Clinical-Stage Decision Making
The board's role in the decisions that define clinical-stage companies
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.