Bio: Dr. John Kapeghian is a board-certified toxicologist with 40 years of experience in preclinical safety. He obtained his Ph.D. in pharmacology/toxicology at the University of Mississippi, worked as a senior scientist, and lead the experimental toxicology group at Ciba Pharmaceuticals, now Novartis, before taking a position as Director of Operations and VP of Regulatory Consulting at Sierra Biomedical, a primate research facility in Nevada. Sierra then became Charles River Preclinical Services, where John started and ran the Navigator Advisory Services group.

John started his own consulting company in 2006, and has drafted several INDs, NDAs, and regulatory dossiers for multinational Pharma and Biotech companies. He also sponsored and conducted several Study Director training workshops for CROs and Pharma toxicologists. John joined Frontage Laboratories in 2023 as Executive VP of Global Safety & Toxicology while continuing to consult for numerous biotech clients.

Abstract: The Study Director is the single point of contact and control for nonclinical safety studies; however, circumstances often arise when a Study Director must 'think outside the box' to understand and assess the nature of a finding on their study. Key stakeholders like the Study Pathologist, Consultant, and Sponsor representative may hold essential information needed for the Study Director to determine whether an effect is indeed related to treatment with the test article, and if that finding represents an adverse change. Case studies highlighting the importance of pharmacology, chemical structure and class, as well as precedence in the literature as factors allowing the Study Director to better interpret study findings will be provided.