Debra Aub Webster, PhD

Principal Scientist, Regulatory Affairs and Product Development

Debra Webster, PhD, is Principal Scientist, Regulatory Affairs and Product Development, for the Regulatory Sciences group of Cardinal Health Specialty Solutions. 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.

Role responsibilities

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.

Professional experience

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.

Therapeutic experience

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.

Education

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.

Areas of Expertise


Biologics

Nonclinical consulting services

Regulatory application and approval process

FDA interactions

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