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Cloud-based data systems in drug regulation: an industry perspective

Cloud-based systems for data submitted by sponsors to drug regulatory agencies have the potential to accelerate drug development, streamline regulatory review and enhance regulatory decision-making. Here, we provide a vision for integrating cloud-enabled practices in drug regulation globally.
Sanofi, Cambridge, MA, USA.
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Sanofi, Cambridge, MA, USA. Serves as Chief Regulatory Officer or equivalent position.

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Roche/Genentech, Basel, Switzerland.

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GlaxoSmithKline, Ware, UK. Serves as Chief Regulatory Officer or equivalent position.

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Eli Lilly and Company, Indianapolis, IN, USA. Serves as Chief Regulatory Officer or equivalent position.

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Eli Lilly and Company, Indianapolis, IN, USA.

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Pfizer, Collegeville, PA, USA. Serves as Chief Regulatory Officer or equivalent position.

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Bristol-Myers Squibb, Lawrenceville, NJ, USA. Serves as Chief Regulatory Officer or equivalent position.

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Novartis Pharmaceuticals, Cambridge, MA, USA. Serves as Chief Regulatory Officer or equivalent position.

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Merck & Co., Upper Gwynedd, PA, USA. Serves as Chief Regulatory Officer or equivalent position.

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Janssen Pharmaceuticals, Beerse, Belgium.

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AbbVie, N. Chicago, IL, USA.

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Roche/Genentech, Basel, Switzerland. Serves as Chief Regulatory Officer or equivalent position.

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Pfizer, Collegeville, PA, USA.

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Amgen, Thousand Oaks, CA, USA. Serves as Chief Regulatory Officer or equivalent position.

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AbbVie, N. Chicago, IL, USA. Serves as Chief Regulatory Officer or equivalent position.

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Janssen Pharmaceuticals, Beerse, Belgium. Serves as Chief Regulatory Officer or equivalent position.

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Bayer, Wuppertal, Germany. Serves as Chief Regulatory Officer or equivalent position.

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doi: 10.1038/d41573-019-00193-7

Acknowledgements

The authors are members of the Charles Forum, founded in 2018 by request of the Hever Group of Pharmaceutical R&D heads to advance the identification, prioritization, and pursuit of progressive and global issues affecting biopharmaceutical industry regulation. Current Charles Forum members include regulatory heads and regulatory policy leads from 12 multinational biopharmaceutical companies. The authors acknowledge the many industry consortia working in partnership with the FDA to advance information exchange through cloud technologies.

Competing Financial Interests

The authors are all employed by multinational biopharmaceutical companies, as indicated in their affiliations.

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