Operation Warp Speed For Rare Diseases: Expected Boom In Drug Development And Approval

By Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Executive Director, Biosafety Services

The burgeoning field of gene therapy is poised to receive a significant boost, courtesy of the forthcoming launch of "Operation Warp Speed for Rare Diseases" by the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER).

Gene therapy has witnessed remarkable accomplishments, especially in the treatment of challenging cases such as resistant or refractory B cell leukemias, achieving astounding overall response rates exceeding 90%. Additionally, the expeditious development of COVID-19 vaccines during the initial Operation Warp Speed serves as a testament to the field's potential.

Now, the FDA's CBER is charting an ambitious course aimed at making substantial advancements in the realm of addressing rare diseases. Delve into this article to learn more about the initiative and what sites should do to prepare.