To influence policy on critical issues like the Priority Review Voucher, biotech CEOs are forming consortiums and going to Washington as a unified group. This collaborative approach is more effective than individual company efforts because it demonstrates a widespread industry problem that needs a legislative solution.

A significant disconnect exists between the FDA leadership's public statements promoting flexibility and the stringent, delay-prone reality faced by companies. For areas like gene therapy, firms report feeling the "rug was pulled out," suggesting investors should be skeptical of the agency's accommodating PR.

CEOs of major corporations are now forced to spend a significant portion of their time—estimated at 15-20%—managing political risks created by the Trump administration. This 'Trump Drag' functions as a direct tax on innovation and long-term strategy, as executive focus shifts from business to political firefighting.

Pfizer's CEO was named a "Best CEO" not for pipeline success but for effectively managing political pressure from the Trump administration. He made deals that appeased the White House on drug pricing without harming shareholder value, highlighting how a modern pharma CEO's job now heavily involves navigating the political landscape.

The transition from a leadership role at a large pharma company like Gilead to a biotech CEO involves a massive shift in scope. Instead of managing one large function with a large team, a biotech CEO is hands-on with every aspect of the company, from science to finance.

The key risk facing biomedical innovation is not just policy chaos, but the normalization of political and ideological influences on science-based regulation. This includes CEOs negotiating prices with the president and FDA enforcing pricing policies, breaking long-standing norms that separated science from politics.

The transition from a resource-rich environment like Novartis to an early-stage biotech reveals a stark contrast. The unlimited access to a global organization is replaced by a total reliance on a small, nimble team where everyone must be multi-skilled and hands-on, a change even experienced executives find jarring.

The biotech industry's messaging to legislators often fails because it focuses on economic contributions. To gain support and combat negative narratives, leaders must shift to "plain speak," using patient stories to humanize their work and focus on their core mission of improving health.

The biotech industry is entering a paradoxical period. Financial markets show signs of recovery with rising follow-ons and potential IPOs, suggesting a bear market end. However, this optimism is contrasted by significant uncertainty and political turmoil at key US agencies like the FDA and NIH, creating a challenging operating environment for innovation.