Bill frist and had the opportunity to watch firsthand governor alexander work was a pretty rowdy Democratic Legislature and tennessee that he came forth with education reform, with infrastructure, investments, industrial recruitment. I think regular order is back in the senate and will be a better country for that. Is fortune is going have a good partner in the house, someone for the good fortune to settle the Energy Commerce committee with, diana degette, and diane reminds me, when i think of her i think of a story my grandmother may read the of the detention a good. I think i can, i think i can. I know i can. Thats diana. Come forth with a major bipartisan vote in the house. Senator alexander come to the good partner and diana, tell us whats going on with you. [applause] thanks, part. Im so happy to be here. They dont invite us to come over from the house very often so its really a treat for us. Im so happy, lamar, to hear your reflections on some of these issues, because to some of you know, chairman upton and i worked really hard. When youre talking about all the hearings we had, we had hearings, we have roundtables, we had white papers, we had union. We worked for about 18 months trying to get consensus, and many other people in this room attended multiple of those hearings. So you know what were talking about. I was really, really pleased when i found out that senator freshman congressman gordon were heading out this effort because they really found meaning areas where we could make substantial updates to bring new treatments and cures to patients. The good news is that this is similar to the consensus chairman upton and i found in the house, and i think what it shows is that there really is a large amount of consensus about what we need to do to the regulatory process but also the resources that we need to bring to bear on expediting Biomedical Research at the nih and bring it to approval at the fda. Across the medical and research fields, as fred and i found, experts from different backgrounds and all different sectors really agreed about the improvements that we can make it todays report that was released, i havent read it in detail yet to read the executive summary, and it offers us a lot of the same proposals that echoes a lot of the things that we heard in the house and then acted on in h. R. Six. I just want to highlight a few of the similarities in this report to what weve seen in our house investigation. For example, in the report that our recommendations to more effectively include the Patient Perspective throughout the drug and Device Development process. H. R. Six has several provisions that strongly echo this policy. In addition there are several recommendations in the report to strengthen publicprivate partnerships. This is something again that we highlighted in the 21st century. Further there is a recommendation to accelerate the development and approval of antibiotics. This is a provision thats been a little bit controversial in the press, especially since h. R. Six past the house. But when crafted in a very careful way, and in hand with the agency giving us technical assistance, we know that this is something really important, specifically to do with those cases of antibiotic resistance. This is also included in h. R. Six. I could go on and on but you be glad to know im not going to. Im under the house rules today, but what i want to say is that i think that we can find a great deal of this consensus. One thing i do want to talk about very briefly is the importance of new resources for our flagship medical research and development institution. Fred and i as part of our quest went all around the country. I was in san francisco, michigan, fred was in denver. We were all over the country at biomedical institutions. And whether wer we are talkingt the fda or the nih, they are were given multiple priorities in a very stifling budget climate and the need to have the ability to carry out the ideas that are circling around right now. I want to keep you an example. We were having one of our bipartisan roundtables over in energy and commerce room, and Francis Collins turned to me and he whispered, he said, diane, if we had had full funding for the nih and we had not been under the budget cut, then we probably wouldve had a vaccine for ebola i know. And i said, francis, youve got to tell the whole crew. He did. He said it on the record. What he meant was because of a lot of the budget constraints, what happened was many worthwhile programs Like Research on ebola vaccines were put on the back burner in favor of diseases that are naturally in this case seemed to be much more of a threat. So really with all of the great breakthroughs we have going on now, we need to also be able to research the innovation. As most of you know, we passed 21st century and house at the beginning of the month. We passed it 34470. You cant pass a journal without by the way. So we were really gratified by our efforts but we know, and we hope, that this bill will just be a resource to the senate as the senate embarks upon its very important investigation this fall. Im also really encouraged that our efforts have been joined by serious discussions and working groups at the senate h. E. L. P. Committee. The Bipartisan Policy Center initiative really adds the substance expert analysis and further momentum for the conversation. We have an opportunity to make important updates and reforms to our Biomedical Research and development systems. After the last century of remarkable medical discoveries, we want to make sure that in the 21st century the pace of breakthroughs, treatment and cures accelerate to meet the challenges of our time. Some of you know fred and i did traveled around together or 18 months, and so i would be remiss if i didnt make the fred upton point right now, which is the appropriation under 21st century cures begins in fiscal year 2016, so thats october 1. Anyway, we are glad to be here. Were glad to be of any resources that we can be. We are thrilled the senate is taking up, and we are thrilled to be here at this update. Thank you very much. [applause] thank you very much. Good afternoon to my name is janet. Im glad you all made it to be. We had a bit of a shower coming into our event. I served as director of Health Innovation of the Bipartisan Policy Center. On behalf of bpc, welcome all of you today. So the going to spend all a bit of time going through the report and you should have it if you walked in. And with that we are delighted to you from our cochairs, and if i could ask you to come to the table and hard by the committee. While theyre doing some going to take just a minute to introduce each of them. You able to meet with senator bill frist the open us up to date. Is a nationally recognized health and Lung Transplant surgeon. Imagine the also a former Senate Majority leader. On his left the also, this is congressman gordon, representative gordon, former congressman who served as the chairman of the help committee on science and technology. During his tenure in congress focus a great deal of his time on improving americas competitiveness. And weve got a lot of that can report and well hear about that during our panel discussion. And lets see. All the way to your, lets see, to your very left, youre very right im delighted to introduce patrick soonshiong, just look in your from los angeles, hes a physician, surgeon and scientist and has pioneered for both diabetes and cancer, published over 100 scientific papers and has over 95 issued patents a groundbreaking advancements standing newt of fields. And then final im delighted here on my left to introduce mark boutin who ive known for a long time. Mark is the chief executive officer of it or position called the National Health council, a really amazing organization. Brings together, provides a unified voice for more than 1339 people in our country, nations and individuals, those who are sick and those who have disabilities. And has been a real strong support for medical innovation. Im sure that our third Advisory Committee member, mark mcclellan, who serves as a senior fellow and director of Health Care Innovation and got initiatives at the center for Health Policy at the Brookings Institution couldnt be with us in person today. So im going to move over here so we can get into the panel discussion. [inaudible] there we go. Our first question, i thought senator, folks have just seen the executive summary, the longer letter is on the website, pretty long, 80 pages. I wonder if my able to to folks in the room sort of a broadbrush around whats in the report. Janet, thank you. Again the website makes it available but for those of you who are here, the report is hot off the press. The final finishing touches this morning. Easily digestible but let me point out a couple of things. The first area of the report is focused on, we have four areas, and its easy to think about it this way. First area is on improving the medical Product Development process. The article budget issues covered but to give you sense of those with the highest priority but their circle is the following. We call for congressional action to increase in the generation and use of realworld evidence. All of this data is accessible today but its hard to get into the fda in the consideration process. How to take advantage of all this data of information, technology is generating on us underground devices about drugs . Not only postmarket surveillance, which is critical, but also approval of the new indications for existing products. Ultimately, into the Clinical Trials themselves that are used for regulatory review. We also call for actions that enable the dissemination of scientific information to support that whole clinical decisionmaking regarding something thats misunderstood i think generally but for me as a heart, lung, transplant surgeon, that is what the offlabel use. Very confusing to people but it has to be addressed up front. More than one in five outpatient prescriptions, one in five are written for offlabel therapies today. It is critical, fundamental, lifesaving. All of that is to get the approval process is set up to get approval for a new indication, drug or device has got to go to an entire Clinical Trial process. That doesnt mean for drug you know works and has been shown scientifically to work should not be given to patients in need. The fda doesnt regulate the practice of medicine. Nothing prohibits physicians from prescribing drugs offlabel that you know will help them. Manufactures interestingly are generally restricted, they can share that information, good, Accurate Information offlabel use of the product. That inability to share is a huge barrier into effective and safe use of those drugs. In order to balance the risk and benefits of offlabel uses, physicians, that doctors have to have that information, that i could information that right now is being denied them. Nobody is intended to deny. As an example of an example of an antiquated structure very good for the times, right now for the today, scientist and so fast, needs to be reform. We also call for harmonization of International Requirements and standards. I think bart, you come to that because anyone of our discussions we know america is great, the best, the most innovative but theyre good things happening around the world in a scientific way they need to be assimilated into our thought processes and databases. You also see, i dont have the pages before you right now, but we address the whole issue of interoperability, improved interoperability of Health Information technology. Lamarr implied it, you did imply it, with all these different standards, to improve the outcomes for patients. This is a foundation i think for where we are today, not on improving the medical Product Development process from idea to clinical delivery, also for the broad aspects of health care which lamarr did mention, including delivery, getting into the field, payments for the strategy for empowering the patient who has all this information today that we didnt have 10 years ago. We talk about the increasing regulatory clarity. I am going to what all that means that is what regulations actually mean, who is responsible for what, who is in charge and to get clarity. Very, very confusing today. Congressional action is going to be needed to approve the regulatory clarity and the violation of things like combination products, where you are putting different things, different stuff together. Who is responsible for regulating that . Some of the most Innovative Products unlike when dad was practicing medicine 40 years ago is the ability to combine drugs and devices in ways that heretofore have been impossible. This whole field. In my own field of heart specialty, an example would be a drug to begin about 15 years ago for the treatment of coronary artery disease, which mechanically opens up the coronary artery. Insulation devices instead of injecting for the management of diabetes, patches for the treatment of early parkinsons disease are all examples. Theres a lack of inter center, between center elimination of the roles and responsibilities. For those of you who follow the fda closely know what im talking about when you look, who is really responsible for them to lead on it to be clear for the clinical investigator, you need to know who is responsible. That is the rules of the road. Uk conflicting feedback, lack of clarity, chaos which slows down the field as people try to rectify that. A Regulatory Framework can do that for approval and delivery, rejection. There is little consistency and predictability in the decisions made by the office of a combination of products. Since the nonleague center if you centers, if a nonleague center received no user fees for the work, they dont get paid for it yet their part of the process that becomes very confusing. There is little incentive for a time and review of data and products by the nonleague center. Another example, clarity regarding regular effort to associate with the laboratory develop test, its very confusing. Many of us have expressed with directly but when it comes down to Laboratory Tests, diagnostic tests, trying to figure out what is good, bad, what works, its not a big part of spending the e Laboratory Test due to a vatican clinical decisions made. So he was approving and who is responsible is very important. We call for congressional clarification, including clinical software, the things we carry on our iphones around, i. T. Software should not be regulated as a medical device. That software cant be because the medical device is a device, its a thing. When we have Regulatory Framework, it just doesnt work it slowed the innovation. That uncertainty keeps people from innovating. Also clarity is needed uncertain regenerative cell therapy. Great example, adult stem cells is exploded in my own field of Heart Disease and orthopedics and as all of us page you tend to Pay Attention to those things. Right now we are trying to approve these regenerative cell therapies and an antiquated system designed 20, 30 years ago when it didnt exist there. Stem cells, other genetically modified cell therapies argument hold the most promise for curing many of todays insurmountable untreatable diseases that are out there. Additional therapy is needed to assure fdas regulatory, or recognition of unique nature of the stem cell therapeutics, in particular oncologist and similar therapies. Different world when i was in the senate, all embryonic. Adult stem cells got locked down there. More work needed Oversight Framework of come as lamar mentioned, the president s Precision Medicine, what exactly is that and what is a Regulatory Framework. Third area we talk about is strengthening the fdas ability to carry out this mission, its culture. We have so many great people, smart people working every day but working with an outdated framework. We focus on the nation. Mark mcclellan could not be with us, but a lot of time talking about how important that is. We have a number of recommendations in the report relating to the fdas human resources, how do you hire people today, many of these will require elaboration with hhs and the office of personnel management. We all know in government the hiring of a process, hiring and firing and recruiting process, happens in the legislative branch, it needs to be addressed. That whole human resources. Recall of the need for fda to expand the effect effectiveness of publicprivate partnerships. Finally, ive gone on too long, with a section on improving access to medical products for unmet Public Health needs. It is a Government Role and responsibility to look at the unmet needs that may not have a financial incentive to go into. The Biggest Drug Company would amount to make a lot of money just to go to the scientist do not concentrate. Researchers will not be there but theres a Huge Population of Public Health needs and that is a specific role of government that the fda has a very important obligation and responsibility. Lastly let me just say another area is the need to accelerate the development of something, again, that affects everybody in the room that is use of antibiotics. We see a lot in the press today. We know superbugs are an issue. How can we, we know theres a problem, window people are dying from it and it is created by our use of other antibiotics. We need to celebrate to treat, teacher and the attitude. We have to give special attention to the approval for the superbugs. I hope we can talk more about it. I went on way too long but those are the four sections. Read the report and we can talk more about some of those sections as we go through. Thank you, senator frist. As he mentioned theres a lot of recommendations in the executive summary and what we have on our website and represented th to gt vocal of it about this is a combination of cures that we hope the senate will move forward. Things that our interest that would like to go over that further and one of those is around the use of realworld evidence of a postmark of the premarket. And our number of new ideas that are not in the 21st century, cures legislation. You could go to the bpc website. Weve been isdc crosswalk for you. Were going to run through a couple of the topic areas and one thats very important to us is about competitiveness of american companies. I wonder, representative gordon, if you may talk a little bit about that and other port recommendation improve our country, our nations competitiveness . Is this on now . Maybe you have to turn viewers off. Hello . Senator frist is excited about this report. [laughter] i think for good reasons. The best thing for me to do is decide a man. Following senator alexanders senate model i was a Little Something anyway. As you know when we worked together, we found after world war ii to the end of the last century the United States pretty much led the world in all economic areas. The way we did it is witty simple formula. We invested in education soviet a Skilled Workforce and we invested in research for new ideas, improved ideas, new services. And by many report half of our gdp resulted from our investment in that research your answer then comes the next century and were seeing a couple of things happen. Our investments are starting to either be stagnant or going down, and the rest of the world is increasing their investments. They read the book. They figured out what the secret formula was. Just a quick example. In the area of our and the in the pharmaceutical and medical device area, from 20072012 r d our share of the worlds investment went from 50 to 44 . At the same time asia went from 16 to 23 . We have to get our competitiveness back again. We talk about putting more money into the pot and assorted that is one aspect, but if we can get more use of the money we are spending, you get the same results. A couple areas i think of her import for us to look at is interoperability have senator frist mentioned, and i think the great resource, and a republican specific recommendations. And if you see the government start to lead in these areas to know the a Market Driver for other areas. Another thing i think is going to be ignored and we have unique ties to do this is this is looking at interoperability as well as harmonization and mutual acceptance on a variety of international standards. We just got through passing, you all just after passing fast track. To like it or not here it comes. Tpp is being worked on now. Ttip will be coming up soon after that anderson unique opportunities whether it is through the agreement itself or through that vehicle to have these discussions. Find out how can we have some harmonization, the to acceptance in a safe way to help reduce the cost of bringing drugs to market. Right now in the United States it takes about 10 years and 2 billion to get a new drug on the market. Surely we can do better than that. Thank you. Dr. Patrick, youve had a long history of developing and implementing new and innovative ways to battle cancer. I know the whole topic of precision nation is one thats very interesting and a passion for you. Can you talk of love that about advancements in this area and application for fda . How does and they need to devolve getting all the fans went in science . So i think the issue, and you brought up Precision Medicine, this is a bipartisan event. It is so fantastic in terms of timing. What i will do is maybe layout, i spent 30 years of my life down looking at this issue of cancer as a problem, first as a professor, then leaving the university for breast cancer, pancreatic cancer and lung cancer. For that event i want to play up the problems, scale that as we age. The reason weve lost the war engages because weve gone down the wrong assumption. Ill explain that. Then i explain a Precision Medicine actually can save us. And explain what we need to do. Weve always assumed as a nation and as a society that cancer was a single clone, that is horrible clone have happened in your cells as they clone grows and youll to a. Over 40 years weve been going down this path of single drug of single dose of chemotherapy or radiation therapy. It made sense. In fact, it was a simple clone, quasimade sense, that we tried to kill this clone, put you through a horrible process and hope you come out at the end of that alive with the clone did anybody a life. And if that were true we would have cheered cancer today. Amazing, that assumption was made by single mathematical calculation which in retrospect was in error that cancer cell just grew linearly. It turns out now through nextGeneration Sequencing that cancer, there are 10,000 clones that happen in your body. It also turns out that you and i as were sitting there producing probably 10,000 cancer cells a day but your body actually has a protective mechanism to protect your body from actually having those cells grow and as a way of killing it. So they are 10,000 clones which are now discovered osha nextGeneration Sequencing and through genome sequencing. Then the idea of zapping you with, nuking a patient with maximum tolerated dose of cancer has failed because it killed the one cancer cell and the others come out and so those be, weight. Weve gone down this path, and by, in 1990, 25 years ago i wrote the first paper on this very ancient self at you and i have everybody called a natural killer cell that floats around in our body. If we can cause the celtic yuba county would find a new way. Et cetera for years weve been wiping out the very same cell thats giving us maximum dose of chemotherapy. When i left the university, only drug approved in the country, in the world, one of my challenges want to go around trying to explain to the oncologists we must was taught this identity maximum tolerated dose. I lost the argument by the way. I secretly went and ran my own clinical protocol. So this is the wonders of america because i came from south africa as a physician as a surgeon and a scientist, though they company that pursued which became a multibillion dollar company. So i can pursued this opportunity. So on that idea we then gave lowdose chemotherapy, entity with patients with pancreatic alive for years, five years, eight years alive without the disease, they would normally be dead in two months. So the challenge then is how do we now have changed that but what we have now discovered it is one, ill take you through the Precision Medicine, we can now do the next Generation Sequencing on human beings. Announced this at the rate of 2000 today. They are 13 million cancer survivors in our country. We can identify a sequence and know which clone to get, which naturally. You need to get with lowdose multiple forms of chemotherapy that was just stress the cell and not kill so you can harness your immune system to inject that into the blood and reverse that. Tomorrow we are going public. That Companies Going public in which the natural killer cell want to launch on this nation. Science is so complex that most clinicians cannot understand the science which means they need interoperable Decision Support tools. I came to this white house, for four years, worked with to employ 40 billion we would spend with Electronic Medical records in which we are actually spending the money and medical records that prove by its nature will not talk to each other, and epic system, a proprietary system by nature will not talk to each other. So if you dont have interoperability you do not have shared information, dont have intelligence. How then could you treat the patient who has two months to live with information that could affect his life for her life in realtime . So thats what is now put in place. This is the opportunity now through this system. The next question how to put in place the capacity or every human being to have this sequence done in realtime to know with specificity which drug to give commen, and by the way,y would a combination of drugs, some owned by five, three different pharmaceutical companies. How can we regulate the competition . Whos going to prove giving a combination . How are we going to fund that combination . These are the challenges i think faces and this is all Precision Medicine which im happy to say that has been at the forefront and we have the capacity now to go into this. Thank you, dr. Patrick. You for we move to q a, mark, weve got a lot of recommendations into about integrating the voice of the patient and helping them with access to needed treatment. Can you share a little bit about those, and then well move to q a. Thank you, janet. Lets touch on two issues that are near and dear to my heart, sort of , on now . All right. So the National Health council is an Umbrella Organization of the nations leading Patient Advocacy workstations, and many are represented here in the room. I want to speak to you and the audience and say collectively the National Health council represents 35 of the population here in the United States. So asked by raising your income, and get somebody somebody in your immediate family or circle of friends with a chronic condition . Raise your hand. Thats why we are all here today. I want to talk to you just about to provisions that have been put forward but the overwhelming weight of these recommendations is huge. It renovates our entire Innovation Ecosystem integrates the environment for us to develop highly needed, highvalue treatment for all the people we care about in our family. The first issue is patient engagement. Its a little bit ironic but we have created a system where everybody speaks for the patient. The doctor speak for the patient to the researcher speak for the patient. And as a surrogate for what is important to us. Their opinions are important, but when you ask them what is most important for the patient and then you ask the patient, you get a different answer. Its ironic that we have built up a system that has created barriers to the biopharmaceutical sector and the regulators to actually engage the patient. Let me be specific. Right now for a Biopharmaceutical Company to engage with patients, they potentially could be subjected to millions of dollars in fines for marketing and im approved product. Everybody in the room has a smartphone. The developers of those products that you all have in your pocket would not change the color or any feature of the phone without engaging the enduser first to understand how it would impact them. Yet we dont do that in the development of medication. Every major Biopharmaceutical Company has spent more than 2 billion developing a product, brought it to market and realize it didnt answer the question that were important to the patient. That is a huge amount of money that couldve been devoted to treatment that answered a question was important to a patient. We are not invited to determine the research question, and when we are those research question, in a different way. We are not invited to determine what the patient reported outcome should be. Think about that for a minute. Other people are deciding for us what are the most important outcomes. We should be part of that process. They are our great methods for doing it. We have a president that has been elected twice using these methods in the social sector. We dont use patience when we develop Clinical Trials and as a result we had a hard time popular and then and a hard time keeping people in them. Huge opportunity to shorten of Drug Development time by having as participate in the development of Clinical Trial protocols. We are not involved in the determination that is a judgment about risk and benefit. Huge lost opportunity. At the end of the day of judgment that fda makes on risk and benefits is just that, 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 of benefit and risk, their tolerance for the disease, their tolerance for existing treatments. Huge opportunity to get that information into a label. This is not a substitute for the current Regulatory Approval process, which is the gold standard. Its adding Additional Data would go into the labeling, out of the back end so that when i meet with my doctor and tell him whats important to me, they can determine from among multiple treatments which one will address what i want addressed. Huge opportunity, huge consensus in the patient community, and the biopharmaceutical sector and within the fda. This is a huge opportunity for congress to remove some of the barriers that exist and to encourage fda to move forward in changing its culture to make this a reality. The second issue i like to address deals with ensuring that treatments for unmet medical needs are develop. There was legislation introdud in the house that had 90 cosponsors, in the senate, introduced legislation dealing with dormant therapies. This is legislation that is critical 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 develop a medicine without a strong patent, the less well understood fact is that many potential treatments, potential as many as 80 , dont qualify for a patent. As a result they are never developed. Second, 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 is going to last 15 years because the development of the disease takes too long. For a company to invest 2 billion to build a treatment for alzheimers and then only have a few years left to market it without generic competition means that they abandon a promising product. We see companies leaving the neurologic space, the autoimmune space, the prevention space in cancer. We have an opportunity to say patent system works but we can provide an alternative pathway if you have a product that addresses an 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 for 133 Million People with chronic diseases and disabilities, all people in your family. Thank you. [applause] back 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 charged us, but it is a process that we initiated this as i mentioned with dr. Mcclellan, senator thune, mark three and half months ago. I think theres lots of definition. Even tried to modernize fda before, took some at medical innovation to we have gone back and studied the progress that has been made and the result over all of these attempts have been, some have been successful but many have not. An example of Great Success is really what was passed in 2012 because we are seeing results in these breakthrough therapies. Looking at approval to more than triple for breakthrough therapies in 2014 compared to 2013. At a track record is continued into 2015. We know what action at identifying the problems and action legislatively that we can have fantastic result which is for encouraging. But as we talk about todays listening to whats come up, and mentioned the Regenerative Medicine field, we mentioned Precision Medicine, we mentioned compound cancer therapy. All of these we need to have further acceleration because if not all are at risk for being held back, being bring back by overzealous regulation or vague regulation. All our areas as we look at the the superbug area that they mentioned where we know that we can do it. When a people are being hurt, we know if we focus on we can make a big difference. Alzheimers is the only other top 10 killers that we have today that cannot be prevented and cannot be cured, inexcusable when all the people with alzheimers. Also think its good for todays discussion that Congress Wants to different we have former legislators, the history with yours and the Real Progress that has been made there. We are chairman Alexander Pickler said with a process will be earned on and things are out money for. The administration is open to innovative legislation. They sent the signal, talking Precision Medicine made active from executive site. The political will is there. The timing is there. Which is dated make sure that the law that gets passed, is the most effective, smartest, most targeted piece of legislation, there. I think this report with the bpc, its all of us coming together bringing all the stakeholders together, its a great first, second or third in him when you start counting step, but we intend to delve into each of the issues and we for little pieces of today, deeper and deeper and deeper that have been identified in the report. I think thisll Regenerative Medicine, i do want to close on that, because as pointed out again and again how things are being held back in the regenerative a few. Hopefully we can collaborate on that issue. We welcome everybodys feedback. Weve got a lot of work to do. Great step forward and that we need an effective legislation that will get the benefit as lamar said every single American Life today. This is one piece of legislation, we all have our favorite piece passing effective fda modernization. Every single american, every child out the will be a beneficiary. Thank you, senator. [applause] we have time for questions before senator bennet gets you. If you could raise your hand. I see one. It is a mic runner. Jeffrey lerner. And if you could raise your hand. Thank you very much. That was a terrific set of presentations. With so much innovation how do we discern what actually has staying power . What really becomes an actual innovation we can use . If my understanding that part of the political aspect of this legislation are that, agencies, the agency for Health Care Research and quality would be eliminated. So what is the mechanism for trying to determine what actually works well, what works best . Is there a way speed let me give an answer that sort of any reaction and then let me turn to my two colleagues. That is no single answer. The whole government approach being able to analyze the Health Service is inexcusable that they think theres any consideration is disappearing when Health Services, frequent ourselves economy, 2. 3 selfservice, no way to evaluate the from economic standpoint i think youre right. I think the answer really is iss not the oldest it cant be just a medical scientist. The political figures on the least equipped to address accept they can get bigger if it can listeners, can write the legislation. I think the patients, very small Advisory Committee, mark cameras have been all but they represent just about all of them out there and that voice ultimate in this day and time ultimate this country the most powerful voice. Market, why dont you continue to . I would agree. I think the opportunity is to look at the whole package. I dont think theres a single innovation that is a silver bullet. Some of you have heard me tell the story and i like it takes. I had growing up in northern maine where i lived in a very rare world committee, no electricity, no Running Water which is common in this area of the state. When my parents who died young, most of my family died young which is why im a patient advocate, i had to go home and renovate the house. I didnt realize when i was growing up my mom wallpapered the house but she put carpets down, curtains up and everything was in floral print, looked great to meet at the time. She was so good at the wallpapered pancetta rub the wall to find the light switch last night it was a challenge. What i realize when the password and had to sell this house with nobody was going to buy it. It had accumulated stuff over the course of 20 years. Our Innovation Ecosystem has not had a major update in almost 35 years. And science has changed dramatically. The recommendations in this report go long 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. Thats what we need in our Innovation Ecosystem. Please join me in thanking our panel. [applause] thank you very much. Its now with great pleasure that i announce our next speaker, senator michael bennet. Since arriving in washington he hasnt wasted a moment in his unrelenting fight to create good paying jobs for colorado, folks in colorado, and to restore fiscal responsibility to washington. And he has emerged as a very effective leader with a proven record of bringing people together. And was a member of the Bipartisan Group of eight, four democrats and fo four republica, that introduced a bill to fix our broken immigration system in a way that boosts the economy, strengthens National Security and provides a tough but fair path to citizenship for millions of undocumented immigrants. Senator bennet as their active member of the senate h. E. L. P. Committee and weve talked about some of the legislation that is introduced, senator, today. And a wonderful advocate for medical innovation. So please join me in welcoming senator bennet. [applause] well, i appreciate it. Im a little hesitant to even read one of these notes, the long day you guys better let me start by saying to senator frist, wed be happy to have you back anytime you want to come back to the United States senate. Its been unbelievable couple of days here, and it continues to be. Actually i might say, because when a voting in till 10 tonight, so happy to go in the time between now and then. I wanted to come by to congratulate the Bipartisan Policy Center on the release of this report, advancing medical innovation for healthier america. I know senator alexander was here earlier today, and he has done an astonishing job leading the help committee as chair. He and patty murray came together around no child left behind, which was a bill we were supposed to past seven years ago that was before us in the United States senate. When we were in the majority we couldnt get it on the floor. Lamar and patty were able to get a process on the help committee resulted in a unanimous vote after all of that, a unanimous vote to reauthorize no child left behind. When rand paul and Bernie Sanders are both members of your committee and you get a unanimous vote, you are doing something right which is the a lot of optimism, board for the work weve got to do. Asked the panel was saying and as all of you know, the reason you here, a critical time for the life science sector. 15 years ago the first human genome cost nearly 3 billion to sequence. We can do that for a thousand dollars today. Remarkable. 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 to to address 21st century innovation and to address the 21st century economy that we have which is how i got into this work to begin with. They said we can raise Venture Capital and the United States anymore. Its all going to asia and europe. This was fighters ago. But we have 400 bioscience firms pay an average salary of 740,000 in colorado. That seem like a challenge to do not want to hold onto highpaying jobs. Senator burr from North Carolina and i went to Work Together with chairman alexander and Ranking Member murray to work towards reform the fda. That your a therapy bill that he and i with senator hatch has now resulted in the approval of 25 new breakthrough therapies, almost half of the new drugs that the fda has approved have come through the new pathway, Cystic Fibrosis drugs, lung cancer drugs, leukemia drugs. We need more of that innovation at the fda, not less. Senator burr, hatch, and are trying to replicate this with a to focus on bringing breakthrough devices to market in a safe and effective manner. A few more of the areas were working on are recommending in the bpc report and i appreciate your including them. Earlier this year senator hatch and i introduced a med tech act which would bring more certainty than 50 certainty of medical software, perhaps and health i. T. By setting clear rules of the road our leading software and medical Device Companies as well as consumers will have a better expectation of whether some of the most Cutting Edge Products they need cash that they used me to have a stamp of approval or not. Were working on the 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 and at least 23,000 die or its difficult for our when divorced sometimes become infected with deadly pathogens for which are under treatment. Under our bill fda wouldve to approve and the products the most dont infections and the same standards of safety and effectiveness but for a limited population of people that need it the most to our focus this year in the help committee should be on giving fda patience and a Life Science Companies clear rules of the road for a sector, public and private sector but it is a sector that we leave above all other countries in the world. We are trying to tackle economic innovation issues an error of lab develop test. Our nations leading laboratories need clarity about what needs to be regulated by the fda and what might not need to be regulated. This must be done with an eye towards safety, innovation so patients have access to the cutting edge recession. When i first got here there was a lot of discussion about how to strike that balance. We do need to strike that balance but we need to realize that therapies that are not edible to patients are also therapies that create a lack of safety for threatened peoples lies because if they cant get access to it, it has the same result. Finally, as the report acknowledges we need to have the conversations about how to incentivized companies to focus on the hardest conditions in our country to treat. When there are more than 10,000 conditions for which only 500 treatments exist we know theres a lot more to be done. The help committee as senator alexander is probably a reset is focusing on these medical innovation issues. Bipartisan issue that make sense for both our economy and for patients. I wanted to office look forward to working with Bipartisan Policy Center as we always have defined way to thread it through the crazines craziest washingtot something done for the people in my case in colorado but also across the state. Thank you for including me today. Its nice to be here. [applause] [inaudible] sure. I may not have an answer. I come from boston. Before i come into this meeting i was in the second floor, another gentleman there, thinking about the National Institute of health. How you guys are going to be able to see, make more money for these people . We are the baby boomers, and we are going to need more help when we get any type of sickness. So thank you very much for inviting me. Thank you very much for being here. I would like for you to give me catch about that, thank you. Did you say your name is caroline . I have a 15 yearold caroline but she is out camping in colorado. This is a constant struggle at a struggle for two reasons. One struggle is, has to do with acrosstheboard cuts in something called sequestration of the sequestered which by the way was the result of a vote at 2 00 in the morning on i think new years eve in the United States the senate. It was a 928 boat. I was one of three democrats voted against it because i think having acrosstheboard cuts is a rational way to approach to governing unethically cut a terrible deal for america. It turned out it was terrible because 90 days later the sequestered went into effect. So the broad issue is that we have to effective placeholder establishing priorities and funding priorities, treating our budget like it reflects our values. The second part is when to recognize the are people here who believe theres almost no legitimate function for the federal government