Johnson & Johnson
PROJECT
Expanding Patient Access to a Phase III Lung Cancer Trial
ROLE
Clinical Trial Associate (Portfolio Delivery Operations Co-op)
TIMELINE
November 2022 – May 2023
TEAM
Strategy and Business Transformation Group, Senior Corporate Counsel, Procurement
Sponsor
Johnson & Johnson Innovative Medicine
Investigational Agent
Rybrevant® (amivantamab-vmjw)
Study Design
Phase III, global, multi-site oncology trial
Disease Area
EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
NCT04606381
01 Summary
I streamlined contract agreements for a Phase III Rybrevant® trial by bringing on an external patient-matching vendor, one using molecular data to identify eligible NSCLC patients before traditional enrollment. I worked with Senior Corporate Counsel to set the data-sharing and compliance terms, with projected expanded access to over 800 patients across 20 countries.
CORE COMPETENCIES:
Contract Development and Negotiation, Vendor Management, Regulatory Compliance, Biomarker Patient-Matching Strategy, Cross-Functional Coordination
02 Approach
I engaged a biomarker-based patient-matching vendor to evaluate integration with two ongoing J&J Phase III NSCLC trials. I mapped the referral workflow end to end, from tumor sequencing through physician outreach to site referral, and synthesized concept review decks for Senior Corporate Counsel and Procurement. Through an iterative review process, I refined the vendor engagement to strengthen data-sharing terms, compliance guardrails, and the proposed scope of services and pricing, before the proposal was presented to leadership as a formal proof-of-concept.
03 Impact
The two trials I supported had a combined planned enrollment of 800+ patients across 20+ countries. The underlying therapy, amivantamab plus lazertinib, went on to receive FDA approval in 2024 as the first chemotherapy-free combination regimen shown to outperform the prior standard of care for EGFR-mutated non-small-cell lung cancer.
