Aspesi has held positions as Global Head of Quality for Aventis and Wyeth Pharmaceuticals and led the Wyeth Pharmaceuticals Global Regulatory Affairs Chemistry and Control organization. In addition to the United States, he has worked in South Africa, United Kingdom, Germany, France, and Italy. He has led up to 5,000 people and been part of executive management teams at Aventis, Wyeth, and Novartis.
He has been active in external industry initiatives for many years. He engaged with the US Food and Drug Administration (FDA) on process analytical technology (PAT) and the initiative “Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach.” He’s been recognized by the US FDA as an industry leader for the implementation of PAT and manufacturing science approaches.
How did your career journey unfold?
I graduated from the University of Milan in Italy with a degree in organic chemistry. I stayed at the university as an assistant professor and was working on research about compounds or molecules to fight obesity. After four years there, I joined a pharmaceutical company that later, through three mergers and acquisitions, became Sanofi. My passion has been always to help provide new and proper treatments to patients.
What projects are you most proud of?
There are many projects I’ve worked on that I am proud of but a few that stand out include building a greenfield pharmaceutical manufacturing plant in South Africa, being part of the team that built a $2 billion plant in Frankfurt, Germany, to produce the first recombinant DNA human insulin, and, on the compliance side, one of the companies I worked for had a major issue with European health authorities. I led 500 people in 5 different countries to file 3,200 marketing authorization variations to bring 5 plants back to compliance.
I’m also proud of the mentoring I’ve done. Until recently, I worked with Dr. Tony Moreira with the University of Maryland, Baltimore County; Purdue University; and the University of California, Davis, to provide students with opportunities and new courses taught by industry experts to help prepare the students to join the pharmaceutical industry and navigate the work world.
What advice do you give students?
Some might find this advice shocking, but one thing I think is particularly important for emerging leaders to be, is to be humble enough to learn as much as possible, both about technical issues and people management. Continuing education and knowledge improvement is very important. You have to build your soft skills and be willing to challenge yourself or change when needed.
How do you benefit from volunteering with ISPE?
I serve as Chair of the Pharmaceutical Engineering Committee (PEC) where our goals are to ensure the committee has international representation and that major industry topics, especially from a manufacturing standpoint, are considered.
When you are in a certain position of responsibility, you need to have a basic understanding of the technical issues your company might face because you are going to make decisions that could impact the company at the level of billions of dollars. Pharmaceutical Engineering, for me, has always been a reference to understanding what else was going on in the pharmaceutical engineering industry. It gave me the chance to read articles that were pertinent to what I was doing, which helped me better understand certain issues. I have always seen the magazine as a positive tool for my job.
ISPE is a great place for networking and personal advancement. When emerging leaders ask, “How can I improve myself?” I tell them to become a member of ISPE. There, you’ll find anything you want: more insights into your job, the industry, science, and technology as well as a great people network.
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