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

Psychedelics Today

Psychedelics Today, LLC

Life Sciences, Science, Medicine, Health & Fitness

4.6 • 598 Ratings

🗓️ 18 June 2024

⏱️ 63 minutes

🔗️ Recording | iTunes | RSS

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Summary

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.

Transcript

Click on a timestamp to play from that location

0:00.0	Hello, everybody, welcome back to psychedelics today. This is Joe Moore coming at you from
0:16.8	Breckenridge, Colorado. Today on the show, we have Amanda Hawley,
0:22.0	who is a former FDA regulator,
0:26.4	spent a lot of time in Washington, D.C,
0:29.0	and has a lot of insight for us
0:31.7	around this whole FTA situation.
0:33.8	So FDA situation for those who aren't aware
0:37.3	is it's not exactly crystal clear that the FDA will approve MDMA.
0:44.3	That's kind of saying it lightly. But we get into some of the details here in a bit. And I hope it's educational for you.
0:51.6	Amanda has some awesome expertise spent time working in the psychedelic
0:57.3	wing of the FDA and yeah, it has some really interesting stories to share. So hope you enjoy it.
1:04.7	Thank you, Amanda. Please check out Amanda online and hope we can do more. All right, everybody,
1:10.6	see you on the other side.
1:14.9	Hello, everybody. Welcome back to psychedelics today. This is Joe Moore coming out from
1:19.3	Brackenridge, Colorado. Today on the show, we have Amanda Hawley. Amanda, how are you doing today?
1:23.6	I'm great. Thanks for having me. I'm really excited. So we connected a couple months back and had a really interesting phone call about procedure at the FDA.
1:34.8	And today we're recording on June 6, which is the day after or two days after, the FDA made some suggestions internally about which way to rule on the maps thing.
1:46.9	But before I dig into all that, can you tell us a little bit about your background and the work
1:51.1	you were doing at the FDA? Yeah, absolutely. So I was raised as an academic scientist for a really
1:57.7	long time. So, you know, I did the traditional route of, you know,
2:01.8	bachelor's, master's, PhD, and then I did two postdocs, one in toxicology and pharmacology.
2:09.8	Couldn't get enough. Couldn't. I really did love research, but I did not love academia.
	...

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