Drug Supply Manager
As a Drug Supply Manager, Gary Scott oversees every step of the manufacturing process of medicines used in Clinical Trials. After a PhD and several postdoctoral placements, Gary began work as a Chemist in Drug Discovery. “I was involved in that for about 3-4 years,” he says, “That kind of ran its course, and then I moved more into project management. I was always associated with the drug development office and then the project management side of things. With my chemistry background I was chosen to head up this drug supply role to manage more effectively the way we deliver and produce drugs for our Clinical Trials.
“In the last 2-3 years I’ve been receiving a lot of training in Good Manufacturing Practice and what’s required to take drugs into Clinical Trials, from development of a synthetic process to controlling that process and ensuring that the final drug that goes into patients meets all the regulatory requirements.” Good Manufacturing Practice provides a framework through regulations and guidelines that must be followed to ensure that every batch of a medicine is uniform and made to the highest levels of quality, safety and efficacy.
While Gary arranging the manufacture of experimental medicines in Clinical Trials, he also works with the trial team to coordinate their supply. “My role within the drug development office is sitting in an interface between what’s required from a European Good Manufacturing Practice point of view to an interface with the Good Clinical Practice side, making sure we have drug available for all our clinical trials that we have,” says Gary.
His principal responsibility is to work with manufacturing organisations such as the Cancer Research UK Formulation Unit to ensure continuity of drug supply to the clinical trials that are recruiting patients. This involves working closely with the Qualified Persons (QPs) at the manufacturing organisation who release the drug to the clinic. The QPs certify that the drug has been manufactured to the appropriate regulatory requirements and specifications.
Gary enjoys his work, especially, “…the varied nature of the interactions with all the different projects that we have and we have such a broad portfolio of different drugs that we work on, that range from some cell products, gene therapy studies, through to small molecules. I guess everyone has got his own interesting challenge, and it’s having all those different projects and different challenges that keeps things interesting.”