The USC School of Pharmacy awarded the Doctor of Regulatory Science, abbreviated as DRSc, to Martin Solberg, Michael Jamieson and Susan Bain at the USC commencement ceremony on May 13, an international first.
This professional doctorate is a novel, specialized program of study that cultivates research, leadership and inquiry skills in advanced students pursuing the emerging profession of global regulatory science. The curriculum focuses on product lifestyle strategy, project and personnel management, and global regulatory strategy and policy.
According to professor Frances Richmond, who directs the regulatory science program, all students are required to visit regulatory agencies and leaders in both Europe and Asia as part of the curriculum. To Martin Solberg, one of this year’s graduates, this offered a very extraordinary opportunity.
As vice president for global regulatory affairs at Genzyme Corporation in Cambridge Massachusetts, Solberg oversees regulatory issues in some 185 countries where his company does business.
“While you can’t be an expert in every country, this program provides a framework through which to analyze a situation and put the pieces together allowing you to effectively function in any country and to move projects forward,” notes Solberg.
Solberg also noted the advantages of visiting regulatory agencies in Europe and Asia as part of his academic work. While he has had meetings with these agencies many times over the course of his industry work, he found the experience of visiting as an academic pursuit more informative and candid.
Given the global nature of today’s marketplace and the attendant international travel that comes with that, it might seem baffling that professionals working in this area are able to find time to pursue a professional doctorate. But like Solberg, Susan Bain, vice president of operations at SpineWorks, a medical device company in Huntington Beach, agrees that the program is of great value to a working professional. Bain is also a former FDA investigator.
“When you work at a start-up company, you need a ‘soup to nuts’ toolkit to navigate through licensing, regulatory, quality, manufacturing and clinical trials,” says Bain. “The doctoral program provided me access to the necessary tools and gave me unique insights into the international marketplace.”
Echoing his classmates, Michael Jamieson, who has worked in a variety of industry roles for nearly 30 years, found that the program offered him a distinctive opportunity to enhance his career. With broad global experience, Jamieson has provided regulatory consulting services to companies throughout North and South America and Europe.
During the course of his career, he confronted hurdles with taking university-based technologies to market and this challenge motivated him to study it in his dissertation entitled “Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views”. Given his real-world experience, his dissertation provides a resource for both university tech transfer offices and industry when navigating academia-industry relationships.
In addition to the three doctoral degrees awarded at this year’s commencement, the regulatory science program also conferred 23 MS in regulatory science degrees. The School also offers PharmD students an opportunity to pursue a dual PharmD/MS in Regulatory Science dual degree. More information about the School of Pharmacy Regulatory Science Program is available at https://mann.usc.edu/programs/rs/.