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

Blair Fraser, Ph.D., joined Biologics Consulting Group, Inc., as a Senior Consultant in January, 2009. Dr. Fraser is a biochemist (Ph.D., The Pennsylvania State University) who brings 30 years of experience with the U.S. Food and Drug Administration (FDA) in both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). 

Until recently Director, Division of Pre-Marketing Assessment I, Dr. Fraser joined CDER, in 2004, as Deputy Director, Division of New Drug Chemistry II. In 2005, Dr. Fraser served as Chief, Branch 2, Office of New Drug Quality Assessment, prior to becoming Director in 2006. During this tenure, he engaged in the full range of CMC scientific and regulatory endeavors from review to policy.

Previously, Dr. Fraser served as Chief, Chemical Biology Laboratory, Division of Cytokine Biology, from 1993 until 1999, then as Division Director (Acting). In the Division of Therapeutic Proteins, he served as Chief, Laboratory of Chemistry, combining research and regulation. During the 1990s, Dr. Fraser evaluated many new biotechnology products during development and licensing, participating both as a reviewer and an inspector.

In 1978, Dr. Fraser joined the Division of Bacterial Products, Bureau of Biologics, FDA, investigating the bacterial polysaccharides used in human vaccines. Over the next five years, Dr. Fraser established a research laboratory and became Chief, Chemical Biology Laboratory, Division of Biochemistry and Biophysics, CBER. During these early years of the biotechnology revolution, Dr. Fraser participated in many key venues that led the regulation of biologics and biotechnology products.

Prior to joining the FDA, Dr. Fraser was a Staff Fellow, NIAID, NIH, and a Research Associate, The Rockefeller University.

As a Senior Consultant with Biologics Consulting Group, Inc., Dr. Fraser will utilize his professional and regulatory experience in development of drugs, biologics, and vaccines by:

• Advising clients in overall strategy and development of biologic products, biotechnology products, combination products, and drugs
• Advising clients about regulatory projects involving chemistry, manufacturing, and controls (CMC) for biologics, biotechnology products, and drugs
• Assisting clients with technical development, preparation, and evaluation of regulatory submissions, specifically by planning, preparing, and reviewing CMC technical sections of pre-IND, IND, End-of Phase 2, NDA, and BLA documents
• Providing clients with review of CMC submissions to ensure that drug development strategies and regulatory submissions are appropriate for that stage of development  and conform to policies, regulations, and available guidance
• Providing insight and direction to clients in understanding and resolving scientific and regulatory issues pertaining to complex drug substances, complex drug products, combination products, quality systems, and inspections

View Dr. Fraser's Curriculum Vitae...

Page Updated January 14, 2009