{"version":"1.0.0","segments":[{"startTime":0.0,"endTime":2.002,"body":"[Auto-generated Transcript]"},{"speaker":"Stephen Hansen","startTime":2.002,"endTime":4.871,"body":"A deep dive"},{"speaker":"Stephen Hansen","startTime":2.002,"endTime":4.871,"body":"analysis shows new targets and cell"},{"speaker":"Stephen Hansen","startTime":4.871,"endTime":8.808,"body":"therapies for Parkinson's disease"},{"speaker":"Stephen Hansen","startTime":4.871,"endTime":8.808,"body":"that go beyond symptom control."},{"speaker":"Stephen Hansen","startTime":9.142,"endTime":14.447,"body":"Plus, AstraZeneca's build-out in obesity,"},{"speaker":"Stephen Hansen","startTime":9.142,"endTime":14.447,"body":"and FDA is hoping that a package of"},{"speaker":"Stephen Hansen","startTime":14.447,"endTime":18.752,"body":"reforms can cut the time required to"},{"speaker":"Stephen Hansen","startTime":14.447,"endTime":18.752,"body":"launch a clinical trial in the US."},{"speaker":"Stephen Hansen","startTime":19.119,"endTime":21.421,"body":"But will it meaningfully"},{"speaker":"Stephen Hansen","startTime":19.119,"endTime":21.421,"body":"close the gap with China?"},{"speaker":"Stephen Hansen","startTime":21.855,"endTime":25.291,"body":"The agency also appears to be"},{"speaker":"Stephen Hansen","startTime":21.855,"endTime":25.291,"body":"unwinding regulatory barriers"},{"speaker":"Stephen Hansen","startTime":25.291,"endTime":28.661,"body":"established under former Commissioner"},{"speaker":"Stephen Hansen","startTime":25.291,"endTime":28.661,"body":"Marty Makary's leadership."},{"speaker":"Stephen Hansen","startTime":28.995,"endTime":32.932,"body":"I'm Stephen Hansen, co-host of the"},{"speaker":"Stephen Hansen","startTime":28.995,"endTime":32.932,"body":"BioCentury This Week podcast, and"},{"speaker":"Stephen Hansen","startTime":32.932,"endTime":37.003,"body":"joining me today is our Washington"},{"speaker":"Stephen Hansen","startTime":32.932,"endTime":37.003,"body":"editor, Steve Usdin, our VP and"},{"speaker":"Stephen Hansen","startTime":37.003,"endTime":42.008,"body":"editor-in-chief, Simone Fishburn, and,"},{"speaker":"Stephen Hansen","startTime":37.003,"endTime":42.008,"body":"our biopharma analyst, Lindsay Martin."},{"speaker":"Stephen Hansen","startTime":42.308,"endTime":46.112,"body":"As you'll clearly recognize, our normal"},{"speaker":"Stephen Hansen","startTime":42.308,"endTime":46.112,"body":"host, Jeff Cranmer, is not here this week."},{"speaker":"Stephen Hansen","startTime":46.479,"endTime":50.55,"body":"I believe he's off on a beach"},{"speaker":"Stephen Hansen","startTime":46.479,"endTime":50.55,"body":"somewhere uh sipping on, what I'm"},{"speaker":"Stephen Hansen","startTime":50.55,"endTime":52.152,"body":"guessing are probably mai tais maybe."},{"speaker":"Stephen Hansen","startTime":52.185,"endTime":52.652,"body":"I don't know."},{"speaker":"Stephen Hansen","startTime":52.986,"endTime":56.489,"body":"Simone, what do you think Jeff's preferred"},{"speaker":"Stephen Hansen","startTime":52.986,"endTime":56.489,"body":"cocktail is for getting sunburned?"},{"speaker":"Simone Fishburn","startTime":57.023,"endTime":61.327,"body":"I think Jeff just"},{"speaker":"Simone Fishburn","startTime":57.023,"endTime":61.327,"body":"drinks whiskey all times of day actually."},{"speaker":"Stephen Hansen","startTime":62.195,"endTime":63.329,"body":"Regardless of location?"},{"speaker":"Stephen Hansen","startTime":63.363,"endTime":64.964,"body":"You think even on a beach he'll, uh…"},{"speaker":"Simone Fishburn","startTime":65.165,"endTime":68.334,"body":"Yeah, you know, truth"},{"speaker":"Simone Fishburn","startTime":65.165,"endTime":68.334,"body":"isn't subject to geography, so, you know"},{"speaker":"Stephen Hansen","startTime":69.536,"endTime":71.805,"body":"I think maybe that should"},{"speaker":"Stephen Hansen","startTime":69.536,"endTime":71.805,"body":"be the trivia question for next week."},{"speaker":"Stephen Hansen","startTime":71.871,"endTime":75.208,"body":"We can, we can all guess what is, what"},{"speaker":"Stephen Hansen","startTime":71.871,"endTime":75.208,"body":"is Jeff's favorite beach cocktail?"},{"speaker":"Stephen Hansen","startTime":75.542,"endTime":78.745,"body":"well at least there I've already, already"},{"speaker":"Stephen Hansen","startTime":75.542,"endTime":78.745,"body":"generated a bit of content for Jeff in"},{"speaker":"Stephen Hansen","startTime":78.745,"endTime":80.313,"body":"a, in a teaser for him when he returns."},{"speaker":"Stephen Hansen","startTime":80.38,"endTime":84.517,"body":"But um you know, in the meantime…"},{"speaker":"Stephen Hansen","startTime":80.38,"endTime":84.517,"body":"sorry, did you have a guess, Steve?"},{"speaker":"Stephen Hansen","startTime":84.517,"endTime":87.454,"body":"Did you wanna guess what you think"},{"speaker":"Stephen Hansen","startTime":84.517,"endTime":87.454,"body":"Jeff's uh preferred beach cocktail is?"},{"speaker":"Steve Usdin","startTime":88.221,"endTime":91.458,"body":"No, I think I, I, I've seen"},{"speaker":"Steve Usdin","startTime":88.221,"endTime":91.458,"body":"him drink a lot of different cocktails"},{"speaker":"Stephen Hansen","startTime":95.128,"endTime":95.462,"body":"All right."},{"speaker":"Simone Fishburn","startTime":95.528,"endTime":96.696,"body":"Could be"},{"speaker":"Simone Fishburn","startTime":95.528,"endTime":96.696,"body":"a paper plane, actually."},{"speaker":"Simone Fishburn","startTime":96.729,"endTime":97.297,"body":"I know he likes that."},{"speaker":"Simone Fishburn","startTime":97.43,"endTime":98.231,"body":"Anyway, let's get going"},{"speaker":"Stephen Hansen","startTime":98.698,"endTime":99.099,"body":"There we go."},{"speaker":"Stephen Hansen","startTime":99.132,"endTime":99.799,"body":"Let's get going."},{"speaker":"Stephen Hansen","startTime":100.1,"endTime":102.035,"body":"So we're gonna start off,  Lindsay."},{"speaker":"Stephen Hansen","startTime":102.068,"endTime":103.503,"body":"welcome back to the podcast."},{"speaker":"Stephen Hansen","startTime":103.536,"endTime":105.071,"body":"Uh, great to have you joining us again."},{"speaker":"Lindsay Martin","startTime":105.338,"endTime":106.072,"body":"Thanks, Stephen"},{"speaker":"Stephen Hansen","startTime":106.439,"endTime":109.742,"body":"you've dug deep into an"},{"speaker":"Stephen Hansen","startTime":106.439,"endTime":109.742,"body":"analysis of the landscape of therapies"},{"speaker":"Stephen Hansen","startTime":109.742,"endTime":112.779,"body":"and development for Parkinson's and"},{"speaker":"Stephen Hansen","startTime":109.742,"endTime":112.779,"body":"kinda how they're moving beyond this"},{"speaker":"Stephen Hansen","startTime":112.779,"endTime":114.481,"body":"historical focus on symptom control."},{"speaker":"Stephen Hansen","startTime":114.914,"endTime":118.084,"body":"but before we did dive in, you know,"},{"speaker":"Stephen Hansen","startTime":114.914,"endTime":118.084,"body":"I did wanna ask you whether you came"},{"speaker":"Stephen Hansen","startTime":118.084,"endTime":122.255,"body":"across a favorite new target or genetic"},{"speaker":"Stephen Hansen","startTime":118.084,"endTime":122.255,"body":"variant while putting this together."},{"speaker":"Stephen Hansen","startTime":122.255,"endTime":125.458,"body":"Was there, is there one name"},{"speaker":"Stephen Hansen","startTime":122.255,"endTime":125.458,"body":"that really, you know, stuck out"},{"speaker":"Stephen Hansen","startTime":125.458,"endTime":126.326,"body":"to you as being your favorite?"},{"speaker":"Lindsay Martin","startTime":126.86,"endTime":128.761,"body":"Yeah, I, I"},{"speaker":"Lindsay Martin","startTime":126.86,"endTime":128.761,"body":"think I do have a favorite."},{"speaker":"Lindsay Martin","startTime":128.962,"endTime":132.832,"body":"maybe, maybe I'm biased, but,"},{"speaker":"Lindsay Martin","startTime":128.962,"endTime":132.832,"body":"there are like over forty new"},{"speaker":"Lindsay Martin","startTime":132.832,"endTime":136.169,"body":"targets or potential first-in-class"},{"speaker":"Lindsay Martin","startTime":132.832,"endTime":136.169,"body":"targets in the clinic right now."},{"speaker":"Lindsay Martin","startTime":136.503,"endTime":141.407,"body":"A handful of these are genetic targets,"},{"speaker":"Lindsay Martin","startTime":136.503,"endTime":141.407,"body":"targeting factors that are rooted"},{"speaker":"Lindsay Martin","startTime":141.407,"endTime":147.547,"body":"in genetic variants that may cause"},{"speaker":"Lindsay Martin","startTime":141.407,"endTime":147.547,"body":"overactivation of kinases and, and things"},{"speaker":"Lindsay Martin","startTime":147.547,"endTime":152.585,"body":"like that that lead to accumulation"},{"speaker":"Lindsay Martin","startTime":147.547,"endTime":152.585,"body":"or aggregation of alpha-synuclein,"},{"speaker":"Lindsay Martin","startTime":152.619,"endTime":156.055,"body":"which is really the key driver of"},{"speaker":"Lindsay Martin","startTime":152.619,"endTime":156.055,"body":"Parkinson's disease, is having these"},{"speaker":"Lindsay Martin","startTime":156.456,"endTime":158.925,"body":"excess misfolded toxic proteins."},{"speaker":"Lindsay Martin","startTime":159.392,"endTime":162.629,"body":"But I think the one that really"},{"speaker":"Lindsay Martin","startTime":159.392,"endTime":162.629,"body":"stood out to me was LRRK2."},{"speaker":"Lindsay Martin","startTime":162.929,"endTime":168.034,"body":"And this kinase has had a bit of a,"},{"speaker":"Lindsay Martin","startTime":162.929,"endTime":168.034,"body":"a troubled past, I guess you could"},{"speaker":"Lindsay Martin","startTime":168.034,"endTime":172.372,"body":"say, in that this month it has seen"},{"speaker":"Lindsay Martin","startTime":168.034,"endTime":172.372,"body":"another failure  in May, Biogen"},{"speaker":"Lindsay Martin","startTime":172.372,"endTime":178.811,"body":"and Denali announced a Phase IIb"},{"speaker":"Lindsay Martin","startTime":172.372,"endTime":178.811,"body":"miss for LRRK2 in their LUMA study."},{"speaker":"Lindsay Martin","startTime":179.112,"endTime":183.95,"body":"But this study included Parkinson's"},{"speaker":"Lindsay Martin","startTime":179.112,"endTime":183.95,"body":"all-comers, so not just patients"},{"speaker":"Lindsay Martin","startTime":183.983,"endTime":185.919,"body":"with the genetic variant."},{"speaker":"Lindsay Martin","startTime":186.419,"endTime":190.056,"body":"And I think the target still"},{"speaker":"Lindsay Martin","startTime":186.419,"endTime":190.056,"body":"holds out hope in that there are"},{"speaker":"Lindsay Martin","startTime":190.056,"endTime":193.76,"body":"still patients that this target"},{"speaker":"Lindsay Martin","startTime":190.056,"endTime":193.76,"body":"could really work for potentially."},{"speaker":"Lindsay Martin","startTime":194.127,"endTime":197.33,"body":"and some of the other companies"},{"speaker":"Lindsay Martin","startTime":194.127,"endTime":197.33,"body":"that are pursuing this target are"},{"speaker":"Lindsay Martin","startTime":197.33,"endTime":202.569,"body":"pursuing ways to enrich the target"},{"speaker":"Lindsay Martin","startTime":197.33,"endTime":202.569,"body":"population or the patient population"},{"speaker":"Lindsay Martin","startTime":202.702,"endTime":205.972,"body":"to better achieve sufficient targeting."},{"speaker":"Lindsay Martin","startTime":206.372,"endTime":209.776,"body":"And I think that some of those"},{"speaker":"Lindsay Martin","startTime":206.372,"endTime":209.776,"body":"strategies might play out"},{"speaker":"Simone Fishburn","startTime":210.643,"endTime":213.78,"body":"So Lindsay um break"},{"speaker":"Simone Fishburn","startTime":210.643,"endTime":213.78,"body":"this down a little bit because LRRK2,"},{"speaker":"Simone Fishburn","startTime":213.813,"endTime":219.252,"body":"also a good name, L-R-R-K-2, has been"},{"speaker":"Simone Fishburn","startTime":213.813,"endTime":219.252,"body":"around in Parkinson's for a while,"},{"speaker":"Simone Fishburn","startTime":219.252,"endTime":221.955,"body":"and you know, obviously because"},{"speaker":"Simone Fishburn","startTime":219.252,"endTime":221.955,"body":"we've got clinical data coming out."},{"speaker":"Simone Fishburn","startTime":222.355,"endTime":226.793,"body":"So just sort of for those who are"},{"speaker":"Simone Fishburn","startTime":222.355,"endTime":226.793,"body":"not in the field or refreshers maybe"},{"speaker":"Simone Fishburn","startTime":226.793,"endTime":230.964,"body":"for those who are peripheral in the"},{"speaker":"Simone Fishburn","startTime":226.793,"endTime":230.964,"body":"field, explain how this kinase works"},{"speaker":"Simone Fishburn","startTime":230.964,"endTime":233.199,"body":"and how that relates to the pathology."},{"speaker":"Simone Fishburn","startTime":233.666,"endTime":239.138,"body":"I think it's still not clear"},{"speaker":"Simone Fishburn","startTime":233.666,"endTime":239.138,"body":"to me why it's taken until now."},{"speaker":"Simone Fishburn","startTime":239.138,"endTime":241.674,"body":"Like, what's gone wrong"},{"speaker":"Simone Fishburn","startTime":239.138,"endTime":241.674,"body":"and what's different now?"},{"speaker":"Simone Fishburn","startTime":241.674,"endTime":245.812,"body":"Is it like a segmenting of the population"},{"speaker":"Simone Fishburn","startTime":241.674,"endTime":245.812,"body":"that is the reason you're still bullish?"},{"speaker":"Simone Fishburn","startTime":245.812,"endTime":249.515,"body":"You're, you're still buying"},{"speaker":"Simone Fishburn","startTime":245.812,"endTime":249.515,"body":"LRRK2, as it were, in terms of"},{"speaker":"Simone Fishburn","startTime":249.515,"endTime":251.684,"body":"your, your target stock picks"},{"speaker":"Lindsay Martin","startTime":251.951,"endTime":252.752,"body":"Yeah, yeah."},{"speaker":"Lindsay Martin","startTime":252.752,"endTime":256.789,"body":"I think so the t-the"},{"speaker":"Lindsay Martin","startTime":252.752,"endTime":256.789,"body":"target itself is a kinase."},{"speaker":"Lindsay Martin","startTime":257.023,"endTime":262.462,"body":"well, it really has three functions, but"},{"speaker":"Lindsay Martin","startTime":257.023,"endTime":262.462,"body":"the main function of the protein is its"},{"speaker":"Lindsay Martin","startTime":262.495,"endTime":267.9,"body":"kinase function, and that leads to… or"},{"speaker":"Lindsay Martin","startTime":262.495,"endTime":267.9,"body":"patients that have LRRK2 genetic variants"},{"speaker":"Lindsay Martin","startTime":268.234,"endTime":270.77,"body":"end up having overactive kinase signaling."},{"speaker":"Lindsay Martin","startTime":271.237,"endTime":275.642,"body":"And this leads to excess phosphorylation"},{"speaker":"Lindsay Martin","startTime":271.237,"endTime":275.642,"body":"of the kinase's downstream"},{"speaker":"Lindsay Martin","startTime":275.675,"endTime":279.012,"body":"target, which is Rab GTPases."},{"speaker":"Lindsay Martin","startTime":279.012,"endTime":283.283,"body":"And then this impairs the brain's"},{"speaker":"Lindsay Martin","startTime":279.012,"endTime":283.283,"body":"ability to clear waste, and,"},{"speaker":"Lindsay Martin","startTime":283.349,"endTime":287.487,"body":"and that itself can lead to"},{"speaker":"Lindsay Martin","startTime":283.349,"endTime":287.487,"body":"accumulation of the alpha-synuclein"},{"speaker":"Lindsay Martin","startTime":287.487,"endTime":288.788,"body":"and, like, toxic aggregation."},{"speaker":"Lindsay Martin","startTime":289.322,"endTime":295.061,"body":"So having this genetic variant really"},{"speaker":"Lindsay Martin","startTime":289.322,"endTime":295.061,"body":"just predisposes the patients to having"},{"speaker":"Lindsay Martin","startTime":295.128,"endTime":300.066,"body":"an inability to clear waste in the brain,"},{"speaker":"Lindsay Martin","startTime":295.128,"endTime":300.066,"body":"and that leads to the downstream effects."},{"speaker":"Lindsay Martin","startTime":300.566,"endTime":304.804,"body":"Really the thing now is having"},{"speaker":"Lindsay Martin","startTime":300.566,"endTime":304.804,"body":"patient stratification will be a key"},{"speaker":"Lindsay Martin","startTime":304.937,"endTime":306.673,"body":"in order to see a difference, right?"},{"speaker":"Lindsay Martin","startTime":306.673,"endTime":310.71,"body":"So, like, previous trials that have"},{"speaker":"Lindsay Martin","startTime":306.673,"endTime":310.71,"body":"looked at all comers had patients"},{"speaker":"Lindsay Martin","startTime":310.71,"endTime":312.679,"body":"with and without the genetic variant."},{"speaker":"Lindsay Martin","startTime":313.179,"endTime":318.518,"body":"And then other strategies that I'm"},{"speaker":"Lindsay Martin","startTime":313.179,"endTime":318.518,"body":"more optimistic about are enriching for"},{"speaker":"Lindsay Martin","startTime":318.618,"endTime":324.824,"body":"patients that have the genetic variant or"},{"speaker":"Lindsay Martin","startTime":318.618,"endTime":324.824,"body":"go one step further identifying patients"},{"speaker":"Lindsay Martin","startTime":324.824,"endTime":330.73,"body":"that maybe don't have the genetic variant"},{"speaker":"Lindsay Martin","startTime":324.824,"endTime":330.73,"body":"but have a similar genetic profile to"},{"speaker":"Lindsay Martin","startTime":330.73,"endTime":332.632,"body":"those that do have the genetic variant."},{"speaker":"Lindsay Martin","startTime":332.999,"endTime":340.84,"body":"So for example, is using SNPs or small"},{"speaker":"Lindsay Martin","startTime":332.999,"endTime":340.84,"body":"regions within the genome to identify"},{"speaker":"Lindsay Martin","startTime":340.873,"endTime":345.678,"body":"patients that look like those LRRK2"},{"speaker":"Lindsay Martin","startTime":340.873,"endTime":345.678,"body":"patients, even if they're not necessarily"},{"speaker":"Lindsay Martin","startTime":346.079,"endTime":348.047,"body":"genetically having that variant."},{"speaker":"Lindsay Martin","startTime":348.314,"endTime":353.252,"body":"in doing so, they can identify a broader"},{"speaker":"Lindsay Martin","startTime":348.314,"endTime":353.252,"body":"population, so about thirty percent"},{"speaker":"Lindsay Martin","startTime":353.286,"endTime":357.657,"body":"of the population with Parkinson's"},{"speaker":"Lindsay Martin","startTime":353.286,"endTime":357.657,"body":"rather than the small percentage"},{"speaker":"Lindsay Martin","startTime":357.99,"endTime":361.661,"body":"less than, you know, five percent"},{"speaker":"Lindsay Martin","startTime":357.99,"endTime":361.661,"body":"that have the true genetic variant."},{"speaker":"Lindsay Martin","startTime":362.028,"endTime":369.969,"body":"And so I think now being able to um enrich"},{"speaker":"Lindsay Martin","startTime":362.028,"endTime":369.969,"body":"for patients that maybe, you know, don't"},{"speaker":"Lindsay Martin","startTime":369.969,"endTime":373.773,"body":"necessarily have the genetic variant"},{"speaker":"Lindsay Martin","startTime":369.969,"endTime":373.773,"body":"but could still be treated well by this"},{"speaker":"Lindsay Martin","startTime":373.806,"endTime":376.943,"body":"type of therapy is a more powerful move."},{"speaker":"Lindsay Martin","startTime":376.943,"endTime":379.579,"body":"And so that's why I'm more"},{"speaker":"Lindsay Martin","startTime":376.943,"endTime":379.579,"body":"optimistic about the target now"},{"speaker":"Simone Fishburn","startTime":380.113,"endTime":381.748,"body":"You know, one"},{"speaker":"Simone Fishburn","startTime":380.113,"endTime":381.748,"body":"more quick question on this."},{"speaker":"Simone Fishburn","startTime":381.748,"endTime":387.186,"body":"So you know, with this particular"},{"speaker":"Simone Fishburn","startTime":381.748,"endTime":387.186,"body":"mutation, first of all, do you see early"},{"speaker":"Simone Fishburn","startTime":387.186,"endTime":391.491,"body":"onset Parkinson's or is it something"},{"speaker":"Simone Fishburn","startTime":387.186,"endTime":391.491,"body":"that accumulates, you know, the damage"},{"speaker":"Simone Fishburn","startTime":391.491,"endTime":395.561,"body":"accumulates over time, which is, is"},{"speaker":"Simone Fishburn","startTime":391.491,"endTime":395.561,"body":"there sort of an age component to this?"},{"speaker":"Simone Fishburn","startTime":395.995,"endTime":401.1,"body":"And then the SNPs, you know, you talk"},{"speaker":"Simone Fishburn","startTime":395.995,"endTime":401.1,"body":"about the profile even in patients"},{"speaker":"Simone Fishburn","startTime":401.1,"endTime":403.336,"body":"who don't have LRRK mutations."},{"speaker":"Simone Fishburn","startTime":403.77,"endTime":410.243,"body":"So maybe You could talk a little bit about"},{"speaker":"Simone Fishburn","startTime":403.77,"endTime":410.243,"body":"how that pathology looks and if that's"},{"speaker":"Simone Fishburn","startTime":410.243,"endTime":414.614,"body":"being used to segregate patients or um"},{"speaker":"Simone Fishburn","startTime":410.243,"endTime":414.614,"body":"stratify, it's a better word, the patients"},{"speaker":"Lindsay Martin","startTime":414.881,"endTime":415.314,"body":"Yeah."},{"speaker":"Lindsay Martin","startTime":415.314,"endTime":419.886,"body":"So, okay, so your first question, can"},{"speaker":"Lindsay Martin","startTime":415.314,"endTime":419.886,"body":"this be used in early-onset Parkinson's?"},{"speaker":"Simone Fishburn","startTime":420.219,"endTime":421.854,"body":"No, that's"},{"speaker":"Simone Fishburn","startTime":420.219,"endTime":421.854,"body":"not actually… I'm sort of"},{"speaker":"Simone Fishburn","startTime":421.854,"endTime":425.491,"body":"saying why, you know, you have"},{"speaker":"Simone Fishburn","startTime":421.854,"endTime":425.491,"body":"the mutation from birth, right?"},{"speaker":"Simone Fishburn","startTime":425.625,"endTime":429.228,"body":"It's a congenital mutation rather"},{"speaker":"Simone Fishburn","startTime":425.625,"endTime":429.228,"body":"than one that's acquired, I assume."},{"speaker":"Simone Fishburn","startTime":429.395,"endTime":429.662,"body":"Right?"},{"speaker":"Simone Fishburn","startTime":429.729,"endTime":435.067,"body":"And so is it that the accumulation"},{"speaker":"Simone Fishburn","startTime":429.729,"endTime":435.067,"body":"of toxins sort of, you know, happens"},{"speaker":"Simone Fishburn","startTime":435.201,"endTime":439.305,"body":"over decades and it sort of in"},{"speaker":"Simone Fishburn","startTime":435.201,"endTime":439.305,"body":"your later years, or are there"},{"speaker":"Simone Fishburn","startTime":439.639,"endTime":443.776,"body":"other factors that sort of trigger"},{"speaker":"Simone Fishburn","startTime":439.639,"endTime":443.776,"body":"this as, as people get older?"},{"speaker":"Lindsay Martin","startTime":444.11,"endTime":444.644,"body":"I see."},{"speaker":"Lindsay Martin","startTime":444.644,"endTime":445.044,"body":"Okay."},{"speaker":"Lindsay Martin","startTime":445.244,"endTime":449.982,"body":"Yeah, so in patients that do have"},{"speaker":"Lindsay Martin","startTime":445.244,"endTime":449.982,"body":"the genetic variant, the genetic"},{"speaker":"Lindsay Martin","startTime":449.982,"endTime":453.719,"body":"variant and then overactivity of"},{"speaker":"Lindsay Martin","startTime":449.982,"endTime":453.719,"body":"the kinase itself is what starts"},{"speaker":"Lindsay Martin","startTime":453.719,"endTime":455.221,"body":"to trigger Parkinson's disease."},{"speaker":"Lindsay Martin","startTime":455.254,"endTime":459.692,"body":"So these patients have like"},{"speaker":"Lindsay Martin","startTime":455.254,"endTime":459.692,"body":"genetic variant-driven Parkinson's."},{"speaker":"Lindsay Martin","startTime":460.259,"endTime":464.831,"body":"In patients that are, say, idiopathic,"},{"speaker":"Lindsay Martin","startTime":460.259,"endTime":464.831,"body":"so not necessarily they have a"},{"speaker":"Lindsay Martin","startTime":464.831,"endTime":469.335,"body":"specific genetic variant it could be"},{"speaker":"Lindsay Martin","startTime":464.831,"endTime":469.335,"body":"a variety of factors that eventually"},{"speaker":"Lindsay Martin","startTime":469.335,"endTime":470.87,"body":"lead to them having Parkinson's."},{"speaker":"Lindsay Martin","startTime":470.87,"endTime":474.841,"body":"And the thought is that patients that"},{"speaker":"Lindsay Martin","startTime":470.87,"endTime":474.841,"body":"don't have the specific genetic variant"},{"speaker":"Lindsay Martin","startTime":475.141,"endTime":481.147,"body":"but have SNPs that give them a similar"},{"speaker":"Lindsay Martin","startTime":475.141,"endTime":481.147,"body":"genetic profile are still experiencing"},{"speaker":"Lindsay Martin","startTime":481.414,"endTime":485.518,"body":"Parkinson's in a similar way to those"},{"speaker":"Lindsay Martin","startTime":481.414,"endTime":485.518,"body":"that do have the genetic variant."},{"speaker":"Lindsay Martin","startTime":485.518,"endTime":490.89,"body":"So the cause is still the, overactivity"},{"speaker":"Lindsay Martin","startTime":485.518,"endTime":490.89,"body":"of the kinase and the misfolding of the"},{"speaker":"Lindsay Martin","startTime":490.89,"endTime":494.56,"body":"protein in the same manner, but they"},{"speaker":"Lindsay Martin","startTime":490.89,"endTime":494.56,"body":"don't have that one-- like specific"},{"speaker":"Lindsay Martin","startTime":494.827,"endTime":498.831,"body":"seven genetic variants that are"},{"speaker":"Lindsay Martin","startTime":494.827,"endTime":498.831,"body":"traditionally thought to be the cause"},{"speaker":"Stephen Hansen","startTime":499.565,"endTime":502.134,"body":"Lindsay, I, I took"},{"speaker":"Stephen Hansen","startTime":499.565,"endTime":502.134,"body":"a little sneak peek into your deck"},{"speaker":"Stephen Hansen","startTime":502.134,"endTime":504.604,"body":"there, and obviously there was,"},{"speaker":"Stephen Hansen","startTime":502.134,"endTime":504.604,"body":"there was quite a broad array of"},{"speaker":"Stephen Hansen","startTime":504.604,"endTime":505.905,"body":"stuff you're digging into there."},{"speaker":"Stephen Hansen","startTime":506.239,"endTime":509.141,"body":"M-maybe give us a little bit of an"},{"speaker":"Stephen Hansen","startTime":506.239,"endTime":509.141,"body":"overview as to what are the other sort"},{"speaker":"Stephen Hansen","startTime":509.141,"endTime":512.845,"body":"of areas in, in the disease and, and,"},{"speaker":"Stephen Hansen","startTime":509.141,"endTime":512.845,"body":"and sort of new findings that you've"},{"speaker":"Stephen Hansen","startTime":512.845,"endTime":514.213,"body":"come across that you can maybe highlight."},{"speaker":"Stephen Hansen","startTime":514.213,"endTime":515.915,"body":"You know, maybe just pull out"},{"speaker":"Stephen Hansen","startTime":514.213,"endTime":515.915,"body":"some of the highlights from there"},{"speaker":"Lindsay Martin","startTime":516.749,"endTime":517.016,"body":"Yeah."},{"speaker":"Lindsay Martin","startTime":517.016,"endTime":521.22,"body":"So we've talked a bit about the"},{"speaker":"Lindsay Martin","startTime":517.016,"endTime":521.22,"body":"genetic targets um specifically LRRK2."},{"speaker":"Lindsay Martin","startTime":521.521,"endTime":524.056,"body":"There's other genetic targets that"},{"speaker":"Lindsay Martin","startTime":521.521,"endTime":524.056,"body":"are being pursued in the clinic"},{"speaker":"Lindsay Martin","startTime":524.056,"endTime":528.594,"body":"right now, like GABA or GCase"},{"speaker":"Lindsay Martin","startTime":524.056,"endTime":528.594,"body":"and then alpha-synuclein, which"},{"speaker":"Lindsay Martin","startTime":528.594,"endTime":530.229,"body":"is the top target in the clinic."},{"speaker":"Lindsay Martin","startTime":530.796,"endTime":536.302,"body":"And alpha-synuclein obviously is,"},{"speaker":"Lindsay Martin","startTime":530.796,"endTime":536.302,"body":"the accumulation drives Parkinson's"},{"speaker":"Lindsay Martin","startTime":536.302,"endTime":541.14,"body":"disease and Lewy bodies um having"},{"speaker":"Lindsay Martin","startTime":536.302,"endTime":541.14,"body":"these toxic misfolded proteins."},{"speaker":"Lindsay Martin","startTime":541.574,"endTime":546.612,"body":"So the biological basis for"},{"speaker":"Lindsay Martin","startTime":541.574,"endTime":546.612,"body":"targeting alpha-synuclein is strong."},{"speaker":"Lindsay Martin","startTime":546.879,"endTime":551.484,"body":"and so I think that we'll see"},{"speaker":"Lindsay Martin","startTime":546.879,"endTime":551.484,"body":"a big advancement in targeting"},{"speaker":"Lindsay Martin","startTime":551.484,"endTime":552.952,"body":"alpha-synuclein as well."},{"speaker":"Lindsay Martin","startTime":553.319,"endTime":559.191,"body":"We have a couple of targets that are more"},{"speaker":"Lindsay Martin","startTime":553.319,"endTime":559.191,"body":"advanced in the clinic, two that are in"},{"speaker":"Lindsay Martin","startTime":559.258,"endTime":565.665,"body":"Phase III right now, one in an open label"},{"speaker":"Lindsay Martin","startTime":559.258,"endTime":565.665,"body":"extension, buntanetap from Annovis, and"},{"speaker":"Lindsay Martin","startTime":565.665,"endTime":569.235,"body":"then prasinezumab from Prothena and Roche."},{"speaker":"Lindsay Martin","startTime":569.569,"endTime":573.272,"body":"and so those are gonna be some exciting"},{"speaker":"Lindsay Martin","startTime":569.569,"endTime":573.272,"body":"readouts in the next few years."},{"speaker":"Lindsay Martin","startTime":573.706,"endTime":577.777,"body":"But really, I'm most excited, I"},{"speaker":"Lindsay Martin","startTime":573.706,"endTime":577.777,"body":"think, about the cell therapies"},{"speaker":"Lindsay Martin","startTime":577.777,"endTime":579.545,"body":"that are in the clinic right now."},{"speaker":"Lindsay Martin","startTime":579.946,"endTime":585.318,"body":"And so in March, Japan granted"},{"speaker":"Lindsay Martin","startTime":579.946,"endTime":585.318,"body":"conditional authorization to the"},{"speaker":"Lindsay Martin","startTime":585.351,"endTime":591.023,"body":"allogeneic cell therapy, Amchepry"},{"speaker":"Lindsay Martin","startTime":585.351,"endTime":591.023,"body":"(raguneprocel) from Sumitomo."},{"speaker":"Lindsay Martin","startTime":591.457,"endTime":594.86,"body":"And this is the first cell therapy"},{"speaker":"Lindsay Martin","startTime":591.457,"endTime":594.86,"body":"that has been approved for Parkinson's"},{"speaker":"Lindsay Martin","startTime":594.894,"endTime":599.432,"body":"disease, the program is currently"},{"speaker":"Lindsay Martin","startTime":594.894,"endTime":599.432,"body":"in Phase I and II testing in the US."},{"speaker":"Lindsay Martin","startTime":599.865,"endTime":604.103,"body":"There's a similar regenerative"},{"speaker":"Lindsay Martin","startTime":599.865,"endTime":604.103,"body":"cell therapy from BlueRock,"},{"speaker":"Lindsay Martin","startTime":604.203,"endTime":609.041,"body":"bemdaneprocel, that's also in Phase"},{"speaker":"Lindsay Martin","startTime":604.203,"endTime":609.041,"body":"III testing in the US right now."},{"speaker":"Lindsay Martin","startTime":609.075,"endTime":613.079,"body":"And so I think we're going to see"},{"speaker":"Lindsay Martin","startTime":609.075,"endTime":613.079,"body":"regenerative cell therapies as"},{"speaker":"Lindsay Martin","startTime":613.112,"endTime":618.417,"body":"an emerging option to modify the"},{"speaker":"Lindsay Martin","startTime":613.112,"endTime":618.417,"body":"root cause of Parkinson's disease."},{"speaker":"Lindsay Martin","startTime":618.784,"endTime":623.623,"body":"So the idea is that you're replacing"},{"speaker":"Lindsay Martin","startTime":618.784,"endTime":623.623,"body":"the lost dopaminergic neurons rather"},{"speaker":"Lindsay Martin","startTime":623.623,"endTime":629.261,"body":"than just treating the symptoms or"},{"speaker":"Lindsay Martin","startTime":623.623,"endTime":629.261,"body":"addressing a specific protein or kinase"},{"speaker":"Simone Fishburn","startTime":630.162,"endTime":631.797,"body":"Well, we probably"},{"speaker":"Simone Fishburn","startTime":630.162,"endTime":631.797,"body":"don't have time to get into that,"},{"speaker":"Simone Fishburn","startTime":631.797,"endTime":635.201,"body":"but we'll follow that in the future"},{"speaker":"Simone Fishburn","startTime":631.797,"endTime":635.201,"body":"because again, that has been on the"},{"speaker":"Simone Fishburn","startTime":635.201,"endTime":638.904,"body":"list of, the to-do list for Parkinson's"},{"speaker":"Simone Fishburn","startTime":635.201,"endTime":638.904,"body":"for a very long time 'cause it, the"},{"speaker":"Simone Fishburn","startTime":638.904,"endTime":642.441,"body":"idea was you could just implant the"},{"speaker":"Simone Fishburn","startTime":638.904,"endTime":642.441,"body":"neurons 'cause it's very really known"},{"speaker":"Simone Fishburn","startTime":642.475,"endTime":644.443,"body":"which ones undergo degeneration."},{"speaker":"Simone Fishburn","startTime":644.443,"endTime":647.613,"body":"So it'd be interesting to see"},{"speaker":"Simone Fishburn","startTime":644.443,"endTime":647.613,"body":"what's different now and why,"},{"speaker":"Simone Fishburn","startTime":647.68,"endTime":649.715,"body":"why that might be shaping up"},{"speaker":"Lindsay Martin","startTime":650.049,"endTime":651.884,"body":"Yeah, I'll"},{"speaker":"Lindsay Martin","startTime":650.049,"endTime":651.884,"body":"just add a quick bit on that."},{"speaker":"Lindsay Martin","startTime":651.884,"endTime":656.856,"body":"I think, like these really stand out from"},{"speaker":"Lindsay Martin","startTime":651.884,"endTime":656.856,"body":"previous fetal cell therapies in that"},{"speaker":"Lindsay Martin","startTime":656.856,"endTime":661.527,"body":"these are more homogenous cells that are"},{"speaker":"Lindsay Martin","startTime":656.856,"endTime":661.527,"body":"being input into the patient's brain."},{"speaker":"Lindsay Martin","startTime":661.994,"endTime":666.999,"body":"And so they can know exactly"},{"speaker":"Lindsay Martin","startTime":661.994,"endTime":666.999,"body":"what stage of proliferation or"},{"speaker":"Lindsay Martin","startTime":666.999,"endTime":668.601,"body":"differentiation the cells are at."},{"speaker":"Lindsay Martin","startTime":668.868,"endTime":674.64,"body":"And so there's a, a safety advantage"},{"speaker":"Lindsay Martin","startTime":668.868,"endTime":674.64,"body":"in using this newer next gen therapy as"},{"speaker":"Lindsay Martin","startTime":674.64,"endTime":676.876,"body":"opposed to the previous fetal cell grafts."},{"speaker":"Lindsay Martin","startTime":677.276,"endTime":681.747,"body":"And I think that also lends to efficacy"},{"speaker":"Lindsay Martin","startTime":677.276,"endTime":681.747,"body":"as well in having the, the graft survive"},{"speaker":"Lindsay Martin","startTime":682.181,"endTime":683.949,"body":"and be a durable treatment for the patient"},{"speaker":"Stephen Hansen","startTime":684.917,"endTime":685.251,"body":"Great."},{"speaker":"Stephen Hansen","startTime":685.484,"endTime":686.218,"body":"Well, thanks Lindsay."},{"speaker":"Stephen Hansen","startTime":686.285,"endTime":688.821,"body":"Yeah, really looking forward"},{"speaker":"Stephen Hansen","startTime":686.285,"endTime":688.821,"body":"to uh reading this through."},{"speaker":"Stephen Hansen","startTime":688.821,"endTime":691.791,"body":"I believe it's gonna be coming out"},{"speaker":"Stephen Hansen","startTime":688.821,"endTime":691.791,"body":"sometime this week so everyone can"},{"speaker":"Stephen Hansen","startTime":691.791,"endTime":694.026,"body":"check out that deck when it's available"},{"speaker":"Lindsay Martin","startTime":694.827,"endTime":695.461,"body":"Thanks, Stephen"},{"speaker":"Simone Fishburn","startTime":696.228,"endTime":698.497,"body":"Stephen um let's"},{"speaker":"Simone Fishburn","startTime":696.228,"endTime":698.497,"body":"actually turn to another thing."},{"speaker":"Simone Fishburn","startTime":698.497,"endTime":701.901,"body":"I'm taking over your role for"},{"speaker":"Simone Fishburn","startTime":698.497,"endTime":701.901,"body":"a nanosecond here um because I"},{"speaker":"Simone Fishburn","startTime":701.901,"endTime":703.536,"body":"want to ask you a question now."},{"speaker":"Simone Fishburn","startTime":703.536,"endTime":708.441,"body":"So AZ has, you know, transformed"},{"speaker":"Simone Fishburn","startTime":703.536,"endTime":708.441,"body":"itself in the last, I would say,"},{"speaker":"Simone Fishburn","startTime":708.441,"endTime":711.444,"body":"decade as a major force in cancer."},{"speaker":"Simone Fishburn","startTime":711.711,"endTime":715.848,"body":"in parallel with that, obviously"},{"speaker":"Simone Fishburn","startTime":711.711,"endTime":715.848,"body":"the biggest story at least from"},{"speaker":"Simone Fishburn","startTime":715.848,"endTime":719.185,"body":"a science point of view or a, a"},{"speaker":"Simone Fishburn","startTime":715.848,"endTime":719.185,"body":"drug development point of view,"},{"speaker":"Simone Fishburn","startTime":719.218,"endTime":721.253,"body":"is obesity in the last few years."},{"speaker":"Simone Fishburn","startTime":721.587,"endTime":723.522,"body":"Now those two forces are combining."},{"speaker":"Simone Fishburn","startTime":723.522,"endTime":729.061,"body":"So what's, what's going on with AZ and"},{"speaker":"Simone Fishburn","startTime":723.522,"endTime":729.061,"body":"building, building a footprint in obesity?"},{"speaker":"Simone Fishburn","startTime":729.128,"endTime":729.995,"body":"Talk us through that"},{"speaker":"Stephen Hansen","startTime":730.596,"endTime":731.263,"body":"Yeah, happy to."},{"speaker":"Stephen Hansen","startTime":731.263,"endTime":735.067,"body":"So  as you say, AZ's been sort"},{"speaker":"Stephen Hansen","startTime":731.263,"endTime":735.067,"body":"of on this huge growth trajectory"},{"speaker":"Stephen Hansen","startTime":735.067,"endTime":736.569,"body":"from, from a lot of other programs."},{"speaker":"Stephen Hansen","startTime":736.602,"endTime":740.473,"body":"But while a lot of that has come from"},{"speaker":"Stephen Hansen","startTime":736.602,"endTime":740.473,"body":"deals outside of, of this area, they"},{"speaker":"Stephen Hansen","startTime":740.506,"endTime":744.376,"body":"are, you know, they've been using sort"},{"speaker":"Stephen Hansen","startTime":740.506,"endTime":744.376,"body":"of a combination of internal development"},{"speaker":"Stephen Hansen","startTime":744.376,"endTime":749.315,"body":"and deal-making to bring together,"},{"speaker":"Stephen Hansen","startTime":744.376,"endTime":749.315,"body":"you know, what's not by no means the"},{"speaker":"Stephen Hansen","startTime":749.315,"endTime":751.951,"body":"deepest obesity pipeline in the industry."},{"speaker":"Stephen Hansen","startTime":751.984,"endTime":756.188,"body":"It, it-- They basically are getting"},{"speaker":"Stephen Hansen","startTime":751.984,"endTime":756.188,"body":"a footprint in kind of each of the"},{"speaker":"Stephen Hansen","startTime":756.188,"endTime":758.657,"body":"major sort of trending areas there."},{"speaker":"Stephen Hansen","startTime":758.657,"endTime":764.396,"body":"One thing people might not remember is"},{"speaker":"Stephen Hansen","startTime":758.657,"endTime":764.396,"body":"that AZ is actually no stranger to GLP-1s,"},{"speaker":"Stephen Hansen","startTime":764.396,"endTime":770.503,"body":"as they actually had the world's first"},{"speaker":"Stephen Hansen","startTime":764.396,"endTime":770.503,"body":"once-weekly GLP-1 agonist uh Bydureon,"},{"speaker":"Stephen Hansen","startTime":770.569,"endTime":772.104,"body":"if you remember that from years ago."},{"speaker":"Stephen Hansen","startTime":772.138,"endTime":774.106,"body":"That used to be originally"},{"speaker":"Stephen Hansen","startTime":772.138,"endTime":774.106,"body":"an Amylin program."},{"speaker":"Stephen Hansen","startTime":774.473,"endTime":776.475,"body":"but it was only in type two diabetes."},{"speaker":"Stephen Hansen","startTime":776.475,"endTime":780.412,"body":"It really didn't have the efficacy to,"},{"speaker":"Stephen Hansen","startTime":776.475,"endTime":780.412,"body":"to kind of be pursued in, in obesity."},{"speaker":"Stephen Hansen","startTime":780.746,"endTime":782.681,"body":"They still have that"},{"speaker":"Stephen Hansen","startTime":780.746,"endTime":782.681,"body":"sort of history there."},{"speaker":"Stephen Hansen","startTime":783.048,"endTime":786.352,"body":"And basically they've kind of picked up"},{"speaker":"Stephen Hansen","startTime":783.048,"endTime":786.352,"body":"that mantle again and kind of are, are"},{"speaker":"Stephen Hansen","startTime":786.352,"endTime":790.389,"body":"now carrying it forward with, you know,"},{"speaker":"Stephen Hansen","startTime":786.352,"endTime":790.389,"body":"a clinical pipeline that you know, is"},{"speaker":"Stephen Hansen","startTime":790.389,"endTime":798.097,"body":"led by elecoglipron, which is their small"},{"speaker":"Stephen Hansen","startTime":790.389,"endTime":798.097,"body":"molecule GLP-1 agonist that had phase 2B"},{"speaker":"Stephen Hansen","startTime":798.097,"endTime":800.366,"body":"data presented at ADA uh this past month."},{"speaker":"Stephen Hansen","startTime":800.8,"endTime":806.372,"body":"That's one they licensed in from Eccogene,"},{"speaker":"Stephen Hansen","startTime":800.8,"endTime":806.372,"body":"a Chinese company uh several years ago."},{"speaker":"Stephen Hansen","startTime":806.405,"endTime":809.809,"body":"So that's now moving into"},{"speaker":"Stephen Hansen","startTime":806.405,"endTime":809.809,"body":"Phase III uh later this year."},{"speaker":"Stephen Hansen","startTime":810.109,"endTime":813.012,"body":"And behind that they have"},{"speaker":"Stephen Hansen","startTime":810.109,"endTime":813.012,"body":"four other clinical programs."},{"speaker":"Stephen Hansen","startTime":813.078,"endTime":820.753,"body":"So these span from AZD6234 their"},{"speaker":"Stephen Hansen","startTime":813.078,"endTime":820.753,"body":"amylin  receptor program AZD9550,"},{"speaker":"Stephen Hansen","startTime":820.786,"endTime":824.023,"body":"which is a GLP-1 glucagon dual agonist."},{"speaker":"Stephen Hansen","startTime":824.723,"endTime":828.928,"body":"AZ also spent, I think, around $1.2"},{"speaker":"Stephen Hansen","startTime":824.723,"endTime":828.928,"body":"billion earlier this year to get rights"},{"speaker":"Stephen Hansen","startTime":828.928,"endTime":833.199,"body":"to a GLP-1 GIP receptor dual agonist."},{"speaker":"Stephen Hansen","startTime":834.133,"endTime":837.436,"body":"But the one that I'm really kind"},{"speaker":"Stephen Hansen","startTime":834.133,"endTime":837.436,"body":"of, I think, most excited to see"},{"speaker":"Stephen Hansen","startTime":837.67,"endTime":843.108,"body":"data for is a activin    inhibitor"},{"speaker":"Stephen Hansen","startTime":837.67,"endTime":843.108,"body":"program that they acquired via their"},{"speaker":"Stephen Hansen","startTime":843.108,"endTime":845.544,"body":"takeout of SixPeaks couple years ago."},{"speaker":"Stephen Hansen","startTime":845.544,"endTime":850.516,"body":"So this is a subcutaneous   antibody"},{"speaker":"Stephen Hansen","startTime":845.544,"endTime":850.516,"body":"targeting the activin pathway."},{"speaker":"Stephen Hansen","startTime":850.85,"endTime":855.054,"body":"And just from a sort of quality weight"},{"speaker":"Stephen Hansen","startTime":850.85,"endTime":855.054,"body":"loss perspective, this is one of those"},{"speaker":"Stephen Hansen","startTime":855.087,"endTime":860.726,"body":"targets that potentially ideally is"},{"speaker":"Stephen Hansen","startTime":855.087,"endTime":860.726,"body":"suited for not only delivering weight"},{"speaker":"Stephen Hansen","startTime":860.726,"endTime":865.731,"body":"loss, but this high-quality weight loss"},{"speaker":"Stephen Hansen","startTime":860.726,"endTime":865.731,"body":"because you have both hitting ALK7,"},{"speaker":"Stephen Hansen","startTime":865.764,"endTime":869.869,"body":"which is reducing lipolysis and taking"},{"speaker":"Stephen Hansen","startTime":865.764,"endTime":869.869,"body":"down sort of fat selective weight loss."},{"speaker":"Stephen Hansen","startTime":870.336,"endTime":874.206,"body":"But then at the same time, you're"},{"speaker":"Stephen Hansen","startTime":870.336,"endTime":874.206,"body":"activating the myostatin pathway, so"},{"speaker":"Stephen Hansen","startTime":874.206,"endTime":876.775,"body":"you're building muscle in the same way."},{"speaker":"Stephen Hansen","startTime":876.775,"endTime":881.113,"body":"So you know in talking to AZ, I think"},{"speaker":"Stephen Hansen","startTime":876.775,"endTime":881.113,"body":"this was one of the programs that they"},{"speaker":"Stephen Hansen","startTime":881.113,"endTime":886.018,"body":"were most excited about, and they were"},{"speaker":"Stephen Hansen","startTime":881.113,"endTime":886.018,"body":"kind of outlining how they think they"},{"speaker":"Stephen Hansen","startTime":886.018,"endTime":890.556,"body":"could potentially hit 10% weight loss"},{"speaker":"Stephen Hansen","startTime":886.018,"endTime":890.556,"body":"as monotherapy with this, where if"},{"speaker":"Stephen Hansen","startTime":890.556,"endTime":894.894,"body":"you think about 10% weight loss as a"},{"speaker":"Stephen Hansen","startTime":890.556,"endTime":894.894,"body":"standalone monotherapy, that's pretty"},{"speaker":"Stephen Hansen","startTime":894.894,"endTime":899.865,"body":"much in line with what we're seeing"},{"speaker":"Stephen Hansen","startTime":894.894,"endTime":899.865,"body":"with most of the small molecule GLP-1s."},{"speaker":"Stephen Hansen","startTime":900.432,"endTime":903.535,"body":"It's in line with some of"},{"speaker":"Stephen Hansen","startTime":900.432,"endTime":903.535,"body":"the amylin programs as well."},{"speaker":"Stephen Hansen","startTime":903.569,"endTime":908.04,"body":"And so while the activin's pathway had"},{"speaker":"Stephen Hansen","startTime":903.569,"endTime":908.04,"body":"really kind of been thought about as"},{"speaker":"Stephen Hansen","startTime":908.04,"endTime":912.678,"body":"really something that would be added"},{"speaker":"Stephen Hansen","startTime":908.04,"endTime":912.678,"body":"on top of a GLP-1 to try and make the"},{"speaker":"Stephen Hansen","startTime":912.711,"endTime":915.948,"body":"quality of the weight loss better, just"},{"speaker":"Stephen Hansen","startTime":912.711,"endTime":915.948,"body":"wondering whether there's the potential"},{"speaker":"Stephen Hansen","startTime":915.948,"endTime":918.183,"body":"for this just as a monotherapy as well."},{"speaker":"Stephen Hansen","startTime":918.183,"endTime":918.717,"body":"I mean"},{"speaker":"Simone Fishburn","startTime":919.385,"endTime":922.788,"body":"Stephen, is it a,"},{"speaker":"Simone Fishburn","startTime":919.385,"endTime":922.788,"body":"is it a different patient population"},{"speaker":"Simone Fishburn","startTime":922.788,"endTime":927.126,"body":"or a s- I mean, is it still obese"},{"speaker":"Simone Fishburn","startTime":922.788,"endTime":927.126,"body":"patients or is it a, a subset?"},{"speaker":"Simone Fishburn","startTime":927.126,"endTime":928.994,"body":"As you say, the population is so huge."},{"speaker":"Simone Fishburn","startTime":929.161,"endTime":933.265,"body":"Certainly if you get 1%, let"},{"speaker":"Simone Fishburn","startTime":929.161,"endTime":933.265,"body":"alone 10%, you know, you can do"},{"speaker":"Simone Fishburn","startTime":933.265,"endTime":935.167,"body":"some significant business there"},{"speaker":"Stephen Hansen","startTime":935.434,"endTime":935.834,"body":"Yeah, yeah."},{"speaker":"Stephen Hansen","startTime":935.834,"endTime":939.371,"body":"It's a great point, and, and I think"},{"speaker":"Stephen Hansen","startTime":935.834,"endTime":939.371,"body":"that's what-- if you look at AZ's"},{"speaker":"Stephen Hansen","startTime":939.605,"endTime":942.942,"body":"sort of decision-making around how"},{"speaker":"Stephen Hansen","startTime":939.605,"endTime":942.942,"body":"they've selected their pipeline, I"},{"speaker":"Stephen Hansen","startTime":942.975,"endTime":946.946,"body":"think it really reflects that, you"},{"speaker":"Stephen Hansen","startTime":942.975,"endTime":946.946,"body":"know, what I think is that coming"},{"speaker":"Stephen Hansen","startTime":946.946,"endTime":948.681,"body":"segmentation of the obesity market."},{"speaker":"Stephen Hansen","startTime":948.714,"endTime":952.318,"body":"So you have the oral therapy for"},{"speaker":"Stephen Hansen","startTime":948.714,"endTime":952.318,"body":"patients that just want an oral,"},{"speaker":"Stephen Hansen","startTime":952.351,"endTime":953.819,"body":"that don't want to do the injectable."},{"speaker":"Stephen Hansen","startTime":954.186,"endTime":957.957,"body":"You have sort of the, you know,"},{"speaker":"Stephen Hansen","startTime":954.186,"endTime":957.957,"body":"they're gonna be testing their, dual"},{"speaker":"Stephen Hansen","startTime":957.957,"endTime":961.393,"body":"agonists in combination with their"},{"speaker":"Stephen Hansen","startTime":957.957,"endTime":961.393,"body":"amylin program, which could potentially"},{"speaker":"Stephen Hansen","startTime":961.393,"endTime":964.897,"body":"drive, you know, much higher weight"},{"speaker":"Stephen Hansen","startTime":961.393,"endTime":964.897,"body":"loss, so that's for the, the highly"},{"speaker":"Stephen Hansen","startTime":964.897,"endTime":966.865,"body":"obese patient segment population."},{"speaker":"Stephen Hansen","startTime":967.266,"endTime":969.435,"body":"And then you have something like"},{"speaker":"Stephen Hansen","startTime":967.266,"endTime":969.435,"body":"the activin, you know, pathway"},{"speaker":"Stephen Hansen","startTime":969.435,"endTime":974.473,"body":"program uh AZD-1043, where that's"},{"speaker":"Stephen Hansen","startTime":969.435,"endTime":974.473,"body":"probably really targeted at a more"},{"speaker":"Stephen Hansen","startTime":974.54,"endTime":979.945,"body":"elderly frail population that might"},{"speaker":"Stephen Hansen","startTime":974.54,"endTime":979.945,"body":"be more might have more risk of, of"},{"speaker":"Stephen Hansen","startTime":979.945,"endTime":981.68,"body":"sarcopenia or these sorts of things."},{"speaker":"Stephen Hansen","startTime":981.947,"endTime":985.284,"body":"And, and each of these are, are"},{"speaker":"Stephen Hansen","startTime":981.947,"endTime":985.284,"body":"on their own still huge markets."},{"speaker":"Stephen Hansen","startTime":985.784,"endTime":989.455,"body":"But you know, I think what we're seeing"},{"speaker":"Stephen Hansen","startTime":985.784,"endTime":989.455,"body":"now is, you know, as these different"},{"speaker":"Stephen Hansen","startTime":989.455,"endTime":992.925,"body":"targets can be segmented out towards"},{"speaker":"Stephen Hansen","startTime":989.455,"endTime":992.925,"body":"different subpopulations of the-- of"},{"speaker":"Stephen Hansen","startTime":992.925,"endTime":997.93,"body":"obesity patients, and I think AZ's"},{"speaker":"Stephen Hansen","startTime":992.925,"endTime":997.93,"body":"really sort of trying to identify what"},{"speaker":"Stephen Hansen","startTime":997.93,"endTime":1001.1,"body":"those are and then, and then develop"},{"speaker":"Stephen Hansen","startTime":997.93,"endTime":1001.1,"body":"therapies that can go after each of them."},{"speaker":"Stephen Hansen","startTime":1001.1,"endTime":1003.836,"body":"So lots of data that should"},{"speaker":"Stephen Hansen","startTime":1001.1,"endTime":1003.836,"body":"be coming in the next sort of"},{"speaker":"Stephen Hansen","startTime":1003.836,"endTime":1005.671,"body":"year or so from this pipeline."},{"speaker":"Stephen Hansen","startTime":1005.704,"endTime":1009.074,"body":"And uh you know, I think they're"},{"speaker":"Stephen Hansen","startTime":1005.704,"endTime":1009.074,"body":"very much gonna be trying to compete."},{"speaker":"Stephen Hansen","startTime":1009.074,"endTime":1013.012,"body":"As I said, they, they don't have the same"},{"speaker":"Stephen Hansen","startTime":1009.074,"endTime":1013.012,"body":"depth that a Lilly or Novo does, but you"},{"speaker":"Stephen Hansen","startTime":1013.012,"endTime":1016.515,"body":"know, they obviously have the commercial"},{"speaker":"Stephen Hansen","startTime":1013.012,"endTime":1016.515,"body":"where-wherewithal to compete with them."},{"speaker":"Stephen Hansen","startTime":1017.016,"endTime":1019.385,"body":"And from the sounds of it, you"},{"speaker":"Stephen Hansen","startTime":1017.016,"endTime":1019.385,"body":"know, they're, they're spending"},{"speaker":"Stephen Hansen","startTime":1019.385,"endTime":1020.519,"body":"on manufacturing as well."},{"speaker":"Stephen Hansen","startTime":1020.552,"endTime":1022.688,"body":"So I think they're hoping that"},{"speaker":"Stephen Hansen","startTime":1020.552,"endTime":1022.688,"body":"they'll be able to scale up and"},{"speaker":"Stephen Hansen","startTime":1022.688,"endTime":1023.889,"body":"compete commercially there too"},{"speaker":"Simone Fishburn","startTime":1024.656,"endTime":1027.826,"body":"Yeah, I mean, it's looks"},{"speaker":"Simone Fishburn","startTime":1024.656,"endTime":1027.826,"body":"like it's still gonna be an area that"},{"speaker":"Simone Fishburn","startTime":1027.826,"endTime":1032.131,"body":"has a lot to give us in the next few"},{"speaker":"Simone Fishburn","startTime":1027.826,"endTime":1032.131,"body":"years, certainly in terms of coverage"},{"speaker":"Stephen Hansen","startTime":1032.531,"endTime":1033.265,"body":"I think that's right."},{"speaker":"Stephen Hansen","startTime":1033.365,"endTime":1034.033,"body":"I think that's right."},{"speaker":"Stephen Hansen","startTime":1034.099,"endTime":1034.4,"body":"Yeah."},{"speaker":"Stephen Hansen","startTime":1034.633,"endTime":1036.301,"body":"keep everyone posted, but"},{"speaker":"Stephen Hansen","startTime":1034.633,"endTime":1036.301,"body":"that story should be coming"},{"speaker":"Stephen Hansen","startTime":1036.301,"endTime":1037.436,"body":"out later this week as well."},{"speaker":"Stephen Hansen","startTime":1037.803,"endTime":1040.005,"body":"So you can check it out at biocentury.com."},{"speaker":"Stephen Hansen","startTime":1040.272,"endTime":1042.474,"body":"Let's go to a break,"},{"speaker":"Stephen Hansen","startTime":1040.272,"endTime":1042.474,"body":"and we'll be right back"},{"speaker":"Voice Talent","startTime":1043.042,"endTime":1046.245,"body":"This episode of BioCentury"},{"speaker":"Voice Talent","startTime":1043.042,"endTime":1046.245,"body":"This Week is brought to you by the"},{"speaker":"Voice Talent","startTime":1046.311,"endTime":1051.884,"body":"second BioCentury Grand Rounds Europe"},{"speaker":"Voice Talent","startTime":1046.311,"endTime":1051.884,"body":"in Amsterdam, September 23rd to 25th."},{"speaker":"Voice Talent","startTime":1054.953,"endTime":1059.191,"body":"The 2nd Edition of BioCentury Grand"},{"speaker":"Voice Talent","startTime":1054.953,"endTime":1059.191,"body":"Rounds Europe convenes the leaders"},{"speaker":"Voice Talent","startTime":1059.425,"endTime":1061.093,"body":"shaping the future of biopharma."},{"speaker":"Voice Talent","startTime":1062.094,"endTime":1065.03,"body":"This time we meet in"},{"speaker":"Voice Talent","startTime":1062.094,"endTime":1065.03,"body":"Amsterdam, September 23rd to"},{"speaker":"Voice Talent","startTime":1065.33,"endTime":1071.97,"body":"25th, gathering academic innovators,"},{"speaker":"Voice Talent","startTime":1065.33,"endTime":1071.97,"body":"biotech CEOs, pharma R\u0026D leaders and"},{"speaker":"Voice Talent","startTime":1072.037,"endTime":1076.508,"body":"investors to debate the translational"},{"speaker":"Voice Talent","startTime":1072.037,"endTime":1076.508,"body":"science that will define the next decade."},{"speaker":"Voice Talent","startTime":1077.91,"endTime":1082.214,"body":"Grand Rounds Europe focuses on what"},{"speaker":"Voice Talent","startTime":1077.91,"endTime":1082.214,"body":"matters most: Breakthrough biology."},{"speaker":"Voice Talent","startTime":1082.781,"endTime":1084.349,"body":"Transformative technologies."},{"speaker":"Voice Talent","startTime":1085.05,"endTime":1087.953,"body":"And how to make"},{"speaker":"Voice Talent","startTime":1085.05,"endTime":1087.953,"body":"early-stage R\u0026D investable."},{"speaker":"Voice Talent","startTime":1089.288,"endTime":1092.991,"body":"Grand Rounds is where rigorous"},{"speaker":"Voice Talent","startTime":1089.288,"endTime":1092.991,"body":"science meets real-world execution."},{"speaker":"Voice Talent","startTime":1094.226,"endTime":1098.897,"body":"Join BioCentury and Regional"},{"speaker":"Voice Talent","startTime":1094.226,"endTime":1098.897,"body":"Host Chairs Forbian and BGV, and"},{"speaker":"Voice Talent","startTime":1098.931,"endTime":1102.935,"body":"take a deep dive on translational"},{"speaker":"Voice Talent","startTime":1098.931,"endTime":1102.935,"body":"opportunities in the Benelux region."},{"speaker":"Voice Talent","startTime":1104.236,"endTime":1106.705,"body":"BioCentury Grand Rounds Europe."},{"speaker":"Voice Talent","startTime":1106.772,"endTime":1108.974,"body":"Where discovery moves toward impact."},{"speaker":"Voice Talent","startTime":1109.908,"endTime":1113.011,"body":"Register at BiocenturyGrandRounds.com."},{"speaker":"Stephen Hansen","startTime":1114.68,"endTime":1117.683,"body":"Welcome back to"},{"speaker":"Stephen Hansen","startTime":1114.68,"endTime":1117.683,"body":"BioCentury This Week I think we need"},{"speaker":"Stephen Hansen","startTime":1117.716,"endTime":1121.22,"body":"to uh maybe go to Washington and Steve."},{"speaker":"Stephen Hansen","startTime":1121.453,"endTime":1127.292,"body":"maybe we can start by talking about your"},{"speaker":"Stephen Hansen","startTime":1121.453,"endTime":1127.292,"body":"three-part analysis of FDA's Operation"},{"speaker":"Stephen Hansen","startTime":1127.326,"endTime":1132.364,"body":"TrialBlazer, which is the agency's attempt"},{"speaker":"Stephen Hansen","startTime":1127.326,"endTime":1132.364,"body":"to reform and accelerate the conduct of"},{"speaker":"Stephen Hansen","startTime":1132.364,"endTime":1137.669,"body":"clinical trials in the US So Steve, can"},{"speaker":"Stephen Hansen","startTime":1132.364,"endTime":1137.669,"body":"you fill us in on uh what is Operation"},{"speaker":"Stephen Hansen","startTime":1137.703,"endTime":1141.273,"body":"TrialBlazer and how it compares to"},{"speaker":"Stephen Hansen","startTime":1137.703,"endTime":1141.273,"body":"getting a trial up and running in China?"},{"speaker":"Steve Usdin","startTime":1141.94,"endTime":1142.207,"body":"Yeah."},{"speaker":"Steve Usdin","startTime":1142.207,"endTime":1147.479,"body":"So first, Operation TrialBlazer is"},{"speaker":"Steve Usdin","startTime":1142.207,"endTime":1147.479,"body":"not just FDA, it's an all of HHS plan."},{"speaker":"Steve Usdin","startTime":1147.746,"endTime":1151.15,"body":"Um, but the most salient and"},{"speaker":"Steve Usdin","startTime":1147.746,"endTime":1151.15,"body":"certainly the most well-articulated"},{"speaker":"Steve Usdin","startTime":1151.15,"endTime":1153.085,"body":"parts of it are at FDA."},{"speaker":"Steve Usdin","startTime":1153.418,"endTime":1159.024,"body":"basically it's a package of incremental"},{"speaker":"Steve Usdin","startTime":1153.418,"endTime":1159.024,"body":"reforms that taken together will"},{"speaker":"Steve Usdin","startTime":1159.024,"endTime":1163.629,"body":"slash the time required to launch a"},{"speaker":"Steve Usdin","startTime":1159.024,"endTime":1163.629,"body":"clinical trial in the United States if"},{"speaker":"Steve Usdin","startTime":1163.662,"endTime":1165.964,"body":"everything is executed according to plan."},{"speaker":"Steve Usdin","startTime":1166.398,"endTime":1170.335,"body":"The timeline in the best case"},{"speaker":"Steve Usdin","startTime":1166.398,"endTime":1170.335,"body":"scenario in the United States to"},{"speaker":"Steve Usdin","startTime":1170.335,"endTime":1173.972,"body":"launch a, a Phase I trial would"},{"speaker":"Steve Usdin","startTime":1170.335,"endTime":1173.972,"body":"decrease to about fifteen months."},{"speaker":"Steve Usdin","startTime":1174.406,"endTime":1177.876,"body":"Good news is that's less than"},{"speaker":"Steve Usdin","startTime":1174.406,"endTime":1177.876,"body":"half of what it takes now."},{"speaker":"Steve Usdin","startTime":1178.377,"endTime":1182.047,"body":"the bad news, if you're benchmarking"},{"speaker":"Steve Usdin","startTime":1178.377,"endTime":1182.047,"body":"against China, is it's still about seven"},{"speaker":"Steve Usdin","startTime":1182.047,"endTime":1184.483,"body":"months longer than it takes in China."},{"speaker":"Steve Usdin","startTime":1184.816,"endTime":1188.987,"body":"And then the question is what happens"},{"speaker":"Steve Usdin","startTime":1184.816,"endTime":1188.987,"body":"once you've got the trial started because"},{"speaker":"Steve Usdin","startTime":1189.254,"endTime":1194.193,"body":"another advantage that China has over"},{"speaker":"Steve Usdin","startTime":1189.254,"endTime":1194.193,"body":"the United States is the ability to very"},{"speaker":"Steve Usdin","startTime":1194.193,"endTime":1196.762,"body":"rapidly enroll once a trial is started."},{"speaker":"Steve Usdin","startTime":1197.029,"endTime":1200.899,"body":"There are elements of Operation"},{"speaker":"Steve Usdin","startTime":1197.029,"endTime":1200.899,"body":"TrialBlazer that are intended to"},{"speaker":"Steve Usdin","startTime":1200.899,"endTime":1204.536,"body":"address that issue, but they're"},{"speaker":"Steve Usdin","startTime":1200.899,"endTime":1204.536,"body":"really not as robust or, or"},{"speaker":"Steve Usdin","startTime":1204.67,"endTime":1206.205,"body":"worked out as the other issues."},{"speaker":"Steve Usdin","startTime":1206.772,"endTime":1210.042,"body":"The thing that I, I talk about in my"},{"speaker":"Steve Usdin","startTime":1206.772,"endTime":1210.042,"body":"story, if you're benchmarking against"},{"speaker":"Steve Usdin","startTime":1210.042,"endTime":1214.012,"body":"China, and it's relevant to benchmark"},{"speaker":"Steve Usdin","startTime":1210.042,"endTime":1214.012,"body":"against China because the Operation"},{"speaker":"Steve Usdin","startTime":1214.046,"endTime":1217.416,"body":"TrialBlazer report, it's about twenty"},{"speaker":"Steve Usdin","startTime":1214.046,"endTime":1217.416,"body":"pages long, and in that twenty pages it"},{"speaker":"Steve Usdin","startTime":1217.416,"endTime":1219.785,"body":"mentions China a dozen times, you know."},{"speaker":"Steve Usdin","startTime":1219.785,"endTime":1224.856,"body":"So it, frames this initiative"},{"speaker":"Steve Usdin","startTime":1219.785,"endTime":1224.856,"body":"as a response to China."},{"speaker":"Steve Usdin","startTime":1225.057,"endTime":1228.46,"body":"What they don't do in the report"},{"speaker":"Steve Usdin","startTime":1225.057,"endTime":1228.46,"body":"is actually compare what the"},{"speaker":"Steve Usdin","startTime":1228.46,"endTime":1229.895,"body":"United States does with China."},{"speaker":"Steve Usdin","startTime":1230.062,"endTime":1233.465,"body":"They don't compare what the timelines"},{"speaker":"Steve Usdin","startTime":1230.062,"endTime":1233.465,"body":"are in the United States versus China."},{"speaker":"Steve Usdin","startTime":1233.732,"endTime":1237.202,"body":"so I did it for them, and that's what,"},{"speaker":"Steve Usdin","startTime":1233.732,"endTime":1237.202,"body":"my story is all about, one of my stories."},{"speaker":"Steve Usdin","startTime":1237.569,"endTime":1241.006,"body":"The most important thing, I think,"},{"speaker":"Steve Usdin","startTime":1237.569,"endTime":1241.006,"body":"if you're comparing the United States"},{"speaker":"Steve Usdin","startTime":1241.006,"endTime":1245.577,"body":"and China and TrialBlazer to what"},{"speaker":"Steve Usdin","startTime":1241.006,"endTime":1245.577,"body":"the reality in China is now, is"},{"speaker":"Steve Usdin","startTime":1245.677,"endTime":1247.079,"body":"that they take a different approach."},{"speaker":"Steve Usdin","startTime":1247.412,"endTime":1249.715,"body":"What they're doing in China"},{"speaker":"Steve Usdin","startTime":1247.412,"endTime":1249.715,"body":"basically is they're doing a lot"},{"speaker":"Steve Usdin","startTime":1249.715,"endTime":1252.918,"body":"of the things that are being done"},{"speaker":"Steve Usdin","startTime":1249.715,"endTime":1252.918,"body":"in the United States sequentially,"},{"speaker":"Steve Usdin","startTime":1253.085,"endTime":1254.653,"body":"they're doing them in parallel."},{"speaker":"Steve Usdin","startTime":1255.12,"endTime":1258.39,"body":"You know, it's really-- there's,"},{"speaker":"Steve Usdin","startTime":1255.12,"endTime":1258.39,"body":"there's a limit to how much you can"},{"speaker":"Steve Usdin","startTime":1258.624,"endTime":1261.293,"body":"compress the time to do certain things."},{"speaker":"Steve Usdin","startTime":1261.727,"endTime":1265.13,"body":"The US approach is only"},{"speaker":"Steve Usdin","startTime":1261.727,"endTime":1265.13,"body":"gonna get you so far, right?"},{"speaker":"Steve Usdin","startTime":1265.163,"endTime":1268.767,"body":"And they've kind of maxed out again,"},{"speaker":"Steve Usdin","startTime":1265.163,"endTime":1268.767,"body":"if they implement what they've talked"},{"speaker":"Steve Usdin","startTime":1268.767,"endTime":1272.104,"body":"about, they've kind of maxed out"},{"speaker":"Steve Usdin","startTime":1268.767,"endTime":1272.104,"body":"on, on that part of it, at least"},{"speaker":"Steve Usdin","startTime":1272.104,"endTime":1276.508,"body":"until we have new technologies that"},{"speaker":"Steve Usdin","startTime":1272.104,"endTime":1276.508,"body":"dramatically reduce the need for um"},{"speaker":"Steve Usdin","startTime":1276.508,"endTime":1278.01,"body":"animal studies and things like that."},{"speaker":"Steve Usdin","startTime":1278.543,"endTime":1283.315,"body":"But what the United States isn't doing"},{"speaker":"Steve Usdin","startTime":1278.543,"endTime":1283.315,"body":"is taking a more parallel approach like"},{"speaker":"Steve Usdin","startTime":1283.548,"endTime":1286.351,"body":"is being done in China, and honestly,"},{"speaker":"Steve Usdin","startTime":1283.548,"endTime":1286.351,"body":"it's also being done in other countries,"},{"speaker":"Steve Usdin","startTime":1286.351,"endTime":1288.353,"body":"in Australia and the UK to some extent."},{"speaker":"Steve Usdin","startTime":1288.72,"endTime":1291.423,"body":"They're also looking at"},{"speaker":"Steve Usdin","startTime":1288.72,"endTime":1291.423,"body":"these parallel approaches."},{"speaker":"Steve Usdin","startTime":1291.757,"endTime":1294.159,"body":"There's pluses and minuses to doing that."},{"speaker":"Steve Usdin","startTime":1294.693,"endTime":1298.597,"body":"The main kind of negative in doing"},{"speaker":"Steve Usdin","startTime":1294.693,"endTime":1298.597,"body":"the kind of parallel approach"},{"speaker":"Steve Usdin","startTime":1298.597,"endTime":1302.801,"body":"that is being done in China is"},{"speaker":"Steve Usdin","startTime":1298.597,"endTime":1302.801,"body":"that  it's higher risk, right?"},{"speaker":"Steve Usdin","startTime":1302.901,"endTime":1306.872,"body":"Because if you're doing a lot of,"},{"speaker":"Steve Usdin","startTime":1302.901,"endTime":1306.872,"body":"for example, the, preclinical uh"},{"speaker":"Steve Usdin","startTime":1306.905,"endTime":1311.109,"body":"toxicology, and you're doing other"},{"speaker":"Steve Usdin","startTime":1306.905,"endTime":1311.109,"body":"things in parallel with the ethics"},{"speaker":"Steve Usdin","startTime":1311.109,"endTime":1315.347,"body":"review and with the regulatory review,"},{"speaker":"Steve Usdin","startTime":1311.109,"endTime":1315.347,"body":"it's possible that you'll hit a snag or"},{"speaker":"Steve Usdin","startTime":1315.347,"endTime":1319.651,"body":"even a roadblock on one aspect of it,"},{"speaker":"Steve Usdin","startTime":1315.347,"endTime":1319.651,"body":"and you'll have done a bunch of other"},{"speaker":"Steve Usdin","startTime":1319.651,"endTime":1321.286,"body":"work you know, that won't be used."},{"speaker":"Steve Usdin","startTime":1321.286,"endTime":1322.087,"body":"it'll, it'll be thrown out."},{"speaker":"Steve Usdin","startTime":1322.521,"endTime":1324.589,"body":"And I've heard it described, the"},{"speaker":"Steve Usdin","startTime":1322.521,"endTime":1324.589,"body":"Chinese approach as kind of a,"},{"speaker":"Steve Usdin","startTime":1324.623,"endTime":1326.024,"body":"a brute force approach, right?"},{"speaker":"Steve Usdin","startTime":1326.058,"endTime":1329.828,"body":"And the United States is taking, takes"},{"speaker":"Steve Usdin","startTime":1326.058,"endTime":1329.828,"body":"a more you could say more elegant or"},{"speaker":"Steve Usdin","startTime":1329.828,"endTime":1331.463,"body":"more phased approach to the whole thing."},{"speaker":"Steve Usdin","startTime":1331.963,"endTime":1337.102,"body":"But anyway, I think that, that's a summary"},{"speaker":"Steve Usdin","startTime":1331.963,"endTime":1337.102,"body":"of the US versus China aspect of it."},{"speaker":"Steve Usdin","startTime":1337.102,"endTime":1338.804,"body":"If you want, we can spend a little"},{"speaker":"Steve Usdin","startTime":1337.102,"endTime":1338.804,"body":"bit of time talking about the"},{"speaker":"Simone Fishburn","startTime":1339.037,"endTime":1340.072,"body":"So Steve, yeah, I"},{"speaker":"Steve Usdin","startTime":1340.172,"endTime":1340.739,"body":"what they're doing."},{"speaker":"Simone Fishburn","startTime":1341.239,"endTime":1343.141,"body":"I wanted to"},{"speaker":"Simone Fishburn","startTime":1341.239,"endTime":1343.141,"body":"dig in because you started this"},{"speaker":"Simone Fishburn","startTime":1343.141,"endTime":1346.845,"body":"with saying that, you know, the"},{"speaker":"Simone Fishburn","startTime":1343.141,"endTime":1346.845,"body":"US is slashing timelines, right?"},{"speaker":"Simone Fishburn","startTime":1347.145,"endTime":1351.35,"body":"And then you qualified that by saying"},{"speaker":"Simone Fishburn","startTime":1347.145,"endTime":1351.35,"body":"it's half, but still longer than China."},{"speaker":"Simone Fishburn","startTime":1351.883,"endTime":1358.19,"body":"So  one of the things that I find is that"},{"speaker":"Simone Fishburn","startTime":1351.883,"endTime":1358.19,"body":"a lot of the conversation really is about"},{"speaker":"Simone Fishburn","startTime":1358.223,"endTime":1363.195,"body":"China and about Australia, but there are"},{"speaker":"Simone Fishburn","startTime":1358.223,"endTime":1363.195,"body":"plenty of other places in the world that"},{"speaker":"Simone Fishburn","startTime":1363.195,"endTime":1367.432,"body":"we've been writing about that are also"},{"speaker":"Simone Fishburn","startTime":1363.195,"endTime":1367.432,"body":"changing at the same time you know, trying"},{"speaker":"Simone Fishburn","startTime":1367.432,"endTime":1369.735,"body":"to attract people to do clinical trials."},{"speaker":"Simone Fishburn","startTime":1370.202,"endTime":1374.172,"body":"And I sort of… I'm, I'm wondering,"},{"speaker":"Simone Fishburn","startTime":1370.202,"endTime":1374.172,"body":"you know, this is gonna be a big focus"},{"speaker":"Simone Fishburn","startTime":1374.172,"endTime":1378.643,"body":"for us going forward, but to what"},{"speaker":"Simone Fishburn","startTime":1374.172,"endTime":1378.643,"body":"degree do you think this is all in"},{"speaker":"Simone Fishburn","startTime":1378.643,"endTime":1383.315,"body":"sort of FDA policy hands versus the"},{"speaker":"Simone Fishburn","startTime":1378.643,"endTime":1383.315,"body":"hands of other players like academic"},{"speaker":"Simone Fishburn","startTime":1383.382,"endTime":1387.386,"body":"medical centers and, and pharma"},{"speaker":"Simone Fishburn","startTime":1383.382,"endTime":1387.386,"body":"companies' decision-making and so on?"},{"speaker":"Steve Usdin","startTime":1387.886,"endTime":1390.989,"body":"Well, so, that's actually a"},{"speaker":"Steve Usdin","startTime":1387.886,"endTime":1390.989,"body":"good segue because the most interesting"},{"speaker":"Steve Usdin","startTime":1390.989,"endTime":1396.695,"body":"part of FDA's plan is to establish"},{"speaker":"Steve Usdin","startTime":1390.989,"endTime":1396.695,"body":"a network of what they're calling"},{"speaker":"Steve Usdin","startTime":1396.695,"endTime":1402.467,"body":"qualified research institutions, QRIs"},{"speaker":"Steve Usdin","startTime":1396.695,"endTime":1402.467,"body":"that include academic medical centers,"},{"speaker":"Steve Usdin","startTime":1402.534,"endTime":1407.239,"body":"CROs, regulatory advisors, and these"},{"speaker":"Steve Usdin","startTime":1402.534,"endTime":1407.239,"body":"are third parties that are gonna partner"},{"speaker":"Steve Usdin","startTime":1407.239,"endTime":1412.043,"body":"with sponsors to review IND components"},{"speaker":"Steve Usdin","startTime":1407.239,"endTime":1412.043,"body":"before their formal submission."},{"speaker":"Steve Usdin","startTime":1412.544,"endTime":1417.582,"body":"That it's kind of an echo of or it's, it's"},{"speaker":"Steve Usdin","startTime":1412.544,"endTime":1417.582,"body":"reminiscent of what's done in Australia,"},{"speaker":"Steve Usdin","startTime":1417.783,"endTime":1421.052,"body":"but it's fundamentally different in o-"},{"speaker":"Steve Usdin","startTime":1417.783,"endTime":1421.052,"body":"in one important way, which is that in"},{"speaker":"Steve Usdin","startTime":1421.052,"endTime":1425.924,"body":"Australia, you have third party ethics"},{"speaker":"Steve Usdin","startTime":1421.052,"endTime":1425.924,"body":"committees that for low risk INDs have"},{"speaker":"Steve Usdin","startTime":1425.924,"endTime":1429.528,"body":"the authority to give the approvals"},{"speaker":"Steve Usdin","startTime":1425.924,"endTime":1429.528,"body":"or the okays for them to go ahead."},{"speaker":"Steve Usdin","startTime":1429.895,"endTime":1434.466,"body":"In the United States, FDA is still"},{"speaker":"Steve Usdin","startTime":1429.895,"endTime":1434.466,"body":"gonna maintain that final say so"},{"speaker":"Steve Usdin","startTime":1434.466,"endTime":1436.067,"body":"on whether an IND can go ahead."},{"speaker":"Steve Usdin","startTime":1436.234,"endTime":1439.871,"body":"But you're gonna see third parties"},{"speaker":"Steve Usdin","startTime":1436.234,"endTime":1439.871,"body":"playing a bigger role in the"},{"speaker":"Steve Usdin","startTime":1439.871,"endTime":1443.542,"body":"IND review process in the United"},{"speaker":"Steve Usdin","startTime":1439.871,"endTime":1443.542,"body":"States than they have in the past."},{"speaker":"Steve Usdin","startTime":1443.875,"endTime":1448.713,"body":"But the big issues are things like"},{"speaker":"Steve Usdin","startTime":1443.875,"endTime":1448.713,"body":"contracting with hospitals, ethics"},{"speaker":"Steve Usdin","startTime":1448.713,"endTime":1454.453,"body":"reviews, trying to get single IRBs"},{"speaker":"Steve Usdin","startTime":1448.713,"endTime":1454.453,"body":"for multi-site clinical trials."},{"speaker":"Steve Usdin","startTime":1454.853,"endTime":1457.956,"body":"And those are, those are in the plan,"},{"speaker":"Steve Usdin","startTime":1454.853,"endTime":1457.956,"body":"but they're things where the United"},{"speaker":"Steve Usdin","startTime":1457.956,"endTime":1462.794,"body":"States government has less leverage"},{"speaker":"Steve Usdin","startTime":1457.956,"endTime":1462.794,"body":"over it than some other countries do."},{"speaker":"Steve Usdin","startTime":1462.994,"endTime":1464.663,"body":"It's a less centralized system."},{"speaker":"Steve Usdin","startTime":1464.663,"endTime":1467.332,"body":"It's a more decentralized system in"},{"speaker":"Steve Usdin","startTime":1464.663,"endTime":1467.332,"body":"the United States than in other places."},{"speaker":"Steve Usdin","startTime":1467.966,"endTime":1470.802,"body":"And, and one of the other things that"},{"speaker":"Steve Usdin","startTime":1467.966,"endTime":1470.802,"body":"I think that's structurally that's the"},{"speaker":"Steve Usdin","startTime":1470.802,"endTime":1476.374,"body":"most interesting is in China and in some"},{"speaker":"Steve Usdin","startTime":1470.802,"endTime":1476.374,"body":"other countries, hospitals themselves"},{"speaker":"Steve Usdin","startTime":1476.408,"endTime":1480.846,"body":"play a bigger role in the regulatory"},{"speaker":"Steve Usdin","startTime":1476.408,"endTime":1480.846,"body":"system than they do in the United"},{"speaker":"Steve Usdin","startTime":1480.846,"endTime":1484.549,"body":"States, and they have more authority,"},{"speaker":"Steve Usdin","startTime":1480.846,"endTime":1484.549,"body":"and they have more accountability for"},{"speaker":"Steve Usdin","startTime":1484.583,"endTime":1489.321,"body":"regulating clinical trials and in some"},{"speaker":"Steve Usdin","startTime":1484.583,"endTime":1489.321,"body":"cases you know, even early commercial"},{"speaker":"Steve Usdin","startTime":1489.321,"endTime":1490.922,"body":"access than in the United States."},{"speaker":"Steve Usdin","startTime":1490.922,"endTime":1492.457,"body":"So it's, so it's a different model."},{"speaker":"Steve Usdin","startTime":1492.457,"endTime":1493.458,"body":"I think it's really fascinating."},{"speaker":"Steve Usdin","startTime":1493.458,"endTime":1496.061,"body":"We're seeing these different"},{"speaker":"Steve Usdin","startTime":1493.458,"endTime":1496.061,"body":"experiments, these different"},{"speaker":"Steve Usdin","startTime":1496.061,"endTime":1497.662,"body":"approaches tried around the world."},{"speaker":"Steve Usdin","startTime":1498.563,"endTime":1501.766,"body":"What really needs to happen um"},{"speaker":"Steve Usdin","startTime":1498.563,"endTime":1501.766,"body":"ultimately, what's gonna be the best"},{"speaker":"Steve Usdin","startTime":1501.766,"endTime":1505.57,"body":"for patients and what's gonna be best"},{"speaker":"Steve Usdin","startTime":1501.766,"endTime":1505.57,"body":"for the biopharma industry is to kind"},{"speaker":"Steve Usdin","startTime":1505.57,"endTime":1509.574,"body":"of step back and say, you know, w-what"},{"speaker":"Steve Usdin","startTime":1505.57,"endTime":1509.574,"body":"are these different countries doing"},{"speaker":"Steve Usdin","startTime":1509.574,"endTime":1513.211,"body":"around the world that are the most"},{"speaker":"Steve Usdin","startTime":1509.574,"endTime":1513.211,"body":"effective, that's the most efficient,"},{"speaker":"Steve Usdin","startTime":1513.512,"endTime":1517.282,"body":"and then everybody around the world"},{"speaker":"Steve Usdin","startTime":1513.512,"endTime":1517.282,"body":"kind of trying to recalibrate all the um"},{"speaker":"Steve Usdin","startTime":1517.282,"endTime":1521.086,"body":"regulatory agencies and, and governments"},{"speaker":"Steve Usdin","startTime":1517.282,"endTime":1521.086,"body":"around the world trying to recalibrate"},{"speaker":"Steve Usdin","startTime":1521.486,"endTime":1526.458,"body":"to incorporate the best aspects of"},{"speaker":"Steve Usdin","startTime":1521.486,"endTime":1526.458,"body":"learnings from arou-ar-around the world."},{"speaker":"Steve Usdin","startTime":1526.558,"endTime":1528.093,"body":"And this… Yeah."},{"speaker":"Lindsay Martin","startTime":1528.493,"endTime":1532.03,"body":"Oh, I was just gonna"},{"speaker":"Lindsay Martin","startTime":1528.493,"endTime":1532.03,"body":"touch on you, you mentioned uh hospitals"},{"speaker":"Lindsay Martin","startTime":1532.163,"endTime":1537.202,"body":"having, I guess, obligation for"},{"speaker":"Lindsay Martin","startTime":1532.163,"endTime":1537.202,"body":"trials and more of a responsibility."},{"speaker":"Lindsay Martin","startTime":1537.202,"endTime":1540.705,"body":"And I think one of the things that stood"},{"speaker":"Lindsay Martin","startTime":1537.202,"endTime":1540.705,"body":"out to me in, in reading your TrialBlazer"},{"speaker":"Lindsay Martin","startTime":1540.705,"endTime":1545.01,"body":"story was the planned components"},{"speaker":"Lindsay Martin","startTime":1540.705,"endTime":1545.01,"body":"for trial access and enrollment,"},{"speaker":"Lindsay Martin","startTime":1545.043,"endTime":1550.782,"body":"and how FDA can encourage clinicians"},{"speaker":"Lindsay Martin","startTime":1545.043,"endTime":1550.782,"body":"to increase enrollment in the US."},{"speaker":"Lindsay Martin","startTime":1550.815,"endTime":1553.685,"body":"Can you speak a little bit more"},{"speaker":"Lindsay Martin","startTime":1550.815,"endTime":1553.685,"body":"about, like, the details behind that?"},{"speaker":"Steve Usdin","startTime":1554.486,"endTime":1557.322,"body":"Well, it-- and I can't"},{"speaker":"Steve Usdin","startTime":1554.486,"endTime":1557.322,"body":"really give the details about it"},{"speaker":"Steve Usdin","startTime":1557.355,"endTime":1559.124,"body":"because the details aren't in the plan."},{"speaker":"Steve Usdin","startTime":1559.124,"endTime":1560.091,"body":"That's part of the problem."},{"speaker":"Steve Usdin","startTime":1560.392,"endTime":1563.562,"body":"That's kind of vague, and there's"},{"speaker":"Steve Usdin","startTime":1560.392,"endTime":1563.562,"body":"a little bit of, of-- I'd say a"},{"speaker":"Steve Usdin","startTime":1563.562,"endTime":1567.032,"body":"little bit of hand-waving in the,"},{"speaker":"Steve Usdin","startTime":1563.562,"endTime":1567.032,"body":"TrialBlazer  report about that."},{"speaker":"Steve Usdin","startTime":1567.299,"endTime":1571.369,"body":"But that really is one of the key things"},{"speaker":"Steve Usdin","startTime":1567.299,"endTime":1571.369,"body":"that has to happen in the United States."},{"speaker":"Steve Usdin","startTime":1571.369,"endTime":1576.575,"body":"There has to be a more efficient"},{"speaker":"Steve Usdin","startTime":1571.369,"endTime":1576.575,"body":"system and a much broader scope for"},{"speaker":"Steve Usdin","startTime":1576.608,"endTime":1579.21,"body":"bringing patients into clinical trials."},{"speaker":"Steve Usdin","startTime":1579.477,"endTime":1583.882,"body":"The percentage of patients who have"},{"speaker":"Steve Usdin","startTime":1579.477,"endTime":1583.882,"body":"cancers that can't be effectively cured"},{"speaker":"Steve Usdin","startTime":1583.882,"endTime":1588.053,"body":"in the United States who participate"},{"speaker":"Steve Usdin","startTime":1583.882,"endTime":1588.053,"body":"in clinical research is very small."},{"speaker":"Steve Usdin","startTime":1588.153,"endTime":1589.988,"body":"it should be very, very large."},{"speaker":"Steve Usdin","startTime":1590.055,"endTime":1594.492,"body":"Most, most cancer patients, I think, who"},{"speaker":"Steve Usdin","startTime":1590.055,"endTime":1594.492,"body":"who have a cancer that can't be readily"},{"speaker":"Steve Usdin","startTime":1594.492,"endTime":1598.563,"body":"controlled using an approved therapy"},{"speaker":"Steve Usdin","startTime":1594.492,"endTime":1598.563,"body":"should be on a clinical trial, and"},{"speaker":"Steve Usdin","startTime":1598.563,"endTime":1601.833,"body":"that's for their benefit, and it's also"},{"speaker":"Steve Usdin","startTime":1598.563,"endTime":1601.833,"body":"for the benefit of the system because"},{"speaker":"Steve Usdin","startTime":1601.833,"endTime":1603.735,"body":"it's gonna lead to faster innovation"},{"speaker":"Lindsay Martin","startTime":1604.202,"endTime":1606.504,"body":"Yeah, that was"},{"speaker":"Lindsay Martin","startTime":1604.202,"endTime":1606.504,"body":"definitely something that came up at"},{"speaker":"Lindsay Martin","startTime":1606.504,"endTime":1610.208,"body":"the Seattle Grand Rounds Conference"},{"speaker":"Lindsay Martin","startTime":1606.504,"endTime":1610.208,"body":"too in discussing what are some of"},{"speaker":"Lindsay Martin","startTime":1610.208,"endTime":1613.745,"body":"the actionable steps that, that we"},{"speaker":"Lindsay Martin","startTime":1610.208,"endTime":1613.745,"body":"can do to increase trial enrollment."},{"speaker":"Lindsay Martin","startTime":1613.745,"endTime":1618.183,"body":"And, and yeah, I think having better"},{"speaker":"Lindsay Martin","startTime":1613.745,"endTime":1618.183,"body":"patient education and clinician"},{"speaker":"Lindsay Martin","startTime":1618.183,"endTime":1619.718,"body":"engagement will help with that"},{"speaker":"Steve Usdin","startTime":1620.051,"endTime":1620.385,"body":"Yeah."},{"speaker":"Steve Usdin","startTime":1620.452,"endTime":1623.321,"body":"So one of the things that's in the"},{"speaker":"Steve Usdin","startTime":1620.452,"endTime":1623.321,"body":"plan, the, the TrialBlazer plan, is"},{"speaker":"Steve Usdin","startTime":1623.321,"endTime":1628.526,"body":"an idea to link electronic health"},{"speaker":"Steve Usdin","startTime":1623.321,"endTime":1628.526,"body":"records to clinicaltrials.gov so you"},{"speaker":"Steve Usdin","startTime":1628.526,"endTime":1632.864,"body":"can identify patients who would be"},{"speaker":"Steve Usdin","startTime":1628.526,"endTime":1632.864,"body":"good candidates for clinical trials."},{"speaker":"Steve Usdin","startTime":1633.298,"endTime":1635.834,"body":"That's something that's"},{"speaker":"Steve Usdin","startTime":1633.298,"endTime":1635.834,"body":"gonna take long time to do."},{"speaker":"Steve Usdin","startTime":1636.034,"endTime":1640.472,"body":"If it's done right and if it's done"},{"speaker":"Steve Usdin","startTime":1636.034,"endTime":1640.472,"body":"relatively fast, which will probably"},{"speaker":"Steve Usdin","startTime":1640.472,"endTime":1644.743,"body":"mean, you know, in, in the scope of"},{"speaker":"Steve Usdin","startTime":1640.472,"endTime":1644.743,"body":"a year or two or three to get going,"},{"speaker":"Steve Usdin","startTime":1644.876,"endTime":1649.547,"body":"that's something that potentially could"},{"speaker":"Steve Usdin","startTime":1644.876,"endTime":1649.547,"body":"increase clinical trial enr- enrollment"},{"speaker":"Steve Usdin","startTime":1649.547,"endTime":1651.983,"body":"in the United States if it's done"},{"speaker":"Steve Usdin","startTime":1649.547,"endTime":1651.983,"body":"along with other things in the package"},{"speaker":"Stephen Hansen","startTime":1653.985,"endTime":1656.087,"body":"So Steve, I wanted"},{"speaker":"Stephen Hansen","startTime":1653.985,"endTime":1656.087,"body":"to uh to ask you about another"},{"speaker":"Stephen Hansen","startTime":1656.087,"endTime":1657.288,"body":"one of your, your, the topics."},{"speaker":"Stephen Hansen","startTime":1657.288,"endTime":1662.727,"body":"Um, so you know, while FDA is moving"},{"speaker":"Stephen Hansen","startTime":1657.288,"endTime":1662.727,"body":"forward on clinical trial reforms  the"},{"speaker":"Stephen Hansen","startTime":1662.727,"endTime":1666.731,"body":"agency's also taking a new look at"},{"speaker":"Stephen Hansen","startTime":1662.727,"endTime":1666.731,"body":"therapies that were derailed under Martry"},{"speaker":"Stephen Hansen","startTime":1666.731,"endTime":1668.867,"body":"Makary and Vinny Prasad's uh regime."},{"speaker":"Stephen Hansen","startTime":1669.334,"endTime":1673.538,"body":"I think we've counted up to 11 reversals"},{"speaker":"Stephen Hansen","startTime":1669.334,"endTime":1673.538,"body":"so far in kind of what appears to be a,"},{"speaker":"Stephen Hansen","startTime":1673.905,"endTime":1675.407,"body":"you might call a reversion to the mean."},{"speaker":"Stephen Hansen","startTime":1675.974,"endTime":1677.008,"body":"So can you maybe fill us in"},{"speaker":"Steve Usdin","startTime":1677.308,"endTime":1677.642,"body":"to the mean."},{"speaker":"Stephen Hansen","startTime":1678.176,"endTime":1679.844,"body":"what you did"},{"speaker":"Stephen Hansen","startTime":1678.176,"endTime":1679.844,"body":"call a reversion to the mean."},{"speaker":"Stephen Hansen","startTime":1680.245,"endTime":1683.114,"body":"So y- can you fill us in maybe on"},{"speaker":"Stephen Hansen","startTime":1680.245,"endTime":1683.114,"body":"what the latest one of those was?"},{"speaker":"Stephen Hansen","startTime":1683.114,"endTime":1686.284,"body":"And, you know, what I'm curious"},{"speaker":"Stephen Hansen","startTime":1683.114,"endTime":1686.284,"body":"about is whether this signals to"},{"speaker":"Stephen Hansen","startTime":1686.284,"endTime":1692.157,"body":"investors and companies a return to"},{"speaker":"Stephen Hansen","startTime":1686.284,"endTime":1692.157,"body":"business as usual at FDA or, or not."},{"speaker":"Steve Usdin","startTime":1692.557,"endTime":1694.859,"body":"so yeah, so,"},{"speaker":"Steve Usdin","startTime":1692.557,"endTime":1694.859,"body":"so I had a story last week."},{"speaker":"Steve Usdin","startTime":1694.859,"endTime":1696.461,"body":"I, I totted up 11 products."},{"speaker":"Steve Usdin","startTime":1696.461,"endTime":1700.265,"body":"They're not all products that have"},{"speaker":"Steve Usdin","startTime":1696.461,"endTime":1700.265,"body":"received approvals, but they're"},{"speaker":"Steve Usdin","startTime":1700.265,"endTime":1705.103,"body":"all products that either had a, a"},{"speaker":"Steve Usdin","startTime":1700.265,"endTime":1705.103,"body":"complete response letter or some"},{"speaker":"Steve Usdin","startTime":1705.103,"endTime":1710.041,"body":"other kind of setback that the company"},{"speaker":"Steve Usdin","startTime":1705.103,"endTime":1710.041,"body":"announced from advice from, from the"},{"speaker":"Steve Usdin","startTime":1710.041,"endTime":1714.412,"body":"path that they were on prior to uh"},{"speaker":"Steve Usdin","startTime":1710.041,"endTime":1714.412,"body":"Makary, Prasad, and now they seem"},{"speaker":"Steve Usdin","startTime":1714.412,"endTime":1716.915,"body":"to be back onto a more normal path."},{"speaker":"Steve Usdin","startTime":1717.182,"endTime":1720.351,"body":"It's unlikely that every single one"},{"speaker":"Steve Usdin","startTime":1717.182,"endTime":1720.351,"body":"of them is gonna get approved, but"},{"speaker":"Steve Usdin","startTime":1720.585,"endTime":1722.52,"body":"probably a lot of them are going to be."},{"speaker":"Steve Usdin","startTime":1722.787,"endTime":1728.026,"body":"The most recent one was Regenxbio's"},{"speaker":"Steve Usdin","startTime":1722.787,"endTime":1728.026,"body":"therapy for an MPS, for MPS II."},{"speaker":"Steve Usdin","startTime":1728.226,"endTime":1731.963,"body":"That's a, a very rare"},{"speaker":"Steve Usdin","startTime":1728.226,"endTime":1731.963,"body":"neurodegenerative disease."},{"speaker":"Steve Usdin","startTime":1732.397,"endTime":1738.403,"body":"FDA had i- issued a, a CRL and they"},{"speaker":"Steve Usdin","startTime":1732.397,"endTime":1738.403,"body":"basically had, They'd questioned or"},{"speaker":"Steve Usdin","startTime":1738.403,"endTime":1742.24,"body":"they'd, they'd said that they'd changed"},{"speaker":"Steve Usdin","startTime":1738.403,"endTime":1742.24,"body":"their mind about the kind of fundamental"},{"speaker":"Steve Usdin","startTime":1742.24,"endTime":1746.611,"body":"aspects, the endpoint, the clinical"},{"speaker":"Steve Usdin","startTime":1742.24,"endTime":1746.611,"body":"trial design, the patient population."},{"speaker":"Steve Usdin","startTime":1746.878,"endTime":1750.949,"body":"And it really disheartened"},{"speaker":"Steve Usdin","startTime":1746.878,"endTime":1750.949,"body":"MPS II families."},{"speaker":"Steve Usdin","startTime":1750.949,"endTime":1754.552,"body":"I spoke with some of the, the,"},{"speaker":"Steve Usdin","startTime":1750.949,"endTime":1754.552,"body":"the parents, and they were um"},{"speaker":"Steve Usdin","startTime":1754.552,"endTime":1755.92,"body":"they were devastated by this."},{"speaker":"Steve Usdin","startTime":1755.92,"endTime":1761.392,"body":"They felt that FDA was completely off"},{"speaker":"Steve Usdin","startTime":1755.92,"endTime":1761.392,"body":"base in its assertions, and that they're"},{"speaker":"Steve Usdin","startTime":1761.392,"endTime":1766.097,"body":"really not only yanking the rug out"},{"speaker":"Steve Usdin","startTime":1761.392,"endTime":1766.097,"body":"from underneath kids who have MPS II"},{"speaker":"Steve Usdin","startTime":1766.097,"endTime":1770.335,"body":"who might benefit from this therapy, but"},{"speaker":"Steve Usdin","startTime":1766.097,"endTime":1770.335,"body":"more broadly from uh neurodegenerative"},{"speaker":"Steve Usdin","startTime":1770.335,"endTime":1775.306,"body":"diseases because investors would shy away"},{"speaker":"Steve Usdin","startTime":1770.335,"endTime":1775.306,"body":"from investing in any companies  in the"},{"speaker":"Steve Usdin","startTime":1775.306,"endTime":1777.075,"body":"space as a result of what FDA had done."},{"speaker":"Steve Usdin","startTime":1777.442,"endTime":1783.214,"body":"So now FDA has reversed its position"},{"speaker":"Steve Usdin","startTime":1777.442,"endTime":1783.214,"body":"according to a statement from the company."},{"speaker":"Steve Usdin","startTime":1783.414,"endTime":1788.486,"body":"they're allowing the submission to"},{"speaker":"Steve Usdin","startTime":1783.414,"endTime":1788.486,"body":"proceed along the, the lines that it"},{"speaker":"Steve Usdin","startTime":1788.486,"endTime":1790.889,"body":"had been prior to Ma- Makary and Prasad."},{"speaker":"Steve Usdin","startTime":1791.122,"endTime":1794.893,"body":"So you know, we'll, we'll see what"},{"speaker":"Steve Usdin","startTime":1791.122,"endTime":1794.893,"body":"happens, but this is something that the"},{"speaker":"Steve Usdin","startTime":1794.893,"endTime":1800.198,"body":"parents and other companies are watching"},{"speaker":"Steve Usdin","startTime":1794.893,"endTime":1800.198,"body":"really closely because it'll say a lot"},{"speaker":"Steve Usdin","startTime":1800.198,"endTime":1803.868,"body":"about whether, for example FDA is willing"},{"speaker":"Steve Usdin","startTime":1800.198,"endTime":1803.868,"body":"to accept external natural history"},{"speaker":"Steve Usdin","startTime":1803.868,"endTime":1807.372,"body":"controls in these very rare diseases."},{"speaker":"Steve Usdin","startTime":1807.505,"endTime":1811.176,"body":"it's gonna say whether it's gonna"},{"speaker":"Steve Usdin","startTime":1807.505,"endTime":1811.176,"body":"go back on track, to honor the"},{"speaker":"Steve Usdin","startTime":1811.176,"endTime":1814.279,"body":"commitments that it had made"},{"speaker":"Steve Usdin","startTime":1811.176,"endTime":1814.279,"body":"earlier in the development program."},{"speaker":"Steve Usdin","startTime":1814.913,"endTime":1818.016,"body":"And um you know, it seems like"},{"speaker":"Steve Usdin","startTime":1814.913,"endTime":1818.016,"body":"all that's gonna, gonna happen."},{"speaker":"Steve Usdin","startTime":1818.183,"endTime":1821.486,"body":"You know, as we talked uh about,"},{"speaker":"Steve Usdin","startTime":1818.183,"endTime":1821.486,"body":"there's, 10 other programs that"},{"speaker":"Steve Usdin","startTime":1821.686,"endTime":1823.688,"body":"are also uh, getting back on track"},{"speaker":"Stephen Hansen","startTime":1824.389,"endTime":1824.722,"body":"Right."},{"speaker":"Stephen Hansen","startTime":1825.29,"endTime":1829.861,"body":"So, I mean, all this is happening"},{"speaker":"Stephen Hansen","startTime":1825.29,"endTime":1829.861,"body":"under a sort of an interim"},{"speaker":"Stephen Hansen","startTime":1830.094,"endTime":1831.796,"body":"leadership, correct, at FDA."},{"speaker":"Stephen Hansen","startTime":1832.43,"endTime":1835.934,"body":"And so I guess it raises, you know, the"},{"speaker":"Stephen Hansen","startTime":1832.43,"endTime":1835.934,"body":"question it raises to me is, does this--"},{"speaker":"Stephen Hansen","startTime":1836.467,"endTime":1841.94,"body":"is there any risk that once new FDA"},{"speaker":"Stephen Hansen","startTime":1836.467,"endTime":1841.94,"body":"leadership does step in, the permanent"},{"speaker":"Stephen Hansen","startTime":1842.073,"endTime":1846.544,"body":"new leadership steps in, is there, is"},{"speaker":"Stephen Hansen","startTime":1842.073,"endTime":1846.544,"body":"there any concern that, these, this kind"},{"speaker":"Stephen Hansen","startTime":1846.544,"endTime":1850.415,"body":"of, this reversion to the mean could,"},{"speaker":"Stephen Hansen","startTime":1846.544,"endTime":1850.415,"body":"could revert back to an outlier stance?"},{"speaker":"Stephen Hansen","startTime":1850.448,"endTime":1853.084,"body":"You know, is this, is this the end"},{"speaker":"Stephen Hansen","startTime":1850.448,"endTime":1853.084,"body":"of the political influence over FDA"},{"speaker":"Stephen Hansen","startTime":1853.451,"endTime":1856.221,"body":"decision-making, or is it, is, is"},{"speaker":"Stephen Hansen","startTime":1853.451,"endTime":1856.221,"body":"there still a risk that that could,"},{"speaker":"Stephen Hansen","startTime":1856.287,"endTime":1857.856,"body":"that could rear its ugly head again?"},{"speaker":"Steve Usdin","startTime":1858.223,"endTime":1861.292,"body":"Look, this, this has"},{"speaker":"Steve Usdin","startTime":1858.223,"endTime":1861.292,"body":"been a rollercoaster ride under um in"},{"speaker":"Steve Usdin","startTime":1861.292,"endTime":1865.53,"body":"the second uh Trump administration,"},{"speaker":"Steve Usdin","startTime":1861.292,"endTime":1865.53,"body":"and uh anybody who predicts uh with,"},{"speaker":"Steve Usdin","startTime":1865.597,"endTime":1870.435,"body":"with real confidence where things are"},{"speaker":"Steve Usdin","startTime":1865.597,"endTime":1870.435,"body":"going is either extraordinarily uh"},{"speaker":"Steve Usdin","startTime":1870.435,"endTime":1872.47,"body":"knowledgeable or extraordinarily foolish."},{"speaker":"Steve Usdin","startTime":1872.77,"endTime":1875.206,"body":"Uh, and I … So I'm not gonna,"},{"speaker":"Steve Usdin","startTime":1872.77,"endTime":1875.206,"body":"I'm not gonna try to do that."},{"speaker":"Steve Usdin","startTime":1875.206,"endTime":1879.11,"body":"But I, I agree, yeah, look, it's really"},{"speaker":"Steve Usdin","startTime":1875.206,"endTime":1879.11,"body":"important who the next commissioner is."},{"speaker":"Steve Usdin","startTime":1879.244,"endTime":1883.314,"body":"It's also gonna be important who's gonna"},{"speaker":"Steve Usdin","startTime":1879.244,"endTime":1883.314,"body":"take on the CDER and CBER directorship"},{"speaker":"Steve Usdin","startTime":1883.314,"endTime":1885.316,"body":"roles in a, a permanent basis."},{"speaker":"Steve Usdin","startTime":1885.516,"endTime":1888.62,"body":"The rumors that are going around"},{"speaker":"Steve Usdin","startTime":1885.516,"endTime":1888.62,"body":"Washington are that uh we're"},{"speaker":"Steve Usdin","startTime":1888.62,"endTime":1892.357,"body":"gonna see a nomination for an"},{"speaker":"Steve Usdin","startTime":1888.62,"endTime":1892.357,"body":"FDA commissioner pretty soon."},{"speaker":"Steve Usdin","startTime":1892.624,"endTime":1896.06,"body":"there are, you know, some names that"},{"speaker":"Steve Usdin","startTime":1892.624,"endTime":1896.06,"body":"are uh that are being talked about."},{"speaker":"Stephen Hansen","startTime":1896.294,"endTime":1897.829,"body":"I was gonna say, do"},{"speaker":"Stephen Hansen","startTime":1896.294,"endTime":1897.829,"body":"you have any, do you have any names?"},{"speaker":"Steve Usdin","startTime":1898.463,"endTime":1900.932,"body":"So, well, look, I've been"},{"speaker":"Steve Usdin","startTime":1898.463,"endTime":1900.932,"body":"holding off on, on naming the names."},{"speaker":"Steve Usdin","startTime":1900.932,"endTime":1902.8,"body":"I've been hearing the same"},{"speaker":"Steve Usdin","startTime":1900.932,"endTime":1902.8,"body":"names that other reporters have"},{"speaker":"Steve Usdin","startTime":1902.8,"endTime":1904.469,"body":"been hearing for about a month."},{"speaker":"Steve Usdin","startTime":1905.203,"endTime":1908.539,"body":"they, they're getting, they're getting"},{"speaker":"Steve Usdin","startTime":1905.203,"endTime":1908.539,"body":"named uh you know, more frequently"},{"speaker":"Steve Usdin","startTime":1908.539,"endTime":1910.108,"body":"now, so, so I'll bring them up."},{"speaker":"Steve Usdin","startTime":1910.108,"endTime":1912.01,"body":"Look, so one of them is Heidi Overton."},{"speaker":"Steve Usdin","startTime":1912.277,"endTime":1917.715,"body":"another one is uh Jeffrey Vacirca,"},{"speaker":"Steve Usdin","startTime":1912.277,"endTime":1917.715,"body":"and another one is Stephen Ferrara."},{"speaker":"Steve Usdin","startTime":1917.882,"endTime":1920.251,"body":"Those are the three that"},{"speaker":"Steve Usdin","startTime":1917.882,"endTime":1920.251,"body":"seem to be in the lead."},{"speaker":"Steve Usdin","startTime":1920.451,"endTime":1923.788,"body":"Overton is uh deputy director of the"},{"speaker":"Steve Usdin","startTime":1920.451,"endTime":1923.788,"body":"White House Domestic Policy Council."},{"speaker":"Steve Usdin","startTime":1923.788,"endTime":1927.625,"body":"Before that, she was uh at the"},{"speaker":"Steve Usdin","startTime":1923.788,"endTime":1927.625,"body":"America First Policy Institute."},{"speaker":"Steve Usdin","startTime":1927.625,"endTime":1932.23,"body":"She's closely aligned with the uh"},{"speaker":"Steve Usdin","startTime":1927.625,"endTime":1932.23,"body":"MAHA movement and, and with Makary."},{"speaker":"Steve Usdin","startTime":1932.664,"endTime":1937.468,"body":"Vacirca is CEO of the Board of New"},{"speaker":"Steve Usdin","startTime":1932.664,"endTime":1937.468,"body":"York Cancer and Blood Specialists,"},{"speaker":"Steve Usdin","startTime":1937.468,"endTime":1939.971,"body":"and is past president of the"},{"speaker":"Steve Usdin","startTime":1937.468,"endTime":1939.971,"body":"Community Oncology Alliance."},{"speaker":"Steve Usdin","startTime":1940.371,"endTime":1943.741,"body":"And Ferrara  he's been chief"},{"speaker":"Steve Usdin","startTime":1940.371,"endTime":1943.741,"body":"medical officer for the Navy."},{"speaker":"Steve Usdin","startTime":1943.942,"endTime":1947.178,"body":"He served in the CIA, and he's in"},{"speaker":"Steve Usdin","startTime":1943.942,"endTime":1947.178,"body":"a job at the, at the Pentagon now."},{"speaker":"Steve Usdin","startTime":1947.679,"endTime":1951.349,"body":"None of the three of them are"},{"speaker":"Steve Usdin","startTime":1947.679,"endTime":1951.349,"body":"traditional candidates for the job."},{"speaker":"Steve Usdin","startTime":1951.449,"endTime":1952.283,"body":"They're not, they don't"},{"speaker":"Stephen Hansen","startTime":1952.383,"endTime":1954.619,"body":"I'm gonna say it didn't,"},{"speaker":"Stephen Hansen","startTime":1952.383,"endTime":1954.619,"body":"didn't sound like they have the same"},{"speaker":"Stephen Hansen","startTime":1954.619,"endTime":1957.155,"body":"resumes of maybe past commissioners,"},{"speaker":"Steve Usdin","startTime":1957.388,"endTime":1958.79,"body":"No, no, they, they don't."},{"speaker":"Steve Usdin","startTime":1958.79,"endTime":1961.492,"body":"So it's not really clear"},{"speaker":"Steve Usdin","startTime":1958.79,"endTime":1961.492,"body":"what they would do."},{"speaker":"Steve Usdin","startTime":1961.693,"endTime":1965.63,"body":"I think that a- any one of them,"},{"speaker":"Steve Usdin","startTime":1961.693,"endTime":1965.63,"body":"if they get um confirmed, is likely"},{"speaker":"Steve Usdin","startTime":1965.63,"endTime":1970.802,"body":"to be under more control from"},{"speaker":"Steve Usdin","startTime":1965.63,"endTime":1970.802,"body":"downtown, from HHS, particularly"},{"speaker":"Steve Usdin","startTime":1970.868,"endTime":1975.84,"body":"from Chris Klomp who's effectively"},{"speaker":"Steve Usdin","startTime":1970.868,"endTime":1975.84,"body":"running HHS now, than Makary was."},{"speaker":"Steve Usdin","startTime":1975.84,"endTime":1979.077,"body":"I think that the Trump 2 administration"},{"speaker":"Steve Usdin","startTime":1975.84,"endTime":1979.077,"body":"has kind of learned its lesson."},{"speaker":"Steve Usdin","startTime":1979.077,"endTime":1983.581,"body":"It doesn't really want to see bold"},{"speaker":"Steve Usdin","startTime":1979.077,"endTime":1983.581,"body":"um you know, media, especially um"},{"speaker":"Steve Usdin","startTime":1983.581,"endTime":1987.318,"body":"high-profile media moves from um"},{"speaker":"Steve Usdin","startTime":1983.581,"endTime":1987.318,"body":"the FDA commissioner going forward."},{"speaker":"Steve Usdin","startTime":1987.685,"endTime":1990.922,"body":"But we don't know what any one"},{"speaker":"Steve Usdin","startTime":1987.685,"endTime":1990.922,"body":"of these three really would do,"},{"speaker":"Steve Usdin","startTime":1990.922,"endTime":1992.156,"body":"what their attitudes would be."},{"speaker":"Steve Usdin","startTime":1992.39,"endTime":1995.593,"body":"And a- again, I think that the critical"},{"speaker":"Steve Usdin","startTime":1992.39,"endTime":1995.593,"body":"thing, since none of them have deep"},{"speaker":"Steve Usdin","startTime":1995.593,"endTime":1999.964,"body":"experience at FDA, none of them have"},{"speaker":"Steve Usdin","startTime":1995.593,"endTime":1999.964,"body":"deep experience with the regulatory"},{"speaker":"Steve Usdin","startTime":1999.964,"endTime":2004.769,"body":"system, if any one of the three of"},{"speaker":"Steve Usdin","startTime":1999.964,"endTime":2004.769,"body":"these is nominated and confirmed, the,"},{"speaker":"Steve Usdin","startTime":2004.802,"endTime":2009.307,"body":"the really critical thing is going"},{"speaker":"Steve Usdin","startTime":2004.802,"endTime":2009.307,"body":"to be who's running CBER and CDER."},{"speaker":"Steve Usdin","startTime":2009.64,"endTime":2012.91,"body":"And, and I think we're gonna find"},{"speaker":"Steve Usdin","startTime":2009.64,"endTime":2012.91,"body":"out all at once because the slate is"},{"speaker":"Steve Usdin","startTime":2012.91,"endTime":2015.847,"body":"gonna be announced  all at once, and"},{"speaker":"Steve Usdin","startTime":2012.91,"endTime":2015.847,"body":"it, it could be as soon as this week"},{"speaker":"Stephen Hansen","startTime":2016.714,"endTime":2016.914,"body":"Yeah."},{"speaker":"Stephen Hansen","startTime":2017.281,"endTime":2017.682,"body":"Interesting."},{"speaker":"Stephen Hansen","startTime":2017.682,"endTime":2020.451,"body":"Well, I'm sure you'll be keeping"},{"speaker":"Stephen Hansen","startTime":2017.682,"endTime":2020.451,"body":"abreast of the rumor mill, Steve,"},{"speaker":"Stephen Hansen","startTime":2020.451,"endTime":2023.621,"body":"as uh as the week progresses,"},{"speaker":"Stephen Hansen","startTime":2020.451,"endTime":2023.621,"body":"so you can look out for that."},{"speaker":"Stephen Hansen","startTime":2023.654,"endTime":2025.623,"body":"Otherwise you know, really fascinating."},{"speaker":"Stephen Hansen","startTime":2025.623,"endTime":2026.224,"body":"Thanks, Steve."},{"speaker":"Stephen Hansen","startTime":2026.257,"endTime":2029.427,"body":"Uh, you can find all of those"},{"speaker":"Stephen Hansen","startTime":2026.257,"endTime":2029.427,"body":"stories on FDA reforms and renewed"},{"speaker":"Stephen Hansen","startTime":2029.427,"endTime":2032.33,"body":"regulatory decisions at biocentury.com."},{"speaker":"Stephen Hansen","startTime":2032.897,"endTime":2036.0,"body":"I think that is all that"},{"speaker":"Stephen Hansen","startTime":2032.897,"endTime":2036.0,"body":"we have time for today."},{"speaker":"Stephen Hansen","startTime":2036.234,"endTime":2040.238,"body":"Before you go don't miss our latest"},{"speaker":"Stephen Hansen","startTime":2036.234,"endTime":2040.238,"body":"BioCentury Show in which my colleague"},{"speaker":"Stephen Hansen","startTime":2040.238,"endTime":2045.109,"body":"Jeff Cranmer is in conversation"},{"speaker":"Stephen Hansen","startTime":2040.238,"endTime":2045.109,"body":"with Hengrui's Frank Jiang, they go"},{"speaker":"Stephen Hansen","startTime":2045.109,"endTime":2049.68,"body":"behind the curtain on deals and R\u0026D"},{"speaker":"Stephen Hansen","startTime":2045.109,"endTime":2049.68,"body":"at China's top biopharma company."},{"speaker":"Stephen Hansen","startTime":2049.981,"endTime":2050.948,"body":"Thanks for tuning in."},{"speaker":"Stephen Hansen","startTime":2051.049,"endTime":2052.116,"body":"we will see you next week"}]}