Dr. Benjamin J. Del Tito, Jr.
Biologics Consulting Group, Inc.
Dr. Del Tito joined Biologics Consulting, as a Senior Consultant (Quality & Regulatory Affairs) on March 2, 2015. He’s had thirty-plus years of experience in both large pharmaceutical and small to mid-sized biotechnology companies specializing in products such as protein therapeutics, vaccines and monoclonals. His career has focused on the areas of analytical development, quality control, bioanalytical assays, quality assurance, and regulatory affairs. He is knowledgeable in global drug development (Phases I-IV), IND, IMPD, NDA, and BLA submissions, regulatory interactions, and regulatory inspections for US, Canada, Latin America and Europe/UK.
Ben previously served as Executive Vice President of Regulatory Affairs and Project Management, where he oversaw both departments for Auxilium Pharmaceuticals, Inc. (now Endo Pharmaceuticals). He earned a BA in Biology from Millersville University, an MS in Biochemistry from Western Kentucky University, and a PhD in Molecular Biology from Lehigh University.