Summary
ADNCA is a CDISC-compliant ADaM dataset purpose-built for Non-Compartmental Analysis (NCA). This webinar will cover the dataset’s structure, its value in regulatory submissions, and its critical role in driving standardized, reproducible workflows. We’ll also demonstrate how ADNCA integrates with validated tools such as Phoenix to ensure compliant, transparent, and efficient pharmacokinetic analyses.
Key Learning Objectives:
Educate attendees on the structure, utility, and regulatory relevance of the ADNCA dataset, showcasing how it enhances traceability, consistency, and compliance in NCA workflows—particularly when integrated with tools like Phoenix.
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Pharmacokinetic Scientist – Consulting
Alexia Di Quinzio, MSc brings a unique blend of scientific rigor and business insight, shaped by experience across both scientific and investment roles in the life sciences sector. At Certara, she supports regulatory and clinical strategies through pharmacokinetic (PK) analyses such as non-compartmental analysis (NCA), dose proportionality, and bioequivalence, contributing to high-quality, submission-ready deliverables.
Before joining Certara, Alexia spent over three years at AmorChem, a Montreal-based venture capital fund, where she evaluated early-stage academic innovations for investment. Her work included scientific due diligence, intellectual property analysis, market assessment, and strategic support for portfolio companies. Earlier in her career, she held roles in GMP operations at Pharmascience Inc., where she contributed to quality system improvements and compliance training initiatives.
Alexia holds a Master of Science in Drug Development from the University of Montreal.
Director of Product Innovation
Jeff Abolafia is currently Director of Product Innovation at Pinnacle 21 and supports multiple offices at the FDA. Previously, Jeff held the position of Chief Strategist of Data Standards and was a member of the faculty in the Department of Biostatistics at the University of North Carolina. Jeff has been involved with public health research and data standards for over thirty years. Jeff co-founded the RTP CDISC User’s Group and is a member of the CDISC ADaM and Analysis Results teams and several PHUSE Real World Evidence working groups. His areas of interest include real world evidence, mobile health, data standards, regulatory submissions, and bioinformatics.
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