Embedding Regulatory Strategy in Cell and Gene Therapy Development
In this GEN webinar, experts from Rose BioSolutions, a CDMO and Cell Solutions organization formed from Charles River Laboratories’ businesses, will discuss how integrating regulatory strategy at the earliest stages of development can reduce overall risk and improve program outcomes. The post Embedding Regulatory Strategy in Cell and Gene Therapy Development appeared first on GEN - Genetic…
Jeffrey Mocny, VP of Scientific Leadership at Rose BioSolutions, is dedicated to translating client needs into concrete development and manufacturing strategies. His team, comprising scientists skilled in various fields such as cell and molecular biology, virology, immunology, immunotherapy, T-cell biology, and viral vector transduction, ensures the programs align with regulatory requirements while offering scientific backing for manufacturing methods.
Mocny, a PhD holder from SUNY at Buffalo, brings extensive experience in quality management, strategic planning, and risk mitigation to guide projects from initial concept to completion. His career, spanning over two decades, is marked by innovation in both CDMO and CRO sectors, encompassing analytical, manufacturing, market entry/positioning, and regulatory strategy facets.
Felicia Irons, the Global CDMO Regulatory Affairs & Compliance Lead at Rose BioSolutions, guarantees top-tier quality, regulatory compliance, and safety for all cell and gene therapy programs within the company’s CDMO unit. A certified Six Sigma Green Belt and member of several professional organizations, including RAPS and PDA, Irons has held significant roles in regulatory affairs across multiple companies, including Charles River Laboratories, Natureplex, PharMEDium Services, and Drexel Chemical.
She holds a BS in chemistry and biochemistry from the University of Memphis and has a keen interest in community service, particularly in youth mentorship, through her foundation, JusLuv Community Foundation.
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