Our second panel. I am very excited for this actually. I have my good friend, janet woodcock, who is the principal fda commissioner and has been there for a number of years and helped reorganize and restructure offices. And is probably one of the best investors i know in the public and private sector. She has always been willing to do the hard work that others are unwilling to do and make hard decisions. And continuing our brain traps, we have dr. Mark mcclellan who ran two federal agencies including serving as the fda commissioner area i am an eternal pragmatist so this is fun for me because you are going to spend time talking about how to fix agencies and organizations. During the pandemic, the biomedical innovation complex works pretty well. We got vaccines, had therapeutics, and it took time to happen and in record time. All of us are probably sitting here today because these things actually happened. We got them out community. The Public Health infrastructure unfortunately offering largely in a silo and fragment cross move qualities and effect. And fragmented across lowquality states and the fed. We had the fda, cdc and nih which all functioned very differently during the pandemic. I hope was to spend time talking about how the fdas successes, which was not perfect but did a pretty darn good job, and what we can learn from this, thinking about how to fix the cdc and nih Going Forward. To make a more robust Public Health infrastructure. Dr. Janet woodcock, a few thoughts from you to start us off. I do not want to criticize my fellow agencies but i would say that we do not have a systemic approach to medical product development, testing, and response. It is very fragmented. All these cracks showed like with the pandemic. The cdc struggled a great deal because of the distributed nature of Public Health systems in other countries that had a more nationalized Public Health system were able to respond more systematically because they were unified into there was some kind of central approach. I think that we suffer from this. We celebrated our federated nature, but we also were victims of it in some extent. From the fta standpoint, they take the Public Health data about vaccinations and its effectiveness. We relied on scandinavia and israel for those data. Everybody is beating up on us like why are you quoting those data . But they had all the information. I know the biologic center, who had set up a Surveillance Program for adverse events and to help records. Who was vaccinated was not in the medical records because it was done through a different system. And to the states, with their own privacy laws and own approaches, could not get the data. We could not link albers events were outcomes light, did you get covid or not . We cant link that to whether you were vaccinated or not. We cannot draw conclusions about vaccine efficacy and safety in the u. S. The cdc is relatively small. There are many thousands of people. But they had an academic link program they were using for this. But it has some small data. We had really bad problems with false signals which is what you get with small data that is incomplete. For vaccines and adverse events, they are really safe or should be. So, we needed thousands of exposures to look for adverse events. If you only have 100 people, you do not have a viable vaccine. I think this was repeated. The same for dust tummy if i am talking too much. Tell me if im talking too much. The same for Clinical Development programs. We funded getting we funded a lot of stuff and that was fairly successful. But there was not Clinical Trials network in the u. S. That we could utilize. The industry in the u. S. Looks at Clinical Development worse. Frankly, the pandemic planning presumed there would be influenza, pandemic flu, and there would be treatments and diagnostics already rated dust already. The Clinical Development evaluation was completely neglected in the sense of thinking about how large of an effort that would. At the end of the day, it was industrial effort of Clinical Trials in the u. S. That actually gave leading data and they did the vaccine trials. They were supported by warp speed obviously. But the industry did the therapeutic trials to be great extent of forex data, but not totally, that got these extent of works data, but not totally, that got the vaccines available. The u. K. Was able to put together a recovery trial, a large pragmatic trial, and had a cheap group of steroids were useful which was the ards type of problem. Mark, you probably remember, we have been arguing in medicine for 40 years about whether or not they are whether or not steroids should be used. At least this, with covid and respiratory failure, steroids proved to be vital. A cornerstone of the therapy. They were only able to do this or that cheap, widespread medicine was available and could be used in many countries. They were able to show this because they had a Clinical Network and were able to rapidly assemble a Clinical Network. And i will say one more thing before i stop. I talked with one if the pis in the u. K. With his permission, i coined it landrys law, a number of Patients Enrolled at any site is inversely proportional to the number of professors. [applause] [laughter] i would say that the nih networks are all in Academic Health centers. Enough said. Where the industry preferred sites are usually not because they are focused on patient enrollment. They actually were the ones that delivered the industry. I will stop there. Pulling on this thread, the question is something we all have talked about. What makes an agency successful . Agencies are organizations like businesses. One of the things we talked about his performance metrics, accountability, and a clear budget. How do you think the fda is distinct from the cdc and nih in that regard. The fda, picking up on janets point, have a nationally focused mission. We do not have state and local drug review boards but one national system. I am concerned about some of the Regional Court systems that challenge that. But we have one National Court system that is able to put a lot of expertise into the system. As we move into having better and far from perfect but better postmarket data available, we are learning more from realworld evidence too. Overall for the fda, that is tied to clear metrics. A lot of the budget for the drug and virologic centers is related to get to clear guidance and clear response. This all came in very handy in the covid risk response. I want to back up and talk about metrics to where i think they really are needed. As you know, we are both involved in the covid Planning Group effort which was intended to support what could potentially be a bipartisan convention to look at what works and what not. People really disagree on some issues now but that is why any deep and thoughtful, bipartisan did this after 9 11 and after other Major National crises. The person involved in leading this and help bring this whole effort together, we did not get this commission. There was an effort by senator byrd and senator murray in congress to get this over the line with some other legislation called the prevent act. This one did not quite come together. At some part to have meetings and discussions like this to think about what worked and what did not and to try to get past some of highlevel talking points people have. What if he thinks he found is, the reality is little different than what people are summarizing. One of the things that is most critical as we do not have and we dont have a National Strategy to bring components of the federal government together so they can do the things they need to do as part of an effort for National Response in a crisis like this and support the state and local responses. We are a federal government. We are a federal country. Every part of the country has somewhat different governance, institutions, capabilities. And that can be a good thing. Were so diverse. But that means you need federal support to make it easier for these the things that can and should be done at the local level to be done effectively. F. D. A. , working with industry, was able to do this. Especially for warp speeds signature success in the pandemic of getting vaccines tested at large scale. Mass produced and available. The other components were problematic. C. D. C. Is a critical Public Health agency with all the flexibilities to deliver care at home and so forth. And c. D. C. Tried as well. When we get back to some of the failures in all of these areas, but while we have the best treatments and vaccines and we have the by late 2020 the largest availability of good diagnostic tests too, including ones penal can use at home, we did have some real problems in translating that into impact and part of that the c. D. C. Has been blamed for and we can talk about that too. Part of it i think goes beyond that because any Infectious Disease threat Going Forward requires a different kind of response than we had in the 20th century. Its no longer good enough to go door to door and find a locally spreading infection and try to understand it, grow it in the will be a or whatever. From now on these infections can 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 in a matter of days. We were able to do that with covid. We should be able to produce large scale socalled p. C. R. Tests. This is basic technology and make those available not only in Public Health lance but in health will be as but in health care labs but in Health Care Organizations that do testing around the country. We saw this happen with imposter response now too. 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 in the 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 show that they can work and manufacture them at scale. And vaccines too. But we also need along with that a capacity to engage the public so they understand whats going on, what we do and dont know, at each step of the way. Starting to detect the infection, hopefully understanding it and taking good steps quickly to contain spread. And respond. And that requires not just c. D. C. But also our assistant secretary for preparedness and response and it requires the Health Care System to act differently. We had heroic health care responses during the pandemic as new york and other parts of the country were hit first and then hit repeatedly by successive waves. Where we have struggled a bit more was in, to janets point, engaging people about whether they want to get vaccinated or not. For identifying people who are at highrisk, making sure they had tests available and had access to treatments, that prevention, communitybased side of health care was much more uneven. Again, there were some really bright spots, organizations that got out there and were already doing like virtual visits and knew who highrisk patients were and had discussions with them and there were a lot of parts of the country with 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, we ought to be able to identify it quickly, identify where and how its spreading, contain it through these other steps. That requires not just new accountability at the c. D. C. , but i think some new accountability in health care as well. If you think about where were moving in our Health Care System, its more about can we identify health risk its before they progress, the technologies are there. Test and treat applies to virtually every Health Problem today. Its not only medical responses that we need, but that is an important part of it. So theres a lot to learn here that we havent really put together yet. But i really appreciate us coming to talk about it. Talking about some of the problems and opportunities and hoping the rest of our time we can move forward from that. Brian in some sense actually its not necessarily even a surprise that the c. D. C. Struggled because we didnt actually necessarily set it up for success. Janet thats true. Brian right . Because we tasked the agency with addressing Public Health everything and then we are surprised when theres a once in a century pandemic and they foes canned focused on a variety of other components of Public Health and that readiness and response function has atrophied. Mark the c. D. C. Has a limited overall that then relatively flat over some decades took a hit with the budgetary challenges, with the Great Recession of 2008 and hadnt really recovered by the time covid came around. Thises would emphasize this would emphasize that unlike f. D. A. Which is a National Structure for getting safe and effective treatments to people and using them to protect and promote health, c. D. C. Is, as janet said, very much a federal agency. So most of its limited budget goes as kind of passthroughs with c. D. C. Oversight to state and local Public Health 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 c. D. C. Split into a bunch of different silos. Some of which were about Emergency Response, some of which were about other good Public Health goals, to your point. You know, smoking cessation, Maternal Health, filling in gaps in our Health Care System around Infectious Diseases. H. I. V. , you know, patients that get fired by our Health Care Providers. Its understandable that its hard for them to put all that together. I think there is a path forward and the new c. D. C. Director, incoming c. D. C. Director talks about this, more partnerships with health care, maybe more partnerships with f. D. A. , certainly more partnerships at the state and local level with in north carolina, some of our effective responses were getting out into rural communities. Like the ag extension service. Good point of contact for farmers. And Frontline Health care providers. But they need support to do this. So its something where c. D. C. Could help, cant do it alone, but also where health care and social Service Providers could be involved too. Brian do you think perhaps a more focused mission for the c. D. C. With staffing and culture built around that could help . Mark its a very Broad Mission and if you look at the c. D. C. 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 not certainly not just about hygiene and making sure the waters clean and the foods are safe and so forth. Important collaborations with f. D. A. There too i think. But also about all these opportunities with technology with 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 dz,000 per person 13,000 per person on health care in the United States. We spend about 3500, 4,000 on social services, all those things affect health. 300 per capita, 350 maybe between c. D. C. Funding and other federal and state and local Public Health funding. You see how this has got to be a partnership in order to work better. Brian absolutely. Although i would say for the c. D. C. The question is, what is the return on the investment for the population in investment in say chronic disease and is c. D. C. The right lever to do that . And should another agency be taking on some of those maybe at a more local or state level rather than a federal level and that would allow the c. D. C. To sort of blossom in its Pandemic Response and Infectious Disease response and perhaps have a different work force . Mark i think were making starting to take steps in that direction. Another area where it would be productive to have discussions about how you can do that better. Take the Healthy People, 20 30 these are all goals out there. You look kind of below them, who is exactly supposed to be doing what to get there . Janet well, and also every year we make new goals or every 10 years and the population keeps getting worse on all the measures. So were doing were not