By Garo Armen, Ph.D.
Chairman & CEO, Agenus Inc.
Endpoints News recently published a piece headlined “‘Bat-sh*t crazy’: Biopharma leaders unload on regulatory chaos,” summarizing open-text comments from its Q1 Biopharma Sentiment Index. The article reads as a lament for stability lost stating staff departures, leadership turnover, regulatory uncertainty, and discomfort with change at FDA and HHS.
What Endpoints misses is the most important point of all: the old system needed to be disrupted because it was failing patients. Stability was not a virtue when it preserved a regulatory regime that rewarded delay, incrementalism, and risk avoidance while patients with advanced cancer ran out of time.
I support the leadership and structural changes underway. I have argued for them, forcefully, for decades. But support for change does not mean patience for continued inertia. Reform that does not accelerate access for patients is not reform.
The Old Guard Was Not Working for Patients
The prior regulatory paradigm was built for another era of medicine, an era dominated by chemotherapy and single-agent targeted drugs. It relied on endpoints (no pun intended) and trial designs optimized to measure short-term cytotoxic effects, not immune activation, immune memory, or durable responses and most importantly cures even in a proportion of patients who would otherwise succumb to death.
That framework may have produced predictability for institutions and incumbents, but it did not produce urgency for patients. It normalized multi-year trial timelines for diseases measured in months. It privileged statistical perfection over biological plausibility. And it created a culture where saying “not yet” felt safer than saying “now,” even when the alternative was certain decline.
The voices in the Endpoints survey mourning the loss of stability are, in many cases, the beneficiaries of that system. Their discomfort should not be confused with patient harm. In fact, it was precisely that stability, the comfort of the old guard, that left patients waiting too long for meaningful innovation.
Disruption Is Necessary but Not Sufficient
Leadership change at FDA and HHS was necessary. Clearing out entrenched thinking was overdue. But disruption alone does not save lives.
What matters is whether the regulatory system now moves faster, thinks differently, and aligns evaluation standards with modern medical science, particularly immunotherapy combinations designed for cancers historically resistant to treatment, such as microsatellite-stable colorectal cancer (MSS CRC).
Immunotherapy does not behave like chemotherapy. It requires different endpoints, different timelines, and a different tolerance for uncertainty, especially in patients who have exhausted standard options.
Yet too often, regulatory evaluation still defaults to outdated templates. The result is delay layered upon delay, despite compelling scientific rationale and urgent unmet need.
A Patient Trapped by Time and Process
Consider a patient I know well.
An early-onset metastatic colorectal cancer patient in his 30s. A single father with a toddler at home.
He has undergone surgery, chemotherapy, and additional conventional treatments. His cancer has progressed anyway. Now he is offered a final option: radical surgery removing multiple organs, his bladder, colon which would permanently alter the course and quality of his remaining life, for a marginal chance at extended survival.
His physician believes there may be a better option, an immunotherapy approach under development, grounded in modern science. But accessing that option in the United States is labyrinthine. The process is slow, unpredictable, and burdened by administrative complexity that can take longer than the patient has.
In other countries, once safety is established, patients and their physicians are empowered to weigh risk and benefit together and act. In the U.S., even when companies are willing and doctors are aligned, access to therapies under development are so cumbersome that many patients die waiting.
That is not protection. It is a sign of a failed system.
Endpoints Is Measuring the Wrong Anxiety
Endpoints frames today’s moment as one of regulatory chaos. That is the wrong diagnosis.
The real crisis is not uncertainty at FDA. It is the persistent failure to modernize how we evaluate value, risk, and benefit for patients with life-threatening disease. The article amplifies anxiety about staffing changes and funding shifts, but it avoids confronting why so many patients remain locked out of innovation until it is too late.
Calling for a return to “predictability” without asking predictable for whom is a profound misread of the moment. The system was predictable when it took ten years to approve therapies that delivered weeks of benefit. Patients cannot afford that kind of predictability anymore.
Change Must Deliver
The old guard needed to go. The old system was not working. On that, reformers and patients are aligned.
But now comes the hard part: execution.
Reform that stops at disruption is unfinished. Reform that does not shorten timelines, modernize evaluation, and expand access for dying patients is incomplete.
At Agenus, our mission is to extend the promise of immunotherapy to patients left behind by first-generation approaches. We will continue to support regulatory change, but we will also continue to press for more, and for faster.
Because for patients like the young father deciding between radical surgery and fading hope, time is not a policy debate. It is everything.
Garo Armen, Ph.D., is the Chairman and CEO of Agenus Inc. and the founder of the Children of Armenia Fund (COAF). More articles featuring Garo Armen on OncoDaily.