NEW! This Cell and Gene Therapy Trials course will examine the challenges inherent in cell and gene therapy manufacturing and clinical trials. This module is divided into four chapters and introduces fundamental concepts of these regenerative medicines, along with case studies and scenarios.
The first chapter covers background knowledge on cell and gene therapies and the regulations that govern them. The second chapter addresses the unique challenges in maintaining quality control in manufacturing these products. The third chapter discusses the difficulties of conducting clinical trials for cell and gene therapies and provides guidance on navigating common or significant challenges that arise. The fourth chapter will provide information on expedited regulatory pathways to bring cell and gene therapy products to market sooner.
Although the content can be generalized for the clinical research work force, this course is geared towards investigator-initiated trials at academic medical institutions.
This work was supported by grant UL1TR001855 from the National Center for Advancing Translational Science (NCATS) of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
