George Mills, M.D., has joined the Perceptive Informatics division of Parexel International. His new title: vice president, medical imaging consulting. He’s previously had several positions at FDA, including division director of medical imaging and hematology products.

Here’s the official quote welcoming Mills to the company:

“George is a leading, highly respected medical imaging expert who uniquely combines in-depth scientific knowledge with more than 13 years of regulatory agency experience. We expect him to make tremendous contributions in guiding our clients’ use of imaging results for earlier and more effective go/no-go decision making. We believe his guidance and direction will be invaluable to clients in designing clinical trials and supporting regulatory submissions, as well as in using imaging techniques to help demonstrate evidence of safety and efficacy for their products,” said Mark A. Goldberg, M.D., president of clinical research services and Perceptive Informatics at Parexel.

ClinPage recently had the opportunity to chat with Mills, and it’s clear he was basically present at the inception of the FDA’s review of images, which dates to the early 1990s. He can recall the days when every image was reviewed individually, perhaps arriving from a sponsor on a 3.5 inch floppy disk. It doesn’t sound like all those discs in those days were fully readable, to be honest.

Terabytes of Image Data

Today, Mills reports, the FDA is receiving image-intensive submissions on a monthly basis, and some contain terabytes of data. He estimates that the use of imaging may have cut years off the timelines for some drugs in oncology. “Imaging has played a vital role in two approved products for non-Hodgkin’s lymphoma,” Mills notes.

He doesn’t have a dollar figure for imaging in industry-sponsored clinical trials. But he does see it growing. He sees imaging as being important in both no/no-go decisions and, later in the development process, for identifying new surrogate endpoints.

Over time, he says, the industry’s use of independent interpretations of all those CT scans, X-rays and other images will grow. “By the late 1990s,” he reports, “it became obvious that Parexel/Perceptive were doing an excellent job of the independent reads. It became obvious to us that we had to spend more time looking at the output from the independent reads.”

Mills was also involved in helping to formulate the Critical Path research agenda, but notes that imaging’s ascendance in regulatory terms predates that initiative. “The momentum and the activity has had a long term development. It’s become focused with the Critical Path Initiative, but it was well on its way before that time.”

Sight Training

The issue of genuinely standardized methodologies for clinical trials is complex. But even prior to joining the company, Mills thought Perceptive/Parexel understood not only how to generate the images, but also how to review and archive them in the manner appropriate to a regulated environment—not just the general clinical practice. “Parexel has a very efficient model to train and maintain standardization at the clinical site,” says Mills.

He sees his new employer as being able to extend the use of imaging across the globe. “We’re going to have an international capacity and a platform that will be effective to bringing submissions back to the agency or back to other regulatory bodies,” he says.

Perceptive and Parexel understand, he says, that imaging can’t be considered purely a technology or a service. It’s a blend. And as the use of imaging expands into new therapeutic areas, Mills suggests it may be closely integrated not only into therapeutics but diagnostics as well.