Instead of trying to anticipate every potential harm, AI regulation should mandate open, internationally consistent audit trails, similar to financial transaction logs. This shifts the focus from pre-approval to post-hoc accountability, allowing regulators and the public to address harms as they emerge.

While crucial, the slow, administrative, and sometimes political process of defining "responsible AI" is becoming a deterrent for pharma companies. Aditya Gherola argues that regulators must move faster to provide clear guidelines, preventing the concept from becoming a roadblock to critical innovation in drug discovery.

AI delivers the most value when applied to mature, well-understood processes, not chaotic ones. Pharma's MLR (Medical, Legal, Regulatory) review is a prime candidate for AI disruption precisely because its established, structured nature provides the necessary guardrails and historical data for AI to be effective.

The FDA is abandoning rigid, fixed-length clinical trials for a "continuous" model. Using AI and Bayesian statistics, regulators can monitor data in real-time and approve a drug the moment efficacy is proven, rather than waiting for an arbitrary end date, accelerating access for patients.

By using big data for continuous, real-time post-market surveillance, the FDA can identify safety signals almost instantly. This robust safety net after a drug is launched paradoxically allows the agency to lower the evidence threshold required for initial approval, accelerating access to new cures.

An FDA-style regulatory model would force AI companies to make a quantitative safety case for their models before deployment. This shifts the burden of proof from regulators to creators, creating powerful financial incentives for labs to invest heavily in safety research, much like pharmaceutical companies invest in clinical trials.

AI tools can be rapidly deployed in areas like regulatory submissions and medical affairs because they augment human work on documents using public data, avoiding the need for massive IT infrastructure projects like data lakes.

In sectors like finance or healthcare, bypass initial regulatory hurdles by implementing AI on non-sensitive, public information, such as analyzing a company podcast. This builds momentum and demonstrates value while more complex, high-risk applications are vetted by legal and IT teams.

The FDA approved Artera AI’s prostate cancer diagnostic without understanding *why* it works. This precedent suggests that massive retrospective validation on patient data can substitute for model interpretability, changing the strategic focus for medical AI companies.