David Brown

BIO

David Brown

VP, Epidemiology

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Experienced Vice President with a demonstrated history of working in public health, acute care, academia and the biotechnology, medical devices and pharmaceuticals industries. Skilled in Epidemiology, Pharmacoepidemiology and Real-World Evidence. A highly collaborative and motivated professional widely respected by peers, colleagues and clients. A visionary leader, critical thinker and problem-solver.

Nineteen years of experience in pharmaceutical companies and clinical research organizations. Established the Epidemiology function at four companies with increasing levels of financial responsibility and global reach. Experienced principal investigator, scientific committee board member, published author, invited speaker and mentor.

Expert in Real-World Science with a deep understanding of real-world data applications across the product lifecycle to meet the needs of different stakeholders; in framing a public-health focused research questions; and, in real-world study design conceptualization, pharmacoepidemiologic methods, protocol and report development, and the interpretation and communication of study results.

Core competency in understanding and anticipating regulatory expectations. Experienced negotiating with and presenting to regulatory agencies. Passionate about patient safety and regulatory agency-mandated post approval safety studies. Comprehensive knowledge of global scientific and stakeholder requirements in support of efficacy evaluations in BLA and NDA submissions.

Highly experienced in the practical applications of epidemiologic principles to pharmacovigilance, risk management, and market access. Experienced in rare disease epidemiology. Participant in a joint public health and military bioterrorism exercise; contributor to a bioweapons preparedness plan for state government; recognized expert in drug safety signal detection. Conceptualized a structured approach for facilitating the decision-making process for and evaluation of establishing an external (aka, “synthetic”) control for a pivotal clinical trial.

Holds advanced degrees in biology, public health and epidemiology. Trained in cancer epidemiology through the United States National Cancer Institute's Cancer Prevention & Control Pre-doctoral Fellowship program; and in infection surveillance, prevention and control through the National Center for Infectious Diseases, Hospital Infections Program at the US Centers for Disease Control and Prevention Control.