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Albert Bourla

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52
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2021-12-18
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2021-12-18
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  1. Thank you for your interest, and I'm happy, as I was telling you before, that I can brag with my kids. I was in your podcast because you are their hero. You made it. I made it.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  2. I would repeat something that Steve Jobs has said. Death is life's biggest invention. It eliminates the old and gives place to the new. Life is all about moving forward. Life is all about creating new things. Maybe everyone is a contributor, but no one is the owner.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  3. That's a very interesting question. I was discussing with a lot of people that I was fearless of death. I couldn't care less when I was young. The first time that I start feeling that I want to be around was when I had kids. And then I started feeling that, oh gosh, I hope I will be around to see their wedding. I hope they will be around to see their children. If there is something that scares me is the possibility I will not be part of their lives anymore and I will not be watching. I hope there is life upstairs. So I will be able to watch them from there

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  4. I think the human ingenuity. I think although the world always is progressing, although there are a lot of things that need to be fixed in the society of 2020, Side of 2020 is better at large than things 50 years back, 100 years back, in all different aspects, from poverty, human rights, from science, from quality of life, from any aspect. I am positive that humans can create and always create a better future and will continue doing so.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  5. But Slovak has been studying thousands of people and will be under the scrutiny Not only of regulators, but as we will go into the implementation, as it happened in many countries, they will monitor to see what happened. Let's say that whatever with one cities out there, within a few weeks, they will know all hospitals, if it works or not, because they will see the statistics.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  6. Reason why a medicine like I have a marketing, which is a parasitic site, to be able to act on COVID. And so they don't seem that there is any connection and they haven't seen any paper that describes someone that used it that had any results. I'm sure that there will be some people that will claim because people are claiming anything. But I don't think that there was any paper in any peer review magazine, a reliable scientific magazine to support this claim. So we are focusing on saving people's lives. We are not focusing on Craziness.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  7. It's not the first time, if you remember, there were other compounds that were claimed that they are the solution to COVID. And clearly they were proving that they are not. There are compounds, that there are solutions and compounds that they are not. As a scientist, and I discuss with our scientists, they don't see any.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  8. These are spectacular results for something that you can take home and stay home. The biggest problem right now in Europe, in the US, when you have surges, every time that you have a surge of COVID, it is that the ICUs are full, the hospitals are paralyzed, they have to postpone electric surgeries, they have to postpone other operations because they don't have the capacity because of that. Keeping people out of the hospitals, home, keeping people out. Without dying, it is something I didn't have before. And this is significant, significant game changer.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  9. First of all, what this is about, this is a real game changer. This is a course of treatment that you get only if you get the disease. You get COVID. Then what happens is that you will take for five days pills day and night. twice a day for five days. And instead of 10 people from those that diseases to go to hospital, only one will go. This is an end. With all the caveats that the numbers are small, no one died. It was 100% efficacy on deaths. Of course, I'm sure that in real world, when the numbers are getting very high, we may have 99 instead of 100.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  10. I think choosing to vaccinate children makes a choice so that something could not potentially hurt them, which is the disease. That's why we are doing vaccinations since ever. I know that there are people that they are concerned for themselves and for their kids. What I know it is that I'm a scientist and I'm a parent. And I am telling you that vaccines is a very good thing for kids and thank God we were able to develop them.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  11. The rate is lower, but kids they do die. And how can you say that I'm not going to protect a kid for something that is likely to happen? And it is not only that. What happens in the school when they stop the education process? Because a kid got the disease and they don't have vaccines so that they can control. It is such a big disruption and such a big risk for the health of the Kids, that it shouldn't be a debate. Look, How many kids are having polio right now? Way fewer number than those that they're having COVID in the hospital. But everybody's getting the vaccine.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  12. Now that we have the vaccines, I'm sure that those that they are afraid of the vaccine, not of the disease, which are a smaller number admittedly. Also, if they are afraid of them, I'm sure that they will be afraid even more about their kids because they love, I would say, more than they love themselves. So it's going to be this situation. And again, the same. How can you do to demonstrate, to convince people, to win the minds and the hearts of the people that this is the right thing to do?

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  13. You know, because people know who I am. I had the opportunity to interact with parents before that was, let's say, approved. And there were so many, way more than... I had a lot of empathy because they were afraid for their kids because they didn't have a vaccine. They were the ones that were speaking at that time. Bring me a vaccine. When are you going to bring me a vaccine? I really fear. I feel that this is unfair, that I'm protected, my husband is protected. My old son is protected and my little sweetheart because he's below the age. He's not protected.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  14. It works, right? This 10% was never going to move, I felt. Because no matter what, you have a small number of people that really are scared. And they don't feel comfortable to do it. It worked in our case. We took it to 96%. I'm happy for those people. A lot were not diseased and some were not dying of those people. But it's not to me to say, because the debate, it's a serious debate. And there are a lot of pros and cons you need to push people if you need to give them the freedom. It comes with the territory if you are elected to run a country. You should be ready to make difficult decisions.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  15. I think it is a very difficult. And a very difficult decision whoever needs to make it. And clearly it's not me. It is the public health officials of every country that they have to make this decision. I have to make the decision for Pfizer, employees. And I had to balance the fear of those that they work, that they want to feel that the others are vaccinated and the fear of those that they don't want to get the vaccine. And eventually I came to the decision that we will mandate it at Pfizer. We are flexible, we are giving exceptions, of course, for health, maybe some religions, but we decided to mandate it. Now, at Pfizer, when we did this decision, we were at 90% vaccination rates when we said we are going to mandate it. And that took it up to 96.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  16. The third dose. I don't know with Omicron, if how long this will last. And frankly, I don't know if we will need a new vaccine tailor-made to Omicron based on everything we know so far. We are monitoring and we'll know way more in the weeks to come. If there is a need for a new vaccine, we will have it. And if there is a need for mass production of this new vaccine, I can also feel very comfortable that we will not lose any of our capacity that we have developed. Right now we are running at 1 billion almost approximately doses per quarter, four per year. And if we have to sweets and have half of that in the new half of that in the old, we will do still 4 billion doses. So I think The world should feel very, very comfortable that if there is a need, we will be ahead of the virus.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  17. And it was based on the data that I had. But then Delta came because I always making the caveat that with abs and a new variant with everything we know. With Delta, it was proven that we need the booster to move to the six months. And this is what happened. And I still said, I think the booster is a six months, and then I think it will be an annual revaccination. Likely. We have to monitor to see the data, but this is the likely scenario. Now we have Omicron. And Omicron says that to dos might be challenging. We don't know exactly yet. But three doses work. So clearly a lot of countries already started moving now, the third dose, not from six months to three, so that they will reduce the period that people will not be protected with

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  18. In the beginning, when we had the first months of the vaccine, people would ask me, do we need another one? And I said, we don't know. Was very clear about it. Then around April, May, I start seeing the first data and I made statements that I think we will need a booster around eight to 12 months after the second dose. And then after that, annual revaccinations. This is what I said believe is one of the most likely scenarios.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  19. Not only been clear as to what I want to say so there are no misunderstandings, but also I maintain the trust of the people. I don't think that someone who only cherks information and only emphasizes positive things. It's someone that it is the one to be trusted and I won't me and Pfizer to be trusted.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  20. I never said something 100%. Every time I speak, if a number is 100%, I rush to say that in biology there is nothing 100% because always there will be when you go to the millions. There were in the study things that were 100%, for example, deaths or in South Africa. When we tried, if there was 100% efficacy. Clearly, in small numbers, when the numbers will become much bigger, the 100% will not hold, but will be 95. So still, the direction this is the point. So I'm very, very careful what I tweet. And in addition to how careful I am, I have people that are looking it and they are having second or third opinions to make sure that we don't put. Why? Because I know that people are listening to me right now, everything I say. And I want to make sure that they continue not only

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  21. Very old parents back in Greece. We start calling them to making sure because we know that that will be picked up by Greek newspapers and they will publish it. They are those people that wrote these things. They know very well that my wife didn't die and died because she was vaccinated, right? So this is the narratives that they are on purpose forming to profit from the stress and the anxiety of good people.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  22. What I'm saying is there is a small number of people that they have made business for them to Profit from this anxiety. I'll give you an example. I have been arrested by FBI. This is what someone wrote. I read it. I laughed. I mean, okay, this is where they take it. There was a reason why they wrote it there. The Pfizer CEO was arrested FBI because they want to create doubts in the minds of the people that they're afraid and say, look, if FDI arrested him likely, I will not do the vaccine. But I laughed. A week later, The wife of the Pfizer CEO died. There is a picture in this website of my wife. Someone sends to me. Now I'm pissed. I'm not laughing. I try to find my kids. To tell them if you read something mom is fine, don't worry. Then I remember that she has

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  23. The fact that you are educated doesn't mean that you are having either humility or empathy or you have good human qualities. This was never and will never be a metric of judging this type of virtues. Those that they do this, they're wrong. And actually they are not doing good service to the public health because they are undermining. People are not stupid. They see if you be respecting them and if you're not respecting their need to learn because that affects their health, the health of the mother, of the kids. So I fully agree with you that we should be very patient to explain again and again and again what is happening. And the vast majority of the people that they don't get vaccinations right now is because they're afraid. It's not for any other reason. It's not that they have an agenda.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  24. And as people can see that I'm not wearing a tie and you are, but it's not about... Being able, those that they have the power to impose on the others the stigma that what you are saying is misinformation. But there are a few things that a society we have accomplished, and science is one of them. And data is, and analytics of data is another one. And to say that something which is highly scientific by people that they are not scientists, I think that it is not what you are describing, what used to happen in the Soviet Union or in any other autocratic regime in the world right now.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  25. This should not fear something like that. It's completely wrong. There is no medical product in the history of humanity that have been tested as much as this vaccine has been administered to hundreds of millions of people. And because of the importance of COVID, they have been scrutinized those people constantly. Right now, healthcare authorities are looking for every single signal around the world of people that they got the vaccine and try to see if it is vaccine related or not. There are electronic medical records that will tell us when and what happened to a person when he did got the vaccine. And we know now we have so high certainty that it is so safe. Exactly as the data set says about this vaccine more than any other product. They should not be afraid of something like that and they should not listen to

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  26. For a new vaccine. The discovery phase of a new molecule, like the treatment that we have now, the pill against COVID, takes four years. We then ask them to do it in three. We asked them to do it in four months, which is what they did. When you are setting this type of goals, they know immediately they cannot just think within the box. And immediately this is where the human ingenuity and the heart comes. And this is how they surprised all of us.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  27. People don't know what they can and what they cannot do. And if anything, they have a serious tendency to underestimate what they can do. And always, when you ask them something that is seemingly impossible, they will think out of the box to be able to deliver. Discussed about the timing instead of eight years. We then asked them to do it in six. We asked them to do it in eight months. Our normal manufacturing Yearly production fizz was 200 million doses of vaccines every year. That was we are doing in the last 10 years. didn't ask him to make 300 million doses for a new vaccine. We asked him to make a billion.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  28. They got the vaccine because heart attacks will happen if you have 50,000 people because it's part of life. These are all these processes are very well established since years. What we did, the last one was exactly the same as we did always. We just didn't lose time. We were not careful with money instead of recruiting 50,000 people over a year because we had, let's say, 30 hospitals doing the recruitment, we went with 150 hospitals doing the recruitment. That cost a lot of money. But instead of recruiting them in a year, we recruited them in three, four months. So I did this type of things by taking return on investment, taking cost out of the equation, and we were able to achieve this result. But it's not the process, believe me. It is the heart of the people.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  29. So, all of that is blind. The idea is that when you go into this study, you need to make sure that you are going with the right one. That's why it takes so much time. But the study is the study. You need to have a significant number of people that will give the two, and then you let them live their lives, and then you see how many of them will get the disease. And then you see if there are differences in percentage of infections for the vaccinated compared to the non-vaccinated. At the same time, you're monitoring all of them to see if there are differences in the safety profile, if those that they go to placebo have the same, let's say, heart attacks with those that they didn't.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  30. That I think this is the vaccine, this is the dose, this is the scheme that I believe will give me the best results. And when you have that, then you go to do what we call the phase three. This is a very big study with thousands of people where you use the vaccine that you think is the right one and a placebo. The placebo in the vaccine, they look identical. Nobody knows if it's injected a placebo vaccine. The physician that makes the injection. The doctor doesn't know if he's injecting placebo or vaccine. He knows a barcode. Only the computer knows. In order to go into this computer, there are keys and there are at least two people that needs to put their keys so that someone can see the data. And those people, they have legal obligations never to do that. So before a certain point.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  31. You go, first of all, with smaller doses in humans, and then after you have done a lot of experiments in animals so that you can feel that it is safe enough to go to humans and then go with very low dose, and then you gradually increase the dose, and then you monitor those humans to make sure that there are not any, let's say, reactogenicity to what you are giving them. At the same time, you start to measure what is doing in terms of immune responses. So you do that with multiple vaccines and you do that with multiple doses, and you do that with multiple ages of people, young people, old people. And eventually, from the 20 vaccines to multiple doses to multiple schedules after three weeks, the second dose, or is it after four weeks or after six months? All of that will inform you.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  32. Say that there are so many faces when you try, first of all, to find what is the right vaccine. We tried from 20 different vaccines, we nailed down to four. And for those four, we selected eventually two and then eventually one. Once you have those selections, what is the dose you are going to use? And then we try it multiple different doses to see which one we think is the best.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  33. The vaccines take years to do that. And the time that it takes, it is basically the vast majority, the time to conduct the final phase three study, that is the confirmatory study. And you do that because the phase three study cost a lot of money. In our case, cost almost a billion. So you don't want to go and risk a billion in blinded data normally before you do a lot of experiments to make sure that the product that you are putting in the phase three is the right one. We didn't have the time, so we risk all the money. So we went into, we condensed all the time towards this phase three. But the phase three study had to follow all the rules that any study follows when you do this trial.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  34. And most of the sponsorship that you have, it is more on pace-related organizations. rather than we are very careful not to sponsor other things that can be perceived, not even influenced, but perceived that we may influence. So we are very, very careful on that. This is not the case with us.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  35. You need to know that we are so, so careful with sponsorships. First of all, we have very few, very, very few. We have a team that for every single one could be $2,000, they will try to see if there is a conflict of interest in the way we do it. And also, what is the reputation of the persons or the programs that we are sponsoring? So I don't think our friend I think was from Texas.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  36. I think people could go one way or another because of multiple reasons. From our perspective, I don't think we have aggressive. Marketing, what do we do? Go on TV and we are having ads about our products. And they are highly regulated. I think it is the right of people to know, to learn that if there is a product like that, it's very clearly that we cannot say things, that they are off-label, that have not been approved. We need to have every time we go into V, as you know, FDA is forcing us to say also the bad things that can happen for a medicine. Sometimes that takes more time than the good things. And I don't think that we are doing aggressive marketing. Now, people could be influenced and can be biased in the podcasts or in the other type of media activities that they have for multiple different reasons.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  37. I think that we try always to do the right thing. And that's, as I said, very well embedded into our culture. If you don't do the right thing, sooner or later you will pay for it one way or another. And right now, for us doing the right thing, it is being able to find innovations to issues that are real. Diseases that they do not have good coverage, good treatments right now. We try to find treatments that significantly Surpass the current standards of care. And we try not only to comply with what regulators are asking us to do. This is what you need to do to prove the safety or the efficacy, but exceed No matter what we do on that, I'm sure that people will find opportunity because, as you said, there are a lot of lawyers to sue us. But we believe in the justice system, and we believe that eventually if you are doing the right thing,

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  38. I don't think that these things happened since then. We have a stellar record from 2009 until now of complying with every single regulation and rule. We have internal processes to make sure that these are not happening by individuals that may have an interest. For example, to get a promotion, they may try to do things that are not the right things. And we have more importantly, a culture in this company that really sets aside people that they think differently. So I didn't like what happened in 2003. But I believe a lot has changed in the 20 years that followed, or almost 20 years.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  39. Correct, and this is something that it is allowed when physicians are speaking to physicians, but it is not allowed for the pharmaceutical companies to refer to these studies, because usually there are studies that are happening of label. And apparently several of our reps in 2003, they did it, and we had to settle in 2009, and we paid a very big fine, as you said. The fine was related not to the severity of the contact, but the size of the revenues. So the fines are, if Dexter was a small product, we would get a small fine. Bexter was a very big product, and we got a very large fine. Very bad, what happened in 2003?

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  40. The Bextra case in 2009 was related to things that happened in 2003. And the things that happen in 2003 were things that basically several of our reps did off-label promotion. So they spoke about with the physicians, about off-label use of the product, and they shouldn't.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  41. I think it was the private sector that came with solutions with diagnostic tests when we didn't have solutions with respirators, when we didn't have, solutions with treatments, solutions with vaccines. And I think that demonstrated very clearly to the world the value of thriving life sciences sector, private life sciences sector, to society Also affected very positively the reputation, both of the sector and of Pfizer. I'm not going to make the mistake to consider given. I'm not to make the mistake that because our computation is high, that will remain so. We need to earn it every day. Every day with everything we do, with everything we say, with the way we behave. And I hope that we'll rise to this occasion and we will do that.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  42. Reputation is something that you can lose in buckets, but you can end back in drops. And once you lost it, you are going to take a lot of effort to bring it back. And the pharmaceutical industry lost it. It's clear that the reputation of the industry in the last decade was on the lowest that we have seen ever. There are many reasons for that, but clearly there are reasons that are related also with the behavior of the industry. That needed to change, and I'm hopeful that. Very few who disagree that the industry is a very different industry right now. Been I truly believe that if there is one lesson that stands out from the main lessons that we learned during COVID is the power of science in the hands of the private sector.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  43. I would say that I recognize what you said about what happened, and I'm sure that what you describe in the country that you're coming from, it was how you experienced it. And I know that there are other countries that you need to do these things to do your job. I don't think it's the case in this country, particularly when it comes to those agencies that you mentioned. I think they have a very high track record. And also, I don't think that there are a lot of people that they are worried about it or doubt it. I'm sure, like everywhere, there will be a minority, but the vast majority of the Americans, the vast majority of the Europeans, the vast majority of the Brits, the vast majority of the Israelis, they trust what FDA or EMA or CDC or MHRA will say.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  44. I think there is always the fear of corruption, particularly when you speak about public servants. But clearly the risk is very different country by country. And speaking about, and agencies by agencies, I think the regulatory agencies have a very good track record in history of the US, of Europe, of England, of very, very good track record of integrity.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  45. Always, always they are unbiased and they are trying the best. And it's not only one or two people. They have processes to make sure that there are self-checks and balances within the agencies, both in CDC and in the FDA. Difficult decisions, they bring external experts that they should express. Easy decisions, there are internal experts that they are debating a lot. And if there are disagreements, they elevate them. So I think we are lucky to have good regulators. I think I agree with what you said before with all governmental agencies, there is bureaucracy, and the bureaucracy needs to be addressed. And by saying bureaucracy is not relaxing the bar, the bar needs to remain high, but being focusing on what matters rather than on the... On the detail

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  46. I have zero doubts that this is not affecting at all their ability to be unbiased and regulate. And in order for the system also reinforces that by creating significant time barriers, if someone moves from an industry to FDA, he won't be able to deal with topics for a period of time and then for even an enhanced period of time with topics that are related with a company he or she may come from. I think this regulators are really very strict, rightly so. If anything, I feel sometimes that maybe they should be a little bit more open-minded, particularly when it comes to new technologies, rather than trying to judge and implement the same framework of evaluation of new technologies to all. They are always as regulators in the conservative side.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  47. This is not a black box. We know very well what is the process. Everybody knows very well what are the processes. The review process also, it is very detailed. They have scientists of very, very high caliber. Not every regulator in the world, but the Europeans, the Brits, the FDA clearly, they have very, very high caliber of scientists that they are going into a lot of details. And also, Basically, everything for a study is really released by law in the specifications of the product. That's a very detailed document that it is issued and has basically the essence of everything was discussed. I don't know about specific documents if take them time to release, but clearly this is not a black box type of process.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  48. I think the relations with regulators, they have been always very transparent, and there are a lot of laws that they are forcing Regulators and companies to put out there their interactions and what exactly was discussed. Now to go into specific details of some discussions, I don't know what is the reason that FDA wants to take the time, but I'm sure they have very good reasons.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  49. Not at all, because the studies are highly regulated Everybody knows what regulators, and when I say regulators, FDA, European authorities, UK authorities, Israeli authorities, Japanese authorities, Canadian authorities want to see how the study needs to be conducted and what exactly they need to see to approve it or not. So clearly everybody takes into consideration how much money I'm going to invest and what is the chances that I'm going to lose them. But what you can do is to change the rules of the game so that you won't lose the money. There are very well established methodologies that would say very high precision if your medicine is effective, if your medicine is safe. And those are there for all and are playing with the same rules.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source

  50. I think about it all the time and I know very well that if you focus too much on making money, you will never make. You should focus in what is the real. Value driver. And the real value driver is to make breakthroughs that change patients' lives. If you don't do that, you will never make money. If you do that, don't worry. Things will fall into place and also money will follow. But the mentality of the company is to be how to help the patients. And that's what the management was, that the shareholders want, because that's the only way that we can create value. In this particular case, we're not thinking at all about what are we going to make when we sell it or if we don't sell it, because what we were focusing 100% was how to bring a solution to the world that will help all of us.

    2021-12-18 · Lex Fridman Podcast · #249 – Albert Bourla: Pfizer CEO · IDENTIFIED FROM THE TRANSCRIPT · source