Clinical-Stage Decision Making
The board's role in the decisions that define clinical-stage companies
Reading a Clinical Trial Protocol as a Board Member
A clinical trial protocol is the document in which a program's fate is largely already decided. Most directors never read one, and don't need to read it like a scientist. But knowing where to look — and what a handful of choices commit the company to — is one of the highest-leverage skills a clinical-stage director can have.
Compassionate Use: Governing the Decision No One Wants to Make Wrongly
A dying patient wants a company's investigational drug. The request is human, urgent, and hard to refuse — and the decision carries clinical, ethical, operational, and development consequences that a board should ensure the company has thought through before the first request arrives, not after.
Biomarker-Driven Development: What Boards Need to Understand About Betting on a Signal
A biomarker strategy can transform a program's odds — a smaller, faster, more likely-to-succeed trial in the patients most likely to respond. It also introduces a second development program, a second regulatory relationship, and a set of risks boards routinely underestimate.
Evaluating a Pivot: When Changing Direction Is Wisdom and When It's Denial
A pivot can be a company's smartest move or its most expensive form of denial. The board's job is to tell the difference — and the tell is rarely in the new plan itself, but in the honesty of the reckoning with the old one.
The Board's Role During a Clinical Hold
A clinical hold is one of the few events that can halt a company overnight. It is also a moment when boards are most tempted to do the wrong things — react to the market, second-guess the science, or go quiet. What effective oversight looks like when the program stops.
Statistical vs. Clinical Significance: What Boards Misread in Trial Results
A trial can hit its endpoint and still fail commercially. The gap between a statistically significant result and a clinically meaningful one is where a great deal of biopharma value quietly disappears — usually with the board's unwitting consent.
When the CEO Wants to Proceed and the Data Says Wait
The most difficult governance moment in a clinical-stage company is not a scandal or a crisis. It is the quiet meeting where a capable, committed CEO wants to advance a program and the data are telling a more cautious story.
Regulatory Strategy Oversight: What the Board Owns and What It Doesn't
Regulatory strategy is where a biopharma company's scientific ambitions meet the agency that decides whether they reach patients. Boards routinely under-govern it — treating it as a technical function rather than the strategic determinant it actually is.
Pipeline Prioritization When Capital Is Scarce
Most clinical-stage companies have more programs than capital. Deciding which to fund, which to slow, and which to kill is among the most consequential — and most avoided — decisions a biopharma board makes.
The Information Asymmetry Problem in Biopharma Boards
In every other industry, a competent board can independently verify the substance of what they are being told. In biopharma, most directors cannot. How to govern effectively when you cannot verify the underlying science.
How Boards Should Evaluate Ambiguous Clinical Data
When the clinical results are not clearly positive or clearly negative, the board faces its hardest test. A practical framework for navigating the gray zone.
The Board's Role in Trial Go/No-Go Decisions
The most consequential decision a clinical-stage biopharma board makes is whether to advance a program to the next trial phase. Most boards get the process wrong.
Governance vs. Management in Clinical Development
Where the board's oversight role ends and the management team's execution authority begins — and why getting this boundary wrong is the most common governance failure in biopharma.