Discover this podcast and so much more

Podcasts are free to enjoy without a subscription. We also offer ebooks, audiobooks, and so much more for just $11.99/month.

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

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

FromBusiness Of Biotech


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

FromBusiness Of Biotech

ratings:
Length:
39 minutes
Released:
Sep 8, 2020
Format:
Podcast episode

Description

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. 
Released:
Sep 8, 2020
Format:
Podcast episode

Titles in the series (100)

The Business of Biotech is the pod dedicated to leaders of emerging biopharma firms. We bring you insight into organizational, finance and funding, HR, clinical, manufacturing, and regulatory challenges you’ll face as you navigate your company from an idea to success in the clinic. Each episode features guest commentary and best practices from accomplished founders and biopharma industry luminaries. The Business of Biotech is produced by BioProcess Online and brought to you by Cytiva, formerly GE Healthcare Life Sciences.