The market is currently ignoring the long-term impact of deep cuts to research funding at agencies like the NIH. While effects aren't immediate, this erosion of foundational academic science—the "proving ground" for new discoveries—poses a significant downstream risk to the entire biotech and pharma innovation pipeline.

The focus in advanced therapies has shifted dramatically. While earlier years were about proving clinical and technological efficacy, the current risk-averse funding climate has forced the sector to prioritize commercial viability, scalability, and the industrialization of manufacturing processes to ensure long-term sustainability.

The number of startups founded in China dropped from 51,000 in 2018 to just 1,200 in 2023, a 98% decrease. Roelof Botha attributes this collapse to unpredictable government regulations that stifle entrepreneurial risk-taking, serving as a warning for how policy could impact innovation elsewhere.

Despite massive turnover and internal dysfunction at the FDA, biotech investors have largely shrugged off the regulatory uncertainty. This disconnect suggests the market believes the negative impacts, like drug review delays, are a lagging indicator that won't materialize immediately, creating a potential future risk for the sector.

The NIH's cancellation of mRNA research is a profound strategic error. The technology's key advantage is speed, which is critical not only for future pandemics but also for personalized cancer treatments. These therapies must be developed for individual patients quickly, making mRNA the most promising platform.

Unicure's setback with its Huntington's gene therapy demonstrates a new political risk at the FDA. A prior agreement on a trial's design can be overturned by new leadership, especially if the data is not overwhelmingly definitive. This makes past regulatory alignment a less reliable indicator of future approval.

An ideologically driven and inconsistent FDA is eroding investor confidence, turning the U.S. into a difficult environment for investment in complex biologics like gene therapies and vaccines, potentially pushing innovation to other countries.

Industry sentiment on the FDA is not monolithic. A recent survey reveals that while biotechs largely maintain confidence in the agency's hardworking staff and their day-to-day interactions, there is deep concern and a lack of trust in the agency's top leadership. This nuanced view highlights that the perceived problems are rooted in politicization and leadership competence, not frontline operations.

Venture capital for US seed and Series A cell and gene therapy companies has collapsed from a historical high of 17-21% of deals to only 7% this year. The sharp decline is driven by a confluence of factors including patient deaths, persistent manufacturing challenges, and growing regulatory uncertainty.