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The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management.

Authors
  • Ahluwalia, Kabir1
  • Abernathy, Michael J2
  • Beierle, Jill2
  • Cauchon, Nina S3
  • Cronin, David4
  • Gaiki, Sheetal5
  • Lennard, Andrew6
  • Mady, Pradeep7
  • McGorry, Mike8
  • Sugrue-Richards, Kathleen9
  • Xue, Gang10
  • 1 Department of Global Regulatory Affairs - CMC, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA; University of Southern California, School of Pharmacy, 1985 Zonal Ave, Los Angeles, CA 90089, USA.
  • 2 Department of Global Regulatory Affairs - CMC, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • 3 Department of Global Regulatory Affairs - CMC, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: [email protected]
  • 4 Cognition Corporation, 24 Hartwell Ave, Lexington, MA 02421, USA.
  • 5 Biotherapeutic Development & Supply, Janssen Pharmaceuticals, 1000 Route 202 South, Raritan, NJ 08807, USA.
  • 6 Department of Global Regulatory Affairs - CMC; Amgen Ltd, 1 Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom. , (United Kingdom)
  • 7 Product Quality Management, Janssen Pharmaceuticals, 1000 Route 202 South, Raritan, NJ 08807, USA.
  • 8 Biotherapeutic Development & Supply, Janssen Pharmaceuticals, Barnahely, Ringaskiddy, Co.Cork, Ireland. , (Ireland)
  • 9 Department of Global Regulatory Affairs - CMC, Amgen Inc., 40 Technology Way West Greenwich, RI 02817, USA.
  • 10 Biotherapeutic Development & Supply, Janssen Pharmaceuticals, 200 Great Valley Pkwy, Malvern, PA 10355, USA.
Type
Published Article
Journal
Journal of Pharmaceutical Sciences
Publisher
Elsevier
Publication Date
Oct 02, 2021
Identifiers
DOI: 10.1016/j.xphs.2021.09.046
PMID: 34610323
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Recent advancements in data engineering, data science, and secure cloud storage can transform the current state of global Chemistry, Manufacturing, and Controls (CMC) regulatory activities to automated online digital processes. Modernizing regulatory activities will facilitate simultaneous global submissions and concurrent collaborative reviews, significantly reducing global licensing timelines and variability in globally registered product details. This article describes advancements made within the pharmaceutical industry from theoretical concepts to utilization of structured content and data in CMC submissions. The term Structured Content and Data Management (SCDM) outlines the end-to-end scientific data lifecycle from capture in source systems, aggregation into a consolidated repository, and transformation into semantically structured blocks with metadata defining relationships between scientific data and business contexts. Automation of regulatory authoring (termed Structured Content Authoring) is feasible because SCDM makes data both human and machine readable. It will offer health authorities access to the digital data beyond the current standard of PDF documents and, for a review process, SCDM would "enrich the effectiveness, efficiency, and consistency of regulatory quality oversight" (Yu et al., 2019). SCDM is a novel solution for content and data management in regulatory submissions and can enable faster access to critical therapies worldwide. Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

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