Lawrence Callahan

Chemist at FDA, USA

Speaker

Dr. Lawrence Callahan obtained his Ph.D. in Chemistry from the University of Chicago. He was previously employed at NIH and the United States Pharmacopiea (USP). He has been involved in Nucleic Acid, HIV, and tuberculosis research and was responsible for the development of analytical methods for biotechnology-derived products and numerous USP monographs. Dr. Callahan was also responsible for the management and development of chemical/biological databases for the National Institute of Allergy and Infectious Disease (NIAID), National Library of Medicine (NLM), and National Cancer Institute (NCI).

Dr. Callahan is currently responsible for the development and management of the Global Substance Registration System (GSRS). The goal of the GSRS is to define all substances in FDA regulated products, assign a Unique Ingredient Identifier (UNII) and create meaningful relationships between substances. The GSRS also links substances to products, applications, clinical trials and adverse events. The GSRS is a collaborative effort between NIH’s National Center for Advancing Translational Sciences (NCATS) and foreign regulatory authorities.

Drs. Callahan, Dr. Frank Switzer and Dr. Herman Diederik were the primary editors of the ISO 11238 Standard for defining substances in medicinal products. Dr. Callahan is also the FDA lead on the Global Ingredient Archival System (GInAS) project, which attempts to integrate regulatory, toxicological, and clinical information on all substances in medicinal products.