Gene editing has moved from the laboratory to the clinic and is likely to transform treatment for our patients with inborn errors of immunity. In this episode, Caroline Kuo, MD, explains genome editing technologies and how these tools may enable precise, potentially curative therapies.

The LEAP trial fundamentally changed our understanding of immune tolerance, demonstrating that early oral exposure can dramatically reduce the risk of developing peanut allergy. In this episode, Edwin Kim, MD, FAAAAI, will help us explore the immunologic mechanisms of early food introduction and tolerance development and what the evidence tells us about other food allergies.

Join us as Kelly Stone, MD, PhD, FAAAAI, explains the evolution of the U.S. Food and Drug Administration and its central role in ensuring the safety and efficacy of therapeutics in the United States. We discuss the modern drug approval process from preclinical development through clinical trials and post-marketing surveillance and explore what makes this pathway different for biologics and biosimilars so you have a better understanding of the therapeutics that we prescribe every day in the clinic.

Biosimilars

MedWatch:The FDA Safety Information and Adverse Event Reporting Program

FDA History

Drug Development Process