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 doing something right, ok . So mark and despite us having better knowledge of what behavioral, nonmedical steps can improve Public Health, and having better drugs, diagnostics than ever before, that also could contribute to all of these. C. D. C. Does not have the budget to be held accountable to get to those goals by themselves. Janet right. Mark were starting to see in many Health Care Organizations, this is a c. M. S. Priority, youve heard about shifting from fee for Service Payment to paying for accountability, for Better Health outcomes. So more payments to Health Care Providers, say for diabetes. Did you screen your population of patients effectively . Did you get to effective heap hemoglobin levels indicating good diabetic control through a whole combination of neckism ins . Mechanisms . New diabetes treatments. Food is medicine prescriptions, help with engaging people in using personal health apps to get healthier. So thats something that c. M. S. Can help with and i agree with your point about state and local levels. Were seeing a lot of really innovative work happening across blue states, red states, indiana, north carolina, massachusetts, wherever, on trying to integrate social services and Community Resources around people and have tracking and accountability at the local level for sort of the equivalent of these Healthy People 20, 30 years old. But this is way bigger than something that c. D. C. Can work on alone. Brian absolutely agree. One of the questions to ask is, should a function reside at the federal level or might it 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 for you, janet. I was think being Clinical Trials. We talked about how the biomedical innovation complex works quite well and were all thankful for that. The n. I. H. Is a powerhouse for basic science. What do you think or do you think there are lessons for what we should focus some of the n. I. H. s translational science efforts on . Janet well, you know, i have long been a proponent, if the n. I. H. Is going to sponsor Clinical Trials, that they really ought to think about the infrastructure, funding an infrastructure rather than funding what i call the s. E. T. s, i wont mention that here. But the small, not very good trials. [laughter] right. That they have traditionally funded as part of ro1 grants and so forth. What we lack in the United States, because we have left the Clinical Development to industry, and thats fine, they do it efficiently and effectively and so forth and so on, but then when a crisis arises like this, or for Public Health issues, the industry isnt necessarily going to pursue, right, because they have a different objective or set of objectives, we really lack an infrastructure to do that. As mark said now, we have the opportunity, for example, we could harness realworld evidence. We could do largescale experiments, we can really see. Because some of the things you raised, mark, they cry for cluster randomization. Because, look, week offer been having a weve been having Healthy People for 30 years and we havent made progress against. So we need evidencedriven or datadriven interventions, even social interventions, rather than best intention interventions that we keep doing. Even though theyre not working. So i do think but i dont think the n. I. H. Is set up for that. And i dont know the answer for it. But what i would say, theres a big gap in the Public Sector of research and that is the huge gap on the clinical evaluation, the giant gap. I wanted to ask about dying not ticks. So dying not ticks. The diagnostics. The real issue there, covid diagnostics really took off. Congress gave 1 billion i think to n. I. H. For the radx program and they put in a program, they developed standards, reference standards and sirrum and so forth. So brian like a standard test . Janet exactly, an algorithm, and they helped with it. So manufactures are sending manufacturers are sending us covid tests and they tested them in 30 people and theyre supposed to be used by millions and they didnt work and this was universities too who did this. But if we had offered a standard evaluation protocol that the third party could do, we could run those through very quickly and gotten a lot of those on the market because the data would have been generated. Mark certification of conformity in a known test bed is something that is used in the telecomindustry all the time. Janet thats what i mean. This isnt rocket science, its been around for 20 years. So they were all out there, little diagnostic companies who might have good scientists but they didnt have the clinical and people couldnt get a hold of the variants and so forth. But if we pulled our pooled our efforts and pooled reference standards in place, you could run a lot of different diagnostic tests through there very rapidly, give the evidence to the f. D. A. , it would be standardized so we didnt have to question it and inspect it and thats what happened. When that happened then all these tests became available because they could be easily evaluated. Mark and these include direct to consumer tests. Tests at home with Rapid Response time. It might not be quite as sensitive but still can be a really, really valuable part of the tech in containing an outbreak. Brian were pro opponents of real world evidence proponents of real world evidence trials into a broader, Larger Community setting, right . Like h. D. A. Should have a massive Clinical Trials apparatus. Like all these large Health Systems in the community should have that. Should be part of clinical care. And so what do you think that the n. I. H. s translational effort could target to help promote that . Mark i think n. I. H. Can help. F. D. A. Can do some further steps to help here too and certainly is a high priority for the current commissioner as well as janet to try to make progress. The hardest thing about doing trials in a real world set something you actually have to deliver real world care. And the solution of, well, lets just expand our funding for traditional n. I. H. Trials by bringing in, you know, protocol reviewers and local oversight of trial conditions and data collectors and all that just doesnt lend itself to the delivery of care in routine practice. Health Care Organizations are pretty stressed these days financially. So its going to have to be something simple. Good news is we got a lot better electronic data than we used to. A lot of data used for payment is pretty darn accurate. We have Health Care Systems that are no longer working at the oneoff clinician level so were not talking about a traditional small, crumby trial, that would have come from, like, hey, one academic at this one institution pairing up with a few of his or her friends, we can produce a study where you really would worry about is that particular clinician really implementing objective standards and the right kind of consent process and are they collecting data accurately . Were talking about systems that have systemic implementation of electronic record systems, of clinical protocols supported by e. M. R. s, whole teams of people who are working together. So holding those individual clinicians accountable for, well, how exactly is the trial going in the same way we did in the old style, investigatorled research, is just not right. And getting to ways of kind of certifying Health Systems as having good patient protections, consent, oversight, good objective data collection, that theyre already using for their own care and their own payments in many cases are based on that data, thats the future, but i dont think either of the n. I. H. Funding for sort of these platform kinds of practical randomized Clinical Trials or frankly a lot of the f. D. A. Oversight regulations have yet matched up with the potential there. Janet well, this morning before i came down here i was talking to the people in the u. K. , there was a group there on the revision of the good Clinical Practice Guidelines which are i. C. H. Guidelines. The pragmatic trialist, which is really what were talking about here, stage a little bit of a revolution against that which appropriate. Trials should be fit for purpose, ok . And there arent quick regulatory trials and we should decide what kind of decisions youre going to make out of that decision and you information and you should design the trial to yield that data and information in a reliable way. So i think we will be revising, including revising like how who is responsible and how can you do distribute it . Weve sent out some guidance and information on that. Because we have to recognize that the world is changing in the way things are done and the way things are done is changing. That would have, you know but the question is, what brians question, i think, is what would have enabled the u. S. To put together more rapidly, ok, Clinical Trials say out of workspace in i had a tremendous amount of problems getting that done at enough scale and its because we didnt there were Small Networks but we didnt have the kind of scope, say, that because the u. K. , the recover trial, managed to incorporate, even investigatal agents or test them, they did a lot of repurposed agents. Mark that could be a good use for the n. I. H. s transational research efforts. Or even helping come up with real world evidence measures. How do you clean e. H. R. Data, for example . Janet but then you need a group or unit at n. I. H. Thats focused on clinical evaluation and methodology. If you look around the country, ok, we have some, but im talking about an institute. Where are the departments of clinical evaluation around the country at medical schools . There arent any. This is a sideline for most people. It isnt supported by robust grant. So i think per n. I. H. , its traditional role could be, if they sort of open their eyes about this, at least to support not just the basic science but the clinical evaluation and the science of clinical evaluation. That might be n. I. H. s true role, not courting the actual evaluation itself. That might be a bridge too far. I mean, they do some of that. Brian i think thats a really good point. Because that could rapidly speed up development, decrease costs and also increase access, all on one specific policy change. Janet and it might improve the quality overall in the United States of investigations. Ive published on the fact that phroeft of the trials fact that most of the trials that were set up in the United States by the Academic Centers were inadequate. They werent adequately powered. They didnt enroll enough. They couldnt answer the questions, we had thousands and thousands, tens of thousands of Patients Enrolled in trials that were not able to answer questions that were asking. On your face. So raising the level of expertise around clinical evaluation, not having it simply be i mean, at warp speed i had to bring in people from industry and they were the people who knew actually how to do this and get this done at scale. So we just dont have that set of expertise in the government except maybe some, you know, points of light here and there. But you really need a kind of machine, ok, to really get this done at scale. Mark this would be a significant change at n. I. H. To do Something Like that at scale. I think the other pieces are lining up. I work with a group called advancing Clinical Trials at the point of Care Coalition which includes a number of these Health Systems which to janets point just dont feel like the premarket Clinical Trials are answering all the questions that theyd like answers. What are the longterm effects of these treatments, what do i do about drug interactions . Is it the right dosage . If i have a side effect, whats the best way to manage it . Those are impossible questions to answer in a standard premarket n. I. H. Type clinical trial. They are exactly the kinds of questions that you could answer at a if you had much larger scale platforms and were focusing on the key Data Elements to collect. We already at that point have a good understanding of major side effects, mechanism of action, things like that. And these organizations said, these are 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 for with longterm use at higher doses. New treatments for neuro degenerative diseases. Comparetific effectiveness. Im not quite seeing yet the n. I. H. Big change to get there. One other possibility might be the new funding for arpah. So this is a program thats intended for advanced transformative projects and maybe a jumpstart here around a few platforms could lead to the desired goal. Faster, better evidence and transformation. Janet ive been trying to push them toward there was just a study published, this sounds like, why habit we done this hadnt we done this electrocompulsive therapy instead of ket mine for severe depression. Thats little edgy. But those are the questions Health Care Systems and insurers need to answer. What should we pay for . Or if people they have this chronic disease and theyve been on this regiment and theyre not responding, what should you go to . Right now its all, like, well, you know my mentor taught me this or this is what [talking simultaneously] mark these small, crumby observational studies . Janet yeah. Brian and it is an art instead of it being a science. Janet thats right. Its not evidencedriven. And thats much of health care right now. And yet its amenable to actually have evidence generation if wed only organize it a little bit. That means, like mark said, that those who would be participating in this Health Care System, insurers have to see the value of this information. To them. Brian i think well open it up to questions. Janet a microphone is coming to you. There you go. Questioner as a data person, we have more data flying around in this country that we are not using well. And i guess im thinking of leap frog. The leap frog group. Who about 20 years ago revolutionized getting hospital data. Ing mer a good hospital measuring a good hospital, not on an a, b, c, d scorecard. Pretty simple to understand. Yes, theres data behind it, theyre gathering to determine whether its a, b, c or d what did that lead to . It led to in part valuebased contracting. Because Insurance Companies dont want to send who theyre going to have to pay for to the hospital. So why we cant take that lesson and morph it. Ill give you one absurd example of an Insurance Company whos decided to pay for getting people to walk companion dogs for people at end of life because that companion dog delivers more value to that person who is remote and alone than any other thing. So we have an example of what is going on the private side and that we are not morphing to the public side. And its about time that we grow up as a country and learn from whats going on from the standards of care that are going on in north carolina, utah, massachusetts, etc. Thank you. Mark its a great point. It just highlights how important it is to shift out of the traditional way weve paid in health care for stuff thats done in hospitals and institutions and recognize that all these factors influence health. To make that work, though, you need to leap frog really emphasized, you need to measure what matters and create a way of aligning payments with that. And a lot of this is happening in the private sector, as you said, but some of those examples are in Medicare Advantage programs that are publicly funded, privately delivered. With some accountability and theres some things we can do to improve that program. It very much aligns with the stuff weve been talking about here today. Brian i would say the challenge is in measurement right now because we dont have those networks. Because we dont have the ability to measure stuff with scale in the real world and we dont have and we spend billions of dollars on translational research, publicly funded. But dont have these sort of questions in line mark we do know the measures. This is like a measure of patient experience, care giver experience, or standard ways to do that. We have Digital Tools that can help. Theyre not as widely accepted and theyre not as widely used. But thats an issue where policy can make a difference. So regulatory stuff like janet was describing around, hey, if these measures digitally collected, remotely, could be used for Clinical Trials or including practical Clinical Trials and if c. M. S. Would put maybe more emphasis on paying for what people really care about. That could help advance these approaches too. Janet the knife edge you walk though is a lot of these i have some friends who are actually involved in some of these programs, implementing or being 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 they are spending an hour on all this stuff that people could dream up that would be helpful for patients. So i think the design of the programs needs to be evaluated and i think Medicare Advantage does that to some extent. Mark theres more we could do. Janet it should be evidencebased. Is this way of Holding People accountable actually change their behavior . Mark and having that infrastructure to answer that question quickly. Janet thats right. We dont have that. Mark you also talked about vaccinations and football fields and i would take that a step further in saying its fine for the football fields to be the vaccination sites but we should have the plan in place and machinery ready to go to set that up quickly. A lot of lessons that were pulling from this is that we need to be pragmatic and that we need to be flexible and ready to go. Brian and that a lot of our infrastructure is not that way. And that infrastructure thats sitting there unused and has billions of dollars spent on it every year is not necessarily what we need. We need the ability to rapidly scale and deploy. Janet and probably some creativity. Because i think in need creativity in advance. I think you mentioned Ag Extension Services. So when we had we got the monoclonal antibodies at warp speed, we got them developed, we paid for them, we had them in hand and we couldnt deliver them. I wasnt in charge of that for quite a while until i staged a revolution about it. We couldnt deliver them. If we saw in advance, ok, who do people turn to . It turned out the ambulance services, the e. M. T. s, they were fabulous at this. They knew their communities. But we had to send it to them. I think the Ag Extension Services for rural areas, we really they could pair up with the emergency e. M. T. Services and they could deliver like but thats creativity. Who do people actually interact with . Who do they work with, who do they trust . Who is there . And then how do we would we arrange to send them stuff so that we reach all our population . Because the feebleds work if you Live Football fields work if you live near a football stadium or whatever but then you need the personnel to give it and so forth. So i really think in times of peace we shouldnt just think of the Public Health system and all the people in there. We have to think of who is capable. Brian i think one of the threads i wanted to pull on there is youre talking about a decentralized system coupled with central systems. Having e. M. S. Is not having someone in d. C. , atlanta, boston, chicago, telling them what to do. Its a they get the supplies they need and maybe theres some federal coordination. But it is often a lot or state effort. We cant underestimate their importance. Janet i agree. Thats where we need to think of that in advance because it took us a while and then we had to mobilize all those people and we had the dialysis centers. Theyre good at i. V. E. s and stuff like that. The Home Health People were able to help with delivering the monoclonals and so forth. But we had to dream all this up in the middle of a crisis and then reach out to all these people. The ambulance people, some Community Organizers in different communities were fabulous at organizing vaccination in delivery of therapeutics to their people. But they werent the people who came to mind instantly. Mark were seeing good examples of everything you said. Thats the good news. That the challenges, how you make that scaleable and how you make it easier to replicate and sustain financially. Most of the funding for thatk some of its going to come from c. D. C. And Public Health. Theres just not a whole lot of resources there. A lot more around social service grants, many states like indiana did a great job of integrating eligibility programs and precision programs in their social programs, help a lot with these issues and linking it to Health Care Providers who are trying to address needs for individuals. On the health care side, lots of Health Care Providers around the country are playing key roles in local and state public responses. The best response its around the country were in responses around crit were a combination of state and local government and Business Leaders and especially health care leaders, including ambulance providers and so forth. But we arent systemically giving them the data that they need. Weve got praguemented fragmented Public Health data, data that could support all of this with further steps likely than talking about them in c. M. S. And our Big Health Care payment programs. And i hope thats an area for progress. There are, again, some states and locates that are doing it well. This is all connected back to your point about what are the goals that were trying to work on together . Can we get to some more real accountability . Are we truly ready . Have we done a real stress test for the next regionalstate response to a 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 and things like that . Brian and i think going to that actually we often give locates funding tied to very narrow goals without providing right. So they end up with like 15, 20 different funding streams that are tiny pweuts of money with broad goals and no flexibility to organize them. Janet thats not the rate way to do it. Brian its not thoughtful or practical. Questioner thanks. I wanted to give you an opportunity to talk a bit about various Regulatory Approval processes. E. U. A. Became familiar to all of us during the pandemic. So i wanted to hear a bit about the role of different pathways to approval, especially during a pandemic, how theyre functioning, how they can be doing better. I think its important to talk about this. Because people sometimes can get confused about why things are approved, why approval is sometimes revoked, why it might take a while to get full approval and so on. Whats role of these different pathways within the f. D. A. And are they doing well, could they be doing better . Janet i think the emergency authorization pathways is a very good one and function very well for the country. It enables the f. D. A. To get out things. What it basically does is no longer investigational. And have all the informed consent and all these its deemed as good enough, considering the emergency that it could be made available, authorized for availability without, you know, being investigatal anymore. Without i. N. D. And all the Different Things that go along with that. On the other hand it doesnt require the and thats i do think what confused the population. Because, for example, for the vaccines, they probably had some of the largest vaccine trials ever done. And we had a huge amount of data on safety and effectiveness of these. So we werent cutting corners there. But theres all sorts of things required for reliability of manufacturer and everything that we couldnt cut off in an emergency. Mark is the vaccine going to be stable for a year . Janet exactly. It was flying off the shelves. So we could do all those things and have those flexibilities with the e. U. A. But i think the major problem with it is it confused the public who was thinking it was a lesser standard overall and they were getting substandard stuff where wed taken shortcuts. Of course this was combined with the social narrative 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 . So i think we probably need to pay more attention if Something Like this happened again to how we position this and what the narrative is around why were doing this. We tried but we arent nobodys really good at communicating extremely well these more complex concepts during an emergency. But the actual mechanism functioned extremely well. The f. D. A. Put out dozens of e. U. A. Products and then, ok, revoked, it would be revoked because more data came out or there was a 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, then you get a better one. They arent revoked but nobodys using the old one anymore because something more effective or safer came along. So explaining that Natural Evolution that is accelerated during a crisis is difficult for the public. Mark another issue we havent solved yet which is effective communication, especially in an emergency, when some is known, the Knowledge Level improves and changes quickly but lots 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. C. D. C. Can be a good source of analytic information, especially if theyre able to get good data. But if you look at National Polls across republicans, democrats, people getting their information from different frames, they do have some commonalities around trusting their local health care provider, clinician, pharmacist, trusting others in their community who could be allied, who could partner. Were talking about ag extension, things 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 trusted source about what it means for them. I dont think we solved that problem yet either. Janet we had and i know the c. D. C. Had, we had a huge Partner Network of all these different patientconsumer organizations and all kinds of organizations and we had he weekly phone calls with them and we had materials and we gave them talking points and we answered their questions and everything but we still, it was still very difficult to get the tphfpgs out and have it information out and have it heard. I think there was a big effort to bring in the local communities and recognition that those are the communities we reach out to, that those are the folks that people listen to and trust. Brian we have a country of countries. Janet yeah, thats for sure. Thats right. Brian well, i have one question actually i wanted to ask thats been sort of burning. Its about diagnostics testing. And so originally when we actually had the early stages of the pandemic, we didnt have access to tests and there were a variety of reasons why that happened. I guess my question for each of you is, what do you think we should do to make sure that that doesnt happen in the future . Janet well, as i said earlier, i think that we ought to really have a very rigorous playin and plan and the plan is what mark said. We get the p. C. R. , we get the virus or whatever it is, the agent, we get it in, we theres a collective systemic effort to develop Reference Panels, we get syrum from infected people. We get other possible interference, we get all that, make a panel. And then we invite people, industry, academic labs, the c. D. C. , whoever, to contribute to that. You need a gold standard, ok, but we have that, we can do these, you know, you can do the pwhrots and you can do the below thes and the p. Blots and the p. C. R. And Everything Else on this Reference Panel and characterize it. I cant even emphasize enough what an Important Development tool that is and people do not have, i mean, you have to do testing of robustness and proficiency testing and so forth like that to make sure the test is actually durable in peoples hands but having these Resources Available to various parties so they can do Rapid Development and generate the evidence needed for an e. U. A. , it just cant be but we have to have a plan to do that rather than just put the plan together mark to add to, that i think one thing that to think one thing that theres a lot of agreement on, theres a lot of issues where theres disagreement on, how do we respond to the next Public Healthmental, but where there is agreement is that the technology is there through genomics and p. C. R. To make available very quickly, and there will be other tests to build on it for more rapid findings and things that people can do on their own at home. But through our laboratory network, including not just the Public Health labs which we kind of relied on at the beginning of covid, and not just through c. D. C. , but through all of the labs that 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. So number one, we all would agree on is can we get those tests out to Health Care Partner organizations all across the country to enable us to do hopefully a quick assessment of just how much this new agent is spreading and if you work with the Health Care Organizations, all these labs are connected via nationally consistent electronic standards in ways that could feedback that data. At least at an aggregate level to local respondsers, state and local Public Health agencies, the Health Organizations they work with, as well as the c. D. C. And whoever is in charge of National Planning for the Emergency Response at that point. Like i said at the beginning, we havent worked that out yet. That seems like some Common Ground and that could then, couple that with janets reference testing for any new tests that come along, the scale is up and make available the best ones, that would be a really different response and variable to pull off. Brian absolutely. Janet marks talking about the very beginning, as 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 other about this and that and the other thing. And then as that moves forward, that out of that effort comes a Reference Panel really, you have to objectively decide youre going to construct that. And then mark that needs to be a Public Health effort together. Janet thats right. You have to get those samples from health care so you can create that. And then the diagnostic companies can really theyre the ones who can do this at scale. Lets get over it, ok . And so they can do the easy test or the strip test, they can do all this stuff. But they need the tools, they need to have substraights given to them. Brian they need multiple platforms which parties can develop a standard. Then on top that for rollout, they need to be title of the bill have the logistics to get the tests out but then also get the data in a standardized form. There needs to be standards so its more portable. On top of that you need to, sort of like starbucks, can measure the number of cups of coffee sold at probably each of their Stores Across the world, to be able to at the local, state or federal level, get those data and identify and secure. Mark it sounds complicated but we do some things like this now. We have electronic reporting for, like, today, covid cases from hospitals and emergency rooms. We did have some states and localities adopting electronic standarded for sharing standards for sharing lab report data. We just havent done it nationally yet and this seems like a great combination of what we can support nationally through c. D. C. , f. D. A. And at c. M. S. And innorming and informing and supporting a very well done local responses that are faster, more informed and therefore more effective. Brian well, thank you. Thank you all for joining us. Well 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, maybe 30, 40 years from now, well be in a better place. Thank you for joining us. [applause] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] [captions Copyright National cable satellite corp. 2023] he se energy and Resources Committee is about two hours