Stephen T. Colgan

Meet Stephen T. Colgan

Pivotal moment
“I am very proud of my work with the Analytical and Pharmaceutical Quality Executive Team (APQ ET) of the AAPS. The delivery of safe and efficacious medicines in a global environment is greatly facilitated when companies work with each other, and with regulatory authorities. As part of the APQ ET, I was able to identify individuals with similar interests and passions and then work with them on common goals. With the help of many colleagues in the community of stability scientists, global regulatory guidance and practices have (and continue) to evolve, which is great news for our patients.”

Change
“I would like to see better global alignment of regulatory guidance and more consistent application of guidance by regulators. Global regulators and the pharmaceutical industry share the common goal of providing safe, efficacious, and constantly improving medicines to patients. Divergent guidance does nothing to improve patient safety and can result in delayed access to new medicines for patients. By better leveraging science- and risk-based approaches to drug development and manufacture, patients across the world would see a big change in timely access to medicines.”