Individual Leadership Project – Jennifer Sloan
ILP Project Client:
Pfizer, the world’s largest research-based pharmaceutical company
ILP Project Title:
Individual Leadership Project (ILP) on the development of a Quality by Design (QbD) filing approach for Alzheimer’s disease drug
Develop a QbD approach for filing a new Alzheimer’s disease drug for regulatory approval
Jennifer Sloan, MSEM ’12, Senior Quality Assurance Manager, Pfizer:
“Pfizer has been working to bring a new drug for Alzheimer’s disease to market. My Individual Leadership Project (ILP) focused on developing a strategy for implementing a Quality by Design (QbD) approach for commercial licensure of this product. QbD is a relatively new approach to product and process quality that is being adopted by the U.S. Food and Drug Administration (FDA) and by the European Medicines Agency (EMA). The goal of this project was for Pfizer to file a commercial product license with FDA using this novel filing strategy for a complex biologic drug.
I was excited about this project because it would allow me to reach beyond my typical role and responsibilities, and to work with a diverse group of colleagues around the globe. It would also allow me to gain valuable regulatory experience with various boards of health and to showcase my abilities to senior management. The project brought me into the world of Quality by Design (QbD), which includes definition of design space using mathematical models developed through Design of Experiments (DOE) studies. Thanks to the DOE course in my MSEM program, I was not a fish out of water with this topic as I would have been prior to my studies.
I’m proud to say Pfizer was one of the first companies to pilot the process for a commercial product license with the FDA using a QbD approach for a complex biologic drug. Global quality forums were held to discuss QbD principles and practices and their impact to our investigation and change control programs. Soon after I completed my ILP, I was promoted. This project was a stretch goal for someone at my level in the company. I had to prepare a presentation and speak with my manager and my manager’s manager about why I was the right person to work on this project. Ultimately, I was selected over someone one layer of management above me who was looking to serve the same role. My ILP gave me the confidence to go after what I want in the workplace, rather than wait for it to come to me.”
Patricia Parker, Quality Operations Leader, Pfizer Biotech and Jen’s ILP Sponsor:
“Jen’s ILP established the groundwork at Pfizer for the QbD approach to regulatory filing. She conducted several learning sessions at various levels of the organization, including for Pfizer’s broad Quality Assurance group, to cross-pollinate her findings from this project throughout the company. We expect to gain great efficiencies by using the QbD approach.
Jen has developed into and is recognized as a subject matter expert in QbD, and she is a resource for the Pfizer Quality Assurance organization. Completing the MSEM program strengthened her already strong skills a great deal. I anticipate her career at Pfizer will progress quickly.”