Laurie Graham, PhD Food and Drug Administration

Ms. Graham joined the Division of Monoclonal Antibodies (DMA) at the FDA in 1993 as a full time research biologist investigating the response of immune cells to perturbation by physiological ligands or pharmaceutical agents, such as monoclonal antibodies. In 2003, Ms. Graham became a staff scientist at the FDA assuming both research and regulatory review responsibilities. The regulatory review responsibilities included reviewing the chemistry, manufacturing, and control (quality) information in regulatory submissions for monoclonal antibodies, novel antibody products, and Fc-fusion proteins. In 2007, Ms. Graham assumed full time CMC/product quality review responsibilities and became a CMC/product quality team leader in 2013. Ms. Graham's responsibilities were focused on immuno-modulatory antibody products. Ms. Graham also provided expertise in, among other things, biosimilars, quality by design (QbD), immunogenicity assay validation, and inspectional activities.

Currently, Ms. Graham is in the Office of Pharmaceutical Quality (OPQ), Office of Policy for Pharmaceutical Quality (OPPQ) at CDER. Ms. Graham is the Acting Director of the Division of Internal Policies and Programs (DIPAP), which leads the development and evaluation of OPQ internal policy documents.