Cell and gene therapies have the potential to be one of the most important advances in effectively treating and controlling disease. While the number of patients receiving cell and gene therapy is quite small compared to other therapeutics, many researchers and manufacturers have started investigating its effects on small populations. There is a lot to consider when creating a study in this area – from study design to regulatory hurdles.
Join us on September 17 for a workshop that will cover tips and tricks that may be critical to achieving long-term success in developing cell & gene therapy.
This workshop will cover:
· Product development
· Pre-clinical and toxicology considerations
· Manufacturing and CMC considerations
· Regulatory Framework and Interactions
*This program is a product of a collaboration between Johnson & Johnson Innovation – JLABS (JLABS) and the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.