Manufacturing & Analytical Characterization
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Neha Shah, Ph.D.
Director, Product Development
Societal CDMO
Gainesville, Georgia
Kiran Pedada, Ph.D.
Associate Director, Analytical Development
Societal CDMO
Gainesville, Georgia
Description: Focus on good early drug product CMC development strategy is critical for commercial success. A well-structured forward-looking, and phase-appropriate CMC development strategy, including risk assessments and mitigation plans at various stages, is crucial for avoiding late-stage roadblocks, dead-ends, and rework. Good decisions in early CMC development can provide flexibility for the clinic, faster and lower cost development, and a more streamlined commercial manufacturing process that provides better results and lower unit conversion costs.