PT522 – An Inside look at the FDA and Early Drug Development, with Dr. Amanda Holley

In this episode, Joe interviews Dr. Amanda Holley: pharmacologist and regulatory consultant in nonclinical drug development, and previously a nonclinical pharmacology/toxicology reviewer at the FDA. With Lykos Therapeutics working towards FDA approval of MDMA-assisted psychotherapy for PTSD, ICER (Institute for Clinical and Economic Review) recently published its draft evidence report, concluding that they couldn't endorse this modality. While disappointing to the psychedelic space, this report doesn't determine the FDA's official stance, and also really highlights a lot about how the FDA works, the knowledge gap between consumers and regulators, and how clinical studies should be designed in the future. Holley talks about the FDA's dedication to safety and data, and how, essentially, drug development comes down to a risk/benefit analysis.  She discusses:  Misconceptions about the FDA, especially related to psychedelics The path of a substance in early drug development and how breakthrough status works The complications with blinding psychedelics, the placebo effect, and how much therapy is a factor The contrast between productization and harm reduction: Should we be concerned with creating products, or understanding these substances better? How changing one molecule really does create a different drug and much more! For links, head to the show notes page.