YouSaid · the spoken record

Robert M. Califf

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54

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2020-01-14

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2020-01-14

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1. “So, I think the FDA of the future is going to be far more digital and informed by data at all times. A lot of the activities are going to be automated so that we can focus our time and attention on the things that need to happen first, that we're going to be able to ultimately understand how products are performing across time and actually use that information from across time to right-size indications in a smart way.”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

2. “And I think that if I follow on that line of thinking, it's also about longitudinality. It's about saying, here's a surrogate or an intermediate set of endpoints that we're going to monitor, but we're actually going to understand longitudinally. Has that then translate to what we understand is happening across time? Historically, the way we've often thought about effectiveness as sort of as a fixed book of work, and I think that what you're going to see over time is we're going to talk more and more about longitudinal performance. And this is a perfect example of that.”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

3. “Yeah, I think a lot of it is also having the biomarkers that you can know that to your point, I think a lot of what you've been talking about is just it's about measurement. It's about understanding how those measurements correlate with harm. And that I think we just need to know what to measure. And that's work to be done. But I think that's something that I think is a part of the science already.”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

4. “Well, so to begin with, I think that it helps us to distinguish between aspects of biological aberrance, right? Like where essentially biology has gone bad and we're trying to think about treatments to fix it versus the really difficult construct that you're talking about, which is how do we essentially apply preventative approaches and have the confidence that these approaches are both safe and effective in a longitudinal frame that really is hard to contemplate because we don't know if we've ever gotten there. It's really hard to know that this particular treatment was indeed successful for this individual. So I'm curious, you know, as you do this here, this has certainly been an area of focus for you. What's your thoughts?”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

5. “Maintain a database of all the different genomes so that we can also track back and do this more quickly. And so that's kind of where things have been going in the food outbreak space. The other side of it is the application of technology to trying to improve our ability to go essentially farm to table. So for example, blockchain and distributed ledger technology to make sure that we can trace all the way from the farm to the grocery store. And one of the things we've been contemplating at FDA is ultimately, could you imagine the application on your phone that allows you to scan peaches and understand did the peaches have a full supply chain that we could monitor? And so these are the kinds of things that are now a part of the lexicon at FDA. We have a program called Smarter Food Safety and that whole book of work is around thinking about how do”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

6. “Since we're going to go back to CSI for a second. So these days, if there's a food borrowing illness, we will take the bacteria and essentially do whole genome sequencing to really understand the outbreak as well as which individuals who are ill are they all related to the same outbreak. And for example, with Listeria, which particularly likes to be cold. So it tends to get stuck on the nozzle in the plant and ends up in, for example, your frozen peas or other places that ultimately you can trace now through whole genome sequencing the fingerprint of the listeria then all the way back to the individual who had the bad product at their local Whole Foods, for example. And so the ability to now trace that all the way through is doable through modern technology. And one of the things the FDA does in concert with CDC and now really through international database is”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

7. “Another aspect of this I think is really fascinating is also all the things you have to do with foodborne illnesses and just thinking about how does the FDA sort of wrap their heads around that considering that food could be coming from anywhere and these threats are coming from anywhere”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

8. “So I think these innovations have shaken things up a lot, right? So if we think about meat, there's a clear interplay in the United States between what's the responsibilities of the FDA versus what's the responsibility of the USDA. And so, you know, just in this particular space, we had to start to figure out, again, that language of the authorities, where do we appropriately say this is the part that the FDA is responsible for, and sort of our unique set of science-based skills versus this is the part that the USDA sees as their core responsibility trying to want to make to keep markets intact. And last year we ultimately developed agreements with U.S. Practically speaking, what's rice milk on almond milk and dairy milk? How do we make sure that consumers understand what this is all about? And so as I think about the innovations in food.”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

9. “No, that's fascinating. Okay, so let's change the channel one more time. So let's go to Food Network. So there is an FNFDA, right? And the food part, I think, is often underappreciated. And so I'm curious to dive in there. And we could combine shows and talk about Star Trek on the food network. So one of the fascinating areas that we see is genetic engineering and synthetic biology connecting to food. And you're seeing things like cultured meat, like meat that maybe originally the DNA came from an animal, but that what you get out of it is like flame magnon or something like that in principle. And that when you start to see that being created, how do you even think about that? Would you worry about how do you balance this innovation with making sure that we're being safe?”

   2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

10. “There's a bunch of different examples along the way, but if I then think about what was happening in terms of parallel legislation on the House and the Senate side that ultimately became 21st century cures, we had this conversation going on around innovative legislation to try and accelerate the development of cures. But I don't know if many of you probably remember it largely got put on the shelf. And then we were moving into the election in November 2016. The election happens and now as a country sort of in a rather tumultuous state trying to figure out what might be bipartisan. And 21st century cures gets pulled back off of the shelf and in December 2016 gets signed into law. And so I think, you know, again, this was a piece of legislation that was, had been formed over the prior two years, a lot like that IOM report from 2007. It was generally ready to go.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

11. “Financial crisis, which then led to the stimulus bill. So it was because that treatise was already ready and also came along with the point of view of we need a digital infrastructure to pull this off that embedded within the context of the stimulus bill, we got the high-tech act, which led to the full-scale distribution of electronic health records. And we can all talk about electronic health records and good and bad points of view, but what you can see is that a big international experience, the GFC, actually then had a direct day-to-day result in terms of an enabling digital infrastructure in the United States circa 2009.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

12. “It's really interesting. So, if we look back, so Medicare Modernization Act was passed in 2003. So I'll sort of use that as my starting point. If I look back to MMA in 2003, around that time, we were contemplating a sort of new payment delivery models, comparative effectiveness. There was a report from the Institute of Medicine in 2007 around building a learning healthcare system where basically available interconnected data could help us continuously optimize both healthcare delivery but also understanding performance of drugs and devices. That piece of work from the Institute of Medicine in 2007 basically said in order to pull this off we need a digital infrastructure and basically you know it was a treatise said here's here's what's going to happen. The reason that's so important is that then we had something really important in 2008 or so.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

13. “To start to figure it out. My last point around this, which is that it is really hard to do because it takes putting the toe in the water and that has to happen with some company or some investigators core baby, and that actually is really hard because it's hard to want to subject your particular product that you're studying right now. It may be you're only shot on goal into a clinical evidence framework that we're still trying to all figure out. And so I'm not surprised it's taking us a while to figure out. We have to figure out not only how to do the work of new clinical evidence development paradigms, but actually people have to be ready to participate. And it's taking us a while.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

14. “Totality of the evidence around this particular product. So I think this is the landscape we're going to. I also think that we had essentially an accelerant put into the story in December 2016, which was 21st century cures. If you look underneath the hood of the 21st century cures legislation, what you see are a number of elements that push us in the direction of starting to accelerate our clinical evidence development process. What kind of elements? So this includes starting to double down on how we think about surrogate endpoints, how we use patient-reported data in the process, how we actually start to understand and enable platform trials, how we now use real-world evidence, and asking FDA to get smart about when we can confidently use real world evidence. And so I think that all of those were enabling features within 21st century cures. And now we all have a responsibility.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

15. “There's some of them phase one too. Some of them are just expansion cohorts in what's traditionally caused phase one. But practically speaking, I think that what we're seeing is a blurring in the phases. What we're also seeing now is contemplation of platform trials. We've been talking about platform trials for a while. They're really hard to pull off. They're hard to pull off because of issues of contracting and intellectual property. They're hard to pull off because the underlying infrastructure is tough, which I'll come back to. But practically speaking, we've talked about platform trials where we can now, in one clinical trial setting, start to evaluate multiple investigational products simultaneously. We've started to say, can we, once approving a drug, start to now use information in the real world setting, whether that is prospective or retrospective, but classically said real world data and real-world evidence to start to create a total product story or a total.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

16. “So, three things to kind of go into this that will underscore ultimately what I believe is a resounding yes. So, practically speaking, we are already starting to see new drug development paradigms in terms of”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

17. “So, I also wanted to talk to you about a different way to think about data, which is we could imagine in clinical trial the future that's maybe fairly different. So I don't think anybody disagrees, or maybe I could be wrong, that it's important for the FDA to test toxicity. We don't want to put out things that are toxic. But maybe a bold thing to say is that FDA will run phase one clinical trials, will review phase one clinical trials, but maybe we don't need phase two or three. Maybe we, especially for maybe life-threatening diseases, we let real world evidence and payers decide efficacy as they're going to do anyways through reimbursement. And that maybe the FDA could actually pull back and data gets used differently. Do you think that's viable?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

18. “Absolutely fierce when it comes to security and understanding who's accessing what data for what purposes. But it's also, when do we start using, for example, synthetic data? How do we actually start to think about what new tools and techniques and tricks we can use for data now and in the future to preserve privacy? And I think it's all of our responsibility.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

19. “It's really very hard to deny. And it's not just genomics data, right? The longitudinal story of your healthcare, every single time you visited the doctor, how much medicine you received, whether or not you got an additional test, such as an EKG, that pattern is your unique footprint as well. And so there's lots of different ways that data these days actually has a unique and representative pattern that really is individual to you. And I think the reason I brought this up at FDA as a chief privacy officer is that practically speaking, even information that is de-identified from a HIPAA perspective actually still is probably re-identifiable even in our context. And we need to be starting to think about what does that mean now and in the future. And also, you know, what are some of the creative ways that we can start to prepare? Some of it's just having the conversation. Some of it is making sure that we are absolutely”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

20. “To what prompted the question, which is with the ascension data and what's going on right now in the Google story, I think practically speaking, our laws of the past, HIPAA, really contemplated a different world than we live in right now, whereby essentially in 2019 and going forward, it's very hard to maintain privacy of any individual.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

21. “I thought you were going to go there in this session So, data ownership and privacy. So there's an easy way for me to get out of this as the FDA, which is that practically speaking, when the data comes to the FDA, it's much of the data that comes to the FDA is the proprietary information and confidential information that belongs to the company. And so we treat it as confidential information. And then there's other information that we use, for example, for drug surveillance and those kind of things that are sort of more publicly available data sets. So, you know, in a lot of ways, I think that the easy FDA answer is we don't have a lot of things that we specifically have to worry about. But in my CIO role, I just recently started pushing on the fact that I really think we need a chief privacy role at FDA, which we don't currently have. And when I brought this up, people said, well, the data that comes to us is de-identified were, you know, this is not the problem that we're really living in. But if we go back.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

22. “Actually, one bit of news that came up was Google purchasing a huge amount of healthcare data. Data and understanding how that gets regulated is, I would think, would also be a really tough question. I mean, how do you think about how these new kinds of data that people are generating and then new people want to get access to that? How does the FDA think about ownership of the data, privacy, and what are the opportunities there and the challenges”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

23. “As a diagnostic or treatment activity, but it's a software product that's intended to support life sciences more globally, whether that's to make clinical trials more efficient, to match patients to clinical trials, to curate data, to help do workflow in the hospital. And all of those kinds of software products we don't directly regulate, but importantly, those products also need some good signals of here's what good looks like and here's how you should think about good software controls in those settings as well.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

24. “So this is something that, as FDA, we've been speaking publicly about quite a bit. Can we come up with essentially preconditions for software updates so that if there are strong quality controls in the way software is developed, well understood product performance in terms of the expectation updates, can you now have algorithm updates that are as expected and don't require the same level of review? And so that's something that we're certainly spending a lot of time working on through a series of pilot projects. Also, the other part of what you've just mentioned in terms of our sci-fi land is that practically speaking, software and algorithms are actually also innovating all across the spectrum of life sciences and healthcare just outside of what we regulate. So it may not necessarily be a software product that's acting”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

25. “So, this is a really important area of, again, new regulatory paradigms and really trying to figure out how do we do this? And as I think about algorithms and the regulatory paradigms around them, first of all, I tend to divide this into two main categories. Algorithms that have a responsibility of acting as a medical treatment. So essentially software as a medical device. And there's a risk-based paradigm that asks the question, does this particular software product ultimately basically take the place of the judgment of the physician and ultimately now make a clinical decision on the physician's behalf without the physician intervening? And depending on whether or not that's going to happen, then there's a differing set of expectations in terms of the development of the regulatory paradigm. There's a couple of issues, though, that goes along with this. One is that as software can update”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

26. “And maybe the ultimate sci fi example of thinking about FDA into new areas are that even algorithms themselves can have therapeutic or diagnostic value. And how do you think about sort of regulating these algorithms themselves as they change and go through revisions and have impact on how we make either clinical decisions or even our therapies themselves?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

27. “So, you know, it goes back to this issue of authorities and sort of where's our core responsibility and how we need to move things forward. Practically speaking, we're responsible for thinking about medical products that are now going into commercial use. And specifically for now the treatment of medical problems or sort of justifiable claims. So the individual patient who's buying it off the internet, injecting it into their side, it gets into this very fuzzy area of exactly what are our authorities. And I think that becomes now really much more of a national conversation around rights and privacy as opposed to FDA approval of the kit. And practically speaking, if the kit was going to be approved for commercial purposes,”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

28. “So, you know, getting back to this genie out of the bottle, the fact that you can get these crisps or kits on Amazon, and actually literally you can YouTube this. There's some guy that has 15 glowing dogs. How do you think about that when people can do things like that in their home? How do you think about what should the FDA do about things like that?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

29. “Where do we manage them in the hospitals? Ultimately, we went to the home. How are we going to do that? What's the actual therapy as well as supportive therapies are going around, including supportive therapy for the family? And we slowly but surely worked our way through not only the individual treatment, but also all the processes that we needed to go along. And I think what you're going to see in, for example, cell therapy and many of these other places is that not only do we develop in-of-1 activities where we say biological plausibility and safety and good manufacturing and effectiveness, but we also start to refine how they perform in a greater scenario or greater system of care. And we've seen that happen over and over again across time.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

30. “So not only is anyone not precedented, if we kind of go back across medicine across town, we actually really started off as a one medicine and became more quantitative across time, especially as we had interventions that were applicable to populations, including in the millions. So practically speaking, we do have frameworks for innovative therapies. You mentioned surgery. Another one, you know, in the landscape that I came from in cancer medicine, was bone marrow or some cell transplant, right? These are places where we needed to first have the scientific innovation that goes along with biological plausibility to start to figure out how we're going to move forward with new techniques and treatments about what to do. But then start to apply a systematized set of expectations about how to refine this and get it right. So if I go back to Bomar transplant, we started to develop refined processes to understand which patient was appropriate for transplant.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

31. “So let's drill down a little deeper because the end of one framework sounds like mind-boggling from a therapeutic point of view. But maybe there's actually presence. So if you think about surgeries, like heart surgeries are all kind of n equals one. People are different. There's some similarities. Perhaps we're starting to look at things like CAR-T, not just as, actually, backup. So CART is in this sci-fi category. You take T cells out of your body, out of your blood, you re-engineer them to make them sort of supercharged, and you put them back into the patient. And the results of that are just mind-boggling, that tumors can melt away within days and people are just literally cured of cancer. Maybe it has a sense of doing molecular surgery.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

32. “Anything starts to become more and more of an issue across this space. And then practically speaking, what are the ethics? What's going to happen in the clinic? We may not be responsible in our authorities for ethics, but I think we're responsible for at least consciously thinking about what's going to go on. So as I think about this space of incredible new therapies coming forward, we all need frameworks that we can apply and where every one of us can look at through a different lens and say, I can understand why that's the order and that's how we're going to start to work our way through it.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

33. “And practically speaking, that includes what do we know about safety? What do we know about safety in vivo and in vitro in animals and in the petri dish? What do we know about biological plausibility? What's our understanding from a biology perspective that this would indeed work in the way that we would expect it to work? What do we have in terms of a predefined set of expectations in terms of clinical outcomes that we can monitor in an objective way to understand whether or not this intervention is making the difference that we expect it to make? Also, what do we need to think about with respect to whether or not this is going to apply just to one individual person or we might now start to apply and scale this approach across multiple individuals? And that's actually going to start to balance how much risk we're going to take for this particular scenario. What can we think about consistency in manufacturing?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

34. “I think one of the things to go back to is this issue of risk-based regulation. How are we going to start to solve for this in a way that appropriately has the right regulatory paradigm for this problem at hand and aligns with the level of risk? And as I think about this space, I think that we are living in a space that gets closer and closer to customized or individualized therapies. The landscape of the N of One and how do we make sense of that? And practically speaking, in order to get there, you have to have some kind of framework that you apply that says, all right, before we talk about CRISPR specifically or anti-sense oligonucleotides, before we talked about any specific thing, what's the framework we're going to apply and how do we do so in a risk-based way.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

35. “It's both gene editing, it's a therapy, there's a delivery aspect, does this live with the FDA? Does this live with the AMA? How do you even start to think about people throwing these crazy new developments at you that could radically transform medicine and cure disease, but now has to really push the paradigm for the FDA in new ways?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

36. “Fantastic. So let's change the channel. So let's talk about the future because the future that's really becoming today, like stuff that I remember like five, ten years ago were things that I thought would be sci-fi, like gene therapy, gene editing, CRISPR therapies, it's kind of crazy that I was actually talking with my eldest daughter and she was finding that you could get kits off of Amazon to do DIY CRISPR and that she could make our dog glow in the dark. She liked it not to make our dog glow in the dark, but I think in the end I think it was just crazy that this is the world that we're living in. And so, you know, there's two sides of this to dive into. So maybe the first side is like we'll get to kids and dogs glowing in the dark in a second. But for thinking about the clinical side of this, how does the FDA think about something like CRISPR?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

37. “It takes some time a while to build that muscle, right? You can imagine we have to first understand what are the causes of drug shortages and how are we going to go after them, but then practically speaking, once we do so, we can help to avert that crisis. I see the same kind of thing right now in foodborne outbreaks where we have a call every morning at 9 a.m. where we're sort of talking about the things that worry us for the day. I've officially stopped eating.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

38. “As you were saying, this I was trying to come up with some crises I could talk about. That was actually so here's one that I just recently learned about. I think we're all very worried about drug shortages. I'm an oncologist by background. I practiced in academia. I took care of adults, but certainly when we think about children with leukemia, one of the drugs that's currently in shortage is a leukemia drug for pediatric leukemia. And we try and think through how do we help avert drug shortages. And in 2018, we had something north of 50 drug shortages, but the little-known secret is that we helped to avert over 160 drug shortages. That's because practically speaking, we have developed a whole staff focused on drug shortages. We've tried to start to figure out ways to predict what is going to cause a drug shortage and try and intervene beforehand, speaking directly to manufacturers.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

39. “Yeah, no, I think it's fascinating to imagine that there is this world where the FDAs doing deep learning machine learning to be able to do this. I think perhaps also we underestimate maybe cases where maybe you have averted crises that we never heard of. Those may be the best TV shows. I mean, are there any cases like that?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

40. “Inspecting trucks. We have something called the Predict program. And the Predict program is a 10 years old rules engine that's been written by some of the different centers across FDA where the rules start to predict which truck is most likely to have unsafe food. Now you can imagine that if we wrote those rules 10 years ago, they might be old rules. And it's true that we update the rules every year, but we do so by hand. And as I think about trying to develop a more modern agency, can't we update the way that we modernize those rules? And so right now we've got an experiment going on where we're looking at machine learning-based prediction of which trucks we should inspect on the border. And can we now use machine learning as a way to be smarter? Importantly, though, going back to your point about we can't get it wrong because we lose consumer confidence when we get it wrong, we can't just say machine learning is going to be great.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

41. “Yeah, so as I got to the agency, I was surprised to find not only a responsible for regulating about 20% of international GDP. As I mentioned, that sort of this cross-broad number of products and the we that we regulate is different by product. So about 15% of our food is imported. We need to be able to make sure that the food is appropriately safe. It's appropriately labeled, that it's legitimate for sale in this country. And so that means that if you're standing at the border of Mexico, we need to basically investigate trucks that are coming across the border and look for violative products that aren't appropriate for sale in the United States, either for safety concerns or commercial concerns. How do you know which truck to look at? And if we don't get that right, we can basically stop traffic for miles. So we have, in the case of”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

42. “In that sense of being handling the authoritative nature of things, you've got to make some tough decisions. Even things like contaminated food going across the border, like you've got to inspect trucks, how do you know which truck to look for?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

43. “Of addiction and start to solve a problem on that side. So as FDA, we have to stick in our swim lanes, but then we have to think about how that grooves with everything else across government so that there's more of a nationwide approach.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

44. “Authorities, yes, yes. Yes. So our area is a responsibility and sort of legitimate jurisdiction. And practically speaking, with respect to the opioid crisis, we need to go back and say where is FDA do we have authority to try and help resolve this problem? So practically speaking, we can help reduce the number of opioid tablets, for example a patient has access to after back surgery or knee surgery in order to reduce the chance that this particular person has access and becomes addicted in the first place. As a second example, we can increase methods for access for, for example, naloxone-based treatments in the field. And we've done a number of projects to try and make sure that there is patient-informed labeling and other aspects in the field. And then also we can start to think about developing and helping to develop new treatments for the treatment of pain as well as new treatments for the treatment.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

45. “And say, what do we formally do? And so, as an agency, we put in place an action plan that had several parts that focus on what we're responsible for. And I'm going to come back to that key point in just a second, but then also asked, how does that interdigitate with all the other plans that are going on across government and also across the healthcare setting to try and solve for. So I'll say the last piece that I found very interesting since I've been in government is that there are very clear rules of the road of our authorities. It took me a while to get used to that word, but the word would be...”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

46. “Practically speaking, the FDA is responsible for many types of medical products. And any one of those can have a crisis I've discovered. So we have food and drugs. We have biologics and devices. We have animal food and drugs. We have cosmetics. We have nicotine-based products, vapes. And so the distribution of potential crises are real. And as you think about something like the opioid crisis, a problem that snuck up on us in many different ways. And as I step back and I came to the FDA in March, so I've had sort of the opportunity to watch this as an insider outsider during this period of time. That information comes from the public. It comes from across different places in government. And now we need to step back as a nation, but as also as an agency.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

47. “I think what's interesting is to think about that in even the other context of what the FDA does. I think people often don't realize that the FDA isn't just about, let's say, approving drugs. We think about clinical trials. There's a lot of things that you do to protect American consumers. And when we're talking about it, it's almost like I feel like you could have a show that's like CSI FDA or something like that, where you have these investigations of the crises. Sometimes it's slow moving crises like the opioid epidemic. How do you, like for crisis like that, where it slowly sneaks up on us and then it's too late? How does the FDA even think about that?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

48. “Particularly worried that I'm going to do something wrong and I'm going to flub up, and that's actually going to have very public impact. And we see that all the time. I think that in order to develop solutions for regulatory innovation, then what you really have to do is come up with flexible mechanisms that also allow us to deal with the risks, but also take some risks when appropriate. And so that means that as FDA, one of the things we focus on is risk-based scientific decision making and trying to right-size the degree of review and expectation with the potential risk of this particular product. And what do I mean by risk? Sometimes those are safety risks, right? So the risk of, for example, hepatic failure or the risks that this drug might take a person's life, sometimes the risks of the size of the population impacted. So you're trying to balance the urgency of this particular problem sitting in front of you with the number of people where this product may impact. Also, there's risks of public perception.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

49. “Yeah, in addition to the infrastructure, it's interesting to think about the culture. And because, for example, if there's a great drug that nobody ever gets about it, let's say there was a cure to cancer, but the FDA didn't approve it, there's no outcry because no one ever knew about it. But on the other hand, if the FDA lets something through that actually has harmful effects, thalidomide and other classic examples, then there's a huge backlash. How do you build and how do you innovate in a culture that has to deal with such strong asymmetries?”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source

50. “And as I think about where we're going in the future, practically speaking, in order to become more efficient FDA, we're going to need to receive more and more of those applications in digital formats that start to represent structured data, structured data that we can review at scale, and also structured data that allows us to now continuously surveil medical products in a better way in the future. And so what I realized was that if I was going to be a person focused on data at FDA, I was going to need to also think about how do we modernize the FDA's underlying infrastructure to take that forward. And that's why I took on the CIO job.”

    2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source