Dr. Paul Ciaccio is a pharmaceutical toxicologist in ToxStrategies’ Biopharmaceuticals and Pharmaceuticals Practice. With 25 years of experience, he has a broad knowledge base in investigative, molecular, and regulatory toxicology and has worked on cross-disciplinary teams to support progression from early discovery through prenomination for both small molecules and monoclonal antibodies and first-in-human (FIH) milestones for small molecules. His early development experience includes being a co-author of INDs/CTAs, IBs, and IMPDs in the immune-oncology space. His investigative and discovery experience extends to leading efforts on novel high-content assay development & screening, gene expression profiling for mechanistic annotation and biomarker discovery, and contributing to prenomination milestone documents and discovery toxicology guidance documents to support risk management, decision making and toxicologist mentoring. Dr. Ciaccio has led or supported toxicology discovery advisory fora, exploratory discovery project teams in the hunt for novel targets and programs, and toxicity problem-solving teams in both discovery and development.
Dr. Ciaccio has expertise in multiple disease areas, including neuroscience, pain control, microbial infection, and oncology. Given his background in various aspects of the toxicology discipline, he has a strong customer focus on developing and implementing diverse nonclinical safety testing strategies and mitigation work plans. Working for multiple global-level pharmaceuticals producers, Dr. Ciaccio has in his career served in various roles, as Scientist, to Principal Scientist, to Senior Principal Scientist (equivalent to Senior Director).