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European Pharmaceutical Contractor

Future Functions

It is nearly 20 years since the first commercial imaging core laboratory was founded. Today, there are numerous commercial imaging core laboratories, numerous international imaging biomarker meetings and regulatory guidance documents to support the use of imaging in drug development. Many academic, government and commercial entities have contributed to the growth of this approach, which has become a mainstream tool for the development of numerous therapeutic drugs.

Medical imaging endpoints are accepted in many clinical trials, and when included in the study design, the FDA requires the implementation of a central, independent image review process. The proliferation of medical imaging endpoints and the resulting management, analysis and submission of medical imaging data has fostered the healthy growth of the medical imaging core lab industry, both for commercial and academic labs. The increase in the number of labs and studies for which they provide services led to a somewhat varied set of documentation and implementation of various technology methods for what is a largely consistent undertaking. Pharmaceutical trial sponsors and the FDA initiated the desire for standardisation in these trials, and DIA has provided the leadership needed to obtain collaboration from all affected parties.


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James Conklin is the Senior Vice President for medical and scientific affairs at ICON Medical Imaging. James is a John Hopkins-trained research physician with undergraduate and graduate training in electrical/computer engineering and a Masters degree in Management. He has been a Professor of Radiology at several medical schools, published over 100 scientific papers and edited four books. One of the textbooks, Imaging Techniques in Biology and Medicine, published by Academic Press in 1987, provided the technical foundation for Bio-Imaging Technologies, Inc. He is board certified in both internal medicine and nuclear medicine.
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James Conklin
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