A pathway proposed by FDA to cut the time it takes biopharma companies to get to first-in-human trials is more ambitious than similar policies in Australia, China and the U.K. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the proposal, as well as a concession for the biopharma industry on first-in-human studies in PDUFA reauthorization negotiations with FDA. The analysts also discuss the latest pair of billion-dollar biotech deals: Gilead&#x27;s $3.2 billion takeout of antibody-drug conjugate company Tubulis and the acquisition of Soleno by Neurocrine for $2.9 billion for its Prader-Willi asset. Finally, BioCentury’s analysts discuss the new $6.3 billion Blackstone Life Sciences fund and the €1 billion vehicle unveiled last week by European VC Jeito Capital. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech. View full story: https://www.biocentury.com/article/659127 #FDA #FirstInHuman #BiotechMergers #BiotechInvesting #LifeSciencesVC 00:01 - Sponsor Message: IQVIA Biotech 03:24 - FDA First-in-Human 11:44 - America First PDUFA Policy 17:43 - Gilead Buying Tubulis 23:41 - Blackstone&#x27;s New Fund 28:37 - Jeito Capital 30:44 - Parker Institute 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. 360 - FDA’s FIH plans. Plus: billion-dollar deals, funds

BioCentury This Week

# Full Transcript

**Podcast:** BioCentury This Week

## Participants

- **Jeff Cranmer** (BioCentury)
- **Simone Fishburn** (BioCentury)
- **Steve Uzden** (None)
- **Paul Bananos** (BioCentury)

## Transcript

is brought to you by IQVIA Biotech, a full-service CRO right-sized for biotech, dedicated to helping biotech leaders close unproductive gaps in clinical development so they can protect timelines, preserve capital, and stay ahead of risk. A pathway proposed by FDA to cut the time it takes

biopharma companies to first in human trials is more ambitious than similar policies in Australia, China, and the UK. But how long could it take to implement it? We'll discuss the proposed policy on the latest BioCentury This Week podcast. Plus, BioTech's deal-o-rama continues as Gilead adds

debt in ADCs with a $3 billion takeout of European biotech tubulus and a similar-sized deal puts neurocrine strength behind Solano's Prader-Villie drug. We'll also discuss new funds from Blackstone and JATO and get an update on negotiations on the PDUFA agreement that is

emerging between FDA and industry. I'm Jeff Cranmer, host of the BioCentury This Week podcast. Joining me to discuss all of this are Editor-in-Chief Simone Fishburn, Washington Editor Steve Uzden, and Paul Bananos, Director of Biopharma Intelligence. But first, BioCentury Grand Rounds US is returning for its third year this June in the Pacific Northwest,

specifically Seattle. This is not a large generic conference. It's a focused forum where VCs, biopharma executives, academic innovators, and biotech founders engage in the kind of cross-sector dialogue that rarely happens elsewhere. As a delegate, you'll debate translational science's

biggest hurdles, hear world-class presentations from researchers at the translational frontier, and connect directly with the funders shaping what gets built next. Attendees have called it intimate, potent, on point, and a master class in curating dialogue. Simone, you'll be there. Yeah, Jeff, I am super excited. As you know, this one is close to my heart, this academia industry

interface. We talked about it before, and we will continue to talk about it again, but we have a whole bunch of Nobel laureates there and some great fireside chats in addition to some really in-depth scientific panels. So check out the website at wherever Jeff tells you. Biocentury Grand Rounds US.com. And you can register there. You can apply to present. My colleague,

Karen Dekach-Tusman, and I will take a look if you're one of the super early innovative companies that is interested in getting on stage at Biocentury Grand Rounds. All right, Steve, a proposal by FDA could sharply reduce the cost and time required to launch first in human studies. Wow. This was a proposal that we only really have about a 250 word blurb about it. So everything that I'm

going to say now is extrapolated from that plus conversations that I've had with people around it. What FDA is proposing is a new regulatory ...

Ep. 360 - FDA’s FIH plans. Plus: billion-dollar deals, funds

Transcript

Built for investment professionals

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

Ep. 360 - FDA’s FIH plans. Plus: billion-dollar deals, funds

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.