FDA’s new leadership is sailing the agency into calmer waters amid a search for a permanent commissioner and permanent center directors. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses how FDA’s new, interim leaders have changed the tone at the agency and why they are putting medicines derailed under former FDA Commissioner Marty Makary back on track. Usdin also highlights FDA’s new real-time clinical trials initiative. BioCentury’s analysts then turn to deals, including an analysis of the 20 deals Eli Lilly has done this year; Servier’s move to expand in neurology via BD; and Monday’s billion-dollar deals by Incyte, which will acquire Vega Therapeutics, and Johnson &amp; Johnson, which is buying Firefly Bio. The team also discusses Grand Rounds U.S., held last week in Seattle, including the conference’s Rising Star prize winner Sylvain Simon of Fred Hutchinson Cancer Center. View full story: https://www.biocentury.com/article/659699 #FDA #BiopharmaDeals #ClinicalTrials #BiotechMA #GrandRoundsUS 01:23 - Grand Rounds Seattle Takeaways 04:43 - FDA&#x27;s New Leaders 11:48 - FDA&#x27;s Real Time Trials Pilot 20:40 - Servier Bets on Neuro 25:33 - Lilly&#x27;s Deal Spree 30:21 - Dealmaking Roundup To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Ep. 370 - Calmer waters for FDA; Servier, Lilly deals

BioCentury This Week

# Full Transcript

**Podcast:** BioCentury This Week

## Participants

- **Jeff Cranmer** (BioCentury)
- **Simone Fishburn** (BioCentury)
- **Stephen Hansen** (BioCentury)
- **Steve Usdin** (BioCentury)

## Transcript

FDA's new leadership is rowing the agency into calmer waters as it seeks a permanent commissioner and permanent center directors. We'll check in with Washington editor Steve Usdin on the latest as FDA enters a new phase.

Also on the BioCentury This Week podcast, FDA's real-time clinical trials initiative may have real but unexpected benefits. Meanwhile in deal land, Servier continues its M&A build-out, its acquiring Edgewise's neuro programs as it seeks to add a new pillar to its pipeline.

That was one of several billion dollar plus deals in biopharma over the past few days. We'll have a look at the latest in biopharma deal-making and check in with the 900 pound gorilla in biotech deals, Eli Lilly. I'm Jeff Cranmer, executive editor at BioCentury and host of the BioCentury This Week podcast.

Joining me our editor in chief Simone Fishburn, our man in the UK Stephen Hansen and of course Steve Uzzin. Welcome to the show guys. Gonna start off with Simone back from Seattle. Simone, how was your time up in the PNW? So actually Jeff would you like to hear my new theory about Seattle which I got about. I told about 10 people this and they all agreed with me. So Seattle really wants to be part of Canada.

It doesn't really want to be part of the US. I'm just saying because everybody in Seattle doesn't really live there. They live in these little islands around and they all take little boats or planes to get into Seattle. I don't think they like Americans so much. I think they like Canadians. And they're all kind of like Canadian nice in July. I'm just saying that great place, but. So yeah, I also want to say that your Cascadia idea got a lot of momentum there. You know, it's true.

I continue to be a proponent of Cascadia bringing together Alaska, British Columbia, Washington State, Oregon, California. And we'll even throw on Baja because you know who doesn't like those beaches down near Cabo. The lot of coast. I like it. Right. When the AI bots take over all some other than the yeah. No, I mean Grand Rounds is a huge success. And now we're very excited about Amsterdam in the fall.

But, you know, we have a podcast coming out later this week. There were a few highlight sessions, you know, for me, I get the pleasure of a fireside chat with Chris Arendt, who's the Cso of Takeda, really talking about how that company is imbuing it like really working with AI throughout. And that was a very interesting take he had. And another panel is a topic we're going to talk a lot about, which is first in human trials.

And one of the issues comes up between if you want to expedite them, how much the universities themselves can do, like improving the IRB process and reducing certain amount of back and forth. And we've got a lot of issues around protocol...

Ep. 370 - Calmer waters for FDA; Servier, Lilly deals

Transcript

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Ep. 370 - Calmer waters for FDA; Servier, Lilly deals

Transcript

Built for investment professionals

Every day you wait, your competitors are findingedge in conversations you're not hearing.

Every day you wait, your competitors are finding
edge in conversations you're not hearing.