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Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Advanced

This session will delve into how prior knowledge can be used to support decision making and development in the CMC dossier. Specifically, how prior knowledge can support patient centric specifications and predictive stability will be explored.

Learning Objectives

Describe what prior knowledge may be meaningful in supporting patient centric specifications and predictive stability; Discuss how prior knowledge may reduce regulatory burden.

Chair

Celeste Frankenfeld Lamm

Speaker

Industry Perspective: Prior knowledge to Inform Specifications and Control Strategy
Sarah Demmon, MS

Regulatory Perspective
Ingrid Markovic, PhD

Overview of ICH Q6
Andrew Chang, PhD

Industry Perspective: Prior Knowledge, Advanced Kinetic Modeling for Stability, and ICH Q1/5C
Warren Roche


Speakers
avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →
SD

Sarah Demmon

Vice President, Eli Lilly, United States
Sarah Demmon, M.S., is Vice President at Eli Lilly and Company. With 28 years in biopharmaceutical development, she specializes in late phase development and commercialization of fusion proteins and monoclonal antibodies. She started as an analytical chemist developing methods for... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Senior Director, Global Regulatory Affairs – CMC, Merck Sharp & Dohme LLC , United States
Celeste Frankenfeld Lamm, Ph.D., is a seasoned industry professional with 18 years of experience in the field. As a Senior Director of Global Regulatory Affairs – CMC at Merck & Co., she spearheads the company's global CMC policy efforts. In this role, Celeste engages externally... Read More →
avatar for Ingrid Markovic

Ingrid Markovic

Senior Science Advisor, Office of the Center Director, CBER, FDA, United States
Ingrid Markovic, Ph.D. is Senior Science Advisor for CMC at the FDA's Center for Biologics where she spearheads CMC policy activities partnering with internal and external stakeholders to ensure consistent application of CMC policies and programs. She led FDA efforts for modernization... Read More →
WR

Warren Roche

Statistician, Sanofi, Ireland
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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