Senior Director at Appia Bio
Strategic scientific leader with over 15 years of experience in cancer immunology and host-pathogen interactions with broad cross-functional knowledge in discovering and developing engineered cellular therapy products and new modalities from pre-IND to BLA/commercial stages. Core competencies include extensive experience in engineered immunity and cancer immunology, design and implementation of chemistry and manufacturing controls, analytical method development/validation and life cycle management, project leadership and team building. Areas of Expertise • Analytical Method Life Cycle Management – Method development using quality by design (QbD), analytical target profile (ATP), and design of experiment (DOE) approaches; method qualification and validation per ICH guidelines; implementation of risk-based approaches (method FMEA) for phase-appropriate life cycle management; phase-appropriate analytical method control strategies; analytical method tech transfer to clinical and commercial QC; continuous method monitoring, systematic deep-dive analyses of method performance, and implementation of method improvements to reduce invalid rates in commercial QC; implementation of new technologies into clinical and commercial QC • Product Quality Systems – Establishment of early and late target product profile (TPP/QTPP); development of phase-appropriate analytical methods for understanding process parameters, and product and material attributes; risk-based approaches (PQRA) to assigning critical quality/material attributes (CQA/MQA) and critical process parameters (process FMEA); implementation of analytical control strategies • Chemistry, Manufacturing and Controls – Author and review pre-IND briefing booklet, IND, BLA and MAA sections (Module 3; e.g. drug substance, drug product, elucidation of structure, analytical methods and controls); response to questions (RTQ); CMC strategies for analytical methods and controls
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