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Peter Attia MDPeter Attia MD

346 - Scaling biotech and improving global health: lessons from an extraordinary career in medicine

Susan Desmond-Hellmann is a physician and scientist whose remarkable career has spanned clinical medicine, oncology, biotech innovation, and global health leadership. In this episode, Susan shares insights from her journey training in internal medicine during the early AIDS crisis, treating HIV-related cancers in Uganda, and developing groundbreaking cancer therapies like Herceptin and Avastin. She reflects on her leadership roles at UCSF and the Bill and Melinda Gates Foundation, offering lessons on guiding large-scale health initiatives, navigating uncertainty, and fostering scientific innovation. The conversation explores the promise of precision medicine, the integration of patient care and policy, and the evolving role of artificial intelligence in transforming diagnostics, drug development, and global access to care. View show notes here: https://bit.ly/4inBEeF Become a member to receive exclusive content: https://peterattiamd.com/subscribe/ Sign up to receive Peter's email newsletter: https://peterattiamd.com/newsletter/ We discuss: 0:00:00 - Intro 0:01:37 - Susan’s medical training, the start of the AIDS epidemic, and the transformative experiences that shaped her career 0:12:56 - Susan’s experience working on the frontlines of the HIV/AIDS crisis in Uganda 0:29:54 - Susan’s time working in general oncology and her transition to biotech where she helped develop taxol—a top-selling cancer drug 0:41:21 - Genentech’s origins, and its groundbreaking use of recombinant DNA to develop biologic drugs 0:51:03 - Susan’s move to Genentech, and her pivotal role in the development and success of Herceptin as a groundbreaking therapy in targeted oncology 1:00:57 - The rise of antibody-based cancer therapies: the development of Rituxan and Avastin 1:12:12 - The step-by-step drug development process and the scientific and strategic challenges involved 1:24:40 - The ethical and economic controversy surrounding Avastin’s high cost and limited survival benefit 1:27:22 - Susan’s tenure as chancellor at UCSF: leading during a financially strained period, and her strategic approach to fundraising and institutional development 1:41:14 - What Susan learned as CEO of the Bill and Melinda Gates Foundation: strategic processes and decision-making frameworks 1:53:18 - Susan’s philosophy of leadership and how she sought to build an empowering, values-driven culture at the Gates Foundation 1:58:15 - The erosion of public trust in science during COVID, the communication failures around controversial treatments like ivermectin, and the need for better public health engagement and transparency 2:14:30 - The role of AI in transforming medicine: from drug development to cancer detection and beyond -------- About: The Peter Attia Drive is a deep-dive podcast focusing on maximizing longevity, and all that goes into that from physical to cognitive to emotional health. With over 90 million episodes downloaded, it features topics including exercise, nutritional biochemistry, cardiovascular disease, Alzheimer’s disease, cancer, mental health, and much more. Peter Attia is the founder of Early Medical, a medical practice that applies the principles of Medicine 3.0 to patients with the goal of lengthening their lifespan and simultaneously improving their healthspan. Learn more: https://peterattiamd.com Connect with Peter on: Facebook: http://bit.ly/PeterAttiaMDFB Twitter: http://bit.ly/PeterAttiaMDTW Instagram: http://bit.ly/PeterAttiaMDIG Subscribe to The Drive: Apple Podcast: http://bit.ly/TheDriveApplePodcasts Overcast: http://bit.ly/TheDriveOvercast Spotify: http://bit.ly/TheDriveSpotify Google Podcasts: http://bit.ly/TheDriveGoogle Disclaimer: This podcast is for general informational purposes only and does not constitute the practice of medicine, nursing, or other professional healthcare services, including the giving of medical advice. No doctor-patient relationship is formed. The use of this information and the materials linked to this podcast is at the user's own risk. The content on this podcast is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Users should not disregard or delay in obtaining medical advice for any medical condition they have, and they should seek the assistance of their healthcare professionals for any such conditions. I take conflicts of interest very seriously. For all of my disclosures and the companies I invest in or advise, please visit my website where I keep an up-to-date and active list of such companies. For a full list of our registered and unregistered trademarks, trade names, and service marks, please review our Terms of Use: https://peterattiamd.com/terms-of-use/

Peter AttiahostSusan Desmond-Hellmannguest
Apr 28, 20252h 28mWatch on YouTube ↗

EVERY SPOKEN WORD

  1. 0:00 – 1:37

    Intro

    1. PA

      What I really enjoy about this type of discussion though, Sue, is one, it's the story of your career, but it's also the story of oncology. You are just a remarkable inspiration, period, as a physician, as a, as a business leader. I have been a fan of yours for-

    2. SD

      Thank you

    3. PA

      ... so long.

    4. SD

      People felt like you just needed to hit the cancer hard. You just needed to hit the cancer smart. [laughs] Hard wasn't the point.

    5. PA

      A lot of people might not realize you're on the board of OpenAI, and you're the only person in medicine on that board.

    6. SD

      I think using AI more and more on pieces of the clinical trials process, so that if something takes time, it's because it's benefiting a human. The other thing is, you and I both know if you have five hundred patients in a trial and you look at safety, that's so limited.

    7. PA

      Yep.

    8. SD

      Why don't we follow safety in every patient on the drug?

    9. PA

      Exactly. Ongoing.

    10. SD

      Ongoing. So I think the opportunities in clinical trials are massive.

    11. PA

      Do you think this is the most important thing that from a promise perspective, that AI has, has brought to medicine since-

    12. SD

      So far.

    13. PA

      Yeah.

    14. SD

      Yeah.

    15. PA

      Okay.

    16. SD

      I do. So far. Yeah.

    17. PA

      And, and so what do you think would be the next mega unlock?

    18. SD

      I define culture in a really specific way, um, that when you come to work, y- you feel like the atmosphere, the, the surround sound brings out the best in you.

    19. PA

      Mm.

    20. SD

      And that you have some ownership of tweaking it if it doesn't.

    21. PA

      [upbeat music] Hey everyone, welcome to "The Drive" podcast. I'm your host, Peter Attia.

  2. 1:37 – 12:56

    Susan’s medical training, the start of the AIDS epidemic, and the transformative experiences that shaped her career

    1. PA

      Sue, thank you so much for making the trip, um, out to Austin. Um, really, really was excited to meet you last year. Um, and, uh, you know, just an, just an honor to spend part of a day with you and then realize that I could somehow twist your arm into coming on the podcast.

    2. SD

      I'm happy to be here. I look forward to it.

    3. PA

      You've had just an unbelievable career. You are an absolute giant in, in many ways, but I, I love to always kind of give people a sense of how someone got to where they got. So if I recall, you grew up in Reno, is that right?

    4. SD

      I did. Yes.

    5. PA

      And you went to high school and college and even medical school-

    6. SD

      I went to-

    7. PA

      all the way through, right?

    8. SD

      ... to, uh, um, I went to Catholic school for twelve years in Reno. That's, uh, I, I explain that when people wonder if I was at a casino for my childhood. [laughs]

    9. PA

      [laughs]

    10. SD

      And then I went to University of Nevada, uh, both to undergrad and to medical school.

    11. PA

      And then, uh, was it then that you ended up at UCSF for your residency?

    12. SD

      My dream, uh, you know this, with residencies, my dream residency was internal medicine at UCSF, uh, my first pick, and I got my first pick and went to UCSF as an internal medicine resident.

    13. PA

      And that would've been what year that you landed there?

    14. SD

      Nineteen eighty-two.

    15. PA

      Okay. So remind me where we were in the AIDS epidemic in San Francisco in '82. What was known?

    16. SD

      If you read MMWR, uh, that's 1981-

    17. PA

      Mm-hmm

    18. SD

      ... was the first, uh, um, indication. In 1982, we knew, um, uh, that there was, uh, something happening, especially to gay men, um, but there was a sense it was homosexuals, hemophiliacs, and Haitians. Remember that?

    19. PA

      Yeah.

    20. SD

      The, uh, three H's. And, um, it was, there was so much mystery still involved that, um, uh, I was and my colleagues were in a study to look at drawing our blood to see if we had been infected as a result of treating patients.

    21. PA

      And what were they presenting with at the time? Because again, this is, it's hard for anyone of even my generation.

    22. SD

      Mm-hmm.

    23. PA

      You've never seen a drug naive patient, right? So you don't under- like all of my experience with HIV, which was a lot in j-

    24. SD

      Right

    25. PA

      ... in Baltimore many years later, but, but everyone was on something. So, so how would these men present to you as a, as a medicine resident?

    26. SD

      Pneumocystis. Pneumocystis carinii pneumonia was the number one diagnosis, so that's what you saw in the hospital-

    27. PA

      Mm-hmm

    28. SD

      ... that, um, brought patients to attention. But it, it became increasingly clear-

    29. PA

      And tell, tell folks why that's so unusual.

    30. SD

      Oh, it, it was a, a disease that immunosuppressed patients could get very rarely.

  3. 12:56 – 29:54

    Susan’s experience working on the frontlines of the HIV/AIDS crisis in Uganda

    1. PA

      me about how you wound up in Uganda.

    2. SD

      After I got my, uh, master's in, in, uh, public health, I became the oncologist at, at, uh, UCSF in the university hospital, um, for the AIDS clinic. So all the patients-

    3. PA

      This is Moffitt?

    4. SD

      This is Moffitt.

    5. PA

      Yep.

    6. SD

      So the, San Francisco General had a very well-known program run by oncologists for AIDS patients who were in the safety net hospital. Um, but in the university hospital, if you were very sick and you had Kaposi sarcoma, you saw me.

    7. PA

      Mm-hmm.

    8. SD

      Um, and my husband, 'cause we had just gotten married, um, who was an e- we were interns together, he was in the lab in ID doing, uh, immunology work.

    9. PA

      Mm.

    10. SD

      So, um, the, uh, two of the chiefs of medicine at UCSF were approached by the Rockefeller Foundation, who had started to become worried about heterosexual transmission of HIV. Remember I talked about the Haitians and the, the hemophiliacs and homosexuals? One H wasn't heterosexual, and so there was a lot of disbelief about African HIV, and in fact, some people thought it must be, um, uh, gay sex, but people are too embarrassed to admit it.

    11. PA

      Mm-hmm.

    12. SD

      Um, there were other theories, but, um, people just did not understand what was going on in Africa, and so the Rockefellers said, "We'll give you a grant at UCSF. We'll, uh, grant you money to study heterosexual transmission of HIV."

    13. PA

      And this was through an epidemiologic contact tracing lens, not necessarily going into the lab and trying to figure this out.

    14. SD

      Not going to the lab, but really looking at epi and, and particularly there was a hypothesis that if it was heterosexually transmitted, there was something to do with sexually transmitted diseases.

    15. PA

      Mm-hmm.

    16. SD

      Um, and that there was something about increasing your risk if you had untreated STDs-

    17. PA

      Yeah

    18. SD

      ... sexually transmitted diseases. So, um, uh, the w- we were asked to go. Um, UCSF had no global health, um, [laughs] just to, to put this into context. Um, we had a, a flat and two Honda Civics. I still remember this, that, uh, we gave my dad power of attorney, we sublet our flat, and we sold our Hondas [laughs] and, and moved to Uganda, which I'm, I'm laughing in part because I had never been east of Chicago.

    19. PA

      [laughs]

    20. SD

      I mean, [laughs] this was, this was a, uh, pretty dramatic thing to do, and it was only-

    21. PA

      And I'm sorry, you, your husband, and who else? That's it.

    22. SD

      The two of us.

    23. PA

      That's the team.

    24. SD

      That's the team.

    25. PA

      That's the, that's the dream team. [laughs]

    26. SD

      That's the team. That's the team. And, and Uganda was a place where on the positive side of things, the NCI had set up a collaboration with Uganda Cancer Institute-

    27. PA

      Mm-hmm

    28. SD

      ... uh, where they did some really great things in lymphoma and, um, Burkitt's lymphoma, if you remember-

    29. PA

      Yep

    30. SD

      ... those stories, and, um, a- and one of the physicians at UCSF had been associated with that, um, John Ziegler. So there was a connection to the Uganda Cancer Institute.

  4. 29:54 – 41:21

    Susan’s time working in general oncology and her transition to biotech where she helped develop taxol—a top-selling cancer drug

    1. PA

      And so you came back to the US after about three years.

    2. SD

      Uh-huh.

    3. PA

      And did you go back to UCSF?

    4. SD

      Well, we wanted to go back to UCSF, but we had not, um, uh, uh, kept our academic careers going as much as we should have. Um, we didn't publish enough, and they didn't have a global health program or money for us.

    5. PA

      Taking care of a million people with HIV wasn't, wasn't enough to justify coming back to [laughs] UCSF.

    6. SD

      It, it actually wasn't.

    7. PA

      Yeah.

    8. SD

      Uh, so we said, well, gee, you know, w-when the chief of medicine outlined for us the plan for us to stay, a large part of it was taking care of patients to pay our way.

    9. PA

      Yeah.

    10. SD

      So we said, boy, taking care of patients, we know what that looks like, so we went into private practice.

    11. PA

      In San Francisco?

    12. SD

      No, we moved back to Kentucky, where Nick is from.

    13. PA

      Okay.

    14. SD

      So we moved back to Kentucky, and, um, I was, uh, in a two-person oncology practice with a former classmate of Nick's, uh, in Lexington.

    15. PA

      You were doing, at this point, oncology unrelated to... Not necessarily focusing on HIV and AIDS-related cancer, breast cancer.

    16. SD

      I, I was doing good old-fashioned American oncology.

    17. PA

      Okay.

    18. SD

      Yeah, and I hadn't, um, I didn't take my oncology boards when we went to Uganda because I was in Uganda. So, um, I still sort of laugh about taking the, uh, DeVita [laughs] oncology book with a yellow Sharpie. [laughs] And I reread, uh, the big oncology book twice.

    19. PA

      Is this the DeVita, Hellman, Rosenberg book?

    20. SD

      Yes, yes.

    21. PA

      Yeah, yeah, yeah, of course.

    22. SD

      Yeah, yeah. It's brown these days, I think. It's, uh... And I reread it twice and t- took my boards and, and did fine. So I was ready. [laughs]

    23. PA

      This is unbelievable. So you're sitting in l- in Kentucky practicing garden variety oncology.

    24. SD

      Mm-hmm.

    25. PA

      And w- and then you... So, so talk to me about what that's like 'cause that, that just must seem... I mean, that's completely orthogonal to what you've been doing for the past couple of years.

    26. SD

      It was so, so, so, so different. And, um, I think the good news was that, um... And, and Nick was in a practice where he was more like a hospitalist. You know, they, somebody'd get a fever in the ICU, and they'd call that ID group.

    27. PA

      Mm-hmm.

    28. SD

      Um, and, uh, a- and my practice was a two-person practice. It was very classy. I saw a lot of lung cancer. It was Kentucky, you know, so there's a lot of smoking, a lot of people from Appalachian. Um, uh, the... I actually like taking care of patients, so that part I liked, but I really missed the kind of intellectual research, um, collegial stuff, uh, that I was used to at UCSF 'cause we had been there nine years by that time, you know, because we were still UCSF faculty when we were in Uganda. Um, so it, it, Nick was called about, um, Bristol Myers Squibb search for an expert on HIV because they were trying to follow AZT with, uh, the next antiretroviral. I think it was DDI and D4T were both in development then. And so they recruited Nick to come and work at Bristol Myers Squibb out of private practice. And Nick said, um, "I won't come unless you have a job for my wife." And they said, "No, we have a nepotism clause. We, we don't allow couples to work at Bristol Myers Squibb." So he said, "Fine, I won't come." He's a good husband. [laughs]

    29. PA

      [laughs]

    30. SD

      This is, this is one of our favorite stories 'cause it's a true story. [laughs] So, so they called him back, and they said, "We really, really, uh, want you to come 'cause w- we want this program to do well, and, um, could your wife be a consultant? Will she, would she agree to be a consultant and not a full-time employee?" And he said, "Yeah, that'll work." So we moved to Connecticut, and, um, he had a, a, a job, and I was the trailing spouse. And I can just see what this looked like. I'm making this up now. [laughs]

  5. 41:21 – 51:03

    Genentech’s origins, and its groundbreaking use of recombinant DNA to develop biologic drugs

    1. PA

      So you left Bristol Myers Squibb in '95?

    2. SD

      '95, yeah.

    3. PA

      And you went to Genentech.

    4. SD

      Mm-hmm.

    5. PA

      Tell me where Genentech was in its life cycle then. So Genentech had been around for a while, but I mean, when did Genentech get founded, in the sev- mid-'70s, late?-

    6. SD

      1976.

    7. PA

      Okay. Give, give folks a little bit of a history of Genentech. Genentech's a, a storied company-

    8. SD

      Yep

    9. PA

      ... but also a different company in that it was founded on a new technology.

    10. SD

      Yeah, Genentech's a really interesting, um, company 'cause it, it, it claims to be the first biotech company. There's some cetus, uh, back and f- uh, and forth about that, but it was based on genetic technology. That's where the Genentech name came from, and what Herb and Bob, the co-founders of Genentech, wanted to do is kind of do a proof of concept, um, uh, that you could use genetic technology and make medicines, make big medicines, proteins, antibodies, medicines that would almost certainly have to be injected rather than swallowed 'cause they're large, um, and they're, uh, protein, so you break them down if you swallow them. But their initial goals were focused on insulin, which they out-licensed to Lilly and Pfizer, um, and growth hormone, human growth hormone. So before Genentech, uh, when you were a parent and your child was short, you needed to give that child, um, growth hormone that came from cadavers, and that had a risk of, uh, this slow virus disease, and that was the, um, uh, not a good trade-off for, for parents. So the concept of having recombinant, of having human-like growth hormone was a really wonderful thing. So Genentech's first drug was human growth hormone, and the, um, it was a tour de force. It was really amazing that, um, uh, in the late '70s, they were able to, to do this fermentation and purification because they had to prove to FDA it was pure human growth hormone with no contaminants. Um, and it became famous for that, and, and people were excited and thought this was cool.

    11. PA

      Tell people kind of briefly how this worked. What was recombinant DNA technology? How, what were they putting the gene into? How did they get the gene to make-

    12. SD

      Yeah

    13. PA

      ... the protein? Like, it's such a, we take this all for granted today 'cause we have-

    14. SD

      It's tricky, yeah. [laughs]

    15. PA

      Yeah, but, but it's, it's so incredible.

    16. SD

      So what you, w- w- what you see if you go to Genentech or a company like Genentech is you see these tanks, and the tanks are like a cell ICU, you know, like an ICU for a cell. So the, the cell is the, y- y- what you're doing is you're teaching the cell to make at very high amounts growth hormone, way higher than your cells or my cells would. Very high. And then you're teaching the cell through this genetic engineering to secrete it into a medium, into this soup that is really a lot of growth hormone, and then you're taking away the cells after they secrete it. You're purifying that growth hormone, and you put it in little vials, and that's the process of biotechnology. And you can trick a cell into making almost anything you want, not completely, but almost anything you want, and make it very much like human, which is neat. So you don't have to go to a human to donate you growth hor- hormone 'cause it would be too small.

    17. PA

      Or in the case of insulin, I mean, they were using insulin from pigs and other-

    18. SD

      Porcine insulin that made allergies.

    19. PA

      Yep.

    20. SD

      And expensive.

    21. PA

      Yep.

    22. SD

      So human insulin really changed how you thought about treating, uh, people who have, um, uh, diabetes. So Genentech made growth hormone, and, and Genentech sold growth hormone and set up something I actually think is a really neat thing that Genentech, uh, did, which people said, "How do you know that by giving, uh, kids extra growth hormone it won't cause leukemia or, you know, a fourth arm to sprout out or so," you know, weird things to happen.

    23. PA

      Hmm.

    24. SD

      And Genentech said, "Well, we'll follow every child." So they set up a patient registry, one of the first patient registries ever, and followed every child until they reached their final adult height. And the physicians and their staff entered this into a computer. And so this is an amazing amount of information. So if the FDA ever asked us, "You know, do you have this with growth hormone? Did you have that with growth hormone?" We had not an example, not like you s- you wouldn't even do statistics on it. It's every child ever treated with Genentech's growth hormone.

    25. PA

      Do you have a sense of how many kids that was over the-

    26. SD

      Oh, hundreds of kids, thousands of kids by now.

    27. PA

      Yeah.

    28. SD

      Yeah, yeah. And, um, so Genentech got really good at that. And in fact, when I went to Genentech in 1995, the chief medical officer at Genentech was a pediatric endocrinologist, an expert on short stature and, and growth hormone, but it's a pretty small market. This is-

    29. PA

      Yeah

    30. SD

      ... you know, uncommon. So Genentech decided that they, uh, um, they would get good-

  6. 51:03 – 1:00:57

    Susan’s move to Genentech, and her pivotal role in the development and success of Herceptin as a groundbreaking therapy in targeted oncology

    1. PA

      it.

    2. SD

      Yeah.

    3. PA

      You finally earned the respect you deserve. You've got this struggling company, Genentech. Was it the opportunity?

    4. SD

      Oh, yeah.

    5. PA

      Yeah.

    6. SD

      Yeah, for, for sure it was the opportunity. I will tell you, if you were me in 1995 sitting down with Art Levinson, and he was the head of research then.

    7. PA

      Yep.

    8. SD

      And he was talking about the future in oncology and what the plans were, you'd have gone, too. [laughs]

    9. PA

      Yeah.

    10. SD

      You'd have gone, too. It, it, for sure it was the opportunity. Um, we were doing well. I, I, I will say that, um, further down on the list of pros and cons was, uh, West Coast is home. I mean, Connecticut was kind of snowy and cold. [laughs]

    11. PA

      Yeah.

    12. SD

      I didn't come over on the Mayflower, turns out. [laughs] But I mean, I loved people at Bristol Myers Squibb. I loved the job. Um, uh, and I loved being-

    13. PA

      But heading back to San Francisco was-

    14. SD

      In San Francisco.

    15. PA

      Yep.

    16. SD

      Yeah, yeah. So that, that was a big deal. But I believed Art when he said we're gonna be a cancer company.

    17. PA

      So what was the first thing you worked on?

    18. SD

      Uh, [laughs] thrombopoietin. I, they hired me to work on thrombopoietin.

    19. PA

      Interesting.

    20. SD

      It was going to be the third leg of the stool. Uh, EPO, so for, make your red cells go up, uh, Neupogen for your white cells, and, uh, TPO for your platelets. And it was a big race. Amgen was in the race.

    21. PA

      Who developed EPO?

    22. SD

      EPO's, uh, Amgen.

    23. PA

      Amgen, okay.

    24. SD

      Yeah, EPO and Neupogen.

    25. PA

      Got it, okay.

    26. SD

      Yeah, so they were the... And you know, Amgen and Genentech had always been kind of-

    27. PA

      Yep

    28. SD

      ... uh, rivals. And, uh, when, when they cloned, um, thrombopoietin at Genentech, like everybody know... You know, I read the paper, and then they called me, did I wanna come work on it? It was that kind of thing.

    29. PA

      Yep. And when you clone it, does that, if you publish it, that doesn't give you the right to... I mean, it's a race for everybody.

    30. SD

      It's a race.

  7. 1:00:57 – 1:12:12

    The rise of antibody-based cancer therapies: the development of Rituxan and Avastin

    1. PA

      where does... I mean, we've gotta be getting close to Avastin now too, right?

    2. SD

      Yeah, so we, um, but, but don't forget Rituxan [laughs] 'cause that's-

    3. PA

      Oh, yes, yes.

    4. SD

      So when I said people didn't believe in, in you could, you could treat a solid tumor, they thought you could treat lymphoma because we did. So antibodies were so, um, Disliked. People did not believe in antibodies, that in '95, '96, IDEC was gonna run out of money. So IDEC had made an antibody to CD20, a very important marker on, on all, uh, lymphomas. And they were gonna run out of money, so some of our business development folks talked to them about, uh, Genentech doing a deal with them on Rituxan. And that, it, it, you know, I think f- uh, it, it is impossible to overstate how important Rituxan is in lymphoma. You, I often think when I'm in product development of patients I've cared for, I had this great 83-year-old pharmacist who wa- when I was in practice, and he had, uh, a lymphoma that was low grade. It wasn't really... You know, he was a little tired. He was fine. And so we did watch and wait, my not favorite [laughs]

    5. PA

      [laughs]

    6. SD

      ... strategy of oncology. Let's watch and wait as you dwindle. He'd be a perfect candidate for Rituxan, just, like, perfect. Four doses, you can repeat it. It's, it, and it just... In fact, it works so well. H- here's when I changed my mind on antibodies. Somebody runs in my office and said, "Oh, we have a case of tumor lysis syndrome." So tumor lysis syndrome being somebody got Rituxan, they had a lot of lymphoma, and the cells are breaking down so fast their kidneys can't keep up, and they have to be dialyzed.

    7. PA

      [laughs]

    8. SD

      Oh, that's only an antibody. No chemo, no, no payload, nothing. That's when you know you've got, uh, a good drug.

    9. PA

      And how many cells in the body, how many types of cells in the body express CD20?

    10. SD

      Um, it's mainly a B cell, uh, um-

    11. PA

      But it's not as specific as CD19, is it?

    12. SD

      I think 19 and 20 are CD, both, uh, B cells.

    13. PA

      They're both.

    14. SD

      I'd have to look at it to see.

    15. PA

      Yeah, I, I know that CD19-

    16. SD

      Yeah

    17. PA

      ... is on the B cell, but I don't, I didn't know the, uh, okay.

    18. SD

      Yeah.

    19. PA

      And, um, and this is, we were talking about this earlier. This is chimeric.

    20. SD

      It's chimeric, yeah.

    21. PA

      Yeah, so tell folks what that-

    22. SD

      Yeah

    23. PA

      ... implies 'cause that's another wrinkle in the story.

    24. SD

      Well, that's the other thing that I think is y- you know, there's so many dogmas of, that we believe until data proves us, uh, otherwise. So one of the warts of, of Rituxan was thought that it was a chimera, that we would-

    25. PA

      [laughs]

    26. SD

      ... uh, it, it had too many mouse parts to human parts and that we would cause, um, [lips smack] uh, human anti-chimeric antibody, HACA. Um, and FDA was very concerned about this, so we measured and measured and measured. And it, it, uh, turned out probably because the patients had lymphoma that they didn't get HACA. They, uh, very tiny numbers, and they, not clinically-

    27. PA

      Mm

    28. SD

      ... relevant. And you can treat them a lot. Yeah, I mean, you can treat patients over and over again. Herceptin's 93% human, so not a chimera, but not fully humanized. Um, and none of the patients treated with antibodies that I've seen, uh, not with Genentech or IDEC antibodies, have really had problems. They've had other problems based on target-related problems, not based on the antibody.

    29. PA

      And the CD20 antibody was just also a straight naked antibody?

    30. SD

      Straight naked antibody.

  8. 1:12:12 – 1:24:40

    The step-by-step drug development process and the scientific and strategic challenges involved

    1. PA

      hit, hit pause. I wanted to do this later, but this, I think this is the right drug to go through two things. One, even though I've done this probably half a dozen times on the podcast, you should never assume somebody remembers it. I want people to understand what the difference is between a Phase I, a Phase II, a Phase III study.

    2. SD

      Mm-hmm.

    3. PA

      Also understand what's pre-clinical. Um, it's not intuitive to people why-

    4. SD

      Mm

    5. PA

      ... it costs a billion dollars to get a drug to market and why it can take a decade. Um, and then se- within that, if you could just embed enough of the details about decisions that you can make that will make or break you, right?

    6. SD

      Yeah, yep.

    7. PA

      You, how many times has a drug failed because the experimental design, the wrong patient selection-

    8. SD

      Mm-hmm, mm-hmm

    9. PA

      ... the wrong disease selection?

    10. SD

      Yeah.

    11. PA

      You, it is, you have got to line up four pieces of Swiss cheese just right to get the pen through to hit it. So let's-

    12. SD

      Yeah

    13. PA

      ... sorry to interrupt, but let's go back to-

    14. SD

      No, no, no, that's good

    15. PA

      ... you got Judah Folkman talking about VEGF, VEGF, VEGF.

    16. SD

      Yeah.

    17. PA

      That then turns into, well, if we made an antibody to VEGF, okay, so there's your idea. Now-

    18. SD

      Yeah

    19. PA

      ... start the clock and start the dollars.

    20. SD

      Yeah, so if you, um, if you start with a target-

    21. PA

      Hmm

    22. SD

      ... often in oncology today, we'll start with a target. Th- there's two things you have to s- to start with. One is what's the best way to turn down or turn off that target? Is it a small molecule? Is it an antibody? Um

    23. PA

      Tell folks the difference. How do you think of small molecule versus antibody? Where do we draw the line?

    24. SD

      So here's a really simple way I think of that helps me. Small molecule is chemistry. Small molecule is, it can be, not always, a pill. Uh, um, a small molecule, you're, you're impacting on often pathways or enzymes or things that happen in the cell. Um, a large molecule, whether it's a protein or especially an antibody, an antibody's biology. An antibody, you're trying to do something that may be immune in nature, or you use the antibody as a delivery device. You're getting something to the cell. Um, it's a, a company like Genentech, um, and many modern companies really like antibodies. I like antibodies because when something happens, it's on target. It, it doesn't tend to be off target. Small molecules, that chemistry tends to have surprises in negative ways off target, like liver toxicity-

    25. PA

      Yeah, so this is-

    26. SD

      ... or kidney toxicity.

    27. PA

      This is the way I, I do this through cardiovascular medicine-

    28. SD

      Uh-huh

    29. PA

      ... to explain to people the difference between a statin and a PCSK9 inhibitor. You have these two very common drugs that are used to lower cholesterol.

    30. SD

      Yeah.

  9. 1:24:40 – 1:27:22

    The ethical and economic controversy surrounding Avastin’s high cost and limited survival benefit

    1. SD

      excited.

    2. PA

      Yeah. Now, at this point, I'm in medical school-

    3. SD

      [laughs]

    4. PA

      ... just down the street. I'm at Stanford, and I remember we had a d- big discussion about this. I'm in my first year of medical school, and the discussion we had in class was, I think at the time Avastin was $100,000 for the treatment. Extends median survival by whatever, but I think it was eight months.

    5. SD

      Yeah.

    6. PA

      The UK said no. The NHS said-

    7. SD

      Right

    8. PA

      ... "We are not paying for this"-

    9. SD

      Yep

    10. PA

      ... because at the time, the NIH, uh, pardon me, the NHS had this $100,000 quality adjusted life year hurdle.

    11. SD

      Yeah.

    12. PA

      So they were, which is understandable, right? That's-

    13. SD

      Yeah

    14. PA

      ... how do you throttle supply side economics. They said, "Look, we can't pay for a drug, we can't pay more than $100,000 for an incremental year of quality adjusted life year. This is only giving you eight months." That's why I know it was less than 12, and so the NHS flatly said, "We're not paying for this."

    15. SD

      Yep.

    16. PA

      And I do believe people in the UK could pay out of pocket for it.

    17. SD

      You can get it out of pocket, but not through the National Health Service.

    18. PA

      That's right.

    19. SD

      Yeah.

    20. PA

      People in Canada could not, because you couldn't have private insurance in Canada, though you could come to the US for treatment. And so of course, this just became a great topic of discussion for-

    21. SD

      Yeah

    22. PA

      ... med school-

    23. SD

      Yeah

    24. PA

      ... you know, freshmen. Um, what was your thought at the time of, you know-

    25. SD

      Yeah

    26. PA

      ... have we moved the needle enough? How do we think about the economics of this?

    27. SD

      Had a, a lot of different reactions. First of all, with Avastin, it was the first time I remember reading, and I think it was one of those curtain raiser, um, things in The Wall Street Journal for the breast cancer study. It, and the, the title of it, the headline was, um, "Avastin might help breast cancer patients, but can they afford to take it?" And it, I was shocked that it was the first time I had read, in as long as I had been at Genentech, um, that somebody couldn't afford one of our drugs. Like, that, that instead of saying, "Oh, isn't that cool? Rituxan, Herceptin, Avastin," it was too much money, and that felt really important to me and really, uh, um, not good. Uh, we had as a company a philosophy that no patient should go without any of our drugs because of an inability to pay. So we had a bunch of patient, um, uh, what do you call those? Patient support programs, whatever.

    28. PA

      Yeah.

    29. SD

      Um, so we had a bunch of different things in place. So I knew we had those programs, but that doesn't help the patients in the UK, and it doesn't help the overall cost 'cause we're actually supplementing, but the cost is still really high. And we started to have a lot more discussion at the executive committee about the price and how we would think about it and how we would price the drugs, um, because that was, like I say, that was not, um, uh, not good.

  10. 1:27:22 – 1:41:14

    Susan’s tenure as chancellor at UCSF: leading during a financially strained period, and her strategic approach to fundraising and institutional development

    1. PA

      How, uh, did you go straight from Genentech to being the chancellor at UCSF? Well, th- I, just because I wanna stay with the story, I wanna continue the arc of your career.

    2. SD

      [laughs]

    3. PA

      'Cause we haven't even, we're at the halfway point, right?

    4. SD

      [laughs]

    5. PA

      We're like the, we're one third of the way into-

    6. SD

      Early days.

    7. PA

      Yeah, yeah, yeah, yeah, yeah.

    8. SD

      We're in the '90s.

    9. PA

      So what, how did you, given the incr- like, you are truly on the cusp of what is happening in oncology and biotechnology.

    10. SD

      Yeah.

    11. PA

      And now the same institution that said you can't come back here to have a clinical appointment-

    12. SD

      [laughs]

    13. PA

      ... after saving the people of Uganda is now offering you the highest post essentially outside of a provost-

    14. SD

      Mm-hmm

    15. PA

      ... I'm guessing, right? Or I, I don't even know what a chan-

    16. SD

      It is the highest post.

    17. PA

      It is the highest post. Okay, so, so that's-

    18. SD

      [laughs]

    19. PA

      ... that's kind of remarkable. And, and does that just speak to the, what, what they saw as the vision of that institution, which was, you know, few people have learned what Sue has learned in the last 10 years, and we want that type of leadership here?

    20. SD

      So first of all, on the Genentech side of things, Roche bought us.

    21. PA

      That's right.

    22. SD

      So they had a-

    23. PA

      That was '99? What year was it?

    24. SD

      That was 2009.

    25. PA

      Oh, 2009. Oh my God. Okay, I'm off by a whole decade. I thought that was sooner.

    26. SD

      2009, so the, um, which was not what we wanted. We, like, it was a f-

    27. PA

      It's a hostile takeover.

    28. SD

      A hostile takeover.

    29. PA

      Yeah.

    30. SD

      Yeah. They, they call it in the business world a squeeze out.

  11. 1:41:14 – 1:53:18

    What Susan learned as CEO of the Bill and Melinda Gates Foundation: strategic processes and decision-making frameworks

    1. PA

      So then let's get to the next chapter. What, what all of a sudden, um, in 2013, 2014, leads to the next transition to being the CEO of the Bill & Melinda Gates Foundation?

    2. SD

      Well, uh, to my surprise, um, I, uh, I think I got an email or a, I think it was an email from Melinda, um, did I have time to talk. Um, and, uh, UCSF throws a big event every year that's kind of friend making, fundraising, everything, and we give out, um, awards, you know, recognition to people whose, um, uh, whose work we respect a lot. So I had invited Melinda the year before and thought, "She'll never come." [laughs] You know, you invite people, like a, the throwaway invite.

    3. PA

      Hmm.

    4. SD

      And she accepted and came. Actually came with her mom and dad, even better. And I thought that was nice. Uh, so she sent me an email, uh, and she said that she and Bill, um, wanted me to look at being the next CEO of the Gates Foundation. And I was surprised. I had not, you know, expected that. And, um, so I started having discussions with them. It was actually funny because I, uh, I went up to Seattle, and they were having all this hush-hush. You know, this was very, uh, cloak and dagger. So I went to their house, um, to, uh, 'cause I had had a meeting with Melinda, and I needed to meet with Bill, and it was Halloween. [laughs] The kids are coming and going, and it was kinda crazy. Um, and so I had talked to him, and, and I talked to my husband. You know, my husband worked at the Gates Foundation. He led the HIV and TB programs about five years before. And-

    5. PA

      Was he still there?

    6. SD

      No, no.

    7. PA

      Oh.

    8. SD

      He had gone.

    9. PA

      Yeah.

    10. SD

      He was commuting to Seattle, which was dreadful.

    11. PA

      Oh.

    12. SD

      Um, and, uh, uh, so he, but he knew the Gates Foundation, so he and I were talking about this, and I was like, "Oh, God, you know, I'm only been at UCSF five years. It's not, I f- I've just found where the bathrooms are," you know, that kind of thing. Um, and it was going well. I was happy with that. Um, so they got on, they asked for a teleconference, and they got on the phone, and especially Bill made this big pitch that only, that, that a lot of people could do the UCSF job, with all due respect, [laughs] as Bill would put it, but I was the only person who they both wanted and who could do this job. I was perfect for the job, and it's really important for the world, and I needed to do it. [laughs] It was-

    13. PA

      I assume that the rationale for that was their, ob- obviously their focus is, um, on he-

    14. SD

      Glo- global health

    15. PA

      ... global health.

    16. SD

      Global health, yeah.

    17. PA

      And you have the background in the clinical side, the research side, the epidemiologic side, the management side.

    18. SD

      Right.

    19. PA

      So there's kind of, those are four legs of a chair. Were there other things that I'm missing that they felt were kind of essential pillars?

    20. SD

      I think now, I, I think it was less obvious then, but I think now they had started to kind of have disparate views of how the foundation should operate. Melinda's been really all over women's issues, you know, all over. And Bill Would do, you know, another run at polio. [laughs] You know, it's like they, they, they... Their passions. They-- The, the goal broadly that all lives have equal value, which by the way, I think is a, a wonderful thing, um, they share, but they come at it from different ways. And so I think that the, the thing that resonated for me is that I could see both those points of view.

    21. PA

      But those points of view don't strike me as mutually exclusive for an organization with enormous resources, right?

    22. SD

      Yes and no. Um, I think, uh, it, it's one thing to have enormous resources. It's another to know where one of the most important, um, assets they have is the time and energy of Bill and Melinda.

    23. PA

      Hmm.

    24. SD

      You know, they actually show up-

    25. PA

      Yeah

    26. SD

      ... things happen.

    27. PA

      So how did you weigh this decision?

    28. SD

      I thought that I could add value. I thought I would learn a lot. Um, and I did think that, that UCSF would be fine without me. I felt like we were back on our feet financially. I thought that Sam Hawgood, who was the dean of the School of Medicine, I had a ton of respect for him and thought he was the obvious person to take my place, um, and that it would be okay.

    29. PA

      Were they surprised? Were they-- Did they try to talk you out of this?

    30. SD

      I don't think they did. I actually think they had a lot of respect for the Gates Foundation and thought, "Oh, well, that's a cool job."

  12. 1:53:18 – 1:58:15

    Susan’s philosophy of leadership and how she sought to build an empowering, values-driven culture at the Gates Foundation

    1. PA

      And are you basically only able to affect that through your interaction with your direct reports and just hope that that's the infusion of culture that then trickles down? Because y- it's hard to go two levels below your management, and yet the people who probably need this compassion the most are people you're not even going to meet.

    2. SD

      Yes and no. Um, one thing about traveling a lot or having, you know, you have big events or things like that is, is you meet people on trips.

    3. PA

      Mm-hmm.

    4. SD

      And that's different people-

    5. PA

      Yeah

    6. SD

      ... throughout the organization. So I think there are opportunities. I also set up meetings, like when people would have a, a grant that needed to be signed, the pr- business process was it would show up on my computer. So I changed the business process, so I got the group that, that, uh, could fit around the table in my office, and we would talk about the grant. So I could interact with more people that weren't my reports-

    7. PA

      Hmm

    8. SD

      ... which I really liked. Um, so I do think it is mostly through your reports, but I think there are ways that, um, a, at a senior level you can interact with people culture-wise.

    9. PA

      Yeah. Uh, the word culture is, is, is something that, that I think i- it's very misunderstood, right? When, when you think about the culture that you wanted to bring to the Gates Foundation, I'd like to understand what that was and how successful you, you think you were able to, to, to be. Uh, and I say that because-

    10. SD

      Mm-hmm

    11. PA

      ... you were in an organization where you also had very powerful other present people-

    12. SD

      Yeah

    13. PA

      ... whose culture was also a part of the organization.

    14. SD

      S- so for me, um, I define culture in a really specific way, um, that when you come to work, y- you feel like the atmosphere, the, the surround sound brings out the best in you.

    15. PA

      Hmm.

    16. SD

      Um, and that you have some ownership of tweaking it if it doesn't. So that, that's something that you feel like you can control, 'cause if you're the, in, uh, thousands of, of people or hundreds, thousands, tens of thousands of people, y- and you're the CEO, you're not gonna do that. But that you set up that culture. O- o- one of the, my favorite, um, stories from Genentech was being at a product development meeting that, um, my, uh, successor as medical officer, Hal Baron, was running. And Art and I both attended just 'cause we loved it and we wanted to be there, but we weren't decision-makers. We were just attendees.

    17. PA

      Which is kind of odd, right? The person who's the decision-maker is sitting in the presence of the two most senior people in the company.

    18. SD

      Mm-hmm. Mm-hmm. Just-

    19. PA

      But you're leaving it to him to make the decision.

    20. SD

      We're leaving it to him.

    21. PA

      Yep.

    22. SD

      Yeah. But in this case, there was someone who, um, the discussion was about Herceptin and h- h- how, how well the test to find who was HER2 positive performed, and if you got more patients, you would get more commercial, right? But you would have patients who wouldn't benefit. And someone who I won't name said, "You know, but if we have a, a test that does like this, we can get more money." And as if in unison, Art and I both rose up from our chairs and said, "We never do that. We don't do that here." Done. Like, everyone kind of sat down and... [laughs] We weren't the decision-makers. But see, that's culture.

    23. PA

      Yeah.

    24. SD

      That's like, you know, y- if you wondered, it's right where the decisions are being made and everything else. That, that for me is, is culture.

    25. PA

      Hmm.

    26. SD

      Um, um, the other one that, because I'm in so many meetings and was in so many meetings at Gates Foundation I had a practice that it, I would sit, Bill would be there, or Melinda would be there, but often Bill and me there, and you're presenting. And Bill's peppering you with questions, some of them very tough, um, in a very tough way. I would look at you. "You got this." I would just-- I, I can't tell you how many people-- I actually didn't even know I did it, that I would nod-

    27. PA

      You were the coach

    28. SD

      ... smile, coach. I would also stall. I'd s- "Hey, hold on a minute, Bill. I think he's, he's just getting ready to answer that question. You're talking over him right now." You know, just a nice way, not confrontational. That for me is culture.

    29. PA

      Hmm.

    30. SD

      I want you to succeed. I want you to know I want you to succeed, you know, and I want, if somebody's, you know, it's, it's the guy who runs the foundation. It's the two people who are the chairs, and so it's gonna be scary. Um, so if there are-- That's why I think that bringing out the best in people and giving people agency to do that on their own means that if somebody sees Art Levinson say, "That's not the way we do it here," they'll go down the hall in a different meeting and say, "You know, I heard Art say..." I think that's really powerful.

  13. 1:58:15 – 2:14:30

    The erosion of public trust in science during COVID, the communication failures around controversial treatments like ivermectin, and the need for better public health engagement and transparency

    1. PA

      So this brings us up to kind of 2020, and was, w-were you at the, uh, the foundation when COVID hit?

    2. SD

      I had announced that I was leaving and w-- you know, literally packing the house as COVID hit. A-actually a few miles from us, the first case in Washington State.

    3. PA

      Yeah.

    4. SD

      Nursing home.

    5. PA

      Yeah, yeah. Interesting. Um, l-let's talk a little bit about COVID, right? So, um, I've talked before about this idea of the difference between science and advocacy, and I still haven't really wrapped my mind fully around it other than kind of a sense of lost opportunity with COVID. Um, uh, w-what are your-- And what do I mean by that? Well, on the, on the one level, there was so many pretty incredible things that happened with respect to the speed with which a vaccine could be developed that really made a difference-

    6. SD

      Mm-hmm

    7. PA

      ... in terms of mortality for a subset of the population. Um, but a lot of that's overshadowed today by the lingering doubts, the lingering suspicions, um, the mistakes that were frankly made. And my fear is I'm not convinced we're better off today in terms of preparedness for a pandemic than we were in twenty nineteen, which seems like an unimaginable statement given what we've been through.

    8. SD

      Mm-hmm.

    9. PA

      So do you think I'm too pessimistic, or w-how do you feel?

    10. SD

      I do not think you're too pessimistic. I am absolutely horrified. Horrified. Uh, uh, it, it is... It's shocking to me that the, the narrative has, is in the place it is today. Um, and the-- And I'm honestly still processing how we got here from there because it's, um, it is a really bad place, and I think you're right. I think if it happened again today, it would be the way it was with worst of COVID, but even worse because trust and, um, a-and also the, the, um, the need to have sides and winning and losing. I mean, I'm, I don't remember, um, health and medicine being winning and losing and sides, um, as I've been in this business for forty years. It's just weird. I don't get it.

    11. PA

      Yep. I, I, I concur with all of that. Um, and I do wonder what it will take to restore confidence. I, I, I-- You know, look, we could sit here and talk about mistakes. It might be that the medical community and the scientific community need to be more vocal about acknowledging mistakes, and I do think an enormous mistake, though it's understandable to me why it happened because so much was happening so fast, but I believe deep down it was an enormous mistake to be the head of science, to be the head of advocacy. I think having, having Dr. Fauci as being both of those hats was a cataclysmic error. No-- And it's not about him.

    12. SD

      Mm-hmm.

    13. PA

      No human can do that. A scientist has to be an impartial-

    14. SD

      Yep

    15. PA

      ... observer of fact who is happy to change his or her mind-

    16. SD

      Mm-hmm

    17. PA

      ... in the presence of new information with no attachment to what has been said in the past.

    18. SD

      Yep.

    19. PA

      An advocate has to be driving policy and action, and sometimes they have to settle for the best you can do.

    20. SD

      Yeah.

    21. PA

      Any port in a storm.

    22. SD

      Yeah.

    23. PA

      When you put those two hats on the same people, I worry that you lose all trust. And I, I do wish the medical community could have an open and honest discussion about that. And, and I would, I would say that not if, but when-

    24. SD

      Mm-hmm

    25. PA

      ... we will have another pandemic.

    26. SD

      Mm-hmm, mm-hmm.

    27. PA

      There's zero doubt in my mind.

    28. SD

      Bird, bird flu's working hard on it right now.

    29. PA

      Yeah, we will absolutely have another pandemic. I hope it is decades from now, but we will. I hope somebody will remember that lesson and say, "We want our chief communicator of the s- of the state of the science-"

    30. SD

      Yep

  14. 2:14:30 – 2:28:17

    The role of AI in transforming medicine: from drug development to cancer detection and beyond

    1. PA

      I wanna talk a little bit about AI. A lot of people might not realize you're on the board of OpenAI. Um, and you're the only person in, in, in medicine on that board. [lips smack] So talk to me a little bit about how that came about, um, and I, and I wanna obviously talk about the implications of that, what you're excited about and what you're afraid of.

    2. SD

      So I joined, um, the OpenAI board almost a year ago now, um, when they had, um, had had in November of, uh, 2023 what they call the blip-

    3. PA

      Mm-hmm

    4. SD

      ... which is, uh, CEO fired-

    5. PA

      Yep

    6. SD

      ... board changed, uh, over. Um, and I have been, um, so impressed by the intellect, the commitment, the sense of responsibility of folks at OpenAI. Um, I hope this is, um, this is maybe a, a little crazy, but here's what I hope. Uh, if, if I had a top two things for AI, one is in some of the things we've been talking about in product development. I mean, I love product development. I think it is the best job on Earth.

    7. PA

      Mm.

    8. SD

      You get to make new medicines for people who are sick. Who wouldn't w- you know, you go home and tell your mom and dad that, they're happy.

    9. PA

      Yeah.

    10. SD

      So, so what if we could take the tool of AI and make easy the things we can make easy? So you don't use AI to change a clinical trial. I still wanna know, does your tumor shrink? Do you feel better? Do you have side effects? But there's a lot of study reports, there's toxicology reports, there are a lot of things that are labor, uh, and paperwork that are actually very important to establishing the safety, uh, especially, but also the efficacy of a drug. I think using AI more and more on pieces of the clinical trials process so that if something takes time, it's because it's benefiting a human, not because we just couldn't do it fast enough. So the clinical trials, I think, still has some, uh, opportunities for that.

    11. PA

      Well, tell, give me a time and money sense in terms of savings.

    12. SD

      Yeah.

    13. PA

      'Cause I, uh, this is a very important question. How many... Yeah.

    14. SD

      If you said that there's, the cl- the entire clinical trials program for a drug is six years, let's just make that up, six, seven years.

    15. PA

      IND to approval.

    16. SD

      IND to approval.

    17. PA

      Okay.

    18. SD

      Um, I would wanna cut it down by two years. And-

    19. PA

      You, and you believe AI can do that right now?

    20. SD

      I think-

    21. PA

      I mean, or we're on the path to that?

    22. SD

      I think we could be on a path to that, yeah. Now, the, the challenge of it is gonna be, if you say, uh, this example I like to give 'cause it's, it makes sense for people. If I'm changing five-year survival, if this is sort of a mature-

    23. PA

      Yes

    24. SD

      ... established thing, I gotta wait five years.

    25. PA

      Yep.

    26. SD

      I can estimate things, and I can work with FDA to make sure if people can benefit, we can look at that.

    27. PA

      But, and you could argue with a regulatory change in the FDA, if we said greater emphasis on safety to approval-

    28. SD

      Right

    29. PA

      ... greater emphasis on post-market surveillance for efficacy, we shift this thing a little bit. Now you could say at three years we're trending, you get a provisional approvement, uh, uh, approval.

    30. SD

      Approval.

Episode duration: 2:28:17

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