A unique feature of the Advanced Therapeutics Department is its Investigational Drug Program. The mandate of this program is to expedite the development of promising new therapeutic agents to the stage where they can be tested in clinical trials. This development process must be conducted in accordance with specific regulatory guidelines of the Health Boards of Canada and the United States. A team has been established whose focus is to conduct the pharmaceutical formulation, manufacturing and pre-clinical testing activities required for permission to initiate clinical trials and to ensure that Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations are being met.  As part of this program, we have a pharmaceutical clean room facility that can prepare parenteral drug products under GMP for use in Phase I and Phase II clinical trials.  This facility, as well as the Investigational Drug Program in general, holds an establishment license as a production and testing facility for pharmaceutical agents.  As such, we are well situated to work with academic researchers and pharmaceutical companies to bring new anticancer agents into the clinic in a timely and cost-effective manner based on sound scientific investigation.