We are going to move on to our second panel. Very excited. My good friend has been at the fda for a number of years to reach structure offices and one of the private sector whos been willing to do the hard work of others are unwilling to do and continuing, we have doctor mark who ran to federal agencies including serving as fda commissioner so we are going to spend time talking about organizations. We eventually got them out into the community. The Public Health infrastructure unfortunately operated largely inh un a silo, fragmented across localities, states, and the fed. And then as we think about agencies come with three primary agencies. We had the cdc, the fda and the nih, and they all functions very differently duringda the pandem. And so my hope was to spend sometime talk about how the fdas successes, it was not perfect but it did a pretty darn good job, and what we can learn from that thinking about how to fix this cdc and the nih Going Forward and make a a more robt Public Health infrastructure. Dr. Woodcock, ane few thoughts r you to start us off. Well, i dont want to criticize my fellow agencies, but i would say that we dont have a systemic approach to medical Product Development testing and response. Its very, very fragmented, and all those cracks showed like with the pandemic, right . Cdc struggle i think a great deal because of the distributed nature of Public Health systems in other countries that had him or nationalize Public Health system and health care system, too, able to respond more like systematically because they were unified and there was some central approach, unified approach. So i think we suffer from this which we celebrate our federated nature, but we also were victims of it in some extent because from fdas standpoint, say take the Public Health data, the data about vaccinations and its effectiveness. Wewe relied on scandinavia and israel for those data. Everybody is beating up on us, why are you quoting those data . They had all the information. I know the biologic center who had set up a Surveillance Program safe for adverse events, for health records, vaccine, who was vaccinated was not in the medical records because it was done through a different system. And the states with their own privacy laws and their own approaches, we couldnt get those data. We couldnt like adverse events or outcomes like did you get covid or not, we couldnt link that to whether your vaccinated or not. So we were unable to draw conclusion about vaccine efficacy and safety from the real world data in the United States. The cdc hadnd a relatively, and reduce a small, its just the fact you need many thousands of people, so they had an academic link, link program ever using for that, but that at such moldl data we had some really bad problems with false signals which is what you get with small data, incomplete data. So for vaccine adverse events, vaccines are really, really safe, or they should be. So you need hundreds of thousands of exposures to look for adverse events, or you should. If he only did one of people and you dont have a viable vaccine, right . I think that was repeated. That same for come if im talking too much. Okay. So the same for say the Clinical Development programs. I was ag therapeutic operatn warp speed, okay . De refunded getting, we find that a lot of stuff and that was fairly successful but there was not a Clinical Trials network in the United States wewo could utiliz. The industry does in the United States most of the development, Clinical Development work. And, frankly, the pandemic planning presumed that would be influential, pandemic flu and there would be treatments are ready and diagnostics and everything. So the clinical, the development, clinically feltman and evaluation was Something Else completely neglected in a sense of thinking about how large of an effort that would be. At the end of the day it was the ancestral efforts, the Clinical Trials and so forth in the United States that actually gave the leading data that were able, he did the vaccine trials. We were supported by warp speed obviously but industry did the therapeutic trials purported to great extent of warp speed kidding, but not totally at ease treatments available and vaccines available, whereas the uk was able to put together the recovered trial through their National Health system, large pragmatic trial and showed a very cheap agent, steroids were useful in the late stages of the disease which is ards type of problem. We, mark, you probably remember when you were training, we have been arguing in medicine for 40 years about this, whether or not steroids should be used, and it leased for this type for covid related respiratory failure, the steroids did prove to be lifesaving and are now a cornerstone of the therapy. They were only able to do that, the cheap, widely available could be used in any country, many different formulations of it. They were able to show that because they had a network, they were able to rapidly assemble clinical network, and i will say one more thing before i stop, im sorry. But martin was one of the apis in uk with his permission i coined lampreys law, and landry slot is the number of Patients Enrolled atum any site is inversely proportional to the number of professors. [laughing] and i would say that the nih networks are all Academic Health centers. Enough said all right. Where as the industry preferred sites are usually not because they are focused on Patient Enrollment and so forth. And they actually were the ones that delivered the industry site so i will stop there. A question, something we all have thought about, what makes an agency successful . Agencies are organizations just like businesses. One of thens things we talked about performance metrics and accountability and a clear budget, how do you think the fda is distinct from the cdc and the nih in that regard . On janice webmac, have a very clear nationally focused mission. We dont have state and local drug review boards but one National System. Im concerned that some of the recent court cases that have challenged some of that. The one National System that is able to put a lot of expertise into answering questions. As we move into having better far from perfect but better post market electronic Data Available to a lot more from realworld evidence, too. Overall for fda that tied to clear metrics. A lot of the budget for the drug of biologic centers is related to being able to get to clear response. All of that came in very handy in the covid response. I do want to like back up a little bit in talking about metrics to our think they really are needed. Th as you know, were both involve inw, the covid Planning Group effort which is intended to support what could potentially be a bipartisan commission, to look at what works, what didnt. People really disagree to some of these issues now but thats why you need to have deep, thoughtful bipartisan, we did after 9 11, that after of the Major National crisis. A person involved in leaving that and bring this whole effort together, we didnt get that commission. There was an effort by senator burr, senator murray in the last congress to get that over the of the othere legislation, the difficult to prevent actor this one didnt quite come together so its very important meetings and discussions like this to think about like what worked and what didnt and try to get past some of the high level talking points that people have. One of the things we found in this effort was reality is a little different than what different people are summarizing. One of the things that is most critical here is we dont have and still have a unified National Strategy for how you bring different components, the federal government together so they can do each of the things they need to do as part of an effort for National Response in ais crisis like this and support the state and local responses. We are a federal government, a federal country. Every part ofy the country has somewhat differentre governance, institutions, capabilities and that can be a good thing we are so diverse but that means you need federal support and it easier for the things that can and should be done at the local level to be done effectively. Fda working with industry was able to do this especially for warp speed, signature success in the pandemic of getting vaccines tested at largescale, massproduced and available. The other components were more problematic. He mentioned visible for cdc, also a big role for again a critical Public Health agency with all the flexibility and implement quickly to deliver care at home. Cdc tried as well. We get back to some of the failures in all of these areas, but while we have the best treatments and vaccines, by 2020, by late 2020 largest available good diagnostic test, we did have some real problems in translating that into impact. Part of that, i knew the cdc has been playing for a big talk more about that, too. Part of it goes beyond that because any Infectious Disease threat going for required different kind of response that we had an the 20 century. There is no longer good enough to go doortodoor and find a local spreading infection and try to understand it, you know, grow in a lab or whatever. From now on these infections could potentially spread globally super quickly, but we have the technology to manage that. Any new Infectious Disease threat should be something we should be able to sequence economically and a a matter of days and were able to do that with covid. We should be able to produce largescale, socalled pntr tests. This is basic technology and make those available not only a Public Health labs by the Health Care Organizations that do most of the testing around the country. We are seeing this happen with imposter pox now. We should have treatments off the shelf because we know what kind of virus or infectious agent this is, that we can try to apply any kind of testing framework that janet was talking about quickly. We have Synthetic Biology that enables us to make monoclonal antibodies and other technologies, treatments, a matter of weeks to months so they can work and manufactured in the scale, and vaccines, too. Weth also need along with that i capacity to engage the public so they understand whats goingan , what weon do and dont know at least a step of the way, starting to detect infection, hopefully understand it and taking good steps quickly to contain spread, and respond. And that requires not just cdc but also aspr, our assistant secretary for preparedness and response, and it requires the Healthcare System to act differently, to with heroic healthcare responses during the pandemic as new york and of the parts of the country were hit first and then hit repeatedly by successive waves. Where we have struggled a bit more ways in, engaging people about whether they want to get vaccinated or not. For identifying people for high risk in making sure that test of able and had access to treatment, that Prevention Community based side of healthcare was much more uneven. Again there was some really bright spots, organizations that got out there and werey already doing like virtual visits and knew who their highrisk patients were and had discussions with them or with Community Health workers to help engage them. A lot of parts of the country were we just didnt have that infrastructure in place, could bring in temporary Vaccine Centers at football stadiums, but thats not really an infrastructure thats geared to the fact that for any Infectious Disease threat that comes along without to be able to identify quickly, identify where and how it spreading, contain it through these other steps that requires not just new accountability at d. C. But some new accountability and healthcare as well. Think about where were moving in a Healthcare System, more about can we identify health risk forit the progress. The technologies are there, test and treat applies to virtually every Health Problem today and this that all the medical responses that we need but that is anot important part of it. So theres a lot to learn here that we havent really put together yet. I dont think its a partisan set of issues but i really appreciate us coming to talk about it. Talking that some of the problems and opportunities and hoping the rest of our time we can move forward from that. In some sense actually its notly necessarily even a surprie the cdc struggled because we didnt actually necessary set ip up for success. Right . Because we passed the agency with addressing Public Health at everything. And then we are surprise winners and once in the center pandemic and acu focus on a variety of other components the Public Health and that readiness and response function has atrophied. Cdc has a limited budget overall that been relatively flat over some decades took a hit with the budgetary challenges with the Great Recession of 2008 and have not been recovered by the time covid came around. This would emphasize that unlike fda, which isch a National Structure for getting safe and effective treatments to people and using them to protect and promote health, cdc is as janet said very much the federal agency some most of its limited budget goes as kind of passthroughs with cdc oversight to state andd local public heah offices. There are over 3300 state and local Public Health offices across the country, and with limited Grant Funding and that funding through the way Congress Appropriates for cdc split into a bunch of different silos, some of which arere about emergency response, some of which are about of a good Public Health goals, to your point, smoking cessation, Maternal Health, filling in gaps in our Healthcare System about Infectious Diseases, hiv, patients that get fired by our Healthcare Providers. Its understandable that its hard for them to put all that together. I think there is a powerful word, and the new cdc director talks about this, more partnerships with health care, maybe more partnerships with fda, certainly more partnerships with state and local level. In North Carolina some of our effective responses were getting out into rural communities, who is there and trusted. Like the tag extension service. Good point of contact for farmers. Frontline Healthcare Providers. But they need support to do this. Something where cdc could help, cant do it alone, but also where healthcare and social Service Providers could be involved, to. You think perhaps a more focused mission for cdc with staffing and built around that could help . Its a very broad mission. If you look at the cdc has on its website, its kind of broadly supported this idea of whats called Public Health 3. 0 which is recognizing that Public Health is certainly not just about hygiene and making sure the water is clean and the foods are safe and so forth. Important collaboration with fda, but also about all these opportunities with technology, medical technology, all the opportunities with understanding how behavioral choices and constraints that people face influence their health outcomes. But that is so broad. You think about budgets. We spend about 13,000 per person on health care in the unitedst states. About 3500, 4000 on social services and all those things affect health. About 300 per capita, 350 may 350 may be between cdc funding and other federal and state, local and Public Health fund. He see how this is got to be a partnership in order to work better. Although i would say for the cdc the question is what is a a return on investment for the population in investment is a chronic disease and the cdc the right lever to do that . And should another agency b takg on some of those, maybe at a more local or state level rather than a federal level and that would allow the cdc to blossom in this Pandemic Response and Infectious Disease response and perhaps have a different workforce . We are mayo be starting to take steps in that direction. Its another area where it would be productive that some discussions about how can you do that better . Take the Healthy People with 2030 goals. There are all goals out there. Below them, liked you is exacty supposed be doing what to get there . Also every year we make new goals or every ten years, and