Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Ellen Areman, MS, SBB (ASCP) joined the Biologics Consulting Group, Inc., as a Senior Consultant in December 2005.

Ms. Areman comes to BCG from the Office of Cellular, Tissue and Gene Therapies at FDA/CBER. She joined the regulatory community in 2001 after 15 years of developing and managing cellular therapy laboratories in academic, government and clinical centers; and is considered one of the pioneers in the field of cellular processing and graft engineering.

In the years before she joined FDA, Ms. Areman collaborated with numerous clinical and laboratory scientists as well as biotechnology companies in the development of new techniques for the manipulation of bone marrow, peripheral blood stem cells, umbilical cord blood, and lymphocytes. She has been involved in many aspects of the development, production and quality control of cellular products, including the design and implementation of in vitro experiments and validation studies to support clinical trials.

Ms. Areman has published over 60 journal articles, book chapters and abstracts on such subjects as bone marrow and stem cell processing and transplantation, cell culture and expansion, immunotherapy, and cell cryopreservation and storage. She also edited the first cell-processing manual to be published, which is still used as a reference in many laboratories throughout the world. With her extensive knowledge of the cellular therapy field, she is frequently called upon to review manuscripts for peer-reviewed journals and she serves on the editorial board of Cytotherapy, the official journal of the International Society for Cell Therapy (ISCT).

During her tenure at CBER, as the primary reviewer of over 80 INDs, IDEs, and Master Files, Ms. Areman was able to use her extensive scientific and regulatory background to identify important safety and manufacturing issues specifically related to cellular therapies, especially in the areas of umbilical cord blood banking and cellular treatments for cardiac disease. She also participated in CBER internal working groups such as the Hematopoietic Stem Cell Task Group, Rapid Microbiological Methods Working Group, and the CBER/CDRH Cardiovascular Product Cross-Center Team; all dedicated to the development of policies for appropriate regulation and review of cellular therapies and related products. She has been involved in the development of guidance documents and regulations to address scientific and regulatory issues related to the characterization, manufacture and quality control of hematopoietic and other cellular products for repair and regeneration of human tissues. In addition to intra-agency activities, she also served as FDA Liaison to the DHHS Interagency Working Group for Cellular Therapies and co-chaired the CBER/NHLBI Cell Therapy Working Group for interagency discussions of regulatory-related issues regarding cell-based therapies.

Ms. Areman received her Masters Degree in Experimental Pathology from Georgetown University and her Specialist in Blood Banking (SBB) certification from the National Institutes of Health.

With her diverse experience in the research, clinical use and regulation of cellular therapies and related products, Ms. Areman will provide BCG with the opportunity to provide further valuable assistance to its clients.

View Ms. Areman's Curriculum Vitae...

Page Updated June 16, 2008