1. EachPod

007: Quality Data For FDA Submissions With Dr. Robert Hariri

Author
Matt Pillar
Published
Tue 08 Sep 2020
Episode Link
None

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If ever a biotech unwittingly begged for FDA scrutiny by virtue of its business model, it was Celularity. The company is working on a host of biologic therapies, the development of which is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. That's an approach that simply begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent discussion on the importance of data quality and complete master files for FDA submissions. 

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