Dr. Eleanor Voss
Oncology · Immunotherapy · Phase I–III · Regulatory Affairs
Academic Origins &
Early Discoveries
Fifteen years building the methodological foundation that would later underpin Phase III pivotal trials across four continents.
Doctoral Research in Tumor Immunology
Developed the checkpoint inhibitor response-prediction model that became the basis for three IND applications. Thesis committee included two FDA advisory board members — a relationship that shaped every regulatory submission since.
Postdoctoral Fellowship — Translational Oncology
First-author on seven publications in Nature Medicine and The Lancet Oncology during fellowship. Co-designed the biomarker panel now licensed by three major diagnostic laboratories.
Assistant Professor — Clinical Trials Unit
Launched the Early Phase Trials Program that enrolled 640 patients across 11 Phase I studies in four years. Secured $8.4M in NIH R01 funding across two competing renewals.
"Eleanor's biomarker work didn't just predict response — it redefined how we design eligibility criteria for immunotherapy trials."
Pivotal Phase II & III
Trial Leadership
Serving as Principal Investigator on trials that moved from IND application to NDA submission — 18,000+ patients enrolled across 47 protocols.
VORANT-201
MERIDIAN-PRIME
CATALYST-01
AXIOM-BRCA
MERIDIAN-PRIME led to FDA Breakthrough Therapy Designation
The Phase III data package, authored under Dr. Voss's leadership, secured Breakthrough Therapy Designation in April 2022 — accelerating the NDA review timeline by an estimated 14 months.
Publication
Record
312 peer-reviewed publications. 28,400+ total citations. h-index 54.
Predictive biomarkers for anti-PD-1 response in advanced NSCLC: a prospective cohort study
MERIDIAN-PRIME: nivolumab plus ipilimumab versus ipilimumab alone in metastatic melanoma
Tumor microenvironment remodeling as a predictor of checkpoint inhibitor efficacy
BRCA1/2 mutation status and PARP inhibitor sensitivity in ovarian cancer: AXIOM-BRCA outcomes
Phase I dose-escalation of CTLA-4 blockade with concurrent VEGFR inhibition in renal carcinoma
The record, in their words
Working with Eleanor on MERIDIAN-PRIME was unlike any PI relationship I've had. She anticipates FDA queries before they're asked — her regulatory instinct saved us four months on the NDA timeline.
Her enrollment velocity is extraordinary. VORANT-201 hit 95% of target enrollment in 11 months — a protocol that most sites would have struggled to fill in three years.
The biomarker framework Eleanor developed is now the standard our entire oncology pipeline uses for eligibility stratification. That's not a contribution — that's infrastructure.
Invited Lectures
& Recognition
94 invited lectures across ASCO, ESMO, AACR, and FDA advisory panels. The field calls when the data needs interpreting.
Biomarker-Driven Patient Selection in Immunotherapy: Moving Beyond PD-L1
The MERIDIAN-PRIME Dataset: Implications for Front-Line Melanoma Treatment
Regulatory Perspectives on Surrogate Endpoints in Immuno-Oncology
VORANT-201 Final Analysis: Predictive Modeling in NSCLC PD-L1 ≥50%
Tumor Microenvironment Remodeling: From Mechanism to Clinical Application
Combination Checkpoint Strategies: Lessons from 47 Protocols
The data makes the case.
The next step is yours.
Whether you're assembling a site network, scouting a Principal Investigator, or seeking a co-author whose enrollment track record backs every manuscript — reach out.