About Me

Tressa Allington, PhD

• Over 15 years of experience in biopharmaceutical development including therapies for rare diseases, neurology, metabolics, oncology, hematology, and gene therapies

• Led 10+ acquisitions from preclinical to commercial, defending integrations in MHRA, EMA, and FDA inspections.

• Scientific expertise in bioanalytical analysis, assay validation, data integrity, immunogenicity strategy, and GLP compliance.

• Extensive experience in clinical development, GCP compliance, CRO oversight, regulatory writing (IND/BLA/CTD/MAA), and inspections.

• Hands-on experience bringing therapies from preclinical to market approval.

• Cross-functional leader across clinical ops, data management, stats, IT, Quality, Regulatory, CMC, and clinical supply.

• Expert in ICH E6 GCP gap analysis, risk-based quality management, and ICH Q9 risk management.

• Detail-driven project manager, effective communicator, and enthusiastic team leader.

• Passionate about execution and collaboration with diverse teams.