Lessons in Cell and Gene Therapies

A primer for understanding these remarkable therapies and their impacts in clinical trials.

Cell and gene therapies (CGTs) are a sophisticated and cutting-edge field of therapies. They are considered highly promising, and drug developers’ level of interest in these emerging modalities has significantly increased over the past few years with CGTs comprising a considerable part of many drug development portfolios. This white paper will examine:

• The growth and increasing interest in CGTs
• Preclinical and clinical trial design guidance and planning with an understanding of high-impact factors
• How to navigate the regulatory landscape, become familiar with critical guidance and evolving regulations, and understand the importance of early engagement with regulatory agencies
• Considerations for chemistry, manufacturing and controls

Authors:

Katherine Hanson, Ph.D., Associate Director, Analytical R&D, Clinical Research – Analytical Services

Amy Lavelle, Ph.D., Associate Director, Molecular Genomics, Clinical Research – Analytical Services

Heather Myler, Ph.D., Executive Scientific Affairs Director, Clinical Research – Analytical Services