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Monday June 15, 2026 1:05pm - 1:35pm EDT
Component Type: Session

Quality improvement rarely starts with a blank slate — but what happens when it does? When CRISPR Therapeutics faced a contract deadline and an overly complex QMS, they chose disruption over incremental fixes, rebuilding their Quality processes from the ground up in just 52 days. In this session, CRISPR's Executive Director of Quality and Pharmacovigilance Operations, Kate Ellmer, and Kivo's VP of Services, Chris Xistris, share how stripping away the bells and whistles revealed a simpler, more effective path forward. Walk away with a practical framework for right-sizing your QMS, evaluating vendors under pressure, and turning operational constraints into a catalyst for real change.

Learning Objectives

How to think about Quality Management Systems from an entrepreneurial perspective; What “right-sizing” a Quality system means for smaller / scaling organizations; Concrete examples of simplified processes; What to look for when exploring a new system.

Chair

Kivo, Inc.

Speaker

Speaker
Kate Ellmer, MPH

Speaker
Chris Xistris


Speakers
avatar for Kate Ellmer

Kate Ellmer

Exec. Director, Quality and PV Operations, CRISPR Therapeutics, United States
Kate Ellmer is an Executive leader at CRISPR Therapeutics where she is responsible for Quality and Pharmacovigilance Operations. In her twenty-year industry career, she has explored her passion for implementing QMS and GxP systems that enable seamless business processes. Kate has... Read More →
KI

Kivo, Inc.

United States
avatar for Chris Xistris

Chris Xistris

Vice President of Services, Kivo, United States
Chris Xistris has 25+ years in Life Sciences, starting in Regulatory and Clinical Operations at small and mid-size biotechs. He then moved into consulting, building regulatory operations infrastructure for mid-size clients. Before joining Kivo, he spent over a decade at a Life Sciences... Read More →
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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