Q: What are the regulatory agencies saying about quantification and imaging?
A: FDA has stated that it plans on approving imaging techniques as biomarkers, but that the approval process will require adequate standardization. I feel the team at WCC has a good understanding of these quality steps and can provide some insight into the process.
Q: If the FDA does approve specific imaging techniques as biomarkers, will it be hard for companies to comply with the requirements for standardization?
A: Yes, it will be difficult and require strong quality programs with extensive validation, including periodic analysis of phantom data.
Q: In what therapeutic areas of imaging do you think quantification is important in?
A: It has long played a pivotal role in clinical trials of oncolytics. Over the last few years, we have been involved in a number of Multiple Sclerosis (MS) trials where lesion burden, as assessed by brain MRI, has been demonstrated to correlate with disease recurrence and treatment response.
Q: Are there new therapeutic areas where quantification is expected to have a major role in the near future?
A: Yes, one of the most exciting areas is in Alzheimer’s disease. The imaging in Alzheimer’s patients is very complex, but it can be critical for selecting patients, determining drug efficacy and assessing drug safety. Three different imaging assessments are used in these patients (i.e., 1) Fluorodeoxyglucose positron emission tomography (FDG-PET), 2) Amyloid PET imaging and 3) morphometric analysis of Magnetic Resonance Imaging (MRI). The first two require extensive work with radioactive phantoms and the latter requires longitudinal evaluations of 3D quantification of small brain volumes. This is where our strategic relationship with the Dept. of Radiology at MGH is essential. In collaboration with MGH, we are able to offer these analyses.
An accomplished radiologist with specific knowledge in 3D imaging quantification analysis and expertise in oncology image assessment of clinical imaging studies, Dr. Ma develops cost-effective imaging analysis solutions that increase the precision and accuracy of imaging interpretation. Prior to joining WCC, Dr. Ma worked as an imaging fellow at the Tumor Imaging Metrics Core, a central core lab funded by Dana-Farber/Harvard Cancer Center and 3D Imaging Lab at Massachusetts General Hospital Imaging. He also held a fellowship position at Massachusetts General Hospital Imaging’s Abdominal Imaging and Interventional Radiology. Previous to his fellowships, Dr. Ma was a resident radiologist at the Department of Radiology, Peking University People's Hospital. He holds a medical degree in clinical medicine from the Capital University of Medical Sciences in Beijing, China and a RDMS Certificate from the American Registry for Diagnostic Medical Sonography.
