A recording of the Scientific Liaison Coalition (SLC) webinar, Biomarker Utility and Acceptance in Drug Development and Clinical Trials: An FDA Regulatory Perspective, is now available. This is the first of three SLC webinars discussing issues related to the types of biomarkers, their use, and some of the challenges that lie ahead.
Shashi Amur, PhD, Scientific Lead of the Biomarker Qualification Program in the Office of Translational Sciences, Center for Drug and Evaluation Research (CDER), US Food and Drug Administration ( FDA), and
Christopher L. Leptak, MD, PhD, Biomarker and Companion Diagnostics Lead for the Office of New Drugs within CDER/FDA and Co-Director of the Biomarker Qualification Program
The objectives of this webinar are to: (1) define the different types of biomarkers and how they may be used in drug development programs, (2) describe the different pathways that can lead to regulatory acceptance, (3) provide examples of biomarkers accepted into drug development through IND/NDA/BLA submissions, (4) offer specifics about the qualification program pathway including the history that includes qualification of nonclinical safety biomarkers, (5) update of the qualification status, (6) share some best practices to consider when developing a biomarker for regulatory use, and (7) provide information regarding opportunities for engagement with the FDA if you are considering developing a biomarker for regulatory use.
Dr. Amur's current research interests include biomarkers in Autoimmune Diseases and in Alzheimer’s disease, drug-induced liver toxicity, pharmacogenomics, and HLA-associated adverse events. She is Past Chair of the Pharmacogenomics Focus Group, American Association of Pharmaceutical Scientists.
The focus of Dr. Leptak's work is on biomarker development and diagnostic device utility in clinical trials and drug development, both for drug-specific programs as well as qualification. He is charged with identifying policy, process, and regulatory science needs within the codevelopment space and is involved in multiple inter-office and inter-center working groups to address those needs.
Click HERE to view recorded webinar.
The Teratology Society is a member of the SLC whose mission is “improving the ability of societies to partner with other domestic and international organizations that have objectives consistent with the goal of increasing the impact of the science of toxicology to improve public health” by:
- Strengthening partnerships among scientific- and health-based organizations to increase awareness of the impact of toxicology and related subjects on human health; and
- Functioning as a means to enhance cooperation among societies as equals with the goal of accomplishing tasks benefitting human health and disease prevention through joint and several shared activities.