#409 ‒ Inside modern drug development: the science, economics, and regulatory hurdles behind bringing new medicines to patients | Lloyd Klickstein, M.D., Ph.D.
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What is the opening introduction and purpose of this episode?
Hey
everyone, welcome to the Drive Podcast. I'm your host, Peter Atia. This podcast, my website, and my weekly newsletter all focus on the goal of translating the science of longevity into something accessible for everyone. Our goal is to provide the best content in health and wellness, and we've established a great team of analysts to make this happen. It is extremely important to me to provide all of this content without relying on paid ads. To do this, our work is made entirely possible by our members, and in return, we offer exclusive member only content and benefits above and beyond what is available for free. If you want to take your knowledge of this space to the next level, It's our goal to ensure members get back much more than the price of the subscription.
If you want to learn more about the benefits of our premium membership, head over to peterateamd.com forward slash subscribe. My guest this week is Dr. Lloyd Clickstein, a physician scientist, rheumatologist, and drug developer who has spent more than two decades helping discover and develop new medicines. After beginning his career as a physician scientist at Harvard Medical School and the Brigham and Women's Hospital, Lloyd joined Novartis, where he helped pioneer translational medicine and led the company's new indication discovery unit, identifying entirely new disease and therapeutic. Opportunities. He later held leadership roles at several biotechnology companies, including Versantis Bio, where he led the development of BEMA before the company was acquired by Eli Lilly.
Today he serves as the CEO of Coslap Therapeutics. I wanted to have Lloyd on because very few people have had a front row seat to every stage of modern drug development, from identifying the unmet medical. need to the discovery of new therapeutic targets, to navigating clinical trials, regulatory approval, and even commercialization. While we use BEMA as a case study throughout this conversation, the real goal is to pull back the curtain on how new medicines are actually created, why the process takes so long and costs so much, and how scientists decide which areas are worth pursuing in the first place. In the In the episode, we talk about how new drugs are discovered, developed, and ultimately brought to patients, the science and economics behind choosing which diseases and therapeutic targets to pursue, the differences between small molecules, biologics, gene therapy, and other drug platforms, why drug development takes so long, costs billions of dollars, and so often fails, the story behind this one particular drug from its discovery.
appropriate Novartis to its development as a therapy for muscle loss and obesity, what clinical trials, FDA approval, and patent protection actually involve, and how the next generation of obesity and muscle preserving therapies may reshape the treatment of metabolic disease. So without further delay, please enjoy my conversation with Dr. Lloyd Clickstein. Lloyd, thanks so much for coming out to Austin. Great to see you again in person. It's been uh probably six, seven, maybe eight years since we were last year. It might well be that long, yes. Yeah. So look, for for folks who don't know you as as well as as some of us do, tell us just a little bit about your background. You're a physician and a scientist, but talk a little bit about how those two paths.
Right.
So my original plan when I finished college was to go to medical school, following is basically the family business. But between college and medical school I worked in a laboratory at Brigham and Women's Hospital in Boston. And found two things. One that I love doing science and two that I was pretty good at it. And I ended up doing an MD PhD degree and that is the training. Not required, but helpful for becoming a physician scientist. And uh from there I did medicine training, I was a rheumatology training, and I practiced rheumatology for maybe 10 years. And also had an NIH funded research lab doing very basic science on adhesion molecules in the immune system.
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Chapters
7 chapters
1
What is the opening introduction and purpose of this episode?
0:10–17:00
2
How does Dr. Lloyd Klickstein describe his career path and transition to industry?
17:00–52:23
3
What are the main drug modality categories (small molecules, biologics, devices) and how do they differ?
52:23–1:14:44
4
When should a drug patent be filed relative to IND submission?
1:14:44–1:18:23
5
Why is GMP manufacturing critical for IND approval and how does it differ from gray‑market peptides?
1:18:23–1:28:03
6
How are participants chosen for a first‑in‑human study and what safety endpoints are assessed?
1:28:03–1:54:52
7
What were the primary results and safety signals from the BELIEVE phase‑2 combination study?
1:54:52–2:26:21
Speakers
1 identifiedMore from The Peter Attia Drive
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