392: Epstein's pal attempts a biotech comeback, and Prasad exits the FDA

Welcome to this week's episode of The Read Out Loud, a weekly biotech podcast from STAT. I'm Alison Deangelis. I'm Adam Forrester. And I'm Elaine Chen. It's Thursday, March 12. On this week's episode, stat reporter, Damian Garde, joins us to talk about Boris Nikolic, a well connected biotech investor with deep ties to Jeffrey Epstein, and how one prominent biotech venture capitalist helped Boris raise money years after the Epstein scandal broke. But first, a word from our sponsor and a roundup of this week's biotech news. I'm staff and studio editor, Jesse McQuarters, and I'm talking with doctor Fred Applebaum, executive vice president at Fred Hutch Cancer Center. Doctor Applebaum, how has the work done over the past fifty years of Fred Hutch impacted how we treat cancer today? About fifty years ago, Don Thomas and our team showed that marrow transplantation was possible, which enabled us to cure almost every marrow based disease. Today, over one hundred thousand people worldwide undergo a marrow transplant every year. Going forward, we're developing even better immune therapies, antibody based therapies, cell based therapies that harness the power of the human immune system to eradicate cancer. For more information on Fred Hutch Cancer Center, visit fredhutch.org slash look beyond. So, of course, all of this, Vinay Prasad news happened last Friday right after our our last recording. But we need to note here that, obviously, Prasad, a top official at the FDA, who had been at the center of recurring public controversies, left the FDA for a second time. That announcement, like I said, came last Friday evening. Prasad is going to leave the FDA at the April. His replacement has not yet been identified. Yeah. And if you recall, there were a series of controversial decisions on rare disease drugs under Prasad's tenure. Most recently, we had news around UniCure and their drug for Huntington's disease. The FDA, was not satisfied with the trial that Unicure, ran, which used a, external control arm based on natural history study. And the FDA wanted the company to conduct a sham surgery controlled trial. Now let's just remind you about the chronology here. Prasad was hired last May. He was fired in July. He returned a few weeks later. And once again, he is on his way out from the agency. It's worth noting commissioner Makari said in a social media post, that he was thankful for Prasad's work at the agency, highlighted Prasad's role in reducing the number of clinical trials required to approve a drug, limiting COVID vaccine approvals to those 65 with risk factors and, you know, developing a new pathway for individualized medicines. The industry reacted strongly to this news. I think that several rare disease drug maker stocks jumped on that news. Right? Yeah. They did, Allison. And, you know, under Prasad's leadership, you know, we should note that, you know, at the FDA and CBER, which is the division of the FDA that Prasad ran, you know, …