PT522 – An Inside look at the FDA and Early Drug Development, with Dr. Amanda Holley
Psychedelics Today18 Juni 2024

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.

Det här avsnittet är hämtat från ett öppet RSS-flöde och publiceras inte av Podme. Det kan innehålla reklam.

Avsnitt(774)

PT 656 - Travis Tyler Fluck: Denver Mushroom Decriminalization, Mutual Aid, and the Future of Psychedelic Culture

PT 656 - Travis Tyler Fluck: Denver Mushroom Decriminalization, Mutual Aid, and the Future of Psychedelic Culture

Denver mushroom decriminalization changed the national conversation around psilocybin access, personal use, and grassroots psychedelic reform. In this episode of Psychedelics Today, Joe Moore speaks w...

11 Maj 1h 43min

PT 655 - Martha Hammel and Tasia Poinsatte - Aspen Psychedelic Symposium

PT 655 - Martha Hammel and Tasia Poinsatte - Aspen Psychedelic Symposium

Aspen Psychedelic Symposium is the focus of this conversation with Martha Hammel of the Aspen Psychedelic Resource Center and Tasia Poinsatte of Healing Advocacy Fund. They join Joe Moore to discuss t...

8 Maj 54min

PT 654 - Erica Rex - Seeing What Is There

PT 654 - Erica Rex - Seeing What Is There

Seeing What Is There is at the center of this conversation with journalist and author Erica Rex, who joins Joe Moore to discuss her book Seeing What Is There: My Search for Sanity in the Psychedelic E...

23 Apr 1h 20min

PT 653 - Dr. Michael Alpert and Peter Alberding - ALS, Existential Distress, and Ketamine Therapy

PT 653 - Dr. Michael Alpert and Peter Alberding - ALS, Existential Distress, and Ketamine Therapy

ALS and ketamine therapy are at the center of this conversation with psychiatrist Dr. Michael Alpert and Peter Alberding, who was diagnosed with ALS in late 2023. Alpert is a Boston-area psychiatrist ...

16 Apr 1h 19min

PT 652 - Esme Dark - Psychedelics, Somatics and the Shadow

PT 652 - Esme Dark - Psychedelics, Somatics and the Shadow

Dr. Esme Dark joins Kyle Buller for a conversation on psychedelic therapy, somatic psychotherapy, and shadow work. Based in Australia, Dark is a clinical psychologist, somatic psychotherapist, and psy...

25 Mars 1h 14min

PT 651 - Betty Aldworth & Ismail Ali: MAPS Co-Executive Directors on Leadership, Research, and the Future of Psychedelics

PT 651 - Betty Aldworth & Ismail Ali: MAPS Co-Executive Directors on Leadership, Research, and the Future of Psychedelics

MAPS co-executive directors Betty Aldworth and Ismail Ali join Psychedelics Today to talk about leading one of the most visible organizations in the psychedelic field during a period of transition. Th...

19 Mars 1h 22min

PT 650 - Joe Moore Psychedelics Today on Leadership, Integration, and the Psychedelic Landscape

PT 650 - Joe Moore Psychedelics Today on Leadership, Integration, and the Psychedelic Landscape

Jen Davenport joins Psychedelics Today to interview co-founder Joe Moore about the growth of Psychedelics Today, the broader psychedelic ecosystem, and how professionals are beginning to engage with p...

9 Mars 1h 6min

PT 649 - Melissa Lavasani and Jay Kopelman

PT 649 - Melissa Lavasani and Jay Kopelman

Melissa Lavasani & Jay Kopelman join our podcast to discuss how psychedelic policy is actually moving in Washington, DC. Lavasani leads Psychedelic Medicine Coalition, a DC-based advocacy organization...

19 Feb 1h 10min

Populärt inom Vetenskap

dumma-manniskor
p3-dystopia
allt-du-velat-veta
kapitalet-en-podd-om-ekonomi
rss-ufobortom-rimligt-tvivel
rss-vetenskapsradion
rss-spraket
medicinvetarna
paranormalt-med-caroline-giertz
rss-vetenskapsradion-2
svd-nyhetsartiklar
rss-odla
dumforklarat
rss-arkeologi-historia-podden-som-graver-i-vart-kulturlandskap
det-morka-psyket
hacka-livet
barnpsykologerna
ufo-sverige
sexet
rss-broccolipodden-en-podcast-som-inte-handlar-om-broccoli