Follow these critical steps on your path to IND application.
By Philip J. Kuehl, Ph.D., Senior Scientist and Director of Scientific Core Laboratories, Lovelace Biomedical and Jacob D. McDonald, Ph.D., Senior Scientist and Chief Scientific Officer, Lovelace Biomedical
Cell and gene therapy products are reviewed and approved through the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). As of March 2019, there were 17 approved cellular and gene therapy products.1 With FDA’s trio of gene therapy approvals in 2017, the innovation floodgates opened. Pharmaceutical and biotechnology companies are seeking to capitalize on a revolutionary therapeutic approach that was once deemed too risky. With promising clinical results from early gene therapies, venture capital money is finally freeing up to enable this exciting next generation of medicine.