"Ernie brings to Dendreon over two decades of experience in clinical and commercial grade biopharmaceutical manufacturing ranging from bulk production to final fill and finish operations for a broad range of biotech products," said Andy Scherer, vice president of manufacturing. "We're so pleased to have someone with his background and expertise managing our facility as we complete the build-out of the site and prepare for the pre-BLA inspection by the FDA and commercial production of PROVENGE."
PROVENGE has Fast Track designation and the Company plans to begin submitting its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) on a rolling basis by the middle of this year. The company will apply for Priority Review upon completion of its BLA submission later this year.
Bognar recently served as vice president of manufacturing at Apptec Laboratory Services where he was brought on board to manage and grow a mammalian cell-based contract manufacturing business unit. Prior to that, he was senior director commercial manufacturing for ImClone Systems Inc., where he managed a biopharmaceutical startup operation that produced the company's monoclonal antibody, ERBITUX (cetuximab) Injection for the treatment of colorectal cancer. Previously, he served as director of operations at Baxter Healthcare's Hyland-Immuno Division where he managed a commercial biopharmaceutical operation producing a licensed recombinant protein for the treatment of hemophilia. Bognar also held key manufacturing positions at Cellex Biocences & Verax, Charles River Biotech & KC Biological and Ayerst Research Laboratories.
He received his Bachelor's of Science degree in in vitro cell biology from the State University of New York of Arts and Sciences at Plattsburgh and his Cell Biology Certificate from W. Alton Jones Cell Science Center in Lake Placid, N.Y.
