Publications: Sandra Barbosu

The FDA’s Breakthrough Therapy Designation program underscores the benefits of targeted regulatory innovation. Its success offers valuable lessons for policymakers navigating the balance between speed and safety in approving life-saving therapies.

America’s poor health outcomes aren’t about bad care—they’re about bad habits, and solving them starts long before the doctor’s office.

Many of the world’s biggest challenges are health challenges. The good news is that, more than ever, people are meeting these challenges with innovative solutions.

AI has the potential to transform drug development by enhancing productivity across the entire development pipeline, boosting biopharmaceutical innovation, accelerating the delivery of new therapies, and fostering competition to help improve public health outcomes.

The scope and magnitude of the trade-off between immediate savings from lower drug prices and future health benefits from clinical development remain poorly understood and quantified. To support rigorous evaluations and inform evidence-based policymaking, it is crucial to invest in this area through research grants and improved access to federal and private data.

There is a need for more rigorous evidence and more recent, high-quality data to inform biopharmaceutical policymaking by shedding light on the relationship between pharmaceutical firms’ expectations of financial returns from new drugs and their ability to invest in further R&D to discover future generations of drugs.

Mario Draghi's 2024 report addresses the EU's biopharmaceutical decline, citing challenges like underfunded research, fragmented pricing, and competition from the U.S. and China. It recommends reforms but underplays the impact of EU drug price controls on innovation.

China used to be considered a laggard in biotech. But with a comprehensive national strategy and extensive resources now supporting the industry, it is becoming more innovative. In fact, several indicators suggest it is narrowing the innovation gap with global leaders in the West.

By improving privacy protection and facilitating secure collaborative research, privacy-enhancing technology could complement data-sharing policies and enable analysis of sensitive medical data and support biomedical innovation.

Better evidence is needed to evaluate the impact of policy changes on new drug development. Greater availability of government data should support more rigorous evaluations to inform evidence-based policymaking.