Richard Pazdur, M.D., is the director of the FDA’s Oncology Center of Excellence (OCE), established in 2017 to leverage the combined skills of the FDA’s regulatory scientists and reviewers with expertise in drugs, biologics, and devices to expedite the development of novel cancer products.

The FDA Office of Global Policy and Strategy recently spoke to Dr. Pazdur about his extensive international efforts to advance oncology product development.

I understand you have worked at the FDA for 25 years. Is it fair to say that over the course of your career here that you have become increasingly interested in international outreach? How has your thinking evolved, and why?

When I began my career in the late 1970s, most oncology trials were performed exclusively in the United States. Over the past 45 years, more trials were done in Europe, and now we're seeing an increasing number of trials conducted partially or solely in Asia. I always had an interest in how drugs are developed outside of the United States. Before I came to the agency, I was a clinical investigator and did a lot of work with international drug companies. Over the years at the FDA, I became aware that oncology trials were increasingly conducted globally. I decided that the FDA needed to assume leadership and encourage a dialogue with global regulatory agencies. We began the concept of “cluster calls” where multiple regulatory agencies could speak freely about ongoing applications. To enable this interaction about specific applications, all agencies had signed confidentiality agreements. The thought was that this dialogue would facilitate an understanding of potential differences in our regulatory decision-making. These cluster calls began with the European Medicines Agency (EMA) and later expanded to Canada, Australia, Switzerland, and Japan. The purpose was not to achieve consensus but to understand our differences and why they exist.

You established Project Orbis six years ago to further expand the scope of the FDA’s international oncology work. It has grown in prominence since then. What is Project Orbis? Why was it needed, and has it been successful? 

Well, first of all, the success of Project Orbis is well documented and goes beyond my expectations. The program emanated from our oncology cluster calls with the EMA and other agencies. During these calls, we noticed that the most important drug applications were filed first in the United States.

The smaller regulatory authorities, including Canada and Australia, would experience a lag in the receipt of applications. This filing delay could extend for several months, several years, or sometimes the agencies never received an application. This posed a pragmatic problem. In initiating oncology trials, we want control arms to be the contemporary standard of care in the United States. However, if the standard of care is not uniform across countries, global trials may not be feasible using the most recent treatment that is approved in the United States.

Click to read more of this interview