NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Ellen M. Areman, MS

Practice Area Focus

  • Regulatory Strategy
  • Regulatory Submissions
  • CMC
  • CMC Compliance
  • Biologics
  • Cell Therapy
  • Stem Cell Biology

Biography

Ms. Areman joined NDA Partners as an Expert consultant in 2015. She is an expert biologist with experience in the development of biological products, especially hematopoietic, immunologic, and stem cell therapies.

During her career at the FDA Center for Biologics Evaluation and Research (CBER), she was an Expert Biologist and Product Reviewer in the Office of Cellular, Tissue and Gene Therapy (OCTGT). She also served as the Co-Chair of the Cord Blood Standards subgroup of the CBER Hematopoietic Stem Cell Task Group and the FDA-CBER/NIH-NHLBI Cell Therapy Working Group.

Ms. Areman was formerly the coordinator of the cell processing section of the NIH's Clinical Center Department of Transfusion Medicine, and has worked as the laboratory manager for both the Georgetown University / NHLBI (COBLT) Cord Blood Bank and Pediatric Cancer and Stem Cell Research Program, as well as Technical Director of Georgetown's Cellular Engineering/Molecular and Cellular Hematotherapy Laboratory.

She is a member of several professional societies and has published extensively on biological products.