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New drug approvals in rare diseases are rising, bringing hope to patients. But with accelerated regulatory pathways comes immense pressure on CMC teams to deliver high-quality products under tighter timelines. In our latest Expert Video Series, Deven Shah, 𝗛𝗲𝗮𝗱 𝗼𝗳 𝗖𝗠𝗖 𝗮𝘁 𝗖𝗲𝗿𝘁𝗮𝗿𝗮, shares his perspective on overcoming key challenges—navigating diverse modalities, managing agile manufacturing, and leveraging in silico modeling to optimize formulation and supply strategies.