The Readout Loud

In this engaging conversation, John Crowley, CEO of the industry lobbying group BIO, discusses pressing issues in biotechnology. He sheds light on recent FDA layoffs and the implications for vaccine approval, particularly regarding Novavax's COVID-19 vaccine. Crowley addresses the critical need for a $15 billion federal investment to bolster U.S. biotech against competition from China. He also touches on the complexities surrounding public trust in science, the impact of tariffs on the industry, and how to navigate dialogues with controversial figures like RFK Jr.

Lizzy Lawrence, STAT’s FDA reporter, shares insights into the upheaval within the FDA, revealing how Robert F. Kennedy Jr.'s actions led to high-level resignations amidst a chaotic transition. Joining her is Sharon Barr, R&D executive at AstraZeneca, who discusses the promising results of a new PCSK9 pill that significantly reduces cholesterol, framing it as crucial for AstraZeneca’s growth strategy. The conversation also touches on the broader implications of leadership changes and market pressures in the biotech sector.

Felix Baldov-Lenschen, CEO of Altus Labs, shares insights on his company's innovative AI tool for cancer drug development, called IPRO, which excels in predicting patient survival. The discussion touches on the recent turmoil in health agencies, with job cuts and a significant drug approval for a rare disease. Felix reveals how AI is reshaping oncology, enhancing treatment assessments, and improving clinical trial efficiency. The bankruptcy of 23andMe also emerges as a cautionary tale for biotech, highlighting challenges in the industry.

Adam Steensberg, CEO of Zealand Pharma, shares insights on his company’s innovative amylin-targeting obesity treatment and its strategic partnership with Roche, valued at $1.65 billion. He challenges industry norms by emphasizing sustainable weight loss over drastic changes. Robert Salcedo, CEO of OceanBio, discusses the unique biotech landscape in Puerto Rico, focusing on advancements in gene therapies and the potential for affordable medicine production. Together, they highlight the shifting priorities in obesity treatment and the resilient future of biotech in Puerto Rico.

We bring on our colleague Sarah Owermohle to discuss the White House's sudden move to withdraw the nomination of Dave Weldon as its pick to run the CDC just hours before Weldon's confirmation hearing. It's also the five-year anniversary of the Covid-19 pandemic. We chat with Princeton political scientist Frances Lee about a new book she co-authored that offers an unflinching assessment of the U.S. policy responses to the pandemic and raises some provocative questions about what went wrong.

Will Marty Makary be confirmed as the next commissioner of the Food and Drug Administration? Will he bring back employees laid off by DOGE? And what did he get wrong during his confirmation hearing? We discuss all that and more during this week's special episode.

Lizzy Lawrence, a STAT reporter, gives us an inside look at the current turmoil at the FDA, detailing the chaos of frequent staffing changes and its impact on morale. Jason Mast then discusses the acquisition of Bluebird Bio, shedding light on the company's challenges in gene therapy and its drastic fall from grace. The conversation also touches on the rise of new biotech VCs, fueled by technological advancements and the pandemic, setting the stage for a dynamic shift in the industry.

Jared Holz, a healthcare market strategist at Mizuho Securities, shares insights into the biotech landscape's challenges and prospects. He discusses the impact of recent FDA cuts on drug manufacturing, raising concerns about staffing shortages. The conversation also dives into the disconnect between pharmaceutical goals for weight loss and patient experiences, plus the rise of 'zombie' biotech companies. Holz emphasizes the importance of accountability in a stagnating market and highlights promising developments in gene therapy despite industry hurdles.

Biotech reporter Jonathan Wosen discusses the NIH's significant funding cuts and the looming brain drain that could push young researchers overseas. Health tech reporter Brittany Trang dives into the skeptical reactions towards AI drug developers like Absci and Generate:Biomedicines, who assert they can create drugs from scratch. The conversation sheds light on the potential impact of reduced NIH support on U.S. biomedical innovation and the challenges of relying on AI in drug discovery.

Jason Mast, a reporter for STAT, delves into the troubling downturn in the once-promising CRISPR gene editing field. The discussion highlights the challenges companies face amid market skepticism and compares CRISPR innovations with RNA therapies. The conversation also touches on RFK Jr.'s controversial views as a nominee for HHS secretary, alongside insights into recent pharma earnings that spotlight successes in obesity treatments and the approval of a groundbreaking non-opioid pain drug, revealing the complexities of today’s biotech landscape.