{"version":"1.0.0","segments":[{"startTime":0.0,"endTime":2.869,"body":"[AI-assisted transcript]"},{"speaker":"Voice Talent","startTime":2.869,"endTime":6.506,"body":"BioCentury This Week is"},{"speaker":"Voice Talent","startTime":2.869,"endTime":6.506,"body":"brought to you by CBRE — the global"},{"speaker":"Voice Talent","startTime":6.506,"endTime":9.876,"body":"leader in commercial real estate"},{"speaker":"Voice Talent","startTime":6.506,"endTime":9.876,"body":"services, with a specialized practice"},{"speaker":"Voice Talent","startTime":9.876,"endTime":12.045,"body":"dedicated exclusively to life sciences."},{"speaker":"Voice Talent","startTime":12.345,"endTime":16.683,"body":"From early-stage biotechs to established"},{"speaker":"Voice Talent","startTime":12.345,"endTime":16.683,"body":"companies scaling biomanufacturing"},{"speaker":"Voice Talent","startTime":16.683,"endTime":21.621,"body":"operations, CBRE's life sciences"},{"speaker":"Voice Talent","startTime":16.683,"endTime":21.621,"body":"experts help companies find, build, and"},{"speaker":"Voice Talent","startTime":21.621,"endTime":23.923,"body":"optimize spaces where discovery happens."},{"speaker":"Voice Talent","startTime":24.19,"endTime":27.627,"body":"With deep market intelligence across"},{"speaker":"Voice Talent","startTime":24.19,"endTime":27.627,"body":"the nation's innovation clusters,"},{"speaker":"Voice Talent","startTime":27.727,"endTime":32.132,"body":"top-notch facilities, and a network"},{"speaker":"Voice Talent","startTime":27.727,"endTime":32.132,"body":"of investors and tenants, CBRE has"},{"speaker":"Voice Talent","startTime":32.132,"endTime":33.566,"body":"what it takes to help you succeed."},{"speaker":"Voice Talent","startTime":33.833,"endTime":37.337,"body":"This blend of knowledge and relationships"},{"speaker":"Voice Talent","startTime":33.833,"endTime":37.337,"body":"ensures you receive the best advice"},{"speaker":"Voice Talent","startTime":37.337,"endTime":40.507,"body":"at every stage—so you can focus"},{"speaker":"Voice Talent","startTime":37.337,"endTime":40.507,"body":"on bringing therapies to patients"},{"speaker":"Jeff Cranmer","startTime":45.111,"endTime":49.749,"body":"One of the UK biotech"},{"speaker":"Jeff Cranmer","startTime":45.111,"endTime":49.749,"body":"scene's best assets, Patrick Vallance,"},{"speaker":"Jeff Cranmer","startTime":49.783,"endTime":56.756,"body":"is out as Minister of State for"},{"speaker":"Jeff Cranmer","startTime":49.783,"endTime":56.756,"body":"Science, Research, and Innovation as"},{"speaker":"Jeff Cranmer","startTime":56.79,"endTime":59.793,"body":"Andy Burnham becomes UK Prime Minister."},{"speaker":"Jeff Cranmer","startTime":60.627,"endTime":67.6,"body":"We'll discuss what the latest body"},{"speaker":"Jeff Cranmer","startTime":60.627,"endTime":67.6,"body":"blow for the UK biotech means on"},{"speaker":"Jeff Cranmer","startTime":67.634,"endTime":69.569,"body":"the BioCentury This Week podcast."},{"speaker":"Jeff Cranmer","startTime":69.569,"endTime":72.472,"body":"I'm Jeff Cranmer, executive editor here."},{"speaker":"Jeff Cranmer","startTime":72.472,"endTime":78.711,"body":"Joining me today, editor-in-chief Simone"},{"speaker":"Jeff Cranmer","startTime":72.472,"endTime":78.711,"body":"Fishburn, executive editor Selina Koch,"},{"speaker":"Jeff Cranmer","startTime":78.945,"endTime":81.815,"body":"and Washington editor Steve Usdin."},{"speaker":"Jeff Cranmer","startTime":81.848,"endTime":87.52,"body":"I'm just back from Bio Asia Taiwan"},{"speaker":"Jeff Cranmer","startTime":81.848,"endTime":87.52,"body":"in Taipei, and will share my"},{"speaker":"Jeff Cranmer","startTime":87.52,"endTime":93.026,"body":"thoughts on biotech at max heat,"},{"speaker":"Jeff Cranmer","startTime":87.52,"endTime":93.026,"body":"humidity, and Xiao Long Bao."},{"speaker":"Jeff Cranmer","startTime":93.226,"endTime":98.631,"body":"Plus, Biogen's Phase III bet on its"},{"speaker":"Jeff Cranmer","startTime":93.226,"endTime":98.631,"body":"anti-tau therapy gets complicated,"},{"speaker":"Jeff Cranmer","startTime":98.631,"endTime":101.034,"body":"and a psychedelic buy from Eli Lilly."},{"speaker":"Jeff Cranmer","startTime":101.601,"endTime":105.772,"body":"We'll also check in on"},{"speaker":"Jeff Cranmer","startTime":101.601,"endTime":105.772,"body":"what's happening at FDA."},{"speaker":"Jeff Cranmer","startTime":105.872,"endTime":111.111,"body":"All right, Simone, your phone has been"},{"speaker":"Jeff Cranmer","startTime":105.872,"endTime":111.111,"body":"blowing up this morning as the government"},{"speaker":"Jeff Cranmer","startTime":111.111,"endTime":113.613,"body":"begins to take shape, in your motherland."},{"speaker":"Jeff Cranmer","startTime":114.214,"endTime":115.248,"body":"What are you learning?"},{"speaker":"Simone Fishburn","startTime":115.949,"endTime":116.382,"body":"Right."},{"speaker":"Simone Fishburn","startTime":116.416,"endTime":121.02,"body":"So, I assume you are talking"},{"speaker":"Simone Fishburn","startTime":116.416,"endTime":121.02,"body":"about the new prime minister and"},{"speaker":"Simone Fishburn","startTime":121.054,"endTime":123.256,"body":"not the football team, right?"},{"speaker":"Simone Fishburn","startTime":123.523,"endTime":124.724,"body":"Where I-"},{"speaker":"Jeff Cranmer","startTime":124.891,"endTime":125.291,"body":"but,"},{"speaker":"Simone Fishburn","startTime":125.692,"endTime":127.794,"body":"gotta tell you,"},{"speaker":"Simone Fishburn","startTime":125.692,"endTime":127.794,"body":"there's a lot of people, a lot of"},{"speaker":"Simone Fishburn","startTime":127.794,"endTime":131.331,"body":"people on my phone who seem to think"},{"speaker":"Simone Fishburn","startTime":127.794,"endTime":131.331,"body":"England actually won, and that the"},{"speaker":"Simone Fishburn","startTime":131.331,"endTime":133.032,"body":"other game was just some playoff."},{"speaker":"Simone Fishburn","startTime":133.066,"endTime":133.933,"body":"So there we go."},{"speaker":"Jeff Cranmer","startTime":134.701,"endTime":137.871,"body":"Uh, most exciting,"},{"speaker":"Jeff Cranmer","startTime":134.701,"endTime":137.871,"body":"uh, consolation match in history"},{"speaker":"Simone Fishburn","startTime":138.171,"endTime":139.639,"body":"It was a great match."},{"speaker":"Simone Fishburn","startTime":139.806,"endTime":143.309,"body":"Anyway, uh, what's not so great…"},{"speaker":"Simone Fishburn","startTime":139.806,"endTime":143.309,"body":"Well, at least for biotech."},{"speaker":"Simone Fishburn","startTime":143.343,"endTime":146.179,"body":"So there were, you know,"},{"speaker":"Simone Fishburn","startTime":143.343,"endTime":146.179,"body":"a new Burnham government."},{"speaker":"Simone Fishburn","startTime":146.212,"endTime":148.948,"body":"Obviously, everybody across"},{"speaker":"Simone Fishburn","startTime":146.212,"endTime":148.948,"body":"the UK is like, \"What does"},{"speaker":"Simone Fishburn","startTime":148.948,"endTime":150.049,"body":"this mean?\" Blah, blah, blah."},{"speaker":"Simone Fishburn","startTime":150.383,"endTime":156.389,"body":"And the biotech sector cares about"},{"speaker":"Simone Fishburn","startTime":150.383,"endTime":156.389,"body":"two things, and it got a little"},{"speaker":"Simone Fishburn","startTime":156.389,"endTime":160.527,"body":"bit of a win and quite a loss,"},{"speaker":"Simone Fishburn","startTime":156.389,"endTime":160.527,"body":"but we'll see how it plays out."},{"speaker":"Simone Fishburn","startTime":160.927,"endTime":164.164,"body":"So the little bit of the win is on"},{"speaker":"Simone Fishburn","startTime":160.927,"endTime":164.164,"body":"the announcement of the chancellor,"},{"speaker":"Simone Fishburn","startTime":164.764,"endTime":167.567,"body":"who will be John Healey, right?"},{"speaker":"Simone Fishburn","startTime":167.6,"endTime":171.004,"body":"And At this point, the main"},{"speaker":"Simone Fishburn","startTime":167.6,"endTime":171.004,"body":"thing we know about John Healey"},{"speaker":"Simone Fishburn","startTime":171.237,"endTime":173.072,"body":"is that he's not Ed Miliband."},{"speaker":"Simone Fishburn","startTime":173.139,"endTime":176.876,"body":"The point being that when I spoke"},{"speaker":"Simone Fishburn","startTime":173.139,"endTime":176.876,"body":"to people, they were really pretty"},{"speaker":"Simone Fishburn","startTime":176.876,"endTime":178.578,"body":"concerned about Ed Miliband."},{"speaker":"Simone Fishburn","startTime":179.445,"endTime":181.514,"body":"They… You know, these"},{"speaker":"Simone Fishburn","startTime":179.445,"endTime":181.514,"body":"are business leaders."},{"speaker":"Simone Fishburn","startTime":181.514,"endTime":184.284,"body":"They felt his policies were a"},{"speaker":"Simone Fishburn","startTime":181.514,"endTime":184.284,"body":"little bit left wing for them."},{"speaker":"Simone Fishburn","startTime":184.617,"endTime":187.754,"body":"But more than that, that he would"},{"speaker":"Simone Fishburn","startTime":184.617,"endTime":187.754,"body":"be so focused on net zero that"},{"speaker":"Simone Fishburn","startTime":187.754,"endTime":191.624,"body":"it would take away, investment"},{"speaker":"Simone Fishburn","startTime":187.754,"endTime":191.624,"body":"and so on in life sciences."},{"speaker":"Simone Fishburn","startTime":191.624,"endTime":195.094,"body":"So I think that on that front,"},{"speaker":"Simone Fishburn","startTime":191.624,"endTime":195.094,"body":"people will be reassured."},{"speaker":"Simone Fishburn","startTime":195.094,"endTime":199.432,"body":"And the reality is actually that"},{"speaker":"Simone Fishburn","startTime":195.094,"endTime":199.432,"body":"the chancellor is, whoever it is, in"},{"speaker":"Simone Fishburn","startTime":199.432,"endTime":203.836,"body":"this case Healey, is going to have a"},{"speaker":"Simone Fishburn","startTime":199.432,"endTime":203.836,"body":"much longer and bigger impact on any"},{"speaker":"Simone Fishburn","startTime":203.836,"endTime":207.774,"body":"sector, including the life sciences"},{"speaker":"Simone Fishburn","startTime":203.836,"endTime":207.774,"body":"sector, than any other appointment."},{"speaker":"Simone Fishburn","startTime":208.208,"endTime":212.178,"body":"That said, Patrick Vallance,"},{"speaker":"Simone Fishburn","startTime":208.208,"endTime":212.178,"body":"minister for science, announced"},{"speaker":"Simone Fishburn","startTime":212.178,"endTime":214.747,"body":"today that he will be stepping down."},{"speaker":"Simone Fishburn","startTime":215.248,"endTime":220.553,"body":"And so that is quite a blow because"},{"speaker":"Simone Fishburn","startTime":215.248,"endTime":220.553,"body":"he's really been a big champion."},{"speaker":"Simone Fishburn","startTime":221.287,"endTime":224.19,"body":"You know, not often that a whole"},{"speaker":"Simone Fishburn","startTime":221.287,"endTime":224.19,"body":"sector really likes somebody,"},{"speaker":"Simone Fishburn","startTime":224.19,"endTime":228.962,"body":"especially not a minister, but he"},{"speaker":"Simone Fishburn","startTime":224.19,"endTime":228.962,"body":"really, uh, was very well appreciated."},{"speaker":"Simone Fishburn","startTime":228.962,"endTime":233.299,"body":"and also did great things in the pandemic,"},{"speaker":"Simone Fishburn","startTime":228.962,"endTime":233.299,"body":"but even since then for the sector itself."},{"speaker":"Simone Fishburn","startTime":233.566,"endTime":238.037,"body":"So sort of feels like the, the"},{"speaker":"Simone Fishburn","startTime":233.566,"endTime":238.037,"body":"blows keep coming for UK biotech."},{"speaker":"Simone Fishburn","startTime":238.104,"endTime":239.639,"body":"We'll see how this one plays out"},{"speaker":"Steve Usdin","startTime":240.306,"endTime":244.31,"body":"So, so one of the things I,"},{"speaker":"Steve Usdin","startTime":240.306,"endTime":244.31,"body":"my understanding is, is that the, the new"},{"speaker":"Steve Usdin","startTime":244.344,"endTime":249.349,"body":"government is making a, a big effort to"},{"speaker":"Steve Usdin","startTime":244.344,"endTime":249.349,"body":"try to, kind of spread the, um, economic"},{"speaker":"Steve Usdin","startTime":249.349,"endTime":253.453,"body":"development around, uh, and, and not"},{"speaker":"Steve Usdin","startTime":249.349,"endTime":253.453,"body":"concentrate it in London and the South."},{"speaker":"Steve Usdin","startTime":253.886,"endTime":256.589,"body":"I wonder h- uh, what impact"},{"speaker":"Steve Usdin","startTime":253.886,"endTime":256.589,"body":"do you think that'll have?"},{"speaker":"Steve Usdin","startTime":256.589,"endTime":258.625,"body":"I- uh, will it actually be successful?"},{"speaker":"Simone Fishburn","startTime":259.826,"endTime":260.326,"body":"That's"},{"speaker":"Simone Fishburn","startTime":259.826,"endTime":260.326,"body":"a good question, Steve."},{"speaker":"Simone Fishburn","startTime":260.326,"endTime":264.43,"body":"Um, I think that it's gonna have quite"},{"speaker":"Simone Fishburn","startTime":260.326,"endTime":264.43,"body":"an impact, and I think it, you know,"},{"speaker":"Simone Fishburn","startTime":264.497,"endTime":266.432,"body":"people point to the Manchester example."},{"speaker":"Simone Fishburn","startTime":266.899,"endTime":268.501,"body":"It could be very successful."},{"speaker":"Simone Fishburn","startTime":268.768,"endTime":270.47,"body":"The devil's in the details, though."},{"speaker":"Simone Fishburn","startTime":270.536,"endTime":275.775,"body":"when I spoke to investors mainly, but"},{"speaker":"Simone Fishburn","startTime":270.536,"endTime":275.775,"body":"also biotech executives, you know, they're"},{"speaker":"Simone Fishburn","startTime":275.775,"endTime":280.413,"body":"like, \"If you're gonna force me to start"},{"speaker":"Simone Fishburn","startTime":275.775,"endTime":280.413,"body":"companies to do company creation all over"},{"speaker":"Simone Fishburn","startTime":280.446,"endTime":284.684,"body":"the place, that's not viable 'cause there"},{"speaker":"Simone Fishburn","startTime":280.446,"endTime":284.684,"body":"just isn't the infrastructure for it.\""},{"speaker":"Simone Fishburn","startTime":285.184,"endTime":291.524,"body":"But if what you're talking about is"},{"speaker":"Simone Fishburn","startTime":285.184,"endTime":291.524,"body":"spreading, you know, giving universities"},{"speaker":"Simone Fishburn","startTime":291.591,"endTime":295.995,"body":"more money for translational research,"},{"speaker":"Simone Fishburn","startTime":291.591,"endTime":295.995,"body":"allowing some areas to become, say,"},{"speaker":"Simone Fishburn","startTime":295.995,"endTime":299.699,"body":"very good in manufacturing, you"},{"speaker":"Simone Fishburn","startTime":295.995,"endTime":299.699,"body":"know, tapping into the regional"},{"speaker":"Simone Fishburn","startTime":299.699,"endTime":304.804,"body":"differences, that could be very"},{"speaker":"Simone Fishburn","startTime":299.699,"endTime":304.804,"body":"impactful and, and could absolutely,"},{"speaker":"Simone Fishburn","startTime":305.104,"endTime":307.54,"body":"um, be a good thing for the sector."},{"speaker":"Simone Fishburn","startTime":307.774,"endTime":311.644,"body":"so I, I think that's absolutely"},{"speaker":"Simone Fishburn","startTime":307.774,"endTime":311.644,"body":"what Burnham said he's going to do."},{"speaker":"Simone Fishburn","startTime":311.911,"endTime":315.148,"body":"A lot of people look at"},{"speaker":"Simone Fishburn","startTime":311.911,"endTime":315.148,"body":"Manchester as a very good example."},{"speaker":"Simone Fishburn","startTime":315.181,"endTime":318.651,"body":"I think we all know that being"},{"speaker":"Simone Fishburn","startTime":315.181,"endTime":318.651,"body":"mayor even of a really big place"},{"speaker":"Simone Fishburn","startTime":318.651,"endTime":321.387,"body":"like Greater Manchester is not"},{"speaker":"Simone Fishburn","startTime":318.651,"endTime":321.387,"body":"the same as being prime minister."},{"speaker":"Steve Usdin","startTime":321.821,"endTime":324.29,"body":"so one, one thing that's"},{"speaker":"Steve Usdin","startTime":321.821,"endTime":324.29,"body":"interesting, quickly that I was talking"},{"speaker":"Steve Usdin","startTime":324.29,"endTime":330.863,"body":"to the CMO of one of the largest, um, uh,"},{"speaker":"Steve Usdin","startTime":324.29,"endTime":330.863,"body":"CROs, uh, in the world, uh, last week,"},{"speaker":"Steve Usdin","startTime":331.23,"endTime":332.565,"body":"and we were talking about various things."},{"speaker":"Steve Usdin","startTime":332.565,"endTime":334.667,"body":"We were talking about the U.K., and"},{"speaker":"Steve Usdin","startTime":332.565,"endTime":334.667,"body":"he said, \"Well, the thing is you"},{"speaker":"Steve Usdin","startTime":334.667,"endTime":337.97,"body":"have to understand about the U.K."},{"speaker":"Steve Usdin","startTime":334.667,"endTime":337.97,"body":"is that there's two economies there,"},{"speaker":"Steve Usdin","startTime":338.037,"endTime":343.476,"body":"and that, uh, the prices, uh, and the"},{"speaker":"Steve Usdin","startTime":338.037,"endTime":343.476,"body":"costs of, of doing clinical research"},{"speaker":"Steve Usdin","startTime":343.743,"endTime":347.38,"body":"in the south there are comparable to"},{"speaker":"Steve Usdin","startTime":343.743,"endTime":347.38,"body":"what they are in the United States."},{"speaker":"Steve Usdin","startTime":347.38,"endTime":350.983,"body":"But in the north, it's much less"},{"speaker":"Steve Usdin","startTime":347.38,"endTime":350.983,"body":"expensive, Manchester, Leeds, and the"},{"speaker":"Steve Usdin","startTime":350.983,"endTime":355.621,"body":"capabilities,\" he was saying, \"are just"},{"speaker":"Steve Usdin","startTime":350.983,"endTime":355.621,"body":"as, strong as they are in the south"},{"speaker":"Steve Usdin","startTime":355.621,"endTime":357.924,"body":"of England, they're just as strong"},{"speaker":"Steve Usdin","startTime":355.621,"endTime":357.924,"body":"as they are in the United States.\""},{"speaker":"Simone Fishburn","startTime":358.358,"endTime":359.125,"body":"100%."},{"speaker":"Simone Fishburn","startTime":359.192,"endTime":362.995,"body":"100%. And that, you know, uh, I think"},{"speaker":"Simone Fishburn","startTime":359.192,"endTime":362.995,"body":"it was Kate Bingham actually in a"},{"speaker":"Simone Fishburn","startTime":362.995,"endTime":365.832,"body":"quote was like, \"You know, we, we'd"},{"speaker":"Simone Fishburn","startTime":362.995,"endTime":365.832,"body":"love that. You can do clinical trials"},{"speaker":"Simone Fishburn","startTime":365.898,"endTime":370.67,"body":"anywhere.\" So absolutely, if you can,"},{"speaker":"Simone Fishburn","startTime":365.898,"endTime":370.67,"body":"if you can create… And that's good for"},{"speaker":"Simone Fishburn","startTime":370.67,"endTime":372.538,"body":"those local economies as well, right?"},{"speaker":"Simone Fishburn","startTime":372.538,"endTime":377.677,"body":"So if you can send things to those"},{"speaker":"Simone Fishburn","startTime":372.538,"endTime":377.677,"body":"areas, the issues that Patrick Vallance"},{"speaker":"Simone Fishburn","startTime":377.677,"endTime":380.913,"body":"talked about a lot, as do others, but"},{"speaker":"Simone Fishburn","startTime":377.677,"endTime":380.913,"body":"it was really s- something that, that"},{"speaker":"Simone Fishburn","startTime":381.047,"endTime":385.017,"body":"Vallance, and in fact, Lawrence Tallon"},{"speaker":"Simone Fishburn","startTime":381.047,"endTime":385.017,"body":"as, as CEO of MHRA, the regulator"},{"speaker":"Simone Fishburn","startTime":385.017,"endTime":389.589,"body":"there, have pointed out that very, a"},{"speaker":"Simone Fishburn","startTime":385.017,"endTime":389.589,"body":"really small percentage of eligible"},{"speaker":"Simone Fishburn","startTime":389.589,"endTime":392.058,"body":"patients end up in clinical trials."},{"speaker":"Simone Fishburn","startTime":392.325,"endTime":395.561,"body":"I have to be honest, I don't know how"},{"speaker":"Simone Fishburn","startTime":392.325,"endTime":395.561,"body":"that compares with other countries,"},{"speaker":"Simone Fishburn","startTime":395.862,"endTime":399.966,"body":"but I know that in the U.K. they feel"},{"speaker":"Simone Fishburn","startTime":395.862,"endTime":399.966,"body":"that is a particularly sore point."},{"speaker":"Simone Fishburn","startTime":400.233,"endTime":403.636,"body":"So being able to go to those other"},{"speaker":"Simone Fishburn","startTime":400.233,"endTime":403.636,"body":"regions will be, could be very impactful"},{"speaker":"Steve Usdin","startTime":403.736,"endTime":405.705,"body":"Well, and it's, of course"},{"speaker":"Steve Usdin","startTime":403.736,"endTime":405.705,"body":"it's true in the United States too."},{"speaker":"Steve Usdin","startTime":405.705,"endTime":407.273,"body":"Very, very small percentage of patients."},{"speaker":"Steve Usdin","startTime":407.273,"endTime":410.91,"body":"And if you look at it particularly in"},{"speaker":"Steve Usdin","startTime":407.273,"endTime":410.91,"body":"areas where there should be a lot more,"},{"speaker":"Steve Usdin","startTime":411.11,"endTime":414.313,"body":"for the good of the patients, there"},{"speaker":"Steve Usdin","startTime":411.11,"endTime":414.313,"body":"should be a lot more clinical trial"},{"speaker":"Steve Usdin","startTime":414.313,"endTime":415.915,"body":"participation, for example, in cancer."},{"speaker":"Steve Usdin","startTime":415.915,"endTime":420.486,"body":"You can argue that anybody who has a"},{"speaker":"Steve Usdin","startTime":415.915,"endTime":420.486,"body":"cancer that can't be well treated by,"},{"speaker":"Steve Usdin","startTime":420.553,"endTime":425.992,"body":"uh, an FDA-approved therapy should think"},{"speaker":"Steve Usdin","startTime":420.553,"endTime":425.992,"body":"seriously about being in a, a clinical"},{"speaker":"Steve Usdin","startTime":426.025,"endTime":427.66,"body":"trial, and that certainly isn't the case."},{"speaker":"Steve Usdin","startTime":427.693,"endTime":428.895,"body":"It doesn't happen anything like that."},{"speaker":"Steve Usdin","startTime":429.429,"endTime":431.597,"body":"You know, one o- one other thing is"},{"speaker":"Steve Usdin","startTime":429.429,"endTime":431.597,"body":"really quick that I want to point"},{"speaker":"Steve Usdin","startTime":431.597,"endTime":432.832,"body":"out, you mentioned Lawrence Tallon."},{"speaker":"Steve Usdin","startTime":433.199,"endTime":436.269,"body":"Uh, you know, it's one of the strengths"},{"speaker":"Steve Usdin","startTime":433.199,"endTime":436.269,"body":"of MHRA and one of the strengths,"},{"speaker":"Steve Usdin","startTime":436.269,"endTime":439.238,"body":"I think, of the U.K. that there's"},{"speaker":"Steve Usdin","startTime":436.269,"endTime":439.238,"body":"no talk of him leaving, right?"},{"speaker":"Steve Usdin","startTime":439.272,"endTime":443.743,"body":"That, um, he, he's gonna be staying"},{"speaker":"Steve Usdin","startTime":439.272,"endTime":443.743,"body":"on because it's not like the FDA where"},{"speaker":"Steve Usdin","startTime":443.743,"endTime":447.146,"body":"there's an expectation that every time you"},{"speaker":"Steve Usdin","startTime":443.743,"endTime":447.146,"body":"have a change in government, you have a"},{"speaker":"Steve Usdin","startTime":447.146,"endTime":449.515,"body":"change in, um, leadership of the regulator"},{"speaker":"Simone Fishburn","startTime":450.016,"endTime":450.216,"body":"Right."},{"speaker":"Simone Fishburn","startTime":450.216,"endTime":451.584,"body":"So two or three things there, Steve."},{"speaker":"Simone Fishburn","startTime":451.651,"endTime":454.52,"body":"Number one, I've not heard"},{"speaker":"Simone Fishburn","startTime":451.651,"endTime":454.52,"body":"anything like that, and they would"},{"speaker":"Simone Fishburn","startTime":454.52,"endTime":456.823,"body":"be lunatics to do that, okay?"},{"speaker":"Simone Fishburn","startTime":457.089,"endTime":457.99,"body":"Just lunatics."},{"speaker":"Simone Fishburn","startTime":458.024,"endTime":462.128,"body":"The, the, the Vallance situation is a"},{"speaker":"Simone Fishburn","startTime":458.024,"endTime":462.128,"body":"little bit different for this reason."},{"speaker":"Simone Fishburn","startTime":462.128,"endTime":465.965,"body":"So I think you pointed out on a"},{"speaker":"Simone Fishburn","startTime":462.128,"endTime":465.965,"body":"previous podcast that the MHRA,"},{"speaker":"Simone Fishburn","startTime":466.866,"endTime":470.236,"body":"sure, it's a government, position,"},{"speaker":"Simone Fishburn","startTime":466.866,"endTime":470.236,"body":"but it's not a political one."},{"speaker":"Simone Fishburn","startTime":470.536,"endTime":472.772,"body":"And so I- I've not heard"},{"speaker":"Simone Fishburn","startTime":470.536,"endTime":472.772,"body":"anything like that."},{"speaker":"Simone Fishburn","startTime":472.772,"endTime":476.542,"body":"And, and I think most people really"},{"speaker":"Simone Fishburn","startTime":472.772,"endTime":476.542,"body":"feel strongly that Tallon is doing a"},{"speaker":"Simone Fishburn","startTime":476.542,"endTime":479.178,"body":"good thing, and I don't really think"},{"speaker":"Simone Fishburn","startTime":476.542,"endTime":479.178,"body":"that this is on Andy Burnham's radar."},{"speaker":"Simone Fishburn","startTime":479.512,"endTime":482.715,"body":"The issue with Patrick Vallance is a"},{"speaker":"Simone Fishburn","startTime":479.512,"endTime":482.715,"body":"little bit different, and I just have"},{"speaker":"Simone Fishburn","startTime":482.715,"endTime":486.519,"body":"to say that there are other people"},{"speaker":"Simone Fishburn","startTime":482.715,"endTime":486.519,"body":"who frankly could fill his shoes."},{"speaker":"Simone Fishburn","startTime":486.552,"endTime":489.789,"body":"There's Steve Bates at the"},{"speaker":"Simone Fishburn","startTime":486.552,"endTime":489.789,"body":"Office for Life Sciences, who's"},{"speaker":"Simone Fishburn","startTime":489.789,"endTime":491.224,"body":"I think chief executive there."},{"speaker":"Simone Fishburn","startTime":491.224,"endTime":495.428,"body":"I expect Steve Bates at some point to"},{"speaker":"Simone Fishburn","startTime":491.224,"endTime":495.428,"body":"enter government, in that kind of a role."},{"speaker":"Simone Fishburn","startTime":495.895,"endTime":500.466,"body":"Actually though, the rumors are that,"},{"speaker":"Simone Fishburn","startTime":495.895,"endTime":500.466,"body":"and these are probably well-founded"},{"speaker":"Simone Fishburn","startTime":500.466,"endTime":506.239,"body":"rumors, is that in fact they're going"},{"speaker":"Simone Fishburn","startTime":500.466,"endTime":506.239,"body":"to fold the, Department for Science,"},{"speaker":"Simone Fishburn","startTime":506.305,"endTime":508.508,"body":"Innovation and Technology, that's DSIT."},{"speaker":"Simone Fishburn","startTime":508.508,"endTime":512.745,"body":"It was only created in 2023, and that's"},{"speaker":"Simone Fishburn","startTime":508.508,"endTime":512.745,"body":"what Patrick Vallance was the head of."},{"speaker":"Simone Fishburn","startTime":513.145,"endTime":517.183,"body":"the idea is that they might fold that into"},{"speaker":"Simone Fishburn","startTime":513.145,"endTime":517.183,"body":"the Department for Business and Trade."},{"speaker":"Simone Fishburn","startTime":517.617,"endTime":520.486,"body":"And there are people who say these"},{"speaker":"Simone Fishburn","startTime":517.617,"endTime":520.486,"body":"things should be closer together."},{"speaker":"Simone Fishburn","startTime":520.486,"endTime":525.258,"body":"You really should couple science"},{"speaker":"Simone Fishburn","startTime":520.486,"endTime":525.258,"body":"with trade if you want to do"},{"speaker":"Simone Fishburn","startTime":525.458,"endTime":527.226,"body":"what a sector wants you to do."},{"speaker":"Simone Fishburn","startTime":527.527,"endTime":529.228,"body":"It's, Vallance is great."},{"speaker":"Simone Fishburn","startTime":529.262,"endTime":533.366,"body":"It's always easier to sort of worry about"},{"speaker":"Simone Fishburn","startTime":529.262,"endTime":533.366,"body":"the loss of something when you don't know"},{"speaker":"Simone Fishburn","startTime":533.366,"endTime":534.767,"body":"what it's gonna look like in its place."},{"speaker":"Simone Fishburn","startTime":535.134,"endTime":538.004,"body":"So I just have to say, it doesn't"},{"speaker":"Simone Fishburn","startTime":535.134,"endTime":538.004,"body":"have to be a terrible outcome."},{"speaker":"Simone Fishburn","startTime":538.271,"endTime":542.241,"body":"as with everything, it's really, really"},{"speaker":"Simone Fishburn","startTime":538.271,"endTime":542.241,"body":"the uncertainty that people dislike"},{"speaker":"Selina Koch","startTime":542.508,"endTime":545.912,"body":"So we talked, we talked about"},{"speaker":"Selina Koch","startTime":542.508,"endTime":545.912,"body":"these blows that keep coming, but  in"},{"speaker":"Selina Koch","startTime":545.912,"endTime":550.983,"body":"a positive development, maybe we should"},{"speaker":"Selina Koch","startTime":545.912,"endTime":550.983,"body":"mention the second story that you're"},{"speaker":"Selina Koch","startTime":550.983,"endTime":555.488,"body":"publishing today, Simone, on the UK, which"},{"speaker":"Selina Koch","startTime":550.983,"endTime":555.488,"body":"is about a data resource, a single-- kind"},{"speaker":"Selina Koch","startTime":555.488,"endTime":558.991,"body":"of single point of entry for NHS data."},{"speaker":"Selina Koch","startTime":559.158,"endTime":561.06,"body":"Want to just briefly talk"},{"speaker":"Selina Koch","startTime":559.158,"endTime":561.06,"body":"about the value in that?"},{"speaker":"Simone Fishburn","startTime":561.928,"endTime":563.863,"body":"Yeah, I think"},{"speaker":"Simone Fishburn","startTime":561.928,"endTime":563.863,"body":"that's an interesting thing."},{"speaker":"Simone Fishburn","startTime":563.963,"endTime":566.699,"body":"Um, that's called the HDRS."},{"speaker":"Simone Fishburn","startTime":566.699,"endTime":569.502,"body":"They're not really into very"},{"speaker":"Simone Fishburn","startTime":566.699,"endTime":569.502,"body":"catchy names, I have to say."},{"speaker":"Simone Fishburn","startTime":569.569,"endTime":571.437,"body":"I mean, UK Biobank was"},{"speaker":"Simone Fishburn","startTime":569.569,"endTime":571.437,"body":"a better name than this."},{"speaker":"Simone Fishburn","startTime":571.437,"endTime":576.309,"body":"But HDRS stands for the"},{"speaker":"Simone Fishburn","startTime":571.437,"endTime":576.309,"body":"Health Data Research Service."},{"speaker":"Simone Fishburn","startTime":577.009,"endTime":579.845,"body":"It's annoying 'cause there's a few"},{"speaker":"Simone Fishburn","startTime":577.009,"endTime":579.845,"body":"other HDR things I have to tell you."},{"speaker":"Simone Fishburn","startTime":579.845,"endTime":582.615,"body":"So anyway, HDRS is a, a, a…"},{"speaker":"Simone Fishburn","startTime":582.715,"endTime":587.086,"body":"And it's sort of like a UK"},{"speaker":"Simone Fishburn","startTime":582.715,"endTime":587.086,"body":"Biobank on steroids almost."},{"speaker":"Simone Fishburn","startTime":587.119,"endTime":591.057,"body":"It's called a, a single front door"},{"speaker":"Simone Fishburn","startTime":587.119,"endTime":591.057,"body":"they want for the he- UK Health data."},{"speaker":"Simone Fishburn","startTime":591.39,"endTime":595.161,"body":"And the bottom line is that, you know,"},{"speaker":"Simone Fishburn","startTime":591.39,"endTime":595.161,"body":"they really want people to be able to"},{"speaker":"Simone Fishburn","startTime":595.161,"endTime":599.165,"body":"access NHS data, all patient NA- NHS data."},{"speaker":"Simone Fishburn","startTime":599.165,"endTime":601.2,"body":"That's 68 million patients,"},{"speaker":"Simone Fishburn","startTime":603.469,"endTime":605.171,"body":"longitudinal records, multimodal records."},{"speaker":"Simone Fishburn","startTime":605.504,"endTime":609.208,"body":"And at the moment, if you wanna"},{"speaker":"Simone Fishburn","startTime":605.504,"endTime":609.208,"body":"get hold of that data, you have"},{"speaker":"Simone Fishburn","startTime":609.208,"endTime":613.879,"body":"to apply to each region separately"},{"speaker":"Simone Fishburn","startTime":609.208,"endTime":613.879,"body":"because it's very, very fragmented."},{"speaker":"Simone Fishburn","startTime":614.246,"endTime":618.951,"body":"And so a big initiative was to, create"},{"speaker":"Simone Fishburn","startTime":614.246,"endTime":618.951,"body":"a federated system that would allow"},{"speaker":"Simone Fishburn","startTime":618.951,"endTime":620.886,"body":"you to look across the whole data set."},{"speaker":"Simone Fishburn","startTime":621.32,"endTime":625.524,"body":"And the reason I bring up the UK"},{"speaker":"Simone Fishburn","startTime":621.32,"endTime":625.524,"body":"Biobank is that, we talk to people,"},{"speaker":"Simone Fishburn","startTime":625.524,"endTime":630.329,"body":"Selina, quite a lot, who tell us they've"},{"speaker":"Simone Fishburn","startTime":625.524,"endTime":630.329,"body":"used UK Biobank in drug development,"},{"speaker":"Simone Fishburn","startTime":630.696,"endTime":634.166,"body":"and that's been quite fruitful, but"},{"speaker":"Simone Fishburn","startTime":630.696,"endTime":634.166,"body":"that's like half a million lives."},{"speaker":"Simone Fishburn","startTime":634.567,"endTime":638.104,"body":"And here, uh, you know, i-"},{"speaker":"Simone Fishburn","startTime":634.567,"endTime":638.104,"body":"it's… And I think it's sort"},{"speaker":"Simone Fishburn","startTime":638.104,"endTime":639.505,"body":"of from a single point in time."},{"speaker":"Simone Fishburn","startTime":639.505,"endTime":642.041,"body":"But here this is just much, much bigger."},{"speaker":"Simone Fishburn","startTime":642.041,"endTime":646.145,"body":"And so there certainly, you know,"},{"speaker":"Simone Fishburn","startTime":642.041,"endTime":646.145,"body":"would be nice to see a continuity"},{"speaker":"Simone Fishburn","startTime":646.145,"endTime":649.548,"body":"of that kind of investment in"},{"speaker":"Simone Fishburn","startTime":646.145,"endTime":649.548,"body":"infrastructure and capabilities."},{"speaker":"Simone Fishburn","startTime":649.582,"endTime":652.451,"body":"So to point out, that's"},{"speaker":"Simone Fishburn","startTime":649.582,"endTime":652.451,"body":"a slightly rosier story"},{"speaker":"Jeff Cranmer","startTime":652.985,"endTime":653.552,"body":"Sounds good."},{"speaker":"Jeff Cranmer","startTime":653.552,"endTime":657.957,"body":"Well, we'll drop, links in the"},{"speaker":"Jeff Cranmer","startTime":653.552,"endTime":657.957,"body":"show notes to Simone's stories."},{"speaker":"Jeff Cranmer","startTime":659.191,"endTime":659.625,"body":"All right."},{"speaker":"Jeff Cranmer","startTime":659.625,"endTime":665.598,"body":"Well, I'm a little jet lagged today,"},{"speaker":"Jeff Cranmer","startTime":659.625,"endTime":665.598,"body":"just back from Bio Asia Taiwan in Taipei."},{"speaker":"Jeff Cranmer","startTime":665.798,"endTime":670.336,"body":"reminded me of my Bangkok days, uh,"},{"speaker":"Jeff Cranmer","startTime":665.798,"endTime":670.336,"body":"adjusting to the heat and humidity"},{"speaker":"Jeff Cranmer","startTime":670.336,"endTime":672.471,"body":"while attempting to wear a suit jacket."},{"speaker":"Jeff Cranmer","startTime":672.938,"endTime":677.209,"body":"Uh, sort of a recipe for disaster,"},{"speaker":"Jeff Cranmer","startTime":672.938,"endTime":677.209,"body":"especially when I would walk to my"},{"speaker":"Jeff Cranmer","startTime":677.209,"endTime":682.515,"body":"meetings, half a mile, only half"},{"speaker":"Jeff Cranmer","startTime":677.209,"endTime":682.515,"body":"a mile, and arrive in a-- in just"},{"speaker":"Jeff Cranmer","startTime":682.615,"endTime":687.053,"body":"dripping sweat, and they'd say, \"Would"},{"speaker":"Jeff Cranmer","startTime":682.615,"endTime":687.053,"body":"you like a coffee or, or water?\" And"},{"speaker":"Jeff Cranmer","startTime":687.053,"endTime":688.32,"body":"I'm like, \"Well, that's kind of clear."},{"speaker":"Jeff Cranmer","startTime":688.32,"endTime":694.493,"body":"I need a glass of water.\" And they'd"},{"speaker":"Jeff Cranmer","startTime":688.32,"endTime":694.493,"body":"serve me a piping hot cup of water."},{"speaker":"Jeff Cranmer","startTime":694.894,"endTime":698.931,"body":"so, uh, it took some adjustment,"},{"speaker":"Jeff Cranmer","startTime":694.894,"endTime":698.931,"body":"but I'd like to just say hats off to"},{"speaker":"Jeff Cranmer","startTime":698.931,"endTime":703.169,"body":"Wallace Lin and his team at Taiwan Bio."},{"speaker":"Jeff Cranmer","startTime":703.269,"endTime":708.074,"body":"Uh, the event's been in Taipei"},{"speaker":"Jeff Cranmer","startTime":703.269,"endTime":708.074,"body":"for-- since twenty nineteen, and,"},{"speaker":"Jeff Cranmer","startTime":708.074,"endTime":711.711,"body":"uh, this year attracted more than"},{"speaker":"Jeff Cranmer","startTime":708.074,"endTime":711.711,"body":"three thousand attendees, uh,"},{"speaker":"Jeff Cranmer","startTime":711.711,"endTime":713.913,"body":"from more than fifty countries."},{"speaker":"Jeff Cranmer","startTime":714.28,"endTime":719.952,"body":"particular focus of Dr. Lin, uh, this"},{"speaker":"Jeff Cranmer","startTime":714.28,"endTime":719.952,"body":"year was, uh, regional collaboration"},{"speaker":"Jeff Cranmer","startTime":719.952,"endTime":723.856,"body":"in this year's forum, uh, which"},{"speaker":"Jeff Cranmer","startTime":719.952,"endTime":723.856,"body":"was sort of a subset of the overall"},{"speaker":"Jeff Cranmer","startTime":723.856,"endTime":727.927,"body":"meeting, uh, nearly doubled in size"},{"speaker":"Jeff Cranmer","startTime":723.856,"endTime":727.927,"body":"with representatives from across"},{"speaker":"Jeff Cranmer","startTime":727.993,"endTime":730.563,"body":"APAC, all the way to the Netherlands."},{"speaker":". Steve Usdin","startTime":730.663,"endTime":732.865,"body":"S- so, Jeff, you"},{"speaker":". Steve Usdin","startTime":730.663,"endTime":732.865,"body":"know, you're just fresh back."},{"speaker":". Steve Usdin","startTime":732.865,"endTime":736.869,"body":"what can you say about the"},{"speaker":". Steve Usdin","startTime":732.865,"endTime":736.869,"body":"Taiwanese innovation ecosystem?"},{"speaker":"Jeff Cranmer","startTime":737.903,"endTime":738.838,"body":"Yeah, it's a good call."},{"speaker":"Jeff Cranmer","startTime":738.838,"endTime":741.974,"body":"I mean, they're very, very"},{"speaker":"Jeff Cranmer","startTime":738.838,"endTime":741.974,"body":"good at building companies."},{"speaker":"Jeff Cranmer","startTime":742.041,"endTime":748.047,"body":"TSMC, on the semiconductor side,"},{"speaker":"Jeff Cranmer","startTime":742.041,"endTime":748.047,"body":"um, there's a lot of capital"},{"speaker":"Jeff Cranmer","startTime":748.047,"endTime":753.352,"body":"from Taiwan's families, uh, going"},{"speaker":"Jeff Cranmer","startTime":748.047,"endTime":753.352,"body":"into biotech, also other sectors."},{"speaker":"Jeff Cranmer","startTime":753.352,"endTime":758.357,"body":"There's great government support, for"},{"speaker":"Jeff Cranmer","startTime":753.352,"endTime":758.357,"body":"Taiwan's biotech, and, uh, the companies"},{"speaker":"Jeff Cranmer","startTime":758.357,"endTime":762.828,"body":"that list on the market there, there's"},{"speaker":"Jeff Cranmer","startTime":758.357,"endTime":762.828,"body":"two markets, Taipei and the Taiwan market."},{"speaker":"Jeff Cranmer","startTime":762.895,"endTime":766.799,"body":"Uh, companies can get very strong"},{"speaker":"Jeff Cranmer","startTime":762.895,"endTime":766.799,"body":"support from retail investors."},{"speaker":"Jeff Cranmer","startTime":767.533,"endTime":770.336,"body":"Feels a lot like Singapore, Korea."},{"speaker":"Jeff Cranmer","startTime":770.603,"endTime":774.84,"body":"when you're launching, uh, you"},{"speaker":"Jeff Cranmer","startTime":770.603,"endTime":774.84,"body":"really need to, look beyond"},{"speaker":"Jeff Cranmer","startTime":775.141,"endTime":777.276,"body":"Taiwan's borders from the get-go."},{"speaker":"Jeff Cranmer","startTime":777.276,"endTime":780.246,"body":"Look to the US, as you're"},{"speaker":"Jeff Cranmer","startTime":777.276,"endTime":780.246,"body":"building your company."},{"speaker":"Jeff Cranmer","startTime":780.646,"endTime":785.851,"body":"as I said, the biotech isn't as strong"},{"speaker":"Jeff Cranmer","startTime":780.646,"endTime":785.851,"body":"as the tech in Taiwan, um, but there"},{"speaker":"Jeff Cranmer","startTime":785.851,"endTime":788.587,"body":"are a few companies that I'm watching."},{"speaker":"Jeff Cranmer","startTime":789.321,"endTime":793.058,"body":"Pharmacentia is, uh, the"},{"speaker":"Jeff Cranmer","startTime":789.321,"endTime":793.058,"body":"current market darling."},{"speaker":"Jeff Cranmer","startTime":793.058,"endTime":799.632,"body":"It's a 25-year-old biotech formed when its"},{"speaker":"Jeff Cranmer","startTime":793.058,"endTime":799.632,"body":"founders were lured back from the US to"},{"speaker":"Jeff Cranmer","startTime":799.632,"endTime":802.134,"body":"plant early seeds of the industry here."},{"speaker":"Jeff Cranmer","startTime":802.134,"endTime":804.103,"body":"Uh, Casey Lin is the CEO."},{"speaker":"Jeff Cranmer","startTime":804.136,"endTime":809.708,"body":"He was at Biogen way back"},{"speaker":"Jeff Cranmer","startTime":804.136,"endTime":809.708,"body":"when it had, uh, 200 people."},{"speaker":"Jeff Cranmer","startTime":810.176,"endTime":814.413,"body":"the chair, uh, Ching-Lu"},{"speaker":"Jeff Cranmer","startTime":810.176,"endTime":814.413,"body":"Tang, also a returnee."},{"speaker":"Jeff Cranmer","startTime":814.747,"endTime":818.684,"body":"and the company is right now"},{"speaker":"Jeff Cranmer","startTime":814.747,"endTime":818.684,"body":"waiting on word from FDA on"},{"speaker":"Jeff Cranmer","startTime":818.684,"endTime":821.253,"body":"an expanded label for BESREMi."},{"speaker":"Jeff Cranmer","startTime":821.654,"endTime":826.992,"body":"it's Will become, uh, if approved, in"},{"speaker":"Jeff Cranmer","startTime":821.654,"endTime":826.992,"body":"the US, the first new therapy in 30"},{"speaker":"Jeff Cranmer","startTime":826.992,"endTime":830.596,"body":"years for essential thrombocythemia."},{"speaker":"Jeff Cranmer","startTime":831.63,"endTime":837.136,"body":"Um, another longstanding company, that's"},{"speaker":"Jeff Cranmer","startTime":831.63,"endTime":837.136,"body":"finding its way back to the public markets"},{"speaker":"Jeff Cranmer","startTime":837.136,"endTime":842.975,"body":"is lipid-based platform company, uh, TLC"},{"speaker":"Jeff Cranmer","startTime":837.136,"endTime":842.975,"body":"Bioscience, which is led by George Ye."},{"speaker":"Jeff Cranmer","startTime":843.642,"endTime":851.483,"body":"Uh, the company delisted, uh, in Taiwan"},{"speaker":"Jeff Cranmer","startTime":843.642,"endTime":851.483,"body":"and from Nasdaq, uh, five years ago."},{"speaker":"Jeff Cranmer","startTime":851.483,"endTime":857.423,"body":"They're back on, the Taiwan market,"},{"speaker":"Jeff Cranmer","startTime":851.483,"endTime":857.423,"body":"and they're now looking ahead to"},{"speaker":"Jeff Cranmer","startTime":857.423,"endTime":864.129,"body":"back-to-back submissions in the US"},{"speaker":"Jeff Cranmer","startTime":857.423,"endTime":864.129,"body":"and Japan for, uh, its pain therapies."},{"speaker":"Jeff Cranmer","startTime":864.129,"endTime":868.968,"body":"It's also developing a GLP-1"},{"speaker":"Jeff Cranmer","startTime":864.129,"endTime":868.968,"body":"with reduced dosing frequency"},{"speaker":"Jeff Cranmer","startTime":868.968,"endTime":870.536,"body":"for the maintenance se- setting."},{"speaker":"Jeff Cranmer","startTime":870.736,"endTime":872.438,"body":"two other companies I'll quickly mention."},{"speaker":"Jeff Cranmer","startTime":872.438,"endTime":879.078,"body":"Uh, one, uh, Bora, led by Bobby Shang,"},{"speaker":"Jeff Cranmer","startTime":872.438,"endTime":879.078,"body":"stole the show in terms of deal-making,"},{"speaker":"Jeff Cranmer","startTime":879.411,"endTime":880.98,"body":"uh, when it partnered with Insilico."},{"speaker":"Jeff Cranmer","startTime":880.98,"endTime":881.013,"body":"Uh,"},{"speaker":"Jeff Cranmer","startTime":883.015,"endTime":888.754,"body":"the company is rapidly expanding via"},{"speaker":"Jeff Cranmer","startTime":883.015,"endTime":888.754,"body":"acquisitions, uh, in the US, uh, where"},{"speaker":"Jeff Cranmer","startTime":888.754,"endTime":891.023,"body":"it does niche and rare indications."},{"speaker":"Jeff Cranmer","startTime":891.323,"endTime":896.829,"body":"our colleague Karen Tkach Tuzman will"},{"speaker":"Jeff Cranmer","startTime":891.323,"endTime":896.829,"body":"have a story on that coming ahead."},{"speaker":"Jeff Cranmer","startTime":896.829,"endTime":902.001,"body":"And, and another one, uh, the one"},{"speaker":"Jeff Cranmer","startTime":896.829,"endTime":902.001,"body":"younger company in the crowd, Hanker"},{"speaker":"Jeff Cranmer","startTime":902.001,"endTime":908.507,"body":"Bio, which has, an, FC-based designer"},{"speaker":"Jeff Cranmer","startTime":902.001,"endTime":908.507,"body":"biologics platform, and they are,"},{"speaker":"Jeff Cranmer","startTime":908.507,"endTime":912.711,"body":"uh, looking to sail through the"},{"speaker":"Jeff Cranmer","startTime":908.507,"endTime":912.711,"body":"headwinds that have sunk other,"},{"speaker":"Jeff Cranmer","startTime":915.014,"endTime":915.281,"body":"CD47 bets."},{"speaker":"Jeff Cranmer","startTime":915.281,"endTime":921.02,"body":"So, uh, that's another one that we'll"},{"speaker":"Jeff Cranmer","startTime":915.281,"endTime":921.02,"body":"be, we'll be watching, uh, there."},{"speaker":"Steve Usdin","startTime":921.487,"endTime":924.323,"body":"Well, you know, I, I, I think"},{"speaker":"Steve Usdin","startTime":921.487,"endTime":924.323,"body":"it's really good and really interesting"},{"speaker":"Steve Usdin","startTime":924.323,"endTime":926.458,"body":"that you're keeping a close eye on Taiwan."},{"speaker":"Steve Usdin","startTime":926.792,"endTime":930.93,"body":"I, when I was… I was first there in the"},{"speaker":"Steve Usdin","startTime":926.792,"endTime":930.93,"body":"late 1970s and early 1980s, and I remember"},{"speaker":"Steve Usdin","startTime":930.93,"endTime":933.599,"body":"at that time it seemed like a backwater."},{"speaker":"Steve Usdin","startTime":933.599,"endTime":936.101,"body":"It seemed like, you know, there"},{"speaker":"Steve Usdin","startTime":933.599,"endTime":936.101,"body":"were people there who were talking"},{"speaker":"Steve Usdin","startTime":936.101,"endTime":938.003,"body":"about trying to get into tech."},{"speaker":"Steve Usdin","startTime":938.003,"endTime":941.373,"body":"There were people talking about trying"},{"speaker":"Steve Usdin","startTime":938.003,"endTime":941.373,"body":"to get into, com- in computer technology"},{"speaker":"Steve Usdin","startTime":941.373,"endTime":944.41,"body":"then and into semiconductors and"},{"speaker":"Steve Usdin","startTime":941.373,"endTime":944.41,"body":"things, and they were kind of… People"},{"speaker":"Steve Usdin","startTime":944.41,"endTime":945.711,"body":"thought, you know, this is a backwater."},{"speaker":"Steve Usdin","startTime":945.711,"endTime":947.012,"body":"They're never gonna be anything, right?"},{"speaker":"Steve Usdin","startTime":947.379,"endTime":950.082,"body":"And, uh, and that was a mistake , right?"},{"speaker":"Steve Usdin","startTime":950.082,"endTime":952.117,"body":"You know, as, as, as"},{"speaker":"Steve Usdin","startTime":950.082,"endTime":952.117,"body":"you, as you mentioned."},{"speaker":"Steve Usdin","startTime":952.117,"endTime":956.055,"body":"You know, they're, they're powerhouses now"},{"speaker":"Steve Usdin","startTime":952.117,"endTime":956.055,"body":"in, in semiconductors, and I, and I think,"},{"speaker":"Steve Usdin","startTime":956.221,"endTime":959.925,"body":"it, it'll be really interesting to see"},{"speaker":"Steve Usdin","startTime":956.221,"endTime":959.925,"body":"if they can kind of follow through with"},{"speaker":"Steve Usdin","startTime":959.925,"endTime":962.227,"body":"that same playbook, uh, in, in biotech"},{"speaker":"Jeff Cranmer","startTime":962.861,"endTime":963.162,"body":"Yeah."},{"speaker":"Jeff Cranmer","startTime":963.395,"endTime":967.466,"body":"I, I'm certainly impressed that,"},{"speaker":"Jeff Cranmer","startTime":963.395,"endTime":967.466,"body":"uh, TLC, PharmAscentia, Bora,"},{"speaker":"Jeff Cranmer","startTime":967.866,"endTime":972.171,"body":"these are companies that have been"},{"speaker":"Jeff Cranmer","startTime":967.866,"endTime":972.171,"body":"around for more than 20 years."},{"speaker":"Jeff Cranmer","startTime":972.538,"endTime":976.208,"body":"Um, so that staying power, is impressive."},{"speaker":"Jeff Cranmer","startTime":976.241,"endTime":980.479,"body":"Uh, PharmAscentia, uh, the chair"},{"speaker":"Jeff Cranmer","startTime":976.241,"endTime":980.479,"body":"told me that, one thing that's really"},{"speaker":"Jeff Cranmer","startTime":980.479,"endTime":985.617,"body":"different about Taiwan's markets is"},{"speaker":"Jeff Cranmer","startTime":980.479,"endTime":985.617,"body":"that its retail investors, they like"},{"speaker":"Jeff Cranmer","startTime":985.617,"endTime":990.055,"body":"their local heroes, and so they'll"},{"speaker":"Jeff Cranmer","startTime":985.617,"endTime":990.055,"body":"stick with you even after a setback."},{"speaker":"Jeff Cranmer","startTime":990.356,"endTime":994.96,"body":"Uh, they're very, very loyal, and,"},{"speaker":"Jeff Cranmer","startTime":990.356,"endTime":994.96,"body":"uh, that's one key, to success, at"},{"speaker":"Jeff Cranmer","startTime":994.96,"endTime":999.999,"body":"least for that company, and, uh, those"},{"speaker":"Jeff Cranmer","startTime":994.96,"endTime":999.999,"body":"investors are being rewarded now."},{"speaker":"Jeff Cranmer","startTime":1000.399,"endTime":1001.133,"body":"all right."},{"speaker":"Jeff Cranmer","startTime":1001.166,"endTime":1005.738,"body":"Well, we're gonna take a quick break,"},{"speaker":"Jeff Cranmer","startTime":1001.166,"endTime":1005.738,"body":"and then we're gonna get We're gonna"},{"speaker":"Jeff Cranmer","startTime":1005.738,"endTime":1011.31,"body":"take a look at what's happening"},{"speaker":"Jeff Cranmer","startTime":1005.738,"endTime":1011.31,"body":"with Biogen's tau program, with my"},{"speaker":"Jeff Cranmer","startTime":1011.31,"endTime":1013.612,"body":"fellow executive editor, Selina Koch."},{"speaker":"Voice Talent","startTime":1013.679,"endTime":1016.648,"body":"This episode of BioCentury"},{"speaker":"Voice Talent","startTime":1013.679,"endTime":1016.648,"body":"This Week is brought to you by the"},{"speaker":"Voice Talent","startTime":1016.648,"endTime":1021.186,"body":"13th China Healthcare Summit, taking"},{"speaker":"Voice Talent","startTime":1016.648,"endTime":1021.186,"body":"place November 2nd to 4th in Shanghai"},{"speaker":"Voice Talent","startTime":1022.888,"endTime":1026.458,"body":"Everyone has an opinion about China"},{"speaker":"Voice Talent","startTime":1022.888,"endTime":1026.458,"body":"biotech, but there's a difference"},{"speaker":"Voice Talent","startTime":1026.458,"endTime":1029.995,"body":"between reading about cross-border"},{"speaker":"Voice Talent","startTime":1026.458,"endTime":1029.995,"body":"deals and seeing it for yourself."},{"speaker":"Voice Talent","startTime":1030.562,"endTime":1033.999,"body":"The 13th China Healthcare Summit"},{"speaker":"Voice Talent","startTime":1030.562,"endTime":1033.999,"body":"brings you to Shanghai November"},{"speaker":"Voice Talent","startTime":1033.999,"endTime":1037.97,"body":"2nd to 4th for a firsthand look"},{"speaker":"Voice Talent","startTime":1033.999,"endTime":1037.97,"body":"at China's innovation moment."},{"speaker":"Voice Talent","startTime":1038.537,"endTime":1042.875,"body":"Join BioCentury, BayHelix, and"},{"speaker":"Voice Talent","startTime":1038.537,"endTime":1042.875,"body":"insights partner McKinsey \u0026 Company"},{"speaker":"Voice Talent","startTime":1043.075,"endTime":1047.88,"body":"for a deep dive into China's biopharma"},{"speaker":"Voice Talent","startTime":1043.075,"endTime":1047.88,"body":"ecosystem and meet the biotech leaders"},{"speaker":"Voice Talent","startTime":1047.88,"endTime":1049.681,"body":"who are driving all the newsflow."},{"speaker":"Voice Talent","startTime":1050.149,"endTime":1051.183,"body":"Sourcing innovation."},{"speaker":"Voice Talent","startTime":1051.35,"endTime":1052.418,"body":"Building NewCos."},{"speaker":"Voice Talent","startTime":1052.584,"endTime":1054.52,"body":"Generating faster clinical data."},{"speaker":"Voice Talent","startTime":1054.853,"endTime":1057.089,"body":"Reimagining your R\u0026D strategy."},{"speaker":"Voice Talent","startTime":1057.589,"endTime":1061.293,"body":"For a dozen years, the China Healthcare"},{"speaker":"Voice Talent","startTime":1057.589,"endTime":1061.293,"body":"Summit has gathered the right people"},{"speaker":"Voice Talent","startTime":1061.293,"endTime":1063.062,"body":"to network and build business."},{"speaker":"Voice Talent","startTime":1063.462,"endTime":1065.697,"body":"Now it's your chance to be in the room."},{"speaker":"Voice Talent","startTime":1066.131,"endTime":1067.933,"body":"Join us in Shanghai this November."},{"speaker":"Voice Talent","startTime":1068.167,"endTime":1072.337,"body":"Opt into the tour of Suzhou and a visit"},{"speaker":"Voice Talent","startTime":1068.167,"endTime":1072.337,"body":"to Shanghai clinical trial centers."},{"speaker":"Voice Talent","startTime":1072.671,"endTime":1073.939,"body":"See it for yourself."},{"speaker":"Voice Talent","startTime":1074.373,"endTime":1077.609,"body":"Register at biocenturychinasummit.com."},{"speaker":"Jeff Cranmer","startTime":1080.913,"endTime":1084.149,"body":"We are back on the"},{"speaker":"Jeff Cranmer","startTime":1080.913,"endTime":1084.149,"body":"BioCentury This Week podcast."},{"speaker":"Jeff Cranmer","startTime":1084.683,"endTime":1087.319,"body":"Selina, it always gets busy"},{"speaker":"Jeff Cranmer","startTime":1084.683,"endTime":1087.319,"body":"whenever there's a big, uh,"},{"speaker":"Jeff Cranmer","startTime":1087.386,"endTime":1090.255,"body":"Alzheimer conference for you."},{"speaker":"Jeff Cranmer","startTime":1090.255,"endTime":1093.258,"body":"Uh, in addition to everything"},{"speaker":"Jeff Cranmer","startTime":1090.255,"endTime":1093.258,"body":"else you do around here, you, uh,"},{"speaker":"Jeff Cranmer","startTime":1093.592,"endTime":1094.86,"body":"you like to dig into the data."},{"speaker":"Selina Koch","startTime":1094.993,"endTime":1095.127,"body":"Yeah."},{"speaker":"Selina Koch","startTime":1095.394,"endTime":1095.994,"body":"Thanks, Jeff."},{"speaker":"Selina Koch","startTime":1096.061,"endTime":1100.032,"body":"well, maybe we should start with,"},{"speaker":"Selina Koch","startTime":1096.061,"endTime":1100.032,"body":"why this particular readout mattered."},{"speaker":"Selina Koch","startTime":1100.032,"endTime":1102.201,"body":"I mean, obviously, tau's"},{"speaker":"Selina Koch","startTime":1100.032,"endTime":1102.201,"body":"on a new hypothesis."},{"speaker":"Selina Koch","startTime":1102.568,"endTime":1107.439,"body":"We've seen what feels like failure after"},{"speaker":"Selina Koch","startTime":1102.568,"endTime":1107.439,"body":"failure of tau therapies in phase two."},{"speaker":"Selina Koch","startTime":1107.906,"endTime":1112.611,"body":"that said, it's become apparent"},{"speaker":"Selina Koch","startTime":1107.906,"endTime":1112.611,"body":"in recent years that, um, y- the"},{"speaker":"Selina Koch","startTime":1112.611,"endTime":1116.815,"body":"pattern-- the level and pattern of tau"},{"speaker":"Selina Koch","startTime":1112.611,"endTime":1116.815,"body":"accumulation in the brain as measured"},{"speaker":"Selina Koch","startTime":1116.815,"endTime":1121.62,"body":"on PET imaging, correlates much more"},{"speaker":"Selina Koch","startTime":1116.815,"endTime":1121.62,"body":"closely with the development and the"},{"speaker":"Selina Koch","startTime":1121.62,"endTime":1125.824,"body":"progression and the types of symptoms"},{"speaker":"Selina Koch","startTime":1121.62,"endTime":1125.824,"body":"people get than amyloid ever did, right?"},{"speaker":"Selina Koch","startTime":1125.891,"endTime":1131.196,"body":"So people have high hopes for tau"},{"speaker":"Selina Koch","startTime":1125.891,"endTime":1131.196,"body":"in general, and this particular,"},{"speaker":"Selina Koch","startTime":1131.196,"endTime":1134.6,"body":"candidate stood out in a couple of ways."},{"speaker":"Selina Koch","startTime":1134.633,"endTime":1137.936,"body":"So most… So tau is"},{"speaker":"Selina Koch","startTime":1134.633,"endTime":1137.936,"body":"a very complex target."},{"speaker":"Selina Koch","startTime":1138.303,"endTime":1140.105,"body":"It's one thing that's made"},{"speaker":"Selina Koch","startTime":1138.303,"endTime":1140.105,"body":"it harder than amyloid."},{"speaker":"Selina Koch","startTime":1140.439,"endTime":1142.107,"body":"Amyloid's basically you know where it is."},{"speaker":"Selina Koch","startTime":1142.107,"endTime":1144.209,"body":"It's in the extracellular"},{"speaker":"Selina Koch","startTime":1142.107,"endTime":1144.209,"body":"spaces between neurons."},{"speaker":"Selina Koch","startTime":1144.209,"endTime":1145.177,"body":"That's where you target it."},{"speaker":"Selina Koch","startTime":1145.944,"endTime":1146.578,"body":"Tau is different."},{"speaker":"Selina Koch","startTime":1147.212,"endTime":1150.082,"body":"It exists inside cells,"},{"speaker":"Selina Koch","startTime":1147.212,"endTime":1150.082,"body":"it exists outside cells."},{"speaker":"Selina Koch","startTime":1150.115,"endTime":1152.351,"body":"It is alternatively spliced."},{"speaker":"Selina Koch","startTime":1152.351,"endTime":1154.92,"body":"It's in various fragments and"},{"speaker":"Selina Koch","startTime":1152.351,"endTime":1154.92,"body":"lots of different kinds of"},{"speaker":"Selina Koch","startTime":1154.92,"endTime":1156.622,"body":"post-translational modifications."},{"speaker":"Selina Koch","startTime":1156.622,"endTime":1160.959,"body":"So what that's meant is that the"},{"speaker":"Selina Koch","startTime":1156.622,"endTime":1160.959,"body":"therapies that have come before,"},{"speaker":"Selina Koch","startTime":1160.993,"endTime":1164.796,"body":"they've mostly-- they singled out one"},{"speaker":"Selina Koch","startTime":1160.993,"endTime":1164.796,"body":"hypothesis, you know, a particular"},{"speaker":"Selina Koch","startTime":1164.796,"endTime":1167.699,"body":"fragment or modification, et cetera."},{"speaker":"Selina Koch","startTime":1168.1,"endTime":1172.905,"body":"and they've mostly all been extracellular"},{"speaker":"Selina Koch","startTime":1168.1,"endTime":1172.905,"body":"targeting as well and hope that, you know,"},{"speaker":"Selina Koch","startTime":1172.905,"endTime":1176.575,"body":"they thought had their rationale for why"},{"speaker":"Selina Koch","startTime":1172.905,"endTime":1176.575,"body":"that's the primary disease driver, right?"},{"speaker":"Selina Koch","startTime":1177.075,"endTime":1182.981,"body":"but this therapy, duranersen,"},{"speaker":"Selina Koch","startTime":1177.075,"endTime":1182.981,"body":"goes upstream, and it essentially"},{"speaker":"Selina Koch","startTime":1182.981,"endTime":1184.883,"body":"tries to simplify the hypothesis."},{"speaker":"Selina Koch","startTime":1185.25,"endTime":1191.49,"body":"So it's an antisense oligo, um, made with"},{"speaker":"Selina Koch","startTime":1185.25,"endTime":1191.49,"body":"Ionis that basically lowers the source"},{"speaker":"Selina Koch","startTime":1191.523,"endTime":1196.328,"body":"material that's essential for creating"},{"speaker":"Selina Koch","startTime":1191.523,"endTime":1196.328,"body":"all of those forms of tau rather than"},{"speaker":"Selina Koch","startTime":1196.328,"endTime":1200.732,"body":"trying to figure out which one is the"},{"speaker":"Selina Koch","startTime":1196.328,"endTime":1200.732,"body":"important pathological species, when"},{"speaker":"Selina Koch","startTime":1200.732,"endTime":1202.834,"body":"in fact many could be important, right?"},{"speaker":"Selina Koch","startTime":1202.968,"endTime":1207.439,"body":"so people were looking forward to"},{"speaker":"Selina Koch","startTime":1202.968,"endTime":1207.439,"body":"the result for that rationale, and"},{"speaker":"Selina Koch","startTime":1207.439,"endTime":1211.777,"body":"because there was an interesting"},{"speaker":"Selina Koch","startTime":1207.439,"endTime":1211.777,"body":"early result where, the therapies"},{"speaker":"Selina Koch","startTime":1211.777,"endTime":1217.382,"body":"that came before either failed"},{"speaker":"Selina Koch","startTime":1211.777,"endTime":1217.382,"body":"to lower the, um, tau PET signal"},{"speaker":"Selina Koch","startTime":1219.585,"endTime":1225.724,"body":"Or what we saw in at least one case was"},{"speaker":"Selina Koch","startTime":1219.585,"endTime":1225.724,"body":"normally the tau aggregation accumulates"},{"speaker":"Selina Koch","startTime":1225.724,"endTime":1226.825,"body":"over time and gets worse, right?"},{"speaker":"Selina Koch","startTime":1226.825,"endTime":1228.894,"body":"And so we saw a slowing"},{"speaker":"Selina Koch","startTime":1226.825,"endTime":1228.894,"body":"of that accumulation."},{"speaker":"Selina Koch","startTime":1229.294,"endTime":1236.435,"body":"Well, donanemab actually reversed tau"},{"speaker":"Selina Koch","startTime":1229.294,"endTime":1236.435,"body":"PET, so it was lower than at baseline."},{"speaker":"Selina Koch","startTime":1236.802,"endTime":1238.303,"body":"So that felt like a breakthrough."},{"speaker":"Selina Koch","startTime":1238.37,"endTime":1240.772,"body":"So here this bigger sort"},{"speaker":"Selina Koch","startTime":1238.37,"endTime":1240.772,"body":"of sledgehammer in a way."},{"speaker":"Selina Koch","startTime":1241.373,"endTime":1245.677,"body":"And you could say, well, you know, if"},{"speaker":"Selina Koch","startTime":1241.373,"endTime":1245.677,"body":"you just broadly lower tau, can you"},{"speaker":"Selina Koch","startTime":1245.677,"endTime":1247.412,"body":"actually slow cognitive decline or not?"},{"speaker":"Selina Koch","startTime":1247.913,"endTime":1250.482,"body":"unfortunately, as happens"},{"speaker":"Selina Koch","startTime":1247.913,"endTime":1250.482,"body":"often in Alzheimer's disease,"},{"speaker":"Selina Koch","startTime":1250.515,"endTime":1251.75,"body":"the results are kind of murky."},{"speaker":"Selina Koch","startTime":1252.517,"endTime":1257.322,"body":"Um, you can look at them in a sort"},{"speaker":"Selina Koch","startTime":1252.517,"endTime":1257.322,"body":"of glass half full or glass half"},{"speaker":"Selina Koch","startTime":1257.322,"endTime":1261.46,"body":"empty way as people will, and there"},{"speaker":"Selina Koch","startTime":1257.322,"endTime":1261.46,"body":"will be two camps, of course, as"},{"speaker":"Selina Koch","startTime":1261.46,"endTime":1262.561,"body":"there always is in Alzheimer's."},{"speaker":"Selina Koch","startTime":1262.561,"endTime":1267.165,"body":"Um, so it missed its endpoint, um,"},{"speaker":"Selina Koch","startTime":1262.561,"endTime":1267.165,"body":"which was trying to establish a"},{"speaker":"Selina Koch","startTime":1267.199,"endTime":1273.205,"body":"dose response on the pre-- um, the,"},{"speaker":"Selina Koch","startTime":1267.199,"endTime":1273.205,"body":"uh, cognitive measure of, um, the"},{"speaker":"Selina Koch","startTime":1273.205,"endTime":1277.509,"body":"standard one, CDR sum of boxes,"},{"speaker":"Selina Koch","startTime":1273.205,"endTime":1277.509,"body":"Clinical Dementia Rating, um, Scale."},{"speaker":"Selina Koch","startTime":1278.143,"endTime":1282.114,"body":"But yeah, so the, the lowest dose,"},{"speaker":"Selina Koch","startTime":1278.143,"endTime":1282.114,"body":"60 milligrams every twenty-four"},{"speaker":"Selina Koch","startTime":1282.114,"endTime":1284.716,"body":"weeks performed the best."},{"speaker":"Selina Koch","startTime":1285.217,"endTime":1289.554,"body":"but then if you look at sort of the"},{"speaker":"Selina Koch","startTime":1285.217,"endTime":1289.554,"body":"absolute changes on that scale and the"},{"speaker":"Selina Koch","startTime":1289.588,"endTime":1293.258,"body":"other cognitive endpoints that they"},{"speaker":"Selina Koch","startTime":1289.588,"endTime":1293.258,"body":"measured in phase two, there was a"},{"speaker":"Selina Koch","startTime":1293.258,"endTime":1297.396,"body":"twenty-six percent slowing on CDR sum"},{"speaker":"Selina Koch","startTime":1293.258,"endTime":1297.396,"body":"of the boxes, slowing of progression,"},{"speaker":"Selina Koch","startTime":1297.729,"endTime":1300.832,"body":"which was h-- and then the other"},{"speaker":"Selina Koch","startTime":1297.729,"endTime":1300.832,"body":"endpoints were actually bigger moves."},{"speaker":"Selina Koch","startTime":1300.832,"endTime":1304.736,"body":"So forty-two percent slowing on ADAS-Cog"},{"speaker":"Selina Koch","startTime":1300.832,"endTime":1304.736,"body":"thirteen, fifty percent slowing of"},{"speaker":"Selina Koch","startTime":1304.736,"endTime":1307.372,"body":"progression on the Mini-Mental State Exam."},{"speaker":"Selina Koch","startTime":1307.372,"endTime":1310.876,"body":"So if you just line those up"},{"speaker":"Selina Koch","startTime":1307.372,"endTime":1310.876,"body":"with the approved anti-amyloid"},{"speaker":"Selina Koch","startTime":1310.876,"endTime":1314.88,"body":"antibodies, those results look good,"},{"speaker":"Selina Koch","startTime":1310.876,"endTime":1314.88,"body":"if maybe even a little bit better."},{"speaker":"Selina Koch","startTime":1315.113,"endTime":1319.318,"body":"and that's kind of the basis on"},{"speaker":"Selina Koch","startTime":1315.113,"endTime":1319.318,"body":"which Biogen's moving forward"},{"speaker":"Selina Koch","startTime":1319.318,"endTime":1324.523,"body":"and, and why the, the study's PIs"},{"speaker":"Selina Koch","startTime":1319.318,"endTime":1324.523,"body":"view this as the long-awaited,"},{"speaker":"Selina Koch","startTime":1325.09,"endTime":1326.925,"body":"proof of principle for tau, right?"},{"speaker":"Selina Koch","startTime":1327.459,"endTime":1330.162,"body":"The complexity come… Yeah, comes"},{"speaker":"Selina Koch","startTime":1327.459,"endTime":1330.162,"body":"from the fact that the biomarkers"},{"speaker":"Selina Koch","startTime":1330.162,"endTime":1331.463,"body":"sort of move the other way."},{"speaker":"Selina Koch","startTime":1331.863,"endTime":1334.866,"body":"There was a good dose response"},{"speaker":"Selina Koch","startTime":1331.863,"endTime":1334.866,"body":"for the biomarkers, but not so"},{"speaker":"Selina Koch","startTime":1334.866,"endTime":1336.201,"body":"much for the cognitive endpoints"},{"speaker":"Steve Usdin","startTime":1336.501,"endTime":1338.837,"body":"Ha-haven't"},{"speaker":"Steve Usdin","startTime":1336.501,"endTime":1338.837,"body":"we seen this movie before?"},{"speaker":"Simone Fishburn","startTime":1339.271,"endTime":1341.206,"body":"So I"},{"speaker":"Simone Fishburn","startTime":1339.271,"endTime":1341.206,"body":"gotta do that as well."},{"speaker":"Simone Fishburn","startTime":1341.239,"endTime":1343.575,"body":"So Selina, why is this field so difficult?"},{"speaker":"Simone Fishburn","startTime":1343.608,"endTime":1347.512,"body":"And why… Okay, why is it so difficult"},{"speaker":"Simone Fishburn","startTime":1343.608,"endTime":1347.512,"body":"is one question, but what I'm really"},{"speaker":"Simone Fishburn","startTime":1347.546,"endTime":1351.65,"body":"asking is that just when Steve says"},{"speaker":"Simone Fishburn","startTime":1347.546,"endTime":1351.65,"body":"this movie, before I was thinking the"},{"speaker":"Simone Fishburn","startTime":1351.65,"endTime":1356.488,"body":"same thing, it seems to be that in this"},{"speaker":"Simone Fishburn","startTime":1351.65,"endTime":1356.488,"body":"field in particular, there's this sort"},{"speaker":"Simone Fishburn","startTime":1356.488,"endTime":1360.625,"body":"of, \"Well, I like this bit of data,"},{"speaker":"Simone Fishburn","startTime":1356.488,"endTime":1360.625,"body":"but I don't like that bit of data, but"},{"speaker":"Simone Fishburn","startTime":1360.625,"endTime":1360.992,"body":"I can explain"},{"speaker":"Steve Usdin","startTime":1361.293,"endTime":1364.262,"body":"The, low dose didn't"},{"speaker":"Steve Usdin","startTime":1361.293,"endTime":1364.262,"body":"work, but I mean, the low dose"},{"speaker":"Steve Usdin","startTime":1364.262,"endTime":1367.866,"body":"worked better than the high"},{"speaker":"Steve Usdin","startTime":1364.262,"endTime":1367.866,"body":"dose, and it missed its endpoint."},{"speaker":"Steve Usdin","startTime":1367.899,"endTime":1368.266,"body":"But,"},{"speaker":"Simone Fishburn","startTime":1368.3,"endTime":1370.068,"body":"but it's still"},{"speaker":"Simone Fishburn","startTime":1368.3,"endTime":1370.068,"body":"really good and I'm still gonna"},{"speaker":"Simone Fishburn","startTime":1370.068,"endTime":1372.104,"body":"go forward with it,\" you know?"},{"speaker":"Simone Fishburn","startTime":1372.404,"endTime":1375.44,"body":"So we're not asking you to"},{"speaker":"Simone Fishburn","startTime":1372.404,"endTime":1375.44,"body":"defend them, but, um, can you"},{"speaker":"Simone Fishburn","startTime":1375.44,"endTime":1376.908,"body":"unravel it a little bit for us?"},{"speaker":"Selina Koch","startTime":1377.275,"endTime":1380.645,"body":"Well, so like I said, they"},{"speaker":"Selina Koch","startTime":1377.275,"endTime":1380.645,"body":"lined up these results with the approved"},{"speaker":"Selina Koch","startTime":1380.645,"endTime":1385.117,"body":"anti-amyloid therapies and said, \"Look,"},{"speaker":"Selina Koch","startTime":1380.645,"endTime":1385.117,"body":"it's at least-- it appears to be that"},{"speaker":"Selina Koch","startTime":1385.117,"endTime":1388.42,"body":"could change in Phase III. But for"},{"speaker":"Selina Koch","startTime":1385.117,"endTime":1388.42,"body":"what we have today, it appears to be at"},{"speaker":"Selina Koch","startTime":1388.42,"endTime":1391.757,"body":"least as good as them and they're on the"},{"speaker":"Selina Koch","startTime":1388.42,"endTime":1391.757,"body":"market.\" And eventually everybody thinks"},{"speaker":"Selina Koch","startTime":1391.757,"endTime":1393.492,"body":"this is probably a combination play,"},{"speaker":"Steve Usdin","startTime":1393.992,"endTime":1395.327,"body":"Yeah, that, that's"},{"speaker":"Steve Usdin","startTime":1393.992,"endTime":1395.327,"body":"what I was gonna ask too."},{"speaker":"Steve Usdin","startTime":1395.327,"endTime":1398.73,"body":"Is there, is there any reason to think"},{"speaker":"Steve Usdin","startTime":1395.327,"endTime":1398.73,"body":"that it'll be a cumulative effect if"},{"speaker":"Steve Usdin","startTime":1398.73,"endTime":1400.532,"body":"you have-- if, if you combine them?"},{"speaker":"Steve Usdin","startTime":1400.699,"endTime":1404.002,"body":"and would you get, if, if the"},{"speaker":"Steve Usdin","startTime":1400.699,"endTime":1404.002,"body":"results are about the same, you"},{"speaker":"Steve Usdin","startTime":1404.002,"endTime":1406.772,"body":"know, would you then, if you combine"},{"speaker":"Steve Usdin","startTime":1404.002,"endTime":1406.772,"body":"them, get a doubling of efficacy?"},{"speaker":"Selina Koch","startTime":1407.406,"endTime":1410.242,"body":"It's unclear yet if"},{"speaker":"Selina Koch","startTime":1407.406,"endTime":1410.242,"body":"it'd be quantitative like that."},{"speaker":"Selina Koch","startTime":1410.275,"endTime":1414.813,"body":"And the amyloid hypothesis, you know,"},{"speaker":"Selina Koch","startTime":1410.275,"endTime":1414.813,"body":"posits that the amyloid reduction is like"},{"speaker":"Selina Koch","startTime":1414.813,"endTime":1416.581,"body":"a little bit before the tau reduction."},{"speaker":"Selina Koch","startTime":1416.581,"endTime":1419.684,"body":"But there's a, there's-- this is a--"},{"speaker":"Selina Koch","startTime":1416.581,"endTime":1419.684,"body":"we're talking about very lengthy disease,"},{"speaker":"Selina Koch","startTime":1419.684,"endTime":1423.121,"body":"and there's a lot of overlap in these"},{"speaker":"Selina Koch","startTime":1419.684,"endTime":1423.121,"body":"pathologies in their development."},{"speaker":"Selina Koch","startTime":1423.121,"endTime":1428.46,"body":"So, yeah, I think probably if they're safe"},{"speaker":"Selina Koch","startTime":1423.121,"endTime":1428.46,"body":"enough to combine, you would in principle"},{"speaker":"Selina Koch","startTime":1428.46,"endTime":1430.629,"body":"expect greater efficacy from combining."},{"speaker":"Selina Koch","startTime":1430.629,"endTime":1433.565,"body":"And you could think about… say, \"Oh,"},{"speaker":"Selina Koch","startTime":1430.629,"endTime":1433.565,"body":"it's always the same in Alzheimer's"},{"speaker":"Selina Koch","startTime":1433.565,"endTime":1437.102,"body":"disease,\" but they would say, \" Yes,"},{"speaker":"Selina Koch","startTime":1433.565,"endTime":1437.102,"body":"but that's also true in cancer.\""},{"speaker":"Selina Koch","startTime":1437.436,"endTime":1440.338,"body":"Incremental benefit really matters, and"},{"speaker":"Selina Koch","startTime":1437.436,"endTime":1440.338,"body":"you have to start somewhere, and you"},{"speaker":"Selina Koch","startTime":1440.338,"endTime":1442.007,"body":"have to build on each result, right?"},{"speaker":"Selina Koch","startTime":1442.007,"endTime":1443.608,"body":"So that's the other side of the coin."},{"speaker":"Steve Usdin","startTime":1444.643,"endTime":1446.178,"body":"when do we"},{"speaker":"Steve Usdin","startTime":1444.643,"endTime":1446.178,"body":"find out what happens next?"},{"speaker":"Steve Usdin","startTime":1446.378,"endTime":1446.978,"body":"What, you know, what's"},{"speaker":"Steve Usdin","startTime":1446.978,"endTime":1447.779,"body":"the next shoe to"},{"speaker":"Selina Koch","startTime":1447.879,"endTime":1451.783,"body":"company has decided"},{"speaker":"Selina Koch","startTime":1447.879,"endTime":1451.783,"body":"that it's enough of a single to--"},{"speaker":"Selina Koch","startTime":1451.917,"endTime":1453.585,"body":"a signal to move to phase three."},{"speaker":"Selina Koch","startTime":1453.919,"endTime":1455.854,"body":"Investors weren't so happy about that."},{"speaker":"Selina Koch","startTime":1455.854,"endTime":1460.125,"body":"I think company's market cap"},{"speaker":"Selina Koch","startTime":1455.854,"endTime":1460.125,"body":"fell over two billion that day."},{"speaker":"Selina Koch","startTime":1461.226,"endTime":1466.631,"body":"But that might be also a function of, you"},{"speaker":"Selina Koch","startTime":1461.226,"endTime":1466.631,"body":"know, um, Wieback coming in and saying"},{"speaker":"Selina Koch","startTime":1466.665,"endTime":1470.569,"body":"he's going to diversify the company away"},{"speaker":"Selina Koch","startTime":1466.665,"endTime":1470.569,"body":"from some of these high-risk bets, and,"},{"speaker":"Selina Koch","startTime":1470.602,"endTime":1472.437,"body":"and he has done quite a lot of that."},{"speaker":"Selina Koch","startTime":1472.437,"endTime":1476.074,"body":"But here they are making another,"},{"speaker":"Selina Koch","startTime":1472.437,"endTime":1476.074,"body":"you know, embarking on a very"},{"speaker":"Selina Koch","startTime":1476.074,"endTime":1480.679,"body":"expensive, long, large phase three,"},{"speaker":"Selina Koch","startTime":1476.074,"endTime":1480.679,"body":"um, in a high-risk situation."},{"speaker":"Selina Koch","startTime":1481.246,"endTime":1484.749,"body":"Anyway, for s- the sake of science, it"},{"speaker":"Selina Koch","startTime":1481.246,"endTime":1484.749,"body":"will be interesting to see the result."},{"speaker":"Selina Koch","startTime":1484.95,"endTime":1485.617,"body":"There's no doubt."},{"speaker":"Selina Koch","startTime":1485.65,"endTime":1490.555,"body":"Um, it's, a little complex because"},{"speaker":"Selina Koch","startTime":1485.65,"endTime":1490.555,"body":"when you have-- It's a little hard to"},{"speaker":"Selina Koch","startTime":1490.555,"endTime":1495.594,"body":"interpret the disconnect, the fact that"},{"speaker":"Selina Koch","startTime":1490.555,"endTime":1495.594,"body":"the biomarkers showed a dose response"},{"speaker":"Selina Koch","startTime":1495.694,"endTime":1496.895,"body":"and the cognitive endpoints didn't."},{"speaker":"Selina Koch","startTime":1496.895,"endTime":1498.363,"body":"So how you design your phase three?"},{"speaker":"Selina Koch","startTime":1499.197,"endTime":1504.769,"body":"it may be that, well, that's just a"},{"speaker":"Selina Koch","startTime":1499.197,"endTime":1504.769,"body":"side effect of the small noisiness of"},{"speaker":"Selina Koch","startTime":1504.769,"endTime":1508.874,"body":"phase two and the fact that, you know,"},{"speaker":"Selina Koch","startTime":1504.769,"endTime":1508.874,"body":"Alzheimer's is such a heterogeneous"},{"speaker":"Selina Koch","startTime":1508.907,"endTime":1511.343,"body":"disease, and we d-don't have--"},{"speaker":"Selina Koch","startTime":1508.907,"endTime":1511.343,"body":"like, we're only at the beginning"},{"speaker":"Selina Koch","startTime":1511.343,"endTime":1514.012,"body":"of narrowing that with biomarkers."},{"speaker":"Selina Koch","startTime":1514.513,"endTime":1517.516,"body":"but there's another possibility"},{"speaker":"Selina Koch","startTime":1514.513,"endTime":1517.516,"body":"which would have bigger implications"},{"speaker":"Selina Koch","startTime":1517.516,"endTime":1518.917,"body":"for the whole field of tau, right?"},{"speaker":"Selina Koch","startTime":1519.351,"endTime":1522.954,"body":"which is that if you're taking this"},{"speaker":"Selina Koch","startTime":1519.351,"endTime":1522.954,"body":"kind of a broader approach to lowering"},{"speaker":"Selina Koch","startTime":1522.954,"endTime":1527.392,"body":"tau of all, all of its forms, there"},{"speaker":"Selina Koch","startTime":1522.954,"endTime":1527.392,"body":"are other siRNA therapies doing this."},{"speaker":"Selina Koch","startTime":1527.425,"endTime":1529.761,"body":"There's targeted protein"},{"speaker":"Selina Koch","startTime":1527.425,"endTime":1529.761,"body":"degraders, et cetera."},{"speaker":"Selina Koch","startTime":1530.061,"endTime":1532.931,"body":"there could be a therapeutic"},{"speaker":"Selina Koch","startTime":1530.061,"endTime":1532.931,"body":"window above which getting"},{"speaker":"Selina Koch","startTime":1532.931,"endTime":1534.466,"body":"rid of more tau isn't better."},{"speaker":"Selina Koch","startTime":1534.499,"endTime":1536.568,"body":"Tau is an important protein in neurons."},{"speaker":"Selina Koch","startTime":1536.568,"endTime":1541.239,"body":"It could, in theory, have harms"},{"speaker":"Selina Koch","startTime":1536.568,"endTime":1541.239,"body":"if you get rid of too much of it."},{"speaker":"Selina Koch","startTime":1541.239,"endTime":1545.544,"body":"so, you know, I guess we'll see, um,"},{"speaker":"Selina Koch","startTime":1541.239,"endTime":1545.544,"body":"how they design the phase three in"},{"speaker":"Selina Koch","startTime":1545.544,"endTime":1547.078,"body":"terms of what doses they include."},{"speaker":"Selina Koch","startTime":1547.112,"endTime":1550.315,"body":"But certainly from an efficacy"},{"speaker":"Selina Koch","startTime":1547.112,"endTime":1550.315,"body":"perspective, that, that low"},{"speaker":"Selina Koch","startTime":1550.315,"endTime":1552.851,"body":"dose is looking like the"},{"speaker":"Selina Koch","startTime":1550.315,"endTime":1552.851,"body":"most promising bet right now"},{"speaker":"Jeff Cranmer","startTime":1553.385,"endTime":1554.252,"body":"It sounds good."},{"speaker":"Jeff Cranmer","startTime":1554.252,"endTime":1561.326,"body":"While staying with Neuro, uh, well, Eli"},{"speaker":"Jeff Cranmer","startTime":1554.252,"endTime":1561.326,"body":"Lilly, uh, not to be denied, uh, yet"},{"speaker":"Jeff Cranmer","startTime":1561.359,"endTime":1563.695,"body":"another company that it wants to acquire."},{"speaker":"Jeff Cranmer","startTime":1563.962,"endTime":1570.835,"body":"paying 2.8 billion up front, to enter"},{"speaker":"Jeff Cranmer","startTime":1563.962,"endTime":1570.835,"body":"into psychedelics, buying Eteplirsen."},{"speaker":"Jeff Cranmer","startTime":1572.037,"endTime":1574.005,"body":"Uh, what did you make of the deal, Selina?"},{"speaker":"Selina Koch","startTime":1574.539,"endTime":1579.244,"body":"so yeah, the Tai"},{"speaker":"Selina Koch","startTime":1574.539,"endTime":1579.244,"body":"Beckley, uh, molecule is, um, a"},{"speaker":"Selina Koch","startTime":1579.244,"endTime":1581.846,"body":"psychedelic that is a form of DMT."},{"speaker":"Selina Koch","startTime":1581.913,"endTime":1585.817,"body":"So, it would-- it's just"},{"speaker":"Selina Koch","startTime":1581.913,"endTime":1585.817,"body":"behind in the clinic, I guess."},{"speaker":"Selina Koch","startTime":1585.85,"endTime":1588.787,"body":"Um, another psychedelic, a"},{"speaker":"Selina Koch","startTime":1585.85,"endTime":1588.787,"body":"syl-- a synthetic form of"},{"speaker":"Selina Koch","startTime":1588.787,"endTime":1590.755,"body":"psilocybin from Compass Pathways."},{"speaker":"Selina Koch","startTime":1591.222,"endTime":1594.759,"body":"so they're kind of positioned against each"},{"speaker":"Selina Koch","startTime":1591.222,"endTime":1594.759,"body":"other in treatment-resistant depression."},{"speaker":"Selina Koch","startTime":1595.36,"endTime":1599.864,"body":"Ahead of both of them on the market is a"},{"speaker":"Selina Koch","startTime":1595.36,"endTime":1599.864,"body":"psychedelic-adjacent compound, Spravato."},{"speaker":"Selina Koch","startTime":1599.864,"endTime":1603.368,"body":"It's a, the S enantiomer of"},{"speaker":"Selina Koch","startTime":1599.864,"endTime":1603.368,"body":"ketamine from Johnson \u0026 Johnson."},{"speaker":"Selina Koch","startTime":1603.935,"endTime":1609.474,"body":"Spravato has kind of paved the"},{"speaker":"Selina Koch","startTime":1603.935,"endTime":1609.474,"body":"commercial path for psychedelic-type,"},{"speaker":"Selina Koch","startTime":1609.941,"endTime":1613.578,"body":"therapies, which are delivered with a"},{"speaker":"Selina Koch","startTime":1609.941,"endTime":1613.578,"body":"very different sort of care model than"},{"speaker":"Selina Koch","startTime":1613.578,"endTime":1615.246,"body":"your standard antidepressant, right?"},{"speaker":"Selina Koch","startTime":1615.88,"endTime":1621.486,"body":"what's different b-um, between Spravato"},{"speaker":"Selina Koch","startTime":1615.88,"endTime":1621.486,"body":"and these, these other two, the Compass"},{"speaker":"Selina Koch","startTime":1621.486,"endTime":1626.191,"body":"and the Tai Beckl-Beckley programs,"},{"speaker":"Selina Koch","startTime":1621.486,"endTime":1626.191,"body":"is that Spravato is given fairly"},{"speaker":"Selina Koch","startTime":1626.257,"endTime":1631.863,"body":"frequently, whereas these are-- the"},{"speaker":"Selina Koch","startTime":1626.257,"endTime":1631.863,"body":"hope is that they're given not, you"},{"speaker":"Selina Koch","startTime":1631.863,"endTime":1636.201,"body":"know, once, twice, maybe three times"},{"speaker":"Selina Koch","startTime":1631.863,"endTime":1636.201,"body":"with large gaps in between those doses,"},{"speaker":"Selina Koch","startTime":1636.201,"endTime":1638.269,"body":"and, and then that would be it, right?"},{"speaker":"Selina Koch","startTime":1638.269,"endTime":1642.207,"body":"So that would be the primary"},{"speaker":"Selina Koch","startTime":1638.269,"endTime":1642.207,"body":"differentiator from s-- the way"},{"speaker":"Selina Koch","startTime":1642.207,"endTime":1643.441,"body":"depression is treated today."},{"speaker":"Selina Koch","startTime":1643.942,"endTime":1647.345,"body":"Tai Beckley has said that it thinks"},{"speaker":"Selina Koch","startTime":1643.942,"endTime":1647.345,"body":"it has a best-in-class therapy."},{"speaker":"Selina Koch","startTime":1647.345,"endTime":1652.017,"body":"So our colleagues, Stephen Hansen and, and"},{"speaker":"Selina Koch","startTime":1647.345,"endTime":1652.017,"body":"Tierney Baum, looked into the data to, you"},{"speaker":"Selina Koch","startTime":1652.017,"endTime":1654.252,"body":"know, see what they could find about that."},{"speaker":"Selina Koch","startTime":1654.719,"endTime":1659.624,"body":"Um, if you compare just the Phase IIb"},{"speaker":"Selina Koch","startTime":1654.719,"endTime":1659.624,"body":"results from each, they look broadly"},{"speaker":"Selina Koch","startTime":1659.624,"endTime":1664.129,"body":"similar really, in terms of the, um,"},{"speaker":"Selina Koch","startTime":1659.624,"endTime":1664.129,"body":"point reduction on the primary endpoint."},{"speaker":"Selina Koch","startTime":1664.462,"endTime":1666.064,"body":"They weren't that"},{"speaker":"Selina Koch","startTime":1664.462,"endTime":1666.064,"body":"different from each other."},{"speaker":"Selina Koch","startTime":1666.197,"endTime":1669.167,"body":"And given the, you know, the small"},{"speaker":"Selina Koch","startTime":1666.197,"endTime":1669.167,"body":"differences between the trials,"},{"speaker":"Selina Koch","startTime":1669.2,"endTime":1672.904,"body":"the way they're designed, you know,"},{"speaker":"Selina Koch","startTime":1669.2,"endTime":1672.904,"body":"you can't-- the differences between"},{"speaker":"Selina Koch","startTime":1672.904,"endTime":1676.508,"body":"them, you know, you can't make, um,"},{"speaker":"Selina Koch","startTime":1672.904,"endTime":1676.508,"body":"conclusions about them being meaningful."},{"speaker":"Selina Koch","startTime":1676.775,"endTime":1678.043,"body":"They seem relatively similar."},{"speaker":"Selina Koch","startTime":1678.343,"endTime":1683.281,"body":"Now, Compass, it-- and when it went on to"},{"speaker":"Selina Koch","startTime":1678.343,"endTime":1683.281,"body":"Phase III, it has read out multiple Phase"},{"speaker":"Selina Koch","startTime":1683.281,"endTime":1687.585,"body":"III studies, and the point reductions on"},{"speaker":"Selina Koch","startTime":1683.281,"endTime":1687.585,"body":"the primary endpoint reduced considerably"},{"speaker":"Selina Koch","startTime":1687.585,"endTime":1688.92,"body":"from what they saw in Phase II."},{"speaker":"Selina Koch","startTime":1689.387,"endTime":1693.258,"body":"Still looks effective, still gonna"},{"speaker":"Selina Koch","startTime":1689.387,"endTime":1693.258,"body":"probably be a good addition to"},{"speaker":"Selina Koch","startTime":1693.258,"endTime":1695.226,"body":"the treatment, you know, toolbox."},{"speaker":"Selina Koch","startTime":1695.627,"endTime":1698.496,"body":"but looking more like your"},{"speaker":"Selina Koch","startTime":1695.627,"endTime":1698.496,"body":"standard antidepressant in terms"},{"speaker":"Selina Koch","startTime":1698.496,"endTime":1699.898,"body":"of magnitude of the benefit."},{"speaker":"Selina Koch","startTime":1700.198,"endTime":1704.035,"body":"We'll see what happens with, with"},{"speaker":"Selina Koch","startTime":1700.198,"endTime":1704.035,"body":"the now Lilly program, you know,"},{"speaker":"Selina Koch","startTime":1704.569,"endTime":1706.171,"body":"when it has-- when it's at that stage"},{"speaker":". Jeff Cranmer","startTime":1706.438,"endTime":1706.738,"body":"Okay."},{"speaker":". Jeff Cranmer","startTime":1706.738,"endTime":1710.809,"body":"It's the, uh, twelfth acquisition"},{"speaker":". Jeff Cranmer","startTime":1706.738,"endTime":1710.809,"body":"so far this year for Lilly."},{"speaker":". Jeff Cranmer","startTime":1710.842,"endTime":1716.848,"body":"that brings its total outlay on"},{"speaker":". Jeff Cranmer","startTime":1710.842,"endTime":1716.848,"body":"M\u0026A alone to around twenty-three"},{"speaker":". Jeff Cranmer","startTime":1716.848,"endTime":1718.783,"body":"billion in upfront payments."},{"speaker":". Jeff Cranmer","startTime":1719.384,"endTime":1723.655,"body":"Uh, notably, it's one of"},{"speaker":". Jeff Cranmer","startTime":1719.384,"endTime":1723.655,"body":"Lilly's most clinically advanced"},{"speaker":". Jeff Cranmer","startTime":1723.655,"endTime":1725.09,"body":"acquisitions of the year."},{"speaker":". Jeff Cranmer","startTime":1725.49,"endTime":1730.995,"body":"Uh, mostly it's been, uh, buying"},{"speaker":". Jeff Cranmer","startTime":1725.49,"endTime":1730.995,"body":"earlier stage assets and companies."},{"speaker":". Jeff Cranmer","startTime":1731.296,"endTime":1735.133,"body":". It's Lilly's second major"},{"speaker":". Jeff Cranmer","startTime":1731.296,"endTime":1735.133,"body":"takeout in neurology."},{"speaker":". Jeff Cranmer","startTime":1735.2,"endTime":1740.839,"body":"as we discussed a couple of months ago,"},{"speaker":". Jeff Cranmer","startTime":1735.2,"endTime":1740.839,"body":"Lilly bought Sentessa for six point"},{"speaker":". Jeff Cranmer","startTime":1740.872,"endTime":1745.844,"body":"three billion upfront, along with a"},{"speaker":". Jeff Cranmer","startTime":1740.872,"endTime":1745.844,"body":"one point five billion dollar CVR."},{"speaker":". Jeff Cranmer","startTime":1746.377,"endTime":1751.049,"body":"and that brought it into"},{"speaker":". Jeff Cranmer","startTime":1746.377,"endTime":1751.049,"body":"narcolepsy and hypersomnia."},{"speaker":". Jeff Cranmer","startTime":1751.816,"endTime":1752.617,"body":"all righty."},{"speaker":". Jeff Cranmer","startTime":1752.65,"endTime":1754.686,"body":"Let's head over to Washington Steve."},{"speaker":". Jeff Cranmer","startTime":1754.719,"endTime":1758.757,"body":"Uh, you had a couple of stories last week."},{"speaker":". Jeff Cranmer","startTime":1758.857,"endTime":1761.192,"body":"Uh, where do you wanna begin?"},{"speaker":"Steve Usdin","startTime":1761.626,"endTime":1764.963,"body":"Well, maybe we can start"},{"speaker":"Steve Usdin","startTime":1761.626,"endTime":1764.963,"body":"with, acting FDA Commissioner, Carl"},{"speaker":"Steve Usdin","startTime":1764.963,"endTime":1770.535,"body":"Diamantis, vowing to abandon, uh, Marty"},{"speaker":"Steve Usdin","startTime":1764.963,"endTime":1770.535,"body":"Makary's policy by podcast approach and"},{"speaker":"Steve Usdin","startTime":1770.535,"endTime":1774.639,"body":"returning to conventional methods for"},{"speaker":"Steve Usdin","startTime":1770.535,"endTime":1774.639,"body":"communicating about agency guidance."},{"speaker":"Steve Usdin","startTime":1774.773,"endTime":1778.042,"body":"Interestingly, he talked… He"},{"speaker":"Steve Usdin","startTime":1774.773,"endTime":1778.042,"body":"did-- He actually didn't make"},{"speaker":"Steve Usdin","startTime":1778.042,"endTime":1779.744,"body":"that as an official announcement."},{"speaker":"Steve Usdin","startTime":1779.944,"endTime":1784.849,"body":"Diamantis sent a private letter to"},{"speaker":"Steve Usdin","startTime":1779.944,"endTime":1784.849,"body":"a member of Congress, Representative"},{"speaker":"Steve Usdin","startTime":1784.849,"endTime":1789.42,"body":"Diana DeGette, affirming FDA's"},{"speaker":"Steve Usdin","startTime":1784.849,"endTime":1789.42,"body":"commitment to follow its own"},{"speaker":"Steve Usdin","startTime":1789.42,"endTime":1791.289,"body":"rules on communicating policy."},{"speaker":"Steve Usdin","startTime":1791.623,"endTime":1796.027,"body":"He did that in July, on July the"},{"speaker":"Steve Usdin","startTime":1791.623,"endTime":1796.027,"body":"2nd, in response to a letter that"},{"speaker":"Steve Usdin","startTime":1796.027,"endTime":1799.03,"body":"she sent to Makary back in March."},{"speaker":"Steve Usdin","startTime":1799.43,"endTime":1804.469,"body":"And then at a hearing on July"},{"speaker":"Steve Usdin","startTime":1799.43,"endTime":1804.469,"body":"the 15th, DeGette disclosed"},{"speaker":"Steve Usdin","startTime":1804.502,"endTime":1805.837,"body":"the existence of this letter."},{"speaker":"Steve Usdin","startTime":1805.97,"endTime":1809.44,"body":"The letter hasn't been officially"},{"speaker":"Steve Usdin","startTime":1805.97,"endTime":1809.44,"body":"released, by anybody yet, though"},{"speaker":"Steve Usdin","startTime":1809.574,"endTime":1812.71,"body":"any reporter who's, um, cares about"},{"speaker":"Steve Usdin","startTime":1809.574,"endTime":1812.71,"body":"it has, has gotten a copy of it"},{"speaker":"Steve Usdin","startTime":1812.71,"endTime":1813.945,"body":"one way or another, including me."},{"speaker":"Steve Usdin","startTime":1814.579,"endTime":1817.549,"body":"Um, and, and so it raises"},{"speaker":"Steve Usdin","startTime":1814.579,"endTime":1817.549,"body":"a lot of questions."},{"speaker":"Steve Usdin","startTime":1817.549,"endTime":1820.919,"body":"You've got, on the one hand, I think a"},{"speaker":"Steve Usdin","startTime":1817.549,"endTime":1820.919,"body":"lot of people think, well, this is great."},{"speaker":"Steve Usdin","startTime":1820.952,"endTime":1826.624,"body":"FDA's disavowed these informal, uh, means"},{"speaker":"Steve Usdin","startTime":1820.952,"endTime":1826.624,"body":"of communicating things through podcasts,"},{"speaker":"Steve Usdin","startTime":1826.624,"endTime":1831.196,"body":"through journal articles, through,"},{"speaker":"Steve Usdin","startTime":1826.624,"endTime":1831.196,"body":"um, social media, um, statements, uh,"},{"speaker":"Steve Usdin","startTime":1831.196,"endTime":1833.231,"body":"which caused a great deal of confusion."},{"speaker":"Steve Usdin","startTime":1833.631,"endTime":1836.868,"body":"On the other hand, they haven't"},{"speaker":"Steve Usdin","startTime":1833.631,"endTime":1836.868,"body":"done this in an official way, and"},{"speaker":"Steve Usdin","startTime":1836.868,"endTime":1842.106,"body":"they haven't officially walked back"},{"speaker":"Steve Usdin","startTime":1836.868,"endTime":1842.106,"body":"all the controversial policies or"},{"speaker":"Steve Usdin","startTime":1842.14,"endTime":1846.044,"body":"exactly said, which policies are"},{"speaker":"Steve Usdin","startTime":1842.14,"endTime":1846.044,"body":"gonna be, w- you know, what, what"},{"speaker":"Steve Usdin","startTime":1846.244,"endTime":1849.48,"body":"companies can, r- rely on One example."},{"speaker":"Steve Usdin","startTime":1849.848,"endTime":1853.418,"body":"So DeGette asked about three"},{"speaker":"Steve Usdin","startTime":1849.848,"endTime":1853.418,"body":"specific sets of policies."},{"speaker":"Steve Usdin","startTime":1853.418,"endTime":1856.855,"body":"One of the ones that she"},{"speaker":"Steve Usdin","startTime":1853.418,"endTime":1856.855,"body":"asked about was CAR T therapy."},{"speaker":"Steve Usdin","startTime":1856.855,"endTime":1860.458,"body":"So, uh, Vinay Prasad, when he was"},{"speaker":"Steve Usdin","startTime":1856.855,"endTime":1860.458,"body":"CBER director, was one of the authors"},{"speaker":"Steve Usdin","startTime":1860.758,"endTime":1866.664,"body":"on a, a journal article that said"},{"speaker":"Steve Usdin","startTime":1860.758,"endTime":1866.664,"body":"that FDA basically has moved-- had"},{"speaker":"Steve Usdin","startTime":1866.664,"endTime":1870.902,"body":"moved the goalposts for CAR T, and"},{"speaker":"Steve Usdin","startTime":1866.664,"endTime":1870.902,"body":"that going forward it would require,"},{"speaker":"Steve Usdin","startTime":1871.102,"endTime":1875.34,"body":"demonstrations of superiority over"},{"speaker":"Steve Usdin","startTime":1871.102,"endTime":1875.34,"body":"existing, treatments, and that it"},{"speaker":"Steve Usdin","startTime":1875.34,"endTime":1881.88,"body":"wouldn't allow single arm, trials to"},{"speaker":"Steve Usdin","startTime":1875.34,"endTime":1881.88,"body":"support new CAR T therapies, approvals."},{"speaker":"Steve Usdin","startTime":1882.347,"endTime":1885.149,"body":"There's a lot of concern about"},{"speaker":"Steve Usdin","startTime":1882.347,"endTime":1885.149,"body":"that for a variety of reasons."},{"speaker":"Steve Usdin","startTime":1885.383,"endTime":1891.055,"body":"One of them being that a lot of the CAR"},{"speaker":"Steve Usdin","startTime":1885.383,"endTime":1891.055,"body":"Ts are being used, um, to treat very, very"},{"speaker":"Steve Usdin","startTime":1891.055,"endTime":1897.095,"body":"rare, uh, conditions for which it's really"},{"speaker":"Steve Usdin","startTime":1891.055,"endTime":1897.095,"body":"not, um, uh, not feasible to conduct your"},{"speaker":"Steve Usdin","startTime":1897.095,"endTime":1901.766,"body":"convent-conventional, um, superiority"},{"speaker":"Steve Usdin","startTime":1897.095,"endTime":1901.766,"body":"randomized controlled trials for that."},{"speaker":"Steve Usdin","startTime":1902.133,"endTime":1907.171,"body":"So in his response to, to DeGette,"},{"speaker":"Steve Usdin","startTime":1902.133,"endTime":1907.171,"body":"Amicis said, you know, that article"},{"speaker":"Steve Usdin","startTime":1907.171,"endTime":1912.31,"body":"didn't represent, FDA policy, that"},{"speaker":"Steve Usdin","startTime":1907.171,"endTime":1912.31,"body":"FDA policy, has been spelled out in,"},{"speaker":"Steve Usdin","startTime":1912.377,"endTime":1914.178,"body":"in guidance documents in the past."},{"speaker":"Steve Usdin","startTime":1914.545,"endTime":1919.817,"body":"but if you're a CAR T, uh, developer,"},{"speaker":"Steve Usdin","startTime":1914.545,"endTime":1919.817,"body":"for example now, what are you to do?"},{"speaker":"Steve Usdin","startTime":1919.851,"endTime":1924.122,"body":"Because there's this article that was,"},{"speaker":"Steve Usdin","startTime":1919.851,"endTime":1924.122,"body":"uh, that was published in a peer review"},{"speaker":"Steve Usdin","startTime":1924.122,"endTime":1928.226,"body":"journal that the then CBER director"},{"speaker":"Steve Usdin","startTime":1924.122,"endTime":1928.226,"body":"and the then FDA commissioner said,"},{"speaker":"Steve Usdin","startTime":1928.226,"endTime":1931.195,"body":"\"This is the new policy. This is what"},{"speaker":"Steve Usdin","startTime":1928.226,"endTime":1931.195,"body":"FDA is doing, and this is what you're"},{"speaker":"Steve Usdin","startTime":1931.195,"endTime":1934.732,"body":"gonna have to-- this is what you're"},{"speaker":"Steve Usdin","startTime":1931.195,"endTime":1934.732,"body":"gonna h- the standard going forward.\""},{"speaker":"Steve Usdin","startTime":1935.266,"endTime":1938.236,"body":"And then you've got news articles,"},{"speaker":"Steve Usdin","startTime":1935.266,"endTime":1938.236,"body":"you've got articles in BioCentury,"},{"speaker":"Steve Usdin","startTime":1938.236,"endTime":1942.106,"body":"you've got articles in other publications"},{"speaker":"Steve Usdin","startTime":1938.236,"endTime":1942.106,"body":"saying, well, de Amicis said that that"},{"speaker":"Steve Usdin","startTime":1942.106,"endTime":1946.244,"body":"article's, uh, that journal article's"},{"speaker":"Steve Usdin","startTime":1942.106,"endTime":1946.244,"body":"actually not policy you know, the"},{"speaker":"Steve Usdin","startTime":1946.244,"endTime":1950.648,"body":"policy hadn't changed from what it was"},{"speaker":"Steve Usdin","startTime":1946.244,"endTime":1950.648,"body":"prior to that, but there hasn't been an"},{"speaker":"Steve Usdin","startTime":1950.648,"endTime":1952.617,"body":"official statement of this, from FDA."},{"speaker":"Steve Usdin","startTime":1952.617,"endTime":1956.154,"body":"So you can see it still raises"},{"speaker":"Steve Usdin","startTime":1952.617,"endTime":1956.154,"body":"a, a, a lot of confusion."},{"speaker":"Steve Usdin","startTime":1956.154,"endTime":1958.056,"body":"There's a lot of It's, it's very muddy."},{"speaker":"Steve Usdin","startTime":1958.356,"endTime":1959.891,"body":"Uh, and there, there are other examples."},{"speaker":"Steve Usdin","startTime":1959.891,"endTime":1964.662,"body":"There are two other examples that DeGette"},{"speaker":"Steve Usdin","startTime":1959.891,"endTime":1964.662,"body":"asked DeAmicis about, and the responses"},{"speaker":"Steve Usdin","startTime":1964.662,"endTime":1968.232,"body":"were, were similar, saying that, you"},{"speaker":"Steve Usdin","startTime":1964.662,"endTime":1968.232,"body":"know, these, the what, um, Makary had"},{"speaker":"Steve Usdin","startTime":1968.232,"endTime":1973.838,"body":"said, for example, to, Megyn Kelly"},{"speaker":"Steve Usdin","startTime":1968.232,"endTime":1973.838,"body":"about the agency's plausible mechanism"},{"speaker":"Steve Usdin","startTime":1974.105,"endTime":1979.043,"body":"framework, didn't reflect policy and"},{"speaker":"Steve Usdin","startTime":1974.105,"endTime":1979.043,"body":"that developers should rely on, the"},{"speaker":"Steve Usdin","startTime":1979.043,"endTime":1981.612,"body":"draft guidance that FDA has published."},{"speaker":"Steve Usdin","startTime":1981.913,"endTime":1986.584,"body":"But on the other hand, CEOs have told me,"},{"speaker":"Steve Usdin","startTime":1981.913,"endTime":1986.584,"body":"I've written stories about it, that, FDA"},{"speaker":"Steve Usdin","startTime":1986.651,"endTime":1991.122,"body":"doesn't seem to be complying with that"},{"speaker":"Steve Usdin","startTime":1986.651,"endTime":1991.122,"body":"guidance, at least, in the opinion of,"},{"speaker":"Steve Usdin","startTime":1991.122,"endTime":1994.892,"body":"some of the CEOs who are trying to develop"},{"speaker":"Steve Usdin","startTime":1991.122,"endTime":1994.892,"body":"therapies and, and say that they've"},{"speaker":"Steve Usdin","startTime":1994.892,"endTime":1996.461,"body":"been knocked back when they get to FDA."},{"speaker":"Steve Usdin","startTime":1996.494,"endTime":2001.232,"body":"They think that they qualify for the,"},{"speaker":"Steve Usdin","startTime":1996.494,"endTime":2001.232,"body":"um, plausible mechanism framework, and"},{"speaker":"Steve Usdin","startTime":2001.232,"endTime":2003.401,"body":"FDA said, \"No, you, you, you don't.\""},{"speaker":"Steve Usdin","startTime":2003.434,"endTime":2006.871,"body":"The framework is, according to these"},{"speaker":"Steve Usdin","startTime":2003.434,"endTime":2006.871,"body":"CEOs, they say the framework is really"},{"speaker":"Steve Usdin","startTime":2006.871,"endTime":2011.409,"body":"just for N of one therapies or N of"},{"speaker":"Steve Usdin","startTime":2006.871,"endTime":2011.409,"body":"a very few therapies, and, their,"},{"speaker":"Steve Usdin","startTime":2011.542,"endTime":2015.413,"body":"applications didn't meet that standard,"},{"speaker":"Steve Usdin","startTime":2011.542,"endTime":2015.413,"body":"even though the framework, that's"},{"speaker":"Steve Usdin","startTime":2015.413,"endTime":2019.117,"body":"been published, the draft guidance on"},{"speaker":"Steve Usdin","startTime":2015.413,"endTime":2019.117,"body":"it, and statements from FDA officials"},{"speaker":"Steve Usdin","startTime":2019.283,"endTime":2023.388,"body":"very explicitly said it's not,"},{"speaker":"Steve Usdin","startTime":2019.283,"endTime":2023.388,"body":"limited to N of one or N of a very few"},{"speaker":"Jeff Cranmer","startTime":2024.088,"endTime":2026.691,"body":"All right, Stephen,"},{"speaker":"Jeff Cranmer","startTime":2024.088,"endTime":2026.691,"body":"another way that FDA has,"},{"speaker":"Jeff Cranmer","startTime":2026.924,"endTime":2031.529,"body":"been signaling that things are"},{"speaker":"Jeff Cranmer","startTime":2026.924,"endTime":2031.529,"body":"getting back to normal, Ad Comps."},{"speaker":"Jeff Cranmer","startTime":2031.596,"endTime":2032.53,"body":"what's happening there?"},{"speaker":"Steve Usdin","startTime":2032.697,"endTime":2035.8,"body":"yeah, so, you know,"},{"speaker":"Steve Usdin","startTime":2032.697,"endTime":2035.8,"body":"so under, um, former Commissioner"},{"speaker":"Steve Usdin","startTime":2035.9,"endTime":2040.938,"body":"Makary, the agency, really, really"},{"speaker":"Steve Usdin","startTime":2035.9,"endTime":2040.938,"body":"dialed back on its use of ad comms"},{"speaker":"Steve Usdin","startTime":2041.439,"endTime":2046.644,"body":"and at the same time, it made a lot of"},{"speaker":"Steve Usdin","startTime":2041.439,"endTime":2046.644,"body":"controversial decisions without a lot of"},{"speaker":"Steve Usdin","startTime":2046.644,"endTime":2049.013,"body":"accountability or transparency about them."},{"speaker":"Steve Usdin","startTime":2049.013,"endTime":2053.017,"body":"And many of those decisions were"},{"speaker":"Steve Usdin","startTime":2049.013,"endTime":2053.017,"body":"either complete response letters or set"},{"speaker":"Steve Usdin","startTime":2053.017,"endTime":2058.056,"body":"regulatory setbacks to, companies that"},{"speaker":"Steve Usdin","startTime":2053.017,"endTime":2058.056,"body":"believed that they had aligned with FDA"},{"speaker":"Steve Usdin","startTime":2058.156,"endTime":2062.527,"body":"on, development programs, and then FDA's,"},{"speaker":"Steve Usdin","startTime":2058.156,"endTime":2062.527,"body":"new leadership came in and said no, that"},{"speaker":"Steve Usdin","startTime":2062.593,"endTime":2065.63,"body":"those, understandings were no longer"},{"speaker":"Steve Usdin","startTime":2062.593,"endTime":2065.63,"body":"in effect and that, the companies would"},{"speaker":"Steve Usdin","startTime":2065.63,"endTime":2068.866,"body":"have to do quite different things if they"},{"speaker":"Steve Usdin","startTime":2065.63,"endTime":2068.866,"body":"wanted to get their products approved."},{"speaker":"Steve Usdin","startTime":2069.6,"endTime":2075.506,"body":"So FDA, under acting Commissioner,"},{"speaker":"Steve Usdin","startTime":2069.6,"endTime":2075.506,"body":"uh, Diamantis, Diamantis has said that"},{"speaker":"Steve Usdin","startTime":2075.506,"endTime":2078.509,"body":"they're going to be holding advisory"},{"speaker":"Steve Usdin","startTime":2075.506,"endTime":2078.509,"body":"committees, more advisory committees."},{"speaker":"Steve Usdin","startTime":2078.576,"endTime":2082.013,"body":"FDA staff have told me that that's"},{"speaker":"Steve Usdin","startTime":2078.576,"endTime":2082.013,"body":"gonna be the kind of the default"},{"speaker":"Steve Usdin","startTime":2082.013,"endTime":2086.05,"body":"pathway going forward to resolve,"},{"speaker":"Steve Usdin","startTime":2082.013,"endTime":2086.05,"body":"the regulatory controversies"},{"speaker":"Steve Usdin","startTime":2086.05,"endTime":2088.886,"body":"that occurred, Makary and Prasad."},{"speaker":"Steve Usdin","startTime":2088.886,"endTime":2093.891,"body":"And I think that there's a lot of, uh,"},{"speaker":"Steve Usdin","startTime":2088.886,"endTime":2093.891,"body":"kind of relief among the companies and"},{"speaker":"Steve Usdin","startTime":2093.891,"endTime":2097.562,"body":"the patient groups, that there's going"},{"speaker":"Steve Usdin","startTime":2093.891,"endTime":2097.562,"body":"to be a-another look at these things,"},{"speaker":"Steve Usdin","startTime":2097.562,"endTime":2101.299,"body":"that there's gonna be accountability,"},{"speaker":"Steve Usdin","startTime":2097.562,"endTime":2101.299,"body":"and that hopefully FDA will be getting,"},{"speaker":"Steve Usdin","startTime":2101.566,"endTime":2105.236,"body":"independent scientific judgments"},{"speaker":"Steve Usdin","startTime":2101.566,"endTime":2105.236,"body":"on, uh, on these controversies."},{"speaker":"Steve Usdin","startTime":2105.87,"endTime":2110.608,"body":"The signals that FDA has sent about this"},{"speaker":"Steve Usdin","startTime":2105.87,"endTime":2110.608,"body":"so far are a little bit mixed, right?"},{"speaker":"Steve Usdin","startTime":2110.875,"endTime":2115.48,"body":"Because one of the first advisory"},{"speaker":"Steve Usdin","startTime":2110.875,"endTime":2115.48,"body":"committees that's gonna come up is going"},{"speaker":"Steve Usdin","startTime":2115.48,"endTime":2122.086,"body":"to be looking at whether FDA should allow"},{"speaker":"Steve Usdin","startTime":2115.48,"endTime":2122.086,"body":"bulk compounding of unproven peptides"},{"speaker":"Steve Usdin","startTime":2122.553,"endTime":2125.556,"body":"and that, that's, you know, we've"},{"speaker":"Steve Usdin","startTime":2122.553,"endTime":2125.556,"body":"talked about that on the podcast before."},{"speaker":"Steve Usdin","startTime":2125.59,"endTime":2126.491,"body":"I've written about it."},{"speaker":"Steve Usdin","startTime":2126.624,"endTime":2128.059,"body":"we've written some commentaries about it."},{"speaker":"Steve Usdin","startTime":2128.259,"endTime":2131.095,"body":"It's a really concerning thing"},{"speaker":"Steve Usdin","startTime":2128.259,"endTime":2131.095,"body":"to, to a lot of people in the"},{"speaker":"Steve Usdin","startTime":2131.095,"endTime":2134.132,"body":"public health community, a lot of"},{"speaker":"Steve Usdin","startTime":2131.095,"endTime":2134.132,"body":"people in the, biopharma world."},{"speaker":"Steve Usdin","startTime":2134.298,"endTime":2135.566,"body":"So good news, right?"},{"speaker":"Steve Usdin","startTime":2135.566,"endTime":2137.335,"body":"They're gonna have an"},{"speaker":"Steve Usdin","startTime":2135.566,"endTime":2137.335,"body":"advisory committee about it."},{"speaker":"Steve Usdin","startTime":2137.935,"endTime":2141.706,"body":"Concerning news, that advisory"},{"speaker":"Steve Usdin","startTime":2137.935,"endTime":2141.706,"body":"committee has been packed."},{"speaker":"Steve Usdin","startTime":2141.739,"endTime":2144.876,"body":"They've got, um, new members"},{"speaker":"Steve Usdin","startTime":2141.739,"endTime":2144.876,"body":"that have been added to it."},{"speaker":"Steve Usdin","startTime":2145.51,"endTime":2149.08,"body":"Many of the new members who have"},{"speaker":"Steve Usdin","startTime":2145.51,"endTime":2149.08,"body":"been added to it have financial"},{"speaker":"Steve Usdin","startTime":2150.014,"endTime":2152.416,"body":"stakes in the peptide industry."},{"speaker":"Steve Usdin","startTime":2152.617,"endTime":2157.722,"body":"They're people who, work at, uh, who"},{"speaker":"Steve Usdin","startTime":2152.617,"endTime":2157.722,"body":"own, clinics that administer peptides."},{"speaker":"Steve Usdin","startTime":2157.989,"endTime":2161.692,"body":"They're people who have made, their,"},{"speaker":"Steve Usdin","startTime":2157.989,"endTime":2161.692,"body":"uh, living, prescribing peptides."},{"speaker":"Steve Usdin","startTime":2161.959,"endTime":2167.031,"body":"They've, commented favorably about"},{"speaker":"Steve Usdin","startTime":2161.959,"endTime":2167.031,"body":"these untested peptides on social media."},{"speaker":"Steve Usdin","startTime":2167.565,"endTime":2171.002,"body":"On the other hand, we do have a"},{"speaker":"Steve Usdin","startTime":2167.565,"endTime":2171.002,"body":"change from what was happening under"},{"speaker":"Steve Usdin","startTime":2171.002,"endTime":2178.009,"body":"Makary because FDA staff have been"},{"speaker":"Steve Usdin","startTime":2171.002,"endTime":2178.009,"body":"allowed, maybe even encouraged, to"},{"speaker":"Steve Usdin","startTime":2178.576,"endTime":2180.645,"body":"present their views on, on this."},{"speaker":"Steve Usdin","startTime":2180.678,"endTime":2185.783,"body":"And, um, the briefing memos that,"},{"speaker":"Steve Usdin","startTime":2180.678,"endTime":2185.783,"body":"or review memos that FDA staff have"},{"speaker":"Steve Usdin","startTime":2185.783,"endTime":2190.221,"body":"written and that have been, uh, released"},{"speaker":"Steve Usdin","startTime":2185.783,"endTime":2190.221,"body":"publicly reinforce, um, the agency's"},{"speaker":"Steve Usdin","startTime":2190.221,"endTime":2195.159,"body":"prior position that these peptides"},{"speaker":"Steve Usdin","startTime":2190.221,"endTime":2195.159,"body":"haven't been tested, there isn't enough"},{"speaker":"Steve Usdin","startTime":2195.159,"endTime":2199.964,"body":"known, about their efficacy and safety"},{"speaker":"Steve Usdin","startTime":2195.159,"endTime":2199.964,"body":"to allow them to be, compounded in bulk."},{"speaker":"Steve Usdin","startTime":2200.264,"endTime":2204.569,"body":"And, um, and in fact, uh, for some of"},{"speaker":"Steve Usdin","startTime":2200.264,"endTime":2204.569,"body":"them, they're concerning safety signals."},{"speaker":"Steve Usdin","startTime":2204.969,"endTime":2207.371,"body":"So it's gonna be really interesting"},{"speaker":"Steve Usdin","startTime":2204.969,"endTime":2207.371,"body":"to see how that plays out."},{"speaker":"Steve Usdin","startTime":2208.005,"endTime":2211.776,"body":"The other thing that's gonna be really"},{"speaker":"Steve Usdin","startTime":2208.005,"endTime":2211.776,"body":"interesting to see how it plays out is"},{"speaker":"Steve Usdin","startTime":2212.109,"endTime":2217.181,"body":"an advisory committee meeting that's"},{"speaker":"Steve Usdin","startTime":2212.109,"endTime":2217.181,"body":"gonna be coming up about Replimune's RP1"},{"speaker":"Jeff Cranmer","startTime":2217.982,"endTime":2220.451,"body":"Yeah, see, there's"},{"speaker":"Jeff Cranmer","startTime":2217.982,"endTime":2220.451,"body":"been a lot of noise around this."},{"speaker":"Jeff Cranmer","startTime":2220.451,"endTime":2221.652,"body":"Uh, what are you expecting?"},{"speaker":"Steve Usdin","startTime":2222.553,"endTime":2224.989,"body":"So I, I don't"},{"speaker":"Steve Usdin","startTime":2222.553,"endTime":2224.989,"body":"know what's going to happen."},{"speaker":"Steve Usdin","startTime":2225.056,"endTime":2231.295,"body":"but one of the things that's interesting"},{"speaker":"Steve Usdin","startTime":2225.056,"endTime":2231.295,"body":"is that the, uh, the RP1, BLA is not"},{"speaker":"Steve Usdin","startTime":2231.295,"endTime":2235.766,"body":"going to be going to the ODAC, to the"},{"speaker":"Steve Usdin","startTime":2231.295,"endTime":2235.766,"body":"Oncologic Drugs Advisory Committee,"},{"speaker":"Steve Usdin","startTime":2236.0,"endTime":2238.836,"body":"which is what y- you would have expected."},{"speaker":"Steve Usdin","startTime":2239.07,"endTime":2241.973,"body":"Uh, it's going to the Cell"},{"speaker":"Steve Usdin","startTime":2239.07,"endTime":2241.973,"body":"Therapy, Advisory Committee."},{"speaker":"Steve Usdin","startTime":2241.973,"endTime":2246.577,"body":"It is a cell therapy, but, in the"},{"speaker":"Steve Usdin","startTime":2241.973,"endTime":2246.577,"body":"past, cell therapies, gene therapies,"},{"speaker":"Steve Usdin","startTime":2246.744,"endTime":2251.182,"body":"products, uh, CAR Ts, things like that,"},{"speaker":"Steve Usdin","startTime":2246.744,"endTime":2251.182,"body":"that involve cancer have gone to ODAC,"},{"speaker":"Steve Usdin","startTime":2251.182,"endTime":2253.117,"body":"not to the Cell Therapy Committee."},{"speaker":"Steve Usdin","startTime":2253.384,"endTime":2254.952,"body":"So that's, that's unusual."},{"speaker":"Steve Usdin","startTime":2255.186,"endTime":2259.757,"body":"I think that what's gonna be really"},{"speaker":"Steve Usdin","startTime":2255.186,"endTime":2259.757,"body":"critical is gonna be to see who, who"},{"speaker":"Steve Usdin","startTime":2259.757,"endTime":2262.66,"body":"exactly is on that, um, committee."},{"speaker":"Steve Usdin","startTime":2262.86,"endTime":2267.398,"body":"The, the committee rosters are depleted"},{"speaker":"Steve Usdin","startTime":2262.86,"endTime":2267.398,"body":"for all the advisory committees because,"},{"speaker":"Steve Usdin","startTime":2267.765,"endTime":2271.035,"body":"they, they hadn't been holding very"},{"speaker":"Steve Usdin","startTime":2267.765,"endTime":2271.035,"body":"many committee meetings under Makary."},{"speaker":"Steve Usdin","startTime":2271.335,"endTime":2275.773,"body":"membership, uh, lapsed, and there"},{"speaker":"Steve Usdin","startTime":2271.335,"endTime":2275.773,"body":"weren't, new permanent members appointed"},{"speaker":"Steve Usdin","startTime":2275.906,"endTime":2277.308,"body":"for a lot of those, um, committees."},{"speaker":"Steve Usdin","startTime":2277.308,"endTime":2278.809,"body":"So there are a lot of open positions."},{"speaker":"Steve Usdin","startTime":2279.11,"endTime":2281.512,"body":"I think the key thing that"},{"speaker":"Steve Usdin","startTime":2279.11,"endTime":2281.512,"body":"everybody's gonna have to look"},{"speaker":"Steve Usdin","startTime":2281.512,"endTime":2285.182,"body":"at, are, are two things for that"},{"speaker":"Steve Usdin","startTime":2281.512,"endTime":2285.182,"body":"Replemune advisory committee meeting."},{"speaker":"Steve Usdin","startTime":2285.182,"endTime":2289.92,"body":"One, what kind of expertise is put"},{"speaker":"Steve Usdin","startTime":2285.182,"endTime":2289.92,"body":"on as, temporary voting members,"},{"speaker":"Steve Usdin","startTime":2290.021,"endTime":2293.624,"body":"to the committee, and then what"},{"speaker":"Steve Usdin","startTime":2290.021,"endTime":2293.624,"body":"are the FDA, presentations like?"},{"speaker":"Selina Koch","startTime":2294.058,"endTime":2294.492,"body":"Steve."},{"speaker":"Selina Koch","startTime":2294.725,"endTime":2297.428,"body":"cause one thing I've been curious"},{"speaker":"Selina Koch","startTime":2294.725,"endTime":2297.428,"body":"about is, um, talk about as a"},{"speaker":"Selina Koch","startTime":2297.428,"endTime":2297.628,"body":"return to normalcy, um, but some"},{"speaker":"Selina Koch","startTime":2297.428,"endTime":2297.628,"body":"ways we'll never revert to an"},{"speaker":"Selina Koch","startTime":2301.032,"endTime":2305.002,"body":"FDA that's led by Richard Pazdur, Peter"},{"speaker":"Selina Koch","startTime":2301.032,"endTime":2305.002,"body":"Marks, you know, so on and so forth."},{"speaker":"Selina Koch","startTime":2305.269,"endTime":2310.174,"body":"So if you look ahead though, how much"},{"speaker":"Selina Koch","startTime":2305.269,"endTime":2310.174,"body":"change for the better or just change"},{"speaker":"Selina Koch","startTime":2310.174,"endTime":2314.011,"body":"in general might you expect before"},{"speaker":"Selina Koch","startTime":2310.174,"endTime":2314.011,"body":"there's more like permanent leadership?"},{"speaker":"Steve Usdin","startTime":2314.712,"endTime":2319.583,"body":"Well, so look, y-y-you can't"},{"speaker":"Steve Usdin","startTime":2314.712,"endTime":2319.583,"body":"step into the same river twice, right?"},{"speaker":"Steve Usdin","startTime":2319.617,"endTime":2325.956,"body":"FDA's, is not going to return to where it"},{"speaker":"Steve Usdin","startTime":2319.617,"endTime":2325.956,"body":"was before, January twenty twenty five."},{"speaker":"Steve Usdin","startTime":2325.956,"endTime":2331.162,"body":"Too many people have left, too many things"},{"speaker":"Steve Usdin","startTime":2325.956,"endTime":2331.162,"body":"have happened for that to be the case."},{"speaker":"Steve Usdin","startTime":2331.595,"endTime":2336.233,"body":"I think what's gonna be really critical"},{"speaker":"Steve Usdin","startTime":2331.595,"endTime":2336.233,"body":"is to see who the next commissioner is,"},{"speaker":"Steve Usdin","startTime":2336.467,"endTime":2340.371,"body":"who the permanent center directors are,"},{"speaker":"Steve Usdin","startTime":2336.467,"endTime":2340.371,"body":"who's gonna be made permanent, um, center"},{"speaker":"Steve Usdin","startTime":2340.371,"endTime":2345.109,"body":"director at CDER, who's gonna be made"},{"speaker":"Steve Usdin","startTime":2340.371,"endTime":2345.109,"body":"permanent center director at CBER, and"},{"speaker":"Steve Usdin","startTime":2345.376,"endTime":2352.016,"body":"w-what do they do to try, if anything,"},{"speaker":"Steve Usdin","startTime":2345.376,"endTime":2352.016,"body":"to try to restore, FDA's, scientific"},{"speaker":"Steve Usdin","startTime":2352.016,"endTime":2357.722,"body":"integrity, its independence from political"},{"speaker":"Steve Usdin","startTime":2352.016,"endTime":2357.722,"body":"and ideological, influence, and then"},{"speaker":"Steve Usdin","startTime":2357.722,"endTime":2362.693,"body":"what do they do to, to bulk up or to"},{"speaker":"Steve Usdin","startTime":2357.722,"endTime":2362.693,"body":"bolster, if anything, the, uh, the whole"},{"speaker":"Steve Usdin","startTime":2362.693,"endTime":2364.995,"body":"process, for, for advisory committees."},{"speaker":"Steve Usdin","startTime":2364.995,"endTime":2368.699,"body":"Because it's not like the advisory"},{"speaker":"Steve Usdin","startTime":2364.995,"endTime":2368.699,"body":"committee process was perfect"},{"speaker":"Steve Usdin","startTime":2368.733,"endTime":2370.935,"body":"before, January twenty twenty five."},{"speaker":"Steve Usdin","startTime":2370.935,"endTime":2372.103,"body":"There were a lot of problems with it."},{"speaker":"Steve Usdin","startTime":2372.103,"endTime":2375.306,"body":"I've written a great deal about,"},{"speaker":"Steve Usdin","startTime":2372.103,"endTime":2375.306,"body":"some of those problems and"},{"speaker":"Steve Usdin","startTime":2375.339,"endTime":2377.641,"body":"recommendations for how to fix it."},{"speaker":"Steve Usdin","startTime":2377.675,"endTime":2381.946,"body":"But, you know, the, the issues with"},{"speaker":"Steve Usdin","startTime":2377.675,"endTime":2381.946,"body":"the, with Reptimmune and, and, also"},{"speaker":"Steve Usdin","startTime":2381.946,"endTime":2385.082,"body":"with the peptides point out one of"},{"speaker":"Steve Usdin","startTime":2381.946,"endTime":2385.082,"body":"the, I think one of the fundamental"},{"speaker":"Steve Usdin","startTime":2385.082,"endTime":2388.786,"body":"flaws about the advisory committee,"},{"speaker":"Steve Usdin","startTime":2385.082,"endTime":2388.786,"body":"which is that you can look at it as,"},{"speaker":"Steve Usdin","startTime":2388.919,"endTime":2390.721,"body":"as kind of an adversarial process."},{"speaker":"Steve Usdin","startTime":2390.721,"endTime":2393.958,"body":"It's, maybe it's too simplistic,"},{"speaker":"Steve Usdin","startTime":2390.721,"endTime":2393.958,"body":"but it's a bit like a trial, right?"},{"speaker":"Steve Usdin","startTime":2394.191,"endTime":2398.396,"body":"And you've got FDA presenting one point"},{"speaker":"Steve Usdin","startTime":2394.191,"endTime":2398.396,"body":"of view, you've got the sponsor presenting"},{"speaker":"Steve Usdin","startTime":2398.396,"endTime":2401.399,"body":"another point of view, and you've got"},{"speaker":"Steve Usdin","startTime":2398.396,"endTime":2401.399,"body":"the advisory committee looking at it"},{"speaker":"Steve Usdin","startTime":2401.399,"endTime":2403.367,"body":"basically as if they're a jury, right?"},{"speaker":"Steve Usdin","startTime":2403.467,"endTime":2407.905,"body":"But in this case, the prosecution,"},{"speaker":"Steve Usdin","startTime":2403.467,"endTime":2407.905,"body":"FDA, gets to pick the jury."},{"speaker":"Steve Usdin","startTime":2408.305,"endTime":2413.21,"body":"And I've spoken with, um, senior officials"},{"speaker":"Steve Usdin","startTime":2408.305,"endTime":2413.21,"body":"at, at FDA, um, some of them still there,"},{"speaker":"Steve Usdin","startTime":2413.21,"endTime":2416.814,"body":"some of them who have left, and they"},{"speaker":"Steve Usdin","startTime":2413.21,"endTime":2416.814,"body":"openly acknowledge that they pick people"},{"speaker":"Steve Usdin","startTime":2417.081,"endTime":2420.985,"body":"for advisory committees who, would give"},{"speaker":"Steve Usdin","startTime":2417.081,"endTime":2420.985,"body":"them the results that they thought that"},{"speaker":"Steve Usdin","startTime":2420.985,"endTime":2422.686,"body":"they, that, that were the right results."},{"speaker":"Steve Usdin","startTime":2422.887,"endTime":2424.889,"body":"You know, they had their, their"},{"speaker":"Steve Usdin","startTime":2422.887,"endTime":2424.889,"body":"finger on the scale when they were"},{"speaker":"Steve Usdin","startTime":2424.889,"endTime":2426.557,"body":"picking people for the committees."},{"speaker":"Steve Usdin","startTime":2426.557,"endTime":2429.827,"body":"And then there's a great deal of"},{"speaker":"Steve Usdin","startTime":2426.557,"endTime":2429.827,"body":"concern, and there has been concern"},{"speaker":"Steve Usdin","startTime":2429.827,"endTime":2434.832,"body":"expressed again by, um, former senior"},{"speaker":"Steve Usdin","startTime":2429.827,"endTime":2434.832,"body":"FDA officials, Janet Woodcock and others,"},{"speaker":"Steve Usdin","startTime":2435.166,"endTime":2439.703,"body":"that, um, the rules around conflict"},{"speaker":"Steve Usdin","startTime":2435.166,"endTime":2439.703,"body":"of interest have made it impossible,"},{"speaker":"Steve Usdin","startTime":2439.87,"endTime":2445.042,"body":"in many cases, to appoint members"},{"speaker":"Steve Usdin","startTime":2439.87,"endTime":2445.042,"body":"of advisory committees who have the"},{"speaker":"Steve Usdin","startTime":2445.042,"endTime":2448.245,"body":"requisite or the necessary, uh, expertise."},{"speaker":"Steve Usdin","startTime":2448.446,"endTime":2453.784,"body":"And that's particularly, acute when it"},{"speaker":"Steve Usdin","startTime":2448.446,"endTime":2453.784,"body":"comes to, rare diseases because there"},{"speaker":"Steve Usdin","startTime":2453.784,"endTime":2459.056,"body":"are, rare diseases and very rare diseases"},{"speaker":"Steve Usdin","startTime":2453.784,"endTime":2459.056,"body":"where the only people who would be, who"},{"speaker":"Steve Usdin","startTime":2459.056,"endTime":2462.927,"body":"are really experts, who would really be"},{"speaker":"Steve Usdin","startTime":2459.056,"endTime":2462.927,"body":"qualified to serve on advisory committees"},{"speaker":"Steve Usdin","startTime":2463.227,"endTime":2466.53,"body":"are precluded under the current, uh,"},{"speaker":"Steve Usdin","startTime":2463.227,"endTime":2466.53,"body":"rules unless there's a waiver, which"},{"speaker":"Steve Usdin","startTime":2466.53,"endTime":2472.803,"body":"FDA's, um, reluctant to give because"},{"speaker":"Steve Usdin","startTime":2466.53,"endTime":2472.803,"body":"they've all conducted clinical trials"},{"speaker":"Steve Usdin","startTime":2472.803,"endTime":2476.607,"body":"that were sponsored by companies that"},{"speaker":"Steve Usdin","startTime":2472.803,"endTime":2476.607,"body":"are developing drugs for those conditions"},{"speaker":"Jeff Cranmer","startTime":2477.274,"endTime":2477.675,"body":"All right."},{"speaker":"Jeff Cranmer","startTime":2477.675,"endTime":2478.976,"body":"Thanks for that, Steve."},{"speaker":"Jeff Cranmer","startTime":2479.009,"endTime":2482.947,"body":"Uh, we'll drop links in the show"},{"speaker":"Jeff Cranmer","startTime":2479.009,"endTime":2482.947,"body":"notes, to your stories along"},{"speaker":"Jeff Cranmer","startTime":2482.947,"endTime":2484.949,"body":"with Selina's Biogen story."},{"speaker":"Jeff Cranmer","startTime":2485.216,"endTime":2486.617,"body":"thank you for tuning in."},{"speaker":"Jeff Cranmer","startTime":2487.017,"endTime":2492.756,"body":"if you're hungry for more BioCentury's"},{"speaker":"Jeff Cranmer","startTime":2487.017,"endTime":2492.756,"body":"podcasts, tune in later this week."},{"speaker":"Jeff Cranmer","startTime":2492.857,"endTime":2498.729,"body":"we'll have, VC Jessica Owens in"},{"speaker":"Jeff Cranmer","startTime":2492.857,"endTime":2498.729,"body":"conversation with our very own"},{"speaker":"Jeff Cranmer","startTime":2498.796,"endTime":2502.233,"body":"Lindsay Martin on The BioCentury Show."},{"speaker":"Jeff Cranmer","startTime":2502.533,"endTime":2506.67,"body":"we'll be back next Monday"},{"speaker":"Jeff Cranmer","startTime":2502.533,"endTime":2506.67,"body":"with the next edition of The"},{"speaker":"Jeff Cranmer","startTime":2506.67,"endTime":2508.405,"body":"BioCentury This Week podcast"},{"speaker":"Voice Talent","startTime":2510.241,"endTime":2513.244,"body":"BioCentury would"},{"speaker":"Voice Talent","startTime":2510.241,"endTime":2513.244,"body":"like to thank CBER for supporting"},{"speaker":"Voice Talent","startTime":2513.244,"endTime":2515.212,"body":"the BioCentury This Week podcast."},{"speaker":"Voice Talent","startTime":2515.713,"endTime":2520.351,"body":"To learn more about how CBER's"},{"speaker":"Voice Talent","startTime":2515.713,"endTime":2520.351,"body":"unmatched expertise, resources, and"},{"speaker":"Voice Talent","startTime":2520.351,"endTime":2525.789,"body":"connections empower life sciences"},{"speaker":"Voice Talent","startTime":2520.351,"endTime":2525.789,"body":"companies, visit cber.com/lifesciences"}]}