Oxana Iliach, PhD, Author at Certara

Changing the Trajectory to Accelerate Rare Disease Drug Development

2022年6月24日

In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) launched its Accelerating Rare disease Cures (ARC) Program1 with the vision of speeding and increasing the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. This is a very … Continued

Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting

2021年6月15日

By Oxana Iliach, PhD

Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on 2021年4月15日 was not any different. The agenda included discussion of a biologics license application (BLA) for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans) for the treatment of brittle Type … Continued

Author: Oxana Iliach, PhD