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Days take on a life of their own. I want to say good morning. Good morning, dr. Collins, welcome back to hhs to the appropriations subcommittee. Let me just say a thank you on behalf of the on behalf of the sub come they for hosting members of the subcommittee for the site visit at the nih campus last week. We had a real wonderful opportunity to learn more about nihs work. We met with the researchers who were working to cure Sickle Cell Disease and develop treatments for major depression and shrink cancer tumors in children. We heard from participants whose lives have been changed by Clinical Trials and it was a moving and informative, but a very moving experience, as well. Let me welcome our witnesses including the five institute and senate directors who join us today and in addition, and always a great addition, dr. Francis collins and joined us many times director of the National Institutes of health today joined by dr. Bruce tromberg director of biomedical engineer, the director of the National Center for complimentary and Integrative Health, and dr. Eliseo perez on Minority Health and disparities and dr. Patricia flatly brennan, and the National Library of medicine and dr. Christopher austin, director of the National Center for advancing Translational Sciences. Your work, all of the 27 institutes and centers leads to treatments and cures for diseases and conditions that affect people around the globe. Its transformative and some of the greatest good that we can do in government and each year the subcommittee holds a Budget Hearing to hear from the nih director as well as directors of five or six of the institutes of the center, but todays hearing is an opportunity for the subcommittee members to hear more and to hear from directors of the additional five institutes and centers which was very, very important to all of us. When i joined the subcommittee about 25 years ago, we used to invite every director to testify. Its been a long time since we have heard from many of them and in fact, i dont know if theyve spoken about this, i wanted to include the National Institute of nursing. I wanted to include the foghery interNational Center and the national eye institute, as well this morning. Unfortunately, the administration denied our request on the grounds that we did not provide twoweek notice. Im disappointed, but nevertheless, we will find another opportunity to hear from other directors. I think we ought to be inviting every director at least every two or three years to be able to listen to what you are doing and how we can assist in that process. Its critical for the Sub Committee to get a picture, a full picture of the nihs portfolio as well as the research landscape. Youve heard me say before w each scientific discovery, each medical breakthrough, the nih advances Human Knowledge and above all, it saves lives and i am so proud it increases the nih funding 30 and the subcommittee did this on a bipartisan basis. In fact, for 2020, the house passed appropriations including increased funding consistent with significant annual increases over the last four years. The house bill increases funding for each of the institutes by at least 5 . Our funding bill is a statement of our values and a reflection of our commitment to investing basic Biomedical Research thea the nih. It is not overstating the case to say that the nih has prolonged or improved the life of every american, because of nih research we have childhood decreased cancer mortality, 50 in 25 years. We have a vaccine to prevent Cervical Cancer and a drug that prevents hiv transmission with the 9 effectiveness. In fact, a recent study in the proceedings of the National Academy of Sciences Found that nihfunded research contributed directly or indirectly to every single one of the 210 drug approved by the fda between 2010 and 2016. That is your impact and it is amazing. So to our guest, we say a thank you for everything that you do. We look forward to our conversation today, and now let me turn this over to my colleague from oklahoma, the ranking of the subcommittee, mr. Cole. A couple of housekeeping things if i may. Its wonder have our friend here, and weve not had her back for a while and she has the most excused excused absence of all time. At some point i have to get up and go to a Republican Leadership meeting. Ill be coming back. It has nothing to do with your testimony, ive been called away and i want to congratulate our chair to schedule a perfectly timed hearing because we need something up here to bring this together and you guys actually do that. So its wonderful to see you and as always, the chair of the full committee. Today weve got our second Budget Hearing on the National Institute of health and again, i want to thank the chair for having this hearing and inviting some of the institutes and centers that we do not get to hear from as often as we should and i look forward to learning more about the research being done and learning about the promising cures of the future and i would be remiss if i did not recognize dr. Francis collins. I would like to congratulate dr. Collins on reaching an amazing accomplishment of leading the nih as director and hes heard me say it before and if he can get appointed by both barack obama and President Trump. Thats Pretty Amazing span of appreciation for the manner in which hes led the nih and a great deal of National Confidence in his ability and the Wonderful Team that hes assembled there and has been there for many, many years. Dr. Collins, as an advocate for Ground Breaking research in nih and supported by nih funding and again, ive said it here, but the four years of sustained funding increase which was as the chair said very bipartisan owes a great deal to, frankly, our confidence and dr. Collins as the leader of this institute, as well and hes made the case as to why this is an Important Committee and the bipartisan fashion has highlighted that. I want to highlight some of the work being done at local universities in my district through the support of the nih. Somehow they always seem to miss that when they announce some new cure. It never said funded by the nih or awarded, so we need to work on that and maybe require it when they get grants and working with colleagues at Oklahoma State and the university of Oklahoma Health Science Centers and researchers at the Oklahoma Medical Research foundation are using a novel threedimensional model to use the human tissue for the and its the interstitial virus that affects the lungs. This virus is the leading cause of pneumonia worldwide. It can take a particularly heavy toll on children infecting half of their first year of life and nearly 100 by age 2. The virus is highly contagious and for those with weakened immune systems from conditions like asthma, it can be dangerous and even deadly. These researchers hope to reveal what predisposes infants to severe infection and to create a launching pad for therapies down the line. This petrie dish model could be valuable for studying other infects like flu, allergies and asthma. Another focus for the american medical Research Foundation is lupus. Lupus affects up to 1. 5 million americans and it exacts a particularly toll on africanamerican, hispanics and lupus is a chronic autoimmune disease that causes inflammation throughout your body, an auto immune disease in which your bodys own immune system is involved with the breakdown of its own cells and the information can affect various organs and tissues in the body including ones joints, skin, blood and internal organs. The disease can be severe and potentially lifethreatening. It can cause organ damage and currently theres no known cure for lupus and it is the cause of death in africanamerican women between the ages of 15 and 45 and to understand more about it, scientists are conducting largescale genetic analysis of thousands of lupus patients and thousands of healthy volunteers. No focus on 25 genes that had been previously linked to the disease and the goal is to identify the genetic culprits that disproportionately burden africanamericans with lupus. The study builds on the groundbreaking work of the oklahoma medical foundation is done with the lupus space including the discovery of one of its own researchers dr. Judith james and antimalaria medications can delay the symptoms of lupus. These medications are now part of the standard treatment of care for many lupus patients. There are countless stories like these of Ground Breaking research taking part across the United States as a direct result of nih funding. Nih fosters such ingenuity and one lone researcher can open an entire field of medicine in Biomedical Research. Future generations will benefit from the unfold promises from the research being done today. Despite the controversy that can surround this bill, support for nih bz are has been broad, bipartisan a bipartisan and been supported by nonleadership and the like and i will not take up the time to address all today, because quite frankly i would rather hear from them about their Exciting Research and i do want to thank each of you and your colleagues for your passion, dedication and hard work. I believe the work that the nih has and will change the course of disease, detection and treatment for generations to come. I Hope Congress continues to be a supportive partner in these efforts. Thank you, madam chair for holding this hearing and i yield back my time. Thank you very much, congressman cole. I would just say im not going to go into what they do, but i am so proud that the yale school of medicine has one of the clinical and translational science awards. We are a hub and it is amazing work that gets done there, as well and we thank you for that and with that, let me yield to the chairman of the appropriations committee, my colleague, congresswoman gnida lowey, and i thank the chair and this committee which is very, very important, and i think sorry youre leaving, but i thank my good friend mr. Cole for holding this hearing. Theres no question whether its chairman cole or not chairman cole. There is bipartisan support for the outstanding work you are doing and i thank my good friend the chairwoman for holding this hearing and i welcome our esteemed panelists, dr. Trumberg, dr. Perez, and dr. Langvin, and dr. Austin, dr. Brennan and of course, dr. Collins. Ive been reading you with a big smile for many, many years, and i really appreciate all that you and your team are doing. Earlier in the year, however, the Trump Administration submitted a budget that would cut the nih by almost 5 million. It is Crystal Clear that President Trump doesnt really understand the nature of this committee and how bipartisan it is and no regard for the National Institutes of health and the cutting edge work you do to save lives to improve the health of americans, despite the president s heartless and misinformed efforts to gut the nih, we have responded resoundingly. Unlike the president , my colleagues and i prioritize the health of all americans. We are on track to invest billions more than the president would for our worldclass National Institutes of health. Our house passed fiscal year 1520 and the Services Education and related agencies bill would provide 2 billion more for the nih including a critical, across the board increase for all the nih institutes and centers. This would allow the nih to better respond to scientific breakthroughs that result from astonishing foundational Research Done at the institutes such as those with us today. We have the distinct pleasure to hear from Institute Directors who are leading innovation in their respective fields and theres so much innovation going on, dr. Collins, i dont know if you just threw the numbers of the institutes in a hat to try and pick which ones are here today, but i really look forward to hearing your remarks. Not only will we hear from the encouraging advances achieved to date, but also the exciting innovations that are just over the horizon. We are talking about lifesaving achievements that with our continued commitment and investment could soon be on our doorstep thanks to the nihs extraordinary work. So rest assured, the administrations attempt to slash your budget will not stand. We remain committed to ensuring that you have the tools and the resources you need to deliver for the american people. So i really do want to thank you, and i look forward to our discussion. Thank you all for everything you do just to improve lives. Thank you. Thank you. We now will proceed to Opening Statements from the nih panel. We have six witnesses today. So what we have done is to ask you to please offer three minutes of opening remarks and im sorry to curtail the five minutes and we want to get them all in for an opportunity to get in the questions and dr. Collins, welcome, you know the drill. The full testimony will be entered into the hearing record. You are now recognized for three minutes. Dr. Collins . Thank you. Good morning chairwoman delauro and distinguished committee members, yes, im francis collins, on behalf of nih, i want to thank the committee for your work on the fy20 labor hhs funding bill that passed the house in june. We are grateful for your ongoing and bipartisan support and we are very pleased to host a visit by some of you last week. Today, i am joined by the leaders of five of the nihs 27 institutes and centers. Let me start by introducing dr. Christopher austin who is director of the National Center for advancing Translational Sciences and cats like you, im always impatient for Research Discoveries to be translated into new ways of combatting disease. To date, weve identified the molecular causes for more than 6500 diseases, yet treatments exist for only about 500. So addressing that gap requires translational research, one of my first initiatives upon becoming nih director was to ask congress to create ncats to speed this process and you did and here is the director. Next up is patricia flatly brennan who is next to me to my left and director of medicine, mlm. Like everything at nih, mlms activities are focused on innovation that advances Biomedical Research and one way it does this is a database that provides access to more than 5 million articles from biomedical journals and another is through Clinical Trials. Gov. The online catalog of private and public Clinical Trials which by the way, is a great resource to share with any constituents looking to take part in medical research ask thats where you can find the trials. Now meet the director of the National Center for complimentary and Integrative Health nccih which for this very week celebrated their 20th anniversary. In fact, it was you, this subcommittee that established this in 1999, citing the need for more Scientific Evidence on Complimentary Health practices. That need remains great today. Next, let me introduce dr. Is eliseo stable director of Minority Health and Health Disparities and nihhd, including at the april hearings, many of you asked for Maternal Mortality and also a part of today a distinguished lineup, bruce tromberg, director of the shall nah institute of Biomedical Engineering and mibib. His institute engages, engineering in other new types of investigators to push the innovation envelope to create smart, faster and less expensive medical technologies. I thank you for this opportunity and i hope what you hear today helps explain why i am so excited to lead all of nihs institutes and centers and working together to encourage this next generation of researchers. I can assure you, we will speed the path from discovery to health and my colleagues and i will be happy to entertain your questions. . Thank you very, very much, dr. Collins and for being so su succinct. Its unusual for me. Please, let me recognize dr. Tromberg, thank you again, your full testimony will be entered into the hearing record. You are recognized for three minutes. Thank you. Madam chairwoman and members of the subcommittee, it is an honor to participate in the subcommittee and others across the country who are developing technologies to improve human health. Ive only been director of the bib for nine months and i have new opportunity ijs and photonic technologies as a professor of Biomedical Engineering and surgery at university of california. It is to transform through engineering the understanding of disease and its prevention, detection, diagnosis and treatment. We support cuttingedge research that can be applied to a broad range of Biomedical Health care problems by building strong partnerships with industry, academia and every nih institute and center. Our programs lead to better, faster and less costly ways to advance technologies from blackboard to bench top to bedside. Mibib supports grants each year in four major technical areas, com pew tagz in Artificial Intelligence, engineered biology, sensing and imaging and advanceder this putecs. One of our most innovative and sensitive platforms has been to address the widespread problem of food allergies. We all know eating out can be an anxious and lifethreatening challenge for millions of americans. Recognizing this widespread Public Health problem, researchers have developed a quantitative point of Care Technology and its small enough to fit on a key chain and can test for common allergens such as gluten, milk or nuts at your table in less than ten minutes. Small personal Sensor Technologies are helping drive the development of new personalized imaging platforms to help address the Breast Cancer detection painlessly and without xrays or contrast agents. Researchers are using invisible, laser light pulses. First director seven years ago this week, it was unclear whether our Ambitious Mission to close the transitional gap could actually be achieved. Our accomplishments since then make me more optimistic than i have ever, been that we can indeed both understand french relational science and use that knowledge to increase the promise of science to patients it played. I thank the committee and will be happy to answer questions. Thank you very much. I have a question that goes to the panel. Much of the success of Biomedical Research is attributed to nihs strong support of basic Research Ideas and proposals. Individual scientists at the nih and across the country, and many of the ideas led to major discoveries came from the bottom up, and out from the top down. At the same time, as a director of the institute in experts in your field you have a unique Vantage Point to target resources to specific areas of research the navy promising or compelling or may have been neglected and shortchanged. A questioners, had to strike the balance in allocating resorts between investigator and Initiative Research and targeted initiatives . So whoever would like to start, we dont have to go in order but whoever would like to start to answer the question. I will ask each of you that question. How do strike that balance . Thanks for your question, its actually a very easy one for us in some sense, we are constantly communicating, interacting with our community, we have many methods of convening the Community Together with conferences and workshops and were quite responsive to state of the art and needs from the committee, working together with our colleagues we are able to create targeted opportunities that will respond to those needs. Theres a push and a pull, its very dynamic, ongoing and fluid and and number of mechanism for accelerating targeted mechanisms as well as encouraging the individual investigator allegations. Go ahead. At the nlm, we release notices of areas entrances, we have vast databases and we know that some of the databases may have sparse, incomplete data sets, or maybe biased. Weve released a notice saying we want to understand mathematical approaches to making sure the databases are better. We let the community decide how to respond. Quickly, you both talked about community. Identify the community. Thank you very much. Its the data science and informatics committee, and beyond, the Clinical Care community. Doctor bruce tromberg, quickly. The bylaw materiality, which are developing radiology. When i arrived at nimhd, most of the portfolio was targets why shifted some of those funds to create a new poll of investor initiated applications. We are about 50 50 now, and we need to see how it goes over the next several years. We have senior programs, endowment programs, we have targeted programs. Now, our community, which are the Minority Health Health Disparities scientists, some affiliate organizations are responding to ideas that we have put out but also on their own ideas. I want to answer it this way. I think the way we think about this, that distribution depends on the kind of signs that you are trying to do, and in basic science, investigator initiated model works very well because the person is a unit of productivity, i mention the translation as a team sport, doesnt matter how smart or devoted you are, you can do it yourself, you need a community of 20 different disciplines to do that. The way we tend to think about it and structure them as we have programs use happened in this ecosystem. To have an investigator tool which we do not have. I think thats very necessary for the transitional science community, academically to flourish. At nccih, we study treatment and practices that are occurring in the patient community. This is a grassroots phenomenon, that is going on. Its a natural thing for us to want to extend our research into what we call the real world, how are these treatments actually being implemented, how is it impossible to bring something like, for example, acupuncture and to a hospital and have it be integrated with the rest of the care that is going on . We have a translation arc that goes all the way to implementation and those grants are largescale projects we perform and collaboration with investigators. We have investigator and initiatives to understand. Like, how acupuncture works, so we do a secret it all the way down to animal models, so we rely on the. This is a very important question and something we think about a lot at nih, any point you to the Strategic Plan, which we put together, becaise it has to be done every five years. Had rebalance investigator and violence, and as before, it its different for every institute and it should be. Congressman cole . Im going to direct questions to doctor collins, because i want to get these on the record. As the chair pointed out weve had four years up bipartisan sustained growth here, i know that plan is in the bill that you prepared. I want you to tell us, what difference has this made, and what are the advantages if the congress uses to continue on that course . I appreciate the question and it has been such and a shot in the arm, and talk about the Research Community across many different disciplines and institutions to have this have managed to sustain, for four years going on five and that has changed the whole morale of the community in very substantial weight. As to tell, you when i would visit a university in 2014, it with something difficult to meet with the trainees because they were anxious about whether there was a future for them and whether they got into the wrong field. I dont hear that anymore, i hear a lot of excitement and energy. Over the last four, years to things that happen a lot of, them in the area of technology. They are making in oklahoma in a petri dish something that they can study. That is happening in lots of different laboratories with the ability to do this kind of Regenerative Medicine research. The single cell biology revolution, which five years ago, we didnt really know how to study biology and a single cell, now we do and that has just completely transformed our understanding of biology, but also give us insights into treatments. In terms of a therapeutic approach, the revolution in gene editing has been accelerated by crisper, and i dont know how many of you got to see the 60 minutes piece about six months ago, an individual at our clinical secroe who is cured of Sickle Cell Disease because the opportunity to take jean there appear to another level that we did not think will be able to do this soon. All that takes a lot of money and resources, it means taking risks we dont know where you will go and youve given us that kind of confident we can make deals investments. The one thing i would say is most important is actually investing in the next generation of researchers, i was really worried about that five or six years ago, again, it was very hard for a new faculty member to be sure that they would be able to get nih support, and that their requirement if youre going to run a research lab in an institution around this country. We funded about 600 of those first time investigators in 2013. Weve set a very high mark and towns all the institute to hit it. Refunded funded and 87. As of this morning we also set our goal, we have exactly 1287 again, and we are not done with the year yet, so we will break through that. It will be a new record. We could not do that if it were not for the proved circumstances. You all those things apply to enroll all of us in the largest ever prospective study that it will be critical. The big data as i see as the most significant, to do more in that. It may be more possible for fiscal year 20. So i cant thank you enough. You highlighted the importance of us continuing on the path that we have embarked on. Im a quick question with the time i have left i think you will want to answer and thats thats not kagame of highlighting the challenges you maintain the campus. Theres no the hundred buildings you to insufficient funding for buildings and facilities and other infrastructure for many facilities, and the campus overall has been deferred for many years. So i want to thank you for bringing this to our attention and doing such a thorough review. This is something that we ought to chairman interject and our discussion of on the senate followthrough lead and get the build on, because we need to focus on this. Ive lucky you to comment on the infrastructure. It is a very critical issue, as youve documented, were about 1. 3 billion dollars behind what we need to be enough to support the infrastructure of the nih campus, and thats mostly the clinical center. They recommended an investment of 700 Million Dollars over a fiveyear period, just to catch up with all the deferred maintenance, which has led to all kinds of problems that we have recently experienced in terms of the major leagues and so on. Weve also had another 6 Million Dollars for really new investments into badly needed facilities. The most critical one is a new surgery bring, what is an a pretty dilapidated state. Weve had situations where leaks happen in the ceiling, and the operating room, in the middle of a procedure. Obviously, we cant keep that going. I appreciate very much your invitation to talk a bit more deeply about that to see if we can bring this back up to being the place it financially possibly could be. Congresswoman nita lowey . Thank you again for being here. Some of us have been working on these issues for a long time. If it were up to us, we would keep raising that numbers. Thank you. And particular, kidney and pancreatic cancer. I understand your institute supports Research Related to point of care technologies which may be used for more efficient diagnosis of some cancers. If you can explain some of those technologies, what advances and detection are on the horizon, i would be most appreciative. One of my visits to this hospital, talking about just this issue, and hes a former member of congress you to tell as we should get a scan every year so we know what is happening everywhere. Is that the reason . As if the cost that we are not doing this, or can you repeat respond to me but they more Technical Response . Thank you. There are so many things that are happening that are super exciting so i would like to condense this. And general, does a revolution going on and micro and now devices, such as some of the set i brought with me, a device that can analyze bodily fluids for cancer components, suffered of liquid biopsies . For able to detect the dna from cancers, protein, tumor associated antibodies, we know they exist but we need the technology to be able to manage them quickly with very sensitive hardware and computational approaches. This is whats going, on liquid biopsies. We are also developing liquiding technologies at the point of care. So, what does that mean . Can we have a personalize ultrasound for example at the point of care, like this one. Or do we have optical sensors that can measure tumor metabolism until they respond. Theres also sensors that can be implanted inside of you and follow whether or not you may have cancer and, like this patch. One thing that once they go inside of your, painlessly, and can be delivered to your home, you cant see the needles and they deliver what their pay load is, and then the needles disappeared, you can get another one in the mail and you can do it again and again, and it can create down with a very smart chemistry to be able to sense things and then develop the chemistry. Theres an explosive technologies, big emerging technologies as well are improving dramatically, and there will be a time when were able to go into scanners and have full body imaging and be able to see early stage disease. This is coming. This is happening. Through your investment and support. How widespread are these technologies being used now . How widespread are these technologies . We will, dramatically respond to this that we support all around the country. We have five point of Care Technology Research Centers that our network and coordinated, so this is where that discovery and the validation is occuring. Theyre also deeply engaged in the dissemination and movement of the technologies ultimately for commercialization. We work very closely with the fda to ensure that once easing the validated, they actually get out and impact the most number of people. Weve been talking before about the transitional science spectrum, including returning observations from basic, clinical, and into tangible interventions. I wonder pressure go back to dr. Collins because we used, or wherever else wants to answer quickly, or you can answer because i can remember very clearly years ago, no names. Having these discussions with a former person who had your position who was totally focused on basic research. So, do we have another couple of seconds, someone else wants to add something . I think, probably the ncats director would have an appropriate response to this . I appreciate the question. From our Vantage Point, basic research is absolutely critical. Thats the seed corn that we translate. To get treatment and course to people, and the focus we have is on how slow that processes. It takes about 15 years to go for fundamental discovery to a treatment that is approved to get people who can benefit in the success rate is less than 1 . And that is why this takes so long and costs so much. Whats interesting about the process is that we dont understand it, we dont understand the fundamental science of that process. And thats what ncats its doing, we are from believers that like every other science, whether its engineering or data science, once we understand the fundamental principles we will turn this from a trial and error failure prone process, and that will bring the promise of all of this basic research to people. Thank you. I want to say one more word because having been on this committee along time, i think the hardest thing to do with regard to that issue is how you identify and prioritize. When you get past the basic research where do you go . Ill save this. Thank you, madam chair and full committee chair. Its a pleasure to be here. We can all sit here and talk to you about a long time, i was sadness, i was flying back from the district, otherwise would have been here, but i noticed that there are different folks here, theres a couple of people with that i want to try and hit. How you identify and turn it into where to spend the money and how you get down syndrom. Weve had some conversations about down syndromes research and making sure the funds follow the intent, the other piece on that, i was asked to cosponsored, which i will be, Childhood Cancer bill would respond to research, and what the bill does is, it would enjoy that federal funds match the same percentage of the number of americans citizens under the age of 18 as part of the general population. One of the things we have seen i, heard from disease groups is that that the piece that goes into childrens diseases, or research on Childhood Cancer for example, tends to lag behind, obviously, the adult population. Even if its a higher incidence in a younger population. Im wondering how, and this might be a translational the piece, how we make sure our job has not been to be, this is going to do the research, were not scientists. You are. Weve given that responsibility to you, however, when we have constituents xfactor wasnt say, well, we dont see that the money that were helping is trickling down proportionally. Help us either answer that question on michael changes. And although that you doctor told to get to ever. Its a great question ill ask out of to draw a least one other person and on this. Certainly we are completely in accord to the importance for focusing on Childhood Cancer Research Given how incredibly painful and tragic this could be and we still have these Childhood Cancers and im not been able to point out that happily for many of them we found out extremely well and we currently spend 514 billion dollars a year on Childhood Cancer research and not just counts the part that you can say its research that is directly relevant and many of the advances that have happened interruptions cancer us come from unexpected directions and from very basic science and just understanding what cells divide when they determine what cancer is. Theyre trying to add up all the things that are relevant would be in a larger number and i understand the area of concern that feel like theyre still needs more to be done and in this committee for additional 50 billion dollars earmarked for fi20 and we certainly will find lots of ways to take advantage of that. It would be the case i think though that the advances right now that are happening in the terms of genomics and matt trial will be possible for children that are otherwise not treatable for solid tumors to get them into a creative political trauma which is making it possible for a lot of these new ideas about their piece to be tried out and a very efficient way that offers to those who need it. Ncats is working on the dipg which is horrifying and tragic trump circumstance. I wanna hear about this briefly but. I want to ask doctor austin quickly. Use dipg, an absolutely horrific Childhood Cancer and a short Life Expectancy we teamed up for a number of academic investigators to develop a ploy of a new way of identifying combination or treatments that will be able to treat these children and as we know, very rarely does one drug treat these children and its been a trial and error and those children dont live long enough. So, we 5 pm cats which allows us to take ourselves from the children and put it across tens of thousands of different combinations and then deploy those very rapidly in the clinic. I have a constituent to taken part of that and see the progress. Really briefly, when youre talking about with all these different devices you totally lit up and its almost like the Silicon Valley space of why not, lets do it lets make it worth and i appreciate that very much. Because i feel like we are way slower than that. Speaking of slow, with all of these promising technologies and question about how we get these out and how you get these working. What is the biggest slowdown that we can help with. And then within two seconds. This is a great question. As a Technology Developer and a community that i represent, you think about is a lot. We sit down with the fta plenty of times and some of these are quite famous and we know about the fallacies of death and we are trying to understand how it develops and the reference methods to the 25 or 30,000 new applications to come in. Everyone that comes in has a validation method so that gives them 20,000 different validation members. Were looking to identify and validate the validation that its. This could increase through put and are also looking to develop and fund the prototypes because you can have a device that may look cool and its a pretty good prototype so we wanted to look like this so well have to get to the prototypes faster and we have to have this validation with our applicable to our devices. Thank you. We also have to make sure that we dont have commerce in terms of those devices and that really has happened over and over again and we take a very hard look. Its great to get something to market quickly and to make reference to ecigarettes and so forth and here we go and in terms of difficulty and deaths. Were not talking about people who potentially can die. We have to be careful of cutting these corners. Thank you very much. Thank you doctor and i think your team has always good to see you and that you are continuing this with his life saving work. A couple of questions id like to ask. I have three and im trying to do get in. First of all, let me just mention this request that we had made in terms of the black men in the medical profession, we asserted into the report and 2019 to coordinate with and i h to have a workshop on this topic and American American men are in medical schools and are very underrepresented. Theres looking to get a status on that as we havent received a report back. My second question has to do with the doctor. Ive witnessed the benefit of integrated health as a relaced but also as it relates to preventing an alternative surgery. My late mother and this committee had copd in her latter life and when i was a child, my mother went to the chiropractor and this was in the late fifties and sixties and it worked. Secondly, when she was in her mid eighties she needed Knee Replacement surgery in her left knee. She and her right knee, she got the surgery and it was fine. But when she turns 89 and needed her left knee and the doctors said she had copd and high blood high blood pleasure he did not recommend it. One day she was out and a lot of pain and getting her walker repaired and whats complaining about her knee and gave her some lotion. She tried it and she never was in pain anymore. I would call her to say, how is your knee and she said, its drunk. This was cannabis lotion. So i have witnessed at least my mother and other senior citizens, the Health Benefits of cannabis. I dont know if nih to conduct research on cannabis but they let me know based on personal experience that it works for some people. Finally, let me just ask you about the hiv aids strategy in the funding and will hopefully see our goals with the hiv in aids by 2030. Out to thank you all for your continuous way of supporting the increase for the domestic age and the domestic metaphor and hopefully will end it soon, thank you. Id like to start with the first question. The situation of reversing the scientific workforce with the political profession is a dire one. I agree with you, we have an urgent crisis to diversify our professions. Black man in particular are notable here and its across under represented in the minority groups. We have empirical evidence that more additions of these groups whether its people that look like them or people who dont speak english and this has been consistently shown in three different studies over the last 30 years. Whether its a scientific workforce which also benefits, we dont know but weve had valentine and others who are working on it. The National Academy has a report that came out and had a joint workshop and put into the bill that wanted you all in nih to work with the political economy and work well back in 180 days of what were going to do in terms of increasing the representation best based on 2017 workshops. Id like to make sure that we get that report as soon as possible because this is a dire situation. I agree, its a very serious concern and as you can imagine its a big part of their agenda as well which is a medical professional we will look at that. Thank you for the question about, cannabis. Certainly it is available now and people are using cbd in the forms of oil and the public is using this. Its now playing catch up with whats happening and we need to understand the potential beneficialeffects of some of these compounds from cannabis and particularly for pain. Theres a lot of potential there and it is just funded seven applications of looking at the basic mechanism and minor components that could be useful pain. What i understand is how it works but also its looking at potential interactions with cannabis and drugs and people take these cbd with medication and it could lead to some problems. We need to understand this aswell. But since so many states have passed medical marijuana laws now, we need to catch up with any age and i wanna find out if they can legally do that or how can we help you catch up with, where the states are. The issues and regulation are a broader matter. Theres a problem in that because marijuana is scheduled one, to set up a Shirt Program that weve been talking about the need for some kind of alternative pathway which would have research on potential valuable uses a marijuana without going through such a rigmarole which is even doing the work. We have congress from coming up with a better strategy on that part. Id like to get work with you on that for an ex bill. Thank you very much, thank you for being here. Congressman harris. Thank you very much. Let me please know that we have a bill filed it does exactly that and bouncing around for a couple years and hopefully well research and to the potential benefits of medical marijuana easier and will further expand with a lot of false hopes. Youre absolutely right that there is interaction just last week and the literature was used for medical marijuana and they have less been after surgery and found out that they have more pain after joint surgery and clearly this is not a drug that acts only on its own and clearly is in other parts of the body which is the systems in which we dont fully understand. All ask a question on a very different topic and its a timely question because next month, the homes versus eoc a couple of blocks down the street which involve Sexual Orientation earn and gender identity. Its a latticed myth and two female runners in connecticut have filed for a complaint with the eoc about gender identity issues in sports and my daughter is in all American Division one athlete and ive talked to her about this issue and she cant understand how you can possibly have men competing against women in a women sport. Lets talk about medical research now because a lot of times before this Committee Said its very important and youre studying men and women and wish we studying men and studying women. Its a very simple question. If you have a transgender woman. Wed like who would like to participate in the study are they going to be assigned to the men or the women . I guess the first question is to you because sex is genetically determined and 99. 7 and thats what i looked about and school. Maybe im wrong but gender can be different but in fact when youre doing this research is it the sex or gender that supports where the difference is and how can we do that . In fact, if you say we just a sign that person is that discrimination against them and we dont know what the outcome of this case is, where does this stand with the nih . Its a very important issue and we noted with interest and concern a few years ago its the institute of medicine in support of health of the lgbt that its clearly an indication that this is a circumstance associated with Bad Health Outcomes and particularly with those with depression and suicide. We took that very seriously and set that up at the sexual gender Minority Office to ensure that theyre paying attention with what the Research Needs might be and help them understand as an understanding. Can you define but a sexual line already is. I understand a gender minority looking to fight a sexual minority. So much are we here all about science is. What is a sexual minority . I think at the present time, without trying to be too precise about it, most people would say those who are not in a traditional heterosexual role would be considered a sexual minority. They would be lgbt and others in that category. As a scientist, you believe that sex is not by an airy and is not based on genetics . I believe that sex is assigned at birth and is very heavily and 99 or so influenced by genetics and lets not forget though that there are individuals that are born with ambiguous genitalia where sex is not obvious. Its 99 plus percent, didnt say how to present by said 99. This is serious because our colleagues in the branch are going to have to rule i think on what some people feel is a scientific question and the definition of sex and we also ruled in definition of gender but the law which is what is under review uses the word sexs. It is a scientist i want to ask you. What is the definition of sex . As i said sex is 99 with whether its expects or a chromosome constitution is. But lets billy clear, biologically is one thing but the personal identity could be a difference space and is a very complicated issue and im not saying anything in particular of novel or eliminating this conversation but one is to be inspected for those individuals at five themselves in the circumstance that are not comfortable with their genetics. How will nih will be nih put a transgender woman into a male or a female . I think that study was looking at transgender women. Doctor collins, if its looking at the studies on female collegiate runners. As a transgender woman going to be assigned to the female or the male branch and if theyre assigned to the female branch, isnt there a risk that makes the study less valuable to female runners . I dont have an easy answer to your question. I think they would ask for sex assigned at birth. Thank you very much. Let me just say thank you for an informative and very hopeful tour last week. I just want to say that i also share my concerns about infrastructure and how we talked about and i look with you at that. And as you mentioned, the research has not always been inclusive to certain population groups like racial minorities and are in treatment and health care that did not go with the same effectiveness of everyone. All of us are Research Initiative which has the potential to radically change what we know about Minority Health and how we approach the elimination of the health experience. What was the nih role of all of us Research Initiative and how are we currently working to recruit the diverse and i inclusive population in this Research Program . Thank you congresswoman for that question. I arrived at nih when we were all being conceived. The medicine initiatives got here four years ago. I have been supportive and enthusiastic supporter of the study that in fact have been one of the directors that worked with eric on his Kitchen Cabinet of ic directors. So we are very interested about it. The fact that it will be tremendously Rich Research resources for future investigators. It already is the largest study of latino participants in american participants even though its not yet fully developed for 200,000 fully enrolled. So we are very supportive of it. I would add that the inclusion of diverse participation in the study is improved a lot at about 30 now. One of the problem areas in the studies is systematically addressing that. It seems to me that there are multiple opportunities for nimhd with other institutes to help find a better focus on health equity. To ensure appropriate minority in the Clinical Trials. What you need before the oil has nimhd had in the ten years census acclimated to this institute . Can you give us some examples of Research Studies that are being led by the nimhd way . Thank you again. Our involvement with other institutes is full. Ive met with all of them we, have common areas with every single focus in the center and on the campus. For last four years weve been working on redefining the categories of Minority Health disparities and how they apply off going through a detailed way with nih scientists as well and have a Strategic Plan where all of nih that we have led through Health Disparities is almost completed and its just to go through the final clearance price so i have presented the institute of directors and have worked with them. We participate in several important and i age why the programs and in this in the house study and the National Health and long institute. Its about drug abuse and the abc the and he for study that will agree to support that and part of the center for aids research. Its funded through the National Institute on allergy and infectious diseases. We have put out a call for our own Research Community and we ask others to say if theyre interested. We have a terrific participation for a timely post Hurricane Maria research and puerto rico that had to be from puerto rico and six different institutes that agreed to set aside money if they got applications that are in that area and with Mental Health and drug abuse and institute on aging that they funded what the nine or ten that we find ourselves. For one final questions. There have been some challenges with the nimhd Research Program and i wont elaborate on what those are but has that been reinvigorated in the program contributed to this institute . So, briefly the, program its money that the nih provides to an institution to be thought in the 25 presentable of average endowment for the institutions. They have to bank for at least 20 years after the end of the grant. So the amount varies and right now that 2 million per year and they can get it for ten years or you can do the math for 20 Million Dollars. They used the interest to develop programs that promote their Research Capacity in Minority Health disparities. Most of the institutions are working on and other infrastructure that relate to research and not administrative work. We have gone through an Advisory Council with review and there are no restrictions with applications with the budgetary was full but in fiscal 2020 we will have another funding opportunity announcement and there will be no issues with eligibilaty. It is been linked to having a center of excellence either from nimhd we. Believe thats a limitation that will limit the number much more than anything else that we have. Thank you. Mister John Moolenar gantz. Doctor collins, welcome back and great to see everybody here today and thanks for participating. Theres a couple of questions i want to ask you about. I know in may, there was a symposium that nih participated with the usda and collaboration with Research Opportunities that may lead to transitional benefits and other fields looking at Animal Research and how specifically on farm animals of curious to where you see that going and what benefits might come out of that. Thats one area want to talk about and the other area i want to ask you to address is the anti resistance and what our strategy is for commanding superbugs if you will. Those are both Great Questions and ill start seeing that they should signal me. Basically youre quite right and its a great opportunity for looking at Health Issues by comparing what happens between animals and people. So we are all rather similar when you start looking closely and various metabolic classes and we at many nih have tried at many decades to build on that in instances where we want to understand and the model that appears and he farm animal and use something from that from the actual mechanism thats by squabble to three. In some instance right now there is great concern about the eastern several lightest which is a particularly bad outbreak and in young people in middle age people and thats a disease more that we can understand that is a vaccine and horses and you can go figure its an interesting story. I totally agree and the usc has been a wonderful partner and have been great interest in aloft a lot of their doctors and Service Activities that require that this applies not just to the farm animals but to abdominals related to the very first affective gene therapy for the eye disease. They can general apparatus. It was a top model that was spontaneous for a dog and some of you might admit that are ten years ago because it took quite a tour through the capital having their b work and it worked in the kids. We get it as far as our interactions. With the resistance that continues to be a deepening troubling problem because way in which so many incidents are happening with the organisms that are all known to antibiotics and the outbreaks in hospitals and ive done a lot to try to be sure that we track those down quickly in hospitals by providing the diagnostics necessary to understand the transition. Basically there are two problems here. One is the use of antibiotics that are caused these resistant organisms and the other is market failure thats the development of new antibiotics that is not been appealing in the private sector. This is been in part supported by this congress and providing the sources. To try to make sure that were doing everything we can to develop at next generation i take it further down the pathway towards an actual drug that we normally would have to try to derisk these projects so that the industry partner will the side its worth taking it up and even they know its not going to have a lot of profits there. I think its making progress but we are still well behind where youd want to be to say this is the problem weve solved. If i may, you may be surprised that theyre playing a role in some of this integration of anti microbial approaches. One of our researchers is a biologist to use these methods to understand how these terms actually change over time to determine if theres a point that may have happened earlier in the cycle, thank you. I want to add one thing about the animals. We have a collaboration on 12 of the veterinary schools and with the same number of sales that are working on diseases between humans and animals to see if we can learn and studying those together. A matter of fact, next weeks or thursday at the sea essay meeting that were having a speaker from the usda to talk to the entire groups and how we can technical problem can i also add that the point of platform technologies, have traditionally moved from humans into animal care as well and its a great opportunity for further growth from the diagnostics and the infections are doing that rapidly by owners and wherever they need to do this as well as intervention vaccine that i was just showing. Thank you. Its not likely to my colleague, the issue of animals we need to take a hard look at recent rule that was approved and by the usda the in dealing with a stunning lessening the inspection force in our flin flon swine slaughter and also lives with line of speed and here is its taken off the cap so right now the inspector has about four seconds to look at any animal that is going by and if you put a cap on the speed its going to be very little ability to deal with that and the second part of that is that with the fta and the regulation of the use of antibiotics and livestock its a serious issue and i was thoughtful about this and to take a look at it because in fact we are allowing and dont allow it for growth in motion anymore had antibiotics me we need to have a better in erie provide a prescription but we have a gaping loophole that says that it is we can use we can use antibiotics for prevention and that has opened up unbelievably because of the way we are dealing today with the hurt of 5000 swine that used to be 150 120 and are prone to illness, disease and take care of that and we are also use using antibiotics prevention and that means that you can buy a pork chops, let it move and you get ill and you are and then not able to treat you or treat you flip this resistance. Because its the same thing. Longer that i wanted to go you, will need to check with whats going on with the department of agriculture and with the fda on what is a very serious have a better in erie provide a prescription but we have a gaping loophole that says that it is we can use antibiotics for prevention and that has opened up unbelievably because of the way we are dealing today with the herd of 5000 swine that used to be 150 120 and are prone to illness, disease and take care of that and we are also using antibiotics for prevention and that means that you can buy a pork chops, let it move and you get ill and you are and then not able to treat you or treat you flip this resistance. Because its the same thing. Longer that i wanted to go you, will need to check with whats going on with the department of agriculture and with the fda on what is a very serious issue. Sorry guys and we we did something about it and we said we couldnt use limitation and put a limitation on doing this at the senate so well see where we go thank. Eulogy thank you madam chair thank you for being here. Sorry mr. Testimony, we had two meetings backtoback but i was very happy to hear that running for the first time investigating researchers are up considerably and im very happy for the people back home. Back in march, dr. Collins i asked a question about the study or an update on the National Sciences that had a report from 2011 in 2016 every drug approved by the fta and the nih and i age support then let you ask my question again that would really love to have an update on that. Is there an update on that study . Thats a very important study and published in the proceedings of the Natural Sciences and the author was fred allegedly and at all the 210 drugs are approved by fta between 2010 in 2016. That concluded at 100 of them at a influence from the research to conduct a point of having the fta approved. It was not funded by us and financial Biomedical Research which is a private foundation and i suspect that they might be interested in renewing the effort and see that its almost better if it was not funded by us and i suspect that the answer would be very much the same. In the way in which our ecosystem are and i age funded Research Gets handed off to the industry for them and turns into the in the product thats the envy of the world and it probably hasnt changed but i will reach out to that foundation really. Id appreciate the nudging especially now we talk about back home hour talking about congress and very valid rules. Another question in july, the administration a changes to the use nih of Human Fetal Tissue Research that changes the Advisory Board and said something about no fewer than one third shall be scientists and biomedical or Behavioural Research. I have researchers in madison who conduct this research and would like some clarity on the guidelines of the selection process. Specifically, whether be an effort to appoint scientists to the board and substantial experience or accomplishments and research involving fetal tissue . Youre quite right that the new guidelines require the establishment of this ethics in vice reboard and this constitution is basically laid out from 1993. So this is not a new formula and it does say between one third and not quite one half of the membership should be within that particularly specified disciplinary expertise. The appointments are to be made by the secretary of services and the secretary is the moment our ideas are being put forward by what would be inappropriate roster for that and for nih were really interested in seeing where this goes and the additional applications for the fetal tissue research. I can go through this level of review as going to take some time where will meet over the next several months and will have be improving such applications moving forward and the constitute in such a way that we can review these and thats what we expect will happen. Any idea on the timeline . I couldnt get out at the moment. He finally asked, the question on autism specifically. I know autism relates to people who are transitioning from youth to adults ages. Theres a report i know that came out from the Autism Committee that said 2 or actually less than 2 of the combined Autism Research funds are going to that specific population who are changes in into adulthood. Is there are opportunities for additional investment and research regarding adults with autism and any additional investment in understanding the issues regarding the lifespan of people with autism . Certainly very appropriate question. I think most people when they hear the word autism they are not necessarily thinking about the individuals who are entering adulthood. Many of whom actually would tell you that they dont really appreciate be considered in the same boat as a child with autism which as a lot of interventions and are highly functioning individuals. We are certainly looking at that with the nih National Institute of Mental Health portfolio and autism and through the history and asi e about the priorities about what comes up and josh gordon who is the head of that is considering that with dr. Brendan . Initially mr. Mark pocan idolatries really say we are working into areas with this. Once we have the researcher at the university of cincinnati in a Childrens Hospital who is creating the proper medical record for children aging out of supervised and will i scare. I know it doesnt specifically address the issue of autism but were learning for that is how a young adult and emerging adult moves into such management with health information. The second is that were working with using Innovative Technology to create into adulthood in some of the tools that may be necessary that are less stigmatizing in the illness part of autism. In having social cues and the balance to help your person who tried to function in their adult life. And the cues that they need to be able to work with. Thank you very much. Congresswoman thank you for being lois frankel here. Thank you for being here and i enjoyed my visit today. I want to follow up first with a doctor trump or he. Sometimes you hear something for the first time and on the imagery is there anything new on the mammograms that are going to lead to women not having those regular mammograms all the time . Yes, thank you for your question and that is a very active research in our community and in terms of mammography theyre improving that itself and develop new complications that will help us read mammograms better and there are other technologies withs digital breast to synthesis that has the view of a better appreciation in there and there is alternatives which is using lasers and that can create sound waves so that you dont have with those and so forth and theres enormous activity and using Artificial Intelligence we can actually do mris faster and more and extensively so you can reap the benefits of the mri and possibly do it with smaller and more compact devices. This is a very active area of engagement in this technology built and definitely one of our target points. Where are you in terms of something being out there to the public . So you dont have the compression monograms. . All of these technologies that i mentioned are in various streams of both clinical studies and entirely studies that are amazing advances we were going to have to build some hes technologies, we can model them and do syndicated Clinical Trials and they recently published a peace were due to that exact thing where digital mammograms and did you will see into this and say which one is going to work better. Well have these Clinical Trials and the mri studies are ongoing in terms of all around the country. And photo acoustic and ultrafast laser. That technology is being developed and commercialized. A lot of really interesting alternatives and they can potentially provide information at all stages of care. Those mris are going to those claustrophobic tubes . Suggest there are a number of really great advances in both Magnet Technology where you can manage more portable reconstruction and also if you notice there is that big tube but we also have a coil the picks up the signals after radio frequency is launched and you have coils that pick up the signals from inside and those coils are being made for individuals now and those hand coils things that are in the movements. And those body girls will have mris even more compatible with each of these applications. I dont know if he said you have to go to the tube or not . I think if youre going to have mri organ off some kind of tube. When one of the big advances though in the mri is stupid it a little bit is a small cap that you can wear on your head and that you could still move arounds so as those technologies developed they can be translated to other applications or fashion or imaging and launched about many many times. These technologies are developed and can move into other areas. What about protecting Ovarian Cancer gone with violent and thats overtime on liquid biopsies really exciting really exciting advances of being able to detect things neurosurgery using apology sticky if you think that technology is a take medical research and microscopes and you take you most powerful microscope and he turned it into a small hand held inter scope. You have the same or even more specific information and you could stick it inside the body and you can help glide Cancer Research and we know that surgery is still the best part of cancer. We can get lots of sells out very quickly. But what if you could identify every one of those cells by looking at the same michael structure of a cell that a biologist uses where you take the tissue out and you throw away and examine is examine it for weeks. What if you get that information inter operatively that so that is the one advance. Adam schiff, i have one more question which is, have you had any directives from the Trump Administration to discontinue or change research on Reproductive Health . Youre all looking at each other like no. I dont want to give anyone any ideas. Of course there is as weve talked about a minute ago a limitation on doing research. If you want to include that it that will be the answer to your question. Thank you. I yield back. Congresswoman Bonnie Watson coleman. Being i apologize for not being able to hear your testimony i was in another hearing. From what i heard and the answers to the questions. I want to ask a question about the disparity in health for the mortality with tax and whats happening in researching the particular issue. And you and what resources are applied. Its a critical question and firsts majority in the least establishing the collaboration wars and the senators about this topic and the child health is very much there any Health Across and we have to think of our continuum and its the worst outcome of maternal for amenity and as a woman goes through the process of conceiving of the delivery and when you look at the disparity and the American Indian women is proportionately higher burton and maternal morbidity and have to look at the continuum of at conception and doing care and visiting hospital to take care of the delivery and very importantly for the most part what happens is that each of these places or will be intervening some of the African American of diabetes american women responsible in risk in developing fibrosis we may lead into clots with the lungs. Thats what im getting at why a lot of how we reach losing all of that is a genetic is a behavior illness with and the access to the quality of care we. Are we doing research on the disparities on what we can do about it and we stated the problem when i agree with with research hes what are we doing Research Studies are in the space office, my short and fun. Its come very much to my attention and that examines this level of continuity muellers win related to the Mothers Health that here he was and they care that she was getting and the setting that he was going to in the amount of resources that have been identified for looking at these issues . I. Could i get that report on the dollars spent . Youre not sure whether its one im not sure whether its one of the things that were tracking or it would be automatically keeping track but i will tell you, this is an issue which is of particularly drawing the attention of nih focus on much greater attention considering that theyre all going in the wrong direction and is now a group of High Level Research leader with institute mid Institute Many others were not doing what we should be and identify the factors and the possible interventions with the research. Thank you. Its the first time investigators you did 1287 of them . Last year . Thats exactly right. Yes year as of this morning were also a 1287 and were looking to breakthrough that soon. Could you break down for us racial and ethnic breakdown because of the investigators what the opportunities for us and you may not have them now. Will tell you that they are as nice as you wish they were and were working intensively with the entire set of programs to increase their windfall. Through your chair if, thats possible i would not only like to know of the representation of the efforts being used. I have one last question and a number of them which is set to ask. I was told by doctor that at the age of 75, you no longer get a colonoscopy. Why is that . The United States service task force you sdf which looks at all the evidence for the preventive actions that is justified in terms of benefits and risks theyve looked at all the studies i have been reevaluated to assess what is the benefit of the colonoscopy. Their conclusion is by the time one is 75, if at that point you have not had any identified vitality is you not likely to have them in the future. Its out of this zone and made it clear. No one thinking that youre 75 so not worth it. That was not the reason for their conclusion. Can i ask the question before about autism with the minorities with circuit doses and i just want to ask you for an update on those and with that i yield back in. If we can get those updates would be happy things in response to congresswoman coleman. Doctor langevin, let me address a few things here each. You talk about the facts nccih and the Natural Products and diatery supplements. These products today are unregulated. So, a consumer has to seek out information on safety and the effectiveness of their own. This is a particular interest to me heres and ill say here so its in the record. I believe that we ought to regulate Dietary Supplements. Some of the claims are outrageous but with how do you disseminate with your Research Findings and the general public and how do you work with the fta and other federal agencies to disseminate the Research Findings and what is the outcome. I have we used your research on both positive or negative way to say that it should stay or go . Thank you. These are all very important questions. And terms its highly important and we dont want people to be getting the information friendly from the internet. Ncih is very active for maintaining the information list on their website called herbalist. Its an app that you can used on your phone and if you want to look up specific type of original supplement or a natural product you could just go and look it up and you get the information right there. Thats constantly updated. The other thing you mentioned is finding out are these products affective and if they actually worked. Are they safe. They conducted a number of Clinical Trials earlier on when it was still called and cam about issues like eco and things like that. People were taking and looking to find out what actually worked. Most of these trials ended up showing no significant benefit and what we think though is not a matter should we abandon this research. What we need to do is actually go back to the lab and take these plants or whatever they are and really go into their basic ingredients and you look at the chemistry and see if we can find out in vitro and find out, are there actually having a facts of the anti inflammatory and the really important piece. You find the effects in vitro and it actually works you in Clinical Trial and you cant just go in me that would make any sense. I would love to have fun with this but this area of Dietary Supplements has been left and is pleased to read your testimony and what you are doing. But there needs to be serious collaboration with but can go back and look at the properties and see if its relevant to other areas but there has to be some defining answer to what is on the shelf with people who are just picking up and using without any way of whether or not this is going to address whatever their need is in this regard. Theres supplements with each nih that is close with nccih and one of their goals is to make sure all the information you have is available in labels and 80,000 labels are all Dietary Supplements that contain the information and unfortunately all of it is pretty incomplete because a lot of it is based upon any rigorous experiments. There is a federal tax force last year that pointed out the lack of data and the abuse of the safety and i did see fta earlier this year signaling that they thought it might be time to report these Dietary Supplements and it might actually be getting some traction. I hope so what will proceed to make sure that it does. Let me Ranking Member coal is not going to be able to get back thought im going to ask a couple more questions and then well give you time for your questions. With regard to the Pain Research that you are doing. We are spending which we should have enormous amounts of resources to deal with the issue of oil lights. Your work is critical here and one of the things that i very much wanted to do was to look across country and honestly, today its a grant thats going to deal with boys and get money to be able to do it because its really a crying need. But with the kind of research that you are doing it, needs to be overlaid in my view and not where we are directly in our funding. I dont know how far along we are to provide us with some real sound advice about directing dollars to what is appropriate and what will work rather than just say we gotta do something and heres the money for all of it. That seems to me that we should not be throwing good money after that. I dont know if its working or not working. But you have a really big piece of the puzzle here to help us. I would agree and as i mentioned before, we are conducting a large effort right now we call pragmatic trials. Basically we take their piece that have been shown to be effective in a controlled setting or in a randomized trial compared to a pursue bow and if we put that into the military and theyre having a big effort right now in collaboration with the department of defense and the administration to test behavioural interventions and Service Members and veterans to seek and be implemented in this Health Care System and does it help with pain. That is an area where its very pragmatic and we want to note the way these therapies are being delivered in the Health Care Setting and do they actually work. The other end of the spectrum is to invest in a lot of efforts in our Intramural Program in basic pain mechanism to see what are the effects of emotions and we know that the stimulus is different in the mood they are in and need to understand that better and some therapies are actually interacting with that and opioids for example will have an effect on the brain and is very different depending on the person that is depressed or not. It is very interesting and we need to understand that better and understand the Pain Research better. This is such an important issue and all of the institutes have been asked to come up with the creative possible ideas where we can approach this epidemic of the need for non addictive treatments for the people who suffer every day. We broke this down at the six different themes and to pulitzer right there including meringue about people who are addicted to opioids. Because their mothers have had that issue. That doesnt look like an impressive diagram but underneath that are 40 different the funding opportunity announcements you and in the last year and a half thanks to you because the provision to 5 Million Dollars a year in this particular initiative as the addiction long term. We have an outpouring and unfortunately, what you said is not everyone who had that funded and people are still mad at me because the success rate was 20 just like unusual and its everything from basic size to understanding how pain works and to the Healing Committee studies and to try to see what happens if you bring all of these stakeholders in the opioid announcement none ounce mint about this later this week and its a timely question for you to pose. And i want to assure you that its an all hands on deck and with. Congressman lucille roybalallard. Thank you for coming my first question for the initiation around the inner since they didnt allow the and i and are i want to raise an issue that you are aware of and im very pleased that someone so experienced it has been put in the position of acting director to lead the ninr and i think that there is a lot of concern regarding the fact that years there is not a nurse in that position and what im hoping is that you will quickly find a prepared nurse to lead that institute and i just want to make that point. Dr. Brendan was talking about the workforce of the Behavioural Research and increasing the cultural and diversity is one of the strategic goals ushering in assuring the discoveries that lead to health care and the Patient Health care spurs. As the first nurse director of the largest by the medical library, what efforts are you leading with the hell am and to have the educated workforce and how are you ensuring that this workforce will include physicians of the scientists but also clinical practitioners autumn pharmacists and nurses and physical therapists and psychologist with . Thank you for the opportunity to address that and im with the district of and i and our and my cochair with this with our be off and running and to address the workforce issues weve talked about it at home first so its the internal Training Program for the women and men who worked for the medicine to do individual assessments and big data skills across the board for my variance to scientists to computer scientists and who work with us and were helping to lead across the development of workforce competencies that address not only scientists but those that require new scientific information and that they have the ability to read and understand and to learn from data science driven resources and finally, for funding an initiative about directing hes directing patients to understand the then this discovery. We recognize that the evidence for practice from data discovery is going to require if differently about things shes artificial and that use intelligence of critical images and recommendations about how we might expect the care process to occur and bringing these along to understand how to interpret this information. Were looking at model curriculum and the science workforce and academic Health Science centers that will cross the curriculum in positions in nurses that will have access to this discovery. Finally, we have to recognize that we have not only the pc workforce but we need Community College training and individuals who are able to assist the preparation data and developing the security to make sure that we can actually safely learn from data requiring. Dr. Austin. Really my priorities in congress has been screening. Since the first passes in 2008, they bipartisan screening saves lives act has supported federal programs that expand state and screening programs and ensures Laboratory Quality and supports the secretaries Advisory Committee on disorders and newborns and children. The law also authorizes seems to have newport screenings in Research Program. To identify conditions of the newport screening and innovative treatment. I understand that and cast was created any nih initiative which included three disease Research Programs. Your mission of accelerating new Treatment Development is a priority. That is shared by children born with the types of Rare Diseases that the screening can detect. Given that ncats and the Research Program have similar missions. Im interested in knowing how ncats can Work Together to investigate new treatments of Rare Diseases that could be detected at birth and new therapeutics are you currently investigating with diseases that could be become eligible and recommendeds uniform screening manner . Wow . What a great question. I will try to be brief although that will be difficult. It is absolutely huge. They waited think about this is moving i think i mentioned before but its one disease at a time and eventually its a threat to all seven bounce and newborn screening has novel technologies which will allow us to make that transition what im talking about here is genomes engrossing and most of them can be detected if we use the sequencing before the children leave the hospital. Already doing this with some work we are doing at the hospitals and within sick infants and the larger application is too short circuit entirely and a terrible wandering in the wilderness with rare disease and will go through five, ten, 15 20 years of going from provider to provider until one provider says i know it you have. You have those medical school ones and theyre so rare. They have multiple providers and we could identify this at birth with this graining across and they ask why are we doing this and this is not so much a technical problem where its supported by us in the end i h which is developing in deploying the genome sequencing which will be done in little as 24 hours from the time the consultation goes and the data is given back. And were using ai to interpret the data. Delimitation here is what i talked about in whats called implementation science. When you had proof of principle, it was demonstrated is being used and how do you disseminate it . This is a complex problem but includes embarrassment and etc and the lesson here is that the only reason that the odyssey exists is that oh discuss leaves home in the first place and has to take ten years to go back. We see these children before they left then we would never have that odyssey and the quality and quantity of life its reclining by the time there finally diagnosed they we are feeling our id ideology to reach and this is not like the training 35 years ago. There was nothing we could do and this is utterly changed so we feel a real urgency to diagnose all children who have the disease within a year and many of those are diagnosed and not all but systems exist much more efficiently. This is a limitation science problem. I may have missed it. Is there any collaboration under under kelly . We are joined at the hip with them and we hired a person who used to be at the end i see hst and were also doing this international because this is an International Problem up until last january. There was a chair called the International Rare Disease Consortium and when i was chair, we developed a new strategic goal for the next ten years one of which is to decrease the diagnostic odyssey for ten to 15 years or one year as well as develop in the next ten there be so Rare Diseases. We think the therapies are only possible when you have a diagnosis. Those diagnoses also allow you in these group diseases to do the therapeutic disease at a time and if we can target the drug in a commonality then we have just cured 20 diseases at once or platform technologies that would be a playable for many diseases at a time. This has therapeutic aspects and information aspects as well in rebuilding databases in which what were doing as well. I think we need to do something to help some of those challenges. Im going to submit a number of questions for the record. You all have been wonderful. Do you find that your work i had a couple things at all and with one question for everything. Doctor brennan congresswoman was talking about in dealing with how can we bring more diversity into the clinical studies and can you do that through your efforts . How do we improve on Clinical Trials dot glove to bring more people including the underrepresented . Thank you very much to let me talk about this and they keep the nih as one is to have the public know which trials are available and are the support of leadership to launch the improvement of the interface for Clinical Trials so its easier for people to find studies and there are search strings so i know a word that might be misspelt are night be in the precise way that these trials are described and in addition to this we are also working with these groups and this community might be Breast Cancer dock or or to be able to extract former critical trial and registry an entire study specifically and their neighborhoods are working in and expose those studies through the lens of this specialty organization. Im going to follow up with staff and this is an issue of the Connecticut Medical Society and theyre journal for madeleine but we will focus on that. I do want to do this and i want each of you briefly to i know its about resources and resources are available though. What is the Innovative Research that he would like to pursue. Doctor austin, you mentioned a piece that was quite extraordinary but let me just ask you where would you like to go . What would you like to pursue . Youre looking at me. Does that mean i should start . This is not in order anybody who wants to go first can go first and you go first laughs one of the areas that im excited and passionate about is the idea that current medicine as its practiced takes snapshots and a little bit of a blood chemistry here and of ear to after that and each year or another a year or two that blood pleasure is not very frequently difficult to measure and some of you may know that every time you breathe in and you focus on these dynamics which could be the most important thing about your blood pleasure and you go to the Doctors Office and the pressure is elevated and you go home and you come back later and you see is not working and you come back later so theres is optimization in the timed intervals which is to come up with better and faster and more accurate continuous wearable and implantable sensors that are measuring many complex things because we also know its quite a dynamic. If we can capture the dynamics every, time youre eat youre Credit School crazy to figure out how to better manage diabetes and these diseases to prevent this and what if we couldnt where this flexible patch that is an ultrasound device and continues to monitor your Blood Pressure when we go to a hearing tear Blood Pressure or you follow that one and how it was regulated in which you are from your position. This is a big challenge for us of what it would do to extend so it would prevent a disease better and give people the power to control what we do and how it impacts our future so that is our big challenge. Thank you very much. Thats a interesting personal example rosenworcel and i think it should measure in his Blood Pressure so he bought this machine and i said what are you doing and it has its become just a non functional piece of equipment. Has he tried it with his arm up or down . That is very interesting. I wasnt that serious about the allergy issue. Its quite extraordinary and im certainly looking to make everything and know what you are eating. So doctor langevin thank you. Where would you go . Our big idea right now is the main mindset doctor tromberg was talking about. We have the dynamics and we often think about we want to prevent disease. One of the things we dont think about so much is how new restore health. How do you get people back to health and if you have a chronic position that has relapsed and how do you in turn recover so that theres all these Wonderful Worlds with recovery and resilience and resolution and regeneration and these are all mechanisms that were starting to understand in these models and this basic biochemistry. How do we translate that back to the human level . And how it leads psychologically and what about physically and how its related. We were moving into that space and especially to utilize behavioural and physical nutritional intervention and to encourage indigenous built in mechanism and we all have anxiety and boost them. The National Library of medicine are the things we do is to make information and with the emergence of Artificial Intelligence and machine strategies we have to potential to make a different data types with videos of family interaction and apply so we can more rapidly know whats occurring to better and more transparent and indications about what can actually cause this medical ailment and our work is with the analytics and is crucial to society. Thank you at and am hd one is why some disadvantages individuals are lower than predicted and the factors that lead to these resilience and the method would be the leverage which would link the individual back to the study and the structures that exist. The second one which is related to the American Indian in native population in the u. S. Which is looking for a special way to strengthen and to build their resurgent capacity on non tribal lands within American Indians. How much interaction do you have . Funny you should say. Tomorrow im meeting with the acting director of this program and the Research Office can wilson as the director of that and we met just last friday and theres a reservation in new mexico. The communities seem to have some very serious problems. Before you answer the question doctor, how do you avoid communicating with pharmaceutical companies . Theres two ways to answer that question. One is, the process that we work on 95 of diseases that are being worked on is either because the target is risky or no longer stood enough and because its too low. The area if you will of these diseases that we work on is relatively small. We work there before i was there with the nccih. The science of the drug and development at the signs of translation which includes the regulatory science and a transitional science. That is a more fundamental way of how this whole process works. That has not worked on by pharma and they cant use internal debatable resources so we work quite closely and one of the problems that killed projects in the problems around to just like that when we work with the fta they make up about a third of our Advisory Board with curious exhilaration. Why do love the collaborations. We want to get to the point i want to ask you last question. Is there a point where there is a recognition of the amount of taxpayer dollars and the research is being done that then is picked up by this industry . They are very well a letter of it. But the cost of their treatment is prohibited to the recovery or the cure or the treatment of the individual and the basic research is being done at your institute at the nih and etc. That has to be figured into where we go in terms of the great way to discovered as you do. But its better if people can take advantage of the product. I would leave you with one very burden provocative term would you not of her before. We are quite serious about just in time therapy. Wouldnt it be great, if one could go from a diagnosis to a kind of gene therapy which is customized to whatever the mutation is that you have. In a very short period of time. We are at the point, believe it or not with some gene therapy particular gene therapy which is the same we used which is an ally go therapy made by bio jim. The idea is, to use a molecular bandaid and a mutated xin that is expended from expressing itself. There are thousands of diseases which are characterized as a fundamental genetic indentation and working with some researchers at the Childrens Hospital in boston who have used this kind of technology and with other diseases. It became evident if we worked with the fta, to figure out one of the general talks at all edgy principles that the fda needs to improve an identity for individual patient. They make all that information publicly available and that recipe is right there and treating a physician that wants to treat a new person that they can go to that person and pick that information with the Public Domain and potentially treat the trial very quickly. The other thing as far as things that keep me up at night because the opportunities are so huge are new uses of treatment which is already out there. We have put a lot of this in areas as they were formed but the fundamental idea is through projects like the geno we discover that there are 700 individuals which will function in all individual cell types which would really produce and reuse so as a result, they would target one and used to target many others. You have a good job of exploiting that or one drug, one disease. One example that you may have heard of is the discovery at yale which was this example of academy in has been around since the fifties. With a patient . Some investigators and carlos sought and others discovered this was used for suicide and depression. Its an anesthetic and its an addictive. You can only get it through iv or noisily. Working with nih and the institute of aging, we asked gosh, if it isnt actually kevin doing it. Is there something in the body thats actually doing the activity with all the other stuff . It wouldnt be an associate of or any of that stuff. Its a very fancy chemistry, we figured out what that molecule was. This is what happens when the body takes inaudible working with our colleagues is a Great Team Effort and working through the Drug Development process and the manufacturing and safety and all of that to get to people and what is so exciting this has a completely different mechanism that they will have so its a eliminated novel in concepts in Mental Health and potentially the treatments are not only for evidence and anxiety, sense of compulsive disorder and ptsd. Were doing trials on all of those and probably starting next year. Doctor collins, do you want to just wrap up from your point of view . I also want to talk about this. Yes you do. We havent had a chance because we have had so many things to talk about and to highlight. Its been a remarkable journey to try to figure out a developing new technology and how those 86 billion neurons between your ears work and how to use that information and how to prevent and treat schizophrenia, all timers disease, all to autism, depression and all down and we are a few years in to what we have supported and released in the very near future a plan for the next five years which will knock your socks off. It has the capabilities which are taking a point how the brain actually does what it does. When history look back at this era, they will definitely point to this. Its crossing into New Territory and we begin to understand the most complicated structure in the human brain. Extraordinary. Broadly speaking in terms of the information this morning which is why i was so anxious its very special to hear from each and every director to find out what we are doing so that we can be responsible and the role that we play and fostering what you do. You know, all over kids have their expression and their testimony this morning and its awesome. You can go to any but more than that, we have the ability which we try to do, to provide the resources for you to carry out. They are not unlimited as you know. But we try our best to continue the effort. I will ask you to pursue as you do the science of what you do. None of us are scientists. We are not doctors and we have got to take our lead from you. We cannot just pick and jews who we think dollars should go. We need we do have the faith and trust that you will follow the science and have the money and resources to help you to follow that science for the discovery. An area i ask you as well, you talked about gene therapy and genetics. We cannot allow peoples personal knowledge or belief to direct where our science efforts and discovery dollars go. You are the work against that. Its oftentimes uncomfortable to enter that arena because that is not what your training, your professional ability directs you. But you have such standing, domestically and internationally to guide us through with the safeguards you understand better than anyone of what their safeguards need to be. What the ethics need to be. But we cannot at the federal level be in business of shutting down Biomedical Research. Thats not what we came here to do. You know, as i say, we will again cooperate with your testimony this morning in the work that you do which helps us to do our job and i can only hope that what we do helps you to do your job here. Thank you for being here this morning. Thank you. Thank you

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