James Signorovitch

Managing Principal
James Signorovitch
Boston

Education

Ph.D., biostatistics, Harvard University; B.A., biology, Cornell University

Summary of Experience

Dr. Signorovitch partners with life sciences companies to strengthen regulatory and commercial success through evidence that informs clinical, regulatory, and economic decision making. He has extensive experience designing and implementing evidence strategies across the product lifecycle, from early clinical development through regulatory submissions, launch, technology appraisals, and post-approval settings. Dr. Signorovitch’s practice spans clinical study design, external control development, natural history studies, surrogate endpoint validation, and the generation of regulatory-grade real-world evidence (RWE) to support new product approvals and label expansions across therapeutic areas. He supports sponsors in their engagements with regulators, including the US Food and Drug Administration (FDA) and the European Medicines Agency, to align on evidence design and interpretation. Dr. Signorovitch has expertise in addressing evidentiary challenges in rare and ultra-rare diseases and in cell and gene therapies, where innovative approaches are often critical to advancing new treatments.

Dr. Signorovitch serves on program committees and advisory boards for investigational and post-market studies and advises sponsors and investors on diligence and critical evaluation of clinical programs. He collaborates with patient advocacy organizations to advance understanding of disease natural history and endpoints that support more effective clinical programs, more robust regulatory evaluation, and meaningful patient benefits. His research has been published in more than 200 peer-reviewed articles and has informed decisions by regulators, clinical authorities, and health care payers in the US and internationally. Prior to joining Analysis Group, Dr. Signorovitch was a research fellow at the Harvard–MIT Division of Health Sciences and Technology.

James Signorovitch
Practices