What Surprised an Academic About Drug Development

Drug development needs good science, but the science is the easy part. What’s hard is learning about all the things that are not science-related but must be mastered to get a drug approved—which is the only way it can benefit patients.

When I started KAI, I was doing basic research as a professor at Stanford, having fun, and focused on helping patients. I didn’t care about making money so I didn’t worry about protecting intellectual property. I learned fast that protecting intellectual property is an important part of getting a drug to market. If your discovery isn’t patentable, no company or venture firm will invest millions to develop it into a drug.

Protecting your IP at an early stage isn’t that hard. You do have to be very careful not to discuss your research publicly. If you talk to your colleagues at your institution, that is not considered a public disclosure. But if you talk to a former colleague who is now at another institution or present it at a conference, that is a public disclosure—and your discovery is no longer patentable.

Early in my career as an academic, planning my work five steps ahead was something I never did. Academics are comfortable figuring out things along the way and it’s not random. We write proposals that say in year one we’ll do this, in year three we’ll do this, and in year five we’ll solve the problem. If we ask to renew our funding, that is not a problem, as long as we are productive, publish papers, and contribute to scientific knowledge.

However, developing a drug has a lot of steps that are dependent on each other and delays can be expensive. It’s really important to plan in advance—starting with the end in mind: who is your patient, who are the physicians who will prescribe your drug, what else is currently available, what is the competition. and how can you bridge what you have now to a final product.

You may have experience with teams of people working together and helping each other and that’s nice. But in drug development, you need a level of teamwork that runs much, much deeper. If even one person does not believe in the purpose of the work, the whole thing can be derailed.

Real teamwork is achieved when every person on the team is focused on their contribution but still knows everything that is going on all the time. To build that level of teamwork at KAI, John insisted that we have an all-hands meeting every Friday with everyone sharing what’s going well, challenges, things that were bugging them, and new ideas. Everything. At the time, my first thought was, “I don’t have time for this. I have a job to do.”

But John was adamant and so we did it.

I quickly understood. I could see that every team member was integral to the process and that good ideas can come from anyone. I realized that someone who might not be as smart as you can have knowledge or experience that you don’t have. When you encounter those people, it’s wise to check your ego at the door and take their advice!

Probably the weirdest thing John taught me was to celebrate failures. I learned this lesson when the drug we were developing at KAI failed a Phase 1 clinical trial. It was devastating. We didn’t understand why. Everyone was upset. I was really upset.

I was shocked when John came to me and said we were going to have a failure party with balloons, ribbons, and champagne. He said we needed to celebrate the good effort the research and clinical teams had made and make sure they knew that it was the drug that had failed—not them. He also said we need to talk about the failure so we could all learn from it.

John was so right. For KAI, ideas that were born at our failure party helped us pivot to a new target for our drug. KAI was ultimately acquired by Amgen and KAI’s product, Parasbiv, is approved worldwide.

That’s a story for another time.