When Evidence Gap Becomes a Commercial Liability
The MENA evidence gap for selected portfolios is becoming a commercial liability for drugmakers that could have been prevented at the design stage.
The MENA evidence gap for selected portfolios is becoming a commercial liability for drugmakers that could have been prevented at the design stage.
Are we genuinely building long-term preparedness infrastructure, or are we repeatedly improvising our way from one outbreak cycle to the next?
We should ask a more nuanced question than "does AI work in drug discovery." Rather, we should ask which approaches are about to be proven, and which are about to be exposed, because the field is several bets, and they are not equally sound.
For years the healthcare system has relied on the slow machinery of research — and that system is failing the people it was built for. It was designed for a world that operated with an abundance of caution and lacked the modern tools of today. That world no longer exists.
The in-depth, constantly-changing birds-eye view of disease that computational models provide is an essential next step in linking our ever-expanding clinical knowledge and data with drug development.
For governments and health systems, monoclonal antibodies represent not just another drug class, but a strategic shift toward precision prevention.
AI will continue changing how small molecules are discovered, but the candidates that generate the most interest in silico still have to succeed under real development conditions.
These structures, if not set up and managed correctly from day one, can create significant accounting, tax and compliance headaches down the road.
New FDA guidance on the use of Bayesian statistics signals a broader shift in accommodating more flexible clinical trial designs and the complexities of diseases such as certain cancers and rare disorders, which may lead to more efficient trials, lower development costs, and faster innovation.
By fine-tuning domain-specific models with real clinical operations data — such as historical performance, feasibility outcomes, enrollment patterns, and resource utilization — hidden information can be translated into structured intelligence.
AI can speed up drug discovery and decrease attrition rates in the clinic, but it is important to recognize that both are tall orders. The companies that will benefit most are those that stay grounded, set realistic expectations, and keep experienced scientists at the center of decisions that require genuine creativity and judgment.
As decentralized trials reduce face time with participants, sponsor organizations that treat engagement as an afterthought will pay for it in dropout rates, missing data and failed endpoints.
The success of Pluvicto has created a new challenge in prostate cancer, one the field has not yet fully named or defined.
Difficult packaging comes with tangible consequences, including lower adherence, higher rates of adverse events, and diminished real-world effectiveness. It can also delay FDA submissions and ultimately, market entry.
Now more than ever, NAMs need to be considered a core aspect of modern drug development – and scientists, decision-makers, regulators and governments must keep pace with this evolving landscape to ensure they are equipped to deliver the next-generation of therapies.