#409 ‒ Inside modern drug development: the science, economics, and regulatory hurdles behind bringing new medicines to patients | Lloyd Klickstein, M.D., Ph.D.

Peter Attia, MD (0:11)

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My guest this week is Dr. Lloyd Klickstein, 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 Bima 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 Bima 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 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 at Novartis to its development as a therapy for muscle loss and obesity, what clinical trials, FDA approval, and patent protection actually involved, 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 Klickstein.

Lloyd, thanks so much for coming out to Austin. Great to see you again in person. It's been probably six, seven, maybe eight years since we were last here.

Lloyd B. Klickstein, M.D., Ph.D. (3:20)

It might well be that long, yes.

Peter Attia, MD (3:22)

Yeah. So look, for folks who don't know you as well 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 came together.

Lloyd B. Klickstein, M.D., Ph.D. (3:36)

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 from there, I did medicine training. I was a rheumatology training, and I practiced rheumatology for maybe ten years. And also had an NIH-funded research lab doing very basic science on adhesion molecules in the immune system.

Peter Attia, MD (4:28)

And that was also at the Brigham? Did you stay there after you finished your training?

Lloyd B. Klickstein, M.D., Ph.D. (4:31)

I have a high activation energy for moving and doing other things. So I stayed there my whole academic career.

Peter Attia, MD (4:38)

Yeah, that's right. Medical school, MD, PhD, the whole thing.

Lloyd B. Klickstein, M.D., Ph.D. (4:40)

Only job I ever had until I left and went to industry, which was a little over 20 years ago.

And I went to Novartis Institutes, which was founded by Mark Fishman when he was recruited by the then CEO of Novartis, Dan Vesella, to reimagine how research and early clinical development are done in industry. And they basically brought the whole concept of translational medicine to industry. Now, that term, I think, was coined at Oxford, somewhere in the UK for sure. And this was the first industry manifestation of it.