Robert M. Califf, MD, MACC, joined the U.S. Food and Drug Administration (FDA) in late February. Prior to this position, he served as the vice chancellor of clinical and translational research, director of Duke University’s Translational Medicine Institute and a professor of medicine in the Division of Cardiology at Duke’s Medical Center.

What kind of impact do you hope to have at the FDA in this position?

Robert M. Califf, MD, MACC

The FDA is an amazing place, one served by talented and dedicated people. It’s built on a system designed to make decisions that protect the health of Americans, but it also actively promotes health by working with patients, industry and academia to improve the ecosystem of technology development. Every week, the FDA makes hundreds of decisions that affect the well-being of American citizens and people around the world. My hope is that I can make a difference in several key areas.

First, I want to help the FDA team to work with Congress, patient groups and other stakeholders on pending legislation aimed at improving the environment for biomedical innovation in the U.S. We also have major user fee negotiations over the next two years involving the pharmaceutical and medical device industries. This process can lead to major innovations with the potential to advance the appropriate development and dissemination of evidence about drugs, biologics therapeutics and medical devices.

Second, I want to promote synergy across the FDA in dealing with key scientific themes that affect the whole organization. These themes cover a lot of ground: for instance, accelerating outcomes and endpoint measurement including biomarkers, surrogate endpoints, patient-reported and patient-derived data, and clinical outcomes. I am also committed to supporting efforts aimed at improving the generation of scientific evidence across a spectrum that encompasses preclinical systems biology, human phenotyping, efficient clinical trials, and “big data” drawn from “’real-world” environments and care settings. In addition, we need to consider patient-centered technology development, the globalization of biomedical research, and how scientific research interfaces with academia, other federal agencies and industry. These are broad categories, and significant work is already underway in all of these areas. My hope is that I will be able to further accelerate progress on these critical, cross-cutting issues.

How do you see your expertise in translational research and cardiology tying in to your work with the FDA?

Translational research is oriented toward developing scientific discovery into useful technologies. As such, it’s the cornerstone discipline for regulatory scientists. In many ways, I believe my work has enabled me to understand the key issues that must be dealt with if the translational research system is to operate on a scale capable of providing the kind of rapid progress that’s so urgently needed. The FDA not only facilitates good translational science, but also judges it when the time comes to determine whether the end product – a new technology or therapeutic approach – is ready for “prime time.” An inventor (or university or company) working in this space can benefit by consulting the FDA frequently throughout the translational cycle and by generating the kind of high-quality evidence that enables consumers and clinicians to be confident that a new technology provides a favorable balance of benefit versus risk when used appropriately.

What inspired you to move from clinical research in the academic setting to a policy-based leadership role?

I’ve always admired the work done by the FDA and have enjoyed the privilege of engaging in many policy discussions with key FDA leaders. The way in which the FDA deals fairly with individual applications concerning specific technologies and medical products is in my view outstanding and should serve as a model for other organizations. My hope is that I can contribute to small improvements that, because of the FDA’s central role in the larger system, will have a big impact on science, technology development, and, ultimately, human health.

From my perspective as a researcher, working to answer scientific questions through clinical research is a fun, interesting and immensely rewarding experience. But at the same time, I believe that many aspects of the current clinical research enterprise are suboptimal from both process and outcome perspectives. In my new role with the FDA, I will be working with colleagues from the FDA and other sister agencies within the U.S. Department of Health and Human Services to devise and implement policies that improve the system for everyone. When my work with the FDA is done, I will certainly return to clinical research and clinical practice – having the opportunity to care for patients and to improve the knowledge base that informs that care is a real privilege. 

What previous experiences have prepared you the most for this position?

Many years spent conducting clinical trials – whether they resulted in the approval and use of a new therapy, or showed that a promising therapy just doesn’t work – has entailed numerous interactions with the FDA. Working to develop the “cycle of quality” embodied by the ACC/American Heart Association clinical practice guidelines as well as quality measures and appropriate use criteria have allowed me to engage with the policy community and provided an excellent foundation for moving quickly into my current role. Decades of clinical work have given me insight into the effects of FDA decisions and policies “on the ground,” and I’m already finding that to be helpful. Finally, I hope that the opportunities I have had to learn from great mentors about organizational leadership and to interact with the highly connected global biomedical community have given me the insight that I need to do a good job.

What would you say are the biggest challenges facing you in this role as Deputy Commissioner?

These are the key challenges that I see: first, the FDA, which has a culture marked by an extraordinary dedication to fairness, must make decisions, and often these decisions make someone unhappy. This situation is unavoidable, but a good challenge for the FDA is to do a better job of explaining its deliberations in ways that allow its many constituents to understand the factors driving these decisions. Second, the FDA is at the fulcrum of a scientific revolution that is making it possible to seriously envision treatments and even cures for diseases in ways that were simply not possible in the past. The key scientific themes provide a framework to position the FDA as a reservoir of knowledge – one that provides guidance and insight to help industry, academia and patient groups take advantage of innovation and discovery to produce more effective drugs, medical devices and biologic therapeutics. Third, there is never enough time! I really believe that we are on the verge of a major acceleration in the arena of science applied to human well-being. We just need to figure out how to “connect the dots,” but this will involve a continuous evaluation of priorities. Fortunately, I have a great group of colleagues in FDA leadership to help identify where my energy would be best directed.

How has your ACC membership impacted the course of your career?

When a doctor or scientist chooses an area of focus or specialty, it behooves that person to get involved with the professional society serving that discipline. As I was growing in my profession as cardiologist, I found the ACC to be a natural home. Many of its leaders were role models for me and I was fortunate to be able to learn from them. Over the years, I’ve had the privilege of serving together with colleagues who represent key expertise in their respective subspecialties on many committees and special task forces, including those tasked with developing clinical practice guidelines. By focusing on its professional mission, the ACC can fulfill a pair of important roles: furthering the personal development of its members and advocating for policy decisions that benefit all Americans, as well as patients worldwide.

What advice would you give to other cardiovascular clinicians aspiring to influential leadership roles such as yours?

In my view, the key to being a truly great leader is having a trustworthy internal compass. It is sometimes easy to get swept up in career aspirations and lose sight of the reason for doing the job in the first place. Volunteering for leadership roles is important, but solid, competent, conscientious application to the tasks at hand is the best way to advance toward such a role. I also believe that it is helpful for people to read and attend educational sessions that teach positive leadership skills, including emotional intelligence, articulating concepts clearly in speech and writing, and learning to balance long-term and short-term goals when making decisions.

Please engage with the FDA and help us in the quest to protect and improve the health of Americans and the global community!

Keywords: Cardiology Magazine, ACC Publications, Advisory Committees, Biomarkers, Biological Products, Biomedical Research, Knowledge Bases, Leadership, Mentors, Systems Biology, Translational Medical Research, United States Food and Drug Administration

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