Editorial Contributions & Industry Insights

As an international key opinion leader with extensive experience in the healthcare ecosystem, I have been at the forefront of shaping industry discussions and policy. Since 2018, I have contributed to PharmaBoardroom, offering in-depth analysis and insights on emerging trends, regulatory changes, and strategic developments within the global healthcare landscape. My work is grounded in a deep understanding of the industry's complexities, making me a trusted voice for stakeholders across the healthcare spectrum.

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Healthcare Policy, FDA, Regulatory Policy Monica Dudley-Weldon Healthcare Policy, FDA, Regulatory Policy Monica Dudley-Weldon

From Engagement to Evidence: Building a Holistic Measure of Patient-Focused Drug Development

While Patient-Focused Drug Development (PFDD) has elevated the patient voice in healthcare, significant gaps remain in translating these insights into measurable outcomes. True patient centricity goes beyond consultation—it requires embedding patient perspectives into every stage of drug development, from trial design to post-market evaluation. Yet, challenges persist: inconsistent patient engagement, lack of standardized metrics, and limited frameworks to assess the impact of patient input on decision-making. Measuring the success of patient-centric initiatives demands clear indicators, such as improvements in patient-reported outcomes, enhanced treatment adherence, and tangible changes in clinical or regulatory decisions. Only by identifying these gaps and establishing robust metrics can we ensure that patient-centered strategies deliver meaningful results rather than symbolic gestures.

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ACA, Healthcare Policy, Insurance Monica Dudley-Weldon ACA, Healthcare Policy, Insurance Monica Dudley-Weldon

CON Laws and the ACA — The Next Frontier for Affordable Healthcare Reform

More than a decade after the Affordable Care Act expanded coverage for millions, a harsh reality remains: coverage does not equal access. Premiums continue to rise, rural care deserts are widening, and consolidated insurers and middlemen dominate every layer of the system. In this article, I explore the ACA’s most overlooked weakness—its failure to confront the structural barriers that suppress competition. From Certificate-of-Need laws to PBM pricing distortions and marketplace consolidation, these forces inflate costs and restrict care long before patients reach the exam room. To achieve true affordability and access, we must finish the job the ACA started by opening the system to innovation, transparency, and competition.

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