Director Francis Collins about their 2018 budget request, as well as various kinds of medical Research Done by the agency. This is about two hours. Senator roy blunt chairs the twohour Senate Appropriations hearing subcommittee. Will come totee order. The appropriations subcommittee labor,r, wealth health, Human Services, and agencies will come to order. For my opening statement, i , whoke to recognize we had an opportunity to meet and talk about her cancer fight and the success she has made nih awhen we were out at few days ago. We are glad you are here. And i was just told the young us of your six children just got their drivers license, so good luck with that. Good luck with all of that. We are all glad to have a chance to meet with her. Im glad to have dr. Collins and the other Institute Directors here today. The budget, of course, proposes cuts. Rest assured, i think this committee will find them unacceptable, the 7. 5 million cut from nih would, according to analysts, this funding would cost nearly 90,000 jobs nationwide, result in 15. 3 million 15. 3 billion of lost economic activity. In my home state of missouri, that equates to a loss of nearly 1700 jobs and 292 million of economic activity. The cut is one that i think you can, rest assured, this committee will not take. I fundamentally disagree with the proposed funding reduction, however this is not the first president to propose a reduction. President obama for post a 1 billion cut in his budget last year. We went 3 billion beyond his proposal, i am not sure we could do anything like that this year, but i also mentioned in a hearing earlier this week that when his budget was submitted to the senate, 98 senators voted against it and one senator voted for it, so we have a long history of congress asserting itself on issues of how to allocate money. I believe this committee will do the same thing this year. Last two years, with significant encouragement from the whole committee, particularly from senators murray, alexander, in durban, and the whole committee we had the whole committee out will committee we had the whole committee out on nih, the biggest delegation to go there. The afternoon. F i hope you, dr. Collins, and or Institute Directors know how much your work is appreciated. In the last two years, we have increased nih funding by little more than 13 , and we will be listening carefully to your presentations today. Before that, i would like to turn to senator murray for her opening comments. Thank you to you and all of your team for being here today. We appreciate all that you do to champion the critical work of nih. You have been a great partner, and we really appreciate your leadership and all of your teams. I look forward to having a discussion today about the devastating impact the president s budget would have on nih. As you all know, President Trump has proposed cutting nih by 22 , most of it by arbitrarily capping indirect costs, resulting in the lowest running for Biomedical Research since 2002. Three months after releasing this proposal, we have no basic information from the administration on how nih would implement a 7. 5 billion reduction without severe to Research Facilities and tens of thousands of scientists that rely on its grants to support their work. Facilities like the Fred Hutchinson institute in the home state in my home state of example whereone scientists have pioneered bone marrow transplants and are searching for cures to cancer sexy. Iv cap scene this could to radically scale vaccineir efforts to. This could radically scale back their efforts. I hope that both parties, once again, reject President Trumps Budget Proposal and continue to Work Together, as we have to ensure nih is able to carry out its final work that gives hope to those living with chronic and lifethreatening disease. Economic tal or bolster Economic Growth and competitiveness. But i have to know that todays hearing takes place in the midst of a very Pivotal Moment for our Health Care System as a whole. All week, ourrd republican colleagues appear to be dead set on jamming their version of trumpcare through the senate in a matter of days. Beenis a bill that has subject to no hearings, no public debate, and no expert testimony. Is the bill so secret that apparently, until just moments ago, Many Republican senators were telling present constituents they cannot say what was in the bill. It was so secret that even President Trumps Top Health Care advisor, he told us last week that he did not know what was in it. Secret and so closely guarded that not even the 13 male senators who made up the socalled working group could comment with certainty on what was in that or when it would be wrought up for procedure. In fact, the bill is so secret that even the White House Press secretary cannot can term weather President Trump or any in the white house, for that matter how i have seen the bill, which begs the question, as i have said this week, what are Republican Leaders so ashamed of . And is becoming very clear now that those who wrote the Trumpcare Bill knew they would not be able to go back home and defend it because based on what we are now learning, this bill is going to be the same kind of Trumpcare Bill that went in the house, and it will have tremendous impact on patients and families. Higher costs for families, especially seniors, and people with preexisting conditions. Insurance companies no longer will be required to cover basic health care, like Maternity Care or Mental Health services. Women would lose access to their theyrs, and to the care need at planned parenthood, and plenty of people across the country would see their medicaid coverage taken away. That means people nationwide who are finally getting treatment for Substance Use disorders like opioid addiction or Mental Health care or access to a primary care doctor under medicaid are going to lose that access. Democraticof my colleagues have said, this is not a health care bill, it is an attack on Families Health and financial security. I want to reiterate my message to Republican Leadership, it is not too late to dump this Trumpcare Bill. It is not too late to make the right choices and work with us as democrats to fix our Health Care System. As the chairman and others on this committee should know by now, democrats stand ready, as we always have, to Work Together to actually make health care more affordable and accessible for patients and families across the country. We cannot begin that conversation until Republican Leadership has reversed its course. Lastly, i do have to say that after hearing this week about so many of my republican colleagues feeling frustrated about this bill and the process, who were angered about being shut out of this process or receiving orflicting information, maybe even shocked by the text just released, you have the power to do something about it, not to complain. You could assist us on hearings, open debate, increase transparency, because lets be very clear people across the country are really worried about the approach that is being taken. They are watching, they will be paying close attention, and we need to get this right, not what is being jammed through the senate. Back to you. Thanks, senator murray. We are pleased to have the Ranking Member of the committee with us today, the chairman does not have a statement but i think you may, senator leahy. I request my statement be printed in the record. Thank you. Thank you, chairman. Im glad to be here with you and, of course, with senator murray. I completely agree with her statement. This is important, and dr. Collins, good to have you here and your whole team. My mother, when she was still with us, she was a firstgeneration italianamerican, and she saw on dr. Collins was going to be here, she said say hello to that nice young man. Or rather, save on this affects. You have tohe fact support the middle growth middleclass and support the most foldable. Has been a shining example, but sequestration has had devastating effects. I think those consequences will last for generations. My children and grandchildren. This budget makes it even worse. Deep budget cuts, those have drawn the most bipartisan opposition. Said. Ard what sen. Blunt the most bipartisan criticism has been reductions for the National Institutes of health. Blunt to commend chairman and Ranking Member murray in their efforts to bolster the nih budget in recent years. This budget we have been given by the white house turns the progress upside down, it slashes and ih resources nih resources wanted 1 . 21 . ,ou know better than i do medical research, you cannot just turn it off or a few years, wese studies and trials, will come back in five years and pick them back up again. You cannot do it. You dont hit pause on studies. You cannot have ups and downs based on the whims. Based on whims. The cap on research is being done around the nation, universities and other entities. Im not being parochial, but i mentioned the university of vermont, they receive grants every year. It is unlikely they could continue their research on this budget. They have been doing cuttingedge research and cancer, among other things. A full copy of their letter to be placed on the record. Without objection. Sen. Leahy this is where we can lead the world. Not only that, we can make life so much better for our own people. And people around the world. Toill fight for every dollar be gained back that i can. And you very much, mr. Chairman. Thank you, sir. Dr. Collins, we are pleased you are here. We look forward to your opening statements, and when you are through, we will go to opening will go to questions. Dr. Collins to my right, dr. And thenodes, gordon, andoshua you have already recognized dr. Fauci feared on the far nearsighted, gary gibbons. We brought the 18 today. A team today. It is a great honor to be with you today. I am privileged to continue in this role as nih director geared i want to thank all of you for your sustained commitment to nih, a commitment that ensures that we remain a leader in Biomedical Research. I would like to highlight several areas of exceptional scientific opportunity. I would like to introduce you to a few patients and also talk about some young researchers who are working hard to make these dreams come true. I will show a few images over on the screen. Lets start with an opportunity that shows the transformational power of investing in nih basic science. Imagine you could determine the precise molecular structures of proteins like you see here. Interactactly how they with each drug. This is starting to happen things to a new technology. This image shows the structure of a protein channel, indicated in a great mesh, it regulates salt and water balance in the lungs. Folded misfolded in Cystic Fibrosis. Give mutation that causes Cystic Fibrosis was discovered in my own Research Years ago. Only now, are we able to design better drugs to help cystic abilynns, like little feud she is doing pretty well now. That this ago, she probably would not have made it the on her teens. Havenger, aired today, we no longer. Drugs that help cf. Among the early stage investigators tackling this fromenges is a scientist alabama. He plans to transform in fundamental ways the way we design and deliver drugs for all kinds of conditions. We need that. Treatments only exist today for about 500 of the 7000 diseases for which a molecular cause is now known. Among those in desperate need of a breakthrough is sickle cell disease, a disorder in which red blood cells clog. Today, the only way it can be cured is from a bone mero transport. Transplant beard it can work well for some people, like chris shown here. He is now essentially cured. Most that dont have a well matched most do not have a well matched bone marrow. What if we could correct the sickle cell in a patients blood cells . Once, i wouldve said it is unlikely. That is changing. There is a new gene editing system. The goal is to fix the underlying genetic defect and make the patients own cells healthy. If courtney and other scientists can get this to work for sickle cell, think what they might be able to do for thousands of others. Are 86 billion neurons in the brain. Brain disorders are taking and a normas toll on and a normas toll on our economy. Enormous toll on our economy. Lets imagine that using tools and technologies created by the Brain Initiative, you could easily identify someone at risk for alzheimers and apply effective ways of defending the disease that has touched effective ways of correcting the disease that has touched so many. Investigator from Massachusetts General Hospital is among those taking on this challenge. Her work is focused on the largest known group of people in the world with inherited alzheimers. A Family Living in the mountains of columbia. Using pet scans to compare the brains of family members who have the alzheimers gene with those who do not. Curing alzheimers will not be easy, but they have the talent and drive to make it happen. You all are part of that. Your emphasis on alzheimers and related Dementia Research in fiscal 2016 and 2017 is enabling progress toward our mutual goal toward effectively treating these devastating conditions. All of us are motivated today by a sense of urgency to help haitians in need of breakthroughs. The next generation of innovative and passionate researchers will be the critical part of that bright future. Nih announced the next generation researchers and initiative to bolster support to early and mid career investigators like a three you see here. Our Nations Health and wellbeing depend on your strong support for them. Thank you, mr. Chairman, my colleagues and i welcome your questions. We are glad you are here. I was pleased with the president s decision to continue your leadership at nih. Many of us have advocated for that and we are pleased to see it happen. Your team and what your team does is inspiring to all of us. We will have a fiveminute round of questions. I think there are a lot of competing things going on today so we will try to keep that as close to five minutes as we can, starting with me. Want to askareas i ask specifically about in the president s proposal, one was to eliminate the Fogarty International center. I think particularly with the zika process we are going through, that center was pretty actively involved. Be about whatmay the center does as opposed to commenting on it necessarily the president s view of this. I appreciate the question, im going to let dr. Comment onndeered that. Center is the fogarty critical to what we do. Nationally and internationally. Know nous diseases borders. Some cogent examples of how the fogarty training of International Scientific colleagues has benefited the United States of america, and the two in most recent memory are the Ebola Outbreak and the zika outbreak, not to mention the longstanding commitment trials inids, and subsaharan africa. These trials are almost all led by International Scientists trained by fogarty grants. Mightegard to ebola, you recall that in africa, they had 11,000 deaths. If that had gone beyond those aliders to places like m or nigeria, it couldve been a bigger catastrophe. Went toted individuals mali or nigeria, it did not make much press because it was a success, but the investigators were able to isolate and stop it in those countries before it , particularly in nigeria, the most populous country in africa. Each of those individuals were people who were trained at the Fogarty International center. We look upon them as our true colleagues. I refer to them, and i mean it sincerely, as our brothers and sisters in the battle against infectious diseases. If this were a metaphor of a military thing, they would be our closest allies. They may be where a different uniform, but they are our allies. The impact of the folk training has been extraordinary. We really need to continue. Cinderblock senator blunt the agency for Health Care Research and equality would be consolidated into, i believe a proposed a new institute in your organization youd if you want to comment about that generally come and if that was not going to happen, all their are there alternative ways to do that without creating a new institute . Dr. Ankford the 8 the agency is focused on Health Safety and quality. How to prevent Health Problems such as hospital readmissions, infections from intravenous catheters for example. Withve close connections them and we regularly look at our portfolios to make sure we are being complementary and not duplicative. If it were the case that ahrq was moved into nih, we would there out how we could make best of that circumstance in order to keep that Important Research going forward. Your other question is, would there be other models to achieve this other than a new institute . Certainly, we could consider other models such as having the q distributedahr among the existing institutes that do Similar Research and incorporating the staff into the nih staff without them being a separate entity. That would be another option. I might point out something i should have mentioned earlier, and follows senator murrays view. Prioritization that eliminated programs and consolidated programs and these were programs we have to determine doing everything we hoped they would do. The priority could be placed on what you are doing. This is one of those times when Congress Really has chosen to make decisions that for a lot of members were really hard, and for some were almost impossible to make. The case youre making is an important case for us to be able to understand and talk about. Senator murray. Sen. Murray thank you. There is tremendous concern among the Research Community about President Trumps proposal to cap indirect costs. What can you tell us about the status of efforts to replace the longstanding practice for killing indirect cost a 10 flat fee . Was your staff participating in that discussion . Dr. Collins indirect cost is a somewhat unfortunate term. Another term is facilities and administration. Are about 28 of the grant awards in the extramural community but it varies from institution to institution. They cover things like the building, the utilities that supply light and water, the operations of the various Administrative Service like animal care, Human Services and so on. These are not things that can be as described to a single grant but are basically necessary for the institution to be able to conduct research. Certainly the proposal to reduce the amount that would go from nih to indirect costs from 28 to 10 has attracted a lot of attention in the community because universities who do this work see that as potentially quite dangerous for their ability to go forward. Were looking at every possible way we might be able to assist in this conversation by identifying areas in which various administrative organs that we ask meditative burdens we ask institutions to follow, that they see if they are necessary. Might in the process he able to identify a way to reduce somewhat the burden, but i dont think it would add up to and in enormous two an difference. What would happen if the cost for cap at 10 were kept at 10 . Dr. Collins calculating indirect cost is a little difficult. It was recently looked out, about 30 , similar to what we see in the intramural nudity. For the intramural program, there would be no other source of funds. Would be hard for anyone to imagine what we would do if that was required to drop to 10 , given we have the buildings and power and so on. Sen. Murray it would be pretty devastating. Dr. Collins i am having hard time imagining how we would manage. This proposal assumes that states or some other benefactor will step in to cover the indirect cost once nih abandons that responsibility to bash responsibility responsibility. There are not always a large funds that can cover the difference. What would happen to these institutions if they are forced 10 for indirect costs . It is difficult to speculate what would happen, but institutions like the Cancer Research center have been central to the advances we have made in Cancer Research. A scientist received the nobel prize for the work you did. More recently, there was an effort to do research on use of immunotherapy for patients with a certain kind of cancer. This has led to a breakthrough for those patients who have this disease. Melanoma,as common as that the skin cancer that has the highest mortality rate. Recently the fda approved a cancer immune checkpoint inhibitor for treatment of this disease, the first offense first advance in many years. At the scripps institute, for performingey are brick through research on trying to inhibit a particular gene that is involved in at least 50 of human cancer, but we dont yet have interventions that are successful for that. These are just some examples of the breakthrough treatments that are being developed at these institutions. Sen. Murray it would have a direct impact, cuts would make it hard for them to continue that . Mr. Lowy certainly. Sen. Cochran let me join you in congratulating the panel. Dr. Collins, how is the nih working to ensure minorities are represented in Alzheimers Research activities . Dr. Collins we are very interested in making sure the resources Congress Gives us are utilized in an optimal way. That is a Research Across all of the fields represented people at this table. He specifically asked about you specifically asked about alzheimers, im going to let dr. Hodes address that. Dr. Hodes thank you very much for the question. In fact, in our efforts in all summers research, prominent among them is attention to disparities. All americans have rights to the fruits of research, but also understanding alzheimers comes by understanding how it affects individuals of different racial and ethnic grounds. Even the genetic factors for across groups. Included these groups, we have active recruitment efforts, we also have collaboration with some existing resources. For example, some of the populations studied through other programs, they are being harmonized with other studies. We look across all of these, do comparisons with risk factors and causes and look for interventions. Sen. Cochran thank you. Sen. Durbin let me first acknowledge mr. Lowy. An to chicago. Oming thank you for your years of service as the acting director of in ci, i understand you will be stepping aside. Your work personally has helped to develop a vaccine against cervical cancer, a leading cause of cancer deaths among women. It has saved and will continue to save countless lives. Our nation and beyond are forever indebted for your dedication to research. I hope that reports that you will continue on at nih in other capacities are true. I want to thank you on behalf of this committee and the people who have benefited why your great work over the years. Thank you, dr. Lowy. Thank you. Dr. Collins, if i was to ask you about a certain medical device, could you trace the lineage of the research so you could tell me a yes or no is nih was involved . Dr. Collins i think we could in about 75 or so. In those questions you ask, yes, nih would play a role. Not necessarily a direct proximal role to the actual product, but ideas listening ideas about therapeutics and the like. They involve nih research and the like. Sen. Durbin we are all sitting here wearing clothing and suits in such, and somewhere is a label inside, where it is made. Go to the market and we buy identity,nd have an producer and contents. I think it is about time the nih have a label. ,pplied to Pharmaceuticals Medical devices, so you can connect the Device Connect the dots. Nih is part of the sourcing of what is happening. You have so many miraculous stories to tell. I dont know how many people would be able to identify what the letters nih c and four. I think it is time we do something about it. I would like to ask the chairman and others to think about joining me in a bipartisan effort to make sure credit is given where it is due to the americans come to appreciate that you are a part of basic research that makes their lives an awful lot better. I will work on something and work with you to make sure we do it in the right way. Dr. Collins i really appreciate you emphasizing the importance of this being more widely recognized. It is important if you ask people on the street what is nih, i think the last survey was less than 20 . Much higher recognition for nasa , yet obviously a lot of the taxpayer dollars going into what we are doing. I would give a tv, there isat on a serious. Subsequentful, three weeks, twohour segments, you follow and see what happens to patients and their families as they go through what are clearly circumstances that are quite desperate. That is how people come to us, all other options have been ruled out. That would be a good way for america to get a sense about what we do and why it matters so much. Sen. Durbin thank you. , we are in the middle of a heroin and opioid crisis. It is an incredible crisis generated by the production of 14 billion opioid tablets a year in the United States, another for every adult to have a onemonth prescription to opioids. That production number is approved by the federal government each year. The department of Drug Enforcement and administration. That gets into the general population by prescriptions written by doctors. I know youre looking closely at this and could not join us when we visited, but would you comment on the fact that at least at this moment, the United States government is complicit in the overproduction of opioids . Think the system would have to recognize our involvement in creating the opioid crisis. It was the result of a wellintentioned initiative to treat patients suffering from chronic pain. But without proper understanding of the tools we are using to treat those patients, we were predominantly relying on opioids. As a result, there was an over prescription. That led to abuse and transfer into herrion heroin and synthetic opioids. What we are doing is taking a multipronged approach to address it. The initialthat driver, we are aiming to create public and private partnerships. We are energizing the development of alternative analgesics that will not be addictive. Another one is incentivizing public and private partnerships to develop formulations for medications that we currently have for treating opioid disorders as well as actually developing alternative treatment. Finally, through public and private partnership to develop prevention interventions for overdose, and even more reversal medications like narcan. Senator moran. Dr. Collins, welcome to you and your fellow colleagues. In i join my colleagues expressing my appreciation for your work. You improve the life and wellbeing of millions of americans and people around the globe. It has always been my belief we can devote Additional Resources into finding cures, it is one of the suggestions i have made a long time, we can have a significant benefit to the cost of health care. We have a debate going on about how to pay for health care, and i hope we never forget the opportunity to look at why Health Care Costs so much in the first place. Who pays is a different question, that is a challenge for a lost of a lot of folks, but if we can reduce the cost, i hope we can continue support to support nih in its mission. Let me ask a process question, i guess to dr. Collins. One of the things brought to my attention is the way in ih spending occurs nih spending occurs in grant support. I raise this with secretary price when he was in front of our Committee Last week. It is my understanding that some Research Institutions make, and particularly universities, make the salaries of their researchers contingent upon receiving an nih rant. Instances in which some researchers receive up to 80 of their salaries as a result of a grant. The question i raise is, is there thought about trying to focus the nih grant dollars on the research as compared to the salaries of the researchers such that more money goes into i know you cannot have research ithout the scientists, but also know that universities and other institutions, in my view, should be supporting those individuals more, where grant dollars go to the research. Am i missing something . Dr. Collins i think you are accurately stated the facts of the situation. Since world war ii, the government through nih and other agencies for science, has sought to encourage institutions to do Scientific Research as basically contracted with those universities to provide the full cost of the research being done youd that has included being done. That has included the percentage of time of a faculty member going toward a Research Project as an allowable request when the Grant Application is submitted. Lacesimes, there are some were faculty are essentially doing almost all of their work it can climb up to be somewhere in the neighborhood of 50 or 60 or 80 . On the effort, it is much less than that because most researchers have other activities. We do not pay for other activities such as teaching or running committees. It looks as if roughly something between 5 and 10 of the nih budget currently goes to pay the salaries for those faculty members who are doing that research. Institutions would obviously be alarmed at the idea that that would no longer be allowable. I would point out there are caps on the level we will pay. An actual effort to reduce the total percentage, that has not previously been tried. I would also say, we are willing to pay the salaries of the postdoctoral fellows, the technicians working on projects, and some of those would be at 100 because that is all they are doing, the research. If you add up all of the salary coverage, it is probably about 35 to 45 of our grant. But in a way, that is our most critical resource, the people doing the work. We have hopes and dreams they will make the next discovery. Parking back to the arrangement after world war ii, it has seemed consistent. Sen. Moran i may explore with you additional thoughts i have on us outside the hearing. , i chaireddr. Gordon the subcommittee that funds the department of veterans affairs, a new assignment to me. What is the relationship one of the things i think in which greatestces its challenges is the care treatment for those served in the military and the consequential effects on their Mental Health. Too many veterans flip to the in my view, itn is in the Mental Health arena. What is it that takes place in research at the department of veteran affairs that is a different, how was the coordination between what happens at nih and the va. We have a longstanding relationship of coordination with the va. The investigators work with the va investigators. Specific programs we have focused on recently, suicide research. And ptsd suicide prevention, we played an integral part in helping the va develop research to identify those veterans who are highest risk of suicide, so we can help them get into treatment and reduce suicide rates among veterans. That has been implemented throughout the Veterans Administration and will hopefully save lives in the near future. We are also engaged in research programs, particularly around ptsd, but in general around the Mental Health of veterans. One resource the Veterans Administration has constructed is an area of active interest, we are engage with them and trying to help our investigators we fund to use that data to better the health of veterans and really all americans. Sen. Shaheen thank you mr. Chairman, and dr. Collins. Thank you to chairman blunt for arranging the visit. I learned a lot to see your learned a lot and it was impressive to see what you all do. You forvolkow, thank coming to New Hampshire and seen the challenge we face with the opioid academic epidemic. We heard a compelling a grouption about how with dealing with overdoses in the emergency room. Certainly as we look at what is happening in New Hampshire, we have got to do more and provide more resources, more help. I know you responded to senator durbin about some of the things you are working on, but is there something you think colts the most promise that we ought to be focused on, or is this trying to better coordinate everything we are doing . Dr. Volkow in order to solve the crisis, we need an integrated approach working with other agencies. Theone i was describing was development of medications. In the meantime, we need to actually act rapidly. One of the big challenges, or tickling and certainly in particularly and certainly in New Hampshire but not unique to New Hampshire, a program to help patients with disorders. One of our priorities is to take advantage of the fact that there are Health Care Systems throughout the United States. How do we integrate Health Care Systems into being actively involved in the screening, and assistance of patients with opioid disorder . We working with Emergency Departments on of patients with opioid treatment. Models are beginning to emerge in states like New Hampshire, we are trying to evaluate them so we can integrate them elsewhere. There are new models for treating opioid addiction, and it is fundamental. Respond,een how to one of the things that has been critical is medicaid, and we have many hospitals and Mental Health centers that have been able to hire people and are looking at expanding treatment because they are able to count on the medicaid dollars available through the Affordable Care act. As we look at what happens with health care here, that is one of the challenges i think we face. I am not sure, dr. Collins, who to direct this to, but one of the chronic diseases we are challenged with in this country is a diabetes. I have both a personal and policy trust in type one diabetes. I think many people in the country dont understand there is a difference between type one and type two. Type one has nothing to do with lifestyle or what you have eaten. It has nothing to do with where you live, sadly. Increasing at rates that will make it hard in the treatment toord make sure we can address this disease. Byhink the statistic is 2050, 1 in three americans will have diabetes. Type one or type two. Can you talk about what research is happening at nih to address diabetes . Dr. Collins a once happy to do this, because my Research Laboratory is focused on type 2 diabetes. We are learning a lot about type one and type two diabetes. We are using tools to identify the pathways that seem to be confirming susceptibility. Type two, the type running on later in life, although not so late now with juvenile diabetes, is pointless to therapeutics and we have Exciting Program called the accelerating medicines program, it has focus one of its components on type two in his broke has brought the sectors together with interesting ideas about new drug targets. Type one diabetes, were learning more about genetic susceptibility. We dont quite know what the environmental trigger, and we presume every resume msp one. Is theting advance development of an artificial pancreas it would make it possible for kids and adults to have a way of managing glucose and insulin without having frequent injections, which dont work as nicely as one would like. Just last year when i spoke to this panel, i predicted we might find in the next 10 years, and artificial pancreas reaching fda approval. It happened six months later. In november, 2016, the fda approved the first one. It is basically a feedback loop that samples glucose and delivers the appropriate dose of insulin. We believe this kind of artificial pancreas could be even better if it was made not from this kind of machinery, but from your own cells, using the opportunities we are learning with stem cells, and to take your skin cells and turn them into these. It is very exciting. Sen. Shaheen thank you very much for the work that is ongoing. I think we might have some more of our colleagues joining us, that if not, we might have a second round of questioning. , in march we had a meeting on funding and cancer. A doctor in st. Louis was talking about the importance of Precision Medicine. One of the things he thought might be possible to determine was whether 80 of the women that currently have chemotherapy after Breast Cancer surgery would have to have that, i think there is some active discussion that only about two out of 10 women benefit, and how to define that. Immunotherapyand advances, would you talk a little bit about individual cancers and individual people and how they fight those cancers . I know you are working to find ways to find define what treatment they need and how they can fight the cancer. I had the pleasure of visiting the doctor at the Cancer Center last year. Designatedny other Cancer Centers are at the forefront of this area of Precision Medicine. The overall goal, as you point out, is to deliver the right medication for the right patient at the right time, and not to over treat people, because we know over treatment can sometimes have serious side effects. Example, with nci supported research, it was reported that giving people with a certain kind of cancer less treatment, they did better than people with more treatment. An important part of precision the Precision Medicine initiative, which thanks to your committee and congress, has been strongly supported, we have been conducting research that is trying to understand that are how the molecular abnormalities with Breast Cancer and other cancers can have implications for what treatments different patients should be obtaining as we try progressively to refine those opportunities and those interventions. Senator blunt dr. Givens, i think there is some research that having a stroke more than doubles the risk of dementia. Did you talk about that, and also in that area, you might further define, as people get older the stroke might not even be a parent. But what is the cumulative impact of that . I guess my question is stroke as it relates to dementia. It is an important question you bring appeared there are many forms of pathways that promote dementia. You are very familiar with alzheimers, but there are also are there is also another category called vascular dementia that affects about one in five individuals. Can be insidious, as you theied, it may be cumulative effects of a vascular disease over time that leads to cognitive decline. Promoted by risk factors such as ith blood pressure, compromises brain health. This is an active area of investigation. It is an area where women appear to be particularly predisposed in terms of the cause of dementia, as well as africanamericans. It relates to an earlier tostion by sen. Cochran , as senator cochran. We are working in collaboration with colleagues at the national stroke,es of aging and they are doing a trial where we are looking at the effect of lowering let pressure in terms of preserving cognitive function. This is an active area of research. I would think thats another verification of generally, my view and i think the committees view that while prescribing funding in some areas is frankly helpful to get these funds increased and make the case, as in alzheimers, weve gone from i think 400 million 1. 3 billion in two years. You are better at knowing where the pathways are that we than we are, and there is an even chance that you will find something differently than where you are looking for, and there is lots of research that suggests that is the case. Senator moran. Sen. Moran thank you. We have a number of senators raise topics about dementia and alzheimers. State i current have told chairman blunt and we of theagreement, one opportunities this committee has is to highlight to americans ways in which they can change their lifestyle, dietary intake. What is the status of the research in regard to dementia and alzheimers today that we would want every american to know in regard to their activities, behavior and nutrition and diet . Dr. Hodes that is a very important question. All of us want to make sure were doing all we can to decrease the risk of dementia. Nih recently commissioned a study to ask what the level of evidences for the kind of interventions which might have the desired effect of reducing risk. It was released today, i think some of your staff may have been priests been a brief about it yesterday. Was a lotrds, there of encouraging but inconclusive evidence. I can identify three critical areas. One of them was control of hypertension. There is very Strong Association between hypertension in the risk of alzheimers and dementia. Mentioned, dr. Theons mentioned, institutes working together, and we have supplemented a study to look at the impact of dementia. Those of studies are ongoing. It is an area of great promise. Clinical trials may give us conclusive evidence. Controlling for so important. Is the other is physical activity and exercise, it reduces the risk for death and cardiovascular disease. It is suggested it may play a role in decreasing the risk for dementia. There are some studies going on at the university of kansas, they are looking directly at randomized Clinical Trial to see what forms of physical activity might make a difference in lowering the risk of dementia. The other area is that of cognitive training. One study supported by nih some years ago showed that cognitive training was able to induce sustained improvements in cognitive function in particular areas as individuals age. That kind of study needs to be extended further to see if it actually has an impact on dementia. Sen. Durbin what is the example of cognitive training . Sen. Moran what is the example of cognitive training . It was there was a study where individuals were trained and they had improved function over five and up to 10 years. Stresses ist report that there is not yet compelling evidence for any of the other activities, including , touterdriven games identify whether they provide similar outcomes. A good number of studies. Fundingo the increase for Alzheimers Research, we are able to look at what kind of cognitive interventions might play a longterm role in reducing cognitive decline. Thank you. Nih ought to receive more credit for its work. I certainly want that to occur. One of the ways americans result nih, these are the things you do, the chances of your health being maintained, there is a consequence to behavior. It is a way i think you can tie nih to every americans and their lives. They worry about themselves and their families. Let me type another topic let me talk about another topic i care a lot about, down syndrome. There may be a connection with alzheimers. What is the status of our research in down syndrome . I dont know who i should be looking at. What is the status of that research and what we know about the relationship with down syndrome and alzheimers . It probably begins with a genetic base. Down syndrome has annexed copy of a chromosome. It happens to be the chromosome in which the peptide like, and increase ineen an life inspected to in down syndrome, individuals that are relatively early age and high proportion are developing alzheimers like dementia in terms of certain in terms of symptoms. Ofs population is deserving attention and is high risk. Studying the population is likely to inform what we know about Alzheimers Research. Weve been working in collaboration with the child health institute. Have initiated studies with individuals with down syndrome to see what is happening in the brain to better understand, have a basis for ultimately a highly foldable population as well as learning more about the more general problems surrounding alzheimers type dimension. Sen. Moran thank you so much. Thank you for speaking in terms that are reasonably understandable to me. [laughter] senator alexander. Thank you for what you will do for our country. The president ed has asked dr. Collins to lead in a age. We look forward to your implementation of the 21st century cures act, which we all worked on and voted for, and in effect asked nih, what could be put in there to make it easier for you to succeed. Blunt,to salute senator senator cochran, senator durbin and senator moran for their bipartisan support in increasing Biomedical Research. There is very little that is happened in technological change in our country since world war ii that is not had Government Research as part of it. We are leading the world in Biomedical Research and we want to accelerate that. Correct thatam i it is a goal of the Trump Administration to keep more american jobs in the United States . My collins that is understanding. We have about 70 national laboratories. No other country has anything like them. We spent a lot of money on them. The office of science supports 5 billion in the laboratories. In the energy department, 28 billion goes through your agency to universities for research. Is it true that around these universities like stanford, university of oklahoma, kansas and tennessee, grow complexes of industries attracted by the research and who as a result, create jobs around these centers of research . Dr. Collins that is absolutely true. If you look at the geography of where those places have sprung up, it is very much attached often times to a university that is a generator of interesting ideas and visionary scientists. Is also truer that china is making extraordinary investment in new research, even though they have one fourth our Gross Domestic Product and they may succeed us soon. As a result, a number of chinese scholars at our graduate schools are being attracted back home . Dr. Collins that is also true. A recent paper published that in 2000, china spent only 12 of what the u. S. Does on Biomedical Research. I 2015, it was 75 . Not percentage of gdp, but actual, spendable dollars. They are on track to passes. Sen. Alexander to me, it was one of the more harebrained recommendations in the budget, that we lower the amount of forrect cost allowable Research Grants from an average of 28 to 10 . This came up when i was education secretary 25 years ago and produced a huge uproar. Universities said to us at the time, we spend a lot more than the average 28 on research , and the net effect of taking that 20 to 10 would be Less Research, and Less Research we just reminded ourselves, means more jobs moving overseas to cluster around the research wherever it is around the world. Did a quick look the university of tennessee could lose nearly 10 million if the new policy went into place. The university of missouri, 15 million. People think of harvard and stanford when is a think of indirect cost, people say they are rich enough to handle it. Tennessee and missouri might not be. The only way i can think of making that up is Less Research or higher tuition. Less research is not our goal, to me that means more jobs overseas. I understand you may be asked, because of the 27 billion that goes through your agency to the universities for the kind of research were trying to , toease, not decrease report to secretary price and the office of management and budget, which i have great suspicions, that this originated there. What the effect of this would be. Ruralask that you put in in your report the following, that if there are any changes, Congress Wants to be involved. I bet i could get a Bipartisan Group to make sure we are. Theou please ask universities, especially state universities, how much they would lose in funding. How much they contribute to their own administrative facility funding or the money you give them, and whether it would be there would be more or Less Research as a result of this policy. In your report, and if it is appropriate, let us know about that, as well. I hope we can knit this idea in p this idea in the blood, and i hope it is just in there to stir up conversation, but it is a thoroughly awful idea. Bad policy. It would not do what i know the president wants to do, create more american jobs, not fewer. More research, not less. This policy would be less. My time is up, but if you want a constructive way to get more money out of in, look at the National Academies may a take 60 seconds . The National Academies have done to report that says more than 40 of a researchers time is spent on administrative tasks. My guess is most of those came from the office of management budget, too. If you want to reduce some of those administrative tasks and free up more money for Research Grants, that would be a good area to work on. Maybe i can ask you to be prepared to talk to you to talk to us about that. I dont want to put you on the spot now, but i want to register my strong concern and ask that you be very specific in polling universities around the country about how much money would you lose, how much do you put into research yourself, and will there be more or Less Research as a result of this policy should thank you this policy. They do. Lankford appreciate all your hospitality. We are all looking forward to quite a bit of what we saw in research at initial levels and clinicals moving into the general population, getting to see that. Everyone would benefit from things like universal flu zika flexing, the eight sexy, which is getting aids vaccine, which is getting closer and closer. Ongoingciate the research. Let me tap into what senator alexander was mentioning about administrative cost beard costs. Grants and how they are done. I want to talk about coordination. When i talked to grant precipitants recipients, they tell me they are going after money wherever they can get it to be able to do their research. It is up to the entities to determine, we have this one, you should not take this one. The example of a give you is when we do law enforcement, they can tell you the lane that dea has, the fbi has. They know this is not ours, that is theirs. In the research area, it is tougher. The grant recipients are eager to get the money where they can get it. From our end, how can we coordinate that to make sure have good ordination, to make sure we are not doubling up on research in other areas, but prioritizing that . And how can we get more Research Done by reducing administrative costs . , that is justcost paperwork, that is not getting us to greater discovery. How can we simple fight the process and reduce the burden for the researcher and make sure they are coordinating this on the federal level . Greatllins those are two questions. In terms of reducing the administrative running, we are very interested in looking at ways that might be achieved. It was already mentioned, the 42 number that came out youd 22 might be the part we want the investigators to do, which is writing the grant proposal and make sure they have great science ideas they are putting forward and giving us progress reports. But that still leaves a lot. We have some levers we can pull to try and reduce some of those things, effort reporting for instance. Conflicts of interest. Some of those levers we do not hold. That would require other discussions to see if there are ways systematically. That . Do we do dr. Collins i think would be fun to give us a summary of what the current administrative responsibilities are and where those are decided. We have a pretty good list of those. Sen. Lankford thank you. Dr. Collins there was recently a report that goes through a good deal of that information. Lankford for sen. We need the help. Dr. Collins in terms of the very real concern about not having duplication in funding it ines, we want to nip the bud. In our to know what is portfolio or the department of energy. We are looking at those with increasing intensity to identify if there are unintended duplications. Sometimes it is good to have efforts going on in different ways. Certainly with nsf, we have a lot of areas where we specifically coordinate. The Brain Initiative is one where in ih, and assess and darpa have a big role. We are meeting regulate to make sure that is going the way it is supposed to. Other areas, we have a pretty good swim lane. Nsf does plans. Plants. We keep pretty good taps on those things. We ask every investigator when they send us a grant, they have to list of their other support. We have to look at that and make sure what they put their does not sound awfully familiar to what they are asking us to do. We will ask them very carefully if that is the case. Part, weor the most dont have a lot of unintended overlap, but i think the new tools we have developed is an opportunity to do a better job. I hope to follow up with you on that. Understand some are simultaneously applying for other areas. I think that is the weak spot. To say, we have this part of it, you have this part of it. We need all of the Research Done efficiently. Dr. Collins we are with you. I have been in another committee, i am sorry. Dr. Collins, how much money overall in the u. S. , not just the nih, but all the governmental agencies, is a spin on Biomedical Research and how much is spent on spent in the private sector . Whatever it is, it is not enough, i know that. Budget,ins the nih which you all have overseen, and thank you for your strong support in a bipartisan way over many decades, that has led us to be 4 billion for fiscal year 2017. I dont have the number in front va is probably in the neighborhood. The private sector actually outspends government outspends government. Sen. Shelby how much is complementary, you coordinate to some degree in the private sector and other government . There is a lot of overlap. Dr. Collins im glad you asked, it is appropriate my to avoid overlap it also in also encourage collaborative effort. Sen. Shelby how do we do that . Dr. Collins we have a model working pretty well, the accelerating Medicines Partnership eared partnership. It gets scientist and leaders from the Public Sector, mostly funded by nih, and the private sector, and we get around the table and say, what are the needs neither of us can do ourselves that would speed up getting treatment to patients . Those need to be in the precompetitive space or the industry people get nervous. Is a lot of that. We have a project on diabetes, we have a project on alzheimers, we have a project on arthritis and lupus. We started a new one on a parkinsons disease. It is all part of this effort. We put money into it from both places. These projects are turning out to be very successful. We are talking about hundreds of liens of dollars. Talking about hundreds of millions of dollars. Sen. Shelby how much coordination is there in investigating various challenges we have internationally with our International Friends or competitors, in the private and Public Sector . What you are looking for is a cure. Dr. Collins yes indeed. Science has always been a Pretty International enterprise. Scientist collaborate all over the world. When it comes to industry interaction, europe has a similar effort, and we work closely with them. We make sure the what we are doing is complement rate with what they are doing. Until recently, i served as the chair of the heads of International Research organizations that brings together all of the funders in the publicsector of the world, dollars, to those make sure we are not stepping on each others toes and work better with each other. Sen. Shelby that is good to hear. Dr. Collins, we discussed research we have with you privately and many times, involving Cystic Fibrosis and some autoimmune diseases like lupus many times. I know nih has been involved in research and you have made a lot of progress. Could you bring us uptodate on Cystic Fibrosis, on where we are . We have made progress. I know we are looking for a cure. Dr. Collins i am bold enough to say we are on the path to getting there. , the cause was discovered in my laboratory in 1989, but now we are here. We are seeing the development of very effective, targeted drugs. Only treated about 5 of patients with Cystic Fibrosis who had a particular misspelling in the gene. Now it is up to 50 . Example ofonderful Academic Research leading to advances in the private sector. A company, the ceo is bold enough to say when i saw him a couple of weeks to go ago, we are on path to cheering curing 100 of Cystic Fibrosis patients. Sen. Shelby you have extended the lives of a lot of children. That is a milestone in itself. Dr. Collins the Cystic Fibrosis foundation have been incredible supporters of this effort. Those folks have been awesome. Are shelby how many people affected by Cystic Fibrosis . Dr. Collins about 30,000 in the u. S. Ofldwide, primarily people Northern European backgrounds, about hundred thousand. Lupus . Elby what about it is difficult, i know. Dr. Collins this program i mentioned has a focus on lupus ony are doing advanced lupus. Theyre doing advanced research on the kidneys. They are looking at the onion cells in the kidneys at the immune cells and the kidneys. One cell at a time. This is brandnew. Single cell biology applied to lupus in the kidney. They are discovering there are types of cells and the kidney we did not know were playing a role because they were rare. If you look at one cell at a time, you can find them. Or that will take us in terms of new therapeutics, i cannot tell you right now, that this is another example of industry working with academia getting everybody pretty excited about what this could lead to. Sen. Shelby is the money spent overall for all autoimmune, sony things are related to our autoimmune system, is it overlapping that you discover things in basic research . Going to ask the immunologist to jump in. Were the leading institute, but other institutes are doing the same thing. The concept of immune tolerance. Anoimmune disease is inappropriate reaction of your bodys immune system against tissues of your body, depending on what the tissue is. With lupus, it is rheumatoid arthritis. What we are trying to do is essentially go back in the development of an individual and thatnd get the cells normally would have been either deleted or suppressed from the time you were developing as a fetus, because when you develop from the first part of a fetus, you have cells that have capability of attracting attacking all of your tissue. What you do a normal development is those either get suppressed, deleted or taller rise t olerized. We have an amused Tolerance Network that is working to determine how you can shut off the inappropriate response without suppressing your appropriate response. Right now, the crude approach to autoimmunity is to suppress the entire immune system, which unfortunately leads to infections and other adverse events. We would like to be precise. Isnt kidney failure one of the big things dealing with lupus . There are other things, but that is the big one. Multisystem it is a disease. I hope your wife is doing well, you have dealt with this. Sen. Shelby she is doing well, thanks to medical research. Dr. Collins that is wonderful. It can affect different parts of the above the body, including in the brain. Out what isigure the best way to intervene and maybe prevented altogether. Sen. Shelby what role does the unit plan this . Dr. Collins absolutely everything. [laughter] clearly, there are genetic susceptibilities to , they are not of the present time sufficient for us to understand exactly what some people get it and some dont. Some people are susceptible, but there must be some other trigger on top of that. We know that lupus is particularly common in African American women, and we dont entirely understand that. It may be genetic, but some of it may be environment appeared environmental. See inof the things we all diseases of autoimmunity, they have some sort of strong or modest relationship to some genetic previous genetic predisposition. Sen. Shelby is a link. Dr. Fauci it is certainly a link. Sen. Blunt senator shelby took his two rounds all at once. [laughter] those were good questions. Oran. Or m sen. Moran i did not even notice. Perhaps my final question is this, i dont we have the director here for this topic particular, but let me hear from you. I have heard from parents, advocates, Childrens Hospital directors that the difficulties in improving pediatric care treatments, and new drugs, there often developed for adults. Pr pediatric trials are often difficult. Considering the difficulties facing this population, what work is nih doing in research on pediatric issues and what is standing between nih and Pediatric Research that might restrict your capacity to have greater results . The director of the National Institute of child health and development is not at the table, but it would be great to have a chance to meet her. She is a terrific leader in this space. Everyone at this table has some investment and Pediatric Research, because children become adults. But we understand they need special kinds of attention. The focus on pediatrics has been a long tradition of what nih has done. I might ask to of the folks at the table to Say Something about and dr. Ybe dr. Lowy gordon. Dr. Lowy i would like to highlight three new programs which in ci is initiating to support pediatric Cancer Research. As you may know, in the last 15 year period, it has been a 20 decrease in mortality rates from children with cancer, but there are two serious problems. First, some children who get cancer are not helped, and second, the longterm side effects for children who were successfully treated can be devastating. One program we are initiating as part of the use of the cancer moonshot, which is to develop new treatment for children with cancer. As dr. Collins mentioned, Childhood Cancer is not just adult cancer in the small sense, but qualitatively different. It requires a separate kind of research effort, etc. That is number one. Number two, with our regular appropriation that congress has been generous in giving to nci, we are also doing what we are calling the provocative questions initiative, and that is to deal with faxing problems in pediatric Cancer Research. Three, developing the pediatric match trial that will be opening in the next few weeks , building on the success of the adult match trial. It is a paradigm shifting trial that first brings the treatment to the patient rather than the patient the treatment. And based on molecular abnormalities of the patient. Dr. Collins i shouldve put in my response, something about the echo program, which we are very excited about. It stands for environmental influences on child health outcomes. Effort an nih offered to collect information on 50,000 children in terms of genetic risk factors and environmental factors. Beend these have not subjected to such careful scrutiny. There is a lot we dont understand about the role of the environment, even in the prenatal arena. ,s well as an Early Childhood how to fix things like asthma, neurological development, obesity. And whether the child is healthy or not. We want to not just study illness, but health. Echo is about one year on, and involves a large number of components, including an idea spaced pediatric network, basically able to do clinical research. It is new on the scene to try and answer this kind of question. If you want to Say Something about autism . Autism is a trans governmental initiative. The coordinating committee involves colleagues from across the government, the dod, department of education, nih, nsf. Our goal is to understand and formulate strategic plans for research around autism. Threed say there are exciting ongoing things were trying to do. First, we are trying to understand what makes a difference in terms of intervention during childhood, and how that translates into longterm outcome. The second, we are trying to get a better handle on screening, particularly younger and younger so we can identify people at so we canfor autism intervene earlier, and also so we can learn more about what happens in the early ages. The third is recent development in genetics and environment of influence that suggests things are going on in the womb, that is where things are starting. We are learning we have to understand early numeral development to understand the risks for autism and do something about them. Sen. Moran thank you for answering in a timely fashion. One of the lightbulb so went off as you were describing new initiatives such as echo, one of the things that it suggest to me is increasing funding for nih earch, there is always science brings new knowledge, which causes us to look into a new area, and a new initiative arises, which suggests the resources are growing, the need for resources continue to grow. Very few things can we say we no longer need to look at this. Research allows us to say, here is a new way, a new place, a new opportunity for us to find information through research and science that otherwise would not have existed. For is why i have advocated increased funding for nih. It never occurred to me that your success in finding information breeds the need for more funding to get more information. Sen. Blunt there are 19 places, including Washington University that are looking at the adolescent brain, cognitive development. I wonder if you would give us an update on what we are seeing in those 19 locations. Be happyns i would to, but that is an initiative that dr. Volkow spearheaded. We contribute opportunities and the database, but dr. Volkow would be better. Dr. Volkow the happy to, but that is an initiative that dr. Volkow spearheaded. Ideas of the adolescent Brain Cognitive Development is a concept that we have the technology that allows noninvasively to actually image the human brain, in structure and function. Technologyoninvasive widely available. We now have the capabilities to actually monitor how the human brain develops from childhood to adolescence to adulthood. The idea is if you can get the standard, like we currently doing pediatrics where you have a norm that tells you if a child is growing faster or slower, we should be able to get what are the normal distribution of human brain development. When a parent comes to a physician with a child who has problems, you can determine the extent to which the brain is changing. This will allow us to understand, for example, the effects of early exposure to drugs in brain development. Very relevant as it states are legalizing marijuana. The concept of it being not harmful. We will be able to understand how Mental Illness emergence emerges. Understandow us to how physical trauma like sports may negatively influence the development of the brain, how alcohol, tobacco influence the diversity and how our brain works. The study will follow 10,000 children from ages 9, 10 until adulthood. We will evaluate not just their brain periodically but also their cognitive performance, performance at school, and their social networks. It will be an open access study, so any investigator will be able to analyze and extract data and information from that study. Sen. Blunt thank you. Senator kennedy. Sen. Kennedy. thank you. I have two brothers in the medical field. Ive heard them talk with admiration for nih. I was especially pleased to be able to attend the meetings we thatt nih a few weeks ago senator blunt organized. Very impressed. Here is my question. Lets suppose, as you often do, that nih or one of the institutes develops a new pharmaceutical drug or vaccine. And obviously, it is developed your creativity and intelligence and experience, but the money comes from the american taxpayer. You develop it, it is successful, it works. At some point, that vaccine or pharmaceutical drug is turned tor to the private sector develop further and market. Much int happens, how terms of royalty or shared compensation does nih, and more to the point, the american taxpayer, get . The connection between nih research and development of successful drugs, vaccines and devices is strong. You can point to nih funded discoveries in the majority of such instances upon which the Research Track was traveled. In some instances, the nih funding was for very basic science, that it made a lightbulb go on that let a company the figure out how to turn it into a treatment. In other instances, they carry the discoveries further down the line to something that is even patentable and allow the company to develop a product. If that is done by one of our an institution we support, 2500 of them in the country, that institution that holds the intellectual property and if there are worldviews that come forward, they return it to the institution. Kennedy i am talking when it is not one of our grantees. Nih itself. Who negotiates the deal, do you have a law firm, do you send out counsel . What is the standard royalty . How do you know you are getting a good deal . Im not suggesting youre not. To me the details. Dr. Collins we have an office of Technology Transfer to make sure people that make discoveries claim them appropriately. Then they patent gets filed if it seems like it might be were something. Once it is filed, the office of tech transfer works with the scientists to figure out who would be interested in licensing that. Then the industry that steps forward and says we are interested, then that negotiation begins. I think our negotiators are pretty good. Are the inhouse . Househave our own legal in house. We also employ contractors and consultants to help us. You have a special area of Legal Counsel we need. Oft has worked in the return 90 million to the nih of those discoveries for which royalties are flowing back. Sorry to interrupt it. Im down to one minutes six seconds and i want to keep within my time. A little extra time. Everybody else has. Youre much more disciplined than your colleagues, i think. Thank you. The any of you ever had development of a pharmaceutical vaccineprocedure or a that you looked at and he said, may be having completed all the faces that you need and need to do to convince on your but based intelligence, which is considerable, and your experience, i know this is it. Have you ever had one of those . Oh yes, all the time. Have we ever thought in those , a certainty, have you ever given thought, instead of farming it out to someone, lets do it ourselves . Yes. The trick there is when you are in the manufacturing process is something that we want to take on. We dont make pills in general except in very small amounts to good you start that out . I suppose that is a theoretical possibility. There are times when we might do that if it is a rare or neglected disease were there is not industry interest. We try very hard not to step into the territory where the private sector is most capable. We dont want to mess with their success and those circumstances when they are willing to take something out. If they are not coming tony can you say anything . It is a question and something that has crossed our minds multiple times. Scientific out, the and Technical Capability of atting vaccines, to get vaccine production capabilities outside of the already established pharmaceutical industry, is almost impossible to do. It is just not out there. Our experience has been that it makes sense in the scenario that you develop if we develop the very early stages of the vaccine , which are actually in the process of doing it right now with zika and we did it with ebola. You do the concept development, you do it in an animal, you do it in a phase one trial, and you get into it. You are never sure that it is going to work in to redo the trial area there are some that you have a feeling are going to work. Developstage yet to relationship with a pharmaceutical company. Our experience in the past is that one we try to get into the pharmaceutical type approach, the expertise of ongoing, doing that all the time, at the end of the day, it was much more economical to license it to them, get the kinds of royalties the doctor is spoken about, and run with it. We have considered your model, but it just does not work. I want to thank you. I dont doubt for a moment that anyone of you could go into the private sector and quadruple your income. Money is not everything. And i think you live that, you dont just talk it. I just want to thank you. I was so impressed with the two are and talking to your researchers, physicians, and the patients who are willing to talk to us. And i want to thank all of you. Thank you, senator. Senator shelby . Shelby this live here, canaging basic science you put that back up their . It shows the inside and outside of the cell. We show that in the opening statement. The diagram on the left, what is that . That is a photograph at a very high magnification. It is a protein. That is the protein that is responsible for it. As a in the lining cells channel that moves chlorides insults around. Until a few months ago, we did not know what it looks like heard now we do. Sen shelby this is when youre talking about targeting things rather than do the shotgun approach. Exactly. It gives you the opportunity to focused in your drug design. Overlap intodo you Cystic Fibrosis and dealing with the lungs . Would you like to comment on this . Dr. Collins is a pioneer in this area. It is also critical that they have been other elements of the research. For example, he alluded to the fact that certain misspellings changed how that protein traffics in the cell. A lot of that involves basic Cell Biology Research of those cells and where they got stuck in wide. That was very instrumental in aderstanding how to make target that would then change the trajectory of the trafficking. There is always this back and how it affects the cell, the cell function, and the organ function and the effect on the patient. Other a seller elements of the disease, like how much microbial agents invade and affect the long. There are elements that are important as a barrier function. Preventedy have you prevent it . Understanding that in addition to influencing have a channel works, there are other strategies that can be taken to help the patient. Sen. Shelby as you target the ares, what are you you trying to suppress the mucus in some way or get rid of it . You try every tactic you can. One of the drugs that has turned out to be the most useful is makesly something that the mucus more able to get just not sos thick and sticky. There are infections of happened. All of us primarily are looking to the time when you have a drug that is not just reading the symptoms are consequences, but treating the fundamental problem. This, theked about investigator that i highlighted briefly from the university of alabama at birmingham, he was doing the amazing work to look at the structure of the protein at the atomic level. I think he went to medical school at lsu. Maybe, i dont know. Sen. Shelby what kind of timeline do see i know it is hard to say, three years, two years. Breakthroughsany in Cystic Fibrosis, now you have made a big one you think. If you can target that, that will change the game, would it not . Absolutely. Sen. Shelby change the lives of so many promising a lot young people. A forerunner for other rare diseases. Sickle cell disease is a high priority one for us. We are excited about the emerging new technologies that exist for we can modify that misspelling and turn it back into the correct spelling with this Gene Editing Technology that is emerging. That is something that was more of a glimmer before, but now we rapidoking forward to advances related to correcting at a fundamental level these genetic disorders. Sen. Shelby thank you mr. Chairman. Thank you senator shelby. Continued interest in everything youre doing. Do have a final comment . Thank you mr. Chairman to you and the members of this committee. It is a remarkable moment in history. To allow take a moment me to introduce to you the future senator from michigan, my granddaughter, she is sitting back there. Please stand up. [applause] that is wonderful. I dream of a day when she doesnt have to worry about the health of her self, or maybe even her grandfather if you still interested in playing his guitar and riding his motorcycle 20 years from now. Thank you for your support. Thank you for being here. We hope youre still playing your guitar and writing a motorcycle 20 years from now. Thanks for the directors for joining you today. The records they open for one week for additional questions. The subcommittee will stand in recess until june 27 at 1030 10 30 a. M. [chatter] this weekend on cspan3, today on the civil war, the disbanding of the Confederate Army is discussed by professor caroline jenny. Remember, his terms, he had surrendered his army. They had said nothing about declaring the confederacy defunct. There had been no peace treaty. And Jefferson Davis was on the run appeared at 8 00 p. M. On lectures on history, professor on the east Texas Oil Boom of the mid20th century, and the expansion of u. S. Oil businesses to saudi arabia and canada. Ideologist said a geologist said that american oil reserves were going to really collapse by 1970, forcing the country into a difficult situation. So this kind of apocalypse that apocalyptic fear would drive exploration abroad. And sunday on reel america, the Palestinian People have rights. Violence breeds hatred, retaliation brings for the retail he should retaliation. An eye for an eye with high Interest Rates nowadays. And the speech writer for president reagan and a former ambassador to germany recall his 1980s venture to berlin and the Brandenburg Gate speech. It was a great applause line. I knew it was authentic ronald reagan. But you know, history as president obama says, have to have heart. We would never celebrate that famous speech is in fact the events of 1989 had not transpired the way that they did. For our complete American History tv schedule, go to cspan. Org. Senate republicans released a discussion draft of their health care a lot replacement on thursday. The Congressional Budget Office will score the bill by early next week, and a Senate Floor Debate is expected to begin. We posted the bill at cspan. Org. Follow coverage next week on cspan2, online, and on the free cspan radio app. Cspan, where history unfolds daily. In