dr. woodcock, welcome back. i want to thank our chairman, our ranking member and dr. k for testifying. revolutionary science and technological development we have the opportunity to target specific patient populations transform how we approach the prevention and treatment of disease. one of the goals i think particularly worthy of exploration the idea of personalized medicine which a patient may be able to receive more tailored drugs and treatment suited to his or her particular condition. i understand human genome is key to that goal. academics and researchers tell me and potential for researchers and developers to discuss these drug and device innovations with patients during the development phase. dr. woodcock, can you give us the view on upsides and downsides of any increasing permissibility of communication between patients and developers during the clinical trial phase of vesselment? >> that's very interesting question. we have seen from the 1990s where only 5% of drugs were targeted, in 201345% of the drugs we approved were targeted in some way. there are barrie

dr. woodcock. i think you're an excellent witness, i appreciate your answers. >> thank you. >> i wanted to go a little bit further on the problem that congresswoman capps raised about the underrepresentation of women. i know you've said that you found that, actually, women or were overrepresented, but recently the congressional caucus for women's issues sponsored a meeting with leading women, heart experts both clinical and research experts, physicians. those experts raised concerns that the lack of representation from women in clinical trials is limiting our ability to effectively treat women with heart disease. they were focusing in on heart disease. and according to those experts, for the last 50 years women's heart treatment has largely been based on medical research about men. and even today despite that fact what they said is that the women make up more than 50% of the u.s. population, that women comprise only 24% of participants in all heart-related studies. and additionally, scientists from

dr. woodcock earlier today. what is the oncology community doing that is different than other communities. we have research that has been building for decades that is producing exciting results that is actionable and companies are standing up to create drugs for the targets that we're finding for the immune therapies for the genetic therapies, the genetic markers. we are interesting and turning point kind of place. but important relevant to your question, the office of hematology oncology products has also stepped up to the plate. and as was mentioned earlier, the oncology community appreciates the efforts to reach out to the patient community, to reach out to the pharmaceutical community, to reach out to those who do clinical trials. lung map was cited several times. the american cancer society is grateful to con tribute to that. but the fda has become an active partner with the process. so i don't know if that is a best practice or a best example but it's that source of communication. but let's not forget it's

dr. janet woodcock, the director of fda center for drug evaluation and research, dr.ff shuren, director of fda's center for devices and radiological health, dr. james woolliscroft, go blue is right. dr. joe gray, associate director for translational research at the knight cancer institute, oregon health and science university. dr. andrew von eschenbach, president of the samaritan health initiative and chairman of the project fda at the manhattan institute. margaret anderson, executive director of faster cures. dr. peter uber, dr. ellengv sig, sarah despres, director of government at the pew charitable trust and jonathan leff, partner at deerfield management and chairman of the deerfield institute. thanks for being with us today. now, in order to get most out of everyone, i'm going to coop my remarks very -- keep my remarks very short. i'd like to ask diana degette, my co-chair on this effort, to say a few words, and then we're going to introduce eric cantor, the majority leader. i will say in advance steny hoyer planned to be here today, and he had a very last minute

dr. woodcock, you mentioned something called clinical trial network.would you identify any barrier that is you see? do you need legislation to set this up? or what are the barriers now that prevent us from having clinical trial networks? and how can we use our technology platforms to accelerate the cures to bring researchers ask patients and innovators together? a couple of questions. >> well, these are all -- they're all related. and -- [inaudible] however, i think a lot of the barriers have been cultural in the way we've done things in the past, and this is how we've always done them, so this is how we will do them. but the availability of electronic health record, the availability to reach out to clinicians all around the country, to join them together and then to do trials utilizing that infrastructure and training could provide all sorts of linked networks. it could very rapidly answer questions which is really what device development is about. we ask questions; does this work, is it safe? you can rapidly answer those questions. you get products i