The Readout Loud

The podcast dives into the swirling uncertainty surrounding COVID vaccine effectiveness and political narratives. It highlights the delicate balance health officials must strike amid public discontent and changing FDA guidelines. Meanwhile, there’s a noticeable rebound in the biotech sector, with optimism around upcoming IPOs and successful clinical trials. Enthusiastic discussions also spotlight significant advancements in sleep and lung disorder treatments, particularly at the World Sleep Congress and lung cancer meetings.

Chelsea Cirruzzo, Washington correspondent at STAT, joins the conversation to dissect the abrupt ouster of CDC Director Susan Monarez and the wave of resignations among senior officials amid vaccine policy tensions. They discuss the impact on public trust in health institutions and the shifting landscape of health policies. The dialogue also covers STAT's VC rankings report, highlighting the challenges and successes within biotech venture capital, including intriguing insights about fund performance relative to size.

This week, the podcast dives into the dramatic flop of Viking Therapeutics’ obesity drug trial, raising concerns about its treatment effectiveness and the biotech industry's fierce competition. The discussion shifts to the controversial 'pharma to table' trend, which promises direct sales to consumers but is unlikely to lower drug prices as hoped. Insights into cash pay pricing reveal the challenges faced by uninsured patients, while the impact of shifting to direct sales models on pharmaceutical pricing strategies is explored. Tune in for a fascinating take on these pivotal health industry topics!

Marissa Russo, a STAT fellow and PhD candidate at the Mayo Clinic focusing on glioblastoma, joins to delve into the hotly debated topic of alternatives to animal testing. She explores the innovative methodologies like organ-on-chip models and the push from the FDA and NIH towards more humane research practices. The conversation also touches on the complexities of these new approaches and the challenges in ensuring their reliability. Additionally, insights on the shifting landscape of mRNA technology add to the discussion's depth.

In this episode, Natalie Holles, former CEO of Third Harmonic Bio, shares her insights on the tough decisions behind dissolving the company and returning cash to shareholders. She discusses the challenges of biotech leadership amid failures, including Eli Lilly's disappointing obesity drug results and Replimmune's FDA rejection. Holles emphasizes the importance of transparency and data-driven approaches in the industry. The conversation wraps up with a humorous take on the challenges of balancing personal life with professional aspirations in biotech.

In this discussion, guests Brian Skorney, a senior research analyst at Baird, Ned Sharpless, former acting FDA commissioner, and Robert Califf, former FDA commissioner, delve into the impact of Vinay Prasad's departure from the FDA. They examine the political turbulence influencing FDA operations and the biotech sector, especially regarding drug approvals and leadership changes. The conversation highlights the challenges of regulatory integrity, the evolving landscape of gene therapies, and the urgent need for improved data collection in post-marketing drug safety.

Kaylin West, mother of 7-year-old Cooper with Duchenne muscular dystrophy, shares her powerful insights on Sarepta's decision to halt its gene therapy, Elevidys. She reflects on her family's journey through the hopeful yet tumultuous world of gene treatments. The podcast also delves into the emotional impact of such medical developments, highlighting the importance of community support for families navigating similar challenges. Alongside biotech innovations and new drug developments, Kaylin's personal story adds a poignant depth to the discussion.

Just how many employees is Sarepta Therapeutics laying off? And why did the Food and Drug Administration reject Ultragenyx’s rare disease drug over manufacturing qualms? Ultragenyx CEO Emil Kakkis joins us to discuss what was in the rejection letter his company received late last week, and whether he still has confidence in FDA Commissioner Marty Makary. We also discuss Capricor’s drug rejection, and Sarepta’s decision to lay off hundreds of staffers, but give raises to some executives.

On this week’s episode of the Readout LOUD: A closer look at the NIH’s grant-cutting legal playbook, a not-so-transparent transparency push by the FDA commissioner, and another big biotech acquisition. Our colleague Anil Oza joins us to unravel a previously unseen memo he obtained from HHS that lays out the legal framework being used to justify the termination of NIH grants. The disclosure comes as legal fights over the legitimacy of these funding cuts are being challenged in multiple courts.

Helen Branswell, a senior writer for infectious diseases at STAT, and Chelsea Cirruzzo, a Washington correspondent for STAT, dive into the latest CDC happenings, including a heated confirmation hearing for its new nominee. They discuss significant findings from the American Diabetes Association meeting, highlighting challenges with obesity drug side effects. The duo also laments the summer movie season's disappointments while reminiscing about classic blockbusters like 'Jaws.' It’s a mix of health insights and cinematic nostalgia worth a listen!