People dont know that. Theres no statues of these gangsters. This was the epicenter of 1930s era crime. J. Edgar hoover had this building as their headquarters. Its also the building where those bootlegers were tried, sent to alcatraz and other prisons across america. Its where it began and where it ended. Were standing here at this historic fort, looking over the junction of the mississippi river. St. Paul is located up the river from ft. Snelling. Its intimately constructed. Settlers living on the militarys property. Finally the army had had enough of competing with them for resources and felt they should be removed officially from the military property. Settlers then moved across the river to the other side and farmed what became the nucleus of the city of st. Paul. When you think about the story, the history of this region, you think beyond the walls of ft. Snelling. And thats what we try to do here at ft. Snelling, push people to think more about what does it mean when all these cultures came together . What perspectives did they have on these Historic Events . Watch all of our events from st. Paul saturday at noon eastern on cspan book tv and American History tv on cspan 3. Now, hhs secretary sill via burwell, dr. Francis collins and fda commissioner dr. Margaret hamburg talk about ongoing efforts in the medical community to improve and develop new treatments and cures. They talk to the house energy and subcommittee on help about innovations they see on the horizon. This is about two hours. Again, well get started. Good morning, everybody. Today, this morning, were going to continue our really very strong bipartisan efforts on the 21st Century Cures Initiative with this round table to discuss ideas that the committee has received the last couple of months and look to more specifics about the steps that we can take to accelerate the cycle of cures, embrace Technology Advances and the rise of personalized medicine and keep america, in fact, Innovation Capital of the world. Over august and early this month, our Committee Members, including degette, pitts, and johnson, heard how its providing hope, saving lives and, yes, creating jobs. The 21st Century Cures Initiative affects every american, every one, as they, their families or friends have been affected by disease. Our Committee Members heard during august, hard work remains to find and deliver cures and treatments for the approximately 95 of diseases without cures. Weve seen an outpouring of support, both outside and inside washington to Work Together and to achieve this common goal. So today, to continue that work towards more cures and treatments, we brought together truly another allstar round table. Joining us, we have secretary sylvia burwell, secretary of hhs, dr. Francis collins, director of the nih, dr. Margaret hamburg, commissioner of the fda. Michael milken, chairman of the milken institute, dean kamen, founder deka research, mr. Bill parfet, chairman and ceo of research from michigan. And dr. Dan theodorescu, of the colorado cancer center. We need to hear from our participants as much as possible. Thats why we have this round table today. Were going to listen. I know that my colleagues agree with me that the participants are the expert experts, and thi table is an opportunity to learn. To that end, while we may want to ask the experts some questions to guide the conversation, we want to keep our talking to the minimum. And i would also ask the participants to try to keep their answers brief to so that we can keep the conversation moving knowing that we have a hard stop at noon. In closing, i want to thank these folks who have offered their input on the 21st Century Cures Initiatives. I cant tell you how much we appreciate the thoughtful contributions of Everyday Americans and we intend to release a cures legislation draft early in january 2015. Well look to swiftly move the legislation early in the next congress. If you want your idea considered, you can send it to cures mail. House. Gov as quickly as possible. The more specific the idea, the better that it will be. So now i want to turn to my colleague, Diana Degette from the state of colorado. Thank you very much, chairman. Thank you for convening this last round table. I want to welcome everybody here today. I see the chairman today, in whose shadow we toil. Im glad hes here. I want to thank secretary burwell for coming. I know she has a very busy day and, of course, my homie, dr. Theodorescu, thank you for coming all the way out here. As fred said, weve been working together to hold a big series of round tables and hearings on the 21st Century Cures Initiative and have taken many white papers. Weve had a lot of suggestions, but i think we will both agree that we have a lot of commonality in the themes that were hearing and were eager to sit down and actually start drafting legislation. The round table that we had in denver over the break, we talked about personalized medicine. And we had active engagement and interest from the audience. We heard from the nih, the fda. Weve heard from local universities and Health Centers and private investors, industry and researchers and we really are beginning to hone in on some areas that we can think about how we streamline the process so that we can get from the lab to the clinic. And thats very important to all of us. One of the things we talked about, for example, was the potential time and cost savings of a central r. I. B. Process, something ive opinion working on for a long time. We also talked about the importance of sharing data and information among clinical registries. And these are just some of the topics that fall under this. Today, what were doing is were looking for feedback from participants on what weve learned so far and where we could go. And im really happy to see so many members here. Some of the common topics that weve seen are modernizing Clinical Trials, facilitating data sharing, insent advising drug research, incorporating the Patient Perspective into the research and regulatory process and developing young, emerging scientists as well as making sure we have adequate and Stable Funding for Biomedical Research in this country. And so im looking forward to hear from our experts and our colleagues today about how we can make a positive difference. I just want to echo your thanks for all of the members, all of the participants who have worked so diligently on this. It just really shows that theres a need. I want to leave you with one thought. I went around my district in august and some of you might know, just as happens every two years, in election year, colorados a purple state. So we have shock and awe of campaigning going onjdwn thert now. And every time i talk to somebody, democrat, republican or unaffiliated about 21st century cures, their eyes lit up. They were so excited about the prospect of c3bipartisan legislation, where we would actually be working together in congress to do something, but even more to do Something Big about how we can get those cures to the patients. I called a group last night. The big risk is it falls of its own weight. We cant let that happen. We have to Work Together to make it happen. And so i just really appreciate this effort. Thank you, mr. Chairman. Well start with secretary burwell. Thank you, chairman upton and representi degette for convening this round table and having me here today. I am looking forward to working with all of you. While im sorry i wont be able to stay, dr. Collins and dr. Hamburg, two of our best at hhs will ably represent us. I wanted to become of what you both have said. The importance im here today because we want to be your partner in making something go forward. Im a big believer that if were going to deliver, in fact, we need to start by building those strong relationships. That means listening to the experts we have and listening together and being responsive as we Work Together for meaningful solutions. I first want to thank you, also, for what you all did in terms of bringing everyone together but this committee has also done important work previously in this space with fda and our user fee legislation. These round tables are an Excellent Way to continue making some of the progress that weve already made. When we watch a loved one who is taken by alzheimers or als, we all want the same things, the most effective treatments, the groundbreaking cures and the best medical care possible. And so we take at hhs that very seriously and were committed to keeping us on that cutting edge of innovation, science and technology. And nih has supported most every significant advance of Biomedical Research in the last 50 years. From the human genome project and attempting right now to unlock those secrets of the most complex, mysterious things like the brain. And dr. Collins and his team walk the line, i think, some days between science and Science Fiction in terms of whether its robotic, exoskeletons, nanotechnology developments or personalized medicine and what that can mean. This work isnt just improving our Health Care System. Its hopefully going to transform it. These advancements allow us to shift from keeping up with illnesses to getting ahead of illnesses and they empower patients to engage in their own Health Care Like never before. And new biomedical science and technologies create highpaying jobs and strengthen our economy, another important part of what this work is about. In fact, we have estimates that say for every dollar of nih funding, it generates over a dollar in local Economic Growth. So, at a time when the world is vigorously forging ahead, we must protect our competitive Global Leader and not falling behind. With that said, we have a crucial equilibrium to maintain with the oversight that keeps us safe as a nation. Dr. Hamburg will be speaking to those issues. Fda is committed to reducing the length and soft of medical development. Weve shortened the highrisk device review times by a third since 2009, also working to strength sben en and improve th medical product process. Weve expanding accelerate D Development pathways. With review times as short as 4 1 2 months. Over the last years weve made great progress with support and we appreciate that. We also know theres a lot more to be done in that space and we want to focus on that as part of this conversation. Were committed to partnering with you while committed to maintain a safe and accurate product data and information for people. With that, we look forward to working with you all. This kind of session where a conversation can occur, i think, is an important part to moving forward. And the committee process, which we want to engage in support. So, thank you for having me. I just want to say that you and i talked about this, literally, the first week you became secretary of hhs. And you indicated then you would be very supportive. Were delighted for your participation today and all the way down the line. So, we really appreciate you being here, knowing that you still have to leave a little bit early. But thank you. Had you. Peggy, do you want to Say Something . Sure. Well, thank you so much for including me in this discussion and importantly for the leadership that chairman upton and congressman degette have brought to this 21st century cures and all of you on the committee. And it is true, as secretary burwell said, this committee has done great work to support science and the advance of biomedical Product Innovation and most recently with the passage of fadaz, i think we really accomplished something thats important and in a bipartisan way. This goes to the heart of what matters to us at the fda. Our mission is to deliver on the promise of science for the public, to do our part not just in assuring the most streamlined review times, but also in helping to support the most effective and Efficient Research anD Development pathways for promising new products, and to be able to provide information and oversight throughout the lifespan of a product, not justify in the development and review stage but also when its in the marketplace, being used by people when we have the opportunity to learn more about what works and for whom and why. And, you know, we think that the discussion so far has been enormously productive. In the identification of some of the critical area that is congresswoman degette noted very much align with our priorities and perceived needs. We want to work with all of you, to continue to reduce the length and cost of medical Product Development, to improve medical product review. Of course, improving business processes and systems but also to bring new tools and perspectives to bear. More advance science and technology, Patient Perspectives and, of course, increasing the predictability and transparency and partnership in what we do. We think that there are a lot of lessons to be learned from the work thats been going on with accelerateD Development, including the breakthrough designation that we were able to move forward with, with the passage of fadazia. The more the fda engages with stakeholders and more importantly with companies as they develop products to make sure that the right studies are done, we can reduce the time for research anD Development. We can certainly dramatically decrease the time for review. And, most importantly, we can give the American People the products that they want and stryker korpcorporation, a devi Company Located in our district. Im humbled by what i dont know, but excited about what we can do here today as the legislation moves forward. I hope during the two hours that we have here today, what i consider to be the critical success factors for our success going forward, talking about such things as a collaborative role between private sector, industry and government, including regulations that are required and can be a real companion to what were doing, including the changing role of the patient. We have to have a changing role for the patient, including the consequences of risk, which are sometimes becoming so ownerous that risk takers dont want to step up to the plate with really innovative ideas and also looking at the role of government in terms of helping out some of these smaller biotech that is have great ideas but dont have the Funding Sources and finally making sure we can energize our young people to be rigorous scientists. We clearly are the best we have the best Health Care System in the world. We have the best ability to innovate in this world and we want to unleash, unshackle some of the impediments that, over time, have allowed us to be the best we can possibly be. Im pleased to be here and thank you for the opportunity. Im dean kamen. Im not 67, but i spent a lifetime designing and building medical equipment over the last few decades, as everybody in this room is aware. Im concerned that the pace at which technology is developing is increasing. Were in the 1st centus 21st ce accelerating, the pace at which the systems around us are moving makes us feel like were trapped in a 19th century model trying to deal with 21st century opportunities. Over the next few hours, i would like to talk about a few of them. But a list of things that i think should be noncontroversial that should help things go better since, as Michael Milken has said more than once, the whole issue is time and money. We have to shorten the time and reduce the cost. If cms, fda and all the other agencies that are part of the chain of events could Work Together so that we could, for instance, in parallel do all the work we need to do in this industry to deal with cms and reimbursement at the same time as we go through the fda process, things would get faster and simpler and cheaper. Another issue that i hope is noncontroversial, no business i know could run if it lost 25 of its people every year. We have had multiple projects come through the fda and the reviewer changes. One of our most recent projects, the reviewer changed four times. Each time you sought to do a restart. Its expensive, takes time and costs money. We have to find a better way to keep continuity on the government side of this process. The third, and im glad that the congresswoman brought it up, is irbs. You go it you a pretty detailed, extensive process of getting an internal review board to approve it. Thats a necessary thing. It affects the people and the company. You have to do it in three or four medical centers and have to go through theach and every one separately. Thats crazy. International competition. Its not just that they compete sort of in the marketplace. These days, most of my major partners, the Biggest Companies in the world that want to take our products out, look at the situation and because of the lack of certainty in how long it will take to get a product approved or the lack of certainty of what the reimbursement will be for it, almost almost universally now, we transition to a world where our biggest clients would prefer to go and launch a product in europe or japan than in the United States. And that hurts on many levels. It makes the product less accessible in the United States. It has a lot of bad implications. We should be competing to be the most favorable place to