Despite scientific breakthroughs and better technology, the cost per approved drug has steadily increased over the last 60 years. This phenomenon, the reverse of Moore's Law, is called Eroom's Law and highlights a fundamental productivity problem in the biopharma industry, with costs approaching $1B+ per successful drug.
The process of testing drugs in humans—clinical development—is a massive, under-studied bottleneck, accounting for 70% of drug development costs. Despite its importance, there is surprisingly little public knowledge, academic research, or even basic documentation on how to improve this crucial stage.
When a billion-dollar drug trial fails, society learns nothing from the operational process. The detailed documentation of regulatory interactions, manufacturing, and trial design—the "lab notes" of clinical development—is locked away as a trade secret and effectively destroyed, preventing collective industry learning.
A clever legal hack can solve the problem of inaccessible trial data. By purchasing the regulatory documents (Common Technical Documents) of bankrupt biotech firms as assets during liquidation, an organization can legally acquire and then publicly release priceless process knowledge that is otherwise lost forever.
With clinical development cycles lasting 7-10 years, junior team members rarely see a project to completion. Their career incentive becomes pushing a drug to the next stage to demonstrate progress, rather than ensuring its ultimate success. This pathology leads to deferred problems and siloed knowledge.
Drug developers often operate under a hyper-conservative perception of FDA requirements, avoiding novel approaches even when regulators might encourage them. This anticipatory compliance, driven by risk aversion, becomes a greater constraint than the regulations themselves, slowing down innovation and increasing costs.
Critical knowledge on how to run clinical trials is not formalized in textbooks or courses but is passed down through a slow apprenticeship model. This limits the spread of best practices and forces even highly educated scientists to "fly blind" when entering the industry, perpetuating inefficiencies.
The fundamental purpose of any biotech company is to leverage a novel technology or insight that increases the probability of clinical trial success. This reframes the mission away from just "cool science" to having a core thesis for beating the industry's dismal odds of getting a drug to market.
In fields like academic science, young professionals are disincentivized from taking risks. The fear is not just that the risk itself will fail, but that they will be permanently labeled a "troublemaker" by the institution, which can be detrimental to their career progression regardless of the outcome.
Senior professionals can combat systemic risk aversion by lending their social status to younger colleagues. When a junior person raises a valid but risky point, a senior can re-state it as their own concern, using their credibility as a shield to allow the idea to be judged on its merits, not its origin.
A COVID-19 trial struggled for patients because its sign-up form had 400 questions; the only person who could edit the PHP file was a grad student. This illustrates how tiny, absurd operational inefficiencies, trapped in silos, can accumulate and severely hinder massive, capital-intensive research projects.