The Split Vote: UroGen and the FDA

There are nine jurors in a room. Your job? Convince this advisory committee of your drug's safety, that the benefit outweighs the risks. But here's the challenge. Only two of those jurors actually understand how your drug works and the system in the body that it targets. They're specialists. The other seven are not. Under these circumstances, how do you convince a regulatory body that your drug is not only safe, but it's an essential therapy that changes the treatment paradigm and will transform patients' lives. I'm your host, Stephanie Sirota, partner and chief business officer at RTW Investments. And today, I'm excited to welcome the CEO of UroGen Pharma, Liz Barrett. Before that, she served as CEO of Novartis Oncology and also held several senior leadership roles at Pfizer. Liz, thank you so much for joining us. Thank you. Thank you so much for having me. And, I have PTSD from your introduction. Well, good. We're gonna get into that. So tell us a little bit about your pharma journey. What is it like to climb the corporate ladder at a large company, and what do you attribute your success to both at Pfizer and Novartis? I would have never guessed I would be where I am today. I started my career at Kraft Foods and then went to Johnson and Johnson. Their biggest business was the pharmaceutical business. I always joke that I used to think it was really important what kind of toothbrush you use because I was the, you know, brand director on Reach toothbrushes. I actually started reaching out to people on the pharmaceutical side. I started at a small company called Ortho Biotech. My sort of claim to fame is I launched the first DTC ever in oncology. It's hard to work in cancer and not feel very personal about it because either you experience it, someone close in your family, or you know someone who has had cancer. When I started in cancer thirty years ago, five year survival was actually very low. I felt like I was given an opportunity and my career decisions have always been around where can I make the biggest impact and am I being challenged? Am I learning? Am I giving? Was it hard for you to make the transition from big pharma to biotech? Actually, it wasn't. I've been able to be successful in large companies, but also had this in my mind that I would one day do the biotech thing. I was having too much fun. You know, things were going well. I was was continuing to grow. When I got the call, I said, well, you know, I'm not, I'm not really ready at this time. And, you know, Ari, who's our chairman, he just said, just come in and talk to us. And it was really after speaking to our chief medical officer, Mark Schomburg, who's still a practicing urologist, I was like, I've been in cancer for thirty years and I …