Ep. 314 - Prasad, Lilly Obesity, Acadia & Biosecure

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<v Jeff Cranmer>Eli Lilly released new obesity data last week.

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<v Jeff Cranmer>It did not impress investors, but was it all that bad?

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<v Jeff Cranmer>On the latest BioCentury?

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<v Jeff Cranmer>This week podcast will discuss why Lilly's oral GLP-1 should have a leg up in the market.

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<v Jeff Cranmer>Plus we will talk about revamping a 30-year-old biotech Acadia, the return of the Biosecure Act, and we'll touch on Vene Prasad's return to FDA.

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<v Jeff Cranmer>Joining me to discuss all of this are.

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<v Simone Fishburn>Simon Fishburn, editor-in-chief.

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<v Stephen Hansen>Steven Hanson, director of.

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<v Stephen Hansen>Biopharm intelligence.

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<v Selina Koch>And Selina Koch, executive editor.

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<v Jeff Cranmer>All right.

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<v Jeff Cranmer>The whirlwind, year at FDA continues, our colleague, Steve, would normally be all over this, but he has, uh, skipped town to enjoy his usual August vacation.

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<v Jeff Cranmer>And so Simone, why don't you fill us in on what is happening in your neck of the woods?

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<v Simone Fishburn>Yeah, never a dull moment here in DC in this particular era.

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<v Simone Fishburn>so as you pointed out, Vene Prasad is back, head of CBER.

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<v Simone Fishburn>That's the Center for Biologics and Evaluation Research.

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<v Simone Fishburn>I got that right.

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<v Simone Fishburn>Some words in that order, like that CBER and um.

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<v Jeff Cranmer>Put a D in there then.

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<v Jeff Cranmer>Then

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<v Simone Fishburn>so therein lies the story, right?

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<v Simone Fishburn>Because he is basically, as I'm sure all our listeners know, we won't get into that much detail.

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<v Simone Fishburn>He is and was, the head of the unit that regulates biologics, like cell and gene therapies in addition, of course to vaccines.

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<v Simone Fishburn>A highly charged topic in this particular administration.

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<v Simone Fishburn>I don't think we'll know and ever know.

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<v Simone Fishburn>He really went, went on behind the scenes, but he tended his resignation, what is it, Jeff?

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<v Simone Fishburn>Two weeks ago?

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<v Jeff Cranmer>something around then.

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<v Simone Fishburn>two weeks ago.

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<v Simone Fishburn>And then,

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<v Stephen Hansen>He tendered.

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<v Stephen Hansen>He tendered it long enough ago to go to Italy and then come back.

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<v Simone Fishburn>So, you know, now he's back and there's really a lot of conversations.

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<v Simone Fishburn>'cause he actually went to spend more time with his family as somebody who's about to spend a lot of time with their family.

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<v Simone Fishburn>I'm kind of wondering, with a lot of family, I'm kinda wondering whether he was like, you know what, running CBER is easier than this.

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<v Jeff Cranmer>Yeah.

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<v Jeff Cranmer>Yeah.

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<v Jeff Cranmer>My mom's like will come visit me, she begs me to live closer than she.

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<v Jeff Cranmer>Visits and she's like, you know,  It's like fish three days and it starts to stink.

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<v Jeff Cranmer>You know?

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<v Jeff Cranmer>It's like, mom, but mom, I'm your

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<v Simone Fishburn>Well, I gotta tell you, I'm trying to put together just to get some people together  of my family coming from all over the world.

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<v Simone Fishburn>Find a time where we can all celebrate a very, you know, happy engagement and, really running CBER easier.

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<v Simone Fishburn>I, I gotta say that running even in this time, but I do know that there are other theories.

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<v Simone Fishburn>Steven, do you wanna give one of the other theories?

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<v Stephen Hansen>Yeah.

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<v Stephen Hansen>Well, so as I sort of alluded to, I think one of the theories was that he just hadn't earned enough of his PTO time, and so this was sort of a way to.

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<v Stephen Hansen>Uh, be able to get off on a nice little vacation and then, uh, and then come right back.

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<v Stephen Hansen>So, uh, yeah, I mean it's, it's actually something I might, might consider.

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<v Stephen Hansen>Maybe, I don't know.

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<v Simone Fishburn>Well try it.

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<v Simone Fishburn>Just try it, Stephen.

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<v Simone Fishburn>Go ahead.

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<v Simone Fishburn>Just try it.

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<v Simone Fishburn>I, I may not be as loving as the people, you know.

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<v Simone Fishburn>They were desperate, Makary was very keen for him to come back.

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<v Stephen Hansen>You're not going to be my Marty, not to be my Marty Makary, Simone, uh, beg me to come back and.

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<v Simone Fishburn>go ahead Selina.

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<v Simone Fishburn>You wanna bring us back

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<v Selina Koch>Gonna,

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<v Simone Fishburn>Earth, don't you?

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<v Simone Fishburn>the big, uh, the big downside here, right?

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<v Simone Fishburn>Which is that constant upheaval, one thing after another.

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<v Simone Fishburn>It could probably be the worst part of this for the industry.

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<v Simone Fishburn>Yeah, I think that's it.

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<v Simone Fishburn>You know, and  Steve is certainly gonna get into this when he comes back, but let's just go through a few of the things that have happened, which is.

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<v Simone Fishburn>Prasad beforehand had been very, very critical of Peter Marks his predecessor for overruling, decisions made by the staff under him, right, in terms of approvals.

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<v Simone Fishburn>Prasad then came in and did exactly the same thing himself.

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<v Simone Fishburn>In addition to that, what actually happened is the Replimune cases one, but there were a couple of others.

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<v Simone Fishburn>We talked about it previously on the pod.

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<v Simone Fishburn>There were CBER decisions or CRLs that basically reversed what the former FDA guidance had been.

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<v Simone Fishburn>And now after he went, all the biopharmas were like, well, what does this mean going forward?

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<v Simone Fishburn>Now he's back, they're still like, what does this mean going forward?

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<v Simone Fishburn>so to your point of uncertainty, Selina, you know, I think there's a certain level of uncertainty, but there might be people going, hang on, we were just getting used to Prasad beginning to understand and not everybody disagreed with everything he did.

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<v Simone Fishburn>Just to be very clear.

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<v Simone Fishburn>there's that sort of, we don't know what the uncertainty, we are uncertain about the uncertainty level is what I'm trying to say.

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<v Selina Koch>Yeah.

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<v Selina Koch>Like how long is he back is Makary, you know?

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<v Selina Koch>I dunno.

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<v Jeff Cranmer>I, I, I think as we were talking about earlier, Simone, like, you were saying on our, morning editorial call that you know, you, you're out talking to CEOs and.

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<v Jeff Cranmer>The one thing they wanna know is when will this biotech winter end and, and now you've gotta lump in this turmoil at FDA.

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<v Jeff Cranmer>The constant changing as part of that.

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<v Jeff Cranmer>'cause biotechs just need to plan.

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<v Jeff Cranmer>They need to know what the regulatory pathways are.

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<v Simone Fishburn>I mean, I think a couple of things, um, are becoming clear.

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<v Simone Fishburn>So the administration's pullback on mRNA funding, is part of this big picture.

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<v Simone Fishburn>It is just impossible seeing Prasad, for me to see Prasad take a stance that is very pro-vaccine that is gonna push back and say, no mRNA vaccines actually have saved many lives.

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<v Simone Fishburn>That's not what he said in the past.

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<v Simone Fishburn>So I think that, having him there, or even anyone under this administration in that particular.

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<v Simone Fishburn>Part of drug development.

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<v Simone Fishburn>I think we all know that that is,  a, I would say a big cloud.

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<v Simone Fishburn>I think many people feel it's, it's really a bad situation for FDA to be in and public health to be in.

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<v Simone Fishburn>But there's another thing that is kind of becoming clear, which is that he, even though Peter Marks had a pretty high profile, it wasn't a higher profile than the head of CDA, and right now Prasad is getting.

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<v Simone Fishburn>More ink, should we say more headlines, more attention than the head of CDER.

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<v Simone Fishburn>And it sort of suggests that he might have more power there.

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<v Simone Fishburn>Now he's back.

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<v Simone Fishburn>He's actually got tremendous power, arguably.

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<v Simone Fishburn>And so, it'll be very interesting as we pointed out and discussed on our call before, Jeff, because what he's in charge of, which is sort of cell and gene therapies, is really not the majority of drug development.

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<v Simone Fishburn>And yet that's where a lot of the attention is.

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<v Selina Koch>Is he back as Chief Scientific and Medical Officer over FDA.

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<v Selina Koch>And does he also like the the commissioner's prior new priority voucher?

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<v Selina Koch>Is he still in charge of that as well?

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<v Simone Fishburn>we don't know that yet.

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<v Simone Fishburn>at least the last thing I saw, at least before coming on this pod, I, I hadn't seen anything confirming that.

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<v Simone Fishburn>But we do know that  the FDA Commissioner, Marty Makary is a big fan of Prasad's.

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<v Jeff Cranmer>That is true.

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<v Jeff Cranmer>That is true.

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<v Jeff Cranmer>Alright, well, Steve, uh, as Simone said, he'll be back, he'll dig into this and, uh,

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<v Simone Fishburn>To say it with fancier words and just a lot more insight, let's be honest, PTO.

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<v Simone Fishburn>You

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<v Jeff Cranmer>bet.

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<v Jeff Cranmer>Well, this all fits nicely into our annual Back to School issue, the theme of Back to School and.

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<v Jeff Cranmer>As we believe in equity here at BioCentury, many of our longtime readers know, we always publish Back to School right around Labor Day when kids on the east coast of America are going Back to School.

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<v Jeff Cranmer>But hey, Selina and I are already starting to make, those, delicious sandwiches for our kids' lunch this week as they're heading Back to School this week.

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<v Jeff Cranmer>So what better to do than to.

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<v Jeff Cranmer>Publish Back to School this week and then return once our friends in Europe are back from vacation and double dip and release, the package once again complete with a podcast as well.

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<v Jeff Cranmer>And so if you're newer to BioCentury and you don't know what Back to School is, well we've been doing it every year since BioCentury, David.

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<v Jeff Cranmer>Flores and Karen Bernstein founded BioCentury more than three decades ago.

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<v Jeff Cranmer>It is a forward looking package that looks at a broad issue critical to the biopharma industry.

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<v Jeff Cranmer>Here to give us a sneak peek is Simone.

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<v Simone Fishburn>Well, thank you, Jeff.

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<v Simone Fishburn>First of all, I would say I really hated making those school lunches so much that I didn't do it.

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<v Simone Fishburn>Either my husband did it or they did it themselves, so that's my advice to people.

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<v Simone Fishburn>Get your spouse or your kids to make their own.

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<v Simone Fishburn>But if you don't want parenting advice from me, I'm here to help tell you.

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<v Simone Fishburn>and mine turned out pretty good actually, I have to say.

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<v Simone Fishburn>But anyway, I'm here to tell you about, um, Back to School.

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<v Simone Fishburn>And now that he's not here, I can say really incredibly good things about Steve Den.

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<v Simone Fishburn>I know that he doesn't listen to the pod afterwards, but he has written this year's Back to School.

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<v Simone Fishburn>It's really phenomenal and it really shows the deep.

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<v Simone Fishburn>Insights he has and the many years experience, he has like literally decades of covering FDA and his deep sources in FDA and XFDA.

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<v Simone Fishburn>And you'll understand that many of them will not want to have been,  identified.

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<v Simone Fishburn>But I also wanna make it very clear what this Back to School.

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<v Simone Fishburn>Is about, and we would've written it actually that same topic, any administration, any environment.

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<v Simone Fishburn>It's really about how would you build FDA from scratch if you could redo it.

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<v Simone Fishburn>Most people understand and know, and there've been moves afoot to redesign and reorganize, FDA I think maybe that's just become heightened now, but that's really been a.

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<v Simone Fishburn>Priority for a lot of people for a long while.

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<v Simone Fishburn>And so what we did is we sort of said, okay, let's do the thought exercise.

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<v Simone Fishburn>It's just you've got a, a blank slate.

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<v Simone Fishburn>How would you build FDA for today and the future of medicines?

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<v Simone Fishburn>And I'll let Selina weigh in with a few more thoughts in a minute.

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<v Simone Fishburn>Just to let you know that that is the main topic, reimagining FDA.

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<v Simone Fishburn>It is not about today's FDA.

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<v Simone Fishburn>It is about what it should look like.

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<v Simone Fishburn>We do go down the history.

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<v Simone Fishburn>We have a pretty nice history and some good graphics, and Steve talks about how it should be structured and brings up some provocative concepts.

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<v Simone Fishburn>Selina, do you wanna add anything to that?

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<v Selina Koch>Hmm.

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<v Selina Koch>Well on the historical piece of it, I think people are often surprised when they learn that there was a day when drugs were approved first in Europe, so outside the US and US was sort of a secondary destination.

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<v Selina Koch>some of the policies and the, the developments along the timeline that got us to how we are.

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<v Selina Koch>you know where we are today and how FDA also came to be a place that regulated tobacco,  and cosmetics and all of these things.

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<v Selina Koch>there's a lot of interesting stuff in there that helps you understand the current kind of state of play.

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<v Selina Koch>But yeah, going forward, I mean, do we wanna get into the prescriptions he has in there or leave it for readers to read?

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<v Simone Fishburn>We'll leave it for readers to read,

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<v Jeff Cranmer>Well, we'll have goodies for you every day this week.

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<v Jeff Cranmer>Either one or more stories.

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<v Jeff Cranmer>starting Monday, running through Friday, and then once we come back from the Labor Day vacation in the US that's, September 1st this year,  We'll, put out the whole package in one go and we'll follow up with the podcast and, uh, we look forward to having you read it as it's the biggest thing we publish every year.

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<v Jeff Cranmer>We're going to take a quick break and then we're gonna take a look at Lilly's obesity data and more.

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<v Alanna Farro>BioCentury This Week is brought to you by BioCentury Grand Rounds Europe.

00:11:52.311 --> 00:11:57.582
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<v Alanna Farro>Register and learn more at BioCenturyGrandRoundsEurope.com.

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<v Jeff Cranmer>We are back and well, last week, Phase III, data from Lilly's oral GLP-1 in obesity fell well short of investors expectations.

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<v Jeff Cranmer>Steven, did they expect too much?

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<v Stephen Hansen>Jeff, yeah, so as you say, the, uh, headline news was that, orforglipron the name for their small molecule, GLP-1, showed about 11.5% placebo adjusted efficacy on weight loss.

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<v Stephen Hansen>this resulted in literally losing what is the equivalent of a Vertex pharma in market cap they lost about $95 billion.

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<v Stephen Hansen>The worry from the buy side stems from two things.

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<v Stephen Hansen>first, in Phase II, that same dose of orforglipron showed about 11.2% placebo adjusted weight loss at 36 weeks.

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<v Stephen Hansen>in that data, the trend line didn't really appear to be plateauing.

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<v Stephen Hansen>So, you can understand why you would kind of hope that those responses would've been stronger after 72 weeks.

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<v Stephen Hansen>secondly, I saw a lot of chatter about concerns of other oral therapies that are gonna be coming.

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<v Stephen Hansen>That now they would expect, will show better efficacy.

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<v Stephen Hansen>So that's Vikings VK2735, which has Phase II data coming this quarter,  for the oral formulation.

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<v Stephen Hansen>and then also, uh, oral amycretin from Novo Nordisk, which is heading into Phase III testing soon.

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<v Stephen Hansen>so I just wanna say a few things on each of those points, to base solely on the Phase II data readout.

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<v Stephen Hansen>I think it's entirely fair to call the data the Phase III data.

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<v Stephen Hansen>disappointing.

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<v Stephen Hansen>What I think investors may have gotten given a little bit too low of a credence to was the signal or what you could maybe say, the red flag that we got in June from the Phase III data in Type 2 diabetes.

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<v Stephen Hansen>what's pretty well established now is that GLP-1s don't provide as much weight loss in diabetic patients as they do in obesity patients.

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<v Stephen Hansen>And if you go back and look at some of the other, semaglutide, tirzepatide, other molecules that have been further along and have had Phase III data in both settings.

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<v Stephen Hansen>What you typically see is that, for both those programs, it's about 40 to 50% less weight loss in diabetic patients than obese patients.

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<v Stephen Hansen>So when we saw 6% placebo adjusted weight loss in the Phase III diabetes study for orforglipron.

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<v Stephen Hansen>That could have been a bit of a warning to investors that maybe their expectations were a little overwrought.

00:14:45.717 --> 00:15:00.298
<v Stephen Hansen>' cause if you extrapolate, if you kind of apply the same assumptions that you're gonna see, 40 to 50% less weight loss in diabetes for or that basically points you to an 11 to 12% readout in obesity, which is what we got.

00:15:00.599 --> 00:15:01.600
<v Stephen Hansen>so that's the first point.

00:15:02.100 --> 00:15:02.835
<v Stephen Hansen>secondly.

00:15:03.235 --> 00:15:08.606
<v Stephen Hansen>There are gonna probably be other oral obesity therapies that are gonna come out with better efficacy data.

00:15:09.041 --> 00:15:11.143
<v Stephen Hansen>I think that's, that's a perfectly fair assumption to have.

00:15:11.509 --> 00:15:19.217
<v Stephen Hansen>what I think people need to still take into consideration is, the advantage you have is a small molecule relative to a peptide.

00:15:19.717 --> 00:15:25.624
<v Stephen Hansen>the first, uh, you know, I mentioned Viking and amycretin, but really the first competitor is gonna be.

00:15:25.791 --> 00:15:29.327
<v Stephen Hansen>Novo is 25 milligram oral dose of semaglutide.

00:15:29.595 --> 00:15:31.062
<v Stephen Hansen>So that's already under review.

00:15:31.330 --> 00:15:34.566
<v Stephen Hansen>Probably gonna get approved before orforglipron is gonna get approved.

00:15:34.866 --> 00:15:39.370
<v Stephen Hansen>that showed 13.9% placebo adjusted weight loss in their Phase III study.

00:15:39.571 --> 00:15:45.610
<v Stephen Hansen>the issue is, orforglipron, showed numerically better GI tolerability than semaglutide in the Phase III setting.

00:15:45.910 --> 00:15:52.784
<v Stephen Hansen>small molecule didn't show any liver to, which is a known sort of problem with the small molecule GLP-1 programs.

00:15:53.152 --> 00:15:59.825
<v Stephen Hansen>And again,  being a small molecule, Lilly has a clear advantage in terms of scaling up manufacturing and meeting patient demand.

00:16:00.558 --> 00:16:07.166
<v Selina Koch>And what about, the manufacturing advantage of a, I mean, there's oral, but there's oral peptide and there's oral small molecule.

00:16:08.067 --> 00:16:08.500
<v Stephen Hansen>that's right.

00:16:08.667 --> 00:16:17.743
<v Stephen Hansen>Yeah, no, that's a good point, Slee, and I think that's, I guess I would say I'm still skeptical about when it comes to the oral peptides and their ability to really, dominate the obesity market.

00:16:18.277 --> 00:16:22.413
<v Stephen Hansen>So just using the 25 milligram semaglutide as an example.

00:16:22.780 --> 00:16:26.518
<v Stephen Hansen>So for the 25 milligram once daily dose, that's now under review.

00:16:26.985 --> 00:16:39.630
<v Stephen Hansen>That's 73 times the amount of API needed to treat an obesity patient for one week, as compared to Novos once a weekly Wegovy, that's a lot more peptide that they would need to manufacture to meet.

00:16:40.065 --> 00:16:44.068
<v Stephen Hansen>Patients on an oral dose, then they would need to meet on an injectable dose.

00:16:44.570 --> 00:16:47.105
<v Stephen Hansen>And it's a similar thing as you get into some of the other ones.

00:16:47.105 --> 00:17:01.120
<v Stephen Hansen>So we're saying 25 milligrams for semaglutide, they had an efficacious dose at 50 milligrams that they chose not to submit for regulatory approval because of concerns about being able to meet manufacturing capacity and scale.

00:17:01.519 --> 00:17:08.727
<v Stephen Hansen>and I think some of the other peptides, the later ones like Viking and like oral amycretin, those are a hundred milligrams a day being tested.

00:17:08.727 --> 00:17:12.530
<v Stephen Hansen>So that's an even larger amount of API peptide, API that would be required.

00:17:12.964 --> 00:17:23.142
<v Stephen Hansen>So that scalability issue, I think is still a major barrier for an oral peptide therapy, you know, taking a leadership position in this market.

00:17:23.375 --> 00:17:40.392
<v Stephen Hansen>It's not to say that they can't get approved, and it's not to say that they can't be commercialized, but I don't think an oral peptide therapy is gonna have the ability to, sort of steal, start stealing the market and steal demand when you have an oral, small molecule that has much better scalability, much better cogs.

00:17:40.558 --> 00:17:44.529
<v Stephen Hansen>And I think that's the other thing that people are maybe discounting with the small molecule.

00:17:44.930 --> 00:17:50.903
<v Stephen Hansen>I mean, I think Lilly's gonna have a lot more pricing power and ability to potentially price other people out of the market if they really wanted to.

00:17:51.103 --> 00:18:01.814
<v Stephen Hansen>so that's, you know, from my mind,  I think that is just something that maybe investors weren't giving as much, uh, attention to as they maybe should have when all they were worried about was sort of what the headline number was.

00:18:02.713 --> 00:18:05.384
<v Simone Fishburn>Steven, this is maybe a naive question, but.

00:18:05.817 --> 00:18:09.654
<v Simone Fishburn>the obesity medications have just made this massive impact.

00:18:09.654 --> 00:18:16.361
<v Simone Fishburn>I know we're gonna have a lot of, uh, funds unintended here and really shaping reshaping society.

00:18:16.361 --> 00:18:17.028
<v Simone Fishburn>Lily is.

00:18:17.429 --> 00:18:19.030
<v Simone Fishburn>Literally laughing on the way to the bank.

00:18:19.030 --> 00:18:21.599
<v Simone Fishburn>I think Novo Well's done pretty well.

00:18:22.000 --> 00:18:28.574
<v Simone Fishburn>Novo, I know we talked about last week, I sort of wonder, are investors getting greedy in as much as their expectations?

00:18:28.874 --> 00:18:30.709
<v Simone Fishburn>I mean, we talked about this offline, right?

00:18:30.709 --> 00:18:33.811
<v Simone Fishburn>I mean, the results were in any normal world quite good.

00:18:34.113 --> 00:18:35.079
<v Simone Fishburn>They just weren't amazing.

00:18:36.347 --> 00:18:41.053
<v Simone Fishburn>is investor expectation just unrealistic or is that just the way of the world?

00:18:41.286 --> 00:18:44.823
<v Simone Fishburn>You make this far and now you've just always gotta,

00:18:45.156 --> 00:18:55.366
<v Stephen Hansen>I think, I think that's part of it Part of it is that I think Lilly is one of the most closely followed and most closely covered from a sell side perspective, you know, biopharma companies that we have.

00:18:55.834 --> 00:19:08.346
<v Stephen Hansen>And so I think when you have that and you keep hitting, you know, price target bars and these sorts of things, and I'm not calling out any specific, you know, specific signal on this, but you might have situations where like, okay, well how are we gonna get more growth out of this stock?

00:19:08.346 --> 00:19:11.884
<v Stephen Hansen>We know, what do we need to see,  you know, they hit 700, they hit 800.

00:19:12.116 --> 00:19:21.058
<v Stephen Hansen>Well, if, if our new price target's $950, what sort of, you know, growth metrics do we need to see in the future or peak sales metrics do we need to see to be able to justify that?

00:19:21.292 --> 00:19:30.568
<v Stephen Hansen>And you plug it into your model and all of a sudden, you have this sort of consensus that, orforglipron was gonna be a $40 to $50 billion a year peak sales drug.

00:19:30.769 --> 00:19:32.471
<v Stephen Hansen>And that's what expectations were at.

00:19:32.604 --> 00:19:34.705
<v Stephen Hansen>And so then when you see this sort of a number.

00:19:35.140 --> 00:19:49.086
<v Stephen Hansen>they have to downgrade expectations to just $25 billion a year, That's where I think sometimes these can kind of run a bit out of hand because I mean, my overall takeaway is that, the data weren't to home run, but they're fine.

00:19:49.153 --> 00:19:50.689
<v Stephen Hansen>I mean, this is an approval of drug.

00:19:50.821 --> 00:20:01.400
<v Stephen Hansen>It's gonna get used and in the context of how I think the obesity market's going to sort of evolve here, I think that there's gonna be a segment of patients where really high levels of efficacy are what they're gonna be needing.

00:20:01.400 --> 00:20:06.204
<v Stephen Hansen>And so you're gonna have these high efficacy injectables that are gonna fit, a small portion of the population.

00:20:06.571 --> 00:20:11.009
<v Stephen Hansen>But then there's gonna be a majority of patients who aren't gonna need 20% weight loss.

00:20:11.009 --> 00:20:12.778
<v Stephen Hansen>They're gonna be fine with 10 to 15%.

00:20:12.944 --> 00:20:15.681
<v Stephen Hansen>that's where something like this, I think could, could really work.

00:20:15.681 --> 00:20:17.182
<v Stephen Hansen>You get patients down to a healthy weight.

00:20:17.615 --> 00:20:25.457
<v Stephen Hansen>and so I think you combine that with the scalability advantage, the cogs, you know, potential price pricing advantage that you can have here.

00:20:25.790 --> 00:20:27.826
<v Stephen Hansen>I don't see why this isn't gonna do really well for them.

00:20:28.460 --> 00:20:31.630
<v Jeff Cranmer>Steven, what's next as far as, uh, data milestones?

00:20:32.631 --> 00:20:32.763
<v Stephen Hansen>Yeah.

00:20:32.763 --> 00:20:41.240
<v Stephen Hansen>So I think the next really important one will be data that should be coming up either end of this year, could be early next year, but it's, um, Phase III data from their maintenance study.

00:20:41.606 --> 00:20:49.914
<v Stephen Hansen>so here Lilly is looking at patients who actually completed treatment in the, SURMOUNT-5 study, which was the study of, tirzepatide, Zepbound.

00:20:50.382 --> 00:20:52.317
<v Stephen Hansen>Head to head versus, Wegovy.

00:20:52.784 --> 00:21:04.663
<v Stephen Hansen>And then they essentially were immediately enrolled into this study where they're taking orforglipron or placebo for a year to see whether they can maintain their weight loss after having basically come off an injectable.

00:21:05.196 --> 00:21:11.435
<v Stephen Hansen>And so this is a segment of the obesity market that there are a lot of people are aiming for.

00:21:12.304 --> 00:21:32.223
<v Stephen Hansen>So I know, you know, when people talk about amylin monotherapy or Activin's myostatin, siRNAs, all of them are really excited and really hyped about the idea of a maintenance setting where you can, basically, people are on an injectable, they get their weight down and then they transition to something else to help them keep that weight off so they don't have the rebound.

00:21:32.590 --> 00:21:34.292
<v Stephen Hansen>And this is what Lilly's testing.

00:21:34.292 --> 00:21:40.632
<v Stephen Hansen>So they're seeing whether their oral GLP-1 can help keep that weight off, long-term post injection.

00:21:40.632 --> 00:21:51.076
<v Stephen Hansen>And so I think this will be really interesting to see what the data reads out like, and I think it'll be really interesting to give us a sense as to how Lilly is thinking about in terms of positioning, this product going forward.

00:21:51.076 --> 00:21:55.380
<v Stephen Hansen>But, um, that's, that's sort of the next big shoe to drop, I think, for this program, towards the end of the year.

00:21:56.013 --> 00:21:56.515
<v Jeff Cranmer>Excellent.

00:21:56.515 --> 00:21:58.349
<v Jeff Cranmer>Thanks for that update, Steven.

00:21:58.750 --> 00:22:01.053
<v Jeff Cranmer>Let's turn to Acadia.

00:22:01.053 --> 00:22:04.489
<v Jeff Cranmer>This is one of my favorite types of story in biotech.

00:22:04.655 --> 00:22:11.128
<v Jeff Cranmer>We have a company that is, well, they're as old as BioCentury, about 32 years old.

00:22:11.430 --> 00:22:15.032
<v Jeff Cranmer>and they are on the comeback path.

00:22:15.032 --> 00:22:19.037
<v Jeff Cranmer>They've made a pivot to rare disease and they've.

00:22:19.637 --> 00:22:23.208
<v Jeff Cranmer>Rebuilt the management team and Selina took a closer look.

00:22:23.208 --> 00:22:24.009
<v Jeff Cranmer>Selina, what did you learn?

00:22:24.742 --> 00:22:26.611
<v Selina Koch>Let's be cautiously optimistic here.

00:22:26.611 --> 00:22:30.816
<v Selina Koch>They got a long way to go, but, Yeah, this is a classic biotech story.

00:22:31.148 --> 00:22:35.186
<v Selina Koch>so they got an approval back in 2016,  for a drug called Nuplazid.

00:22:35.220 --> 00:22:38.757
<v Selina Koch>It treats,  psychosis related to Parkinson's disease.

00:22:38.923 --> 00:22:46.464
<v Selina Koch>So a lot of people think of that as a motor disease, which it is, but it also can have, psychosis associated with it and it's mechanism.

00:22:46.565 --> 00:22:51.502
<v Selina Koch>It's a inverse agonist for the serotonin 5-HT2A receptor for the aficionados out there.

00:22:51.936 --> 00:22:54.405
<v Selina Koch>they thought it could be useful For a wide variety of things.

00:22:54.405 --> 00:23:02.079
<v Selina Koch>So psychosis and other settings, such as in dementia at large or Alzheimer's, more specifically, in schizophrenia.

00:23:02.079 --> 00:23:06.451
<v Selina Koch>And then outside of psychosis, even in depression, which is a very large indication.

00:23:06.451 --> 00:23:09.820
<v Selina Koch>And they started, you know, marching through them, running the trials.

00:23:09.820 --> 00:23:13.458
<v Selina Koch>And then it was just kind of one, let down after another there.

00:23:13.924 --> 00:23:16.060
<v Selina Koch>slashing, you know, their market cap.

00:23:16.361 --> 00:23:17.362
<v Selina Koch>Quite a lot.

00:23:17.695 --> 00:23:22.366
<v Selina Koch>And they started their kind of retooling, a while ago.

00:23:22.733 --> 00:23:31.675
<v Selina Koch>and their kind of big first step toward, you know, if we can call it a comeback, the beginnings of a comeback, um, was an approval in a rare disease.

00:23:31.942 --> 00:23:35.946
<v Selina Koch>so then near the end of the middle of 20 24, they got a new CEO.

00:23:36.280 --> 00:23:51.730
<v Selina Koch>and they had just got a new head of R&D and the new CEO brought on kind of new managers for the commercial side of things, because she had saw a big opportunity in their new drug, their new rare disease drug, Daybue, which was the first, and I think remains still the only, therapy for Rett syndrome.

00:23:52.130 --> 00:23:55.400
<v Selina Koch>and we've seen some wins on that front.

00:23:55.733 --> 00:23:57.969
<v Selina Koch>they have been growing those sales.

00:23:58.603 --> 00:24:07.045
<v Selina Koch>Modernizing the way they go about commercialization, and I think the next step for them is really showing that they can have more programs behind this one.

00:24:07.945 --> 00:24:17.888
<v Simone Fishburn>Yeah, I think it's always interesting, you know, we talk a lot about new companies, but there's a lot of very good, veteran companies, longer standing companies, maybe.

00:24:18.222 --> 00:24:21.226
<v Simone Fishburn>I think it looks to me like the board is doing its job, right?

00:24:21.226 --> 00:24:23.961
<v Simone Fishburn>The board is saying, bring in new management.

00:24:23.961 --> 00:24:25.297
<v Simone Fishburn>Let's look at what we've got.

00:24:25.297 --> 00:24:28.266
<v Simone Fishburn>Let's, let's work out how we maximize value here.

00:24:28.666 --> 00:24:36.208
<v Simone Fishburn>So they've sort of pivoted to a focus on rare disease and they say they've expanding sort of beyond just neuro.

00:24:36.974 --> 00:24:40.479
<v Simone Fishburn>most of their products are still within the neuro area.

00:24:40.479 --> 00:24:41.011
<v Simone Fishburn>Right.

00:24:41.011 --> 00:24:41.880
<v Simone Fishburn>If I got that right.

00:24:41.880 --> 00:24:49.086
<v Simone Fishburn>And can you just talk a little bit about how much they're building versus licensing in to, create the pipeline?

00:24:49.820 --> 00:24:52.757
<v Selina Koch>so I wouldn't say that they've like pivoted wholesale to rare.

00:24:52.824 --> 00:24:58.696
<v Selina Koch>I think what they're doing is diversifying their pipeline in a way that diversifies their risk.

00:24:58.896 --> 00:25:02.500
<v Selina Koch>Like they certainly feel that rare disease is an area where they can.

00:25:02.834 --> 00:25:04.769
<v Selina Koch>play and win is the way they talk about it.

00:25:05.170 --> 00:25:11.942
<v Selina Koch>they're also, you know, reasonably sized opportunities for a company of their size to go after alone.

00:25:12.410 --> 00:25:22.820
<v Selina Koch>and some of those are coming in through deals, but they also have some large indication, big risk, but big opportunity that's in their pipeline as well.

00:25:22.820 --> 00:25:24.256
<v Selina Koch>So they have a Nuplazid.

00:25:24.623 --> 00:25:28.960
<v Selina Koch>Follow on compound, that they've inherited from the former management team.

00:25:29.528 --> 00:25:38.737
<v Selina Koch>That it was designed in-house through the use of contractors and whatnot, to solve some of the issues of the, of Nuplazid.

00:25:38.737 --> 00:25:45.175
<v Selina Koch>So dial down the QT elongation that was preventing them from pushing the dose or whatever.

00:25:45.175 --> 00:25:48.547
<v Selina Koch>And so they're taking that now into Alzheimer's.

00:25:48.547 --> 00:25:54.586
<v Selina Koch>It's in Phase II and Alzheimer's psychosis, about to be in Phase II for Lewy body, psychosis.

00:25:54.920 --> 00:25:56.354
<v Selina Koch>that could be quite a large drug.

00:25:57.154 --> 00:25:59.089
<v Selina Koch>but then some of the other like things they're bringing in through deals.

00:25:59.089 --> 00:25:59.223
<v Selina Koch>Yeah.

00:26:00.157 --> 00:26:02.626
<v Stephen Hansen>Selina, I was just wondering, does this in some ways also just kind of highlight the.

00:26:03.461 --> 00:26:14.105
<v Stephen Hansen>higher risk that comes with being a neuro only focused company, because I, I feel like I see a lot of parallels though between what Acadia is doing and for instance, like what Biogen did, right?

00:26:14.105 --> 00:26:25.983
<v Stephen Hansen>Because Biogen made that pivot to being a neuro only focused company, and that eventually proved to be too much from a risk perspective and they had to re diversify essentially and get more into immunology and stuff.

00:26:25.983 --> 00:26:27.152
<v Stephen Hansen>And so I'm wondering if there's.

00:26:27.184 --> 00:26:29.820
<v Stephen Hansen>I, I just feel like I see a lot of parallels here between the two of them.

00:26:29.988 --> 00:26:30.454
<v Selina Koch>Yeah.

00:26:30.689 --> 00:26:31.556
<v Selina Koch>More than that.

00:26:31.690 --> 00:26:35.894
<v Selina Koch>I think we're seeing the long time neuro focus companies diversify their risk.

00:26:36.327 --> 00:26:41.532
<v Selina Koch>Before that was also UCB, which also brought, like Biogen brought in neurology.

00:26:41.932 --> 00:26:50.040
<v Selina Koch>There was Lundbeck, who's a good maybe comparator to Acadia, a psych company that now also is doing rare disease.

00:26:50.642 --> 00:26:54.846
<v Selina Koch>Some neurology that's rare,  I think they, we see all the long time players.

00:26:55.880 --> 00:26:57.281
<v Selina Koch>I think neuro is still hard.

00:26:57.548 --> 00:26:59.351
<v Selina Koch>Yeah, we've made a lot of progress.

00:26:59.351 --> 00:27:01.385
<v Selina Koch>There is a new biomarker toolkit.

00:27:01.385 --> 00:27:07.858
<v Selina Koch>There are some, targets that have some genetic rationale behind them, even if they're not causative in their own right.

00:27:07.858 --> 00:27:11.261
<v Selina Koch>And so these are all steps in the right direction, but it's still a high risk area.

00:27:12.096 --> 00:27:13.030
<v Stephen Hansen>I think that's a great takeaway.

00:27:13.064 --> 00:27:14.231
<v Stephen Hansen>Just neuro is still really hard.

00:27:15.299 --> 00:27:15.900
<v Selina Koch>Yeah.

00:27:16.300 --> 00:27:23.875
<v Jeff Cranmer>Selina, one thing you got into in your piece is how, the new CEO Catherine Owen Adams has rebuilt the team.

00:27:23.875 --> 00:27:27.278
<v Jeff Cranmer>She, took over the top job 10 months ago.

00:27:27.278 --> 00:27:32.116
<v Jeff Cranmer>She's a commercial leader with experience at BMS and j and j.

00:27:32.517 --> 00:27:34.419
<v Jeff Cranmer>she is, uh, added some people.

00:27:34.419 --> 00:27:38.556
<v Jeff Cranmer>She's added Thomas Garner as Chief Commercial.

00:27:38.690 --> 00:27:42.093
<v Jeff Cranmer>the new SVP of Rare Disease.

00:27:42.292 --> 00:27:47.298
<v Jeff Cranmer>that's Allyson McMillan-Youngblood and a new head of RD too.

00:27:47.332 --> 00:27:49.099
<v Jeff Cranmer>Uh, Elizabeth Thompson.

00:27:49.401 --> 00:27:59.678
<v Jeff Cranmer>she actually joined right before Owen Adams and has since brought on a new VP of Translational Sciences, Rachael, Hawtin.

00:28:00.310 --> 00:28:07.152
<v Selina Koch>And now they have, a new role for them as part of this like whole modernizing,  company and how they make decisions.

00:28:07.551 --> 00:28:10.020
<v Selina Koch>They have a chief data and information officer.

00:28:10.221 --> 00:28:11.189
<v Jeff Cranmer>Uh, yes, that's right.

00:28:11.355 --> 00:28:11.823
<v Selina Koch>and I think.

00:28:11.955 --> 00:28:12.723
<v Jeff Cranmer>last week, right?

00:28:13.057 --> 00:28:15.426
<v Selina Koch>Yeah, that was, that was very recently last week.

00:28:15.426 --> 00:28:15.559
<v Selina Koch>Yeah.

00:28:15.559 --> 00:28:16.661
<v Selina Koch>Just before their earnings.

00:28:16.694 --> 00:28:40.384
<v Selina Koch>Um, and, and what they keep saying with their messaging right, is by having, much closer contact between commercial and r and d and now, you know, this data and information role and commercial and r and d, they wanna be, making decisions in a way that really optimizes, spots where this company can sort of uniquely play and bring something differentiated, to patients.

00:28:40.785 --> 00:28:41.385
<v Jeff Cranmer>Excellent.

00:28:41.385 --> 00:28:45.022
<v Jeff Cranmer>Well Selina's, piece up on BioCentury dot com.

00:28:45.022 --> 00:28:48.526
<v Jeff Cranmer>I'll drop a link in the show notes, company to watch.

00:28:48.526 --> 00:28:50.228
<v Jeff Cranmer>We'll be watching what they get up to.

00:28:50.627 --> 00:28:52.696
<v Jeff Cranmer>now we'll turn to Bio Secure.

00:28:52.696 --> 00:28:53.798
<v Jeff Cranmer>It's back.

00:28:54.031 --> 00:28:58.803
<v Jeff Cranmer>originally, uh, launched in January of 2024.

00:28:59.104 --> 00:29:13.617
<v Jeff Cranmer>it has been introduced as an amendment in a must pass defense bill, and I caught up with Steve on Friday to discuss this, right before he skedaddled, for vacation.

00:29:13.852 --> 00:29:16.621
<v Jeff Cranmer>so we'll turn to Steve now and my conversation with him.

00:29:17.087 --> 00:29:18.722
<v Jeff Cranmer>Steve, let's get right to it.

00:29:18.823 --> 00:29:24.729
<v Jeff Cranmer>You broke the news on Friday that the Biosecure Act is back.

00:29:24.929 --> 00:29:25.763
<v Jeff Cranmer>What's the deal?

00:29:26.498 --> 00:29:32.237
<v Steve Usdin>so it's not called the Biosecure Act, it's an amendment to the National Defense Authorization Act.

00:29:32.503 --> 00:29:34.538
<v Steve Usdin>but it's very similar to the Biosecure Act.

00:29:34.873 --> 00:29:45.916
<v Steve Usdin>It actually was introduced as an amendment in the Senate on July 31st by Senators Bill Hagerty, the Republican of Tennessee, and Gary Peters, a Democrat of Michigan.

00:29:46.384 --> 00:29:47.852
<v Jeff Cranmer>Steve, let's back up a bit.

00:29:47.852 --> 00:29:51.522
<v Jeff Cranmer>As you always like to say to me, Biosecure Act when did it first come out?

00:29:51.522 --> 00:29:54.959
<v Jeff Cranmer>Again, I, I'm recalling early 2024.

00:29:55.058 --> 00:29:57.095
<v Jeff Cranmer>And what happened to it?

00:29:57.694 --> 00:30:03.734
<v Steve Usdin>So actually the first, introduction was in 2023.

00:30:03.968 --> 00:30:07.605
<v Steve Usdin>and it was introduced at that time, like this time as.

00:30:07.771 --> 00:30:10.974
<v Steve Usdin>An amendment to the National Defense Appropriations bill.

00:30:11.241 --> 00:30:13.076
<v Steve Usdin>It, didn't get a lot of publicity.

00:30:13.377 --> 00:30:15.547
<v Steve Usdin>It didn't get, enacted as part of the bill.

00:30:15.547 --> 00:30:22.787
<v Steve Usdin>It kind of went away, and then it came roaring back in 2024 as a standalone piece of legislation.

00:30:23.086 --> 00:30:24.823
<v Steve Usdin>It went through a lot of iterations.

00:30:24.888 --> 00:30:26.758
<v Steve Usdin>Uh, we certainly talked about it on the podcast a lot.

00:30:26.758 --> 00:30:27.826
<v Steve Usdin>I wrote a lot about it.

00:30:28.292 --> 00:30:42.707
<v Steve Usdin>The core idea is that it's intended to, basically to drive a wedge between, the US biopharmaceutical industry and companies in China that provide services and, uh, development services and manufacturing.

00:30:42.973 --> 00:30:52.549
<v Steve Usdin>There are big differences, however, between what's been introduced this time and the Biosecure Act that, was narrowly defeated.

00:30:52.884 --> 00:30:59.457
<v Steve Usdin>At the end of the session last time, and the differences look like they're intended to make it more likely to pass this time.

00:31:00.325 --> 00:31:01.960
<v Jeff Cranmer>What are those differences, Steve?

00:31:02.326 --> 00:31:17.642
<v Steve Usdin>Okay, so the, big complaint that Senator Rand Paul had and that House Democrats had about the Biosecure Act was that it was unfair that it violated, principles of due process because it named specific companies as biotechnology companies of concern.

00:31:17.709 --> 00:31:22.814
<v Steve Usdin>Those are the companies that the act would apply to without giving them a chance to, present any evidence.

00:31:22.814 --> 00:31:23.780
<v Steve Usdin>To the contrary,

00:31:24.082 --> 00:31:28.118
<v Jeff Cranmer>and just quickly, Steve, I recall it hit two companies quite hard.

00:31:28.118 --> 00:31:32.490
<v Jeff Cranmer>WuXi Apptec WuXi Biologics lost billions in market cap.

00:31:32.757 --> 00:31:36.493
<v Jeff Cranmer>Their stocks only really rebounded, uh, this past spring.

00:31:36.894 --> 00:31:37.428
<v Steve Usdin>That's right.

00:31:37.561 --> 00:31:38.762
<v Steve Usdin>hit them particularly hard.

00:31:39.696 --> 00:31:42.299
<v Steve Usdin>BGI also, was affected.

00:31:42.500 --> 00:31:49.840
<v Steve Usdin>its stock wasn't as affected because it doesn't rely on the United States nearly as much as WuXi AppTec and WuXi Biologics.

00:31:50.141 --> 00:32:00.585
<v Steve Usdin>There's another company called Complete Genomics, which is a unit of MGI tech, a Chinese company that would also be severely, impacted by the Biosecure Act.

00:32:01.019 --> 00:32:02.319
<v Steve Usdin>So this time.

00:32:02.819 --> 00:32:20.238
<v Steve Usdin>In order to avoid the, the accusations that the bill didn't, provide due process, the new version of it, the version of it that was introduced on July 31st basically says, okay, well here's a process for determining what's a biotechnology of concern.

00:32:20.672 --> 00:32:26.044
<v Steve Usdin>And then it allows the companies that have been identified to rebut those claims.

00:32:26.644 --> 00:32:38.455
<v Steve Usdin>It even provides, in some cases for companies an opportunity to mitigate the concerns that have led the process to identify them as biotechnology companies of concern.

00:32:38.623 --> 00:32:42.226
<v Steve Usdin>Now of course, there's an added layer of complexity or several because there always is there.

00:32:42.926 --> 00:32:46.998
<v Steve Usdin>So one, how a layer of complexity is that, the bill has.

00:32:47.365 --> 00:32:51.736
<v Steve Usdin>Two different kinds of biotechnology companies or concerns, or two buckets that it puts them in.

00:32:51.736 --> 00:32:52.135
<v Steve Usdin>Right?

00:32:52.436 --> 00:33:03.381
<v Steve Usdin>One is the one that I just described that goes through an administrative process, whereby companies are identified, they have the opportunity to rebut the, allegations and even, in some cases to mitigate them.

00:33:03.681 --> 00:33:05.415
<v Steve Usdin>There's a second category of companies.

00:33:05.415 --> 00:33:18.496
<v Steve Usdin>These are companies that the Department of Defense lists as Chinese military companies that are operating in the U.S. Those companies are automatically labeled biotechnology companies of concern.

00:33:18.863 --> 00:33:22.266
<v Steve Usdin>And the prohibitions in the bill would apply to them.

00:33:22.467 --> 00:33:24.634
<v Steve Usdin>they don't have an ability to appeal that.

00:33:25.202 --> 00:33:35.046
<v Steve Usdin>The DOD for 2025 includes BGI Genomics, Forensic Genomics International, MGI, and so by extension, Complete Genomics.

00:33:35.512 --> 00:33:40.451
<v Steve Usdin>And Shanghai Origincell Biological Cryo Equipment Co.

00:33:40.550 --> 00:34:07.845
<v Jeff Cranmer>and of course, speaking of, uh, you know, companies like WuXi AppTec, WuXi Biologics, MGI, Complete Genomics . the other, companies that were affected by the bill were US biotechs who were left to scramble to figure out an alternative to the services of Global CDMOs, as those companies provide a broad range of, services, resources to thousands of company in the west and and the east.

00:34:07.845 --> 00:34:10.748
<v Jeff Cranmer>So, Steve, I'm curious, what's the likely impact?

00:34:11.349 --> 00:34:15.686
<v Jeff Cranmer>Of this bill and, grandfathering, how will that work?

00:34:16.086 --> 00:34:27.831
<v Steve Usdin>Okay, so first the impact the bill as as it's been introduced, and again, one, we don't know whether it's gonna be enacted and two, we don't know whether if it is enacted, it will be changed between now and then.

00:34:28.099 --> 00:34:37.708
<v Steve Usdin>But as it's drafted now, it looks to me like it would prevent NIH grants to any of the companies that are considered to be biotechnology companies of concern.

00:34:38.076 --> 00:34:47.518
<v Steve Usdin>It would prevent the Veterans Administration from purchasing drugs that were manufactured, as a result of ties to the biotechnology companies of concern.

00:34:47.818 --> 00:34:53.056
<v Steve Usdin>And it would probably prevent Medicaid from purchasing those kinds of drugs.

00:34:53.356 --> 00:34:56.927
<v Steve Usdin>It probably wouldn't have any impact on Medicare.

00:34:57.327 --> 00:34:57.494
<v Steve Usdin>Okay.

00:34:57.494 --> 00:34:58.496
<v Steve Usdin>So that's impact.

00:34:58.929 --> 00:34:59.764
<v Steve Usdin>There's a timeline.

00:34:59.764 --> 00:35:00.498
<v Steve Usdin>It's complicated.

00:35:00.931 --> 00:35:02.699
<v Steve Usdin>Within one year of enactment of the law.

00:35:03.568 --> 00:35:10.907
<v Steve Usdin>The OMB Director, the Office of Management and Budget director, has to publish an initial list of biotechnology companies of concern.

00:35:11.275 --> 00:35:15.947
<v Steve Usdin>That list is generated in consultation with a bunch of other, government departments.

00:35:16.146 --> 00:35:24.054
<v Steve Usdin>Within 180 days of the publication of that list, OMB has to publish guidance for executive agencies on how to implement it.

00:35:24.621 --> 00:35:38.936
<v Steve Usdin>Within a year of the publication of that guidance, the Federal Acquisition Regulatory Council must update, acquisition laws to incorporate those requirements for companies that are on the DOD list of Chinese military companies operating the United States.

00:35:39.302 --> 00:35:47.210
<v Steve Usdin>The prohibitions on government contracts and grants take effect 60 days after federal acquisition regulatory, changes are made.

00:35:47.545 --> 00:35:58.688
<v Steve Usdin>For companies that are designated as of concern using the processes led by OMB, the prohibitions would take effect 180 days after the far is revised.

00:35:59.190 --> 00:36:12.036
<v Steve Usdin>But as you mentioned, grandfathering, the amendment includes a five-year grandfather clause starting from the time of the FAR revisions for those companies that OMB has designated as biotechnology companies of concern.

00:36:12.702 --> 00:36:15.405
<v Steve Usdin>My reading of it is that it doesn't apply.

00:36:15.505 --> 00:36:21.179
<v Steve Usdin>The grandfathering doesn't apply to the companies that are on the DOD list of Chinese military companies.

00:36:21.846 --> 00:36:34.458
<v Steve Usdin>Now, if all of this hasn't gotten you really confused, you're really very good at following my voice, I would suggest that you go and look at the story that I wrote because it's all spelled out in there and it's a lot easier to understand when you see it in black and white.

00:36:35.159 --> 00:36:37.594
<v Jeff Cranmer>And I'll drop a link, in the show notes.

00:36:37.594 --> 00:36:41.431
<v Jeff Cranmer>It'll also be available, at BioCentury podcast.com.

00:36:41.798 --> 00:36:48.806
<v Jeff Cranmer>And of course, subs can, uh, just find it in their usual spot where you find, uh, things from Mr. Den.

00:36:49.005 --> 00:36:50.974
<v Jeff Cranmer>All right, Steve, enjoy your vacation.

00:36:50.974 --> 00:36:51.943
<v Jeff Cranmer>We'll see you soon.

00:36:52.876 --> 00:36:53.344
<v Steve Usdin>A lot.

00:36:53.577 --> 00:36:54.411
<v Jeff Cranmer>All righty.

00:36:54.411 --> 00:36:58.748
<v Jeff Cranmer>That is it for this week's BioCentury this week podcast.

00:36:58.983 --> 00:37:09.393
<v Jeff Cranmer>but we'll be having a special episode focused on China and East West deals, how they're changing, what's happening in the Hong Kong.

00:37:10.260 --> 00:37:11.795
<v Jeff Cranmer>Stock market.

00:37:12.096 --> 00:37:16.634
<v Jeff Cranmer>We'll have, a consultant on cross border deals,  Ji Li.

00:37:16.934 --> 00:37:26.476
<v Jeff Cranmer>we'll have Mike Patten from top deal maker, top East-West deal maker, Harbour Biomed, and of course, Franck Le Deu.

00:37:26.744 --> 00:37:32.849
<v Jeff Cranmer>One of the big names at McKinsey in Asia, who's been on the pod quite a few times before.

00:37:33.117 --> 00:37:40.757
<v Jeff Cranmer>And we'll have a classic rewind episode of the BioCentury Show, available on podcast only.

00:37:40.757 --> 00:37:43.927
<v Jeff Cranmer>David Altshuler from Vertex.

00:37:43.927 --> 00:37:44.594
<v Jeff Cranmer>He's the CSO.

00:37:44.996 --> 00:37:52.135
<v Jeff Cranmer>Uh, the company announced that he would be retiring next year, so we thought it would be a great time to revisit his conversation with.

00:37:52.670 --> 00:37:55.373
<v Jeff Cranmer>Simone, which, uh, took place in March.

00:37:55.373 --> 00:38:01.177
<v Jeff Cranmer>He told us all about, his lifelong,  fanboy status of Doug Flutie.

00:38:01.378 --> 00:38:08.385
<v Jeff Cranmer>he has a box of Flutie Flakes on his bookshelf behind him, and he is, uh, very happy to talk to you about that.

00:38:08.385 --> 00:38:11.088
<v Jeff Cranmer>And, uh, Simone pressed him on that a little bit.

00:38:11.322 --> 00:38:16.293
<v Jeff Cranmer>And the BioCentury show will return with its, Latest new episode.

00:38:16.427 --> 00:38:17.594
<v Jeff Cranmer>Annalisa Jenkins.

00:38:17.594 --> 00:38:19.230
<v Jeff Cranmer>Simone, what'd y'all talk about?

00:38:19.530 --> 00:38:23.501
<v Simone Fishburn>We talked about the state of U.K. biotech.

00:38:23.800 --> 00:38:26.070
<v Simone Fishburn>We talked about the incoming.

00:38:26.737 --> 00:38:42.987
<v Simone Fishburn>Well kind of already would come in and new head of MHRA, the U.K. regulator who, uh, BioCentury we'll be talking to soon, and the U.K. government's plan for creating life sciences as part of the cornerstone of its life strategy.

00:38:43.286 --> 00:38:52.262
<v Simone Fishburn>Stephen Hansen, of course, has written about this in biotech, Annalisa and I talked about why would this time be different from others and is it different from others.

00:38:52.762 --> 00:38:54.798
<v Simone Fishburn>and we just shut the breeze about a few things.

00:38:55.498 --> 00:38:56.067
<v Jeff Cranmer>Excellent.

00:38:56.067 --> 00:38:57.134
<v Jeff Cranmer>Well look out for that.

00:38:57.134 --> 00:39:02.139
<v Jeff Cranmer>That'll be coming out in the third week of August,  for tuning in.

00:39:02.139 --> 00:39:07.811
<v Jeff Cranmer>If you like what you're hearing, please, Give us a thumbs up or whatever we have on the on the site.

00:39:07.811 --> 00:39:09.980
<v Jeff Cranmer>Leave us a comment, drop us a question.

00:39:09.980 --> 00:39:11.148
<v Jeff Cranmer>We'd love to hear from you.

00:39:11.414 --> 00:39:18.155
<v Jeff Cranmer>And we appreciate Kendall Square Orchestra, which produces the music for all of Bios podcasts.