Stephen M. Tyler

Retired

<b>Stephen Tyler </b>is a Director of Technical Operations for Operations’ Quality Assurance at AbbVie, a biopharmaceutical company, in North Chicago, Illinois, USA. Stephen holds B.S. degrees in Applied Biology and Chemical Engineering and a M.S. in Microbiology. Stephen joined AbbVie (Abbott) in 1984 and the Quality Assurance organization in 2008. He is a former international board member for ISPE, former co-chair of the ISPE PQLI technical committee and current chair for the ISPE PQLI Steering Committee. Stephen was the recipient of the 2013 ISPE Richard B. Purdy Distinguished Achievement Award that recognizes an ISPE member who has made significant, long-term contributions to the society.

Features

Accelerated Pharmaceutical: Product Development, Registration, Commercialization, & Life Cycle CMC Lessons, Part 2

22 August 2019

This article is Part 2 of a two-part series exploring what we can learn from examples of pharmaceutical products being approved using accelerated programs. The series focuses on challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status. In

Features

Accelerated Pharma Product Development, Registration, Commercialization & Life Cycle

10 July 2019

This article is Part 1 of a two-part series exploring what we can learn from examples of pharmaceutical products being approved using accelerated programs. The series focuses on challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status. Part 1 introduces key considerations and themes in general terms and...

iSpeak Blog

Accelerated Pharma Product Development, Registration, Commercialization, & Life Cycle CMC Lessons Part 1

26 June 2019

Stephen M. Tyler

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