Donna Edwards PhD, MPH

Therapeutic Areas: Melanoma – INT Vaccine Programs, Rare Disease, Platform Research Role Level: Strategic Biomarker SME & Functional Lead • Directed biomarker strategy for INT and OTS programs across pre-IND to Phase III, aligning immune-monitoring readouts with mechanistic hypotheses and clinical endpoints, resulting in 20% improvement in patient stratification accuracy using AIM, dextramer, and TCRSeq assays. • Led Whole Blood Stability studies to define processing thresholds for NGS-based INT design, enabling global scalability and supporting regulatory readiness for future IND submissions. • Designed and implemented immune-monitoring assays, including AIM, dextramer, ex vivo expansion, and TCRSeq, to optimize precision dosing and longitudinal profiling, achieving 25% reduction in variability of immune-response data and improving trial efficiency. • Directed exploratory studies across ligand binding, viral vector potency, and multi-omic biomarker technologies, delivering decision-driving data that prioritized three biomarker platforms for development integration. • Delivered biomarker data packages supporting governance milestones and regulatory submissions, accelerating advancement of six oncology and rare disease trials. • Acted as strategic lead for assay selection, collaborating with Clinical, Regulatory, and Immunology teams to implement biomarker plans that achieved 30% reduction in assay turnaround time and ensured alignment with global regulatory standards.

• Developed biomarker strategy from pre-IND through Phase II, establishing sampling plans and SOPs that improved trial readiness by 15% and ensured compliance with regulatory requirements. • Built genomics and big-data biomarker infrastructure, enabling efficient management of 1TB+ of sequencing data across early- and mid-phase trials, improving analysis turnaround time by 40%. • Oversaw development of viral shedding and potency assays to support clinical testing, generating validated data packages that contributed to EU and U.S. regulatory submissions. • Served as biomarker SME for protocol design and dose selection, improving patient stratification accuracy by 18% and supporting successful IND package submissions.

• Directed translational neoantigen-targeting program in smoldering multiple myeloma, delivering proof-of-concept data • Advanced SOX11-targeting inhibitors through in vivo validation and immunophenotyping, producing preclinical data that supported IND-track advancement with biotech collaborators. • Conducted checkpoint blockade resistance studies in bladder and prostate cancer, generating mechanistic insights that informed combination therapy design and advanced two site-sponsored protocols. • Developed immune profiling plans for site-sponsored protocols, positioning assays for correlative analysis that enabled insights into patient response variability.

• Characterized biomarker signatures for aggressive prostate cancer using mIF, qPCR, and RNAi, identifying validated signatures that advanced clinical prioritization of therapeutic targets. • Applied statistical modeling to retrospective translational analyses, generating data that guided target prioritization and informed therapeutic strategies.