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Im steve clemons, editor at large of the hill thank you for joining us for covid19 and a responsible rx supply chain, looking at the resiliency of the Prescription Drug supply chain during a global pandemic. Id like to thank the distribution alliance. The coronavirus pandemic has upended our lives and forced the new normal upon us. While accommodations can be made for our lifestyle choices theres little legibility when it comes to our health care. For those most at riskexaccess to regular medication isnt a choice and in some cases its a matter of life and death. Both the Healthcare System and patience have changed their behaviors. As a consequence concerns have arisen regarding drug availability and shortages. What are stakeholders doing o to ensure that disruptions do not occur and there is collaboration between the public and private sectors and what plans are being put in place for distribution of this vaccine once it becomes available . We discuss all of this with some of the smartestminds in Health Policy but before we get underway i helped a few notes, to us at the hill and events and the hashtag , thehillrxsupplychain. If you experience any trouble with the lifestream they say refreshing it will work i hope. My first guest is a National Health expert and was on the front lines in the implementation of the Affordable Care act. Governor, secretary Kathleen Sebelius served as secretary under president obama and is the ceo of iesebelius resources provide advice to companies and nonprofits and shes my go to person and it comes to issues of knowing what a smart Healthcare System looks like so kathleen, great to see you. Let me ask you, get to the point. You oversaw many of the institutions that we are now looking at today to help save this country whether its in pushing the time curve, developing a vaccine and distributed it, whether its on how you approve various dimensions of this in therapeutics. What would you say is going well , whatwould you say has just been awful . Its good to see you steve and thank you for including me in this program. I dont think theres any question that the socalled operation warp speed, having the United States government that on a number of possible vaccine candidates early on pushed that pipeline has really accelerated the possibility of getting a vaccine or a brandnew coronavirus faster than people could have anticipated and thats good news. That will be beneficial to the United States citizens and hopefully to the rest of theglobe. I say that collaboration, cooperation looks very good and the early investments makes sense so far not Companies Really are drilling down on now massive Clinical Trials, looking at safety results and hopefully competing to get to the starting line 1st so that we could have a number of effective, safe vaccines and kind of record time. So the very bad news again, sticking with just the Vaccine Development is that at every point along the way, this white house president has undercut the public science, undercut confidence in the public messages and by doing that, may really discourage a lot of americans ever volunteering to get the vaccine. Ever believing that it is safe and effective. So that is really nothelpful. Communication strategies, clear effective scientifically based communication from the start is part of any public elf crisis, any Public Health recovery and tying the vaccine to his political election which President Trump has done for months and months, suggesting that there will be an october surprise, there will be an effective vaccine before the campaign, something coming out makes people feel like its being rushed. That we are not on ltrack for safety and effectiveness. We are on track for some kind of political give and nothing could be more harmful l to the confidence that were going to need with a massive Vaccination Campaign and a true Vaccination Campaign. Those are good points and bad points. Id say in the rest of this coronavirus response, weve seen much of the same. Public science which has evolved over time and scientists have learned more and corrected themselves when they learn more. Undercut consistently by the white house has a very different agenda in mind, not Public Health and safety but getting the economy back running as quickly as possible, regardless of the deaths, regardless of. We had a Point Counterpoint in the United States and i think that the clearest indication of that is Johns Hopkins in the fall of 2019 gave grades to countries around the world for pandemic readiness , not knowing what we were going to face. The United States was regarded as the most prepared, best prepared country in the world. And yet we have had i think unquestionably the worst response for any developed country in the world. You were featured recently, you were one of the stars in alex gibneys new movie called totally under control which profiles the response thus far in responding to the pandemic, managing everything from operation warp speed to other dimensions of this and my question is you have real heroes that pop out and show. Some governors that are, were securing ppe, companies that were stepping up and part of the discussion is around supply chain and whether americans can have confidence that there is an infrastructure out there ha thats dependable enough that they can have confidence and faith in regardless of the hi leadership and im wondering how you see that because you saw states competing with one another before over masks and downs and im wondering when a vaccine rolls out will we be able to haveconfidence that it will be wellmanaged . It will only have the confidence if we have a National Plan and its clear that the currentpresident does not want a National Plan. He has pushed every issue on to state that somehow into the private sector in a way that is not transparent to anyone and put burdens i would say onstate as a former governor that they cant possibly achieve. So ppe is a great example. Rather than the United States mobilizing efforts through the defense production act to make more stuff in america, to get it ready to go or to use their incredible purchasing power and previous global context to purchase ppe and distribute it on a fair and equitable manner, use the Defense Department logistics to make sure that equipment and machinery was at the right place at the right time, we had everything from a virtual inventory of where there were extra beds to where there were personnel and the federal government under donald trump washed his hands of the and said its up to the states. So states competed against one another, statescompeted against their own health system. Often ive heard so many stories about states or a Major Health System ordering supplies only to have the federal government confiscate it at the border and put it into the stockpile and then out the United States say the stockpile isnt for the e states, its for us who have us is. Though we had a totally misguided and inappropriate response. We need a National Plan in place right away and we will only get that i would say with a new president who has made it very clear he will have a National Plan. We need a National Strategy for how this is going toio roll out and how we can have confidence in when the fda says we have a candidate that has not been shoved ahead or that the guidelines for the fda which have always been the Gold Standard in the world have not been shortened or rushed due to political pressures. I cant even think of the number of Business Leaders pharmaceutical Industry Leaders ded scientists ive talked to since his pandemic began that one of the interesting things is while you saw a lot of society frees up and get worried about drug therapies etc. The other side of it is that a lot of these companies beyond political control bend over backwards to make sure there were eventually no shortages of supplies and if we went the right way forward. In a few minutes ill have representative Elissa Slotkin on could she Elissa Slotkin on. She passed legislation on strengthening americas Strategic National stockpile and as somebody who had her view of what the private sector is doing with the federal government needs to do but what are some of the parts of the skeletal structure you think we need to amp up other than the national but the ecosystem and what is wobbly that needs to be shored up. I think its going to be of course to do a really ine depth afteraction report. We did that after each one and one and found out but we didnt have decision manufacturing in the u. S. For vaccines so a new contracts now have i think tripled the Production Capacity and thats theed good news. I think putting back in place a responsive red flag focus on National Security within the white house is going to be critical but i think we need to figure out what is the protective equipment supply, gowns and gloves . Should we make it here in United States and what makes sense in how we had have the capacity to deal with this issue when everybody in the world is trying to find equipment and supplies at the same time. I think we are going to need renewed confidence in the Publicprivate Partnership big pharma has really stepped up but what we know about stock piles and particularly stockpilespi fr therapeutic vaccines is unless the government has a pot of money its worth your time to invest in the science to manufacture these drugs and bring them to development. If there isnt a willing buyer doesnt happen. We are facing the possibility of a microbial resistance to antibiotics. We dont have a pipeline of and about i antibiotics in this country so thats an example the government pool of money that happened after 9 11 we have mats of resources for making sure that america was safe and secure which means some of the supplies that will be developed are never used and are never put into action that you have them in place if something happens. We need to be willing to fund proactively and not reactive way. Secretary quickly on a scale of one to 10 how and pending, how bad was the administrations response so far in covid . I think its bad. I think the deaths that we are seeing in the United States are unparalleled for a developed country with the resources that we have. But native American Communities communities is a moral that we didnt move quickly and tell people the truth and take the steps to secure the most vulnerable population so i think we are at about a nine and maybe we can recover some territory with Vaccine Development and distribution but there is no reason in the world that we should have had this many deaths and now we still have almost equal that in the middle of the country in the rural states. Nde virus is raging here in its raging communities that have almost no capacity to deal with it because there is in the end there is no personnel. Secretary Kathleen Sebelius im grateful for every time you get a chance to you and its also very sobering when i talk to you. Thank you for joining us on our program. Thanks for having me. Our next guest believes the medical supplies made in the u. S. Is an issue of real financial security. Congresswoman Elissa Slotkin democrat from michigan running for election right now. I cant tell yout how gratefule got from all this other stuff you have going on but i know this is a priority for you and its a priority for the country so let me ask you point blank what is broken and needs to be fixed . Well listen a lot of my experience through the worst of it in march and april really came down to the fact that it seems like medical supplies and pharmaceutical and major supply chains that help keep us safe or so outsourced in places like china. We couldnt get ahold of them and we reallyld need them and my experience at the pentagon and the National Security world the kind of blew my mind t that whie we have a preference for making things in america with their military equipment and her body armor and their meals ready to eat we didnt have the same buy american requirement another things like medical supplies and pharmaceuticals. Obviously the stockpile we opened that up and a lot of whatsed expired. It was a lot less than we are expecting. We have to make sure theres a better way tohe stockpile equipment when we need it and then in general i think its really my National Security background with major manufacturing. G. In michigan weve been saying for 30 years if you outsource to far you will get caught with their pants down at some point and i feel like we did. The chinese middleman in the middle of the night like something has gone wrong so thats been our work since april. Wheres your legislation now that i just mentioned with secretary sebelius with the National Stockpile . The talk to other Industry Leaders in the pharmaceutical production and they have been talking about identifying that most needed therapeutic medicines that are out there and figure this out but its doable. Where does it stand now . Its actually a series of seven bills by parts in 10 democrats and 10 republicans builtip purposely by partisan because this issue should be bipartisan but they all passed the house in september and now we are in negotiations to have those in the next covid package. Nancy pelosi has been struggling to negotiate. Those bills are in there myti he is after the election were able to get something done that we havent before the election and its something that frankly we should be moving on now. The biggest part of it is the 500 milliondollar Pilot Program for Publicprivate Partnerships and extra pharmaceutical lines for the very things who are mentioning. When we need to surge in go the American Government has an interest in being partners on the Surge Capacity so thats the part im most excited about. Have you talked Industry Leaders and how did they feel in terms of their partnership with government and in terms of what they know is going to be of big load of new vaccines and therapeutics is going to have to be deployed to every corner ofut the country. Are i you finding this to be dashed finding them to be robust partners or do you have concerns . We have one of these companies now at the ready for whether a vaccine is identified and ready to go and ramp up production but weve been talking to them and others about everyone talks about manufacturing in the United States but you haveo to make sue you are talking to the industry to figure out what truly incentivizes people. You cant just decide from washington that you know whats going to bring manufacturing back. We have such an global eyes supply chain that there is a ton of things that come from all parts of the globe and its more than just saying come on back. What i want to relay us from our Business Leaders and i was in this great group called business executivesre for national secury could they have done the after action on our supplychain and im one of the members of that commission that looked at it. The would have to talk to leaders in industry to figure out how to incentivize production. One of the things that i wanted to talk to you aboutan issue cia backed around and your background as an analyst. I happened to talk earlier this week to rick rice and the bar to official who said he was pushed out and he said something on the covid crisis that i didnt realize that a lot of people look back during the obama period and they did a simulation. You did simulations with the cia and you did exercises and not sober of 2019 that anticipated this kind of pandemic that looked at all the government responses in the partnerships with industry and actually underscored the very weaknesses and decisions that we saw. Is there any awareness that its not the playbook but that simulation occurred highlighting many of these gaps among your colleagues and the need to fill them because i was astonished to hear the Trump Administration already have this experience at hand. I dont know how widespread that knowledge is but i certainly and anyone with the National Security background for Many Administration those are people from each administration that looks at these. They have a whole home at Security Council at the white house and i know people who are working over there and i know there are people who focus on it. Theres a difference between having focus in the system looking at the problems and having it rise to the level of Senior Leaders were they do something about it in the most important thing is intense. Do you have the will and the intent to lead the white house or lead from washington and i think it was this paralysis that came from sort of not wanting to accept the gravity of the problem not wanting to address the federal government as the best place to respond to a lot of these scenarios. Those two things we just got to wait at the start and while this kind of thing would stretch any administration of any party the fact that they backed away from that leadership role meant that didnt even seek out the expertise that might have party been in the administrative and. What are the other critical supplies thatt you think the nation needs and what with some of the partnership with the private sector look like from yourur perspective . I think we need to do a look at what are the supply chains for the National Security. Ive got to tell you is someone who is was from michigan were obviously we are never far from thinking about Vehicle Production there are certain batteries and certain capacity around our Energy Storage that we depend on a lot of other countries for that we dont want to be without. There is certainly a lot of technology around superconductors that were at risk having to depend on other countries. I wrote this in to the Defense Departments budget through my role in the Armed Services committee is to look at an identification of those very specific supply chains with National Securitypl importance d once we identify that list we look at more production here at home but we have got to agree upon that list. We have to have a common understanding and then review it every few years but certainly Energy Storage is a big one that we would be loath without. Representative Elissa Slotkin i appreciate your insight in what youre doing to the thing through the ecosystem and how to be smarter than perhaps they have been so im grateful for your time could i know how busy you are so thanks for joining us on todaysks program. Thanks so much. My next guest has been a pharmacist for 30 years and the only pharmacist in congress but he thinks the coronavirus is the wakeup call America Needs to bring back a participle of the pharmaceutical supplychain United States. Buddygr carter a republican up r election in a few days and thank you for taking time to talk to us about it. I just said it, you think this ought to be a wakeup call. What deals do we need to move to make sure america has the supplychain something you can trust to deal of this pandemic . First of all thank you for having me and theres not only difference in knowing something at realizing something. We have known for quitece a whie of the countrys pharmaceutical needs that during the pandemic we have realized that we have to do something about it and the things that we are proposing and that i have legislation active pharmaceutical ingredients drugs and recipients and what we are intrying to do is put back in se of these fordism pharmaceutical manufacturers back intotu our country. 90 of the ibuprofen in our country is made in china. Thats not a good situation for us to be in. Our much of the late 70s and we relates where you are dependent for energy needs and we realized we needed Energy Independence that we achieve that. The same thing can be said now. We have realized we depend on Foreign Countries for pharmaceutical needs a way to do something about it. T. Thats why we have legislation what im trying to do is to attract those companies to come back to america toct incentivize them in repatriate them back to america. Youll remember that opportunity zones were created in the jobs act and that could mean a tax credit if they will locate their manufacturing facilities in the area. We use other incidents as well not the least of which is trying to into the patriotism that we need you to come back to america. Thats very important. Pharmaceutical incentives not only pharmaceutical incentives but also the ppe. We are too dependent on these Foreign Countries for our ppe for personal protective equipment. We need tour make sure we are doing the manufacturing here in america for our ppe as well. Spread congressman one of the interesting things that might delve into this and im glad you made distinction between ppe in the pharmaceutical, we clearly saw the law of the jungle but if you peel it back i think there was a sense of anxiety and crisis about pharmaceuticals. I cant find anywhere were they werent delivered that says supplychain largely works. This time and im just wondering if my bearings areth off somewht today now that you are working on what our National Stockpile should be and what they should look at the key narratives but to look at the experience did things hold together or not . Certainly we have had threats and they didnt come to fruition but we have have threats from china. A. We are going to use what we have to and if we have enough will wills of the taper thats not the situation we need to be in nor is it in the best interest of our national defense. The situation that we should avoid and we can avoid. We do need to get pharmaceutical manufactures and he has seen yes weve t been able to get everything that we need but at what cost . Youve heard of pricegouging thats been happening from Foreign Countries and thats again why we need to address it. Ive talked to leaders in industries that the pharmaceutical and therapeutic manufactures and they think they are interested in partnering with government on things like looking at the strategic stockpile but they said in terms of offshoring or. On shoring some of this capacity that moves abroad it requires a whole economy system could you got to have longterm purchasing and you have to have regulatory changes in you mentioned opportunity zones. My question is, is there a place in our government thats thinking holistically about that apartment to coast if this is done piecemeal it will work. C you are absolutely right. We have got to make it worth our while. Something we have struggled with this protocol and we have to make sure we cover that and thats why its important when we cant piecemeal this to make it work we understand that an thats why ive introduced something that addresses all of those. There are pharmaceuticals in the United States and a lot of them have been asking what about me . In my going to get incentive . The roby incentive to attract them to remain here in america so thats very important and certainly something we need to consider. If i could talk just a second about the stockpile pic is you mentioned that the couple of times. Tii also have two pieces of legislation that are important to address. We all know that we have got the federal stockpile in the strategic stockpile but we recognize weve been too dependent on that sort of got legislation thats Bipartisan Legislation with senator blunt a democrat to address the state strategic stockpile. But this is a dollar for Dollar Dollar for states to have their own stockpiles. We were all too dependent on the National Stockpile. This is a Pilot Program that would grant and encourage states to have their own stockpile. That will help us better prepare for the next time. Again im cosponsoring with the senator from rochester the Central Medicine stockpile. None of the drugs being used or generic drugs. Instead of waiting until we have a shortage of a drug a generic drug and stockpiling it we will. This Central Medicine that i know we are going to need and begin this is a Pilot Program where as we. This National Stockpile with Central Medicine and we have utilized the idea that are being currently utilized in the private sector perpetual inventory making sure we have an inventory of essential medicine so there is a shortage at any given time will be able to pass it on. Thats very important and we can guard against a lot of that going on at eight and from being wasted. I remember when i was in the legislature and we went through the bird flu and millions of dollars worth of and it was the wrong decision back then. [inaudible] theres a new policy in a new procedure using perpetual inventory where we can avoid that. I know we have questions from the audience but i know your role as a pharmacist and i may have a strong but the pharmacist ise like the canary in the coal mine. They know what the inflow and outflow is. Are there things we should know about the pharmacist and what can play enhancing up their role in terms of alerts and what they need is out there of various Key Pharmaceuticals . Thats a great question because pharmacists are the most Successful Health care professionals in america. 95 of all americans live within five miles of a pharmacist. We are not utilizing pharmacist in particular but healthbe care professionals. Ive discussed this with dr. Adams of the department of Public Health and secretary a czar and they all agree azar and they agreed not only situations where you describe aret reseen a shortage of drugs and we can learn about it but also if we are going to this covid19 pandemic being able to test and administer the vaccine. Mostst people receive their vaccines from aa pharmacists now and we need to be able to administer the covid19 vaccine. We need to get it out as quickly and safely as possible. Thank you for that been taking questions from the audience and we have one now from buddy. What is the appetite of industry providers in the Current Administration for the cost challenges of sharing our pharmaceutical supply chain . A great question come are we willing to pay for a . Well that is a great question and i dont think, the question is are we willing to pay for it. We have to pay for it. We have got to be prepared for this and i think that we all agree that this is necessary and in order to attract these Companies Back to america we have got to be competitive. Thats the nature of private companies and they live offshore in the first place with financial incentives whether it be lower manufacturing costs lower labor costs or whatever it is we in america will have to bite the bullet and step up and do what we have to do. I think we recognize that. Levy i follow you on twitter so i know that you right now have signed up for vaccine trial and you said you are going to signup and you believe will come up with a safe and effective vaccine. I just want to wish you well and then i hope it goes well because i really like folks that stand up. I its important. Hows it going so far . So far is going very well and i get my first dose and in three weeks ill get my second dose. The doctor doesnt know the staff doesnt no, its a doubleblind study. Whoever has the key to the vile will know whether its the vaccine or the books ibo. Placebo. I keep a daily diary of mud by temperature is and its important as a member of the health care and a member of congress for me to put my money where my mouth is. Thats why fill confident we will have a safe and affect it vaccine and so confident that i will go through the process myself. If your Blood Pressure and temperature went up right now you can blame the journals Steven Clemons of the hill today know youve got a lot in your plate with the election just around the corner so thanks for joining us. Thank you. United states should support of the most covid19 cases in one week since the pandemic again in infection rates are skyrocketing as we enter the colder months. Thats why. They are Scott Gottlieb former commissioner and a present Company American Enterprise Institute advises lawmakers and governors on Public Health policies and if youre like me up at 6 00 a. M. And click on cnbc you can get really smart on all things gottlieb. Its great to see you again. I often ask you on csn b. C. And squat box what is better so my question to you perhaps unfair is i look at some of this and i see a lot of keystone cops. What do you see has been strong and good and capable about our response so far on covid that you think someone like me is. I think the process with respect to the vaccine and as you know im on the ward of advisers that has the vaccine and advanced development so i have respective on that from my former position on the up d. A. As well as someone who fits into that role. Iit think the process that peter has been following has been very transparent but i think it has a lot of integrity to it and so i think that is gone well and the fact that they are bringing in the products and they have outlined objective criteria and multiple documents. They are not too conservative and not too aggressive. I think they struck the right middle path and recognized they still need to make sure they have rigorous data and the fact that they have that Advisory Committee this past week where they brought that criteria to the committee on it. I think that is gone very well. I think some of the bigger challenges when history looks back at this is a number of things that the one that i come back to is the diagnostics and the facts that back in german and ivorian and we didnt have theve diagnostics to the plaintf written about this many times that i wrote about it at the time as well. When you look back at where were the things we could have done differently that might have had an effect on the epidemic that ensued that would be one of the key was not to game the cdc test out which a lot of people point to but getting that unical labs and getting quest in lab core and the academic labs in the game early back in january recognizing it would take them a month or so to ramp up. You had to get them started early on that. When you look at the drug and therapeutics were the questions we are looking at today is to denote the supply chain is working and is a need to be moved . We are talking about the Fast Development of new vaccines and new therapies could i talk to any number of ceos including from pfizer and others but there is this question of new stuff coming on line and whether the system can handle it in the deployment of vaccines but also what we saw in terms of drug therapies. Did you have any concerns about that . Does the system were . I think people talk about the speed up which we develop these products and its true we develop them quickly but we actually didnt shortcut the development process. The reason we registered in getting products into the clinic very quickly is because we have this established platform that we are able to use to start deriving drug and vaccine constructs. We happen to have the platforms. They were recently far along and pfizer was using it for the flu loccine a modern ahead used it to develop a vaccine against sars and were using it for other purposes. The technology was far along. Its the ones from the coronavirus that started deriving drug concepts. We had developed antibodies against other viruses with the bowl and murders in the case of regeneron so we were able to quickly take those platforms and get drugs into development. The Development Program are actually quite extensive. We didnt take any shortcuts in the fact that pfizer is doing a 44,000 patient trial in moderno is doing a patient trial these will be the largest vaccine Clinical Trials ever undertaken simultaneously against a single target and some of them are almost the largest trials ever undertaken by the Coronavirus Vaccine was over 65,000 satients. The randomized portion is large so these are very big Development Programs. We did not shirk of this at all. Where we did move with speed is getting the product into development in many respects thats reflected by the fact that these are commercially optimized. If you had two years to develop a vaccine or three years to develop a vaccine would you develop a vaccine that requires two doses are optimized into a singlele dose . If you had a lot of time to develop a vaccine would you a vaccine that requires cold so we didnt optimize it but in terms of the Actual Development they are expensive and that needs to be understood. We didnt take any shortcuts and the fda didnt takecu any shortcuts. Its really driven by the regulators in terms of the data. A source of supply chain is concerned the challenges are with respect to the supply available and in some cases it takes time to ramp up and in other cases we will be supply constrained to provide for more supply and thats particularly true of the antibody phase drugs and the method that we have to push harder to expand. The company did a lot of work and extraordinary work but theres probably more they could have done collectively with the federal government to provide a supply and use them as a bridge for a vaccine. As far as the district is concerned i think there will be complexity with how the drugs are being distributed because of the policy choices where making in terms of how we are doing that but as far as logistics are concerned i think the logistics and distribution of done a good job in this crisis and it shows you how good the logistics are in this country when it comes to the medical products and when the supplies were there they were able to just shoot at them and the reason there were shortages was because things werent showing up on time or there just wasnt enough material. Im hearing what youre saying is the distributors need to get their act together and they need a plan. Kathleen sabill easels on our program and shes waiting for a National Plan but i know you talked to governor larry hogan one of my favorite governors in the country and other governors as well but in the new film called totally under control very hogan welcoming a package of ppe from south korea and trying to prevent it from being hijacked by federal authorities. It was the law of the jungle feeling in that moment so you ask yourself as we are getting closer and closer to multiple potential vaccines how do you preempt that same story from occurring again . I think the Vaccine Distribution system that they have created they asked based on my understanding is dont exert a lot of control over how the vaccine is just a beta. First of all the supply based on allocation system tied to the initial authorization. The states are going to get a proportionate allocation based on how many people they have in their state and the criteria. Everyone over the age of 65 and im saying hypothetically. Thats not what im saying is going to be all really dont knw thats 5,560,000,000 people and if you only have 30 million doses everything is proportioned based on how may people they have over 65. The system goes further and that is going to have tight tracking of where all the doses are going and who they are being administered to inside the state so that allows the federal government to region and reallocate vaccines at any point and it also allows them to make sure its going to properly indicated populations although they leave it to the discretion of the state for the final candidate but the price you pay for that level control of an oversight is you have to distribute it through more narrow chain so they will have close monitoring of the sites in the sights and to be registered and they need to go undergo special training so that limits the number of sites. Hopefully therell be enough communities and of sites that are successful for people who have difficulty coming into a cvs or coming into the Vaccine Distribution point or someone at the hospital standing in line. Thats where you start to see concerns. Thople of already have access have problems getting access to it they will be the ones that are most disadvantaged so how do you offset that . If you are governor you try to promote local bands. Is there federal money for that . Is not clear but those are the places where would focus attention places where some incremental friction is going to. Some obstacles that could be getting a Covid Vaccine at least that initial tranche is alike like going to vote where you have to go to a special occasion with a special window to get your vaccine. For most people that would be okay but you worry about people who have obstacles to access but as far as the antibodies are concerned there again you are going to be supply limited but the way the system is designed right now based on my understanding is they plan to destroy those drugs through hospital emergency t rooms in te challenge there is the initial indicated population is older individuals but a lot of people are reluctant to get infusions of antibodies. We know that from the commercial side of the drug market. Peoplele perceive swallowing a pill is something thats less consequential than getting it an infusion of the drug and thats why a lot of primary care drugs are formulated ways that they are notd fusion. People apparently the kit is an infusionnf as more invasive and more risky. You have that bias in the system and now you have a situation where the antibodies need to be delivered right before symptoms come on or before you become a scent before you become symptomatic. You have to convince an older individual who is not that sick would have Coronavirus Diagnosis to go into an emergency room and sit for a 45 minute infusion with a twohour followup and there will probably be away time and youre probably in a location where the coronavirus is an epidemic and their boards going to be busy and some has to drive themy there. They could potentially expose themselves to coronavirus podesta challenging Distribution System and the way its being conceived based on my understanding. We advocated using Home Infusion as an alternative for offering it as an alternative but its doesnt seem to be the direction they are going in. Just to sum up we want to look for challenges in places where you. Friction or difficulties that patients who have obstacles getting into the doctor getting into the emergency room getting access to ae provider site is going to be extra friction for that individual and you want to try to mitigate that put you have to look at it from a Patient Perspective and recognize who are dealing with patients who face more a obstacles getting care because they are older or they come from communities where they dont have good access to health care or good Resources Available to them. I really appreciate that perspective. I just ask you real quickly because you talk to everybody on every side of the island you know whats possible. You tweeted out recently that he thought it was time for a National Mask mandate could you see any way leading republicans and leading democrats might come together and say given the dark winter we are looking at potentially that this might either right time . Im not sure how you would have forced the mandate. I think there are republicans that are on board with trying to promote mask wearing and i think the best way to provide a carrot rather than a stick to pride governors to implement the mandates certainly if he made a more culturally acceptable that would be a good start. The bully pulpit is very powerful and i think if its used in a way to encourage governors to do this, that would go a very long way instead of what we have right now which is some cases masts are being discouraged in some respects. Remember the mask of our to prevent people from being able to transmit the virus. It also offers you protection as an individual but the higher the quality of the mask you wear the more protection it will afford you. Doctors of a former commissioner of the fda my favorite voice on the early mornings great to see you and a scholar at aei. Thank you for sharing your thoughts with us today scott. My next guest have a deep understanding of our Health Care Ecosystem infrastructure but im delighted at t the haunted discussed on the residency of ours pharmaceutical supply chain but their recommendations for seamless rollout of the Coronavirus Vaccine becomes available. Dr. Elena rios. They are Joshua Sharfstein professor at the Johns Hopkins Bloomberg School of Public Health and heather zenk Senior Vice President of Strategic Global sourcing at amerisource burgin corporation. Heather let me start with you. On the reasons we are doing this program today is that americans are anxious about whats going on in the country they are stressed out there and they are anxious about what they have seen of with their management of ppe in the past and they are concerned about how a virus vaccine will rollout in the various there. It should americans be anxious about some parts of this or do they have confidence that the system is going to work . I think american should have confidence that its going to work. We have Lifelong Medical staff and we have lifelong resources that have done this kind of work over and overki again. I think its unprecedented which is another term we used frequently during these times. We are looking at the entire preparation in the short amount of time and with that unprecedented effort a strong supply chain and get health care professionals. We all want to get back to normal. I want to see my family and i enjoy spending the holidays which may not happen this Holiday Season but lets look forward to the next Holiday Season and the thing you rely upon here is to have a robust supply chain. I think the uncertainty is now we are hearing frozen temperatures so it isnt something we typically deal with on a supply chain basis. Outside the norm but not daily and we are looking at vaccinating the entire United States would need a robust plan. We need people who want to do this and we need a willing supply chain to this but its a matter of becoming collaborative together communicate to each other and execute on a plan we can all agree upon to get the vaccine to the patients not just to approval but to the patients. Thank you. Dr. Sharfstein one of the realities we are saying is we are seeing incredible time pressure put on science, but on the industry and the innovators that are out there trying to discover a vaccine but then manufacture and distribute it and at the same time we fill a lot of politics and this is the time of an election. There are concerns really about trusting is the science getting the leeway it needs to produce what it should do or are we taking shortcuts . I know you have balked on this on pressure on the fda but another question is should we be ablest to trust with developing . Trust comes from expertise and knowing people who know what they are doing are making good decisions. It comes through data and transparency. Doesnt come from political interference that undermines trust. What we are poised to have within effective vaccines depends on what the study show. A good review process with the food and drug of with an appended visor committee weighing in on the day that with transparency and the agency to explain itself to the public about getting a vaccine and advising the cdc to weigh in. I thinkk the pieces are moving into, place. I think its very dangerous when it the president accuses people in the agency im not moving fast enough for political reasons and its really doing a lot damaged and making the agency political. I would ask all of you and do not go to the leyna in the early stages when the virus was coming out every day i did a show on where the tests were in why we didnt have a National Testing plan. You go back and look retroactively and applauded dysfunction between things like the fda and the cdc and we saw this virus with mortality rates and infection rates hit parts of this nation in uneven ways and the hispanic population in the lackan population and frontline workers. Again i would come to you and say what needs to be put in place so that we have a fair just and solid response on covid19 along with s supplychn everything but i know youve been working on this so what matters most for you and your community . Two things. One is you have to have the data. Data collection by race and ethnicity is really important and in our Health Care System thats never been mandatory in for an Infectious Disease of this magnitude that is harming and burdening all of america but especially hotspots like africanamerican hispanic and native americans poorer communities in Rural Communities its important to have that data. The second thing i think thats important for people to realize in United States even if they are not documented we need to be vaccinated and we need help access in our communities. Latinos in this country have not applied for Government Programs. They mistrust Government Programs so learning to be messengers, the physicians and nurses in the frontline workers and are Health Care System and our Nursing Homes and other communitybased organizations all need to work with Public Health agencies and we need leadership in the Public Health agencies and our Health Care System to be able to have more trust and to get the campaign to our communities through the mediumpa social media. We have been doing this all year and its important to realize a lot of the organizations that are health carerelated have jumped on the bandwagon toed he. Thank you for that and will see how this rolls out because im interested what kind of action we are going to get. Josh ive been watching this grid and i look at the various companies. There did Farmer Companies and small Farmer Companies. They have different approaches and different phases and trials and darpa, not darpa let operation warp speed and when you look at and you look at that lineup i dont know whos going to get over the line or the differences but can you take us down the track to explain when we are going to be able to see a vaccine in the marketplace for regular folks and how thats going to be tiered between those who most need it . How will we deal with multiple vaccines . I think its important to see this as a series of stages. Have to get one stage iv the next stage to even matter and right now we are in the stage of getting data from the Clinical Trials. They are going to look to see whether people who got the vaccine are less likely to get covid than people who have a placebo and they will look at safety data to make sure it doesnt cause untowardaf side effects in the group that got the vaccine. Only when we know that can we get to the next stage which is starting to think about who should get vaccinated and a vaccine may not be available right away. The first phase of vaccinations will be people who are likely Health Care Workers and states are going to play an Important Role in distributing the vaccine and collaboration with the different partnersnc including e private sector. And then behind that we are going to see a lot or manufacturing. Hopefully more than one vaccine will be proven safe and effective so well have multivaccines being manufactured in the terms of getting the vaccine that may be a question for january or february and what about everyone else would it be the late spring oror summer . Thats if everything goes well but at the first phases have challenges everything gets set back so to even be in this position is further ahead than ever before. Joshua i know you have to leave great thank you for joining us and i want to talk to heather. When we talk about what our experiences were in the past we had 150 million or so vaccinations of the flu in the last year and adding another ea150 million on top. How does that work . Is the system able to carry thas load . The commercial supplychain is built on efficiency and scale so as long as we can do with repetitive that 70. Josh pointed out the phases and that will depend on how the distribution works so add into the status as a traditional vaccine in the flu vaccine at this point we need to follow the stages and the supplychain in the west today. Its a Public Health supplychain and a commercial supplychain anything particularly when you add in the Covid Vaccine thats the time to really rely upon all the people we can vaccinated our supplychain such as physicians and independent channels. We have the ability and we tend to rely have we on the Public Health supply chain. We are going to introduce all of the supplychain the Public Health t supplychain and the current supplychain to make this happen. Scale efficiency and effectiveness is our bread and butter and thats what we need to build on. I want to ask you this coal Tax Coalition 184 countries are members of it. Every other nation is kicking money into it and the United States is not a member could have introduced the minister of health in sweden shes really worried about vaccine nationalism and america which is such a big innovator in such a big part of the puzzle is in part of batches worried about a law are we worse off when not being part of it and what are the implications of back . Seemed personally i think collaboration is important. We are in a society. A lot of pharmaceuticals finished in the u. S. Here. We do need to think globally and act locally. I think we need to understand how we protect are Health Care Workers and then roll this out. I think that we could join a coalition we could think about the global access. We are in a global pandemic. We are not inn the u. S. Pandemi. We are in a global pandemic. The Global Economy does need to come together in the Health Care System needs to come together just because we have so much between countries and continents. Yes a jumpan over to elena about how we get the equation right i want to give the u. S. This past week amid funding to study the coalition for economic appeared as an innovation about 20 million which is a lot to some but a drop in the bucket frankly compared to many countries so there are coalitions and the United States is part of it. We come back to this question would we see a rollout of a doccine dr. Robert redfield made the same point that you did said we are going to have to embrace a person without resources a person who may be homeless without shelter and we have to find a way to bring that person into being tested and if infected give them support and treatment. Otherwise the system comes apart. And i think what heather said about the global dimension is so important. There will be parts of the world that are hard to reach. You are thinking about this more than many of us are. How can we not just be philanthropic but actually be committed like their lives rely on it to make sure we are inclusive as we reached out to the community . At think one of the most important things the whole supplychain every step of the way can do is to think in terms ofep family focused efforts not just individual efforts. The whole family needs to to get back stated that the whole family needs to understand that what they are doing by getting vaccinateded is helping other families and then the families translate into neighborhoods and california has the whole Health Equity lined up in the cdc has hotspots all over the country. There are neighborhoods and census tracts that can be focused on with the essential workers, the Health Workers as well as those who are the most vulnerable. Those people need to bear protected first as the National Academy of medicine of engineering and science has said. I do think theres an Important Role foror commitment through media. We have a lot of people who get information not only from their providers that those who dont doctor corp. Go to the pharmacy to pick up medication could you get information to the media and we have ethnic media that are momandpop type newspapers, magazines and of course the National Networks and spanishlanguage another language, asian languages for example have their own media stations like telemundo who has the same message in Work Together with the ad council to. A major focus on the importance of the vaccine i think we should start now with the flu vaccine season upon us and the importance of getting involved. We are involved with the flu Vaccine Distribution and messages with some of our partners with the cdc. I appreciated. I think heather knows this inside and out as someone whos out there. You realize how complex the backbone, the circulatory system attendance of the supplychain is incredibly impressive but i have to say i was very ignorant of a lot of whats out there so we have a long way to go when we think about the media and what we need to know in terms of what is out there. We have been taking questions from our audience and we have a question from daniel. Daniel. The Daniel Hartnett associate your my question today is how do we ensure the integrity and the security of the covid19 vaccine and how do we ensure adverse actors dont slip into the v supplychain with security thats tampering fraud cybersecurity and there are other cybersecurity threats. This is a big deal. We are talking pharmaceuticals and therapeutics. If you go on ebay there are some ridiculous things going on there so how do we enhance and amp up security . One thing is trust your local healthth care professionals. They trust their supplychain partners. As long as we continue to use the resources we have used over the course of time that is know your partner and trust your partner and validate your partner in the second thing i know the cdc knows where the vaccine is being stored and how its being disseminated. We are taking it very seriously around the transmission and i think its a wonderful question. Its something they do not always think about. Also we always know where distribution locations are where we have pharmaceuticals just out of the safety of those who are choosing pharmaceuticals everyday and thats the same thing my colleagues take seriously. One of the key things is know your partner know who you trust. Elena highwood you up roach that and thank you heather and anna for the question. I think its amply important for communities that already have that trust challenge who dont see folks like them in the messaging so what is perceived risk and the others real risk what your thoughts . Reception is very important. Everyones talking about antibias training and the importance of having equity improvement but i think what really matters is the messenger. I have to applaud what heather said about trusting your own provider making it local so that people can see who they are talking to, trusting the federal government needs to have a face and that was the whole part of the problem for years misuse of information or misinformation. The cdc is the Public Health and the cdc needs to be out there in the Public Health agencies in the State Government the local government working together with the faithbased our religions are very important to communities of color and is committed to leaders and Community Organizations at think we do need to have a face and a messenger lined up are the speakers are a few of the importance of vaccines for covid19. If such an Infectious Disease. The people in our communities need to understand its a very serious disease and how it worked andnd a vaccine is to the decrease in the infection rate given our own families and communities. Look i realize this is a complex time and the stressedout country with a lot of choices so appreciate your thoughts and how we can get this right because i think there are choices out there and they think they are unacknowledged strength out there in the supplychain and the medical chain that we havent been talking enough about but no matter how this election turns out its something we will have to get our heads around and rolling ruling out vaccines and therapeutics but i want to thank Joshua Sharfstein and heather zenk of amerisource corp. And elena rios of that Land Association but i hope youll be back ache as this will be a story will continue to cover so thank you soal much. Thank you. That brings us to the end of our program a big thank you to the Health Care Distribution alliance for their support in all up in the audience for joining us. For those of you who missed any of the conversationk he this afternoon we will have video on our web site shortly. Im Steven Clemons. Be well. Mankiw and my oath grew up in period were people wanted to like who are at they were voting for. That turned out not to be true of donald trump so people say we have a 42 or 43 personal approval rating. Im not saying he will body cam because people dont like and dislike the way he operates will still vote for him because they like his attitude. The group knew america looked at Voting Technology and the potential for voting by smartphone or computer in the future. This is just over one hour. Hi everyone rate base for joining us today. In name is jane hu and im a journalist and contributor. Future tense is a collaboration between Arizona State university new america in a place that examines emergency in Technology Public policies and society. I will be monitoring our conversation today and im thrilled to be joined by Kevin Collier a reporter. Nimit sawhney the cofounder of voatz and larry nord and the director of a center for justice. Just a reminder if you do have

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