The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND
Presenter: Andrew Byrnes
The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND.
Presentation
- The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND
Presenter: Andrew Byrnes. In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials. - The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND
Course List
- Introduction and Scope of OCTGT
Presenter: Patrick Riggins. Patrick Riggins introduces the Office of Cellular, Tissue and Gene Therapies and provides a scope of what the office does. - The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND
Presenter: Andrew Byrnes. In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials. - Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products
Presenter: Denise Gavin. Denise Gavin aims to guide manufacturers toward successful development of quality cell and gene therapy products, in this presentation. - Cellular Therapy Products
Presenter: Keith Wonnacott. Keith Wonnacott discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.