Programs advanced. Outcomes delivered.

Challenge

A mid-size biotech had accumulated 18 months of preclinical data but lacked a coherent regulatory strategy to advance to first-in-human studies. Their IND package had been informally reviewed and flagged for CMC deficiencies.

Approach

CellTC conducted a full gap analysis of the existing CMC documentation, restructured the manufacturing process description, and developed a risk-based comparability framework. We prepared the team for a pre-IND meeting with FDA OTAT and drafted the complete IND submission.

Outcome

IND cleared without clinical hold within 30 days of submission. Phase I trial initiated on schedule.

Challenge

An academic medical center spinout had compelling early clinical data for an allogeneic NK cell therapy in a rare solid tumor indication but lacked the regulatory expertise to pursue expedited designation pathways.

Approach

CellTC assessed the clinical dataset against RMAT eligibility criteria, identified the strongest evidentiary arguments, and authored the designation request. We coordinated with the clinical team to ensure the data presentation aligned with FDA's expectations for serious and life-threatening conditions.

Outcome

RMAT designation granted on first submission. Program subsequently attracted Series B financing citing the designation as a key de-risking milestone.

Challenge

A Phase II-stage company faced a critical inflection point: their autologous manufacturing process was not scalable to support a potential BLA and commercial launch. CDMO capacity constraints and process variability were threatening their development timeline.

Approach

CellTC performed a comprehensive process characterization review, identified the critical quality attributes driving variability, and developed a technology transfer package for a qualified CDMO partner. We led the CDMO selection process and authored the comparability protocol bridging clinical and commercial batches.

Outcome

Technology transfer completed in 9 months. Comparability data accepted by FDA at Type B meeting. Commercial manufacturing readiness achieved ahead of BLA submission timeline.

Challenge

A European biotech developing a TCR-T cell therapy for a pediatric oncology indication needed to establish a parallel EU regulatory strategy alongside their US program. They had no prior EMA experience and faced a compressed timeline driven by investor milestones.

Approach

CellTC mapped the EU regulatory pathway, identified PRIME designation eligibility based on the unmet medical need profile, and authored the designation request. Following successful designation, we led the CTA preparation and coordinated with the national competent authority for the lead member state.

Outcome

PRIME designation granted. CTA approved in lead member state within 60 days. First patient enrolled in EU cohort within 4 months of CTA approval.