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 the population keeps getting worse on all the measures. Thats right. We are not doing something right, okay . Despite as having better knowledge of what behavioral nonmedical steps can approve Public Health and having better drugs, clearly diagnostics than ever before that also could contribute to all of these. Cdc does not have the budget to be held accountable to get to those goals by themselves. We are starting to see in many Healthcare Organizations this is a cms priority. You heard about shifting from feeforservice payment to paying for accountability for Better Health f outcomes. So more payments to Health Care Providers say for diabetes. Did you screen your population of patients effectively . Did you get to effective hemoglobin a1c levels, indicating good diabetic control through through a whole combination of mechanisms . New diabetes treatment. Food is medicine prescription. Help with engaging people using personal health apps to get healthier. So that something that cms can help with, and i agree with your point about state and local levels. We are seeing a lot of really innovative for a company across loose states, red states, in indiana, North Carolina, massachusetts, whatever on trying to integrate social services and Community Resources around people and have some tracking and accountability at the local level for sort of the equivalent of these Healthy People 20, 30 goals but this is way bigger than something that cdc canne work on alone. Absolutely agree. One of the questions to ask his should a function reside at the federal level or might be better at the state level or even at the local level . Who is most effective to undertake the job and coordinate it . Along those lines i had a question actually for you, janet. Im stinky about clinical Clinical Trials. Wewa talked about how the biomedical innovation complex workss quite well and we are all thankful for that. The nih is a powerhouse for basic science. What do you think, or do you think thereor are lessons for wt we should focus on an h sensational efforts on . I have long been a proponent if an h is going to sponsor Clinical Trials that they really ought to think about the infrastructure funding and infrastructure rather than funding what i call the sdt. I wont mention that here, small not very good trials. [laughing] right . That they are traditionally funded as part of like rl one grants and so forth. What we lack in the United States because of that the Clinical Development industry and thats fine, they do it efficiently and effectively and so forth and so on. But thenri when a crisis arises like this, or for Public Health issues, industry isnt necessarily going to pursue, right . Because they have different objective or set of objectives. We really lack and infrastructure to do that. As mark said we had the opportunity, for example, we could harness realworld evidence. We could do largescale experiments. We could really see because some of the things you raised, market, they cry for cluster randomization because look, weve been having Healthy People 2000 or 30 years and we have made progress against. So we need evidence of driven our datadriven interventions, even social interventions rather than best intention intervention that we keepr doing, even thouh they are not working. Okay . I dont think the nih said for that and i dont know the answer for it. T. What i would say, theres a big gap in the Public Sector of research, and that is a huge gap on the clinical evaluation, is a giantan gap. You are to ask about diagnostics. So the real issue there, covid diagnostics really took off. Congress gave a billion dollars i think you nih for the radx program and they putd in the program, they develop standards, okay, and referenced standards and serum, okay and so forth. So manufacture like like a standard test. Exactly. An algorithm at the help with that. Some manufacturers are sending as covid tests and attested them in 30ed people and their supposd be used by millions, right . They did tos work and this is universities, to who did this. But if we get offered a standard evaluation protocol that a third party could do, we could run those through very quickly and got a lot of those on the market because the data would have been generated. Certification off conformity in a known testbed is something that is used in the Telecom Industry all the time. Thats what i mean. This isnt rocket science. Its been around for 20 years. So they were all out there, diagnostic companies who made that good scientist and this and that, but they didnt have the clinical and people couldnt get hold of the variants and so forth. But if we pooled our efforts and pulled referenced standards in place you could run a lot of different diagnostic tests through their very rapidly come give the evidence to the fda. It would be standardized so we wouldnt have to question it. We wouldnt have to inspect it. Thats what happened. When that happened and all these test became available because they could be easily clinically evaluated. These include direct to d consumer tests to use at home with Rapid Response time. May not be quite as sensitive but really, really found the part of detecting and containing an outbreak. One thing you and i are big proponent spoke of mark is realworld evidence, including trials out of whatld janet would say at the moment, very good trials into a broader larger committee setting, like hda should have a massive Clinical Trials apparatus. I called his large Health Systems in the community should have that. Should be part of clinical care. What do you think the nih transitional efforts to target to help promote that . I think nih enough. I think fda can do some further steps to help here and certainly is a high priority for the Kerner Commission as well as janet to try to make progress. The hardest thing about doing trials in a realworld setting is you have to deliver real world care. The solution of, well, lets just expand our funding for traditional an h trials by bringing in protocol reviewers and local oversight of the trial conditions and data collectors and all that just doesnt lend itself to the delivery of care in routine practice. Remember, Healthcare Organizations are pretty stretched these days financially. Has to be something simple. The good news is we got a lot better electronic david andat we used to. A lot of the data for payment is pretty darn accurate. Weve gote Healthcare Systems that are no longer working at the one clinician level so we are not talking about a traditional small crimes trial that would have come from white hey, one academic, this one institution pairing up with a few of his or her friends, say we can produce a study where you really would worry about is that particular clinician really implementing object of standards and the right kind of consent processte and on the collecting data accurately . We are talking assistance at that systematic implementation of electronic record systems come of clinical protocols supported by emr, whole teams of people youre working together so holding those individual clinicians accountable for how exactly is the trial going in the same way that we did in the old style, investigate Letter Research . Is just not right. Dating to ways of certified Health Systems of having good patient protections, consent, oversight, good objective data collection, that they are already using for their own care and the own payments in many cases are based on that data, thats the future. But i dont think janet, that either the nih funding for sort of these platform kind of practical randomized Clinical Trials or frankly a lot of the fda oversight regulations have yet matched up with the potential. This morning before i came down your i was talking to the people in the uk where theres a group there on the revision of the good Clinical Practice Guidelines which are ich guidelines. The pragmatic trial list which is really what were talking about here, stayed a little bit of a revolution against that, which is appropriate. Trials should be set for purpose, okay . There arent regulatory trials and weha should decide what kind of decisions you going to make out of that information and you should design d the trial to yid that data and information in a reliable way. We will be revising, including revisingbl like who was responsible and how can you do distributed . We have sent out some guidance and information on that because we have to recognize the world is changing in the way things are done is changing. That would have, but the question is, what would have enabled the u. S. To put together more rapidly, okay, Clinical Trials say out of warp . I had commenced on the problems problems getting that done at enough scale, right, and because there were small networks, but we didnt have the kind of scope, say, because the uk, to recover trial, managed to incorporate evene, investigatiol agency eventually attested. They did a lot of repurposed agents. I could be a good use for the nih Translational Research efforts. Ra setting up those trials, even helping come up with realworld evidence measures, like how do you clean the h. R. Data, for example . But then you would need a unit a group thats focus on clinical evaluation and methodology. If you look around the country okay. We had some come okay. Im talking about an institute, and institute. Whereth are the departments of clinical evaluation around the country at a medical schools . There arent any. This is a sideline for most people. It isnt supported by robust grant. So i think even for nih traditionalad could be if they sort of opened eyes about this, at least to support, not just the basic science, but the clinical evaluation and the site of clinical evaluation. That might be in the ages true role, not putting the eye to evaluation so. That might be a bridge too far. Thats a good point because that could rapidly speed up development, decrease costs and also increase access all in one specific policy change. Might improve the quality overall in the United States of investigations. I published on the fact most of the trials were set up in the United States by the Academic Centers were inadequate. They were not adequate power. They didnt enroll in a particular answer the questions. With thousands andnd thousands, tens of thousands of Patients Enrolled in trials that were not able to answer questions they were asking. On your f face. So raising the level of expertise around clinical evaluation, not having itself to become at once bia to bring in people from industry and they were the people who knew actually how to do this and get this done at scale. We just d dont have that set of expertise in government, except maybe some, you know, places like here and there. But you really need a kind of machine to really get this done at scale. This would be a change you might see something at scale. The of the pieces are lining up. I work with a group called advancing Clinical Trials at the pointca of care axiom coalition which includes a number of these Health Systems which to try to just dont feel like the premarket Clinical Trials are answering all the questions they would like answered. What are the longterm effects of these treatment . What do i do about drug interactions . Ti is this the right dosage . If i have a side effect whats the best way to manage it . Those are an impossible quess and to any standard premarket nih type clinical trial. They are exactly the kinds of questions youou could answer if you had much larger scale platforms in focusing on the key Data Elements toct collect. You are great at that point have a good understanding of major side effects can mechanism of action, things like that. These organizations said these of the kinds of questions that we want answered whether its around cardiovascular disease drugs, the new diabetes drugs that may be very helpful for prediabetes, may be helpful for obesity, may have unknown as of yet consequences with longterm use at higher doses. New treatments for neurodegenerative diseases. Compared effectiveness. I am not quite seen yet the nih big change to get there. One of the possibility might be a new funding for arthur h. This is a program thats intended for advance transformative projects. Maybe a jumpstart here around a few platforms could lead to the desired goal, a a faster, betr evidence and transmission. I have been trying to push them toward, they just, there was a study published, sounds like why havent we done this electric convulsive therapy versus instead of ketamine for severe depression. For thats a little edgy. Thats a little bit more but those of the questions help her systems really want, and insurers need to answer. What should we pay for . Or a people, they have this chronic disease and had been on this regiment and you need, they are not responding or what have you need, what should you go to . Right now its all like well, my mentor taught me this, or this is what [talking over each other] the small, crummy observational studies. Small, crummy , crumml studies, yeah. Its an art instead of a site. Thats right. Is that evidence driven. Thats much of health care right now. And yet its a minimal to actually have hypothesis driven evidence if we dont organize it a bit. That means lifes work said that those who would be participate in this Healthcare System, insurers, how to see the value of this information to them i think well open it up to questions. A microphone is coming to you. There you go. Thanknkto you. As the date of person we have more data flying around in this country that we are not using well. And and i guess im thinking f leapfrog, the leapfrog group to about 20 years ago revolutionized gettingre hospitl data. Measuring a good hospital not on an a, b, c, d scorecard, Pretty Simple to understand. Yes, theres data behind it, their gathering to determine whether it is a, b, c or d. What did that lead to . It led to impart valuebased contracting. Because, guess what, Insurance Company still want to send who theyre going to have to pay for no more to the employers to the hospital. So why we cant take that lesson and morph it. Give you one absurd example of an Insurance Company whos decided to pay for getting people to walk companion dogs for people at endoflife. Because that companion dog delivers more value to that person who is remote than any other thing. So we have an example of what is going on in the private side and that were not morphing to the public side. And its about time t that we gw up as a country and learn from whats going on from the stand to cut that are going on in North Carolina, utah, massachusetts, et cetera. Thank you. Its a great point and it highlights how importantpo it is to shift out of the traditional way we pay in healthcare for step that set in hospitals and institutions and recognize all these factors influence health. To make that work though you need to, like leapfrog emphasize, you need to measure what matters and create a way of aligning payments with that. A lot of this is happening in the private sector as you said that some of those examples are in Medicare Advantage programs that are publicly funded, privately delivered with some accountability and the somethings we could do to improve that program. Its very muchy aligned with stuff weve been talking about here today. I was a the challenge is measurement right now because we dont have the networks, because we dont have the ability to measure stuff with scale in the real world, and we dont have how can we spend billions of dollars on transitional research, public refunded, but dont have the sort of questions in line. We do know the measures that this is like a measure of patient expense can caregiver experience. Ways of doing that. They are not as widely accepted and not as widely used but thats an issue where policy can make a difference. Regulatory stuff like janet was describing around hey, if these measures digitally collected remotely could be used for Clinical Trials, including practical Clinical Trials, and if cms would put maybe more emphasis on paying for what people really care about. That could help advance these approaches. The knife edge you walk took us a lot of these, i some friends who are involved in some of these programs, implementing, is micromanagement. So you want to value the outcome, not micromanage the people. Because then they have to fill in like the providers a lot of forms and i did this and i screened this for this, and pretty soon theyre spending an hour on all the stuff that people could dream up the would be helpful for patients. I think the design of the programs needs to be evaluated and if the Medicare Advantage to some extent. Theres more we could do. Again it should be evidencebased, is this with Holding People accountable change thehe behavior . Right . And having that infrastructure answer that question quickly. Thats right. We dont have that. You also talked about vaccinations and football fields, and i would take that step further in saying its find that the football field be the vaccination site, but we should have the plan in place in the machinery brady to go to set that up quickly. So a lot of lessons that we are pulling from that is windy to be pragmatic and we need to be flexible and ready to go. A lot of our structure is not that way and infrastructure thats sitting there and used and best diligence of dollars spent on every step necessary what we need. We need the ability to rapidly scale and the blood. And probably some creativity because in the unique creativity need ied you think you mentioned Extension Services. We got the monoclonal antibodies, got them develop, we paid for them, we had them in hand and we couldnt deliver them. I was in charge of that for quite a while until i staged a revolution about it. We couldnt deliver them. If we saw and advanced, okay, who do people turn to . It turned out the paperless services, the emts were five bidders was at this. They knew their communities, but we had to send it to them, okay . I think the act Extension Services for rural areas we could pair up with the emergency emt services and they could deliver exact, but thats creativity, i could the people interact with . Who did it work with . Who do they trust . Who is they are . And then when we arranged to send and stuff so we reached all our population . Because the football field work if you live there a football stadium, or whatever, but then you need the personnel to give it and so forth. I really think in times of peace we should just think of the Public Health system and all the people in there. We have got to of who is capable. One of the threads i i want o pull on there is you are talking about a decentralized system coupled with some central organization. But having ems is that having someone in d. C. , atlanta, boston, chicago telling them what to do. To get the supplies they need a b there is some federal coordination, but its often ate local or state effort. We cant underestimate their import. I agree and thats what we need to w think about it is as because it took us a while in the red to mobilize all those people. We had the dialysis centers. They are good at ieds and stuff like that. The Home Health People were able to help with delivering the monoclonal and so forth. We had to drink all this up in the middle of a crisis and then reach out to all these people. The endless people and some Committee Organizers and different communities were five of us at organizing vaccination and delivery of therapeutics to their people. But they werent the people who came to mind instantly. We are seeing somer good examples everything youve said. Thats the good news. The challenge is how do you make that scalable and how t do you make it easier to replicate and sustained financially . Most of the funding for that some of it will come from cdc in Public Health which a talked about before. Theres not a lot of resources in there. A lot more about social service programs, for many states like indian has done a great job of integrating eligibility programs and precision programs in their social programs and can help a lot with these issues and linking it to Healthcare Providers who are trying to address social needs foro individuals. On the healthcare side, lots of Healthcare Providers around the country are playing key roles in local and state public. The best responses around the country were invariably a a combination of state and local government and Business Leaders and especially healthcare leaders including anchors providers and so forth. But we arent systematically giving them the data they need. We got fragmented Public Health of dataa come healthcare did effect could support all this with further steps likely talking about in cms and our big healthcare paymentpr programs. I hope thats an area for progress. There are taken some states and localities that are doing well. This is all connected, brian, back to your point about what are the goals were trying to work on together . Can we get to more real accountability . Are we truly ready . Have done the real stress tests for the next Regional State response with Public Health emergency with the right kind of federal support . Are we doing the right things to address other local Public Health threats like opioid use disorder, Maternal Health inequities in things like that . Going into that actually we often give localities finding type two very narrow goals without providing so they end up with like 15, 20 different funding streams that are tiny bits of money with broad goals and no flexibility. Thats not the right way to do it. Its not thoughtful or practical. Thanks. I wanted to give you an opportunity to talk a bit about various Regulatory Approval processes the acronym eua became familiar to all of us during the pandemic, and i wanted to a bit about the role of different pathways to approval especially duringnd a pandemic, how their function, how they could be doing better. Its important talk about this because people can get confused about why things are approved, whatat approval is sometimes revoked, what might take a while to get full approval and so on. Whats the role of these different pathways within the fda, and other doing well and could they be doing better . I think the emergency authorization pathway is very good one and function very well for the country edited april the fda fda to get out the thing ths get what it basically does is it so long investigational. You know and have all the informed consent and all these, its dean as good enough considering the emergency that could be made available, authorized for availability without being investigational anymore. All the differenten things thato along with that. On the other hand, it doesnt require that is i do think what confused the population. Because for example, for the vaccines they t probably had soe of the largest vaccine trials ever done. We had huge amount of data on safety and effectiveness of the so we were not cutting corners but theres all sorts of things required for reliability of manufacture and everything that we couldan cut costs in an emergency. Is ahe g vaccine could be ste for your. Was exactly. It was like off the shelves so we could do all those things and have those flex those with the eua. I think the major problem with it is it confused the public. Thinking it was a lesser standard overall and theyre getting substandard stuff will be a taking shortcuts. This was combined with the social narratives that was out there which was very confusing i think to the medical community. Much of us at least, that this was some kind of plot or something foisted on the public, right . Pay morely need to attention should Something Like this happen again to how we position this and what the narrative is around why we are doing this. We tried but we are, nobody is like really good at communicating extremely well, at least for complex concepts during an emergency. But the actual mechanism functions extremely well. The fda put out dozens of eua products, and then, okay, revoked, then would beca revoked because more data came out or was it better alternative that became available, for example, things like that and thats hard to explain to the public. That happens all the time in medicine. If a cancer drug and then we get a better one, well, they arent revoked by nobody is using the old anymore because something more effective or saver came along. Explaining that Natural Evolution that is accelerated during a crisis is difficult for the public. Another issue we havent solved yet, which is Effective Communication especially in an emergency when some isy, known, the Knowledge Level improves and changes quickly, a lot is unknown, and conveying that in a way thats accurate and practical is another area i think where more of these partnerships could be helpful. Cdc can be a good source of analytic information especially if theyre able to get good data. Data. But if you look at national democrats, people gettingei tr information from different frames, they do have some commonalities around trusting their local health care provider, clinician, pharmacist, trusting in their community who could betn outside, who could partner. We are talking about like ag extension like that before but thats a different threat, strategy for not only describing hey, this has been approved but for helping people get the right practical information for them from a a trusted source aboutt it means for them. I dont think we solved that problem yet either. We had an end of the cdc had come we had huge Partner Network of all these different Patient Consumer organizations and all kinds of organizations, and we had weekly phone calls within and we gaveem them materials and we gave them talking points and answered their questions and everything. It was still very difficult to get the sort of reliable and valid information out everybodys hands and havent heard. That might have been for other reasons w but i think theres a big effort to bring in the local communities and recognition that those are theni faith communitis we reach out to, that those are the folks that people listen to and trust. We are in a country of countries. Thats for sure. Thats right. Iht have one question actualy i wanted to ask thats been sort of burning. Its about diagnostics testing. Originally when we actually had the early stages ofad the pandec we didnt have access to tests, and there were a a variety of reasons why that happened. And they can spy question for each of you is, what do you think we should do to make sure that that doesntur happen in te future . As i said earlier i think we ought to really have a very rigorous plan, and plans what mark said. We get the pcr can we get the virus of whatever it is, the agent, we did it in, theres a collective systemic effort to develop Reference Panels. We get serum from infected people. We get other possible interference, we get all that, make a panel and then we invite people, industry, academic labs, cdc, however, to contribute to that. Now, you need a Gold Standard but we can do these come you can do the blots and you can do the future and everything on this Reference Panel and you can characterize it. I cant even emphasize enough what an Important Development tool that is, at people do not have, i mean you have to do testing of robustness and proficiency testing and so forth like that to make sure that test is durable in peoples hands. But having these Resources Available to various parties so they can do Rapid Development and generate the evidence needed for a new eua, it just cant be, but we have to have a plan to do that rather than just put the plan together. One thing, i think theres a lot of agreement on a lot of issues with this disagreement about, how to respond to the Public Health emergency, but where i think there is agreement is that the technology is there through genomics and pcr to make availablee very quickly and the will of the other test to build on it for more rapid findings and things that people can do on their own at home, but through our existing laboratory network, includingh not just a Public Health labs which we kind of relied on at the beginning of covid, and not just to cdc but through all of the labs that didnt want to help. We saw this in covid with Trevor Bedford lab in seattle trying to do early diagnosis. We got the capacity to do this when theres a new threat. Soal like number one, we all wod agree on is can we get those test out to healthcare Partner Organizations all across the country to enable us to do a quick assessment of how much this new agent is spreading . And if you work with the Healthcare Organizations, all these labs are connected via nationally consistent electronic standards in ways that could feedback that data, of these at an aggregate level to local responders,st each state and lol Public Health agencies, the Healthcare Organizations they work with as well as the cdc and whoever is in charge of National Planning for the emergency response. I guess it at the beginning we havent worked that out yet. That seems like Common Ground and and i could then, couplele that with janice reference testing for in new test that come along, scale is up and make available the best ones, that would be really different response and we were able to pull off in covid. Actually. Marcus talk at the very beginning is this threat comes through. We need really good laboratories to be working together to do that surveillance. They have to agree on a standard. They have to get together. We had a lot of people who were fighting with each othert about this and that and the other thing. And then as it moves forward, out ofce that effort comes to Reference Panel really. You have to objectively decide youre going to construct that. It will be a Public Health effort together. Thats right. You have to get samples from healthcare see you can create that. And then the diagnostic companies can, they are the ones they can do this at sku. Lets get over it, okay . And so they can to be easy test, plate test on this trip test. They can doo all the stuff that they need the tools. They need to have substrates given to them. They need a flexible platform upon which multiple partiesmu cn compete to develop test that meet a standard. On top of that for rollout, they need to be able to have the logistics to get the test out but then also get the data in a standardized form. There needs to be development around Public Health on health data so that is more affordable. On top of that you need to sort of like starbucks, can measure the cups of coffee sold at probably each of the Stores Across the world, to be able to at the local, state, or federal level get those data and identify and secure. It sounds complicated that we somethings like this now. We do have electronic reporting for, like today, covid cases from hospitals and emergency rooms. We did have some states and localities adopting electronic standards for sharing lab report data, positive and negative and be identified and protected. We just have done it national yet and the t seems like a great combination of what we can support nationally through cdc, fda and at cms. And informing and supporting a very well done local responses that are faster, more informed and, therefore, more effective. Thank you. Thank you all for joining us. We will end on that note. And hopefully i think that we have a series of ideas and policy principles for a bipartisan way forward, and hopefully the next time we run into a pandemic may be 30, 40 years from now may be sooner. May be sooner, we will be in a better place. Thank you. [applause] [inaudible conversations] [inaudible conversations] [inaudible conversations] the u. S. Senate is gaveling in on this monday or more work on president bidens executive and judicial nominations. Including former new Mexico Democratic congresswoman torres small to serve as deputy agriculture secretary its the number two leadership post at the usda. Lawmakers will consider rosemarie to be director of the justice departments violence against women office. And live now to the senate floor here on cspan2. The presiding officer the senate will come to order. The chaplain will lead the senate in prayer. The chaplain let us pray. Father of love, as we