Biotech has never been an industry for the faint of heart, but the regulatory environment we are navigating today feels different. The forces shaping our industry, from policy upheaval and institutional erosion to a funding market that rewards the few and starves the many, are converging in ways that demand both attention and action.
About our Board of Advisors
The Russo Partners Board of Advisors serves as a strategic sounding board for the agency and its clients. The board brings together a diverse group of senior industry voices spanning venture capital, equity research, regulatory policy, public health, media, and biotech industry leadership.
The board convenes annually to assess the state of the industry, identify emerging challenges and opportunities, and stress-test the narratives that matter most to biotech companies, investors, and policymakers. Their collective insight informs how Russo Partners counsels clients on strategic communications.
At our recent Russo Partners Board of Advisors meeting, our group of industry veterans does what they do best: tell it straight. The conversation was wide-ranging, candid, and at times sobering. As I reflect on the dialogue, one thing is clear: the ground beneath our industry is shifting, and the biotech leaders and investors who understand that shift earliest will be best positioned to navigate it.
In this essay, I explore what our board had to say about healthcare policy, the FDA, and the accelerating erosion of public health institutions, and what all of it means for the road ahead.
Healthcare Policy: When the Signals Keep Changing
The healthcare policy environment our industry is operating in today is, by any honest assessment, uncertain. Day to day, the signals from Washington shift. For an industry that runs on multi-year development timelines and long-horizon investment decisions, that kind of unpredictability creates real planning challenges for both CEOs and investors.
The Department of Health and Human Services has signaled some movement on drug pricing, but our board noted how little structural change the Trump RX initiative represents for the industry.
It is not the science that is struggling. It’s that policy, that regulatory inconsistency that’s killing investment and it’s killing trust in those platforms.
Capital markets have held up better than many expected. But our board was clear that short-term stabilization is masking a deeper issue. The focus from Washington remains on immediate cost control rather than the kind of long-term, systemic reform that would strengthen the environment for innovation and investment.
What our board made clear was that the science and the policy environment are two very different stories. “It is not the science that is struggling. It’s that policy, that regulatory inconsistency that’s killing investment and it’s killing trust in those platforms,” said one board member. Pipelines are advancing, platforms are maturing, and the talent is there. The challenge is not scientific, but strategic.
FDA Reform: The Gap Between Intent and Capacity
The honest assessment from our board on FDA reform was that, to date, the net effect has been neutral. There have been genuine bright spots: Reduced reliance on animal models, organ-on-a-chip technology, and synthetic organ systems are all receiving the regulatory attention they deserve. That progress is meaningful for companies building platform-based therapies where regulatory flexibility is everything.
But the broader reform agenda has not yet translated into tangible benefits, particularly for rare disease companies who had reason to hope the new approval pathways would move faster. What concerns our board more than the pace of reform is the agency’s capacity to deliver on it at all. “Can you imagine working at FDA right now? Half the senior leadership is gone. You don’t know when more staff is going to leave,” said one board member. Junior staff who form the operational backbone of the review process have been largely eliminated. For companies with drugs in the pipeline, that institutional knowledge cannot be replaced quickly.
Beyond staffing, our board raised a more fundamental question about the direction of reform itself. The push from Washington has been focused primarily on getting drugs approved faster. “It’s not about speed so much as I think it is shifting to the regulatory models to keep pace with the technologies that they’re evaluating,” said one board member. That distinction matters. Biotech is no longer bringing single products through a linear process. It is building platforms that evolve continuously, and the regulatory framework needs to evolve with them.
Public Health: A Trust Crisis with Real Consequences
Approximately 2,400 staff, representing 18% of the Centers for Disease Control, have been fired or resigned since January last year. “I can’t believe that in 2026 we are litigating the value of CDC,” said one board member. The number is striking, but the deeper damage runs well beneath the headcount. This is not primarily an operational crisis. It is a reputational one. And while there was acknowledgment that the CDC had experienced mission creep over the years, straying from its core mandate, the consensus was clear: that is a management challenge, not a justification for dismantling the institution itself.
It was about the messaging to the public to motivate the public to play their role in public health. And I think that is completely demolished at this point.
The consequences are no longer theoretical. Measles outbreaks in Florida and South Carolina have forced school closures. These are diseases we had largely conquered. Beyond the outbreaks and the staffing cuts, what our board kept returning to was something more fundamental. The CDC’s value was never only about data collection or disease surveillance. It was about the relationship built with the American public over decades. As one board member put it, “It was about the messaging to the public to motivate the public to play their role in public health. And I think that is completely demolished at this point.”
For biotech, that erosion of public trust is not a peripheral concern. It sits at the center of everything we do. A public that does not trust its health institutions is a public that is harder to reach, harder to treat, and harder to serve. Rebuilding it will take time, commitment, and industry leadership that rises to the moment.
The Moment Calls for Leadership
The challenges our board laid out in this conversation are real, and they deserve to be taken seriously. But what struck me equally was the absence of resignation in the room. These are people who have navigated difficult moments before, and their clarity about what is broken comes from the same depth of experience that gives them confidence it can be addressed. The science is advancing. The talent is there. The platforms are maturing. What our industry needs now is leadership that matches the moment.
In my next essay, I will share what our board has to say about where the capital is going, who is competing for it, and where the genuine opportunities lie for companies willing to think strategically about what comes next.
About the Author
Tony Russo, Ph.D., is Chairman and CEO of Russo Partners, a strategic communications firm serving biopharma, medtech, and digital health leaders for more than 35 years.
