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Jul 25, 2018
07/18
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dr. gottlieb, we are delighted that you are here. two things that i'm going to want to discuss with you all. dr. collins, the all of us research project and making certain that we anonymize and we protect the data that is in that program. and that the privacy of the patients with data is respected as we move forward with this. and, dr. gottlieb, following up on the software act and making certain that the implementation is going well, and we welcome you both and we look forward to the hearing. yield back. >> thanks to the gentle lady. the chair now recognizes the gentleman from texas, the ranking member of the subcommittee mr. green five minutes for an opening statement. >> mr. chairman, thank you for holding today's hearing on the implementation of the 21 century cures act. i want to thank all our witnesses for being here today, especially dr. collins and dr. gottlieb. you are pretty regulars at that table. this december will mark the two-year anniversary of the 21st century cures act being signed into law by president obama and his
dr. gottlieb, we are delighted that you are here. two things that i'm going to want to discuss with you all. dr. collins, the all of us research project and making certain that we anonymize and we protect the data that is in that program. and that the privacy of the patients with data is respected as we move forward with this. and, dr. gottlieb, following up on the software act and making certain that the implementation is going well, and we welcome you both and we look forward to the hearing....
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Jul 26, 2018
07/18
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dr. gottlieb as well. >> i'm say a word and ask dr. mulvaney to fill in more as deputy director of the program. we are very invested in looking at this in the fashion of cutting large dealing with very large data sets, putting the data into a cloud. just had a very interesting all day workshop monday on artificial intelligence and machine learning and how that can be applied to these unprecedented data sets that glean the maximum amount of information and while maintaining the confidentiality and security systems that the participants will expect about their deidentified data. maybe dr. devanei will want to say more? >> one of the data types that will be the most precision is information from health records. this is one of the largest challenges for our program. we have direct partnerships with many healthcare organizations and we're getting those data continuing from those partnerships, but we're also working on other strategies including one in partnership with four of the largest hr vendors right now to work on making the data trans
dr. gottlieb as well. >> i'm say a word and ask dr. mulvaney to fill in more as deputy director of the program. we are very invested in looking at this in the fashion of cutting large dealing with very large data sets, putting the data into a cloud. just had a very interesting all day workshop monday on artificial intelligence and machine learning and how that can be applied to these unprecedented data sets that glean the maximum amount of information and while maintaining the...
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Jul 31, 2018
07/18
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CSPAN2
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dr. scott gottlieb about these concerns and he agrees. dr. gottlieb agreed to quickly issue guidance and develop regulations to provide clarity on what difficult to study means and that we do not change the gold standard of the food and drug administration's drug approval process. also conditional approval is not available for antimicrobial drugs. the language in the bill is clear, and dr. gottlieb understands the conditional be approval is not available for antimicrobial drugs. congress will also conduct oversight to make sure conditional approval is achieving the goal of helping more vets and keeping our food supply safe. this bipartisan legislation will help keep animals healthy, prevent disease outbreaks and protect our food supply. so, mr. president, i ask unanimous consent that the senate proceed to the immediate consideration of h.r. 5554. the presiding officer: the clerk will report. the clerk: h.r. 5554, an act to amend the federal food, drug and cosmetic pact and so forth. the presiding officer: is there objection to proceeding to th
dr. scott gottlieb about these concerns and he agrees. dr. gottlieb agreed to quickly issue guidance and develop regulations to provide clarity on what difficult to study means and that we do not change the gold standard of the food and drug administration's drug approval process. also conditional approval is not available for antimicrobial drugs. the language in the bill is clear, and dr. gottlieb understands the conditional be approval is not available for antimicrobial drugs. congress will...
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Jul 26, 2018
07/18
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dr. gottlieb, throughout several comments -- but there was really ofdata support on the value precision,editing. there's no data presented. host: can you explain for those that don't follow this and don't have a background in medicine about gene therapy? when they hear that word, what are doctors talking about? what our researchers talking about? caller: well, i'm a surgeon, but generally what they talk about is that they want to look at the cells.tent of cancer cancer cells have something wrong with the dna. right now we can monitor and record the dna. cells and to tumor there may be something that sticks out, that there is a medication to specifically target that specific defect. that is what he's talking about, the ramifications. these are dna defects. so drug companies have, for a long time, used clinical trials to determine what drug will work with a group of people. but you look at the individual level and you have a look at finding a drug for each individual. that is precision. that is certainly a more expensive approach. think, as ao you surgeon, about the nih efforts with their
dr. gottlieb, throughout several comments -- but there was really ofdata support on the value precision,editing. there's no data presented. host: can you explain for those that don't follow this and don't have a background in medicine about gene therapy? when they hear that word, what are doctors talking about? what our researchers talking about? caller: well, i'm a surgeon, but generally what they talk about is that they want to look at the cells.tent of cancer cancer cells have something...
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Jul 25, 2018
07/18
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isp is expected to get testimony fromr fromfrom scottp from scottfrom scott gottlieb from scott gottlieb and dr. francis collins. they willp they will be speaking about efforts to accelerate cancerp congress passed thecongress passed the 21st century curescures actp cures act whichcures act which was decide to advanceadvancep advance medical research. >>> our guests can take their seat. recognize myself five minutes for an opening statement. this morning certainly i want to welcome our witnesses.
isp is expected to get testimony fromr fromfrom scottp from scottfrom scott gottlieb from scott gottlieb and dr. francis collins. they willp they will be speaking about efforts to accelerate cancerp congress passed thecongress passed the 21st century curescures actp cures act whichcures act which was decide to advanceadvancep advance medical research. >>> our guests can take their seat. recognize myself five minutes for an opening statement. this morning certainly i want to welcome our...