I have scientific expertise in early phase oncology clinical trial design, patient-centric Clinical Outcome Assessments (COA), and real-world evidence projects to deliver world-class data and help speed innovative therapies to critically ill cancer patients. As a health economics and outcomes research (HEOR) scientist and data scientist in the pharmaceutical and CRO settings, I have collaborated extensively with medical, statistics, regulatory, international, and commercial colleagues to design, execute, and disclose early- and late-phase clinical trials. These oncology clinical trials included first-in-human Phase I trials, dose-optimizing Phase II trials, registration Phase II and III trials, and post-approval Phase IV studies. Tumor types supported include multiple hematologic tumors and solid tumors.
My global launch experience includes multiple breast cancer indications for Eli Lilly’s daily oral CDK4 and 6 inhibitor Verzenio® (abemaciclib) from 2017 through 2021. In 2023, Verzenio® was Lilly’s top-selling oncolytic and No. 3 overall for Lilly with global sales of $3.8 billion. Beyond clinical trial support, I led systematic literature reviews, real-world evidence projects, budget impact model efforts, and the U.S. payer value and evidence AMCP dossiers. I also contributed to patient, payer, and thought-leader advisory boards, companion diagnostic strategy, and HEOR-related innovations.
Prior to Lilly, I worked as a data scientist at Covance Central Laboratories, reviewing and delivering customized files for registration trial results for several medications. Later, I served as the corporate liaison from Covance stationed at Lilly to ensure key client support and timely issue resolution. With sponsor and vendor work experience, I understand the nuances of cancer and non-cancer trial design. I authored protocols, analysis plans, FDA/EMA briefing books, payer reimbursement dossiers, and peer-reviewed disclosures for multiple tumor types.
Since retiring from Lilly, I became a consultant for the Cancer Drug Discovery and Development Accelerator (CD3A) at the IU Simon Comprehensive Cancer Center in 2023.
Key Milestone Expertise in Drug Discovery & Development:
- IND enabling
- Phase I-III trials
