Advanced Therapies: Innovations in CMC Conference

Solutions for CMC challenges in the development and commercialization of cell therapy, gene therapy, and gene editing products.

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Session 4: Starting and Raw Materials in Cell and Gene Therapy

Session Chair(s)

Sofia Buch, PhD, MSc

Vice President for Cell Therapy CMC

Novo Nordisk A/S, Denmark

Starting- and raw materials are an important part of the cell and gene therapy products and can be highly complex in nature. This session will focus on gene edited cells as starting material, approaches to selection and qualification of raw materials and differences in regulations from different countries.

Learning Objective : At the conclusion of this session, participants should be able to:
Have an increased understanding of cells as starting material that are gene edited

Have increased understanding of approaches to raw materials

Have a general overview regulatory landscape for raw materials

Speaker(s)

Overview of Regulatory Landscape for Raw Materials

Benjamin Fryer, PhD

Pluristyx, Inc., United States

CEO

A Risk-Based Approach to Raw Material Applications Throughout Clinical Development of Advanced Therapies

Sara Mills

Dark Horse Consulting Group, United States

Senior Consultant

The Intricacies of Cell Therapy’s Starting Materials

Andrew Ramelmeier, PhD

Sangamo Therapeutics, United States

Executive Vice President, Technical Operations

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