Nirosha Mahendraratnam Lederer, PhD, MSPH
Nirosha Mahendraratnam Lederer, PhD MSPH is a Managing Associate at the Duke-Margolis Center for Health Policy, where she helps lead the Center’s real-world evidence (RWE) portfolio. Immediately prior, she was a Subject Matter Expert in the Oncology Center of Excellence at FDA. While there, she helped implement patient-focused drug development in cancer products including clinical trial study design and product review, as well as foster consensus across US and ex-US healthcare stakeholders on best practices for patient-reported outcome capture, analysis, and communication.
Dr. Lederer has over a decade of pharmaceutical policy and health economics and outcomes research experiences including providing evidence-generation advisory services at Avalere Health, working in commercial and medical roles at Genentech and Bristol-Myers Squibb, respectively, and serving on Capitol Hill during the passage of the Affordable Care Act. She received her PhD in Health Outcomes and Policy from the UNC Chapel Hill with a focus on large database analyses and decision-sciences. She received her MSPH in Health Policy & Management from the Johns Hopkins Bloomberg School of Public Health and BA in Public Health from the Johns Hopkins University.
Nirosha Mahendraratnam, Christina Silcox, Kerra Mercon, Adam Kroetsch, Morgan Romine, Nicholas R. Harrison, Adam Aten, Rachel Sherman, Gregory Daniel, Mark McClellan
Nirosha Mahendraratnam, PhD; Corinna Sorenson, PhD, MHSA, MPH; Elizabeth Richardson, MSc; Gregory W. Daniel, PhD, MPH, RPh; Lisabeth Buelt, MPH; Kimberly Westrich, MA; Jingyuan Qian, MPP; Hilary Campbell, PharmD, JD; Mark McClellan, MD, PhD; and Robert W. Dubois, MD, PhD
Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility
Nirosha Mahendraratnam, Joy Eckert, Kerra Mercon, Katherine Frank, Morgan Romine, Adam Kroetsch, Rachel Sherman, Gregory Daniel, Mark McClellan
Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness
Nirosha Mahendraratnam, Kerra Mercon, Joy Eckert, Morgan Romine, Adam Kroetsch, Katherine Frank, Rachel Sherman Gregory Daniel, Mark McClellan