Hong Yang
Group Leader: Office of Biostatistics and Pharmacovigilance/Division of Analytics and Benefit-Risk Assessment @ FDA - Center for Biologics Evaluation and Research
Silver Spring, Maryland, USA
Description:
Dr. Yang’s laboratory operates in the Division of Analytics and Benefit Risk Assessment (DABRA) within the FDA's Office of Biostatistics and Pharmacovigilance (OBPV), which is part of the Center for Biologics Evaluation and Research (CBER). Our primary objective is to advance the field of cancer immunotherapy through the development of computational, mathematical, and statistical tools.
Comprising a diverse team of scientists with varying backgrounds and interests, our lab leverages our collective expertise to enhance our research endeavors. By utilizing publicly available real-world data, we employ quantitative models that validate and simulate realistic scenarios of the human immune response to neoantigen cancer vaccines or CAR T cell therapy.
Collaboration is fundamental to our approach, and we actively engage with other colleagues at the FDA, including but not limited to clinicians, biologists, chemists, and bioinformaticians. By incorporating their invaluable insights and expertise, we ensure our modeling efforts align with the needs and requirements of the broader scientific community. Together, we strive to contribute to a better understanding of cancer immunotherapies and their implications for patient care.
General Overview:
The mission of the Center for Biologics Evaluation and Research (CBER), the FDA is to ensure the safety, purity, potency, and effectiveness of biological products, including vaccines, blood and blood products, cells, tissues, and gene therapies, for the prevention, diagnosis, and treatment of human diseases, conditions, or injury. The Yang lab focuses on developing computer modeling and simulation methodologies and tools. Our goal is to assist with the evaluation of the efficacy and safety of biological products and their overall benefit-risk assessment to inform the CBER regulatory decision-making process.