Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Shabnam Naseer, DO, MMS
Lead Physician
Division of Anti-Infectives (DAI)
Office of Infectious Diseases (OID)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr. Shabnam Naseer is a Lead Physician at FDA in the Division of Anti-Infectives (DAI). She received a Master’s in Medical Science from Drexel University and her Medical Degree at the Philadelphia College of Osteopathic Medicine in PA. She completed an Internal Medicine Residency at the Albert Einstein College of Medicine in NY and an Infectious Diseases Fellowship at the Georgetown University School of Medicine in Washington, DC. Prior to joining FDA in 2017, she provided Infectious Disease consultative services at University of Maryland for several years and served on the Infectious Disease Prevention and Pharmacy & Therapeutics Committees. As a Lead Physician in DAI, she provides clinical expertise on a multidisciplinary team and oversees a diverse application portfolio of products targeting a variety of infectious diseases. She is also an active member of many Agency committees.
Abstract
Shabnam Naseer’s presentation provides a comprehensive overview of safety considerations in clinical drug development, emphasizing that protection of subjects is the paramount priority in early clinical studies. She outlines the main objectives of Phase I trials, which focus on assessing safety and tolerability, characterizing dose-limiting reactions, and determining the maximum acceptable dose, often involving healthy volunteers. The discussion transitions from non-clinical studies to first-in-human trials, stressing the importance of evaluating animal data for sufficient evidence and recognizing both predictable and unpredictable toxicities. A core element is the determination of the Maximum Recommended Starting Dose (MRSD), derived from the No Observed Adverse Effect Level (NOAEL) in animals and a safety factor that accounts for human-animal variability. Naseer details essential aspects of conducting Phase I trials, such as appropriate protocol design, adequate observation periods, and cautious dose escalation. She highlights the necessity of robust safety monitoring, including clinical and laboratory assessments, and the implementation of clear stopping rules for observed toxicities. The presentation clarifies key regulatory definitions of Adverse Events (AEs), Serious Adverse Events (SAEs), unexpected events, and suspected adverse reactions. She explains that a Serious, Unexpected, Suspected Adverse Reaction (SUSAR) triggers expedited IND safety reports to the FDA, usually within 15 days, or 7 days if fatal or life-threatening. Ultimately, Naseer underscores the evolving nature of safety evaluation and the critical role of investigators in ensuring quality safety assessments and reporting throughout the drug development process.