Why evidence matters: Seema Meloni on making data meaningful  

“In order to help all partners understand the value of a medicine, we provide the wrap-around support of data coming out of clinical trials.” 

Clinical trials answer specific questions in very structured settings and under controlled conditions. Seema Meloni’s team ensures those answers exist within a broader context.  

Her focus is on real-world evidence strategy: defining unmet needs, quantifying disease prevalence, and understanding “what the world looks like with or without our therapies.”  

She works across asset teams to build a comprehensive evidence package alongside the clinical development plan. Clinical trials show efficacy and safety under controlled conditions. Real-world evidence complements trials by capturing the full patient experience and how a medicine performs across broader populations. Her team generates additional evidence to answer those questions and place trial results into context. 

“One of the biggest challenges in pharma is external acceptance of real-world data,” she says. “In these cases, we have less control over data collection and the quality of what is collected compared to traditional randomized control trials, so we have to work hard to ensure we introduce strategies to find the highest quality data and analyze them in the most robust way.” 

Randomized trials remain essential. But she argues that in many instances they are not sufficient on their own to support all scientific and business needs. “We often need additional supportive data to complete the full package of understanding the benefit-risk profile of a medicine,” she says. That requires studies designed with scientific rigor while providing broader data sources to various key external stakeholders.  

“The risk is that without a comprehensive and feasible evidence strategy, treatments that work won’t reach the patients who can benefit from them or can sometimes get removed from the market,” she notes. The consequence is not abstract. It affects patients who may rely on those medicines. 

Her conviction was shaped early in her career. After completing her doctorate, she joined an effort to scale HIV treatment across multiple African countries. “It was trial by fire,” she says. She built electronic medical records systems to capture data at scale, learning how evidence informs patient access, ethics, and policy.  

Today, that perspective remains central. “Science with Purpose is making sure we are being responsible and making decisions based on comprehensive, high-quality data,” she says. 

Evidence is integral. It is protection for patients, for decisions, and for the future of medicines.