Ep. 317 - Biotech IPOs, FDA-Stealth & Patent Threat

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<v Jeff Cranmer>There's been a rarity on NASDAQ as late last week LB Pharma filed to go public on the market.

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<v Jeff Cranmer>This comes as green shoots continue to appear on the Hong Kong stock exchange.

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<v Jeff Cranmer>We'll discuss the state of the market for fresh paper, on the latest BioCentury This Week, plus the latest twist in Stealth Biotherapeutics decade long regulatory rollercoaster is FDA's about face on Stealth's Barth syndrome application, a positive sign for rare disease therapies, air piece, and the university.

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<v Jeff Cranmer>Industry engine that drives U.S. innovation is under attack.

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<v Jeff Cranmer>So says David Beyer and John Osborne in a guest commentary in BioCentury,  and we'll hear from our colleague on the BD side, Josh Berlin as he gets ready to head to Asia for a couple of big events this fall.

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<v Jeff Cranmer>I'm Jeff Cranmer joining me today on the BioCentury This Week podcast.

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<v Jeff Cranmer>Are my colleagues.

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<v Steve Usdin>Steve Usdin, Washington Editor.

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<v Paul Bonanos>Paul Bonanos, Director of Biopharma Intelligence.

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<v Josh Berlin>And Josh Berlin, Head of Business Development.

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<v Jeff Cranmer>Excellent.

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<v Jeff Cranmer>Well, we received a few comments from listeners, uh, last week.

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<v Jeff Cranmer>one was, Hey, you guys start talking about Japan.

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<v Jeff Cranmer>there's more, biotech in Asia than just.

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<v Jeff Cranmer>China.

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<v Jeff Cranmer>so I promise that we'll be coming in an upcoming episode.

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<v Jeff Cranmer>I have a Japan story that it was coming out soon.

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<v Jeff Cranmer>Uh, it'll give us some fodder to chat about things, biotech in Japan.

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<v Jeff Cranmer>Uh, in the meantime, I do wanna give a shout out to Ken Horn, who's on ventures.

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<v Jeff Cranmer>recently closed its debut, Japan focused fund.

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<v Jeff Cranmer>We also received a note from a long time listener who is a licensing and patent attorney who recently headed over to China and he wanted to share some of his takeaways, but had a little trouble getting them to us, and so I had to learn how all this works by working with our production engineer Cole.

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<v Jeff Cranmer>The Reach us by sending a text link in our episode description is a one way street.

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<v Jeff Cranmer>That you can use on a mobile device, for listeners to post comments.

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<v Jeff Cranmer>We can see your messages.

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<v Jeff Cranmer>We can't reply strangely enough, so feel free to send your comments via email to podcasts@BioCentuy.com, which is our address.

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<v Jeff Cranmer>If you want feedback from us, we'd love to hear from this longtime listener and get his take on what, he or she is, uh, seeing.

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<v Jeff Cranmer>On the ground in China, I can also be re reached via LinkedIn,  Alright, well, Paul, you signed off Friday to hit the swampy Little League Diamonds of Gainesville.

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<v Jeff Cranmer>And surprise me by popping back on late last, Friday night to file a story,  on an IPO filing.

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<v Jeff Cranmer>I guess the rare nature of this, uh, little bit of news, not, not an IPO pricing mind you, just a filing, was enough to get you back to your desk.

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<v Jeff Cranmer>what can you tell us Paul?

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<v Paul Bonanos>They, there have not been very many of those lately, and, uh, when they land they tend to land late Friday.

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<v Paul Bonanos>So, as you know, and as you said, the IPO market has been very quiet, for biotechs looking to get out on nasdaq.

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<v Paul Bonanos>We haven't really seen anything substantial buy a therapeutics pure play rather, in more than six months now, uh, there have been a couple of very small offerings, but nothing bigger than.

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<v Paul Bonanos>You know, we usually put the floor at 25 million, for what we think of as a more substantial offering.

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<v Paul Bonanos>Um, and the company testing the market this time is LB Pharmaceuticals based in New York.

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<v Paul Bonanos>It's more or less a single asset company with a neuropsychiatry program.

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<v Paul Bonanos>their molecule is called LB-102 It's an antagonist of serotonin and two dopamine receptors, D2 and D3.

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<v Paul Bonanos>There's a generic drug available in Europe called amisulpride, and this is a methylated formulation of amisulpride, with some dosing and potency advantages, and, uh, result in IP protection as well.

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<v Paul Bonanos>and as we've said a few times over the past few years since IPO started becoming scarce, the best candidates to get out, generally have some clinical data and LB indeed has some.

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<v Paul Bonanos>In January they announced Phase II data showing a treatment effect in schizophrenia, significance on a scale measuring symptoms positive and negative symptoms.

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<v Paul Bonanos>It's a PANSS scale you may have seen, and LB believes that the study, could serve as one of two pivotal trials.

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<v Paul Bonanos>So it's looking to fund a Phase 3 program now, and that's where the IPO comes in.

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<v Paul Bonanos>Its cash position isn't especially strong right now.

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<v Paul Bonanos>The prospectus says they have$14.2 million in cash and equivalence at June 30th.

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<v Paul Bonanos>So, uh, maybe a year of cash for a lien operation.

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<v Paul Bonanos>But they're looking to move ahead with that second pivotal trial and this is how they'll fund it.

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<v Paul Bonanos>they are privately held.

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<v Paul Bonanos>Uh, obviously they've raised about 120 little more than $120 million in equity funding thus far.

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<v Paul Bonanos>Some of the top shareholders I'll name for you, uh, Deep Track Capital, Vida Ventures, Pontifax and TCG Crossover.

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<v Paul Bonanos>and I, I should also mention the company's CEO is Heather Turner, who was president and CEO at Carmot Therapeutics.

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<v Paul Bonanos>You may remember Roche buying it in a 2023 deal.

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<v Paul Bonanos>we don't know how much they're gonna raise, but the banks are Leerink, Piper Sandler and Stifel.

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<v Paul Bonanos>which are typically associated with substantial raises, so, we'll, we'll have to see how demand goes.

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<v Paul Bonanos>remember a couple of companies that filed for IPOs didn't get out this year and, uh, withdrew their offerings.

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<v Paul Bonanos>So, you know, we'll see how it goes for them.

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<v Paul Bonanos>Stay tuned.

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<v Jeff Cranmer>Thanks for that update, Paul, you mentioned a long drought since a few offerings priced early this year.

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<v Jeff Cranmer>who were those companies?

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<v Jeff Cranmer>Uh, I recall Metsera maybe being one.

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<v Jeff Cranmer>And, and how have they done in the aftermarket?

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<v Paul Bonanos>That is one, and I was actually a little surprised when I looked this morning.

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<v Paul Bonanos>There were really four pure play therapeutics companies that went public in January and February and none since I, I don't mean to disregard a couple of life sciences companies that got out since then.

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<v Paul Bonanos>there's like a cell analysis company, Caris Life Sciences, but among drug developers.

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<v Paul Bonanos>Yes, we had Metsera, a metabolic company, uh, Maze, doing renal and metabolic, Sionna Cystic Fibrosis Company and Aardvark, which, uh, has treatments for hunger disorders, and it turns out Metsera.

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<v Paul Bonanos>that one is the big winner.

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<v Paul Bonanos>It's almost doubled in value since pricing.

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<v Paul Bonanos>Um, Sionna is also up.

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<v Paul Bonanos>By about a little more, about 35%.

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<v Paul Bonanos>since getting out, Maze is down a few ticks, but not a ton.

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<v Paul Bonanos>And, um, Aardvark not so much.

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<v Paul Bonanos>Um, it hasn't exactly cratered, but it has lost some value.

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<v Paul Bonanos>so aftermarket performance has not been the worst.

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<v Paul Bonanos>I did mention some withdrawn offerings as well.

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<v Paul Bonanos>Uh, Odyssey Therapeutics, the immunology company, and also Aurion Biotech with an ophthalmic program they filed in January and never made it out.

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<v Jeff Cranmer>Paul, we've both been watching, uh, what's happening in Hong Kong, uh, certainly a bit more activity than on Nasdaq.

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<v Jeff Cranmer>what have you been seeing?

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<v Paul Bonanos>There have been a few.

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<v Paul Bonanos>Yes, we've seen some activity, overseas and one company that went public in Hong Kong recently, a metabolic company called Innogen, out this month and it's performed very well.

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<v Paul Bonanos>It raised about $87 million U.S. and at Friday's close it had nearly tripled over its first week of trading.

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<v Paul Bonanos>a little more than a week.

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<v Paul Bonanos>I think it went out the previous Friday.

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<v Paul Bonanos>Um, and then since then, since it priced, there have been two more companies called LongBio Pharma and Shanghai Bao Pharma that joined the queue last week to list in Hong Kong as well.

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<v Paul Bonanos>So that's encouraging, especially with lots of discussion about licensing deals for assets from China.

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<v Paul Bonanos>Here are some companies that are looking to build sustainable businesses, going public and, gaining value, once they gain liquidity.

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<v Jeff Cranmer>Josh, you're always on the horn with folks, from Japan, China, India, you name it.

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<v Jeff Cranmer>among, white guys from the East coast, you're probably the number one we chatter.

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<v Jeff Cranmer>what are you hearing?

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<v Josh Berlin>maybe I'm an influencer even.

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<v Josh Berlin>Huh?

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<v Josh Berlin>Jeff?

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<v Josh Berlin>Uh, I, you know.

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<v Jeff Cranmer>You know.

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<v Josh Berlin>Yeah, I, you know, I, I think, um, the Hong Kong Stock Exchange has really, been a, you know, a, an amazing story this year that I'm not sure is fully sort of understood by, by everyone in our network.

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<v Josh Berlin>but you know, the, the China partnering craze really in part started because of the bear market in Hong Kong, and it was really the.

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<v Josh Berlin>First bear market in biotech history in China.

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<v Josh Berlin>And that forced a lot of companies to become, much more creative  in terms of, finding ways to, finance the company, primarily via deal making.

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<v Josh Berlin>and now you see the deal making is really starting to have an impact, I think, on, the Hong Kong exchange itself.

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<v Josh Berlin>So you're, you're seeing.

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<v Josh Berlin>The IPOs that, you know, Paul was just talking about.

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<v Josh Berlin>and I think the other thing you're seeing is, uh, you know, if you just go look at the, the Hang Seng biotech index over this year, since the beginning of the calendar year, you know, I think at the beginning of the calendar year was around 8,000.

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<v Josh Berlin>It's now around 17,000.

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<v Jeff Cranmer>Yep.

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<v Jeff Cranmer>Year, year to date up.

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<v Jeff Cranmer>Uh, yeah.

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<v Jeff Cranmer>Sorry to cut you off there, Josh.

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<v Jeff Cranmer>Year to date up a hundred, and 8%.

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<v Jeff Cranmer>And I remember, uh, back in March, Josh, you and I were, uh, hanging out in those, Super cool artificial super trees in Singapore and, uh, chatting up some bankers biotech bankers and, at that time they were still saying, you know, NASDAQ's the only game in town for Asia biotechs.

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<v Jeff Cranmer>And, you know, it's, it's changed now.

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<v Jeff Cranmer>When I talk to CFOs, they're, looking seriously at Hong Kong.

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<v Jeff Cranmer>they're weighing the best place to tell their story.

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<v Jeff Cranmer>so look, we'll see how this continues to develop.

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<v Jeff Cranmer>Well, first up this will be a big theme at our China Healthcare Summit.

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<v Jeff Cranmer>that will be in Shanghai.

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<v Jeff Cranmer>It will be October 22nd to 24th.

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<v Jeff Cranmer>Is that right, Josh?

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<v Josh Berlin>correct.

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<v Josh Berlin>Yeah.

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<v Josh Berlin>October 22 to 24 in Shanghai.

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<v Jeff Cranmer>Excellent.

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<v Jeff Cranmer>So this will be a big theme of that.

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<v Jeff Cranmer>advanced rates for the meeting, end Friday.

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<v Jeff Cranmer>Uh, we're still recruiting, presenting companies.

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<v Jeff Cranmer>we have some great names there.

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<v Jeff Cranmer>And, we'll have some big names on the panels as well.

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<v Jeff Cranmer>Josh, who do we have?

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<v Jeff Cranmer>We have, uh, the CEOs of Duality, Innovent.

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<v Jeff Cranmer>Who else do we have?

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<v Josh Berlin>Yeah, we have, uh, just sort of a who's who of, CEOs, like you mentioned duality, Inno vent we have 3SBio Chairman and CEO, Argo Bio, another company that's, done some deals.

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<v Josh Berlin>Crystal Q in of LaNova Medicines just confirmed, you know, they were the biotech that was just bought out by Sino Biopharma.

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<v Josh Berlin>and, Dajun Yang of Ascentage will be there, you know, which is a, a dual listed, China biotech, also on NASDAQ.

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<v Josh Berlin>So it's gonna be a, a really good opportunity to meet a lot of these CEOs that you've been reading about, via all the deal flow in the news.

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<v Jeff Cranmer>not China.

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<v Jeff Cranmer>We'll have a great.

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<v Jeff Cranmer>Asia Biotech, CEO panel will have Piers Ingram of Hummingbird.

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<v Jeff Cranmer>we'll have the CEOs of, Gexval from Japan and Korea's Orem Therapeutics.

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<v Jeff Cranmer>the CEO uh, SJ Lee was, recently a guest on our sister podcast.

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<v Jeff Cranmer>the BioCentury show.

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<v Jeff Cranmer>and, the CEO of Immuneel, from India.

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<v Jeff Cranmer>I think it should be, uh, quite a fun event.

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<v Jeff Cranmer>But you're, before that you're heading to Japan, is that right Josh?

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<v Josh Berlin>Yeah, I'm, I'm looking forward to getting out to, uh, BioJapan this year, which I haven't been to,  in a very, very long time.

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<v Josh Berlin>really thankful to our friends at, uh, JBA for the invite to come out there, join a panel.

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<v Josh Berlin>and sort of see what BioJapan is all about.

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<v Josh Berlin>It's become a much, much bigger event than it used to be, is my understanding.

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<v Josh Berlin>And then we're also, uh, gonna be co-hosting a reception, for those of you who know, Tim Kendall and his company ConneKTia in Japan, Tim and, and BioCentury teaming up on a reception, uh, October 7th, in Yokohama the night before.

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<v Josh Berlin>BioJapan.

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<v Josh Berlin>So if you're uh, in town and, and wanna join the reception, please send, uh, me a note or send Jeff a note or we'd be happy to have you join us.,

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<v Jeff Cranmer>Yeah, Tim is great.

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<v Jeff Cranmer>he, really knows his Japan, uh, had a good chat with him from my Japan story.

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<v Jeff Cranmer>Recently and,  he knows his stuff.

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<v Jeff Cranmer>Alright, we're gonna take a quick break and then we will, uh, come back and, uh, welcome Mr. Usdin back, from his travels and talk about Stealth Biotherapeutics and IP and quite a bit more.

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<v Alanna Farro>By Century this week is brought to you by the 12th China Healthcare Summit in Shanghai.

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<v Alanna Farro>From in-licensing to New cos cross-border deals from Asia are transforming global biopharma.

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<v Alanna Farro>Meet top decision makers and investors at the 12th China Healthcare Summit.

00:12:50.168 --> 00:12:55.173
<v Alanna Farro>To explore emerging opportunities and tackle key challenges in this rapidly evolving landscape.

00:12:55.875 --> 00:12:58.778
<v Alanna Farro>Join us in Shanghai, October 22nd to 24.

00:12:58.778 --> 00:13:06.652
<v Alanna Farro>To get a firsthand look at China's dynamic life sciences ecosystem, register and learn more at BioCentury China summit.com.

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<v Jeff Cranmer>We are back.

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<v Jeff Cranmer>And Steve, how was the, how was the getaway

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<v Steve Usdin>I don't know why I came back to tell.

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<v Jeff Cranmer>to, to talk to us?

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<v Jeff Cranmer>Yeah.

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<v Jeff Cranmer>thank you for sending me a cat picture of the day.

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<v Jeff Cranmer>The cats really look like they, uh, they run that country.

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<v Jeff Cranmer>All right.

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<v Jeff Cranmer>No, no further comment.

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<v Jeff Cranmer>Uh, Steve is, uh, whenever he is in Turkey or Greece, he, uh, he always seems to encounter some amazing cats.

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<v Jeff Cranmer>But, uh, Steve, you know, I think you, uh, you were writing about Stealth Biotherapeutics when you left.

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<v Jeff Cranmer>And, you're gonna write about 'em again today.

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<v Jeff Cranmer>what's going on here?

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<v Jeff Cranmer>There's a bit of a, an about face.

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<v Jeff Cranmer>This is a company that for years now has been, trying to get a therapy to the, Barth syndrome, community.

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<v Jeff Cranmer>it's community where there is a, uh, dire need for, a therapy.

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<v Jeff Cranmer>Steve, what, is going on with this latest, seeming about face?

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<v Steve Usdin>So yeah, look, it's another extraordinary turn of events.

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<v Steve Usdin>For stealth and for, birth patients.

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<v Steve Usdin>know, as you said, we've been following this closely for years.

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<v Steve Usdin>It's a Byzantine story, but basically they've been getting the runaround from, FDA for years.

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<v Steve Usdin>The company's bounced between four FDA review divisions over five years.

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<v Steve Usdin>during that time, FDA is told stealth to submit an NDA.

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<v Steve Usdin>Then gave it a refuse to file letter.

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<v Steve Usdin>It approved a natural history study design.

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<v Steve Usdin>Then later declared that the results are uninterpretable.

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<v Steve Usdin>at different points, the agency said approval would depend on a new placebo controlled trial, and then said that, it would be unethical or impossible to conduct that kind of trial.

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<v Steve Usdin>Last year it seemed like things were coming to, to an end.

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<v Steve Usdin>An advisory committee voted 10 to six, that stealth biotherapeutics had demonstrated safety and efficacy of its drug elamipretide.

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<v Steve Usdin>At the end of May, the FDA issued a complete response letter.

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<v Steve Usdin>Big surprise, but it didn't ask for substantial new information.

00:15:06.538 --> 00:15:09.375
<v Steve Usdin>This was devastating for Barth patients and for Stealth.

00:15:09.375 --> 00:15:18.182
<v Steve Usdin>Stealth laid off 30% of its workforce, and it said it didn't know if it would be able to stay in business long enough to receive a response from a resubmission.

00:15:18.450 --> 00:15:30.328
<v Steve Usdin>The patient community has been extraordinarily active, in the media and in lobbying,  members of Congress, the Wall Street Journal editorial page called on FDA, commissioner Marty Makary to approve the drug.

00:15:30.596 --> 00:15:34.232
<v Steve Usdin>there have been stories on national television programs last Thursday.

00:15:34.799 --> 00:15:40.471
<v Steve Usdin>FDA said it would grant a final decision on the resubmitted NDA by September 26th.

00:15:40.806 --> 00:15:42.740
<v Steve Usdin>That's months earlier than the deadline.

00:15:43.142 --> 00:15:51.049
<v Steve Usdin>And what's interesting on Friday, Barth syndrome patients met with the FDA commissioner and came out of it, really thrilled and ecstatic.

00:15:51.250 --> 00:15:52.583
<v Steve Usdin>That's really an extraordinary thing.

00:15:52.583 --> 00:15:57.956
<v Steve Usdin>I can't think of another time when an FDA commissioner has met with advocates.

00:15:58.256 --> 00:16:02.827
<v Steve Usdin>For a drug that's under, review, that's pending review, at the agency.

00:16:03.128 --> 00:16:06.899
<v Steve Usdin>So yeah, it looks like it's on the verge of granting accelerated approval.

00:16:07.131 --> 00:16:13.304
<v Steve Usdin>Something FDA ruled out last year, based on data that really hasn't changed, over the last four years.

00:16:13.605 --> 00:16:16.841
<v Steve Usdin>So if that happens, it'll be great news for Barth syndrome patients.

00:16:17.076 --> 00:16:21.613
<v Steve Usdin>But on the whole, I'd say the, the saga isn't really good news for rare disease patients at all.

00:16:22.081 --> 00:16:27.753
<v Jeff Cranmer>Yeah, that's what I was gonna ask is there gonna be a read through to other, companies developing rare disease therapies?

00:16:28.620 --> 00:16:31.856
<v Steve Usdin>Well could be, but we, we really need to see what happens.

00:16:31.856 --> 00:16:42.567
<v Steve Usdin>First of all, the only reason it was possible for stealth to consider developing a drug for Barth, which has about 150 patients in the U.S., not all of whom would be candidates for the drug.

00:16:43.101 --> 00:16:50.609
<v Steve Usdin>Is because it was eligible for a priority review voucher, a priority review voucher for a rare pediatric disease.

00:16:50.908 --> 00:16:56.749
<v Steve Usdin>Congress allowed the rare pediatric priority review program to expire last year.

00:16:57.048 --> 00:17:01.986
<v Steve Usdin>If it isn't renewed, there aren't gonna be any more drugs for conditions like, birth syndrome.

00:17:02.254 --> 00:17:06.125
<v Steve Usdin>there's no economic case for doing it in the absence of a priority review voucher.

00:17:06.424 --> 00:17:06.959
<v Steve Usdin>Second.

00:17:07.092 --> 00:17:22.040
<v Steve Usdin>If FDA doesn't create a predictable and rational path for approval, not one that's dependent on getting the Wall Street Journal or NBC News or BioCentury to report about you, it's not gonna be possible to get companies to invest in this space.

00:17:22.473 --> 00:17:26.412
<v Steve Usdin>if you think about it, there are thousands of rare diseases.

00:17:26.711 --> 00:17:32.084
<v Steve Usdin>It isn't possible to have this level of advocacy, this level of public attention.

00:17:32.617 --> 00:17:33.618
<v Steve Usdin>For all of them.

00:17:33.818 --> 00:17:37.288
<v Steve Usdin>There needs to be one, there needs to be priority review vouchers.

00:17:37.288 --> 00:17:42.126
<v Steve Usdin>So there's an economic case for, developing therapies for these very, very rare diseases.

00:17:42.394 --> 00:17:52.070
<v Steve Usdin>And there needs to be a predictable, rational FDA, review process, that can get these, drugs approved or, or not, but at least a decision made on them.

00:17:52.371 --> 00:17:58.410
<v Steve Usdin>in a reasonable period of time, requiring the level of,  evidence that's appropriate for the disease.

00:17:58.410 --> 00:18:08.086
<v Steve Usdin>There has to be scientific rigor, but there also has to be, a possibility for making this happen, and companies and patient groups need to know in advance what that path is gonna look like.

00:18:08.653 --> 00:18:09.253
<v Jeff Cranmer>All right.

00:18:09.253 --> 00:18:14.358
<v Jeff Cranmer>And, you'll be able to find Steve's story, on BioCentury podcast.com.

00:18:14.660 --> 00:18:17.796
<v Jeff Cranmer>And, Steve, we add a guest commentary.

00:18:18.029 --> 00:18:33.644
<v Jeff Cranmer>We published last week, David Beier, who's managing director of Bay City Capital, and John Osborn, who's a professor of law at the University of Washington, they argued that the university industry engine driving U.S.

00:18:33.679 --> 00:18:36.115
<v Jeff Cranmer>innovation is under attack.

00:18:36.381 --> 00:18:37.249
<v Jeff Cranmer>What's your take on this?

00:18:38.150 --> 00:18:40.118
<v Steve Usdin>So here's the thing that precipitated it.

00:18:40.318 --> 00:18:56.667
<v Steve Usdin>President Trump demanded that Harvard account for its compliance with the Bayh-Dole obligations across its entire portfolio of almost 6,000 patents arising from research that was supported in whole or in part with federal funds.

00:18:56.868 --> 00:18:59.337
<v Steve Usdin>That's an extraordinary demand for a couple of reasons.

00:18:59.704 --> 00:19:07.613
<v Steve Usdin>the idea of the federal government exercising, marching rights on Bayh-Dole has been, anathema to Republicans.

00:19:08.279 --> 00:19:09.213
<v Steve Usdin>Traditionally.

00:19:09.480 --> 00:19:21.460
<v Steve Usdin>and the idea that a university would have to go back retroactively and justify all of the patents that it's ever received, basically  part, from federal funding, is extraordinary.

00:19:21.859 --> 00:19:27.766
<v Steve Usdin>What, David Byer, who by the way was, years and years ago was a domestic policy advisor for Al Gore.

00:19:28.000 --> 00:19:31.403
<v Steve Usdin>he had senior positions at, Genentech and at Amgen.

00:19:31.636 --> 00:19:33.672
<v Steve Usdin>and as you mentioned, he's, at Bay City Capital.

00:19:33.805 --> 00:19:37.409
<v Steve Usdin>what they argue is that this is retaliation for the universities.

00:19:37.643 --> 00:19:39.545
<v Steve Usdin>first amendment protected speech.

00:19:39.744 --> 00:19:51.022
<v Steve Usdin>and basically they say that by going after Harvard on this, that, the Trump administration is creating a threat t o the entire, American biopharma industry.

00:19:51.390 --> 00:19:53.325
<v Steve Usdin>Here's a quote from the end of their commentary.

00:19:53.325 --> 00:20:24.556
<v Steve Usdin>They say, "business leaders, especially those in the life sciences and technology sectors, must recognize that misguided attacks on research universities threaten our innovation infrastructure, and they must raise their voices accordingly." they urge countervailing advocacy to support Harvard and other research universities, and they say that "a  failure to enjoin this counterproductive and illegal exercise of presidential power will lead to predictably disastrous effects, undermining intellectual property rights and limiting economic growth."

00:20:25.624 --> 00:20:30.362
<v Jeff Cranmer>All right, and you can find their guest commentary on BioCentury podcasts.

00:20:31.096 --> 00:20:34.365
<v Jeff Cranmer>Com, that is in front of the paywall.

00:20:34.532 --> 00:20:45.576
<v Jeff Cranmer>I'll also drop a link in the show notes, Also on BioCentury dot com, how China speed is reshaping cross-border business development.

00:20:45.844 --> 00:20:52.317
<v Jeff Cranmer>A perspective, by Josh and myself, looking at how deals are rapidly.

00:20:52.750 --> 00:20:59.625
<v Jeff Cranmer>Evolving as China biotechs are gaining more leverage at the negotiating table with Western companies.

00:20:59.924 --> 00:21:06.632
<v Jeff Cranmer>And, Simone, had a great conversation on our sister podcast with Annalisa Jenkins.

00:21:06.964 --> 00:21:11.569
<v Jeff Cranmer>she is,  an influencer, in biotech to say the least.

00:21:11.803 --> 00:21:17.209
<v Jeff Cranmer>she is, uh, currently chair of Gemma Therapeutics and.

00:21:17.476 --> 00:21:34.558
<v Jeff Cranmer>She and Simone talked about the future of MHRA and, really dug deep into where things are in the U.K. right now as that biotech hub continues to grow and our Back to School issue is out now.

00:21:34.759 --> 00:21:40.398
<v Jeff Cranmer>Steve, uh, wrote, uh, it wasn't as short as, uh, you know, I was, uh, I was led to believe it would be.

00:21:40.398 --> 00:21:52.844
<v Jeff Cranmer>It's a a seven story, series and Steve will be joining Simone, on our sister podcast, The BioCentury Show, first week of September, and there'll be digging deep into the issues.

00:21:52.844 --> 00:21:54.613
<v Jeff Cranmer>Steve, top line, what's it all about?

00:21:55.279 --> 00:22:05.523
<v Steve Usdin>Basically what I did was I said, look, imagine that you were starting from a blank sheet of paper and you wanted to reimagine what medical products regulation in the United States would look like.

00:22:05.523 --> 00:22:06.023
<v Steve Usdin>What would you do?

00:22:06.692 --> 00:22:07.526
<v Steve Usdin>and I followed that through.

00:22:07.526 --> 00:22:18.537
<v Steve Usdin>I talked to a number of thought leaders, current and former FDA officials, former FDA commissioners, CEOs of biotech companies, patient advocates, the opinion leaders.

00:22:18.769 --> 00:22:41.593
<v Steve Usdin>And, there were some commonalities, some things that they all agreed on, some things that there was a little bit of, Disagreement about my conclusion is that if you were going to start over again, and I think that at some point it's going to be necessary to do this, one of the things you would do would be to separate out medical product regulation from the regulation of foods, cosmetics, tobacco and veterinary products.

00:22:41.727 --> 00:22:46.131
<v Steve Usdin>I also call for,  reorganizing the medical products regulation.

00:22:46.565 --> 00:22:56.674
<v Steve Usdin>Primarily around therapeutic areas using the Oncology Center of Excellence as a model for the way that other therapeutic areas, could be organized.

00:22:56.775 --> 00:23:02.980
<v Steve Usdin>and abolishing the distinctions between, the Center for Biologics in this Center for Drugs in the long run.

00:23:02.980 --> 00:23:05.616
<v Steve Usdin>I think also eliminating the Center for Devices.

00:23:05.616 --> 00:23:10.922
<v Steve Usdin>I think that those are kind of outmoded ways of thinking about things and, and organizing regulation.

00:23:11.256 --> 00:23:13.325
<v Steve Usdin>There's a lot more to it, uh, as you said.

00:23:13.325 --> 00:23:18.462
<v Steve Usdin>We'll, we'll get into the, um, details of it, with Simone when we do show conversation about it.

00:23:19.631 --> 00:23:23.535
<v Jeff Cranmer>you can find the entire back to school package on BioCentury.com.

00:23:24.469 --> 00:23:26.904
<v Jeff Cranmer>I'll drop a link in the show notes.

00:23:26.904 --> 00:23:28.839
<v Jeff Cranmer>This is our 33rd back to school.

00:23:28.839 --> 00:23:33.912
<v Jeff Cranmer>We've been doing it every year since David Flores and Karen Bernstein founded BioCentury.

00:23:35.046 --> 00:23:44.288
<v Jeff Cranmer>More than three decades ago and back to school is a forward looking package that looks at a broad issue critical to the biopharma industry.

00:23:44.623 --> 00:23:45.022
<v Jeff Cranmer>All right.

00:23:45.022 --> 00:23:49.627
<v Jeff Cranmer>Well thank you to Josh, Paul and Steve, for joining me today.

00:23:49.894 --> 00:23:58.336
<v Jeff Cranmer>And thank you to Cole Travis, our production engineer, And of course, Kendall Square Orchestra, which provides the music for BioCentury this week.

00:23:58.603 --> 00:24:07.813
<v Jeff Cranmer>Tickets are now on sale for the group's eighth season, they'll be rocking some Mahler, some Brahms, and you can find more by going to their website.

00:24:08.380 --> 00:24:09.146
<v Jeff Cranmer>for tuning in.

00:24:09.314 --> 00:24:10.548
<v Jeff Cranmer>we will catch you next week.