Debra Webster, PhD, is Principal Scientist, Regulatory Affairs and Product Development for Cardinal Health Regulatory Sciences. She began her regulatory career at FDA and has more than 25 years of experience in drug development, focusing on nonclinical toxicology and proof-of-concept.
Dr. Webster is responsible for providing nonclinical and regulatory consulting services to guide products from pre-Investigational New Drug (pre-IND) application interactions with the FDA to New Drug Application (NDA) and Biological License Application (BLA) approval.
Prior to joining Cardinal Health, Dr. Webster was a medical and regulatory writer at Quintiles, where she authored clinical study reports and nonclinical sections of INDs. Previously, she was in private practice, where she authored summaries of nonclinical data to support due diligence and regulatory submissions. Dr. Webster worked for FDA in the Center for Food Safety and Nutrition, where she evaluated color and food additive petitions. Subsequently, she was a pharmacology/toxicology reviewer in the FDA Division of Antiviral Drugs in the Center for Drug Evaluation and Research, where she received the Commissioner Frank E Young Appreciation recognition for her role in the approval of Foscarnet.
Dr. Webster has provided support for the development of abuse-deterrent opioids, acquired immune deficiency syndrome, Alzheimer’s disease, antivirals, biologics and biosimilars, cell therapy, cell therapy/device combination, Crohn’s disease, diabetes, Graft versus Host Disease, seasonal allergy and medical device diagnostics.
Dr. Webster received a doctorate degree in pharmacology and toxicology at Virginia Commonwealth University, Medical College of Virginia. She received a bachelor’s degree in biology from Virginia Polytechnic and State University, where she graduated with honors and worked as a research associate in the anaerobic microbiology laboratory.