How are drugs approved in the USA? In this episode I talk with the developer of Lexapro, and many other worldchanging drugs, about how clinical trials are run and how I could develop my own drug if I wanted to. Enjoy.

Ivan Gergel was born and raised in London where he went to medical school and became a psychiatrist. He then joined the pharmaceutical company GSK in developing new antidepressant drugs, famously some of the SSRIs we all are of course aware of today. This job took him to the US. Ivan Gergel was responsible for the running of hundreds of clinical trials, directed R&D for various pharmaceutical companies, and personally led the development and approval of 14 new therapies such as Lexapro, Paxil, and Namenda that have had fantastic impacts on patient’s lives. He currently is working in healthcare investing with new startup drug and device companies.
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0:00 Intro
1:06 What Is the FDA?
4:09 What Type of Drugs Need FDA Approval?
6:19 When Do the FDA Come In?
8:07 How to Get a Drug Approved by the FDA?
24:55 Phase 1
37:10 Phase 2
52:17 Phase 3
1:06:00 Drugs Getting Rejected/Audited
1:14:46 What Is After Phase 3?
1:16:46 Intellectual Property and Patents
1:19:44 Phase 4
1:21:45 Lexapro, SSRI’s and Antidepressants Drugs
1:30:18 The World of Big Pharma, the Good’s and Bad’s
1:39:45 The Future in the Field
1:43:38 Outro
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Resources:
Clinical Trials Information: https://clinicaltrials.gov/ct2/info/f...
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View the Show Notes Page for This Episode for transcript and more information: zhighley.com/podcast
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Welcome to the Zach Highley Show, where we discuss personal growth and medicine to figure out how to improve our lives. My name is Zach and I’m a medical student, and soon to be physician, in Philadelphia. Throughout these episodes I’ll interview top performers from around the world in business, life, and medicine in hopes of extracting the resources and techniques they use to get to the top.

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