Name: Martha A. Brumfield, PhD
Current Position: President & CEO, Critical Path Institute
Martha A. Brumfield, PhD, heads the Arizona-based non-profit in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science by leading teams that share data, knowledge, and expertise resulting in sound, consensus-based science. She is also a professor of the University of Arizona’s College of Pharmacy.
Brumfield brings 20 years’ experience from Pfizer Inc. most recently as senior vice president of worldwide regulatory affairs and quality assurance. Brumfield also managed broader company relationships with global regulators, trade associations, academics, and others on regulatory policy issues, and served on corporate governance initiatives.
She recently served as chair of the RAPS board of directors and has served on Institute of Medicine consensus committees focusing on global regulatory systems and on falsified and substandard drugs.
Brumfield earned a BS and an MS in chemistry from Virginia Commonwealth University, a PhD in organic chemistry from the University of Maryland, and served as a post-doctoral fellow at the Rockefeller University.
Did you always know you wanted to be a regulatory professional? If not, at what point did you realize this was the career choice for you?
I always wanted a career in the sciences or medicine, but throughout my education the exact path I wanted to take kept evolving. I pursed a PhD in organic photochemistry, but decided I was more interested in a career with a high amount of variety in types of projects which can move at a faster pace. The first time I heard of the regulatory affairs profession was during my post doctoral work at the Rockefeller University. I loved the sound of the job description. An opportunity for me opened at a small New York City-based biotech which produced diagnostic kits for viral pathogens, and I took it.
The industry revealed itself to me as a fascinating nexus of all aspects of a product’s life. I enjoyed how my regulatory work kept me on the cutting edge of science, translating that science into the regulatory space and real world application. With collaboration at a premium, I had to rapidly come to understand the needs of all aspects of the business, including manufacturing, marketing, and clinical application, in addition to the regulatory requirements.
In addition to professional enrichment, the job of a regulatory professional is personally fulfilling. While our work may be separated from the clinics and doctors’ offices where the products we support are used, in the back of every regulatory professional’s mind is the knowledge that the work helps people live healthier lives. Every step of the way, we are fighting for patients.
Did your educational background set you up for success or did you pursue special training to better equip you for work in the field?
Training in a scientific discipline was valuable in preparing me for my profession. An understanding of the scientific process, capturing and interpreting data, familiarity with a peer review process, and experience with scientific writing and documentation were all skills necessary to succeed in the job.
However, the biggest gap in my training was business acumen. When I started my first job, I had no idea how different departments in a company fit together or how to navigate the corporate landscape to make constructive contributions. My first boss was an incredible mentor, and helped me develop these skills. I was able to observe her methods, and work toward implementing them myself, while also learning the regulatory processes as that was also a new area for me.
Based on my experience, I believe that incoming regulatory professionals should have both soft skills and scientific training to be set up for success. Regulatory roles touch many different areas and professionals must know how to facilitate dialogue across disciplines. At my first job, I gained experience in all components of product development, and gained a perspective for the challenges and concerns in multiple disciplines. When I moved to much-larger Pfizer, that experience allowed me to communicate more effectively. Early career professionals need to find a way to be exposed to broader perspectives than just regulatory affairs if they are to be successful.
Once in the profession, were there any key decisions that helped you advance your career?
I was very fortunate to land in roles with amazing mentors who gave me many opportunities, but with each opportunity I had to choose whether I was willing to take on more responsibility or not. My thirst to learn led me to grab any opportunity offered, despite the additional work it entailed. One opportunity early in my career was when I was asked to take on responsibility for a new therapeutic area. I knew anti-infectives well but neuroscience was a completely different beast. While it was intimidating to need to learn about this new therapeutic area, I also quickly realized how transferable regulatory skills are. I believe 80% of regulatory skills are transferable to new product lines and new therapeutic areas. Only 20% seem to be specific, and they are easily learned.
When it came time for me to take on a managerial role, I was motivated by how much greater my contribution could be. The title was less important to me, it was another growth opportunity. Again, there was a learning curve. I worked to develop my management skills and was challenged to keep my employees productive and advancing in their careers and learned that I enjoyed that challenge.
A few years later, an opportunity arose for me to move out of regulatory and into safety & pharmacovigilance. This was a huge opportunity, but I was unsure that I wanted to steer my career away from regulatory affairs. However, upon reflection I realized my only regrets had been for opportunities I had not taken, so, I decided to take the plunge. My world immediately expanded. Not only did I now have responsibility for 300 employees, but I also gained a much deeper understanding of why continuous monitoring of safety is so critical and why much diligence and expertise is required to assess the data. When I eventually moved back into a regulatory line, I was able to take that expanded knowledge and use it to improve my approach to regulatory processes.
After moving into more executive leadership roles, the challenges became more focused on setting strategic direction and assuring those strategies can be implemented. With each transition along my career path I continued to learn and become much more effective as a leader and as a regulatory professional. I would not have advanced this far if I hadn’t pushed myself to embrace each opportunity.
What does being a member of the regulatory profession mean to you?
I absolutely love this profession for so many reasons. To be proficient, regulatory professionals cannot wear blinders. We must understand all aspects of the medical product development process, and develop strong relationships within our companies and with the regulatory agencies’ staff. It is important to appreciate and understand the differences in culture, medical practices, and regulations in all countries, and to incorporate these into developing regulatory strategies for product development.
The profession allows us to advocate for smarter regulatory policies over time both within companies and with regulatory agencies. We must strike the balance between our influence in companies to ensure products meet regulatory standards, but also to inform regulators on advances in science and technology. To successfully navigate the space, we must maintain our integrity at all times and always assure trust is at the forefront of our interactions. While the job can often make you feel like you are in a tornado, with scientific issues, benefit/risk assessments, and economic factors whirling around wildly, regulatory professionals must stay steady and strong to get the best result for the patients who use our products. Over time, we can find ways to help the entire system evolve for the better.
Do you have any advice for someone looking to follow a similar career path?
It took 13 years of education after high school for me to find regulatory affairs. There were no courses one could take at that time but today there are courses on regulatory affairs that one can take to see if it will be a good fit. I also suggest talking to those in the profession about not only what they do but why they do the job. For most of us, it is important to know our work contributes to improving our world, and working to assure the safety and effectiveness of medical products is certainly a worthwhile cause.
Once you’re in the profession, don’t be afraid of hard work and taking leaps. That’s how you grow. Read voraciously about as many topics as you can. That’s how you learn. Always be open to new ideas and pathways. You never know where they might lead.
Are you interested in sharing your regulatory career path? Email Austen Gage for more information!