E.J. Brandreth
Sr. Vice President of Quality and Regulatory
Mr. Brandreth brings over twenty years of experience in the regulatory and quality assurance fields in the biotechnology and pharmaceutical industries. He has managed numerous agency inspections and CMC submissions, and led the Process Validation Programs for five CBER/EMEA product launches, including Aldurazyme® , Naglazyme®, Zevalin®, and CBER’s first approved monoclonal antibody for cancer, Rituxan®. Prior to joining Althea Technologies he was Vice President of Quality at Favrille, Inc., specializing in personalized immunoglobulin therapies. Previous to Favrille, Mr. Brandreth was Senior Director of QA at BioMarin Pharmaceuticals, Inc. where he supported a variety of clinical drugs and the successful commercial launches of two CBER/EMEA products. He held management positions in Quality and Regulatory Affairs at IDEC Pharmaceuticals from 1992-1999. In the PDA Mr. Brandreth is currently the Chairman of the Biotech Advisory Board, an author of PDA TR 42, Process Validation of Protein Manufacturing, and was the Co-Chair of PDA TR 14, Validation of Chromatography Based Systems. He also serves on the BIOCOM FDA Advisory Board, the Interphex Advisory Board, and was a Director for 10 years, President of ISPE, San Diego Chapter. He holds a BS in Biology, UCSD, and a Masters in Business Administration