Jessica Lo Surdo, PhD

Placeholder Person Graphic
Amgen
Regulatory Affairs Senior Manager
Jessica Lo Surdo, PhD, is a Regulatory Affairs Senior Manager at Amgen, Inc., focusing on CMC strategies for global clinical trial applications and postapproval variations for biologics. Jess has been at Amgen for three years, leading commercial product CMC regulatory strategies, with recent focus on established conditions and ICH Q12 implementation through ISPE. She previously worked at Bristol Myers Squibb for 2.5 years as an analytical product lead scientist, leading analytical aspects of prepivotal clinical programs. Jess was at the FDA Center for Biologics Evaluation and Research in the Division of Cellular and Gene Therapies for eight years, with initial focus on bioassay development for cellular therapies, and later as a Staff Fellow and Product Quality Reviewer for cell therapy INDs. Jess holds PhD and master’s degrees in bioengineering from the University of Pittsburgh, and a BS degree in bioengineering from Syracuse University. She has been an ISPE member since 2020.

Related Articles

Figure 1: Redundancies in the postapproval change management process contribute to delayed approval.
Features
Streamlining Postapproval Submissions Using ICH Q12 & SCDM

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...

A Vision for ICH Q12: Current Experience, Future Perspectives
Features
A Vision for ICH Q12: Current Experience, Future Perspectives

Management of global postapproval chemistry, manufacturing, and controls (CMC) changes is a growing challenge for industry with many issues. ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) is a transformative document shaping global regulatory postapproval submissions that will help alleviate some of these issues.