Benjamin J. Del Tito, Jr., PhD

Benjamin J. Del Tito, Jr., PhD

Senior Consultant

Benjamin J. Del Tito, Jr., Ph.D. joined Biologics Consulting in March 2015 as a Senior Consultant (Quality & Regulatory Affairs) with thirty-plus years of experience in both large pharmaceutical and small to mid-sized biotechnology companies specializing in a range of products from protein therapeutics to vaccines to diagnostics. His career has focused on the areas of analytical development, quality control, pre-clinical assay development and validation, quality assurance, and regulatory affairs. He is knowledgeable in global drug development (Phase I-IV), IND, IMPD, NDA, and BLA submissions, regulatory interactions, and regulatory inspections for both US and Europe/UK. He has extensive experience in building teams of development and quality professionals for phases of drug development including early development, clinical manufacturing, licensure, and commercial manufacturing.

Ben previously served as Executive Vice President of Regulatory Affairs and Project Management, where he oversaw the Regulatory Affairs and Project Management departments for Auxilium Pharmaceuticals, Inc. (now Endo Pharmaceuticals), a specialty biopharmaceutical company. Prior to March 2010, Ben served as Senior Vice President of Quality and Regulatory Affairs for Auxilium. Prior to Auxilium, Ben served as Vice President, Analytical and QC Operations at Neose Technologies, Inc., a biotech company that developed second-generation therapeutic proteins using proprietary enzymatic technology for post-expression modifications. Prior to Neose, he served as Senior Director, QC Operations at MedImmune Vaccines, Inc. (formerly Aviron, Inc.), a wholly owned subsidiary of MedImmune, Inc. (now part of Astra Zeneca), a biopharmaceutical company with several commercial products for infectious diseases. Prior to joining MedImmune, Ben was Director of Biotechnology and Microbiology at AAI, Inc. He has also held positions at North American Vaccine, Inc., SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline), and Centocor, Inc. (now Johnson & Johnson)

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.

As a Senior Consultant for Quality & Regulatory Affairs at Biologics Consulting, Ben will utilize his broad technical and regulatory expertise to assist clients in the following areas:

  • Short and long term regulatory strategy for vaccines, biopharmaceuticals and pharmaceutical products
  • Assisting clients with strategy and development of preclinical testing and other clinical and commercial product development issues
  • Assisting clients in interactions with FDA and other health authorities including regulatory inspections
  • Assisting clients in preparing for FDA and other health authority meetings
  • Preparing and assisting in the preparation of INDs, BLAs, NDAs, and ANDAs
  • Providing clients with a comprehensive review of submissions, investigations, and deviations

Education

PhD, Molecular Biology, Lehigh University, Bethlehem, PA (1995)

MS, Biochemistry, Western Kentucky University, Bowling Green, KY (1980)

BA, Biology, Millersville University, Millersville, PA (1977)