Otherwise. The adaptive pathway that some are using did so many to have appeal because we live in the information act. The rapidity in which something can come to fashl approval with the Information Systems we have. It seems this would be a reasonable direction. I hope we can consider it in our legislation and we would be receptive to in the licensing. Its very much a topic of discussion. We have been involved deeply with the authorities that are looking at this as well as the Scientific Community to look at the opportunities to get robust answers from a range of approaches designed and innovative. At the time the fda has an array of tools and regulatory flexibility thanks to work in congress including the breakthrough designation. In fact our approaches are not in the sense that accelerated approval, for example, can use them in that enables us to move a product in the market place that collects data in a continuing way to then assure the final approval if it works and provides an overall benefit for patients. How can we stream line and best adapt the bath ways to make a difference. The secretary mentioned that they use various methods for expedited approval and that is making a huge and being a real by. One of the most important things to emerge in terms of all this work is what makes the most difference in actually reducing times from discovery to the bed side. Its the amount for the researchers and the companies and fda to all Work Together early and in a continuing way to shape the Development Process to identify what is the data that is needed to move us as swiftly as possible over the finish line and i think that is really the most important work needs to be done to make the most difference for patients. I have to add the comment was ready this morning and someone is working with someone in the fda and getting to a point where perhaps the next steps will be taken in. Back to square one. I hear this all the time. This is not new. Thats a huge concern for us. It reflects that people are stretched too thin and worked too hard and challenging. And they are very competitive in other sectors. They need to address the issues that thank you very much. I wanted to commend the conferences and round Table Discussions. They have been very valuable and come home many days. There is a promise of a lot of new innovations. This is an exciting time in medicine. Its the sense of the nih and fda having the ability to do the work in a new fashion. We gave fda a lot of authority to be more nimble and work more collaboratively with those who are developing pharmaceuticals and medical devices. I heard a lot of praise for that. With the nih, there is so clear how dependent the future is going to be on a stable and appropriate funding for biomedical research. If we had a 10year decrease downhill in funding, its not just the people who work at it. Its the whole Health Care System that pays a very heavy price. If we are determined to do anything and i think reflecting the will of the American People overwhelmingly, lets adequately fund nih research and the administrati administration. We have to fund the work through user fees. This is a government function. Those who are trying to develop new breakthroughs have to figure out how to pay the user fees. To set up the user fees, we have to do what we have to do. We shouldnt see the constant decreasing or flattening out of the funds which erode over the years. I also am proud to have my constituent friend here and i thank you for his presentation and the work of this whole panel very much relied on the work of your organization that they have done in the 2011 discussions about barriers that prevent progress. I was struck by the fact that you talked about the cap and trade program for the acid rain to get rid of acid rain which i authored. It seems to me we need to do that to unleash the Market Forces. I dont think the government we need to give the right incentives and step aside and let Market Forces dictate the creation of the infrastructure to accomplish the goals we want. We need to do it more in the environmental area and especially in the health area. Part of that infrastructure must be and because of the areas. That was a blunt instrument. We heard about the and the report of all the other things that will make things easier and instead they make had harder. They would welcome legislations to reform that area. If we come in with a blunt instrument, suddenly recreating the fda authorities. Mandating things or looking for the department of health and Human Services they are not equipped to do and dont fund him to do it, we have to be cautious about the legislation that may be proposed. More than anything we want government to be there to work collaboratively and they still have to recognize the safety and efficacy that American People and most people here would certainly think is necessary for a new product. We want those products out as quickly as possible. I remember the days when we had the first evidence of the aids epidemic and the people that brought home the reform and fda to get some of these therapies out quickly were the groups of the gay community. They studied the law of the fda and argued you dont need to take so long and wait to the end result to show that a therapy is and effective. You can have markets and get the products out more quickly. I think the collaboration between the private sector where the Market Forces were pushed to move forward and we want government not to stand in their way by under mining them with less stability for their work. The private sector and the disease groups and most representatives of disease groups know more about the diseases than anybody else. They have worked so hard to try to understand whats at stake. Pressing the government to be as flexible as possible. I think its important for the infrastructure for the 21st century. I want to say i would be cautious about thinking we can solve big problems with legislation with all the unforeseen consequences that can sit in a panel here years from now. I guess thats not a question, but comments. I thank the witnesses and particularly my friend ask constituent for all that he has done. Thank you, mr. Chairman for convening this round table and thank you to the expert witnesses for your insights. Every time we have one of these hearings or round tables, we learn a lot. We had an excellent round table with the doctors and our chairman. Dr. Burgence and frank was there. Its very, very important. Its important and meepingful. Doctor, let me ask you, you have forcefully made the case that its imperative for congress to prioritize funding for nih. While i understand the importance of ensuring that funning remains stable and predictable. Congress is at a cross roads where federal dollars are already committed, particularly as they relate to federal entitlement and safety net programs. If we are going to find resources to stabilize and or potentially increase nih funding, congress is going to have to work hard at prioritizing resources that are focused on on advancing science and research to spur the next generation of cures. Are there existing sources of Research Funding. This attempts to find federal dollars to help advance the next generation of cures. Your thoughts . I dont envy the position all of you members of congress are in with our nation in a very difficult fiscal deficit. Circumstance trying to figure out how to balance the needs to support important government activities and i would submit that medical research is a very penitentiary government activity that doesnt support the basic science that wont get done. At the same time i know you have to figure out how not to have a circumstance where we bury our heads in the sand. One of the things we have been trying to do. Its to identify other ways to support medical research other than the traditional nih appropriation. Money has gotten started about months ago. A partnership between nih and ten Large Pharmaceutical Companies called the accelerating partnership. Thats really unprecedented in this. The goal here is to try to identify that next generation of drug therapies that we know is waiting to be discovered. That will again get out of it and the expertise doesnt reside in the sector alone, but putting them together, the researchers and the companies could be pretty exciting. The companies recognizing much to their credit, they are willing to engage in a partnership where the data is made accessible. It is not hidden. We would have a hard time participating. This partnership which is being equally supported financially by both the companies and the nih, 5050 split in an unprecedented way is moving forward on diabetes and alzheimers and rheumatoid arthritis. I wanted to be sure it doesnt run off the rails. I think they are quite gratified by how far its come. Thats an example of creative ways to try to identify partnerships. A number of exciting initiatives putting cells on a check to allow you to investigate their way. I got a lung over here. These are basically amazing technologies, bringing together the engineering skills with the biology skills of our investigators to move things forward in a fashion that could be great for identifying drug toxicities as well as effectiveness. Of all the various parts, im on the board by statute. The board of governors includes the director. The patientcentered outcomes is what they are. They are working hard to identify in a research, evidencebased ways, what are the interventions that work and which dont work for patients in the real world. Issues that we need to know about. Its a hardworking organization that only has been around for two or years. I dont know how to balance those kinds of decisions. People are struggling to make. I want to promise the group that we are not just at nih saying give us money and we will keep doing things the way we have. I get it. We have to be creative and make reforms in which we administer our own funds that we have through the public give to us. Woo are looking at every nook and cran tow come up with ways to be more efficient. I promise you this is not just researchers with their hands out saying leave us alone. We understand the obligation to be incredibly creative about what we do and productive. We are willing to put ourselves under the microscope. Can i suggest a couple . One, i would say scoring. When we look at how things are scored, we need to totally reevaluate. I will quickly cite one example. A board member of mine and close friend was diagnosed with cancer and given a short president to live. He engaged in every known Clinical Trial, in this case for prostate cancer. He recovered and over 11 years, i would say ten extremely productive. He led two tours of duty where he led the medical efforts in iraq. One was chemotherapy. They had everyone in the dod. When we had issues, he was called on to solve the problems at walter reed and founded two Bioscience Companies and was previously the doctor for in the scoring, everything he accomplished in the 11 years, not the least of which was 11 years more than his Young Children had with him. They were 3, 4, and 6 at the time. All of them will remember their father and their lives will be different and childrens lives will be different. His score was zero. Of any benefits of the treatments he got. We just count the cost and we dont count the benefits of this Great American patriot. In the 11 years, he got approximately 16 years before their normal lifespan. I would say scorning. Two international lives. The first was supported by henry kissinger. They put up 20 of the money and others put up 80 in the u. S. And they managed 100 of the money. If we focus as part of the state department and other international efforts, other countries on a per capita basis are far wealthier than the u. S. Today. Norway many years ago set up a fund for the north sea. Its kind of a rainy day fund. Their goal is 500 million u. S. That fund today approaches 900 billion. They overshot that fund. That would be like if you had a fund of 60 trillion sitting there. They can play as many other nations can an active role in activities if we had the structure here to get Financial Support from them today. Third is the young scientists. Many are encouraged to work in the field and if you go and get teaching degrees from universities and work in inner cities or difficult areas, we forgive their Student Loans they have. Almost all nobel prizes have been issued for ideas within five years. You might have been 60 years old when you received it, but the idea is generated when you were 25 and 30. Today the average age im assuming is in the low 40s. 42, 43. The first time an individual received a grant. How discouraging can that be for a person with new ideas . Today all of us who had children grow up and go to college and leave are challenged when our teens leave the house and go away to college as to how something works. This is the same technology, but we havent found a way to encourage people and to stay in science and research and stay with the nih. One of them might be easily to forgive their Student Loans that they accrued being a doctor or a scientist, etc. If they work in these fields. There is benefit the same as a teacher in the inner cities. Lastly matching to challenge the American Public and philanthropies. We have funded over 500 young scientists. Its amazing how little the money is. 100 young scientists and 100 young scientists for the nih and others around the country. Lets challenge the American Public where you need matching grants for the scientists. I think we can accrue billions of dollars and matching grants here to keep young people and further their careers. I have a thank you. I have seven people on my list. Thank you all again for those of us who serve on the step committee, its easy to have these exchanges. Doctor, i want to thank you and appreciate the fda and what you have done with the gain we had last session. We have a followup that is more authority to unload the future of antibiotics and hopefully we will do that. My main question, july 30th and 31st joined the nih meeting. You mentioned that the u. S. Government should launch a publicprivate partnership. That would work to establish a master Clinical Trial and protocol for antibiotics. They indicated that they have new drugs for bad bugs. In europe they like acronyms there. It is crucial for bringing together the government acadecaa industry for the challenge. Thats an important opponent and the efforts to revitalize anybody. They feel more about the u. S. Publicprivate partnerships and the master trial protocol. Certainly can and thank you for the question, congressman. The industry got together at that meeting july 30 and 31. We worked closely. Its a very important issue when you see the see infections in hospitals and patients who are very sick, they turn out and they have to be on a trajectory and new antibiotics has been slow. They are slow for what mostly is in financial reasons. Thats not seen by most companies is something that can be profitable. Its delivered with a lot of liability concerns. They are increasingly through revolutionary processes and way too much drug prescribing going on and developing the resistances that we have at the present time the strategy. They will have a preexisting network of Clinical Trials. You want to use that on people who are infected with the nichls. You have to find fortunately right now, you can find them everywhere. They tend to happen in outbreaks if you dont have a preexisting network with staff on the ground and consent and irb approvals and the company has their drug and there is no way to check it out and see if it works in less than many, many months. The idea is to have a master protocol in nih through the allergy and infectious disease. They are very invested in making this happen. In order to provide industry with that platform, its a great example of a partnership where we all have a lot in common. A lot more information. Thats about how to take a look at the problem. Coming from the Council Adviser and a bunch of the rest of us. We hear a lot about ebola and the doctors who are able to get something. An mra is in every hospital in the country. We have loved and constituents. Hopefully we can move forward. 30 seconds. I had the opportunity to go through your wonderful facility a number of times this last year and see the advances of what you have done as it relates to animal testing that can help the drug industry. Tell us about this. As we think about traveling at the same speed and the cracks are the same. The testing and expedite the approval of what you are able to do. Thats what they do with the broad use that is gaping momentum daily. In regular basis, the regulations havent kept up with this. For example, there is no fda imaging approved for biomarkers. And yet when another client and sponsor go for approval, the fda in a great way talks about the ways of working through that and what not and efficacy work and said we know that its not required to do, but do you have any . We do and that results in it. What that says to me is its our fault. In the case of the Regulatory Environment in which we work. Its hard for regulations to keep pace. Its hard for regulations to really help allow for new innovative methods to be tested and used. Maybe there is a way to have an emerging issues task force. Technologies are being used perhaps not in the approval, but being used to supplement and with imaging in particular for Clinical Trials, its incredible what has been achieved as a result of looking at biomarkers, etc. If there were emerging issues and task forces the sponsors in this case and the researchers and innovators can work with the regulators and work with the specialists and the subject Matter Experts so we can have some of this happen. We are breaking new science and risk is part of it. You saw what you saw. There is a lot more advance technology than just imaging. Its coming of age today and it can add insight and reduce cost. Speed as you saw and you know. I would encourage that part of your legislation that would allow us to work to be able to allow to exp