{"version":"1.0.0","segments":[{"startTime":0.0,"endTime":1.735,"body":"[Auto-generated Transcript]"},{"speaker":"Voice Talent","startTime":1.735,"endTime":4.471,"body":"BioCentury This"},{"speaker":"Voice Talent","startTime":1.735,"endTime":4.471,"body":"Week is brought to you by CBRE."},{"speaker":"Jeff Cranmer","startTime":6.206,"endTime":10.944,"body":"Novartis deepens its ADC"},{"speaker":"Jeff Cranmer","startTime":6.206,"endTime":10.944,"body":"capabilities with the billion-dollar"},{"speaker":"Jeff Cranmer","startTime":11.011,"endTime":14.614,"body":"acquisition of UK biotech Myricx."},{"speaker":"Jeff Cranmer","startTime":14.948,"endTime":19.819,"body":"Making regulation a catalyst"},{"speaker":"Jeff Cranmer","startTime":14.948,"endTime":19.819,"body":"for UK life sciences."},{"speaker":"Jeff Cranmer","startTime":19.819,"endTime":26.726,"body":"We'll discuss MHRA CEO Lawrence"},{"speaker":"Jeff Cranmer","startTime":19.819,"endTime":26.726,"body":"Tallon's guest commentary from"},{"speaker":"Jeff Cranmer","startTime":26.726,"endTime":31.631,"body":"last week in BioCentury on this"},{"speaker":"Jeff Cranmer","startTime":26.726,"endTime":31.631,"body":"week's BioCentury This Week."},{"speaker":"Jeff Cranmer","startTime":32.032,"endTime":39.506,"body":"Plus, why a primary loss for a Colorado"},{"speaker":"Jeff Cranmer","startTime":32.032,"endTime":39.506,"body":"lawmaker is a blow to FDA reforms."},{"speaker":"Jeff Cranmer","startTime":39.572,"endTime":44.244,"body":"I'm Jeff Cranmer, host of the"},{"speaker":"Jeff Cranmer","startTime":39.572,"endTime":44.244,"body":"BioCentury This Week podcast."},{"speaker":"Jeff Cranmer","startTime":44.244,"endTime":48.748,"body":"Joining me today, Editor-in-Chief"},{"speaker":"Jeff Cranmer","startTime":44.244,"endTime":48.748,"body":"Simone Fishburn, Washington"},{"speaker":"Jeff Cranmer","startTime":48.748,"endTime":54.32,"body":"Editor Steve Usdin, our colleagues"},{"speaker":"Jeff Cranmer","startTime":48.748,"endTime":54.32,"body":"Danielle Golovin and Paul Bonanos."},{"speaker":"Jeff Cranmer","startTime":54.354,"endTime":60.26,"body":"We'll also discuss how a House committee"},{"speaker":"Jeff Cranmer","startTime":54.354,"endTime":60.26,"body":"is reviving its probe into US drug"},{"speaker":"Jeff Cranmer","startTime":60.26,"endTime":66.232,"body":"makers' clinical trials in China, and"},{"speaker":"Jeff Cranmer","startTime":60.26,"endTime":66.232,"body":"the latest from our Atlas Insights"},{"speaker":"Jeff Cranmer","startTime":66.266,"endTime":72.772,"body":"series, which assesses targetable"},{"speaker":"Jeff Cranmer","startTime":66.266,"endTime":72.772,"body":"directions in Parkinson's disease."},{"speaker":"Jeff Cranmer","startTime":73.139,"endTime":74.707,"body":"Okay, let's get to it."},{"speaker":"Jeff Cranmer","startTime":75.041,"endTime":79.012,"body":"Novartis announced Monday morning"},{"speaker":"Jeff Cranmer","startTime":75.041,"endTime":79.012,"body":"that it would acquire private"},{"speaker":"Jeff Cranmer","startTime":79.012,"endTime":86.82,"body":"UK biotech Myricx, focused on"},{"speaker":"Jeff Cranmer","startTime":79.012,"endTime":86.82,"body":"antibody drug conjugates, or ADCs."},{"speaker":"Jeff Cranmer","startTime":86.82,"endTime":91.825,"body":"The Swiss pharma is paying $1.1"},{"speaker":"Jeff Cranmer","startTime":86.82,"endTime":91.825,"body":"billion up front, with the potential"},{"speaker":"Jeff Cranmer","startTime":92.025,"endTime":94.894,"body":"for $400 million in milestones."},{"speaker":"Jeff Cranmer","startTime":95.161,"endTime":96.696,"body":"Paul, you took a look at the deal."},{"speaker":"Jeff Cranmer","startTime":96.729,"endTime":97.464,"body":"What did you learn?"},{"speaker":"Paul Bonanos","startTime":97.697,"endTime":97.997,"body":"Yes."},{"speaker":"Paul Bonanos","startTime":97.997,"endTime":103.169,"body":"So, as you say uh Myricx uh it's in the"},{"speaker":"Paul Bonanos","startTime":97.997,"endTime":103.169,"body":"U.K. It's a spin out from Imperial College"},{"speaker":"Paul Bonanos","startTime":103.169,"endTime":105.405,"body":"London and the Francis Crick Institute."},{"speaker":"Paul Bonanos","startTime":105.705,"endTime":109.742,"body":"They are working on ADCs, antibody"},{"speaker":"Paul Bonanos","startTime":105.705,"endTime":109.742,"body":"drug conjugates um but with a"},{"speaker":"Paul Bonanos","startTime":109.742,"endTime":111.911,"body":"different payload than other companies."},{"speaker":"Paul Bonanos","startTime":111.945,"endTime":114.747,"body":"A-an awful lot of ADCs"},{"speaker":"Paul Bonanos","startTime":111.945,"endTime":114.747,"body":"out there use TOPO1."},{"speaker":"Paul Bonanos","startTime":114.747,"endTime":116.149,"body":"There are a couple of other payloads."},{"speaker":"Paul Bonanos","startTime":116.716,"endTime":120.954,"body":"Myricx is the only company using"},{"speaker":"Paul Bonanos","startTime":116.716,"endTime":120.954,"body":"NMT payloads that we're aware of."},{"speaker":"Paul Bonanos","startTime":120.987,"endTime":125.758,"body":"NMT, that's a mouthful,"},{"speaker":"Paul Bonanos","startTime":120.987,"endTime":125.758,"body":"N-myristoyltransferase inhibitors."},{"speaker":"Paul Bonanos","startTime":126.159,"endTime":131.097,"body":"Suffice to say, some cancer cells"},{"speaker":"Paul Bonanos","startTime":126.159,"endTime":131.097,"body":"rely on a myst- myristoylated protein,"},{"speaker":"Paul Bonanos","startTime":131.097,"endTime":137.103,"body":"there I said it um and inhibiting NMT"},{"speaker":"Paul Bonanos","startTime":131.097,"endTime":137.103,"body":"can result in anti-tumor activity."},{"speaker":"Paul Bonanos","startTime":137.137,"endTime":140.44,"body":"Um, I think some of us have"},{"speaker":"Paul Bonanos","startTime":137.137,"endTime":140.44,"body":"actually worked on that in the past."},{"speaker":"Paul Bonanos","startTime":140.44,"endTime":140.74,"body":"Yes,"},{"speaker":"Simone Fishburn","startTime":141.074,"endTime":141.608,"body":"Oh, yeah."},{"speaker":"Simone Fishburn","startTime":141.608,"endTime":144.11,"body":"I'm, I'm so jumping in on"},{"speaker":"Simone Fishburn","startTime":141.608,"endTime":144.11,"body":"this one on so many fronts."},{"speaker":"Simone Fishburn","startTime":144.511,"endTime":148.314,"body":"So first of all, I'm very excited because,"},{"speaker":"Simone Fishburn","startTime":144.511,"endTime":148.314,"body":"yes, when I did my postdoc, I actually"},{"speaker":"Simone Fishburn","startTime":148.314,"endTime":154.12,"body":"worked on lipid modifications, including"},{"speaker":"Simone Fishburn","startTime":148.314,"endTime":154.12,"body":"n-myristoylation, Paul, very easily"},{"speaker":"Simone Fishburn","startTime":154.12,"endTime":155.989,"body":"said, myristoylation and palmitoylation."},{"speaker":"Simone Fishburn","startTime":156.322,"endTime":161.661,"body":"And as I'm sure many people know, these"},{"speaker":"Simone Fishburn","startTime":156.322,"endTime":161.661,"body":"are post-translational modifications"},{"speaker":"Simone Fishburn","startTime":161.661,"endTime":166.432,"body":"that add a lipid moiety um at least they"},{"speaker":"Simone Fishburn","startTime":161.661,"endTime":166.432,"body":"used to be, like, several decades ago,"},{"speaker":"Simone Fishburn","startTime":166.699,"endTime":170.503,"body":"to uh proteins that can direct where"},{"speaker":"Simone Fishburn","startTime":166.699,"endTime":170.503,"body":"they go and what they interact with."},{"speaker":"Simone Fishburn","startTime":170.503,"endTime":173.973,"body":"And certainly have been"},{"speaker":"Simone Fishburn","startTime":170.503,"endTime":173.973,"body":"implicated in, in cancer."},{"speaker":"Simone Fishburn","startTime":174.04,"endTime":179.012,"body":"And just want to say a couple of things"},{"speaker":"Simone Fishburn","startTime":174.04,"endTime":179.012,"body":"about this technology and this deal."},{"speaker":"Simone Fishburn","startTime":179.012,"endTime":183.449,"body":"We actually haven't seen a ton on"},{"speaker":"Simone Fishburn","startTime":179.012,"endTime":183.449,"body":"lipid modifications in this area,"},{"speaker":"Simone Fishburn","startTime":183.816,"endTime":188.488,"body":"and I spoke to Jonathan Tobin from"},{"speaker":"Simone Fishburn","startTime":183.816,"endTime":188.488,"body":"Brandon Capital several years ago"},{"speaker":"Simone Fishburn","startTime":188.821,"endTime":194.661,"body":"When they were just investing a seed"},{"speaker":"Simone Fishburn","startTime":188.821,"endTime":194.661,"body":"round in this technology and, it was"},{"speaker":"Simone Fishburn","startTime":194.661,"endTime":195.962,"body":"quite forward-thinking at the time."},{"speaker":"Simone Fishburn","startTime":195.962,"endTime":200.7,"body":"I think it still is, is the idea of using"},{"speaker":"Simone Fishburn","startTime":195.962,"endTime":200.7,"body":"different kinds of payloads on ADCs."},{"speaker":"Simone Fishburn","startTime":200.8,"endTime":204.237,"body":"It actually had been… I think you"},{"speaker":"Simone Fishburn","startTime":200.8,"endTime":204.237,"body":"were gonna tell us about this, Paul."},{"speaker":"Simone Fishburn","startTime":204.47,"endTime":207.006,"body":"This was a pivot from a"},{"speaker":"Simone Fishburn","startTime":204.47,"endTime":207.006,"body":"small molecule play, right?"},{"speaker":"Paul Bonanos","startTime":207.373,"endTime":208.374,"body":"That's right, yes."},{"speaker":"Paul Bonanos","startTime":208.641,"endTime":213.112,"body":"they had been looking at small molecules"},{"speaker":"Paul Bonanos","startTime":208.641,"endTime":213.112,"body":"addressing NMT and they found that"},{"speaker":"Paul Bonanos","startTime":213.112,"endTime":217.383,"body":"there was a narrow therapeutic window,"},{"speaker":"Paul Bonanos","startTime":213.112,"endTime":217.383,"body":"some worries about toxicity, but then"},{"speaker":"Paul Bonanos","startTime":217.45,"endTime":222.989,"body":"pivoted to adding NMT as a payload as"},{"speaker":"Paul Bonanos","startTime":217.45,"endTime":222.989,"body":"part of an ADC, which allowed them to"},{"speaker":"Paul Bonanos","startTime":222.989,"endTime":226.96,"body":"reduce the dosage to a manageable range,"},{"speaker":"Paul Bonanos","startTime":222.989,"endTime":226.96,"body":"and at least in preclinical models,"},{"speaker":"Paul Bonanos","startTime":227.26,"endTime":229.028,"body":"they've generated some compelling results"},{"speaker":"Simone Fishburn","startTime":229.762,"endTime":230.129,"body":"Right."},{"speaker":"Simone Fishburn","startTime":230.163,"endTime":235.602,"body":"And I think, you know just on"},{"speaker":"Simone Fishburn","startTime":230.163,"endTime":235.602,"body":"another issue, I was in touch with"},{"speaker":"Simone Fishburn","startTime":235.602,"endTime":237.036,"body":"a couple of people at Novartis."},{"speaker":"Simone Fishburn","startTime":237.07,"endTime":239.772,"body":"I think they are very excited"},{"speaker":"Simone Fishburn","startTime":237.07,"endTime":239.772,"body":"about this acquisition."},{"speaker":"Simone Fishburn","startTime":240.139,"endTime":244.177,"body":"and I think it's generally, um … I've"},{"speaker":"Simone Fishburn","startTime":240.139,"endTime":244.177,"body":"been having a bunch of phone calls"},{"speaker":"Simone Fishburn","startTime":244.177,"endTime":246.813,"body":"this morning on various things, but"},{"speaker":"Simone Fishburn","startTime":244.177,"endTime":246.813,"body":"they've converged on this very nice"},{"speaker":"Simone Fishburn","startTime":246.813,"endTime":250.683,"body":"deal because it's a very nice proof"},{"speaker":"Simone Fishburn","startTime":246.813,"endTime":250.683,"body":"of principle, I think, for Brandon"},{"speaker":"Simone Fishburn","startTime":250.683,"endTime":255.788,"body":"Capital and the early investors"},{"speaker":"Simone Fishburn","startTime":250.683,"endTime":255.788,"body":"who sort of found this technology"},{"speaker":"Simone Fishburn","startTime":255.822,"endTime":257.59,"body":"and thought it would go somewhere."},{"speaker":"Simone Fishburn","startTime":257.991,"endTime":262.061,"body":"I think for Novartis, you might talk"},{"speaker":"Simone Fishburn","startTime":257.991,"endTime":262.061,"body":"more about this, Paul, but it plays into"},{"speaker":"Simone Fishburn","startTime":262.061,"endTime":263.663,"body":"their strengths they've been building up."},{"speaker":"Simone Fishburn","startTime":263.663,"endTime":267.7,"body":"Obviously, they're leaders in radioligand"},{"speaker":"Simone Fishburn","startTime":263.663,"endTime":267.7,"body":"therapies, but, you know, ADCs is a"},{"speaker":"Simone Fishburn","startTime":267.7,"endTime":272.839,"body":"natural kissing cousin of that, and I"},{"speaker":"Simone Fishburn","startTime":267.7,"endTime":272.839,"body":"think they are, acquiring a lot of you"},{"speaker":"Simone Fishburn","startTime":272.839,"endTime":277.076,"body":"know, pipeline assets and, and building"},{"speaker":"Simone Fishburn","startTime":272.839,"endTime":277.076,"body":"maybe internally in that vein as well."},{"speaker":"Simone Fishburn","startTime":277.277,"endTime":280.046,"body":"And maybe we'll get this, to this"},{"speaker":"Simone Fishburn","startTime":277.277,"endTime":280.046,"body":"afterwards, but a couple of people"},{"speaker":"Simone Fishburn","startTime":280.046,"endTime":283.316,"body":"I've spoken to have also talked about"},{"speaker":"Simone Fishburn","startTime":280.046,"endTime":283.316,"body":"this as, you know, really good for U.K."},{"speaker":"Simone Fishburn","startTime":283.316,"endTime":287.654,"body":"life sciences, 'cause this came out"},{"speaker":"Simone Fishburn","startTime":283.316,"endTime":287.654,"body":"of, as you pointed out, the Crick,  you"},{"speaker":"Simone Fishburn","startTime":287.654,"endTime":292.659,"body":"know, that capital gets recycled into"},{"speaker":"Simone Fishburn","startTime":287.654,"endTime":292.659,"body":"that ecosystem, and so kind of a lot"},{"speaker":"Simone Fishburn","startTime":292.659,"endTime":296.829,"body":"of people for different reasons that"},{"speaker":"Simone Fishburn","startTime":292.659,"endTime":296.829,"body":"have been hailing this particular deal"},{"speaker":"Paul Bonanos","startTime":297.163,"endTime":300.166,"body":"Yes, I, I think we'll touch"},{"speaker":"Paul Bonanos","startTime":297.163,"endTime":300.166,"body":"on a lot of that in the story today."},{"speaker":"Paul Bonanos","startTime":300.333,"endTime":303.436,"body":"you mentioned for Novartis, they've"},{"speaker":"Paul Bonanos","startTime":300.333,"endTime":303.436,"body":"obviously had the strength in"},{"speaker":"Paul Bonanos","startTime":303.436,"endTime":306.773,"body":"cancer in small molecules and more"},{"speaker":"Paul Bonanos","startTime":303.436,"endTime":306.773,"body":"recently in radiotherapy, have done"},{"speaker":"Paul Bonanos","startTime":306.773,"endTime":308.474,"body":"a lot of deals in radiotherapy."},{"speaker":"Paul Bonanos","startTime":308.941,"endTime":313.346,"body":"I did find uh a quote from Vas,"},{"speaker":"Paul Bonanos","startTime":308.941,"endTime":313.346,"body":"the CEO, at this year's J.P."},{"speaker":"Paul Bonanos","startTime":313.346,"endTime":317.95,"body":"Morgan conference, where he said he"},{"speaker":"Paul Bonanos","startTime":313.346,"endTime":317.95,"body":"thought ADCs and bispecifics were"},{"speaker":"Paul Bonanos","startTime":317.95,"endTime":320.52,"body":"op-opportunities to build in oncology."},{"speaker":"Paul Bonanos","startTime":320.853,"endTime":326.359,"body":"Novartis has not done a lot of deals uh"},{"speaker":"Paul Bonanos","startTime":320.853,"endTime":326.359,"body":"in oncology for the past couple of years."},{"speaker":"Paul Bonanos","startTime":326.359,"endTime":329.495,"body":"They've been doing-- They, they've been"},{"speaker":"Paul Bonanos","startTime":326.359,"endTime":329.495,"body":"more active in other areas, neuroscience"},{"speaker":"Paul Bonanos","startTime":329.495,"endTime":331.764,"body":"and such cardiovascular as well."},{"speaker":"Paul Bonanos","startTime":332.131,"endTime":334.2,"body":"Well, th-this is an opportunity to build."},{"speaker":"Paul Bonanos","startTime":334.233,"endTime":338.971,"body":"Um, so it's uh $1.1 billion up"},{"speaker":"Paul Bonanos","startTime":334.233,"endTime":338.971,"body":"front for a preclinical company."},{"speaker":"Paul Bonanos","startTime":338.971,"endTime":339.839,"body":"That's quite a bit."},{"speaker":"Paul Bonanos","startTime":340.239,"endTime":343.876,"body":"More upside for shareholders, as you"},{"speaker":"Paul Bonanos","startTime":340.239,"endTime":343.876,"body":"said, $400 million in milestones."},{"speaker":"Paul Bonanos","startTime":344.277,"endTime":348.648,"body":"Brandon and Sofinnova Partners, we should"},{"speaker":"Paul Bonanos","startTime":344.277,"endTime":348.648,"body":"mention, was the other seed investor."},{"speaker":"Paul Bonanos","startTime":348.981,"endTime":351.517,"body":"A handsome return for"},{"speaker":"Paul Bonanos","startTime":348.981,"endTime":351.517,"body":"both of them, I'm certain"},{"speaker":"Simone Fishburn","startTime":351.684,"endTime":353.953,"body":"I, I know that"},{"speaker":"Simone Fishburn","startTime":351.684,"endTime":353.953,"body":"Abingworth was in there as well."},{"speaker":"Simone Fishburn","startTime":353.953,"endTime":354.187,"body":"There was"},{"speaker":"Simone Fishburn","startTime":354.187,"endTime":356.556,"body":"a, a whole bunch of people"},{"speaker":"Simone Fishburn","startTime":354.187,"endTime":356.556,"body":"who saw this on its way"},{"speaker":"Paul Bonanos","startTime":356.589,"endTime":359.425,"body":"there, there was a Series"},{"speaker":"Paul Bonanos","startTime":356.589,"endTime":359.425,"body":"A Novo Holdings and Abingworth were"},{"speaker":"Paul Bonanos","startTime":359.425,"endTime":364.13,"body":"the leaders, I believe, and um that"},{"speaker":"Paul Bonanos","startTime":359.425,"endTime":364.13,"body":"really, once they had solidified their"},{"speaker":"Paul Bonanos","startTime":364.13,"endTime":366.632,"body":"pivot, that's who moved it forward."},{"speaker":"Paul Bonanos","startTime":366.966,"endTime":368.501,"body":"And so you mentioned Jonathan Tobin."},{"speaker":"Paul Bonanos","startTime":368.501,"endTime":370.036,"body":"I spoke with him a little while ago."},{"speaker":"Paul Bonanos","startTime":370.37,"endTime":372.705,"body":"he said that they were actually"},{"speaker":"Paul Bonanos","startTime":370.37,"endTime":372.705,"body":"struggling at one point trying"},{"speaker":"Paul Bonanos","startTime":372.705,"endTime":377.81,"body":"to raise cash during the pandemic"},{"speaker":"Paul Bonanos","startTime":372.705,"endTime":377.81,"body":"around the NMT small molecule idea."},{"speaker":"Paul Bonanos","startTime":378.077,"endTime":381.614,"body":"And once they made the pivot, you"},{"speaker":"Paul Bonanos","startTime":378.077,"endTime":381.614,"body":"know, I, I, I liked what he said."},{"speaker":"Paul Bonanos","startTime":381.614,"endTime":386.319,"body":"He said, I'll, I'll read you the quote,"},{"speaker":"Paul Bonanos","startTime":381.614,"endTime":386.319,"body":"\"Really the bet was in 2023 that people"},{"speaker":"Paul Bonanos","startTime":386.319,"endTime":391.257,"body":"would shift their attention from linkers"},{"speaker":"Paul Bonanos","startTime":386.319,"endTime":391.257,"body":"and targets to the payloads.\" Right?"},{"speaker":"Paul Bonanos","startTime":391.324,"endTime":395.728,"body":"So, and in Novartis, Novartis' case, yes,"},{"speaker":"Paul Bonanos","startTime":391.324,"endTime":395.728,"body":"they're coming in a little late to ADCs,"},{"speaker":"Paul Bonanos","startTime":395.762,"endTime":399.599,"body":"but the way he saw it, it's as if they've"},{"speaker":"Paul Bonanos","startTime":395.762,"endTime":399.599,"body":"leapfrogged the competition in a way."},{"speaker":"Paul Bonanos","startTime":399.599,"endTime":403.169,"body":"He, he called it the second bounce"},{"speaker":"Paul Bonanos","startTime":399.599,"endTime":403.169,"body":"of the ball was toward payloads."},{"speaker":"Paul Bonanos","startTime":403.736,"endTime":408.608,"body":"So we'll have to see how it plays out,"},{"speaker":"Paul Bonanos","startTime":403.736,"endTime":408.608,"body":"but um certainly a good deal for Brandon"},{"speaker":"Paul Bonanos","startTime":408.608,"endTime":412.779,"body":"and um the other investors we'll see what"},{"speaker":"Paul Bonanos","startTime":408.608,"endTime":412.779,"body":"happens once they get into the clinic too"},{"speaker":"Jeff Cranmer","startTime":413.88,"endTime":415.982,"body":"Surely not a"},{"speaker":"Jeff Cranmer","startTime":413.88,"endTime":415.982,"body":"tennis reference there, I hope"},{"speaker":"Simone Fishburn","startTime":416.416,"endTime":418.684,"body":"Yes, I was"},{"speaker":"Simone Fishburn","startTime":416.416,"endTime":418.684,"body":"thinking just the same, Jeff."},{"speaker":"Simone Fishburn","startTime":419.085,"endTime":420.62,"body":"Um, one quick note, Paul."},{"speaker":"Simone Fishburn","startTime":420.62,"endTime":426.325,"body":"I know that  Jonathan Tobin also said"},{"speaker":"Simone Fishburn","startTime":420.62,"endTime":426.325,"body":"this was the biggest upfront for a"},{"speaker":"Simone Fishburn","startTime":426.592,"endTime":429.195,"body":"preclinical asset in an acquisition."},{"speaker":"Simone Fishburn","startTime":429.595,"endTime":431.364,"body":"well done to them if, if that's correct."},{"speaker":"Simone Fishburn","startTime":431.431,"endTime":433.065,"body":"Or in all events well"},{"speaker":"Simone Fishburn","startTime":431.431,"endTime":433.065,"body":"done to them, I guess"},{"speaker":"Danielle Golovin","startTime":434.0,"endTime":434.5,"body":"Yeah."},{"speaker":"Danielle Golovin","startTime":434.567,"endTime":438.337,"body":"Maybe for Paul or Simone might, you"},{"speaker":"Danielle Golovin","startTime":434.567,"endTime":438.337,"body":"might know, is this payload particularly"},{"speaker":"Danielle Golovin","startTime":438.337,"endTime":441.674,"body":"suited to a specific target or cancer"},{"speaker":"Danielle Golovin","startTime":438.337,"endTime":441.674,"body":"type, or is it pretty ubiquitous?"},{"speaker":"Paul Bonanos","startTime":442.675,"endTime":447.447,"body":"Yeah, I, I, I think"},{"speaker":"Paul Bonanos","startTime":442.675,"endTime":447.447,"body":"Myricx uh saw the NMT inhibitors"},{"speaker":"Paul Bonanos","startTime":447.48,"endTime":451.684,"body":"as an opportunity to create a"},{"speaker":"Paul Bonanos","startTime":447.48,"endTime":451.684,"body":"pipeline with other antibodies."},{"speaker":"Paul Bonanos","startTime":451.951,"endTime":455.354,"body":"their preclinical assets"},{"speaker":"Paul Bonanos","startTime":451.951,"endTime":455.354,"body":"target B7H3 and HER2."},{"speaker":"Paul Bonanos","startTime":455.822,"endTime":459.992,"body":"I know that there's a poster"},{"speaker":"Paul Bonanos","startTime":455.822,"endTime":459.992,"body":"where they describe an NMT payload"},{"speaker":"Paul Bonanos","startTime":460.059,"endTime":464.697,"body":"affixed to trastuzumab that they've"},{"speaker":"Paul Bonanos","startTime":460.059,"endTime":464.697,"body":"circulated as evidence of-- It's"},{"speaker":"Paul Bonanos","startTime":464.697,"endTime":466.132,"body":"some of their preclinical evidence."},{"speaker":"Paul Bonanos","startTime":466.399,"endTime":468.935,"body":"I don't know if they would"},{"speaker":"Paul Bonanos","startTime":466.399,"endTime":468.935,"body":"actually use the same antibody"},{"speaker":"Paul Bonanos","startTime":468.935,"endTime":470.069,"body":"going forward in the clinic."},{"speaker":"Jeff Cranmer","startTime":470.87,"endTime":472.305,"body":"All right,"},{"speaker":"Jeff Cranmer","startTime":470.87,"endTime":472.305,"body":"thanks for that, Paul."},{"speaker":"Jeff Cranmer","startTime":472.305,"endTime":477.043,"body":"Look forward to reading your story,"},{"speaker":"Jeff Cranmer","startTime":472.305,"endTime":477.043,"body":"which will be on biocentury.com."},{"speaker":"Jeff Cranmer","startTime":477.043,"endTime":480.98,"body":"Also, drop a link into the show notes."},{"speaker":"Jeff Cranmer","startTime":481.414,"endTime":485.318,"body":"Simone, quite the past"},{"speaker":"Jeff Cranmer","startTime":481.414,"endTime":485.318,"body":"few days for England."},{"speaker":"Jeff Cranmer","startTime":485.685,"endTime":490.923,"body":"A win by the Three Lions at the"},{"speaker":"Jeff Cranmer","startTime":485.685,"endTime":490.923,"body":"Azteca, Wimbledon in full swing,"},{"speaker":"Jeff Cranmer","startTime":491.357,"endTime":495.127,"body":"and Laurence Tallon penning a"},{"speaker":"Jeff Cranmer","startTime":491.357,"endTime":495.127,"body":"guest commentary in BioCentury."},{"speaker":"Jeff Cranmer","startTime":495.127,"endTime":495.995,"body":"Where to begin?"},{"speaker":"Simone Fishburn","startTime":496.596,"endTime":498.397,"body":"You know, I really"},{"speaker":"Simone Fishburn","startTime":496.596,"endTime":498.397,"body":"thought we were just gonna talk"},{"speaker":"Simone Fishburn","startTime":498.431,"endTime":502.001,"body":"about Cape Verde on the call today"},{"speaker":"Simone Fishburn","startTime":498.431,"endTime":502.001,"body":"and that we weren't really gonna"},{"speaker":"Simone Fishburn","startTime":502.001,"endTime":506.339,"body":"do anything else because I think"},{"speaker":"Simone Fishburn","startTime":502.001,"endTime":506.339,"body":"Steve would appreciate this as well."},{"speaker":"Simone Fishburn","startTime":506.339,"endTime":510.343,"body":"Steve, I, I was really thinking"},{"speaker":"Simone Fishburn","startTime":506.339,"endTime":510.343,"body":"that we should be looking at biotech"},{"speaker":"Simone Fishburn","startTime":510.376,"endTime":514.78,"body":"in Cape Verde and going out there"},{"speaker":"Simone Fishburn","startTime":510.376,"endTime":514.78,"body":"to investigate, and maybe our"},{"speaker":"Simone Fishburn","startTime":514.78,"endTime":516.349,"body":"next Grand Rounds should be there."},{"speaker":"Simone Fishburn","startTime":516.349,"endTime":517.583,"body":"I, I don't know if you've"},{"speaker":"Simone Fishburn","startTime":516.349,"endTime":517.583,"body":"got thoughts on that"},{"speaker":"Steve Usdin","startTime":518.15,"endTime":518.918,"body":"I'm ready to go."},{"speaker":"Steve Usdin","startTime":519.085,"endTime":519.519,"body":"Ready to go"},{"speaker":"Simone Fishburn","startTime":519.986,"endTime":523.856,"body":"Okay, so I feel like"},{"speaker":"Simone Fishburn","startTime":519.986,"endTime":523.856,"body":"there's a burgeoning biotech sector there."},{"speaker":"Simone Fishburn","startTime":524.123,"endTime":526.526,"body":"But I gotta tell you, yeah, the,"},{"speaker":"Jeff Cranmer","startTime":526.659,"endTime":532.298,"body":"gonna be a, a year-long"},{"speaker":"Jeff Cranmer","startTime":526.659,"endTime":532.298,"body":"uh party uh hosted by Vozinha no doubt"},{"speaker":"Simone Fishburn","startTime":532.298,"endTime":532.665,"body":"Yeah."},{"speaker":"Simone Fishburn","startTime":532.999,"endTime":534.3,"body":"Vozinha, yeah."},{"speaker":"Simone Fishburn","startTime":534.6,"endTime":535.167,"body":"And then I"},{"speaker":"Steve Usdin","startTime":535.535,"endTime":537.103,"body":"the music"},{"speaker":"Steve Usdin","startTime":535.535,"endTime":537.103,"body":"scene there is great also"},{"speaker":"Simone Fishburn","startTime":537.87,"endTime":538.404,"body":"What is that?"},{"speaker":"Simone Fishburn","startTime":538.404,"endTime":539.105,"body":"What is great, though, sorry?"},{"speaker":"Steve Usdin","startTime":539.438,"endTime":541.607,"body":"Uh, the music scene"},{"speaker":"Steve Usdin","startTime":539.438,"endTime":541.607,"body":"there is great also, so there we go"},{"speaker":"Simone Fishburn","startTime":542.341,"endTime":543.042,"body":"There we go."},{"speaker":"Simone Fishburn","startTime":543.075,"endTime":546.212,"body":"And then I had somebody tell me that"},{"speaker":"Simone Fishburn","startTime":543.075,"endTime":546.212,"body":"it, the podcast had to be all about"},{"speaker":"Simone Fishburn","startTime":546.212,"endTime":550.65,"body":"Harry Kane, or Sir Harry Kane as he"},{"speaker":"Simone Fishburn","startTime":546.212,"endTime":550.65,"body":"became for a few hours last week."},{"speaker":"Simone Fishburn","startTime":550.65,"endTime":554.353,"body":"Uh, but now most of us are"},{"speaker":"Simone Fishburn","startTime":550.65,"endTime":554.353,"body":"still in recovery from an"},{"speaker":"Simone Fishburn","startTime":554.353,"endTime":556.923,"body":"extraordinary  showing at the Azteca."},{"speaker":"Simone Fishburn","startTime":557.156,"endTime":560.66,"body":"But really I feel like we need a"},{"speaker":"Simone Fishburn","startTime":557.156,"endTime":560.66,"body":"whole separate podcast for that Jeff."},{"speaker":"Simone Fishburn","startTime":560.66,"endTime":562.662,"body":"I, you know, I can't do it justice, but,"},{"speaker":"Jeff Cranmer","startTime":562.895,"endTime":564.096,"body":"Simone in blazer"},{"speaker":"Simone Fishburn","startTime":564.53,"endTime":565.164,"body":"Yeah."},{"speaker":"Simone Fishburn","startTime":565.264,"endTime":568.801,"body":"It's, um … Anyway, anyway,"},{"speaker":"Simone Fishburn","startTime":565.264,"endTime":568.801,"body":"so that's a good one."},{"speaker":"Simone Fishburn","startTime":568.801,"endTime":573.172,"body":"Like uh England fans will understand"},{"speaker":"Simone Fishburn","startTime":568.801,"endTime":573.172,"body":"if uh nobody wants to jinx anything"},{"speaker":"Simone Fishburn","startTime":573.172,"endTime":575.241,"body":"here and say anything else."},{"speaker":"Simone Fishburn","startTime":575.341,"endTime":580.179,"body":"Um, they'll also understand the"},{"speaker":"Simone Fishburn","startTime":575.341,"endTime":580.179,"body":"agony that uh those of us who, who"},{"speaker":"Simone Fishburn","startTime":580.179,"endTime":583.95,"body":"really support the team went through"},{"speaker":"Simone Fishburn","startTime":580.179,"endTime":583.95,"body":"yesterday and every damn day they play."},{"speaker":"Simone Fishburn","startTime":584.45,"endTime":588.321,"body":"but anyway, Lawrence Tallon"},{"speaker":"Simone Fishburn","startTime":584.45,"endTime":588.321,"body":"is not causing such angst."},{"speaker":"Simone Fishburn","startTime":588.754,"endTime":595.895,"body":"He is the CEO of MHRA and reached"},{"speaker":"Simone Fishburn","startTime":588.754,"endTime":595.895,"body":"out to us with a really  compelling"},{"speaker":"Simone Fishburn","startTime":595.895,"endTime":598.197,"body":"uh op-ed, a commentary by him."},{"speaker":"Simone Fishburn","startTime":598.664,"endTime":604.236,"body":"I think what is important about"},{"speaker":"Simone Fishburn","startTime":598.664,"endTime":604.236,"body":"this is it's from him, and He is"},{"speaker":"Simone Fishburn","startTime":604.236,"endTime":610.543,"body":"saying regulation needs to help"},{"speaker":"Simone Fishburn","startTime":604.236,"endTime":610.543,"body":"lead rather than follow innovation."},{"speaker":"Simone Fishburn","startTime":611.01,"endTime":616.282,"body":"Regulation needs to be a catalyst, not"},{"speaker":"Simone Fishburn","startTime":611.01,"endTime":616.282,"body":"a ba- barrier for UK life sciences."},{"speaker":"Simone Fishburn","startTime":616.716,"endTime":621.988,"body":"And he says the MHRA is"},{"speaker":"Simone Fishburn","startTime":616.716,"endTime":621.988,"body":"rethinking how we regulate for"},{"speaker":"Simone Fishburn","startTime":621.988,"endTime":623.956,"body":"the greatest benefit to patients."},{"speaker":"Simone Fishburn","startTime":624.423,"endTime":631.097,"body":"And behind that is, a series of, some"},{"speaker":"Simone Fishburn","startTime":624.423,"endTime":631.097,"body":"are policy changes and some are sort"},{"speaker":"Simone Fishburn","startTime":631.097,"endTime":634.7,"body":"of, I don't know, Steve, you might help"},{"speaker":"Simone Fishburn","startTime":631.097,"endTime":634.7,"body":"me with the words, like shifts in mood"},{"speaker":"Simone Fishburn","startTime":634.7,"endTime":639.805,"body":"or vibe or strategy or whatever, where"},{"speaker":"Simone Fishburn","startTime":634.7,"endTime":639.805,"body":"I think he wants inside the agency to"},{"speaker":"Simone Fishburn","startTime":640.239,"endTime":645.778,"body":"rebalance the way they view risk you"},{"speaker":"Simone Fishburn","startTime":640.239,"endTime":645.778,"body":"know, versus the advantage of innovation"},{"speaker":"Steve Usdin","startTime":646.212,"endTime":650.182,"body":"Yeah, so I, I, I spoke with"},{"speaker":"Steve Usdin","startTime":646.212,"endTime":650.182,"body":"him s- a little while ago also, and the"},{"speaker":"Steve Usdin","startTime":650.182,"endTime":653.686,"body":"expression I think they used was something"},{"speaker":"Steve Usdin","startTime":650.182,"endTime":653.686,"body":"about proportionate regulation, that,"},{"speaker":"Steve Usdin","startTime":653.686,"endTime":657.156,"body":"regulation should be proportionate to"},{"speaker":"Steve Usdin","startTime":653.686,"endTime":657.156,"body":"the risks and the benefits, and I thought"},{"speaker":"Steve Usdin","startTime":657.156,"endTime":658.924,"body":"that was a good way to think about it."},{"speaker":"Steve Usdin","startTime":658.924,"endTime":661.427,"body":"I found his, essay, really interesting."},{"speaker":"Steve Usdin","startTime":661.727,"endTime":665.131,"body":"you know, he says it's too easy"},{"speaker":"Steve Usdin","startTime":661.727,"endTime":665.131,"body":"for regulators in any sector,"},{"speaker":"Steve Usdin","startTime":665.131,"endTime":668.3,"body":"not just healthcare, to be overly"},{"speaker":"Steve Usdin","startTime":665.131,"endTime":668.3,"body":"cautious in decision-making."},{"speaker":"Steve Usdin","startTime":668.634,"endTime":671.337,"body":"He said he, he saw it himself"},{"speaker":"Steve Usdin","startTime":668.634,"endTime":671.337,"body":"as a hospital executive."},{"speaker":"Steve Usdin","startTime":671.771,"endTime":675.574,"body":"and so he's, he's basically talking"},{"speaker":"Steve Usdin","startTime":671.771,"endTime":675.574,"body":"about recalibrating the way that"},{"speaker":"Steve Usdin","startTime":675.574,"endTime":680.146,"body":"the UK thinks about risk and putting"},{"speaker":"Steve Usdin","startTime":675.574,"endTime":680.146,"body":"that into practice in his regulation."},{"speaker":"Steve Usdin","startTime":680.479,"endTime":684.55,"body":"It's something that has been on a lot"},{"speaker":"Steve Usdin","startTime":680.479,"endTime":684.55,"body":"of people's minds around the world"},{"speaker":"Steve Usdin","startTime":684.55,"endTime":688.888,"body":"in the context of therapies for rare"},{"speaker":"Steve Usdin","startTime":684.55,"endTime":688.888,"body":"diseases, and I think that it's going"},{"speaker":"Steve Usdin","startTime":688.888,"endTime":693.659,"body":"to be on people's minds a lot more"},{"speaker":"Steve Usdin","startTime":688.888,"endTime":693.659,"body":"when they're thinking about how to, for"},{"speaker":"Steve Usdin","startTime":693.659,"endTime":698.531,"body":"example, reduce the time that's required"},{"speaker":"Steve Usdin","startTime":693.659,"endTime":698.531,"body":"to launch first in-patient trials"},{"speaker":"Simone Fishburn","startTime":699.098,"endTime":702.735,"body":"One of the things that"},{"speaker":"Simone Fishburn","startTime":699.098,"endTime":702.735,"body":"Lawrence Tallon also talks about is"},{"speaker":"Simone Fishburn","startTime":702.802,"endTime":706.772,"body":"the same sort of strategy in terms of"},{"speaker":"Simone Fishburn","startTime":702.802,"endTime":706.772,"body":"personalized medicine, in particular AI."},{"speaker":"Simone Fishburn","startTime":706.772,"endTime":711.31,"body":"I think a lot of people are wondering"},{"speaker":"Simone Fishburn","startTime":706.772,"endTime":711.31,"body":"what is the role of AI, but the"},{"speaker":"Simone Fishburn","startTime":711.31,"endTime":716.582,"body":"question I wanted to ask you based"},{"speaker":"Simone Fishburn","startTime":711.31,"endTime":716.582,"body":"on FDA and what they've done is, is"},{"speaker":"Simone Fishburn","startTime":716.582,"endTime":719.985,"body":"this something that you sort of have"},{"speaker":"Simone Fishburn","startTime":716.582,"endTime":719.985,"body":"to inculcate throughout the agency"},{"speaker":"Simone Fishburn","startTime":719.985,"endTime":721.654,"body":"at the sort of level of reviewers?"},{"speaker":"Simone Fishburn","startTime":721.687,"endTime":725.091,"body":"Is it a culture change"},{"speaker":"Simone Fishburn","startTime":721.687,"endTime":725.091,"body":"as much as policy change?"},{"speaker":"Simone Fishburn","startTime":725.458,"endTime":728.16,"body":"And, you know, how do"},{"speaker":"Simone Fishburn","startTime":725.458,"endTime":728.16,"body":"you go about doing that?"},{"speaker":"Steve Usdin","startTime":728.627,"endTime":729.862,"body":"Well, it absolutely is."},{"speaker":"Steve Usdin","startTime":729.862,"endTime":730.763,"body":"it has to be."},{"speaker":"Steve Usdin","startTime":731.03,"endTime":735.201,"body":"Some of the m- the kind of, well,"},{"speaker":"Steve Usdin","startTime":731.03,"endTime":735.201,"body":"mess um that we've seen at FDA over"},{"speaker":"Steve Usdin","startTime":735.201,"endTime":739.872,"body":"the last 16 months is a result of"},{"speaker":"Steve Usdin","startTime":735.201,"endTime":739.872,"body":"a disconnect between the people"},{"speaker":"Steve Usdin","startTime":739.872,"endTime":742.007,"body":"who are at the top and reviewers."},{"speaker":"Steve Usdin","startTime":742.308,"endTime":746.545,"body":"I've talked a lot over the years about"},{"speaker":"Steve Usdin","startTime":742.308,"endTime":746.545,"body":"this with with FDA commissioners and with"},{"speaker":"Steve Usdin","startTime":746.579,"endTime":751.45,"body":"um center directors and they all say that"},{"speaker":"Steve Usdin","startTime":746.579,"endTime":751.45,"body":"the only way that you can really get these"},{"speaker":"Steve Usdin","startTime":751.45,"endTime":756.655,"body":"kind of fundamental changes to happen"},{"speaker":"Steve Usdin","startTime":751.45,"endTime":756.655,"body":"is if you work with and you bring the"},{"speaker":"Steve Usdin","startTime":756.655,"endTime":761.594,"body":"review staff, the scientists at the, at"},{"speaker":"Steve Usdin","startTime":756.655,"endTime":761.594,"body":"the agency along with you, that you can't"},{"speaker":"Steve Usdin","startTime":761.594,"endTime":764.029,"body":"just dictate these things from the top."},{"speaker":"Steve Usdin","startTime":764.396,"endTime":767.5,"body":"And, and the way to start that, the"},{"speaker":"Steve Usdin","startTime":764.396,"endTime":767.5,"body":"way to start that conversation is"},{"speaker":"Steve Usdin","startTime":767.5,"endTime":771.17,"body":"to lay out a vision, and that seems"},{"speaker":"Steve Usdin","startTime":767.5,"endTime":771.17,"body":"to be what Lawrence Tallon is doing"},{"speaker":"Simone Fishburn","startTime":771.771,"endTime":773.439,"body":"Yeah, I think,"},{"speaker":"Simone Fishburn","startTime":771.771,"endTime":773.439,"body":"I think you're right, and"},{"speaker":"Simone Fishburn","startTime":773.439,"endTime":774.54,"body":"it's certainly one to watch."},{"speaker":"Simone Fishburn","startTime":774.607,"endTime":777.777,"body":"I can tell you I've been in touch for"},{"speaker":"Simone Fishburn","startTime":774.607,"endTime":777.777,"body":"various reasons with people in the"},{"speaker":"Simone Fishburn","startTime":777.777,"endTime":783.749,"body":"U.K. sector, and there's tremendous"},{"speaker":"Simone Fishburn","startTime":777.777,"endTime":783.749,"body":"support and, you know, belief that"},{"speaker":"Simone Fishburn","startTime":783.783,"endTime":788.754,"body":"Tallon could be a guy to really"},{"speaker":"Simone Fishburn","startTime":783.783,"endTime":788.754,"body":"make a difference for MHRA, which"},{"speaker":"Simone Fishburn","startTime":788.754,"endTime":790.623,"body":"would be important for the sector."},{"speaker":"Simone Fishburn","startTime":790.956,"endTime":795.628,"body":"So he is quite positively viewed"},{"speaker":"Simone Fishburn","startTime":790.956,"endTime":795.628,"body":"by, you know, the sector, which is"},{"speaker":"Simone Fishburn","startTime":795.628,"endTime":800.366,"body":"not always the case for regulators"},{"speaker":"Simone Fishburn","startTime":795.628,"endTime":800.366,"body":"um heads of regulatory agencies, we"},{"speaker":"Simone Fishburn","startTime":800.366,"endTime":801.066,"body":"might say"},{"speaker":"Steve Usdin","startTime":801.3,"endTime":803.202,"body":"And, and you know, one"},{"speaker":"Steve Usdin","startTime":801.3,"endTime":803.202,"body":"of the things that's, that's really"},{"speaker":"Steve Usdin","startTime":803.202,"endTime":807.306,"body":"interesting also is the very beginning of"},{"speaker":"Steve Usdin","startTime":803.202,"endTime":807.306,"body":"his essay points to the major difference"},{"speaker":"Steve Usdin","startTime":807.306,"endTime":812.111,"body":"between MHRA and FDA, which is he says,"},{"speaker":"Steve Usdin","startTime":807.306,"endTime":812.111,"body":"you know, \"We're in an interregnum now"},{"speaker":"Steve Usdin","startTime":812.111,"endTime":815.981,"body":"between governments in the UK,\" which"},{"speaker":"Steve Usdin","startTime":812.111,"endTime":815.981,"body":"was kind of a delicate way to put it."},{"speaker":"Steve Usdin","startTime":816.282,"endTime":819.852,"body":"But um but the point is that"},{"speaker":"Steve Usdin","startTime":816.282,"endTime":819.852,"body":"that he's staying, right?"},{"speaker":"Steve Usdin","startTime":819.885,"endTime":821.187,"body":"He was there before."},{"speaker":"Steve Usdin","startTime":821.42,"endTime":824.49,"body":"He's expects to be there for the"},{"speaker":"Steve Usdin","startTime":821.42,"endTime":824.49,"body":"next one, and most likely for"},{"speaker":"Steve Usdin","startTime":824.49,"endTime":825.724,"body":"the next one and the next one."},{"speaker":"Steve Usdin","startTime":825.724,"endTime":830.296,"body":"So he, he's civil service, he's"},{"speaker":"Steve Usdin","startTime":825.724,"endTime":830.296,"body":"nonpolitical, and that allows for a"},{"speaker":"Steve Usdin","startTime":830.296,"endTime":836.235,"body":"continuity and it allows for a, a kind"},{"speaker":"Steve Usdin","startTime":830.296,"endTime":836.235,"body":"of separation between the regulators"},{"speaker":"Steve Usdin","startTime":836.368,"endTime":840.639,"body":"and political actors that I think"},{"speaker":"Steve Usdin","startTime":836.368,"endTime":840.639,"body":"is, is a real strength um for the UK."},{"speaker":"Steve Usdin","startTime":840.639,"endTime":843.809,"body":"And it's something that in the long run,"},{"speaker":"Steve Usdin","startTime":840.639,"endTime":843.809,"body":"the United States, I think, and I've"},{"speaker":"Steve Usdin","startTime":843.809,"endTime":845.578,"body":"written about this, should aspire to."},{"speaker":"Steve Usdin","startTime":845.578,"endTime":849.381,"body":"We should aspire to having FDA"},{"speaker":"Steve Usdin","startTime":845.578,"endTime":849.381,"body":"run by someone who's nonpolitical"},{"speaker":"Steve Usdin","startTime":849.381,"endTime":854.92,"body":"and who's expected to endure"},{"speaker":"Steve Usdin","startTime":849.381,"endTime":854.92,"body":"throughout, through more than one"},{"speaker":"Steve Usdin","startTime":854.987,"endTime":856.522,"body":"uh presidential administration."},{"speaker":"Steve Usdin","startTime":856.555,"endTime":859.692,"body":"You know, the idea that, that"},{"speaker":"Steve Usdin","startTime":856.555,"endTime":859.692,"body":"the FDA commissioner is a highly"},{"speaker":"Steve Usdin","startTime":859.692,"endTime":863.729,"body":"politicized job and that it changes"},{"speaker":"Steve Usdin","startTime":859.692,"endTime":863.729,"body":"with every president is not a strength"},{"speaker":"Simone Fishburn","startTime":864.797,"endTime":867.466,"body":"Yeah, I, I totally"},{"speaker":"Simone Fishburn","startTime":864.797,"endTime":867.466,"body":"agree with you, Steve, but I also want"},{"speaker":"Simone Fishburn","startTime":867.466,"endTime":872.004,"body":"to just add that at the rate at which"},{"speaker":"Simone Fishburn","startTime":867.466,"endTime":872.004,"body":"the U.K. changes prime ministers,"},{"speaker":"Simone Fishburn","startTime":872.338,"endTime":876.442,"body":"it would be highly problematic if"},{"speaker":"Simone Fishburn","startTime":872.338,"endTime":876.442,"body":"it had to change FDA commissioner"},{"speaker":"Simone Fishburn","startTime":876.809,"endTime":879.278,"body":"or MHRA leaders each time as well."},{"speaker":"Simone Fishburn","startTime":879.278,"endTime":882.381,"body":"But uh you know, therein lies"},{"speaker":"Simone Fishburn","startTime":879.278,"endTime":882.381,"body":"the, the, the strength of the"},{"speaker":"Simone Fishburn","startTime":882.381,"endTime":883.749,"body":"administrative state, so yes"},{"speaker":"Jeff Cranmer","startTime":884.683,"endTime":890.789,"body":"Well, on that note uh let's"},{"speaker":"Jeff Cranmer","startTime":884.683,"endTime":890.789,"body":"take a look at what is going on in the US."},{"speaker":"Jeff Cranmer","startTime":890.823,"endTime":899.031,"body":"Colorado lawmaker Diana DeGette has been"},{"speaker":"Jeff Cranmer","startTime":890.823,"endTime":899.031,"body":"defeated in a Democratic House primary"},{"speaker":"Jeff Cranmer","startTime":899.131,"endTime":905.471,"body":"and that ends the legislative career of"},{"speaker":"Jeff Cranmer","startTime":899.131,"endTime":905.471,"body":"a politician who built bipartisan support"},{"speaker":"Jeff Cranmer","startTime":905.471,"endTime":908.44,"body":"for FDA reforms for quite some time now."},{"speaker":"Jeff Cranmer","startTime":908.741,"endTime":910.342,"body":"Steve thoughts here"},{"speaker":"Steve Usdin","startTime":910.876,"endTime":911.143,"body":"Yeah."},{"speaker":"Steve Usdin","startTime":911.143,"endTime":915.781,"body":"So Representative DeGette as you said,"},{"speaker":"Steve Usdin","startTime":911.143,"endTime":915.781,"body":"she lost her Democratic primary on July"},{"speaker":"Steve Usdin","startTime":915.781,"endTime":922.121,"body":"the 1st to Melat Kiros, a 29-year-old"},{"speaker":"Steve Usdin","startTime":915.781,"endTime":922.121,"body":"attorney and PhD student who's running"},{"speaker":"Steve Usdin","startTime":922.121,"endTime":924.056,"body":"on a democratic socialist platform."},{"speaker":"Steve Usdin","startTime":924.39,"endTime":928.761,"body":"the district that Diana DeGette"},{"speaker":"Steve Usdin","startTime":924.39,"endTime":928.761,"body":"represents, the first district um it's"},{"speaker":"Steve Usdin","startTime":928.761,"endTime":933.832,"body":"Denver, it's heavily Democratic, so"},{"speaker":"Steve Usdin","startTime":928.761,"endTime":933.832,"body":"Kiros is expected to win in November."},{"speaker":"Steve Usdin","startTime":934.333,"endTime":937.937,"body":"DeGette had been ranking member of the"},{"speaker":"Steve Usdin","startTime":934.333,"endTime":937.937,"body":"Energy and Commerce Committee's health"},{"speaker":"Steve Usdin","startTime":937.937,"endTime":942.441,"body":"subcommittee, and she was positioned to"},{"speaker":"Steve Usdin","startTime":937.937,"endTime":942.441,"body":"chair it if Democrats um retook the House."},{"speaker":"Steve Usdin","startTime":942.841,"endTime":945.978,"body":"She was also building support"},{"speaker":"Steve Usdin","startTime":942.841,"endTime":945.978,"body":"for a bill, the 21st Century"},{"speaker":"Steve Usdin","startTime":945.978,"endTime":951.216,"body":"Cures Act 2.0, that was aimed at"},{"speaker":"Steve Usdin","startTime":945.978,"endTime":951.216,"body":"further speeding drug development."},{"speaker":"Steve Usdin","startTime":951.65,"endTime":955.487,"body":"You know, what I wrote is that this"},{"speaker":"Steve Usdin","startTime":951.65,"endTime":955.487,"body":"is really a, is a major setback for"},{"speaker":"Steve Usdin","startTime":955.921,"endTime":961.66,"body":"the bipartisan industry collaborative"},{"speaker":"Steve Usdin","startTime":955.921,"endTime":961.66,"body":"approach to FDA reform that's been the"},{"speaker":"Steve Usdin","startTime":961.66,"endTime":965.164,"body":"norm for the last couple of decades,"},{"speaker":"Steve Usdin","startTime":961.66,"endTime":965.164,"body":"really, at least for the last decade."},{"speaker":"Steve Usdin","startTime":965.564,"endTime":969.935,"body":"DeGette co-authored the 21st Century"},{"speaker":"Steve Usdin","startTime":965.564,"endTime":969.935,"body":"Cures Act which was passed in 2016,"},{"speaker":"Steve Usdin","startTime":970.336,"endTime":972.237,"body":"with Representative Fred Upton."},{"speaker":"Steve Usdin","startTime":972.471,"endTime":974.54,"body":"They were a really close partnership."},{"speaker":"Steve Usdin","startTime":974.74,"endTime":976.108,"body":"it was really fun to see them."},{"speaker":"Steve Usdin","startTime":976.108,"endTime":980.279,"body":"They would go around the country and do"},{"speaker":"Steve Usdin","startTime":976.108,"endTime":980.279,"body":"um town hall meetings and roundtables and"},{"speaker":"Steve Usdin","startTime":980.279,"endTime":984.516,"body":"things together, and it was, you know, it"},{"speaker":"Steve Usdin","startTime":980.279,"endTime":984.516,"body":"was a Democrat and Republican literally um"},{"speaker":"Steve Usdin","startTime":984.55,"endTime":989.955,"body":"arm in arm trying to come up with policies"},{"speaker":"Steve Usdin","startTime":984.55,"endTime":989.955,"body":"that would make the FDA better and"},{"speaker":"Steve Usdin","startTime":989.955,"endTime":991.523,"body":"that would make it better for patients."},{"speaker":"Steve Usdin","startTime":991.857,"endTime":996.328,"body":"21st Century Cures Act modernized"},{"speaker":"Steve Usdin","startTime":991.857,"endTime":996.328,"body":"evidence standards for drug approval."},{"speaker":"Steve Usdin","startTime":996.528,"endTime":1000.899,"body":"It created the RMAT designation, kind"},{"speaker":"Steve Usdin","startTime":996.528,"endTime":1000.899,"body":"of equivalent to breakthrough for"},{"speaker":"Steve Usdin","startTime":1000.899,"endTime":1005.17,"body":"uh biologics, and it enabled tools"},{"speaker":"Steve Usdin","startTime":1000.899,"endTime":1005.17,"body":"um that are now considered routine:"},{"speaker":"Steve Usdin","startTime":1005.604,"endTime":1009.742,"body":"the use of real-world evidence,"},{"speaker":"Steve Usdin","startTime":1005.604,"endTime":1009.742,"body":"external control arms wider use of"},{"speaker":"Steve Usdin","startTime":1009.742,"endTime":1011.71,"body":"surrogate and interim endpoints."},{"speaker":"Steve Usdin","startTime":1012.277,"endTime":1015.481,"body":"The uh 21st Century Cures Act"},{"speaker":"Steve Usdin","startTime":1012.277,"endTime":1015.481,"body":"wasn't the only thing that she did."},{"speaker":"Steve Usdin","startTime":1015.481,"endTime":1019.218,"body":"Actually, she started much earlier"},{"speaker":"Steve Usdin","startTime":1015.481,"endTime":1019.218,"body":"u- under um the George W. Bush"},{"speaker":"Steve Usdin","startTime":1019.218,"endTime":1023.288,"body":"administration authoring the Stem"},{"speaker":"Steve Usdin","startTime":1019.218,"endTime":1023.288,"body":"Cell Research Enhancement Act that was"},{"speaker":"Steve Usdin","startTime":1023.322,"endTime":1028.293,"body":"vetoed twice by Bush, and then Obama"},{"speaker":"Steve Usdin","startTime":1023.322,"endTime":1028.293,"body":"incorporated it into an executive order."},{"speaker":"Steve Usdin","startTime":1028.694,"endTime":1031.196,"body":"she worked very closely with"},{"speaker":"Steve Usdin","startTime":1028.694,"endTime":1031.196,"body":"patient advocacy groups."},{"speaker":"Steve Usdin","startTime":1031.697,"endTime":1034.867,"body":"Uh, I spoke with Ellen Sigal, the"},{"speaker":"Steve Usdin","startTime":1031.697,"endTime":1034.867,"body":"founder of Friends of Cancer Research,"},{"speaker":"Steve Usdin","startTime":1035.134,"endTime":1037.77,"body":"who called DeGette's loss devastating."},{"speaker":"Steve Usdin","startTime":1037.936,"endTime":1039.505,"body":"She says it's a devastating blow."},{"speaker":"Steve Usdin","startTime":1039.838,"endTime":1042.975,"body":"She talked about how DeGette had"},{"speaker":"Steve Usdin","startTime":1039.838,"endTime":1042.975,"body":"gone out of her way to understand"},{"speaker":"Steve Usdin","startTime":1042.975,"endTime":1045.511,"body":"the science and to build consensus."},{"speaker":"Simone Fishburn","startTime":1046.478,"endTime":1049.848,"body":"Steve, um, let me jump"},{"speaker":"Simone Fishburn","startTime":1046.478,"endTime":1049.848,"body":"in and just ask a, a question or two."},{"speaker":"Simone Fishburn","startTime":1050.015,"endTime":1055.788,"body":"So, you know, I think that her legacy"},{"speaker":"Simone Fishburn","startTime":1050.015,"endTime":1055.788,"body":"certainly, you know, speaks well"},{"speaker":"Simone Fishburn","startTime":1055.788,"endTime":1057.256,"body":"to the model that you talk about."},{"speaker":"Simone Fishburn","startTime":1057.79,"endTime":1061.326,"body":"What I do wanna say and ask is,"},{"speaker":"Simone Fishburn","startTime":1057.79,"endTime":1061.326,"body":"you know, w- we've looked at the"},{"speaker":"Simone Fishburn","startTime":1061.326,"endTime":1062.661,"body":"negative side, what we're losing."},{"speaker":"Simone Fishburn","startTime":1062.661,"endTime":1066.398,"body":"It's very clear that the sector"},{"speaker":"Simone Fishburn","startTime":1062.661,"endTime":1066.398,"body":"is losing somebody that was"},{"speaker":"Simone Fishburn","startTime":1066.398,"endTime":1068.333,"body":"an asset really in Congress."},{"speaker":"Simone Fishburn","startTime":1068.434,"endTime":1073.405,"body":"I wanna know whether you see anyone"},{"speaker":"Simone Fishburn","startTime":1068.434,"endTime":1073.405,"body":"stepping into those shoes and, or"},{"speaker":"Simone Fishburn","startTime":1073.405,"endTime":1077.576,"body":"whether her replacement you know,"},{"speaker":"Simone Fishburn","startTime":1073.405,"endTime":1077.576,"body":"I guess it would be the Democratic"},{"speaker":"Simone Fishburn","startTime":1077.709,"endTime":1082.314,"body":"candidate now for that seat offers"},{"speaker":"Simone Fishburn","startTime":1077.709,"endTime":1082.314,"body":"anything, you know, that will affect life"},{"speaker":"Simone Fishburn","startTime":1082.314,"endTime":1084.216,"body":"sciences, or is that largely irrelevant?"},{"speaker":"Steve Usdin","startTime":1084.85,"endTime":1087.152,"body":"You know, there are"},{"speaker":"Steve Usdin","startTime":1084.85,"endTime":1087.152,"body":"other members of Congress who"},{"speaker":"Steve Usdin","startTime":1087.553,"endTime":1089.488,"body":"kind of represent that that style."},{"speaker":"Steve Usdin","startTime":1089.521,"endTime":1093.725,"body":"Um, I've spoken, I, I've done"},{"speaker":"Steve Usdin","startTime":1089.521,"endTime":1093.725,"body":"interviews BioCentury podcasts and"},{"speaker":"Steve Usdin","startTime":1093.725,"endTime":1097.529,"body":"written about Representative Jake"},{"speaker":"Steve Usdin","startTime":1093.725,"endTime":1097.529,"body":"Auchincloss from Massachusetts."},{"speaker":"Steve Usdin","startTime":1097.729,"endTime":1101.867,"body":"he's working on a, package now"},{"speaker":"Steve Usdin","startTime":1097.729,"endTime":1101.867,"body":"clinical trial reforms that he"},{"speaker":"Steve Usdin","startTime":1101.867,"endTime":1104.703,"body":"hopes will be attached to the"},{"speaker":"Steve Usdin","startTime":1101.867,"endTime":1104.703,"body":"next PDUFA reauthorization."},{"speaker":"Steve Usdin","startTime":1105.07,"endTime":1108.24,"body":"And when I spoke with him, I asked him"},{"speaker":"Steve Usdin","startTime":1105.07,"endTime":1108.24,"body":"specifically, and he's, he's doing it"},{"speaker":"Steve Usdin","startTime":1108.273,"endTime":1110.442,"body":"along with Morgan Griffith, a Republican."},{"speaker":"Steve Usdin","startTime":1110.442,"endTime":1113.812,"body":"I said, \"Well, really, is this like"},{"speaker":"Steve Usdin","startTime":1110.442,"endTime":1113.812,"body":"Diana DeGette and Fred Upton and 21st"},{"speaker":"Steve Usdin","startTime":1113.812,"endTime":1117.082,"body":"Century Cures?\" And he said, \"Well,"},{"speaker":"Steve Usdin","startTime":1113.812,"endTime":1117.082,"body":"it, it is.\" And he, and he hopes"},{"speaker":"Steve Usdin","startTime":1117.082,"endTime":1118.817,"body":"that it's as successful as they were."},{"speaker":"Steve Usdin","startTime":1119.384,"endTime":1124.523,"body":"As far as Kiros, the, the candidate who"},{"speaker":"Steve Usdin","startTime":1119.384,"endTime":1124.523,"body":"defeated DeGette one of the reasons, one"},{"speaker":"Steve Usdin","startTime":1124.523,"endTime":1129.995,"body":"of the things that she campaigned on was"},{"speaker":"Steve Usdin","startTime":1124.523,"endTime":1129.995,"body":"DeGette's acceptance of campaign donations"},{"speaker":"Steve Usdin","startTime":1129.995,"endTime":1131.563,"body":"from the pharmaceutical industry."},{"speaker":"Steve Usdin","startTime":1131.897,"endTime":1135.934,"body":"She tied that to a broader democratic"},{"speaker":"Steve Usdin","startTime":1131.897,"endTime":1135.934,"body":"socialist critique of what they"},{"speaker":"Steve Usdin","startTime":1135.934,"endTime":1138.137,"body":"call industry capture of regulators."},{"speaker":"Steve Usdin","startTime":1138.67,"endTime":1142.474,"body":"You know, I think that Kiros and"},{"speaker":"Steve Usdin","startTime":1138.67,"endTime":1142.474,"body":"other candidates who she's politically"},{"speaker":"Steve Usdin","startTime":1142.474,"endTime":1145.811,"body":"aligned with, other politicians"},{"speaker":"Steve Usdin","startTime":1142.474,"endTime":1145.811,"body":"she's aligned with there's a deep"},{"speaker":"Steve Usdin","startTime":1145.811,"endTime":1150.415,"body":"divide between them and mainstream"},{"speaker":"Steve Usdin","startTime":1145.811,"endTime":1150.415,"body":"Democrats like DeGette on FDA issues."},{"speaker":"Steve Usdin","startTime":1150.415,"endTime":1154.953,"body":"DeGette has treated the pharma industry"},{"speaker":"Steve Usdin","startTime":1150.415,"endTime":1154.953,"body":"as a partner to regulate and incentivize."},{"speaker":"Steve Usdin","startTime":1155.287,"endTime":1159.424,"body":"The Democratic Socialist Bloc officially,"},{"speaker":"Steve Usdin","startTime":1155.287,"endTime":1159.424,"body":"if you look at their, their platforms,"},{"speaker":"Steve Usdin","startTime":1159.424,"endTime":1164.963,"body":"they favor public manufacturing of drugs,"},{"speaker":"Steve Usdin","startTime":1159.424,"endTime":1164.963,"body":"limits on profits, IP curbs, and they"},{"speaker":"Steve Usdin","startTime":1164.963,"endTime":1168.934,"body":"have a deep skepticism toward loosening"},{"speaker":"Steve Usdin","startTime":1164.963,"endTime":1168.934,"body":"what they consider loosening evidentiary"},{"speaker":"Steve Usdin","startTime":1168.934,"endTime":1174.806,"body":"standards at FDA What I said in my story"},{"speaker":"Steve Usdin","startTime":1168.934,"endTime":1174.806,"body":"is that really the a- advocates who are"},{"speaker":"Steve Usdin","startTime":1174.806,"endTime":1180.746,"body":"hoping to extend the kind of reforms"},{"speaker":"Steve Usdin","startTime":1174.806,"endTime":1180.746,"body":"that were in 21st Century Cures need"},{"speaker":"Steve Usdin","startTime":1180.746,"endTime":1184.917,"body":"to build a new bipartisan coalition,"},{"speaker":"Steve Usdin","startTime":1180.746,"endTime":1184.917,"body":"and it's gonna be very difficult now"},{"speaker":"Steve Usdin","startTime":1184.917,"endTime":1189.087,"body":"because the environment is far less"},{"speaker":"Steve Usdin","startTime":1184.917,"endTime":1189.087,"body":"hospitable to the brand of consensus"},{"speaker":"Steve Usdin","startTime":1189.087,"endTime":1191.223,"body":"politics that DeGette exemplified."},{"speaker":"Steve Usdin","startTime":1191.79,"endTime":1195.294,"body":"And, you know, and I guess one other"},{"speaker":"Steve Usdin","startTime":1191.79,"endTime":1195.294,"body":"final thing, I think there's some in"},{"speaker":"Steve Usdin","startTime":1195.294,"endTime":1198.964,"body":"the industry who would um take issue"},{"speaker":"Steve Usdin","startTime":1195.294,"endTime":1198.964,"body":"with me saying that DeGette was an"},{"speaker":"Steve Usdin","startTime":1198.964,"endTime":1205.137,"body":"ally of the industry because she also"},{"speaker":"Steve Usdin","startTime":1198.964,"endTime":1205.137,"body":"was a firm proponent a champion of"},{"speaker":"Steve Usdin","startTime":1205.27,"endTime":1209.975,"body":"the Medicare drug price negotiation"},{"speaker":"Steve Usdin","startTime":1205.27,"endTime":1209.975,"body":"provisions and the IRA and other things"},{"speaker":"Steve Usdin","startTime":1210.008,"endTime":1211.543,"body":"that were opposed by the pharma industry."},{"speaker":"Steve Usdin","startTime":1211.543,"endTime":1214.112,"body":"So it's not like she was"},{"speaker":"Steve Usdin","startTime":1211.543,"endTime":1214.112,"body":"the pharma industry's or the"},{"speaker":"Steve Usdin","startTime":1214.112,"endTime":1215.814,"body":"biotech industry's puppet"},{"speaker":"Simone Fishburn","startTime":1215.881,"endTime":1217.683,"body":"no shill"},{"speaker":"Simone Fishburn","startTime":1215.881,"endTime":1217.683,"body":"for the industry kind of"},{"speaker":"Steve Usdin","startTime":1217.716,"endTime":1218.584,"body":"No, she wasn't at all."},{"speaker":"Steve Usdin","startTime":1218.584,"endTime":1219.017,"body":"But, but"},{"speaker":"Simone Fishburn","startTime":1219.017,"endTime":1219.518,"body":"I think"},{"speaker":"Simone Fishburn","startTime":1219.518,"endTime":1219.751,"body":"that"},{"speaker":"Steve Usdin","startTime":1220.519,"endTime":1223.622,"body":"but, but to the extent that"},{"speaker":"Steve Usdin","startTime":1220.519,"endTime":1223.622,"body":"what the biotech industry and what the"},{"speaker":"Steve Usdin","startTime":1223.622,"endTime":1228.527,"body":"pharma industry are doing is aligned"},{"speaker":"Steve Usdin","startTime":1223.622,"endTime":1228.527,"body":"with and must be aligned with public"},{"speaker":"Steve Usdin","startTime":1228.527,"endTime":1231.997,"body":"health benefits and with what's really"},{"speaker":"Steve Usdin","startTime":1228.527,"endTime":1231.997,"body":"important to patients, I think that"},{"speaker":"Steve Usdin","startTime":1231.997,"endTime":1235.867,"body":"DeGette really should be considered"},{"speaker":"Steve Usdin","startTime":1231.997,"endTime":1235.867,"body":"to be you know, a champion and a hero"},{"speaker":"Jeff Cranmer","startTime":1236.635,"endTime":1240.272,"body":"We'll take a quick"},{"speaker":"Jeff Cranmer","startTime":1236.635,"endTime":1240.272,"body":"break, and we'll be back to discuss the"},{"speaker":"Jeff Cranmer","startTime":1240.272,"endTime":1243.542,"body":"latest in our Atlas Insights series."},{"speaker":"Voice Talent","startTime":1244.276,"endTime":1247.246,"body":"This episode of BioCentury"},{"speaker":"Voice Talent","startTime":1244.276,"endTime":1247.246,"body":"This Week is brought to you by the"},{"speaker":"Voice Talent","startTime":1247.246,"endTime":1251.783,"body":"13th China Healthcare Summit, taking"},{"speaker":"Voice Talent","startTime":1247.246,"endTime":1251.783,"body":"place November 2nd to 4th in Shanghai"},{"speaker":"Voice Talent","startTime":1253.352,"endTime":1256.922,"body":"Everyone has an opinion about China"},{"speaker":"Voice Talent","startTime":1253.352,"endTime":1256.922,"body":"biotech, but there's a difference"},{"speaker":"Voice Talent","startTime":1256.922,"endTime":1260.492,"body":"between reading about cross-border"},{"speaker":"Voice Talent","startTime":1256.922,"endTime":1260.492,"body":"deals and seeing it for yourself."},{"speaker":"Voice Talent","startTime":1261.026,"endTime":1264.496,"body":"The 13th China Healthcare Summit"},{"speaker":"Voice Talent","startTime":1261.026,"endTime":1264.496,"body":"brings you to Shanghai November"},{"speaker":"Voice Talent","startTime":1264.496,"endTime":1268.467,"body":"2nd to 4th for a firsthand look"},{"speaker":"Voice Talent","startTime":1264.496,"endTime":1268.467,"body":"at China's innovation moment."},{"speaker":"Voice Talent","startTime":1269.001,"endTime":1273.338,"body":"Join BioCentury, BayHelix, and"},{"speaker":"Voice Talent","startTime":1269.001,"endTime":1273.338,"body":"insights partner McKinsey \u0026 Company"},{"speaker":"Voice Talent","startTime":1273.538,"endTime":1278.343,"body":"for a deep dive into China's biopharma"},{"speaker":"Voice Talent","startTime":1273.538,"endTime":1278.343,"body":"ecosystem and meet the biotech leaders"},{"speaker":"Voice Talent","startTime":1278.343,"endTime":1280.145,"body":"who are driving all the newsflow."},{"speaker":"Voice Talent","startTime":1280.612,"endTime":1281.68,"body":"Sourcing innovation."},{"speaker":"Voice Talent","startTime":1281.847,"endTime":1282.914,"body":"Building NewCos."},{"speaker":"Voice Talent","startTime":1283.081,"endTime":1284.983,"body":"Generating faster clinical data."},{"speaker":"Voice Talent","startTime":1285.317,"endTime":1287.586,"body":"Reimagining your R\u0026D strategy."},{"speaker":"Voice Talent","startTime":1288.086,"endTime":1291.757,"body":"For a dozen years, the China Healthcare"},{"speaker":"Voice Talent","startTime":1288.086,"endTime":1291.757,"body":"Summit has gathered the right people"},{"speaker":"Voice Talent","startTime":1291.757,"endTime":1293.525,"body":"to network and build business."},{"speaker":"Voice Talent","startTime":1293.925,"endTime":1296.194,"body":"Now it's your chance to be in the room."},{"speaker":"Voice Talent","startTime":1296.595,"endTime":1298.397,"body":"Join us in Shanghai this November."},{"speaker":"Voice Talent","startTime":1298.63,"endTime":1302.801,"body":"Opt into the tour of Suzhou and a visit"},{"speaker":"Voice Talent","startTime":1298.63,"endTime":1302.801,"body":"to Shanghai clinical trial centers."},{"speaker":"Voice Talent","startTime":1303.135,"endTime":1304.403,"body":"See it for yourself."},{"speaker":"Voice Talent","startTime":1304.836,"endTime":1308.073,"body":"Register at biocenturychinasummit.com."},{"speaker":"Jeff Cranmer","startTime":1311.109,"endTime":1315.981,"body":"We are back on the"},{"speaker":"Jeff Cranmer","startTime":1311.109,"endTime":1315.981,"body":"BioCentury This Week podcast We're"},{"speaker":"Jeff Cranmer","startTime":1315.981,"endTime":1320.285,"body":"gonna bring in uh our colleague Danielle"},{"speaker":"Jeff Cranmer","startTime":1315.981,"endTime":1320.285,"body":"Golovin now, or bring her back in."},{"speaker":"Jeff Cranmer","startTime":1320.319,"endTime":1324.523,"body":"Uh, she leads our Atlas Insights series."},{"speaker":"Jeff Cranmer","startTime":1324.923,"endTime":1328.093,"body":"and atlases, what are they"},{"speaker":"Jeff Cranmer","startTime":1324.923,"endTime":1328.093,"body":"for the UN initiative?"},{"speaker":"Jeff Cranmer","startTime":1328.26,"endTime":1334.166,"body":"Well, our weekly literature scans"},{"speaker":"Jeff Cranmer","startTime":1328.26,"endTime":1334.166,"body":"frequently identify papers that function"},{"speaker":"Jeff Cranmer","startTime":1334.199,"endTime":1340.405,"body":"as disease atlases, observational"},{"speaker":"Jeff Cranmer","startTime":1334.199,"endTime":1340.405,"body":"patient studies, typically involving"},{"speaker":"Jeff Cranmer","startTime":1340.405,"endTime":1345.377,"body":"large scale molecular profiling"},{"speaker":"Jeff Cranmer","startTime":1340.405,"endTime":1345.377,"body":"that seek to capture the underlying"},{"speaker":"Jeff Cranmer","startTime":1345.377,"endTime":1349.881,"body":"biology in heterogeneity of disease."},{"speaker":"Jeff Cranmer","startTime":1350.449,"endTime":1356.321,"body":"Danielle  you followed up our colleague"},{"speaker":"Jeff Cranmer","startTime":1350.449,"endTime":1356.321,"body":"Lindsay Martin's epic Parkinson's"},{"speaker":"Jeff Cranmer","startTime":1356.355,"endTime":1360.258,"body":"piece with the Parkinson's Atlas."},{"speaker":"Danielle Golovin","startTime":1360.559,"endTime":1362.494,"body":"Yeah, big,"},{"speaker":"Danielle Golovin","startTime":1360.559,"endTime":1362.494,"body":"big shoes to fill there."},{"speaker":"Danielle Golovin","startTime":1362.761,"endTime":1365.163,"body":"Uh, it was, it was a big one."},{"speaker":"Danielle Golovin","startTime":1365.397,"endTime":1366.631,"body":"It was a, a me- uh, what was it?"},{"speaker":"Danielle Golovin","startTime":1366.631,"endTime":1367.599,"body":"A mega chonker?"},{"speaker":"Danielle Golovin","startTime":1367.666,"endTime":1368.967,"body":"Or what, what's on the scale"},{"speaker":"Jeff Cranmer","startTime":1369.167,"endTime":1373.839,"body":"yeah, on the uh the"},{"speaker":"Jeff Cranmer","startTime":1369.167,"endTime":1373.839,"body":"cat scale uh from fine boy to a hefty"},{"speaker":"Jeff Cranmer","startTime":1373.839,"endTime":1375.841,"body":"chonker, I think it was a hefty chonk."},{"speaker":"Jeff Cranmer","startTime":1376.375,"endTime":1384.549,"body":"Um uh for, for dog people, that just"},{"speaker":"Jeff Cranmer","startTime":1376.375,"endTime":1384.549,"body":"means uh something very big and uh potent."},{"speaker":"Jeff Cranmer","startTime":1384.85,"endTime":1387.919,"body":"so what did you find when you looked"},{"speaker":"Jeff Cranmer","startTime":1384.85,"endTime":1387.919,"body":"at the atlases for Parkinson's?"},{"speaker":"Danielle Golovin","startTime":1388.253,"endTime":1388.52,"body":"Yeah."},{"speaker":"Danielle Golovin","startTime":1388.52,"endTime":1391.289,"body":"So last week you heard Lindsay"},{"speaker":"Danielle Golovin","startTime":1388.52,"endTime":1391.289,"body":"walk through how the Parkinson's"},{"speaker":"Danielle Golovin","startTime":1391.289,"endTime":1395.06,"body":"pipeline is finally moving beyond"},{"speaker":"Danielle Golovin","startTime":1391.289,"endTime":1395.06,"body":"dopamine replacement, towards"},{"speaker":"Danielle Golovin","startTime":1395.093,"endTime":1396.628,"body":"disease modifying strategies."},{"speaker":"Danielle Golovin","startTime":1397.396,"endTime":1401.8,"body":"So her examples were cell therapies,"},{"speaker":"Danielle Golovin","startTime":1397.396,"endTime":1401.8,"body":"alpha-synuclein programs, and targeting"},{"speaker":"Danielle Golovin","startTime":1401.8,"endTime":1404.87,"body":"genetic drivers like LRRK2 and GCase."},{"speaker":"Danielle Golovin","startTime":1404.87,"endTime":1409.141,"body":"I would say my analysis of these"},{"speaker":"Danielle Golovin","startTime":1404.87,"endTime":1409.141,"body":"six new single cell multi-omic"},{"speaker":"Danielle Golovin","startTime":1409.141,"endTime":1414.179,"body":"atlases of human Parkinson's tissue"},{"speaker":"Danielle Golovin","startTime":1409.141,"endTime":1414.179,"body":"largely validates those targets."},{"speaker":"Danielle Golovin","startTime":1414.212,"endTime":1417.949,"body":"But what it does is add a layer"},{"speaker":"Danielle Golovin","startTime":1414.212,"endTime":1417.949,"body":"of complexity, and that is in"},{"speaker":"Danielle Golovin","startTime":1417.949,"endTime":1422.387,"body":"which cells and at what stages are"},{"speaker":"Danielle Golovin","startTime":1417.949,"endTime":1422.387,"body":"those pathways actually lit up."},{"speaker":"Danielle Golovin","startTime":1422.854,"endTime":1427.626,"body":"So as we know, Parkinson's disease isn't"},{"speaker":"Danielle Golovin","startTime":1422.854,"endTime":1427.626,"body":"a single fixed state, it's a trajectory."},{"speaker":"Danielle Golovin","startTime":1427.926,"endTime":1432.297,"body":"And if we look at the classic Braak"},{"speaker":"Danielle Golovin","startTime":1427.926,"endTime":1432.297,"body":"staging scheme  Lewy body pathology"},{"speaker":"Danielle Golovin","startTime":1432.297,"endTime":1436.668,"body":"appears first in lower brainstem nuclei,"},{"speaker":"Danielle Golovin","startTime":1432.297,"endTime":1436.668,"body":"climbs through the midbrain structures"},{"speaker":"Danielle Golovin","startTime":1436.701,"endTime":1441.706,"body":"like the substantia nigra, and only"},{"speaker":"Danielle Golovin","startTime":1436.701,"endTime":1441.706,"body":"later reaches like cortical regions."},{"speaker":"Danielle Golovin","startTime":1442.107,"endTime":1445.977,"body":"this means at any given time, different"},{"speaker":"Danielle Golovin","startTime":1442.107,"endTime":1445.977,"body":"brain areas in a patient sit at different"},{"speaker":"Danielle Golovin","startTime":1445.977,"endTime":1449.481,"body":"points along the Parkinson's timeline, and"},{"speaker":"Danielle Golovin","startTime":1445.977,"endTime":1449.481,"body":"this is important for drug development."},{"speaker":"Danielle Golovin","startTime":1449.514,"endTime":1453.819,"body":"The implication is that a single disease"},{"speaker":"Danielle Golovin","startTime":1449.514,"endTime":1453.819,"body":"modifying label  can have different"},{"speaker":"Danielle Golovin","startTime":1453.819,"endTime":1457.956,"body":"biological requirements, you know, at"},{"speaker":"Danielle Golovin","startTime":1453.819,"endTime":1457.956,"body":"different stages in the disease and"},{"speaker":"Danielle Golovin","startTime":1457.956,"endTime":1459.591,"body":"even in different parts of the brain."},{"speaker":"Danielle Golovin","startTime":1459.958,"endTime":1463.161,"body":"So this obviously matters for which"},{"speaker":"Danielle Golovin","startTime":1459.958,"endTime":1463.161,"body":"therapies are likely to show benefit"},{"speaker":"Simone Fishburn","startTime":1463.895,"endTime":1465.831,"body":"Danielle, fill"},{"speaker":"Simone Fishburn","startTime":1463.895,"endTime":1465.831,"body":"us in a little bit on what you"},{"speaker":"Simone Fishburn","startTime":1465.864,"endTime":1468.099,"body":"found across the brain regions"},{"speaker":"Danielle Golovin","startTime":1468.7,"endTime":1471.002,"body":"Yeah, so these"},{"speaker":"Danielle Golovin","startTime":1468.7,"endTime":1471.002,"body":"atlases kind of span all those"},{"speaker":"Danielle Golovin","startTime":1471.036,"endTime":1472.37,"body":"regions, which is really nice."},{"speaker":"Danielle Golovin","startTime":1472.37,"endTime":1475.407,"body":"So this is not longitudinal data"},{"speaker":"Danielle Golovin","startTime":1472.37,"endTime":1475.407,"body":"on a single patient, but it gives"},{"speaker":"Danielle Golovin","startTime":1475.407,"endTime":1478.677,"body":"us sort of a picture of along the"},{"speaker":"Danielle Golovin","startTime":1475.407,"endTime":1478.677,"body":"trajectory, what kind of things are"},{"speaker":"Danielle Golovin","startTime":1478.677,"endTime":1480.779,"body":"going on in the different regions."},{"speaker":"Danielle Golovin","startTime":1480.946,"endTime":1486.785,"body":"So in the substantia nigra atlas, which is"},{"speaker":"Danielle Golovin","startTime":1480.946,"endTime":1486.785,"body":"the classic region for dopaminergic neuron"},{"speaker":"Danielle Golovin","startTime":1486.785,"endTime":1492.023,"body":"loss early on in Parkinson's, it revealed"},{"speaker":"Danielle Golovin","startTime":1486.785,"endTime":1492.023,"body":"a concentrated inflammatory hotspot there."},{"speaker":"Danielle Golovin","startTime":1492.29,"endTime":1495.594,"body":"These were immune cells clustering"},{"speaker":"Danielle Golovin","startTime":1492.29,"endTime":1495.594,"body":"around the stressed support cells"},{"speaker":"Danielle Golovin","startTime":1495.594,"endTime":1497.829,"body":"that carry a marker called CD44."},{"speaker":"Danielle Golovin","startTime":1498.33,"endTime":1502.534,"body":"And the scientists actually did an"},{"speaker":"Danielle Golovin","startTime":1498.33,"endTime":1502.534,"body":"experiment and dialed down CD44 in"},{"speaker":"Danielle Golovin","startTime":1502.567,"endTime":1504.536,"body":"models, and that calmed down the hotspot."},{"speaker":"Danielle Golovin","startTime":1504.903,"endTime":1507.772,"body":"For me, that begged the question, what"},{"speaker":"Danielle Golovin","startTime":1504.903,"endTime":1507.772,"body":"does this mean for the cell therapies"},{"speaker":"Danielle Golovin","startTime":1507.772,"endTime":1509.441,"body":"that Lindsay highlighted in her deck?"},{"speaker":"Danielle Golovin","startTime":1509.674,"endTime":1512.477,"body":"The cell therapies that are in the"},{"speaker":"Danielle Golovin","startTime":1509.674,"endTime":1512.477,"body":"clinic, companies are implanting"},{"speaker":"Danielle Golovin","startTime":1512.477,"endTime":1517.983,"body":"dopaminergic precursor cells into"},{"speaker":"Danielle Golovin","startTime":1512.477,"endTime":1517.983,"body":"the putamen and expecting them to"},{"speaker":"Danielle Golovin","startTime":1517.983,"endTime":1522.053,"body":"migrate to the substantia nigra"},{"speaker":"Danielle Golovin","startTime":1517.983,"endTime":1522.053,"body":"to restore dopaminergic signaling."},{"speaker":"Danielle Golovin","startTime":1522.521,"endTime":1525.056,"body":"And I'm like, what happens"},{"speaker":"Danielle Golovin","startTime":1522.521,"endTime":1525.056,"body":"when the cells arrive to this"},{"speaker":"Danielle Golovin","startTime":1525.056,"endTime":1527.192,"body":"inflamed pocket, if you will?"},{"speaker":"Danielle Golovin","startTime":1527.926,"endTime":1531.363,"body":"Do we just hope the new dopamine"},{"speaker":"Danielle Golovin","startTime":1527.926,"endTime":1531.363,"body":"cells can cope with that environment,"},{"speaker":"Danielle Golovin","startTime":1531.396,"endTime":1533.131,"body":"or does it affect them at all?"},{"speaker":"Danielle Golovin","startTime":1533.131,"endTime":1536.167,"body":"Do we eventually pair the cell"},{"speaker":"Danielle Golovin","startTime":1533.131,"endTime":1536.167,"body":"therapies with something that"},{"speaker":"Danielle Golovin","startTime":1536.167,"endTime":1537.302,"body":"can cool down the hotspot?"},{"speaker":"Danielle Golovin","startTime":1537.602,"endTime":1541.406,"body":"Like, maybe we need to add a"},{"speaker":"Danielle Golovin","startTime":1537.602,"endTime":1541.406,"body":"CD44-targeted drug with the"},{"speaker":"Danielle Golovin","startTime":1541.406,"endTime":1542.641,"body":"implantation of those neurons."},{"speaker":"Danielle Golovin","startTime":1542.707,"endTime":1546.411,"body":"I, I don't know if that's known, but"},{"speaker":"Danielle Golovin","startTime":1542.707,"endTime":1546.411,"body":"that's what came into my head when"},{"speaker":"Danielle Golovin","startTime":1546.778,"endTime":1548.513,"body":"connecting, you know, those two stories."},{"speaker":"Danielle Golovin","startTime":1548.813,"endTime":1553.451,"body":"And by the time the pathology reaches"},{"speaker":"Danielle Golovin","startTime":1548.813,"endTime":1553.451,"body":"the temporal cortex, so this is sort"},{"speaker":"Danielle Golovin","startTime":1553.451,"endTime":1558.49,"body":"of early cortical involvement the"},{"speaker":"Danielle Golovin","startTime":1553.451,"endTime":1558.49,"body":"neurons there aren't dead or gone yet."},{"speaker":"Danielle Golovin","startTime":1558.523,"endTime":1559.791,"body":"They're just rewired."},{"speaker":"Danielle Golovin","startTime":1560.058,"endTime":1563.862,"body":"So the standout there was an excitatory"},{"speaker":"Danielle Golovin","startTime":1560.058,"endTime":1563.862,"body":"glutamatergic subset, which showed"},{"speaker":"Danielle Golovin","startTime":1564.396,"endTime":1570.802,"body":"robust alpha-synuclein overexpression"},{"speaker":"Danielle Golovin","startTime":1564.396,"endTime":1570.802,"body":"and a concurrent 4,000 differentially"},{"speaker":"Danielle Golovin","startTime":1570.802,"endTime":1573.939,"body":"expressed genes, even though the-- So"},{"speaker":"Danielle Golovin","startTime":1570.802,"endTime":1573.939,"body":"the neurons are still there, right?"},{"speaker":"Danielle Golovin","startTime":1573.939,"endTime":1577.275,"body":"The, the cyto architecture is"},{"speaker":"Danielle Golovin","startTime":1573.939,"endTime":1577.275,"body":"preserved, so it looks kind of like a"},{"speaker":"Danielle Golovin","startTime":1577.309,"endTime":1581.98,"body":"stressed or maybe a circuit remodeling"},{"speaker":"Danielle Golovin","startTime":1577.309,"endTime":1581.98,"body":"picture maybe before the neuron loss."},{"speaker":"Danielle Golovin","startTime":1582.581,"endTime":1587.319,"body":"And then when we look late in the disease,"},{"speaker":"Danielle Golovin","startTime":1582.581,"endTime":1587.319,"body":"so the prefrontal cortex, typically a"},{"speaker":"Danielle Golovin","startTime":1587.319,"endTime":1592.691,"body":"late disease stage,  we find glia and"},{"speaker":"Danielle Golovin","startTime":1587.319,"endTime":1592.691,"body":"resident immune cells dominate, and the"},{"speaker":"Danielle Golovin","startTime":1593.058,"endTime":1596.494,"body":"neuronal stress response and protein"},{"speaker":"Danielle Golovin","startTime":1593.058,"endTime":1596.494,"body":"folding pathways are dialed down, so you"},{"speaker":"Danielle Golovin","startTime":1596.494,"endTime":1600.966,"body":"just get this massive proteostasis failure"},{"speaker":"Danielle Golovin","startTime":1596.494,"endTime":1600.966,"body":"I would say overall, you see a common"},{"speaker":"Danielle Golovin","startTime":1600.966,"endTime":1604.669,"body":"thread of lysosomal stress, inflammation"},{"speaker":"Danielle Golovin","startTime":1600.966,"endTime":1604.669,"body":"weaving through the different stages."},{"speaker":"Danielle Golovin","startTime":1604.669,"endTime":1608.073,"body":"And one of the most interesting"},{"speaker":"Danielle Golovin","startTime":1604.669,"endTime":1608.073,"body":"signals that seems to run across the"},{"speaker":"Danielle Golovin","startTime":1608.073,"endTime":1611.142,"body":"stages is a protein called galectin-3."},{"speaker":"Danielle Golovin","startTime":1611.142,"endTime":1613.812,"body":"And this brings us back to one"},{"speaker":"Danielle Golovin","startTime":1611.142,"endTime":1613.812,"body":"of the big themes last week from"},{"speaker":"Danielle Golovin","startTime":1613.812,"endTime":1617.749,"body":"Lindsay's analysis of lysosomal"},{"speaker":"Danielle Golovin","startTime":1613.812,"endTime":1617.749,"body":"dysfunction and neuroinflammation as"},{"speaker":"Danielle Golovin","startTime":1617.749,"endTime":1619.351,"body":"the next frontier beyond dopamine."},{"speaker":"Danielle Golovin","startTime":1619.351,"endTime":1624.089,"body":"And genetic and protein data"},{"speaker":"Danielle Golovin","startTime":1619.351,"endTime":1624.089,"body":"point to higher galectin-3 as"},{"speaker":"Danielle Golovin","startTime":1624.089,"endTime":1625.824,"body":"increasing Parkinson's risk."},{"speaker":"Danielle Golovin","startTime":1626.458,"endTime":1631.83,"body":"And interestingly, lab work, like prior"},{"speaker":"Danielle Golovin","startTime":1626.458,"endTime":1631.83,"body":"lab work, suggests that it helps to leak"},{"speaker":"Danielle Golovin","startTime":1632.063,"endTime":1634.532,"body":"alpha-synuclein out of damaged lysosomes."},{"speaker":"Danielle Golovin","startTime":1634.666,"endTime":1637.602,"body":"And once those are out,"},{"speaker":"Danielle Golovin","startTime":1634.666,"endTime":1637.602,"body":"it revs up the microglia."},{"speaker":"Danielle Golovin","startTime":1638.136,"endTime":1641.74,"body":"I see this as a potential, like,"},{"speaker":"Danielle Golovin","startTime":1638.136,"endTime":1641.74,"body":"knob you could mess with for"},{"speaker":"Danielle Golovin","startTime":1641.74,"endTime":1643.441,"body":"synuclein-driven inflammation."},{"speaker":"Danielle Golovin","startTime":1644.009,"endTime":1648.78,"body":"And interestingly, when I went"},{"speaker":"Danielle Golovin","startTime":1644.009,"endTime":1648.78,"body":"to BCIQ, I saw that there is"},{"speaker":"Danielle Golovin","startTime":1648.78,"endTime":1652.951,"body":"one company testing an antibody"},{"speaker":"Danielle Golovin","startTime":1648.78,"endTime":1652.951,"body":"against galectin-3 in Parkinson's."},{"speaker":"Danielle Golovin","startTime":1653.018,"endTime":1656.855,"body":"So this company, TrueBinding, has"},{"speaker":"Danielle Golovin","startTime":1653.018,"endTime":1656.855,"body":"the only galectin-3 targeted therapy"},{"speaker":"Danielle Golovin","startTime":1656.855,"endTime":1658.757,"body":"in development for Parkinson's."},{"speaker":"Danielle Golovin","startTime":1658.757,"endTime":1661.326,"body":"It's called TB006, and it's in Phase II"},{"speaker":"Simone Fishburn","startTime":1662.46,"endTime":1663.495,"body":"Two things I would say."},{"speaker":"Simone Fishburn","startTime":1663.528,"endTime":1666.798,"body":"One is the moral of the"},{"speaker":"Simone Fishburn","startTime":1663.528,"endTime":1666.798,"body":"story is always go to BCIQ."},{"speaker":"Danielle Golovin","startTime":1667.232,"endTime":1669.2,"body":"Yeah, exactly"},{"speaker":"Jeff Cranmer","startTime":1669.434,"endTime":1673.271,"body":"And, and BCIQ, of"},{"speaker":"Jeff Cranmer","startTime":1669.434,"endTime":1673.271,"body":"course BioCentury's database,"},{"speaker":"Jeff Cranmer","startTime":1673.471,"endTime":1678.276,"body":"hundreds of companies, thousands and"},{"speaker":"Jeff Cranmer","startTime":1673.471,"endTime":1678.276,"body":"thousands of targets uh thousands"},{"speaker":"Jeff Cranmer","startTime":1678.276,"endTime":1680.345,"body":"of programs, great for drug hunters"},{"speaker":"Simone Fishburn","startTime":1681.346,"endTime":1683.415,"body":"And financing and"},{"speaker":"Simone Fishburn","startTime":1681.346,"endTime":1683.415,"body":"all the rest of it, you're right,"},{"speaker":"Simone Fishburn","startTime":1683.415,"endTime":1683.748,"body":"Jeff."},{"speaker":"Simone Fishburn","startTime":1683.782,"endTime":1687.852,"body":"And so a- actually that's sort of the"},{"speaker":"Simone Fishburn","startTime":1683.782,"endTime":1687.852,"body":"other thing I wanted to say is that"},{"speaker":"Simone Fishburn","startTime":1687.886,"endTime":1691.956,"body":"for me, you know, I started out very"},{"speaker":"Simone Fishburn","startTime":1687.886,"endTime":1691.956,"body":"early on in the, you know, my PhDs"},{"speaker":"Simone Fishburn","startTime":1691.956,"endTime":1695.193,"body":"in dopamine receptors and some of"},{"speaker":"Simone Fishburn","startTime":1691.956,"endTime":1695.193,"body":"the questions you raised, Danielle,"},{"speaker":"Simone Fishburn","startTime":1695.193,"endTime":1698.363,"body":"have been around for a long time when"},{"speaker":"Simone Fishburn","startTime":1695.193,"endTime":1698.363,"body":"they've for a long time wanted to do"},{"speaker":"Simone Fishburn","startTime":1698.363,"endTime":1701.032,"body":"implants and the question was, \"Well,"},{"speaker":"Simone Fishburn","startTime":1698.363,"endTime":1701.032,"body":"what happens when they get there?"},{"speaker":"Simone Fishburn","startTime":1701.032,"endTime":1701.399,"body":"Will they know"},{"speaker":"Simone Fishburn","startTime":1701.399,"endTime":1705.737,"body":"when to stop growing, and will they"},{"speaker":"Simone Fishburn","startTime":1701.399,"endTime":1705.737,"body":"connect?\" but it really does seem like"},{"speaker":"Simone Fishburn","startTime":1705.77,"endTime":1710.208,"body":"even though the questions have been around"},{"speaker":"Simone Fishburn","startTime":1705.77,"endTime":1710.208,"body":"a long time, it really seems to be that"},{"speaker":"Simone Fishburn","startTime":1710.208,"endTime":1715.413,"body":"the biology is now unfolding to answer"},{"speaker":"Simone Fishburn","startTime":1710.208,"endTime":1715.413,"body":"them at a completely different pace."},{"speaker":"Simone Fishburn","startTime":1715.447,"endTime":1719.751,"body":"And so things like these atlases turn"},{"speaker":"Simone Fishburn","startTime":1715.447,"endTime":1719.751,"body":"out to be incredibly powerful for both"},{"speaker":"Simone Fishburn","startTime":1719.751,"endTime":1724.622,"body":"uncovering mechanisms and pathways,"},{"speaker":"Simone Fishburn","startTime":1719.751,"endTime":1724.622,"body":"finding synergies and like you talked"},{"speaker":"Simone Fishburn","startTime":1724.622,"endTime":1728.093,"body":"about, like making sense, like you talked"},{"speaker":"Simone Fishburn","startTime":1724.622,"endTime":1728.093,"body":"about the lysosomal deg- degration."},{"speaker":"Simone Fishburn","startTime":1728.093,"endTime":1731.83,"body":"So sort of basically making sense"},{"speaker":"Simone Fishburn","startTime":1728.093,"endTime":1731.83,"body":"of some of the observations that"},{"speaker":"Simone Fishburn","startTime":1731.83,"endTime":1733.131,"body":"people have had over these years."},{"speaker":"Simone Fishburn","startTime":1733.465,"endTime":1736.334,"body":"Seems to be a very exciting time"},{"speaker":"Simone Fishburn","startTime":1733.465,"endTime":1736.334,"body":"in translation in Parkinson's"},{"speaker":"Danielle Golovin","startTime":1737.001,"endTime":1737.936,"body":"Totally agree."},{"speaker":"Danielle Golovin","startTime":1737.969,"endTime":1740.705,"body":"It's like, well, we know all these"},{"speaker":"Danielle Golovin","startTime":1737.969,"endTime":1740.705,"body":"targets, so why do we need these atlases?"},{"speaker":"Danielle Golovin","startTime":1740.705,"endTime":1743.041,"body":"Like, even if we know the targets"},{"speaker":"Danielle Golovin","startTime":1740.705,"endTime":1743.041,"body":"already, well, this is giving"},{"speaker":"Danielle Golovin","startTime":1743.041,"endTime":1744.542,"body":"us information beyond that."},{"speaker":"Danielle Golovin","startTime":1744.676,"endTime":1748.213,"body":"And as Lindsay said in the, in"},{"speaker":"Danielle Golovin","startTime":1744.676,"endTime":1748.213,"body":"the back end of her deck, like,"},{"speaker":"Danielle Golovin","startTime":1748.58,"endTime":1751.382,"body":"biomarkers are gonna be very"},{"speaker":"Danielle Golovin","startTime":1748.58,"endTime":1751.382,"body":"important to stratify patients."},{"speaker":"Simone Fishburn","startTime":1751.449,"endTime":1753.318,"body":"Tune in for"},{"speaker":"Simone Fishburn","startTime":1751.449,"endTime":1753.318,"body":"the next deck kind of thing."},{"speaker":"Simone Fishburn","startTime":1753.418,"endTime":1753.618,"body":"Yes."},{"speaker":"Danielle Golovin","startTime":1754.185,"endTime":1756.588,"body":"And she mentioned"},{"speaker":"Danielle Golovin","startTime":1754.185,"endTime":1756.588,"body":"this group of patients that, you"},{"speaker":"Danielle Golovin","startTime":1756.588,"endTime":1761.459,"body":"know, look like LRRK2 patients, but"},{"speaker":"Danielle Golovin","startTime":1756.588,"endTime":1761.459,"body":"they don't have the LRRK2 variants."},{"speaker":"Danielle Golovin","startTime":1761.693,"endTime":1765.73,"body":"I think just the moral of this atlas story"},{"speaker":"Danielle Golovin","startTime":1761.693,"endTime":1765.73,"body":"is that future biomarkers will need to"},{"speaker":"Danielle Golovin","startTime":1765.73,"endTime":1770.368,"body":"go beyond genetics and not just do you"},{"speaker":"Danielle Golovin","startTime":1765.73,"endTime":1770.368,"body":"have this variant or not, but capture"},{"speaker":"Danielle Golovin","startTime":1770.368,"endTime":1774.372,"body":"whether these pathways are switched"},{"speaker":"Danielle Golovin","startTime":1770.368,"endTime":1774.372,"body":"on in the vulnerable cell types at the"},{"speaker":"Danielle Golovin","startTime":1774.405,"endTime":1776.107,"body":"stage of disease that the patient is at"},{"speaker":"Simone Fishburn","startTime":1776.608,"endTime":1776.908,"body":"Totally"},{"speaker":"Jeff Cranmer","startTime":1777.542,"endTime":1777.942,"body":"All right."},{"speaker":"Jeff Cranmer","startTime":1777.942,"endTime":1779.377,"body":"Thanks for that, Danielle."},{"speaker":"Jeff Cranmer","startTime":1779.677,"endTime":1785.383,"body":"let's turn back to Washington, where"},{"speaker":"Jeff Cranmer","startTime":1779.677,"endTime":1785.383,"body":"the House Select Committee on China has"},{"speaker":"Jeff Cranmer","startTime":1785.383,"endTime":1793.358,"body":"revived and expanded its probe into US"},{"speaker":"Jeff Cranmer","startTime":1785.383,"endTime":1793.358,"body":"drug makers' clinical trials in China."},{"speaker":"Jeff Cranmer","startTime":1793.758,"endTime":1798.463,"body":"It's a move that's consistent"},{"speaker":"Jeff Cranmer","startTime":1793.758,"endTime":1798.463,"body":"with broader congressional concern"},{"speaker":"Jeff Cranmer","startTime":1798.696,"endTime":1801.166,"body":"about Chinese clinical trials."},{"speaker":"Jeff Cranmer","startTime":1801.166,"endTime":1806.971,"body":"Steve, you've been following all of these"},{"speaker":"Jeff Cranmer","startTime":1801.166,"endTime":1806.971,"body":"moves that we've been seeing in Congress."},{"speaker":"Jeff Cranmer","startTime":1807.071,"endTime":1808.373,"body":"what's your thoughts on this one?"},{"speaker":"Steve Usdin","startTime":1808.94,"endTime":1810.008,"body":"Yeah, so this was a letter."},{"speaker":"Steve Usdin","startTime":1810.008,"endTime":1814.012,"body":"It was sent to AbbVie, to Bristol Myers"},{"speaker":"Steve Usdin","startTime":1810.008,"endTime":1814.012,"body":"Squibb, Eli Lilly, Merck, and Pfizer."},{"speaker":"Steve Usdin","startTime":1814.279,"endTime":1819.384,"body":"it repeated the concerns that the"},{"speaker":"Steve Usdin","startTime":1814.279,"endTime":1819.384,"body":"committee expressed in, in prior"},{"speaker":"Steve Usdin","startTime":1819.384,"endTime":1824.789,"body":"letters to those companies about trials"},{"speaker":"Steve Usdin","startTime":1819.384,"endTime":1824.789,"body":"conducted at PLA hospitals in China and"},{"speaker":"Steve Usdin","startTime":1824.789,"endTime":1827.425,"body":"Xinjiang, but it added a new concern."},{"speaker":"Steve Usdin","startTime":1827.425,"endTime":1831.362,"body":"It talked about informed consent"},{"speaker":"Steve Usdin","startTime":1827.425,"endTime":1831.362,"body":"and made allegations that informed"},{"speaker":"Steve Usdin","startTime":1831.362,"endTime":1835.4,"body":"consent in China doesn't meet US"},{"speaker":"Steve Usdin","startTime":1831.362,"endTime":1835.4,"body":"standards or global standards."},{"speaker":"Steve Usdin","startTime":1835.767,"endTime":1840.939,"body":"The letters asked the companies for"},{"speaker":"Steve Usdin","startTime":1835.767,"endTime":1840.939,"body":"their due diligence policies for all the"},{"speaker":"Steve Usdin","startTime":1841.039,"endTime":1844.509,"body":"uh data on all the trials that they've"},{"speaker":"Steve Usdin","startTime":1841.039,"endTime":1844.509,"body":"conducted in China since twenty fifteen,"},{"speaker":"Steve Usdin","startTime":1844.976,"endTime":1850.181,"body":"site inspection reports IP protection"},{"speaker":"Steve Usdin","startTime":1844.976,"endTime":1850.181,"body":"processes all kinds of, all kinds of other"},{"speaker":"Steve Usdin","startTime":1850.181,"endTime":1851.583,"body":"data that they're trying to get from them."},{"speaker":"Steve Usdin","startTime":1851.983,"endTime":1857.055,"body":"But the thing is that the allegations"},{"speaker":"Steve Usdin","startTime":1851.983,"endTime":1857.055,"body":"about informed consent were really"},{"speaker":"Steve Usdin","startTime":1857.055,"endTime":1860.158,"body":"based, I think, on a very thin substrate."},{"speaker":"Steve Usdin","startTime":1860.491,"endTime":1861.726,"body":"And I think this is important."},{"speaker":"Steve Usdin","startTime":1861.893,"endTime":1865.563,"body":"So the committee's suggesting that"},{"speaker":"Steve Usdin","startTime":1861.893,"endTime":1865.563,"body":"policies that would have an enormous"},{"speaker":"Steve Usdin","startTime":1865.563,"endTime":1869.767,"body":"impact on patients in the US, basically"},{"speaker":"Steve Usdin","startTime":1865.563,"endTime":1869.767,"body":"what they're, they're trying to support,"},{"speaker":"Steve Usdin","startTime":1869.767,"endTime":1874.172,"body":"I think is what other congressional"},{"speaker":"Steve Usdin","startTime":1869.767,"endTime":1874.172,"body":"committees have advocated and what some"},{"speaker":"Steve Usdin","startTime":1874.172,"endTime":1878.676,"body":"prominent VCs have advocated, which"},{"speaker":"Steve Usdin","startTime":1874.172,"endTime":1878.676,"body":"is that FDA wouldn't accept Chinese"},{"speaker":"Steve Usdin","startTime":1878.71,"endTime":1881.479,"body":"clinical data to support IND applications."},{"speaker":"Steve Usdin","startTime":1882.08,"endTime":1885.717,"body":"They're trying to do that based on"},{"speaker":"Steve Usdin","startTime":1882.08,"endTime":1885.717,"body":"very, as I said, a very thin uh dataset."},{"speaker":"Steve Usdin","startTime":1885.717,"endTime":1892.123,"body":"So the data that's in the letter comes"},{"speaker":"Steve Usdin","startTime":1885.717,"endTime":1892.123,"body":"from a, a review article that discusses"},{"speaker":"Steve Usdin","startTime":1892.123,"endTime":1897.295,"body":"one survey of a hundred and seventy"},{"speaker":"Steve Usdin","startTime":1892.123,"endTime":1897.295,"body":"patients at a single Chinese hospital."},{"speaker":"Steve Usdin","startTime":1897.795,"endTime":1902.267,"body":"And the review article which is about"},{"speaker":"Steve Usdin","startTime":1897.795,"endTime":1902.267,"body":"Chinese informed consent practices warns"},{"speaker":"Steve Usdin","startTime":1902.267,"endTime":1904.068,"body":"against generalizing from that study."},{"speaker":"Steve Usdin","startTime":1904.302,"endTime":1909.34,"body":"And it also concludes that most of the"},{"speaker":"Steve Usdin","startTime":1904.302,"endTime":1909.34,"body":"documented problems of what's called"},{"speaker":"Steve Usdin","startTime":1909.34,"endTime":1912.777,"body":"therapeutic misconception, that's"},{"speaker":"Steve Usdin","startTime":1909.34,"endTime":1912.777,"body":"the confidence that patients have"},{"speaker":"Steve Usdin","startTime":1912.777,"endTime":1916.314,"body":"that an experimental treatment will"},{"speaker":"Steve Usdin","startTime":1912.777,"endTime":1916.314,"body":"be effective, poor understanding of"},{"speaker":"Steve Usdin","startTime":1916.314,"endTime":1921.019,"body":"alternatives to trial participation,"},{"speaker":"Steve Usdin","startTime":1916.314,"endTime":1921.019,"body":"that these issues mirror well-established"},{"speaker":"Steve Usdin","startTime":1921.019,"endTime":1923.354,"body":"shortcomings in Western clinical trials."},{"speaker":"Steve Usdin","startTime":1923.721,"endTime":1928.159,"body":"They're not unique to China, and in"},{"speaker":"Steve Usdin","startTime":1923.721,"endTime":1928.159,"body":"fact, even the magnitude that was found"},{"speaker":"Steve Usdin","startTime":1928.426,"endTime":1932.463,"body":"in this study of a hundred and seventy"},{"speaker":"Steve Usdin","startTime":1928.426,"endTime":1932.463,"body":"patients at a single Chinese hospital"},{"speaker":"Steve Usdin","startTime":1932.73,"endTime":1938.002,"body":"matches pretty well the results when"},{"speaker":"Steve Usdin","startTime":1932.73,"endTime":1938.002,"body":"um the same kind of issues have been"},{"speaker":"Steve Usdin","startTime":1938.002,"endTime":1943.007,"body":"looked at  in much bigger studies in"},{"speaker":"Steve Usdin","startTime":1938.002,"endTime":1943.007,"body":"the United States and Western Europe"},{"speaker":"Jeff Cranmer","startTime":1943.942,"endTime":1947.211,"body":"Steve obviously"},{"speaker":"Jeff Cranmer","startTime":1943.942,"endTime":1947.211,"body":"uh some big companies here"},{"speaker":"Jeff Cranmer","startTime":1947.245,"endTime":1950.381,"body":"from AbbVie to Merck, Lilly."},{"speaker":"Jeff Cranmer","startTime":1950.815,"endTime":1952.717,"body":"Uh, what have they been saying about this?"},{"speaker":"Steve Usdin","startTime":1953.051,"endTime":1954.285,"body":"I contacted all of them."},{"speaker":"Steve Usdin","startTime":1954.285,"endTime":1955.219,"body":"I reached out to them."},{"speaker":"Steve Usdin","startTime":1955.386,"endTime":1958.389,"body":"I only heard back  from a couple of them."},{"speaker":"Steve Usdin","startTime":1958.556,"endTime":1963.227,"body":"Merck  commented and said it, holds all"},{"speaker":"Steve Usdin","startTime":1958.556,"endTime":1963.227,"body":"of its trials around the world to the same"},{"speaker":"Steve Usdin","startTime":1963.227,"endTime":1968.866,"body":"ethical standards, that it follows ICH and"},{"speaker":"Steve Usdin","startTime":1963.227,"endTime":1968.866,"body":"PhRMA guidelines regardless of location."},{"speaker":"Steve Usdin","startTime":1969.334,"endTime":1973.371,"body":"the committee's letter to Pfizer"},{"speaker":"Steve Usdin","startTime":1969.334,"endTime":1973.371,"body":"noted that the company has already"},{"speaker":"Steve Usdin","startTime":1973.604,"endTime":1977.442,"body":"made a commitment to no longer"},{"speaker":"Steve Usdin","startTime":1973.604,"endTime":1977.442,"body":"sponsor trials in Xinjiang or at"},{"speaker":"Steve Usdin","startTime":1977.475,"endTime":1979.711,"body":"uh military hospitals in China."},{"speaker":"Steve Usdin","startTime":1979.944,"endTime":1982.613,"body":"Other companies basically"},{"speaker":"Steve Usdin","startTime":1979.944,"endTime":1982.613,"body":"sent me um no comment"},{"speaker":"Steve Usdin","startTime":1982.714,"endTime":1983.381,"body":"comments"},{"speaker":"Jeff Cranmer","startTime":1985.45,"endTime":1987.618,"body":"Alright well we'll"},{"speaker":"Jeff Cranmer","startTime":1985.45,"endTime":1987.618,"body":"continue to follow this uh along with"},{"speaker":"Jeff Cranmer","startTime":1987.618,"endTime":1990.288,"body":"other initiatives out of US and China."},{"speaker":"Jeff Cranmer","startTime":1990.488,"endTime":1995.46,"body":"and you can read Steve's story by"},{"speaker":"Jeff Cranmer","startTime":1990.488,"endTime":1995.46,"body":"clicking the link in the show notes."},{"speaker":"Jeff Cranmer","startTime":1995.46,"endTime":1999.197,"body":"If you like what you've been"},{"speaker":"Jeff Cranmer","startTime":1995.46,"endTime":1999.197,"body":"hearing uh subscribe to the"},{"speaker":"Jeff Cranmer","startTime":1999.197,"endTime":2001.165,"body":"BioCentury This Week podcast."},{"speaker":"Jeff Cranmer","startTime":2001.499,"endTime":2006.471,"body":"And coming up this week on our"},{"speaker":"Jeff Cranmer","startTime":2001.499,"endTime":2006.471,"body":"sister podcast, we will have the"},{"speaker":"Jeff Cranmer","startTime":2006.471,"endTime":2012.377,"body":"CEO of Roivant in conversation"},{"speaker":"Jeff Cranmer","startTime":2006.471,"endTime":2012.377,"body":"with our colleague Lindsay Martin."},{"speaker":"Jeff Cranmer","startTime":2012.677,"endTime":2016.481,"body":"thanks for tuning in, and thanks"},{"speaker":"Jeff Cranmer","startTime":2012.677,"endTime":2016.481,"body":"to Kendall Square Orchestra for"},{"speaker":"Jeff Cranmer","startTime":2016.481,"endTime":2018.983,"body":"providing the music for our podcast"},{"speaker":"Voice Talent","startTime":2019.984,"endTime":2022.72,"body":"BioCentury This"},{"speaker":"Voice Talent","startTime":2019.984,"endTime":2022.72,"body":"Week is brought to you by CBRE."}]}