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  5. Celia Cruz, Ph.D. - Transcript
  1. Regulatory Science in Action

Celia Cruz, Ph.D. - Transcript

Enabling innovation by focusing on increasing drug product quality and availability

Dr. Cruz: At one point in my career, I had the choice to continue in industry or think about what does regulatory agency do and what are the things you can learn there that you really can’t learn anywhere else in the world. So I decided to join the FDA about seven years ago and learn the concept of review, inspections, and policy development for products.

Text Slide:

Celia Cruz, Ph.D.

Director, Division of Product Quality Research

Office of Pharmaceutical Quality

Office of Testing and Research

Dr. Cruz: So the goal of our research is called regulatory science, which is understanding what the challenges would be in the future in terms of regulating certain technologies. So it’s not our goal to develop our own medicines, it’s to understand what is needed to ensure the quality of medicines made by this technology in this future.

It is a very important national priority that we try to modernize the pharmaceutical industry so that we can solve issues such as supply of drugs, reduce drug shortages and recalls. And we think that one of the ways to do this is to modernize the equipment, the methods, and the approaches to making medicines in the future.

So we’re trying to enable innovation by focusing on things that will make product quality higher and drug products more available to the American public. And we think the best ways to do that is to enable manufacturing science innovation, such as things like 3D printing which will allow us to make different types of dosage forms. Continuous manufacturing, which will help us make product faster and more readily accessible, and advanced analytics we will be able to detect product quality issues in a faster and more accurate way. So to us those are three ways that we can improve the adoption of innovation in the pharmaceutical industry.

One of the important parts of our mission is to be ready for what comes up next. So for example in our laboratories we make a great effort to buy the pieces of equipment that represent what might be out in industry, so we can have state of the art facilities. And also understanding the methodologies that are coming up. So we stay alert in terms of readiness for new technologies by collaborating with academia and supporting things such as research that goes on in industry.

Industry can come to the FDA and talk about any new emerging technology that they’re interested in adopting and get early feedback from the FDA in terms of what are the potential things that they can work on to make this more easily adoptable in the pharmaceutical industry.

One of the concepts is that innovation and regulatory agencies sometimes don’t go hand in hand, but actually regulatory agencies can do a lot in terms of adopting innovation.

I find the job extremely rewarding and it’s very few places that you can do science and policy in the same place. So to me this is one of the most rewarding jobs I’ve ever had, and I hope to have it for a long time.

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