Associate Director, Regulatory Affairs Lead
UCB Biopharma
Tyler Vandivort, PhD, RAC, DABT - Associate Director, Regulatory Lead at UCB Biopharma - Cincinnati, OH
Tyler Vandivort, PhD, RAC-Drugs, DABT is a board-certified toxicologist and regulatory affairs professional. He currently serves as an AD, Regulatory Lead at UCB Biopharma where he focuses on the development of novel biologics for rare and/or pediatric autoinflammatory diseases. He previously served as Director of Regulatory Affairs at Amplicore, Inc., a clinical stage, biopharmaceutical start-up company in Cincinnati, OH that seeks to develop combination therapeutics to serve unmet medical needs for musculoskeletal disorders. Prior to this, he functioned as a nonclinical regulatory consultant at Medpace (a clinical stage CRO), and as an Immunotoxicology Research Scientist at Charles River Laboratories, designing, validating and executing immunological assays (flow cytometry, cell culture, ADA, biomarkers, etc) for use in GLP compliant, pivotal phase toxicology studies. Tyler’s PhD/postdoctoral work as an NIH Training Grant recipient at the University of Washington and Cedars-Sinai Medical Center focused on the role of extracellular matrix proteins in the acute and chronic immune response to sterile and non-sterile injury.
In addition to being a frequent host for the RAPS Preparing to Take the RAC-Drugs Exam and other workshops, Tyler has authored various articles and chapters in the fields of both toxicology and requlatory affairs. In 2023, Tyler contributed chapters to RAPS' Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective text. Tyler is also active with several mentoring organizations, including the Pathway for Patient Health micro-credential program in Quality, and with City Tutors, an NYC-based organization that provides resources for individuals that have historically faced barriers in entering academic and professional careers in science. He joined the University of Cincinnati's Masters of Science in Drug Development (MSDD) program as an Adjunct Assistant Professor in 2023.
Failure Is Not An Option: How to Avoid and Recover From an IND Clinical Hold
Wednesday, September 18, 2024
4:30 PM – 5:30 PM PDT
Health Authority Forum: CBER - FDA’s Center for Biologics Evaluation and Research (CBER)
Thursday, September 19, 2024
3:15 PM – 4:15 PM PDT