Regulatory Roundup, 4/3/2023 edition

Welcome to the DHC Regulatory Roundup, a new feature courtesy of our stableful of Regulatory experts. For this quarter’s inaugural edition, we’ve got a 2-for-1 content drop in which:

    we begin with a brief overview and FAQ on CATT
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Lunch & Learn takeaways (ATW23)

During Phacilitate’s Advanced Therapies Week ’23 in Miami last week, our former-FDA panel of regulatory experts got together to answer audience questions about both early- and late-stage regulatory concerns during the DHC Lunch & Learn activities. We’ve compiled the questions …

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CEO Anthony Davies on “Gottlieb’s math”

By Dan StantonBioProcess International

“With cell and gene therapies coming of age, experts at Advanced Therapies Week looked to reducing COGs, novel payer models, and even biosimilars to tackle their spiraling price tags…

Read entire article here:…

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Anthony offers insights with Endpoints News

In early April, Endpoints News published “Avoiding Cell Therapy Manufacturing Gridlocks — a Do’s and Don’ts Guide,” in which guidance by our CEO, Anthony Davies, figured prominently. (One of his many quotes is above in the header on this page.)…

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