IA thanks Regulatory Affairs Community Chair Linda Bowen, who has stepped down after more than a decade of service to this DIA Community.

“I started in the biopharmaceutical industry in 1983 in the laboratory (as many people do), then moved to various roles in quality assurance. I moved into regulatory affairs in 1993, so I have been in regulatory for 30 years, and am currently Chief of Staff and lead the Centers of Regulatory Excellence at Seagen, Inc., a medium-sized oncology biotech company,” Linda explains.

What aspects of regulatory affairs improved the most during her career?

“The idea of specialized functions within regulatory, and the move from paper to electronic means of gathering information,” she begins. “Harmonization efforts such as ICH and the growth of ICH to include countries we once considered ‘emerging markets.’ Incorporation of the patient voice. User-fee agreements and their accompanying legislation. New technologies, designations, pathways, and incentives which expedite both development and approval times. Health authority collaborations such as the Access Consortium and Project Orbis. Ensuring that our trials include diverse populations, and ensuring the transparency of health authority information. I’ve seen so much positive change.”

As Linda moves toward new horizons, what does she view as the biggest unmet need in this field?

“We must keep up with evolving changes and, depending on your role, these may include multiple regions and therapeutic areas,” Linda explains. “As the information highway has expanded the material available to us, we must ensure that the ability to locate, analyze, interpret, and integrate that information is part of the regulatory professional’s toolbox. As an adjunct assistant professor in Temple University’s RAQA (Regulatory Affairs and Quality Assurance) Program, my focus has been on helping students sharpen their critical thinking and problem-solving skills. If I were planning to return to school, I would focus on data science, because I have seen the utility of analytics to assist us in regulatory decision making and trend analysis.

“I have had the opportunity to participate in so many interesting projects during my career. But I’m most proud of the time spent educating and mentoring future regulatory professionals, because I know I’ve left the profession in good hands.”

Brooke Casselberry (NNIT) and Peter Terbeek (Astellas) will serve as community co-chairs and representatives on the Community Leadership Council.