I want to echo the Ranking Member for her comment. We want the best care for our parents and theyve earned it. Im hearing an opportunity in the next 2030 years to affect the debt. Like some of you, i have a personal experience to this. I do have a mother and [laughs] shes 89. Shes very tech savvy, this aging in place is a new phase for her. My wifes mother is younger and has been diagnosed with alzheimers. Im very excited about what you are doing with the va. You have a Perfect Laboratory to answer some of these questions that youre hearing typically about cost, acceptability. Sometimes in denial about need. Secondly, you have a medical staff that might be less than receptive potentially to some of these new technologies or not. Maybe its a perfect lab to develop these. I would like to get your experience about cost, general experience and medical staff that you deal with. We have an example of a device that would be in place in veterans home. Im not going to turn it on. This monitors the blood pressure, weight, or temperature. We provide those devices. A device like that cost about 350 and can be repurpose. The cost of using a device like that about 1,600 a year. When i talk about the cost savings i didnt translate the bed days of care and hospital admissions. Last year for the patients we started last year, they had a 54 decrease in hospital bed days of care, numbers of days in the facility. That translate into a significant cost savings. I think its important that devices dont exist alone. They are part of the system, for us we have home telehealth coordinators. About every hundred we have one Care Coordinator. People smarter than me have published about this data, and we had inquiries from all over the world where people want the results. Some of the problems that other people have experienced is not having the Care Coordinator available or selecting the wrong group of patients. There are four diseases for which these are extremely helpful, one is con con Heart Failure and congestive with the fluids back up. Its an incredible important sensor for when someone is start to ing to deteriorate. When the data is conveyed thats a very important piece of information. Another one is copd. Lung disease, chronic obstructive pulmonary disease. For beauty of the device is we do not have to get in the car and travel but the intervention can be made based on the result thats available. I also wanted to mention ptsd which is a very important condition for us. People are able to track symptoms. Another one that i wanted to mention is diabetes. Blood can be monitored. Its a crucial role in communicating with the patient, communicating with the Healthcare Team to make sure interventions happen appropriately. Thank you for the thorough answer and thank you all for contributions. Thank you. Thank you very much for holding this very important hearing and i want to focus on an aspect of security which perhaps hasnt been mentioned so far, and that is the security of the data and the information that is collected, and perhaps begin with you, if you could tell us what specific steps have been taken and what more has to be done to make sure that the personal information, confidential and medical information can be kept secured. Well, were in the mist of a data crisis right now in the United States. You all know about 80 million records that were stolen and the ie ten ie ten the theft associated with them. That includes Insurance Companies for which this data was, in fact, stolen but also includes Healthcare Providers and management of Electronic Medical records, so the good news is that awareness has been heightened in the past four to six months. Awareness has been increased but should have been heightened years ago. Years ago. Its not encrypted. Is yours . I dont have any data, thank god. Ours is encrypted, yes, sir. Do you recommend that data do encrypted to provide that kind of assurance . We certainly recommend for privacy our journey started in the early 2000 decade, the technology that was available to ensure privacy and security has changes and so some of rules and requirements reflect what was available then. Some of our care into the veterans home, for instance, is using devices or technology that was required at that point. There are newer means to conduct those kinds of visits but were migrating that way without compromising security. We have an an ongoing controversy about the 40mile rule. Should apply to clinics or the clinics that provide the care that a veteran needs. The clinic may not be able to provide the care that is needed, so then is able to go to a Public Health provider. What im wondering is whether the telehealth Programs Fund hospitals, 100 plus hospitals to the hundreds of clinics would fill a gap that would enable for more veterans to go to clinic to get the care that they need. How much of that potential have we explored and actually fulfilled in i hope my question is xre it is, sir. Part of the telehealth that we call clinical video, provider sees a patient and a lot of folks are familiar with skype or facebook. Not skype, im sorry. Provide care continues, so those clinical visits can happen from one of our parent hospitals to those Community Patient clinics. They can happen from one clinic to another. Theyre also happening into the patients home. With space is a challenge, were also looking at exploring ways to providers not take up space to be able to provide this kind of care. But we have probably about 12. 7 of our patients engaged in clinical video telehealth or other telehealth. Theres a large opportunity for expansion. We are we are working down the barriers that we see in expanding this as an option. I can tell you that someone wrote in the mid90s, wrote that the Biggest Barriers are not the technologies, theyre the administrative burdens, and what we often refer to is the fact that our nation has a Healthcare System thats excellent but its based on hospitals. On thirdworld countries telehealth has taken off in an incredible way to provide access to patients that have smart phones. Its our foal that we will get to the point where it can be provided timely in a way not clunky, its easy for the provider and veteran to be able to have that care. And you 1220 . 12. 7. Thank you. Thank you all for your excellent work. Thank you. Senator, welcome. Thank you, and thank you all. A very critical topic that we will face in our lives sooner or later. At the va you focused on various telehealth purchase. I want to expand that a little bit. In a state like arkansas we face a couple of challenges that are relevant here, one is a small member of providers, second is also the sometimes slow nature of Broadband Services in rural areas like east arkansas, mountains. How much of the telehealth challenges do you think are going to revolve around that kind of infrastructure limitation, how much is going to revolve around the resistence to change that we all have a as natural human instinct . Thats a good question. I think theres a requirement for multiple parts administratively from the patients perspective. We can tell you stories of eldery patients that coached younger providers in a way that has been very positive for everybody. We use device connection, we use the interactive voice responses and then we use the web browses. The interactive voice responses is how people do their banking, they put their number in the phone and what they want to do with what accounts and so forth. You can do by pushing buttons or voice recognition. The Device Connections can be through the telephone system, just a regular telephone system. Its sometimes pots, plain old telephone system. So we have some devices that are rolling out that has builtin antennas that allow for that kind of connection, but sometimes the technology is a barrier, but its in my experience that so many of veterans that have grandchildren at a distance are becoming more familiar with the face time and the skype and so forth, so they are engaged in the incredible convenience of not having to travel to figure whats going on, to move around to have an appointment and see a provider and be done and not have to engage in all that whole process. Very positive about it as well. You developed a perspective of challenges on the one hand and con sum ear preferences on the one hand . I have looked into the role of carriers. To provide discounts for seniors and, but at this point theres not a Standard Program across all the carriers in the United States that would make Internet Access affordable for many people of lower income, so that is an opportunity. It seems to me we can do a lot more with. The average cellular plan 50 to 60 a month. Internet service plan at 60 a month. Youre out 120 a month, which is beyond the means of many people of lower income. I believe theres an opportunity to work with the carriers and come up with a better idea. I would say for the record the importance of rural broadband. Absolutely. Provide cost from the up front but the savings we can ashie through government and medicare and society as a whole are no doubt substantial. On some of the work youve done, i have no doubt that there are incentives seeing that seniors are rapidly growing. So there are strong market incentive. Are there strong legal barriers for aging in place to develop, that we could address as congress . Legal barriers . Well, i mean, just looking at the environment for aging in place which is the home and Building Code and looking at the new housing for older adults is being designed. Theres nothing that requires smooth thresholds, nothing requires sink heights if youre, in fact, in a wheelchair. It would be to talk to organizations that lobby on behalf of builders and look at what are the barriers and barriers at the state level in 50 states one way or the other to enabling use of standards, even if you move into the house, if is your home able to age with you, thats the question. Great. Thank you you all again. Thank you very much, im very glad you brought up the issue of broadband because thats a real issue of my state as well. I was thinking about some of the sensors and other devices would simply not work in some parts of the state of maine. We need to do more work on. Im just going to ask a couple of other questions. I noticed that you did do the cost comparison that all of all of us are interested in and youve talked about the cost of the set up with the 2,000 and monthly fee of 59 and if my math is right, when you look over at the two and a half years if you had nursing home, its more than 300,000, and so i think this does have very important cost implications for us, and one of the issues i think we as Congress Needs to work with the administration on is what is reimbursable to Healthcare Providers under the medicaremedicaid programs because a lot of times well pay for consequences for unchecked diabetes, but we wont pay for the ongoing consultation that prevents the person from having the complainingations complication. I see many of you nodding. I have one more question to ask you, that is, your testimony you mentioned that i think your motherinlaw didnt want to wear that Emergency Alert pendant. How did you find out about the alternative ways of keeping her safe by the use of sensors, putting them all over the house to make sure shes eating, door, i dont think most people would even know where to begin, how did you get the advice you needed on what you should purchase for her and what was available . I think approach was to find an adviser that could help us. Honestly we started groping in the dark, if you would, explored a couple of things that werent successful and we really reached out and visited with other people that had solutions that did work. Lets find somebody that really knows and understands technology and sort of guide us through this process. My advice is to find a trusted adviser and they can help you identify what technologies are appropriate. Different technologies are appropriate in different circumstances, and so i think in our case rereached to reached out to our Home Security folks and they helped on zero in on things that spoke to the needs that my motherinlaw had. When we couldnt get her to per a pendant we needed to be alerted when she fell. Having the sensors if she was up and about and didnt reach point a to point b it would send alerts, hey, you need to go check on her. So that was very helpful to be able to reach up and have that resource. Thank you. And my final is for dr. Mccarthy, that is you mentioned that you were doing telemedicine from 900 sites. Is that correct on that . I believe thats the correct figure, yes. I guess my real question is s this happening from your clinics and your va hospital or its not individual outside providers that youre contracting with . It could include that but thats primarily va driven. Some of the sites would be clinics or other parts of the country as a network, but also and again, i think the cost savings that youve quoted of 2,000 per veteran per year, when you start multiplying you get into real numbers very quickly. This has been a very interesting hearing. I want to call on the senator for any questions she might have. I dont have if i believe questions, but i do think that we need to go back and see how we began describe distributing scooters. When i began talking about scooters, we actually found one woman who worked in my office whose grandmother had three. In many cases they are needed. How do we get approval for all those to be paid by the medicare programs and what do we need to instead of paying for those pay for sensors that would be Cost Effective and healthy. And more quickly free market in this country comes with products that can be brought to scale, that they can present to the medicare system for possible reimbursement, that would result in these savings, i think the more quickly we could really turn this thing. I urge all of you to continue to reach out and the private partnerships with your companies in the university of maine, partners with the university of missouri and i know the va has a lot of commercial partners, the more quickly we can get the technology to the point that you dont have to have most of us dont have a trusted tech advisor. Most americans dont even know where to find a trusted tech advisor. If you look up on line for a trusted tech advisor youre [laughs] and so the more quickly we can do that, the more quickly we can do some progress in this area. I really appreciate the hearing. I learned a lot of. All of us are motivated and i think all of you if your work and thank you for a good hearing. Thank you very much, i think your comments are very well taken. This commission has held meetings on scams. I want to thank all of your witnesses for being here today. Dr. Kim, i love the fact that you have involved the students at the university of maine and taking them. It is incredible that it came up with 50 different ideas. That should keep them busy for quite sometime. Each of our witnesses has contributed to our understanding of this issue and thank you for taking the time to testify before us today. Committee members will have until friday may 22nd to submit questions to any of our witnesses or additional materials for the record. I want to thank senator and also members of the committee have parented as well as the committee staff, most of all thank you to our witnesses. This hearing is now adjourned. [inaudible conversations] while congress is on break this month we are showing book tv programs that are normally seen on weekends on cspan2. Tonight starting at 8 00 eastern, the dark net inside the digital underworld and steven how music got free, end of an industry and turn of the century. It all start tonight at 8 00 eastern on cspan2. Follow the cspan city store as we travel outside the washington bellway to communities across america. The idea behind the city tour is to take programming American History television and book tv out on the road to produce pieces that are a little bit more visual and provide a window into the cities the viewers wouldnt normally go to. They also have rich histories. A lot of people have heard history of the big cities like new york, la, chicago, but what about the smaller ones like albany, new york . Whats the history of them . We will hit 95 cities in april 2016. Most of the program is event coverage. These are shorter, they take you to a home. Historic time. We partner to explore culture of various cities. The key industry is cable operator who contacts the city. Its the cable industry bringing us there. You really want viewers to identify with these people that were talking about. Its an experience where we are taking people on the road to places where they can touch things, see things and learn about its not just the local history. If somebody is watching, it should be enticing enough that they can get the idea of the story, but also feel as this is just in our backyard, lets go see it. We want viewers to get a sense, oh, yeah, i know that place just from watching one of our pieces. The cspan mission believes in what we do in the road. You have to be able to communicate the message about this network in order to do this job. Its done the one thing that we wanted it to do which is build relationships with the city and Cable Partners andgater gather great programming. Watch to see where we are going next, see our schedule. Work being done in congress on helping medical innovation, republican senator joined democratic senator Michael Bennett and others in forum. Its about 90 minutes. Good afternoon. Today we are going to spend the next hour and a half talking about advancing medical innovation for a healthier america. United states has been a Global Leader in medical innovation for decades, yet tens of millions of americans have neither cures nor effective treatments for their diseases, patients with alzheimers, parkinsons. We have about 10,000 known diseases that have been defined that have names and have science and symptoms but for those 10,000 we only have 500 treatments. We have a lot of to do. U. S. Has invested over time, 20 years 1. 5 trillion. Not billion, 1. 5 trillion. If you look at those investments they have not resulted in progress in that whole process of discovery and development in approval of medical products. Expensive and lengthy developments end up slowing down that advancement of medicine and slow down access to new and effective treatments. We all know and hear statistics that a new drug today takes about two billion dollars in terms of an investment and takes about ten years for the drug to reach the marketplace. For those individuals or those patients who are facing a life threatening disease who might be in trials waiting for a drug that can potentially help or cure that is too long, the clock is ticking away. Workinggovernment plays a role g with the private sector. Its something that needs to be modernized with time in terms of treatments, in terms of the lighting speed, the skyrocketing speed with which new new applications and devices and Information Technology is advanced. The government plays that role in lots of different ways. Food and Drug Administration, fda which is that Regulatory Agency that oversees the safety and effectiveness of products and drugs and devices before the american people. As a former member of congress we talked frequently about it. We are very aware of the role of government. Government can lower barriers or government can stifle Industry Growth and hold back which science has out there which can be made possible if we get rid of barriers. In a sentence the easiest way to think of it is we cant rely today on 20th century technology. Technologies of the 1900. When the world is changing so fast and the world is on a cutting edge of new Health Technologies including medical science and including information on technology. We have to modernize, bring up to date the way drugs and devices are developed and delivered in this country. Its time to act now. Well talk about the Global Implications and the global competitiveness. We have millions of patients waiting out there for cures which are on the shelves ready. Congress plays a Critical Role in removing barriers. Senator, committee known as the Health Committee has given strong voice in advancing the United States leadership in medical innovation to improve our nations competitiveness across the globe on this content but indeed around the world. In january just about seven months ago chairman along with senator released a report innovation for healthier americans for opportunities for meaningful reform for discovery and development process. A little bit later Ranking Members, launched a set of work groups working together collaboratively to identify those sound, fundamental, viable policy that will improve american patients. Fda, advancing medical innovation, to sack to accelerate. That brings me here today. Senator alexander was first elected in the United States senate in 2002. His Top Priorities were fixing no child left behind and Higher Education act and for our purposes today modern modernizing the food and Drug Administration so we can bring more medical drugs and medical devices to the market quickly and for less cost. As a fellow tennessean, come again . A. I do have to look back at the leadership as a governor. I played a tiny role in that as well. Please join me in welcoming senator lamar alexander. [applause] thanks, ladies and gentlemen, thanks for being here. I was retired from politics for the second time when [laughs] he dropped around to see me in 2002 one sunday afternoon. People say, the only cure for politics is embalming fluid. It doesnt take throng get the old juices running and here i end up in the United States senate. Of course, bill was majority leader. I had a chance thanks to his leadership to be on this committee which is the senates Health Committee. We have a lot too, so im im delighted to be here with you and with him specially. When i i want to tell you one other story which will which will explain why i plan to speak for a few minutes and then listen for the rest of the time. Our former colleague used to tell a story of when he was first in the senate. He was sitting there wondering what to do. Boy, dont worry about this, youll get the hang of it in no time. All you have to do to be a United States senator is stand up, Start Talking and eventually youll think of something to say. So i hope to just prove that today. [laughs] im a recovering governor. I keep having outbursts of executive leadership that isnt that easy. When i had townt be opportunity to be chairman of the committee, i wanted to do something useful with it, so we set three big priorities. Fix no child left behind. We were able to form a buy bipartson group. Pretty remarkable during the difficulty of it. [applause] but it shows, the other thing simple regulations, a lot of well intention rules from here and our institutions are struggling in the gender of red pain, so we have a variety of efforts to deal with that. The third area which we identified earlier this year and were approaching in the same bipartisan way to align federal policies in such a way that we are able to move discoveries through the entire process of of innovation, regulation and investment into the medicine cabinet more rapidly and at a lower cost. The house of representatives has a similar goal and passed a bill. I was going to tennessee with president obama earlier this year when he went to announce his Community College initiative. I told him what i told you about three goals. As a result of that, i went to the the white house when he made to the announcement of that. I said to the president , well take your interest in medicine and incorporate it into our work on innovation by medical research, well work bipartisan way. Its fair to say that this is a train that will get to the station. In other words, you have the house already having passed a bill. We are working on a similar bill, not the same bill. The press is interested in what we do. Our timing is in order to get what we want done, itll be thanksgiving or the end of the year before we finish committee work, but thats no delay really, because senator wouldnt have time to put it on the floor anyway between now and the end of the year. I fully expect it oh to be the kind of legislation that could be considered by the congress in election year, something that people can take pride in. It affects every american. So members of our committee which include, you know, elizabeth, Bernie Sanders, rand paul, tim scott and others, we have a diverse committee. We are all breasted interested in this. [laughs] the question is how do we know what to do in the disconnect in life is those of us who are in public life and everybody else who knows what to do or is pretty sure they do and how you get to two together. One person that i thought immediately to help was bill chris. Now, im sure theres somebody who knows the senate better, im sure somebody that knows medical research better. I asked him if he would help us design how to go about this, which he said, yes. He came up with the idea of porking with working with a bipartisan center. This is sort of the outside track, and were going to be con conferring. Im going to say and listen to the panel because i want to devote more structure time to learning what to do. But i would like for you to take the excellent recommendations that youve made in this report and boil them down to specific recommendation that is we can say to legislative counsel. A request that i made of the of the National Academy of sciences along with bart and a couple of others to give specific recommendations of how to make our country more competitive. We got back 20, and then with bills leadership and the democratic leader at the time we passed in congress. Eventually because we had the blueprint it got done. My view is that most ideas in washington failed for lack of idea, not for lack of the politics. So we needed specific recommendations for what to do. Another example is that i i askd to give specific recommendations , and they gave us 59 and 10 in priority order. Duncan is working on some of them. We are going to include as many of those as possible as we can in our reauthorization of Higher Education. We dont want to be wasting money on red tape when we can be reducing television on hiring better professors or giving scholarships to students. Ten specific things you should do in this Senate Legislation that would meet the objective of aligning federal policy so that we can get curious, treatments and other discoveries through the whole process and into the medicine cabinet more rapidly and at a lower cost. Thats what we are looking at. Electronic medical records are a project the government has been involved in. Went pretty well when the government was giving 30 billion. Now the money is gone and the system is a little bit in the ditch, and theres a lot of complaining from the doctors and the hospitals about the next stage of Electronic Medical records because the system isnt working very well. Thats essential to the Precision Medicine initiative, because, for example, dr. Collins is trying to gather a million get that information together and Precision Medicine wont work very well if doctors cant point and click or easily use the information as they make their diagnosis or transfer the information. Its important for that and its important if were going to be able to do a better job for patients in the United States. So as part of this, were looking for the five or six steps we can take to improve the the Electronic Health records system in america and make it something doctors in the hospitals look forward to rather than degreed. Thats the goal. Thats easier and cheaper. If it requires legislation, we have this train running through thats going to get to the station and well put it in there. I invite your participation. I thank you for what youve done. Im delighted to be working with a Bipartisan Policy Center specially with bill and bart whom i respect and know very well and i look forward for comments this afternoon and i look forward to receiving, if you can, take recommendations, boil them to suggestion that is we can look at them, read them, consider them and send as many as possible to legislative counsel to draft and include in our bill. Thank you very much. [applause] ive had the good fortune to be on a number of panels making recommendations, and i can tell you that when you put your time in, you put a good recommendation together and it goes on the shelf, its very discouraging. But for all of your geeks, you now how much fun when you put something together and you see it in legislature or reforms. I feel better listening to alexander earlier today or just then. We had the opportunity to watch firsthand governor alexander in tennessee but came forth with education reform, infrastructure, investments in industrial recruitment, and so i think that past back in the senate and we are going to be a better country for that. Hes going to have a good partner in the house, someone that i had the good fortune to sit in the committee with. That reminds me, well, when i think of her, i think of a story that my grandmother about the little engine that could. Thats diana. She demonstrated that. So senator alexander, you have a good partner here and diana, tell us whats going on with you. [applause] thank you. Im so happy to be here, you know, they dont invite us to come over from the house very often. Its always really a treat for us. I was really happy, lamar, to hear reflections on the issues. As some of you know chairman worked very hard we had hearings, we had round tables, we had you name it. We worked for about 18 months trying to get consensus and many of the people in this room attended a multiple of those hearings. You know what we are talking about. I was pleased when i found out that senator and congressmen gordon were heading up this effort because they really found many, many areas where we could make substantial updates to help renew treatments and cures to patients. The good news is, this is similar to the con con i think it shows theres number of concensus and resources that we need to bring for expediting medical research and approving by the fda. Experts from all different background and all different sectors really agreed about the meaningful improvement that we can make. Todays report that was released. I havent read it in detail yet but i read the executive summary, it offers us a lot of the same proposal, echos a lot of thing that is we heard in the house and acted. I just want to highlight a few of the similarities in this report to what weve seen in our house investigation. For example n the report there are recommendations to more effectively include the Patient Perspective throughout the drug and Device Development process. It has several provision that is strongly echo this policy. In addition, there are several recommendations in the report to strength public partnerships. Further, theres a recommendation to accelerate the development and imapproval approval of hand in hand with the agency giving us technical assistance, we know that this is something really important. And so, this was always included in the hr6. I could go on and on. Im under the house rules today. What i want to say is that i think that we can find a great deal of this con one thing i want to talk about briefly is the importance of new resources for our medical research and development institutions. Fred and i as part of our quest when all around the country. I was in san francisco, michigan. Fred was in denver. We were all over the country, whether were talking the fda or mih, they are working on multiple priorities in a budget climate and they need to have the ability to carry the ideas that we are circling right now. We were having one of the bipartisan tables and he whispered and said to me, we hadnt been under the budget cuts, we probably would have had a vaccine for ebb ebola right now. What he meant is because of Budget Constraints what happens was many worthwhile programs Like Research were put on the back burner in favor of the diseases that inaccurately seem too much much more of a threat, and so really was all of the great breakthroughs that we have going on now. We need to also be able to research the innovation. Now as most of you know, we passed 21 century cures in the house at the beginning of the month, 344 to 70. You cant pass the journal, by the way. We know that and we hope that this bill will just be a a resource to the senate as the senate embarks upon the investigation this fall. I also really encourage that our efforts have been joined by serious discussions at the senate house committee. We have an opportunity to make important updates and reform to our medical research and development system, and after the last century of remarkable medical discoveries we want to make sure that the pace of breakthrough treatments and cures accelerates to meet the challenges of our time. Some of you know, fred and i traveled around together for 18 months. I service the director of health and prevention and on behalf of dpc, welcome all of you today. We are going to spend a bit of time going through the report and you should have it if you walked in and with that we are delighted to hear from our cochairs and if i could ask you to come to the table and our Advisory Committee members. While they are doing so i will take a minute to introduce each of them. You are able to meet with senator bill frist who opened up today. He is a nationally recognized health and long transparent surgeon and as you know also a former Senate Majority leader. On his left this is congressman boarded the representative gordon. Former commerce men who served as the chairman of the Health Committee on science and technology and during his tenure in congress focused a great deal of his time on improving americans competitiveness and we have a lot of that in our report that we will hear about during our panel discussion. Lets see, all the way to your very lets see to your very right im delighted to introduce doctor Patrick Soonshiong. Just flew in from los angeles. Hes a physician, surgeon and scientist and has pioneered for diabetes and cancer and has over 95 issued patents on groundbreaking advancements spanning a myriad and finally im delighted on my lap to introduced marc boutin, who i have known for a long time. He is the chief executive officer of an Organization Called the National Health council, an Amazing Organization brings together over provides a unified force for more than 133 Million People in our country, patient individuals, those who are sick and those who have disabilities and has been a strong supporter for medical innovation. I am sorry that our third Advisory Committee member, Mark Mcclellan who serves as the senior fellow and director of Healthcare Innovation and Value Initiative and the center for Health Policy could not be with us in person. So, i will move over here so we can get into the panel discussion. There we go. Our first question, i folks have seen the executive summary. The longer letter is on our website. Its about 80 pages and i wonder if you might be able to tell folks in the room sort of a broad brush around what is in the report. Thank you. Again, the website is available, but for those of you that are here, the report is hot off the press with the final finishing touches this morning and its easily digestible, but let me point out a couple things. The first area of the report is focused on we have soared up for areas ended it is easy to think about it this way as we come through the process and the first area is a proving that medical process. There are a whole bunch of issues covered here, but to give you a sense with highest priority is the following we called for congressional action to increase in the generation and use of realworld evidence to read all this data is out there today and accessible today , but its hard to get into the fda and consideration process given the structure, so how do you take advantage of this data and Information Technology as it generated and about drugs . Not only postmark surveillance, which is absolutely critical, but also approval of those new indications for existing products. Ultimately into the critical trials themselves that are used for regulatory review. We also call for actions that enable the dissemination of scientific information to support the decisionmaking regarding something that is misunderstood, i think, generally but for me as a heartlung transplant surgeon it was critical to taking care of patients and that is off label use your very confusing to people, but it has to be addressed upfront. More than one in five outpatient prescriptions, one of five are written for off label therapies today. It is critical and fundamental. It is lifesaving and all of that is because the way that approval process is set up to get approval for a new indication, drug or device has to go through an entire Clinical Trial process. That doesnt necessarily mean the drug works and has been shown scientifically to work should not be given to patients in need to read the fda does not regulate the practice of medicine at people think it does, but it doesnt. Nothing prohibits physicians from prescribing drugs and devices off label that you know will help that individual patient. Manufacturers interestingly are generally restricted they cannot share that information, good Accurate Information on off label use of the products. That inability to share information obviously is a barrier for those drugs and in order to balance the risk and benefits of off label uses, physicians, the doctors have to have reliable information, uptodate information, that Accurate Information that is being denied to them right now. No one is intending to deny it and its an example of an antiquated structure. Good the times, right now, for today it needs be reformed. We also call for harmonization of International Requirements and standards. You will come to that because in every one of our discussions we know that america is great. Where the most innovative, but there are good things happening around the world that is in a scientific way that needs to be assimilated into our processes and into our our scientific Clinical Data bases. You also see in their i dont have the pages, but we address the whole issue of that interoperability, which improved interoperability of health Information Technology. Marty kind of implied it there you did imply it as we have these different standards out there which inhibit the exchange of useful scientific information to improve the outcome for patients. This is the foundation, i think, for where we are today and not only improving the medical Product Development process from idea to clinical delivery, but also for the broad aspects including delivery in getting into the field and payments for that strategy, for empowering the patient who has this information other today that we didnt have 10 years ago on how they can use it and it means interoperability of the data. In the report on page 14, we talk about the increasing regulation, regulatory clarity. Dont have time to go into what that means, but its what regulation actually means, who is response before what, whos in charge of regulating and gives clarity. Its very confusing today. Congressional action is going to be needed to improve the regulatory clarity and evaluation of things like, nation products where you are pretty different things, different stuff together, how is that, who is responsible for regulating that in some of the most innovative product out there today unlike when dad was practicing medicine 40 years ago the ability to combine the drugs and to a certain extent devices and ways that before had been impossible. Neither pure devices, drugs, biologics, this whole field in my own field of heart specialty an example would be a drug that really began i guess about 15 years ago for the treatment of coronary Artery Disease and thats the Drug Delivery on the stint itself that mechanically opens up an artery and inhalation devices for insulin delivery instead of injection for the management of diabetes carried transdermal pashas for the early parkinsons disease are all examples. There is a lack of inter center, between center delineation of the roles and responsibilities of those of you who are followed the fda closely know im talking about when you look at crh, and who is really responsible and for them to be clear for the clinical and as a get or you need to know who is responsible and they tell you something that is the rules of the road to read you get this conflicting feedback, this lack of clarity, this chaos which slows them the field as people try to rectify that carry a Regulatory Framework can cure that, can get a pathway for approval in delivery or rejection. Many believe that there is little consistency in predict ability in the decisions made by the office of a combination of products since the nod lead centers receives no user fees for the work, they dont get paid for it yet they are a part of the process that becomes very confusing. There is no incentive for a timely review of data and products by the non lead center. Again, just a conceptual to paint the picture. Congressional clarity regarding not read the tory favorite authority associated with the Laboratory Developed test, the ldt is very confusing and many of us have experienced it directly, but on comes down to Laboratory Tests, diagnostic tests when youre trying to figure out what is good, what is that, what works for a patient, its not a big part of the budget in spending, but Laboratory Test determine eight out of 10 clinical decisions made. Who was approving this test and who is responsible is important to read it also calls for congressional abrogation drop Information Technology including clinical software, the things that we carry on our iphones around in it of software should not be regulated as a clinical device. That Software Just can be because the medical device is a device, its a thing and when we have regular tour framework you to stuff stuff into it like supper he just doesnt work and it slows down innovation and i am certain we can keep people from innovating their. We have done good bipartisan policy with the last few years and have more to do. Also, revelatory clarity is needed on the certain rigid a tory cell therapy. The region a tory stem cells is exploding in my own field of Heart Disease and orthopedics and you begin to pay more attention to those things as you age, but right now, we are trying to approve these regenerative therapies in an antiquated System Design 20 and 30 years ago when it didnt exist their. Stem cell and other genetically modified cell therapies arguably hold the most promise for curing many of todays insurmountable untreatable diseases that are out there. Additional regular tory therapy is needed to assure fda regulatory or recognition of the unique nature of stem cell therapeutics. Its a different world when i was in the United States senate. We are way beyond this with an exciting field carried her work needed in the proper preparatory site framework of as lamarr mentioned that president s initiative a Precision Medicine to read what exactly is that what is the Regulatory Framework . The third area of the report we talk about is strengthening the fdas ability to carry out its mission, its cost share. We have some great people over there that are smart people and working every day, but theyre working with and had framework, so we focus on the mission. Mark mcclellan who we are talking with earlier today could not be with us and spent a lot of time talking about how important that is. With the number of the nation the report relating to the fdas Human Resources. How do you hire people today . Many of these will require collaboration with hhs and office of personnel management. We all know and government the hiring and firing processes and hiring fired a recruiting processes that happens in the legislative branch when you are importing ambassadors it needs to be addressed, but that whole Human Resource and we also caught up the need for fda to expand the effectiveness of the publicprivate partnerships that are out there. How we actually improve and make those real. Finally, and i have gone too long we have a section on improving access to medical products or unmet Public Health needs. There is a government responsibility, for the unmet needs that may not have a financial incentive for going there the biggest most important drug company in the world may want to make a lot of money, it just wont go there. Of scientists wont concentrate their resources, but there is a huge population, Public Health needs and thats a very specific role of government at the fda has a very important obligation to Response Response building. Another area of my pulse of attention to is the need to accelerate the development of something again that affects everyone in the room and that is the use of antibiotics. We see a lot in the press today and we know superbugs are an issue, but how can we when we know theres a problem out there and we know people are dying from it and it is created i the use of other into radix. Need to accelerate innovation to cure it, to treat it and figure out how to do an fda needs to give special attention there to the approval of antibiotics for use in these limited preparations with the superbug. Anyway, that i went when it too long. Those of the four sections three read the report and we can talk more about some of those sections. Thank you, senator frist. As he mentioned there is a lot of recommendations in this executive summary and what we have on our website and representative spoke a bit about this is a common nation of things that are cures that we hope the move further on and things that are in cures and one of those is around the use of realworld evidence not only for post market, but free market and then there are a number of new ideas that are not in the 21st century legislation. You can go to the bbc website with a nice easy crosswalk for you. We will run through a couple of the topic areas and one that is very important to us is about competitiveness of American Companies and i wonder, representative gordon, if you might talk about about that and how the report recommendations improved our country, our nations competitiveness. Let me just speak up then. You think senator frist is excited about this report . [laughter] i think for good reason in the best thing for me to do is just a, a man. Following senator Alexander Senate model i will face of it anyway. As you know senator, when we Work Together on the peace act we found that after world war ii to the end of last century the United States pretty much lead the world in all academic areas, and the way we recently did that was we had a simple formula. The invested in education we had a Skilled Workforce and we invested in research. For new ideas, improved ideas, new services and by many reports half of our gdp resulted from our investments in that research so, then comes the next century and we see a couple things happen. Our investments are starting to either be snagged it going down and the rest of the world is increasing investments. A read the book and figured out what the secret formula was. This is a quick example, in the area of rnd in the healthcare or in the pharma school pharmaceutical and medical device area from 2007 to 2012, our share of the worlds investment went 50 to 44 . At the same time, asia went from 16 to 23 . So, we have to get our competitiveness back again. We talk about putting more money into the pot and certainly, that is one aspect. But, if we can get more use of the money that we are sending you get the same results. A couple of areas that i think are very important for us to look at is interoperability as a senator frisk mentioned and i think that is a great resource there. In our report we give specific organizations and if you will see the government start to lead in these areas, then that will be a Market Drivers for other areas read another thing that i think is going to be important and we have a unique time to do this is that this is looking at interoperability, as well as harmonization and mutual acceptance on a variety of international standards. You know, we just got through passing you all just got through passing fast track, selected or not or not here comes. T tipple, soon after that and i think there is some unique opportunities, whether its through the agreement itself through that vehicle to have these discussions to find out how can we have some harmonization. Some mutual acceptance in a safe way that will help reduce the costs of bringing drugs to market. United States takes that 10 years and 2 billion to get a new drug on the market. Surely we can do better than that. Thank you. Thank you. Doctor patrick, you have had a long history of developing and implement new and innovative ways to battle cancer and i know the whole topic of Precision Medicine is one that is very interesting and a passion for you. Can you talk a little bit about advancements in this area and what are the implications for fda . How does fda need to evolve given all the advancements in science . So, i think the issue you brought up with Precision Medicine and have this is a buyer bipartisan event is so fantastic in terms of timing. What i would like to do is maybe layout i spent 30 years of my life now looking at this issue of cancer and as a problem. Then leaving the university fashionable. [inaudible] through that event of a layup the problem. The reason we have lost the war and cancer is because weve got another wrong assumption and i will explain later. And i will explain how Precision Medicine actually can save us and then explain the urgency of what we need to do. We have always assumed as a nation and as a society that cancer was a single clone, so this horrible clone that happens in yourselves in a single gross and utilitarian so, for 40 years we have been going down this path of single drug of chemotherapy, Radiation Therapy and it made sense if in fact it was a single clone that we are trying to kill this clone while we kill your normal cells. Put you through a horrible process. And hope you come out at the end of that alive with a clone dead anybody life. If that were true we would have cured cancer today. Amazing that assumption was made by some single mathematical calculation, which in retrospect was an error to treat cancer cells to literally. It turns out now through nextGeneration Sequencing that cancer is 10000 clones to happen in your body. It also turns out that uni as we sit here producing probably 10000 cancer cells a day, but your body actually has a protective mechanism to protect your body from actually having those cells actually grow and has a way of killing it. So, these 10000 clones which we have now discovered through nextGeneration Sequencing and through this genome sequencing. Than the idea of zapping you with a patient with maximum tolerated dose of cancer has failed because it killed that one cancer cells and others come out and those that are asleep, wake. So, we have gone down this path and by in 1990, when five years ago i wrote the first paper on this very ancient cell that you and i have in our body called the natural killer cell that floats around in our body. 10 of your white cell that fits their today protecting your body not only from infection, it bulla, cancer and if we could harness that sell and cause that sell to actually kill the cancer you would actually find a new way in to read except for 40 years we have been wiping out the very same cell that is protecting us by giving us maximum tolerated dose of chemotherapy. So, when i left the university to and for lung cancer patriotic cancer which is the only drug approved in this country in the world, one of my challenges was to go to indiana and try to excite oncologists we really must stop this idea of doing maximum tolerated dose. I lost that argument, by the way i secretly went and ran my own clinical protocol, so this is the wonders of america because i come from south africa as a physician and a surgeon and a scientist. It became a multibillion Dollar Company so i could actually pursue this opportunity, so on that idea we then gave lowdose chemotherapy and today we have patients with patriotic cancer alive for years, five years, sixers, eight years alive without the disease. They would normally be dead in two months, so the challenge then is how do we now change that, so what we have discovered is one and i will take you to Precision Medicine. We can now do the next Generation Sequencing on human beings and we Just Announced as a rate of 2000 day there are 13 million cancer survivors out there in our country. We can identify the sequence and know which clone to hit, which not to hit, but you need to get it with low dose multiple forms of chemotherapy that will just stress the seller not kill it, so you can harness your immune system project that into the blood and reverse that. Tomorrow we go public. The company is going public in which this natural killer cell we went to watch on this nation. The science is so complex that most clinicians cannot understand the science, which means they need interoperable decisionsupport at the Electrical Medical record system. I came to for four years worked with to implore that the 40 billion that we would spend with Electronic Medical records in which we are actually spending the money and medical records that through by its nature will not talk to each other, and epic system, a center system, a proprietary system is by its nature will not talk to each other, so you doubt not have interoperability and you dont have a shared information to read you dont have the intelligence. How then can you treat a patient that has two months to live . With information that could affect his life for her life in realtime, so that is what we have put in place. This is the opportunity now through this system. The next question is how do we put in place the capacity for every human being to have this sequence done in real time to know with specificity which drug to give and, by the way, it will be a combination of drugs, some on by five, three different pharmaceutical companies to read how can we regulate that commendation . Who is going to prove giving that commendation . How will we funded a combination . So, these are the challenges i think face as in this is all Precision Medicine, which im happy to say is put in the forefront and we had to have the capacity to do that. Thank you, doctor patrick and before we moved to q a, mark, we have a lot of recommendations here about integrating the voice of the patient and helping them with access to the needed treatments. Can you share a bit about those and then we will move to q a. Yes, thank you, janet. Let me touch on two issues near and dear to my heart. Am i on now . All right. So, the National Health council is an Umbrella Organization of the nations leading organizations and many are represented here the room. Which is speak to you in the audience and say that collectively and members represent 133 Million People with one or more chronic diseases and disabilities. Thats more than 35 of the population here in the United States. So, thats why raising your hand, how many of you have someone in your immediate family or circle of friends with a chronic condition . Raise your hands. That is why we are all here today. Went to talk to you just about to provisions that have been put forward in these recommendations , but the overwhelming weight of these regulations is huge. Is renovating our entire Innovation Ecosystem. It creates the environment for us to develop highly needed, highvalue treatments for all the people we care about in our families. The first issue i would like to speak to you about his patient engagement. Its a bit ironic, but we have created a system where everybody speaks for the patient. The doctor speaks for the patient, the researcher speaks for the patient and they are the surrogate for what is important to us. Their opinions are critically important. But, when you ask them what is most important to the patient and then you ask the patient you get a different answer. It is ironic that we built on a system that is created barriers to the biopharmaceutical sector and the regulators to actually engage patient. I will get specific, right now, for bile biopharmaceutical cup he to engage with patients they could potentially be subjected to millions of dollars in fines for marketing and unapproved product, but everyone in the room has a smartphone. The developers of those products that you all have in your product pocket would not change the color or any feature of that phone without engaging the enduser first to understand how it would impact them. Yet, we dont do that in the development of medications for every major help him him biopharmaceutical come he has that to mean dollars developing a product, brought it to market and realized it didnt answer the question that was important to the patient. That is a huge amount of money that could have been devoted to a treatment that answer a question that was important to a patient. We are not invited to determine the Research Question and when we are the Research Questions on a different way. We are not invited to determine what the patient reported outcomes should be. Think about that for a minute. Other people are decided for us what are the most important outcomes. We should be part of that process and there are great methods for doing this. We have a president that has been elected twice using these methods in the social sector. We dont use patients the way we develop Clinical Trials and the as a result we have a hard time populating them and keeping people in that. Huge opportunity to short drug developing time by having us purchase pay in the development of Clinical Trial protocols. We are not involved in the determination of a judgment about risk and benefit. Huge loss opportunity. At the end of the day the judgment the fda makes on risk and benefit is just that to read its a judgment informed by science, but it ethically has to reflect the enduser. It needs to be stratified to account for the individual patient determination benefit and risk, their tolerance for the disease, their tolerance for existing treatments. Huge opportunities to get that information into the label. This is not a substitute for the current Regulatory Approval process. Which is the gold standard. Its adding Additional Data that would go into the labeling, come out on the back and so that when i meet with my doctor and tell them whats important to me they can determine for from among multiple treatments which one will address what i want addressed. Huge opportunity, huge consensus in the patient community, the pharmaceutical sector and within the fda. This is a huge opportunity for a win, for commerce to remove barriers that exist and to encourage fda to move forward in changing its culture to make this a reality carried the second issue i would like to address deals with ensuring the treatments for that medical needs are developed. Was legislation introduced in the house that had 90 cosponsors in the senate, senators bennett and hatch introduced legislation dealing with therapies. This is legislation that is critically important to the patient community. There are two factors that are not well understood. The first is that while most people recognize you do not developing medicine without a strong patent, the less well understood factor is that many potential treatments potentially as many as 80 dont qualify for a patent and as a result they are never developed. Socket, many products take too long to develop and as a result are discarded. If you look at alzheimers, if you want to develop a product for alzheimers and guarantee that it will impact the progression of the disease, something all of us want, you need to have a Clinical Trial that will last 15 years because the development of the disease takes too long. For a company to invest 2 billion to develop a trip for alzheimers and then only have a few years left to market it without generic competition means that they abandon a promising product and we see companies leaving the narrow logic space, the autoimmune space, the prevention space and cancer. We have an opportunity to say, patent system works, but we can provide an alternative pathway if you have a product that addresses on unmet medical need as defined by the fda and bring that product forward. Huge opportunities for the senate to take action to address huge issues of 133 Million People with chronic diseases and disabilities. All people and your families. Thank you. [applause]. Thank you, mark. As we close the panel, senator, did you want to make any Closing Remarks . Where do we go from here . I think we heard senator alexander charge to us, but it is a stepwise process and we initiated this as i mentioned, with doctor, doctor Patrick Soonshiong only about three and half months ago, so i think theyre different issues and people who try to modernize fda before and to accelerate medical innovation. We have gone back and studied the progress that has been made that has not been made and the results overall have been some have been successful, but many have not. Unexampled Great Success is really what was passed in 2012 because we are seeing results with breakthrough therapy. For the breakthrough therapies in 2014 compared to 2013, and that track record is continuing into 2015, so we know action and identifying the problems in action legislatively that we can have fantastic results, which is encouraging. But, as we talked today and listening to what has come up and i mentioned the regenerative mend the absurd we mentioned medicine, we mentioned the compound cancer therapy, all of these we need to have further acceleration because if not all are at risk for being held back, being reined back by overzealous regulation, so all our areas as we look ahead to read the superbug area that i mentioned where we know we can do it. We know people we focus on and we can make a big difference. Alzheimers is that only of the top 10 killers that we have today that cannot be prevented and cannot be cured, inexcusable when we all know people with alzheimers. Also Congress Wants to do this to read we have heard from legislators and we have former legislators. We have a history with cures and the Real Progress that has been made they are. There chairman alexander who clearly said with the process will be early on and lamarr, thank you for outlining that. As lower mentioned the administration is open to innovative legislation. They are talking Precision Medicine and the act on the executive side, so the political will is there. The timing is there. We just need to make sure that the lot gets passed the one that will be passed as the most effective, smartest and most targeted piece of legislation out there. I think this report today with the Bipartisan Policy Center is all of us coming together bring in all together is a great first, second or third depending on when you want to start counting set, but we intend to delve into each of the issues that we have heard pieces of today deeper and deeper and deeper that has been identified in the report. I think this whole regenerative medicine, what to close on that because the doctor is a great leader and that and has basically pointed out again and again how things are being held back in the regenerative field and hopefully we can collaborate with him on that issue, so we welcome everyones feedback. With a lot of what you to read a great step forward and we need to have effective legislation that fundamentally will be the benefit and again as lamarr said to every single american alive today to read this is one piece of legislation and will have our favorite legislation passing effective fda modernization, every single american, every child out there will be the beneficiary. Thank you, senator. [applause]. So, we have time for questions before senator bennett gets here. If you could raise your hand. I see one. Where is our microphone runner . Jeffrey lerner. Then, if you could raise your hand. Thank you very much to read it really was a terrific set of presentations. One of my questions is with so much innovation on how do we discern what actually has staying power . What really he comes in actual innovation we can use . Is my understanding that part of the political aspects of this legislation are that agencies like arc, the agency for Healthcare Research for quality would be eliminated and so what is the mechanism for trying to determine what actually worked well . What works best . Is there a way to get together . Lamy answer with the Immediate Reaction and then turned to my two colleagues. There is no single answer. Arc, the whole government approach being able to analyze Health Services, inexcusable, i think, that there is consideration of it disappearing when Health Services of eight three trilling telehealth economy and 2. 3 is help services and we know have no way to evaluate them from a government standpoint, so i think youre right on their. I think the answer has to be all of us. It cant just be medical scientists. The political figures are the least equipped to address it except they can be an effective listener and ultimately write the legislation. I think the patients, are very small Advisory Committee. Mark cannot represent them all, but he represents just about all of them out there and that boy supposedly in this day and time will be the most powerful voice their. Mark, what you continue. I would agree. I think opportunity is to look at the whole package. I dont think there is a single innovation that is a silver bullet. But, wait some of you have heard me tell the story and i liken it to the experience i had growing up in northern maine where i live in a very Rural Community community where we had no electricity, no running water, which is common in this area of the state. When my parents died young in fact, most of my family died young which is why i am a patient advocate, i had to go home and renovate the house and i didnt realize it, but when i was growing up my mom wallpapered the house she put carpets down to read she put curtains up and everything was in a floral print and liftgate great to me at this time. She was so good at the wallpaper that we had to rub the wall to find the light switch. It was a challenge, but what i realized when they passed away and i had to sell this house was that no one would buy it and it had accumulated step of the course of 20 years. Our Innovation Ecosystem has not had a major update in almost 35 years. Science has changed dramatically. The recommendations in this report go mung and far and address a lot of those issues. The cumulative impact of that is you get a renovated house that you can sell for top dollar. That is what we need for our Innovation Ecosystem. Please join me in thanking our panel. [applause]. Thank you very much. To her leadership, our cochairs and Advisory Committee. It is now with great pleasure that i announced our next speaker, senator michael bennet. Since arriving in washington, he is not wasted a moment in his unrelenting site to create good paying jobs for folks in colorado and to restore fiscal responsibility to washington. He has emerged as a very effective leader with a proven record of bringing people together. With a member of the Bipartisan Group for democrats and four republicans that introduced a bill to fix our broken immigration system. In a way that boost the economy, strengthens National Security and provides a tough, but fair path to citizenship for millions of undocumented immigrants. Senator bennett is a very active member of the senate Health Committee and we have actually talked about some of the legislation that yet introduced, senator, today. A wonderful advocate for medical innovation, so please join me in welcoming senator bennett cock. I appreciate it. Im a bit hesitant to even read one of these notes at the end of the long day that you guys have had. Let me start by saying to senator frisk, we would be happy to have you back anytime you want come back to the United States senate. It has been unbelievable with a couple days here and it continues to be. Actually, i might stay with you because i think we are not voting until 10 00 p. M. Tonight, so i would be happy to fill in the time between now and then. Wanted to come by and congratulate the senator on release of this report, advancing medical innovation for healthier america and i know, by the way, senator alexander was here earlier today and he has done on astonishing job leading the Health Committee has the chair. He and patty are the lanky mentor member and came together with no child left behind, which was a bill we were supposed to pass seven years ago that before i was in the United States senate. When we are in the majority we couldnt get it on the poor and lemar and patty were able to lead a process on Health Committee resulted in a unanimous vote. After all of that a unanimous vote to reauthorize no child left behind and win ryan paul and Bernie Sanders are both members of your committee and you get a unanimous vote you are doing something right, which gives me a lot of optimism coming forward for the work we have to do. As the panel was saying and all of you know the reason we are here, a critical time for the life science sector. Fifteen years ago the first human genome cost nearly 3 million to sequence and we can do that for nearly 1000 today. What is it mean . It means the pace of what we are learning is moving much faster than it ever has before and we need to update and reform this regulatory structure in order to address 21st century innovation and in order for it to address 21st century economy that we have, which is actually how i got into this work to begin with. Colorado bioscience communities came to see me and said we cant raise metro capital in the United States anymore. Is all going to asia and europe. This was about five years ago and we had 400 bioscience [inaudible] to our desire to want to hold on to highpaying jobs in the United States, so senator burr and i went to Work Together with chairman alexander and Ranking Member murray to work towards reforming fda and that year a therapy bill, which he and i lead with senator hatch has now resulted in the approval of 25 therapies in just four years to read almost half of the new drugs that the fda has approved has come through that new pathway. Cystic fibrosis drugs, leukemia drugs, we need more of that kind of innovation the fda, not less, so senator burr, hatch and i are trying to replicate this with a bill focused on bringing breakthrough devices to market in a safe and effective manner. A few more of the areas we are working across the aisle also recommend in the bpc report that i deeply appreciate you including then there. Earlier this year, senator hatch i introduced the med tech act which would bring more regular tour certainly rounder fda regulation acts in health it. By setting clear rules of the road our leading software and medical Device Company as well as consumers will have a better expectation of whether some of the most cuttingedge products they use need to have an fda stamp of approval or not. Senator hatch and i are also working on a path act which will provide more certainty to patients and companies in the approval of antibiotics. The cdc has estimated 2 million americans become sick every year from antibiotic related infections to read at least 23000 of them die. The two clearly difficult for our Wounded Warriors who somehow become infected with deadly pathogens for which there are no treatment, so under our belt fda would be able to approve at the biotics in the infections under the same standards of safety and effectiveness, but for a limited population of people that needed the most. Our focus this year in the Health Committee should be on getting fda patients and our Life Science Companies clear rules of the road for a sector that sees over a hundred billion dollars a biomedical investment, public and private sector and is the sector that we lead above all other countries in the world. We are also trying to tackle economic and innovation issues in the area of Lab Developed test. Our nation leading Laboratory Medical device coveys the clarity about what needs to be regulated by the fda and what might not be to be regulated. This must be done with and i towards safety and innovation so patients have access to the most cutting edge Precision Medicine when i first got here, there was a lot of discussion about how to strike a balance and we do need to strike that balance, but we also need to realize that therapies that are unavailable to patients are also therapies that create a lack of safety or threatened peoples lives because if they cant get access to it it has the same result. Finally, the report is helpful and acknowledges we need to have the conversations around how to incentivize companies to focus on the heart hardest conditions in our country to treat. When there are more than 10000 conditions for which only 500 treatments exist we know there is a lot more to be done. The Health Committee and senator alexander has probably already said we are focusing on these issues. Of their bipartisan issues and make sense for both our economy and patience. I went to tell you my office looks forward to working with Bipartisan Policy Center as well as have to find a way to thread through the craziness in washington dc and ask a get something done for the people to read in my case in colorado, but all across the United States. Thank you for including me today. Its nice to see. [applause]. Trenton. Hello. I come from boston. Before i came into this meeting i was on the second floor with Elizabeth Warren and another gentleman there talking about the National Institute of health. How you guys going to be able to see making more money to these people we are the baby boomers and we will need more help when we get sick. Thank you very much for inviting me. Thank you very much for being here and i would like for you to give me the answer about that particular. Thank you. You say your name was caroline . I have a caroline, but shes 15 years old and shes camping in the mountains of colorado. This is a constant struggle for two reasons. One struggle has to do with acrosstheboard cuts with something called a sequestration , which by the way, was a result of a phot at 2 00 a. M. In the morning on a think it was new years eve in the United States senate. It was a 92 to eight vote and i was one of three democrats voted against it because i dont think have an acrosstheboard cuts is a rational way to approach governing and i think we cut eight terrible deal for america and it turned out it was terrible because 90 days later the sequester went into effect. The broad issue is that we have to get back to a place where we actually establish priorities and funding priorities, treating our budget like it reflects our values. The second part is we have direct ties there are people here who believe that there is almost no legitimate function for the federal government and they believe in particular that nih is a place where there is no legitimate function for the federal government. I dont think that is what most republicans for replete. But of the thats what most democrats believe, but there are a handful of people here that believe and they think its some sort of institution or if it is federal and affecting basic research and science read i can tell you this, we are at risk and its happening in my state of losing a generation of alzheimers researchers because of our inability to find these institutions to read to have the nih be able to go out and have institutions across the country as they once did through grants, which are now totally uncritical and its another instance where the kind of Cartoon Version, my words not yours, the Cartoon Version of what the Founding Fathers wanted us to be. Its getting in the way of the real world stuff that we actually need to get done. I have people come to see me every year from the private sector to say we need nih fully funded. These are republican Business People who understand that. So, we have to find a way to overcome it and i we will. I think there is a strong sense among a number of republicans that this cannot continue. I am hopeful to see something good come out of this meeting. I am a scientist. I left the lab because i was frustrated with the way research was being done and i agree nih should be fully funded, but it should be fully funded in the smart way. There is a lot of you new innovation out there for research, computational models to predict how pharmaceutical and drugs will affect the body. Trying to collect data from patients to identify new targets and new treatments and i think that is maybe a point of interest for me and for other patients. 92 of drugs fall in the Clinical Trial for several reasons and some of those reasons are the fact that they show a lack of efficiency when they go from Clinical Trial to human Clinical Trial and they also show new toxicities that were not shown in animal models or other studies. I am wondering how the panel and bpc is trying to work on this issue and maybe try to find new ways to do research. I will let the people that know what they are talking about answer that. I would just say on this that one of the things that we need to think about is as science changes and as the innovation happens and is the velocity of change is moving faster and faster and faster, which it is, its unclear to me that washingtons regulatory apparatus including the fda, but other agencies as well are going to be up to the task of being able to keep up with that sort of innovation. I am not coming with a policy recommendation on that. Is just not surveyed and that when you are looking at among other things this kind of computational power that we didnt have even a decade ago to decode the genome, for example, how are we going to figure out how to keep up with it and understand new things and understand what those risks really are . I have to slip out of here. Thank you for having me. Thanks for all of you work. Appreciate it. [applause]. Thank you and thank you for joining us today. We look forward to continuing the conversation. [inaudible conversations] [inaudible conversations] while congress is on break this month we are showing the tv programs that are normally seen weekends on cspan two. Tonight, authors and books on technology and the internet. Starting at 8 00 p. M. Eastern it is john palfrey, why libraries matter more than ever in the age of google. Jamie bartlett who wrote the darknet inside the digital underworld and stephen witt on his book how music got free. At the end of an industry at the turnofthecentury and patient zero of piracy. It all starts tonight at eight p. M. Eastern on cspan two. Are waived to the white house coverage of the presence of candidates continue live from the iowa state fair. On cspan, cspan radio cspan. Org to read as the candidates walk the fairgrounds and speak at the des moines registers candidate soapbox read on friday morning at 11 00 a. M. Eastern it is senator ted cruz. On saturday, republican governors Chris Christie at noon and bobby jindal at 1 00 p. M. During the twitter conversation at dmr soapbox. Cspans campaign 2016, taking you on the road to the white house. That the white house announced today that president obama will travel to new orleans next week. To mark the 10 Year Anniversary of hurricane katrina. It hit the gulf coast august 27, 2010, displace a Million People and killing nearly 2000. A briefing yesterday on the progress made since hurricane katrina. Good morning, everyone. We went to welcome you here for this Media Briefing ahead of the 10 Year Anniversary of hurricane katrina. Today you will hear from secretary and several senior individuals who have worked tirelessly. I went to let you know we will pay questions later in the program from assembled media that is here as well as viewers on the cspan two and we encourage you to send in your questions via twitter at hud god or katrina or by email. Without further delay