Time and i want to make sure that we have just think our panelists and prepare for our next panel which is terrific and pleasing run join me in thanking the panel. [applause] [applause] [background sounds]. Will come up we will move on to her second panel. Im very excited is actually i want to say that i have a good friend doctor Janet Woodcock sue is the Principal Deputy commissioner has been at the fda for a number of years and is helped reorganize and restructure offices and centers. And is probably one of the best executives i know in the public and private sectors. She has always been willing to do the hard work that others are unwilling to do make the hard decisions. And then continuing have a brain trust doctor mark mccalla, who ran to federal agencies including serving as fda commissioner and so, im an a internal printed so this is fun for me because we are going to spend time talking about how to fit agencies and organizations during the pandemic it, biomedical innovations and convex work pretty well we got vaccines we had therapeutics and took some time i have been in record time and all of this probably sitting here today probably because those things actually happened eventually got them out into the community and the Public Health infrastructure unfortunately, operated largely in a silo. Fragmented the kind of locality events. As we think about the agencies are three primary agencies inac the cdc and the fda and the nih. They all function very differently during the pandemic and so my hope was to spend time talking about how the fda successes and it was not perfect but it did a pretty darn good job. What we can learn from that thinkingng about how to fix the cdc and the nih Going Forward and making road right more robust Public Health infrastructure. And doctor Janet Woodcock, a few thoughts from you. Well, i dont want to criticize my fellow agencies but i would say, we do not have a systemic approach to medical chronic testing in response. Its very very fragmented and all of the showed like with the pendant make a right. The cdc struggled i think a great deal because of the distributed nature of the Public Health system. In another country, that had more nationalized Public Health system in Healthcare System as well. Were able to respond more like systematically because they were unified some kind of central approach coming unified approach. So i think that we suffer from this you know which we celebrate our federated nature but we also for victims of it to some extent because yes, from fda standpoint think the Public Health data about the vaccinations and its effectiveness we relied on scandinavia in israel. Dated everybodys beating up on us and why are you putting that into but they had all the information and i do the biologic centers who had set up etsurveillance programs and for the health records. The vaccine, was vaccinated was not in the medical records. Because it was done through different system. In the states with their own privacy laws in their own approaches, we could not get those data. So we could not link adverse events or outcomes like what did you get covid19 or not, we could not link that to whether you are vaccinated or not so we were unable to draw conclusions about vaccine efficacy and safety from the real world data in the United States and the cdc had a relatively when you say small, many thousands of people, so they had academic link program they were using for that but then its a small data that we had some really bad problems with the false signals which is what you get with small data and incomplete data and so forthle r the vaccines, adverse events and there really really safe should be right and so you need hundreds and thousands of exposures to look for adverse events or you should see only have a few hundred people that you dont have a viable vaccine right so what i think that that was repeated in the same for mr, to me if i am talking too much. Okay, so the same for say the Clinical Development programs was a therapeutic operation warp speed and so we find a getting a lot of stuff that was fairly successful but there was not a Clinical Trial network in the United States that we could utilize. E the industry does in the United States most of the development Clinical Development work and frankly, pandemic planning that u. S. Had done, presumed there would be influenza. It will be treatments already in diagnostics already everything. As of the Clinical Development and the evaluation was something completely neglected in the sense of thinking about how large of an effort that would be in at of the day, is industrial effort, the Clinical Trials and so forth, in the United States that actually gave the leading data that we were able they did the vaccine trial. Operation warp speed they did the therapeutic trials and got but not totally got these treatments available Vaccines Available whereas the uk is able to put together a recover Child InternationalHealth System in large pragmatic trial that showeder a very cheap agent and steroid are useful linda late stages disease, ards type of problem and mark you probably remember in medicine even in medicine medicine for 40 years about this whether or not steroids us shouldn be used in rbs penalties for this type for covid19, the related respiratory failure the steroids proved to be lifesaving and now the cornerstone ofov the therapy and so we were only able to do that she widely available could be used in any country in many different relations were able to show that because they had a network a Clinical Network rapidly assemble Clinical Network and also one more thing before i stop and im sorry but i talked to martin one of the prs w and uk and with his permission i point landrys law and his law is the number of Patients Enrolled in any site is inversely proportional to the number of professors. And i would say that the nih networks are all Academic Health center and i said all right where is the industry preferred sites are usually not because theyre focused on patient so forth. And actually were the words that delivered industry sites and i will stop there. Of a question something we all have thought a lot about, what makes an agency successful. And agencies are organizations just likefu businesses, one of things we talked about performance metrics and accountability and clear budget, how do you think the fda is distinct from the cdc and the nih in that regard. I janice point, very clear nationally focus mission we dont have state and local you know review boards, we have one National System and i am concerned about some of the recent court cases that have come to challenge some of that but we have one National System that is able to put a lot of expertise into answering questions about safety of the drugs and you just heard janice say if we move into having that far from perfect but better market look funny Data Available and learning a lot more from realworld evidence and overall, for fda try to clear the metrics and so a lot of the budgets and biologic centers related to enable to get the clear guidance. In all of that came in very handy in the covid19 response in do you want to like backup little bit in talking about the metrics where i think there really are needed as you know, this well we were both involved in a covid19 Planning Group effort which was insupportable could potential to be a Bipartisan Commission we look at what working with did it and people were just going some issues now but that is why any kind of deep thoughtful bipartisan effort after 911 we done for other Major National crises. This whole effort was fully god and we do not get that commission but there was an effort by centerburgr, and marie last congress and so get that over the wind. Some of the other legislation to prevent act, this one did not quite come together so is very important to have meetings and discussions like this to think about what worked and what did not work and probably get past some of the high level talking points of people have been one of the things we got in this effort was the reality is a little bit different to what ise different people are 700 summarizing one of the things that most critical here is that we do not have as soon a unified National Strategy for you bring o different components of the federal government together so that they can do each of the things that they need to do as part of an effort for National Response in a crisis like this and support the responsibly our federal government and federal country every part of the country has somewhat different governments and institutions and capabilities that could be a good thing were so diverse. That means that youak need fedel support to make it easier for these things that can and should be done at the local level to be done effectively in fda, working with industries, was able to do thises especially for warp speed and a signature the pandemic getting vaccines works go and massproduced and available for the other component more problematic than you mentioned the goal for cdc and also roles mask proof or a critical Public Health agency with all of these flexibilities towi deliver care and support. The cdc tried as well to get back to some of the failures in all of these areas but we have the best treatment vaccines we had by late 2020, largest availability of good diagnostic tests including the ones people use it all, we did real problems and translating that into impacting part of that was a cdc is been vying for the talk more about that as well and part of it think goes beyond that but because any Infectious DiseaseGoing Forward requires a different kind of response we had in the 20th century, no longer good enough to go door to door and finally got local spreading infection and try to understand this and grow it in the lab or whatever and from now on, these infections can potentially spread globally super quickly but we havent t technology to manage in any threat should be something we should be able to sequence since no monthly in a matter of days. We should be able to produce large scale and test basic Technology Make those available not only in Public Health labs but health Court Advocate organizations that do most of the testing around the country and we seenti this happen with response out and we should have treatments offtheshelf to know what kind of virus or infectious agent this is we can try to abide testing framework then was talking about quickly. We have Synthetic Biology that enables us to make them monico antibodies and other wetechnologies treatments in a matter of weeks to months so that they can work and factorem them a scale have axes also but we also need along without, a capacity to engage the public so they understand what was going on what we do or dont know every step of the way starting to detect the infections and hopefully understanding it and taking good steps quickly to contain thread and respond to that requires just the cdc, but also the assistant secretary for preparedness and response and it requires the Healthcare System to act differently but we had her growing responses during the pandemic it, york of the parts of the country road to person repeatedly by successive waves we have struggled a bit more within to janice point, engaging people about whether they want to get vaccinated or not. Identifying people at high risk make sure they had test available and access to treatment in the community and communitybased privateht healthcare is much more and even some really bright spots organizations that cut out there and already doing like virtual and he knew the high risk patients were in the test had discussions with Treatment CommunityHealth Workers to help teach them about a person country we just dont have that infrastructure in place. People could bringld in temporay you know Vaccines Centers football stadiums but that is not really an infrastructure that is geared to the fact that for any Infectious Disease we gotta be able to identify quickly and identify where and how spreading containment through these other stuff it requires not just the. D accountability of the cdc but i think the accountability in healthcare as well and think about where we are moving in a Healthcare System and more housing can we identify health risks before they progress and and apply it into virtually every problem today. It is notot only medical respons that we need but that is an important part of it is so there is a lot to learn here we have not really put together yet that are why do not think that is a part of this set of issues but i really appreciate us coming out here to talk about it talk about some of the problems and opportunities and hopefully for the rest of her time we cant. In some senses not necessarily even surprise that the cdc struggle because we didnt actually necessarily set it upt for success right becaue we test the agency with a it printed addressing Public Health everything. And then we are surprised when this once and century pandemic and the focus on that variety of other components of Public Health and that readiness andnd response function atrophy. Monkeys you have a limited overall you know then relatively flat over some decades to help h the budgetary challenges in the Great Recession of 2008, and having the ability to cover recover by the time covid19 came around and this is unlike fda which is a National Pressure forgetting safe and effective treatment of people right now, and using it for the health and cdc, genocide is very much a federal agency and so most of its limited budget goes to will kind of a passthrough cdc oversight for the state and local Public Health offices, ffthere over 3300 seen local Public Health offices across the country, and with limited grant funding, and that funding through the way they appropriate through a bunch of different silos. In the Emergency Response and about other good Public Health goals, to your point, smoking sensation and Maternal Health, and filling in gaps in our Healthcare System and around Infectious Diseases and hiv patient biggest fire our Healthcare Providers. And its understandable that it is hard for them to put all of that together. I think there is about forward in a new cdc director and incoming cdc director talk about this partnerships here and maybe more partnerships with fda has certainly more partnerships the state and local levels withit yu North Carolina and some of our effectively responses were getting onto the Rural Communities and he was there entrusted well, like the egg Extension Services in good point of contact for the farmers and frontline Healthcare Providers within need support to do this is something that you know whato the cdc couldel help them canto it alone in healthcare and social service could be involved as well. In the cdc and staffing and culture built around that could help. Is very Broad Mission and if you look at the cdc what they have on the website and for the Public Health is called Public Health three. Zero recognizing that Public Health is certainly not just about hygiene making sure the water is clean and thes foods are safe and so forth an important collaborations with the fda there and i do but also about all of these opportunities with technology in medical technology and all of the opportunities and have behavioral choices and constraints of people face and influence of the Public Health outcomes, and so broad and i think about budgets and about 13000 per person, in healthcare in the United States and about 3500 or 4000 on social services and all those things and about 300 per capita think 15 maybe in between the cdc funding and other federal state and local Public Health funding, and you know this is gotta be a partnership. Absolutely although i would say the question would be what is the return on the investment of the population an investment in the disease in the cdc is the right lever