Have you noticed that, amid everything else crowding the headlines, we’re about to send four people on a ten day trip around the Moon? Artemis II will strap a crew into NASA’s Orion spacecraft, sling them in a loop around the Moon, and bring them home without ever touching the surface. Along the way, the team will be stress testing the Space Launch System rocket, life support and navigation systems, and deep space operations to prove we can safely take the next steps back to the lunar surface - and, eventually, on toward Mars. It’s a breathtaking blend of risk and reward: enormous technical uncertainty on one side, and the promise of opening up a new chapter of exploration on the other.
In our world, we use “moonshot” to describe pharma projects that feel just as audacious. These are the all in efforts to cure cancer, crack rare diseases, or build pandemic ready antivirals - programs that demand new platforms, new partnerships, and timelines that try to compress decades of progress into a few short years. At the sharp end of that ambition sits first in human (FIH) testing, the very first clinical study of a novel intervention in people, usually at the Phase 1 stage. Here, the goals sound modest - establish safety, tolerability, pharmacokinetics, find a dose range - but for a company, that first human dose is where a long preclinical bet finally meets reality.
For investors, FIH is a classic inflection point. A clean safety and PK readout can dramatically change perceptions of risk and future cash flow potential, opening doors to new capital, partnerships, and pipeline expansion. A bad signal - a serious adverse event, poor exposure, or no hint of pharmacologic activity - can erase years of work and a great deal of equity value in a week. That dynamic creates real pressure to move quickly into FIH, to be “first,” to hit milestones that keep money flowing.
Ethically, though, FIH is also a moral test. Healthy volunteers and medically fragile patients are taking on real risk with little chance of direct benefit; the justification rests on the social value of what we learn and how responsibly we act on it. We know early phase research tends to lean on people with fewer financial options, and that high payments and hopeful messaging can blur their perception of risk. When the same dose that unlocks the next financing round could also be the one that harms a participant, companies have to show whose interests truly come first: shareholders or the people in the bed.
Much like the literal moonshots now back on the launch calendar, FIH studies are defined by this tension between danger and possibility. They are where bold ideas either earn the right to move forward or are stopped before they can do more harm than good. As an industry, our challenge is to keep reaching for those transformative rewards while taking the risks - scientific, financial, and human - every bit as seriously as a crew strapping in for a flight around the Moon.
Mike Auerbach
Group Editor-In-Chief
[email protected]