+Years combined development experience
12IND/CTA submissions supported
3Programs advanced to Phase III

Our Mission

Accelerate the translation of cell therapy science into approved treatments.

We believe the most important breakthroughs in medicine are still ahead — and that rigorous, science-first advisory is what separates programs that reach patients from those that stall in development.

Leadership

The consulting team

EV

Dr. Elena Vasquez

Founder & Principal Consultant

PhD Immunology, MD Oncology

Former Director of Clinical Development at a leading CAR-T biotech. Led three IND submissions and two Phase II trials across hematologic malignancies.

CAR-T DevelopmentClinical StrategyFDA Regulatory Affairs
MC

Dr. Marcus Chen

Senior Advisor, CMC & Manufacturing

PhD Bioprocess Engineering

15 years in cell therapy manufacturing scale-up. Former VP of Process Development at a global CDMO, overseeing autologous and allogeneic platform transitions.

CMC StrategyProcess Scale-UpGMP Compliance
SO

Dr. Sarah Okonkwo

Senior Advisor, Regulatory Affairs

PhD Molecular Biology, RAC

Former Senior Reviewer at the FDA's Office of Tissues and Advanced Therapies. Deep expertise in RMAT designation, BLA submissions, and agency meeting strategy.

FDA OTATRMAT DesignationBLA Strategy

Our Philosophy

No templates. No generalists.

Evidence before strategy

Every recommendation is grounded in a rigorous review of your scientific data, competitive landscape, and regulatory precedent. We do not apply generic frameworks.

Regulatory precision

We write to the agency's expectations — not around them. Our regulatory documents are built to withstand scrutiny, not to check a box.

Long-term partnership

We engage as embedded advisors, not transactional consultants. Our success is measured by your program's advancement, not by deliverable count.

Work with our team.

Schedule a confidential consultation to discuss your program's development challenges.

Schedule a Consultation

For qualified medical and research institutions only.