Year: 2021-22

Company: Amgen

Liaison(s): Mike Abernathy, Jill Beierle, and Nina Cauchon

This project focuses on evaluating the implementation of automation processes for Chemistry Manufacturing and Controls (CMC) data which will enable streamlining of regulatory submissions to a health agency through transforming burdensome word and data documents into digitization forms leveraging modern technology.

Assumptions of automation efforts include modernizing by digitizing CMC data driven sections for the regulatory filing process which will allow for the potential of faster review of products in not only one region of the world, but multiple regions in coordination between sponsors and regulatory agencies when seeking approval for Amgen’s therapeutic products.

The scope of this project focuses specifically on FDA. The project resulted in the development of a tool that quantifies both time and cost savings with automation. In addition, a manuscript for publication and a script for social media were also developed.

In the near future, automation will make the data-entry process less burdensome and modernize regulatory filings. Regulatory professionals can spend more time working on ensuring the quality of the data discussions provide appropriate regulatory and scientific rationale and less time on verifying the information, as data integrity remains intact. Automation will also ensure that multiple stakeholders within the other functions, such as a quality function of the company can view the same data and give their feedback in real time. The benefits of the time and cost savings due to automation can potentially streamline submission and review processes in accelerating access to therapies for patients.