It seems Daniela Drago has seen the regulatory profession from nearly every angle. She currently heads up the regulatory affairs program at The George Washington University’s School of Medicine and Health Sciences, in Washington, DC. Before entering academia, she spent two decades in various corporate regulatory affairs positions for both pharmaceutical and medical device companies. She has worked internationally and is recognized as an expert on global regulatory affairs, and she currently serves as the chair of the RAPS DC/Baltimore Chapter. She holds a PhD in chemistry and the RAC credential.
I recently had the opportunity to interview Daniela as part of our new Regulatory Focus series called ‘Focus on…’ where we talk with regulatory leaders, thinkers and influencers from a variety of backgrounds. The purpose of the series is not only to hear from these accomplished professionals on a range of regulatory-related topics—learning from their experience and insight—but also to get to know a little about them as people. Daniela shares her perspective on preparing students for today’s regulatory challenges, talks about a personality trait that has helped her succeed in her career and tells us about some bad career advice to just ignore. Following is an edited transcript of our interview.
What prompted you to make the move to academia after years working in the pharmaceutical and medical device industries?
I was at a time in my career where I wanted a new challenge. Rather than looking for a new corporate job, I considered how I could best combine my passion, talent and experience. I found out about a position as head of the graduate programs in regulatory affairs at George Washington University’s School of Medicine and Health Sciences. The job description called for a senior, experienced regulatory professional with a doctoral degree. I applied for the position and was hired. I was excited by the opportunity to transition from a subject matter expert to educator and contribute to the education of the next generation of regulatory leaders.
What was the biggest adjustment for you when made the career transition?
Faculty members today are expected to excel in research, teaching and service. Having been away from academia for several years, it has been challenging and exciting to find the time to generate original research, write articles, teach classes, submit grant proposals and serve the university—and the broader community—by being a member of committees and boards.
Academic writing is a skill that must be acquired and practiced regularly to be successful. It not only requires the generation of novel ideas but also the ability to advocate for those ideas and express their limitations. The career path that I have taken has been full of new and varied opportunities. It has required adaptability, resilience and persistence. I feel fortunate that I have had the chance to be exposed to clinical research, learn about the drug discovery and development process, perform both basic and applied research, and teach at both the undergraduate and graduate levels. The knowledge and experiences I have gained from working in academia and private industry have given me a unique perspective on research and science, and have been instrumental in enabling me to be a skilled regulatory professional, a knowledgeable scientist and an effective educator.
Which skills did you find were most transferable from industry to academia?
I employ time- and project-management skills to meet the rigorous and varied demands on faculty. I create case studies that motivate students to work together, conduct research and develop solutions for real-world problems that the industry is currently facing. Additionally, I am able to use the professional connections that I made during my 20-year career to recruit FDA and industry experts to serve as adjunct faculty and guest speakers for our classes.
What is the most important skill for a regulatory professional to develop, and why?
I believe it is adaptability. In the past, traditional business approaches assumed that the world would be relatively stable and predictable. However, in recent years, globalization, new technologies and greater transparency have transformed the business environment. In a new paradigm of risk and uncertainty, more regulatory professionals are gaining a competitive advantage by adapting to new situations and learning to integrate new technologies. Companies that want to survive must innovate constantly. Their employees need to be flexible and acquire new skills quickly. The regulatory professionals who will thrive in this new environment are those who are quick to anticipate and act on subtle signals that indicate a need for change. They should have the necessary skills to manage complex multi-stakeholder systems in an increasingly interconnected world. In addition, and perhaps most importantly, they need to capitalize on their greatest resource: the people they work with.
How do you as an educator best prepare your students to meet the real-world demands of regulatory affairs jobs?
To meet today’s expectations and the needs of employers in the life-science field, as well as those of students and future professionals, I include innovative, experimental and error-tolerant modes of engagement in my courses. I believe that knowledge develops through cooperative inquiry within a community of practice. I construct case studies that require students to work collaboratively to solve problems. For example, I create scenarios in which students discuss and achieve consensus on the development of a regulatory strategy plan. In addition, I use FDA warning letters as examples to let students propose a corrective and preventive action (CAPA) plan. This provides students opportunities to solve problems similar to those they would encounter every day as regulatory professionals. A scenario-based teaching strategy not only links theory with practice, but also provides concrete tools and techniques that students can use in their daily jobs. I also encourage other faculty in my program to use teaching methods that ensure students are highly engaged and learning useful information. I believe that every student who takes a regulatory affairs class at GW should be exposed to the “four Cs”: critical thinking, communication, collaboration and creativity.
What is the worst career advice you have ever heard?
‘Increase your connections. Meet more and more people. It is simply a numbers game.’ I disagree. I believe that networking for the sole purpose of collecting a large number of business cards is a waste of time. I believe that 10 strong connections that one regularly keeps in touch with are often more useful than a network of 100 acquaintances that one lacks the time to email, talk to or see. I advise professionals to choose the people they connect with carefully and take the necessary time to nurture the relationships with them. They can do this by sending relevant articles, providing introductions, and sharing job leads and other resources.
The role of a regulatory professional is complex and not well understood by a lot of people outside the profession. How do you explain it to someone unfamiliar with the regulatory world?
Regulatory affairs is a relatively new field. It was developed from the desire of governments to protect the public health by controlling the quality, safety and efficacy of healthcare products. The companies responsible for the discovery, testing, manufacturing and marketing of these products employ regulatory professionals who play a pivotal role. These individuals use the principles of science, law and business to ensure that patients and consumers have quality products that are safe and effective. I have been in this field for many years and can attest that the responsibilities of regulatory professionals often start in the research and development phases, and extend through premarket approvals, manufacturing, testing, labeling, advertising and postmarket surveillance. Today more than ever, the development and application of regulatory affairs requires a well-educated, scientifically engaged and motivated workforce.
What do you see as the greatest challenge facing the regulatory profession right now?
The main challenges facing the regulatory profession are the changes in the relationships with their key stakeholders, the attraction and retention of talent, and the need to continually innovate. As mentioned earlier, companies today are operating in a new environment with different requirements. Top executives expect that regulatory professionals will have an expansive mindset around business. They no longer want regulatory professionals who serve as narrowly focused technicians providing strict interpretations of the regulatory requirements. Rather, they want regulatory professionals who serve as multidimensional experts and are able to view situations in terms of the needs of the business and support business development initiatives. To do this, regulatory professionals need to stay current on the application of regulatory requirements, and have additional tools and training in the areas of business, project management, technology and data analysis.
Who has most influenced the direction of your life and career and how?
Undoubtedly, the most influential person was my father. When I was young, he demonstrated a thirst for knowledge by reading and discussing many diverse topics. Later, he taught me the importance of a strong work ethic. He did not do so by talking about it, but by truly living it and being a role model for me to emulate. His belief that individuals can do great things has always inspired me. I also had the good fortune to have a creative and energetic chemistry teacher in high school. She taught me the importance of being well rounded and showed me the beauty underlying the world of STEM.
What piques your curiosity?
I am a very curious individual—about everything—all of the time. I have more questions than anyone can answer or even consider. Overall, I believe this is a trait that has served me well. I discovered at an early age that being genuinely curious and having a broad range of interests is important in cultivating and maintaining relationships. At times it is even more important than being interesting. Curiosity drives interest. I also know that I don't have all the answers, and I can learn from each person that I meet and each experience I have.
What is something you are passionate about other than work or family?
I enjoy traveling. I have visited more than 50 countries on five continents. I believe the exposure to new places and new people gives me a new perspective. The opportunity to talk to people and experience a little bit of life in other cultures can be truly humbling. When I travel, I leave my comfort zone and the experience leads to curiosity, maturity and growth.