Meet Mary Ellen Cosenza, PhD, MS ’08, president of MEC Regulatory & Toxicology Consulting LLC and recipient of the Regulatory Science Award at the 2024 USC Mann Alumni Awards Gala. During a 20-year tenure at Amgen, she led its U.S. Regulatory Department and International Emerging Markets Regulatory Department and was an executive director of global regulatory affairs and safety. She also served as Amgen’s senior director of toxicology.
In a few sentences, please describe your career trajectory, including your current work. What are you most proud of in your career so far?
As a trained toxicologist in the biopharmaceutical industry, I worked closely with regulatory colleagues, presented to regulatory agencies and worked on ICH regulatory guidance (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). I eventually moved to the Regulatory Affairs department at Amgen and led several different departments over the years, from an early development-focused group to leading the U.S. Regulatory Department. I am probably most proud of my role as the head of the Emerging Markets Regulatory organization. In this role, I traveled and met with colleagues and regulatory agencies in many developing countries and was able to advocate for advancing regulatory science in these countries.
What originally attracted you to your field? Any particular moment(s) that made you stop and think, “This is the path I want to take?”
I was attracted to toxicology as a field of study in drug development because I was always interested in how better to assess safety risks in patients and special populations. My early research was in developmental toxicity, and I focused on the effects of drugs on the developing fetus. This is an area that still needs more attention.
How did your early experiences as a student at USC guide your career?
I came to USC as a working student who wanted to learn more about the field I was already working in. The availability of graduate programs in Regulatory Science greatly benefits the industry. I often hired students from the program even years after I graduated.
What advice do you have for students who may be interested in following a similar path to yours?
You are never too old to “go back to school”. Learning is a lifelong adventure.
What does the phrase “Trojan Family” mean to you?
The Trojan spirit permeates all aspects of the various programs (undergraduate and graduate) at USC. I am proud to teach in undergraduate and graduate programs now at USC Mann.
Tickets for the 2024 USC Mann Alumni Awards Gala can be purchased by clicking here. For more information, visit the event website or contact Cheryl Stanovich, chief development officer, at firstname.lastname@example.org.