Webinars

Dan Mellon, PhD, Deputy Director, Division of Pharmacology/Toxicology for Neuroscience, Office of New Drugs, CDER, US FDA

Dr. Dan Mellon obtained his BS in biology from Allegheny College in Meadville, PA, his PhD in Pharmacology from Georgetown University, and completed post-doctoral research at the National Cancer Institute prior to joining the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND). He began his career at FDA as a Pharmacology Toxicology Reviewer in the Division of Anesthetics, Critical Care, and Addiction Drug Products in the fall of 2001. In August of 2003, Dr. Mellon was promoted to the Pharmacology Toxicology Supervisor in that division, which has subsequently been renamed the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP). He is currently the Deputy Director for the Division of Pharmacology Toxicology for Neuroscience. He is the supervisory co-chair of the OND Extractable & Leachables Subcommittee and has been a member of the ICH Q3E Expert Working Group since June of 2022.

Silvia H. De Paoli, PhD, Biological Reviewer, Office of Blood Research and Review (OBRR), CBER, US FDA

Dr. Silvia H. De Paoli is a Biological Reviewer in FDA’s Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR). She brings 14 years of regulatory review experience and over 20 years in research, specializing in nanomaterial toxicology, blood-product safety assessment, and CMC regulatory science. Dr. De Paoli earned a PhD in Chemistry from the University of São Paulo (2001) and completed pharmacology coursework at Cleveland State University. She trains new FDA reviewers across CBER and CDER, teaching nonclinical pharmacokinetics/toxicokinetics (CDER) and biocompatibility and toxicological risk assessment in medical devices (CBER). Her regulatory portfolio spans drugs and devices across multiple product categories, and she currently serves as Deputy Topic Lead for ICH Q3E, contributing to international harmonization of pharmaceutical quality standards.

With 45 peer-reviewed publications, Dr. De Paoli has advanced understanding of nanomaterial interactions with human blood components—particularly platelet activation, endothelial cell toxicity, and protein-corona effects—and has investigated subvisible particles, toxicity-screening assays, and cellular mechanisms of nanomaterial-induced toxicity. She has received 15 FDA awards, including the Scientific Achievement Award and multiple team excellence awards for CMC and toxicology review work, and serves as an ad hoc reviewer for journals such as ACS Nano, Nanomedicine, Biomaterials, and Toxicology Letters. At FDA, she integrates toxicological research expertise with CMC review practice to evaluate complex products for safety and manufacturing quality, advancing regulatory science in support of public health.

Tynisha D. Glover, PhD, Distinguished Scientist II, Nonclinical Safety Therapeutic Area Lead for Oncology and Cell Therapy Leader for Nonclinical Safety, Johnson & Johnson

Dr. Tynisha Glover is a Distinguished Scientist II, Nonclinical Safety Therapeutic Area Lead for Oncology and Cell Therapy Leader for Nonclinical Safety. In her role, she provides nonclinical safety leadership for the nonclinical safety aspects of the CAR-T cell and biologics oncology portfolio in discovery and development primarily in the multiple myeloma, lymphoma/leukemia and prostate disease areas.  Additionally, she interfaces with worldwide regulatory agencies and represents Johnson & Johnson on professional cross-industry initiatives, including but not limited to, a member of the leadership team of the CAR-T consortium and Co-chair of BIO’s Cell and Gene Therapy task force and an active member of the Society of Toxicology.