Q: What role does WorldCare Clinical play in the FDA’s approval process?
A: At WorldCare Clinical, we specialize in advancing the clinical testing and drug development process, allowing for trials that are consistent with FDA guidelines and reduce R&D costs. Our adaptive and flexible trial design is based on a ‘learn and confirm’ model where mid-study results are proven as the trial progresses. These results can be used to modify or cancel an ongoing study, and decrease the chances of multiple submittals to the FDA (which is extremely important, since multiple trial submittals may increase regulatory scrutiny of the study). Without compromising the scientific method, we empower the trial sponsor to deploy scientific study modification points that can either be performed frequently (in a sequential design) or at other predetermined intervals. Using this method, our sponsors complete trials faster and without compromising on the quality and safety of the drug.
Q: How do you ensure mid-trial modifications to design don’t have a negative impact?
A: Mid-trial modifications will only have a negative impact if they are not executed properly. As a results-oriented imaging CRO, our expertise in portfolio management has given us years of experience in the drug and testing approval process. WorldCare Clinical has a quality assurance program that is backed up by an objective assessment of independent radiologists that includes the scan’s original integrity and transfer. So prior to the actual conduction of the trial, the imaging equipment has already been verified and calibrated to meet our demanding standards. On top of that, WCC never over-writes image files, and so maintains transparency and documentation for FDA review.
What this means for our sponsors is that our thoroughness in image acquisition and storage gives them the liberty to evaluate the study results in real-time and make decisions regarding the study design without upsetting the validity of the final result.
Q: What are some of the barriers imaging CROs face?
A: Although imaging CROs like WorldCare Clinical have become the crucial lynchpin between healthcare professionals and regulatory bodies, there is still a lot of work that we have to do on the front end to guarantee our studies’ validity. Phase 1 of our process is all about getting greater consistency in imaging equipment. We have emplaced calibration procedures to promise consistency across multiple imaging devices, between images taken from the same device, and images taken across long periods of time. We also use customized computational algorithms that are continually updated for the evaluation and validation of three-dimensional scans.
This rigorous standardization and validation process for images is important to us because it is the basis of all research to come from a study. For example, a Phase III medical imaging study may include 1,000 patients at 100 different clinical sites. With such disperse data to collect, a strict adherence to study protocols for calibration of imaging equipment is necessary. That is why we develop an image acquisition protocol, which is part of our image preparation and submission guide, before the study begins.
John Tomera is responsible for the management of all quality assurance and regulatory affairs operations at WCC, including ensuring adherence to all FDA and other regulatory authority requirements. He also provides medical expertise to WCC project teams and acts as liaison to WCC's network of medical consultants at Massachusetts General Hospital and the University of Chicago Medical Center.
Prior to joining WCC, he served as director of regulatory affairs at Biopure Corporation in Cambridge, clinical development director of oncology agents at Point Therapeutics, and manager of statistical quality assurance at Biogen Idec. His pre-WCC experience also includes five drug/biologic approvals across a variety of therapeutic areas. Tomera holds a doctorate in pharmacology from Temple University School of Medicine, and a B.S. from the University of Pittsburgh. He has also held postdoctoral posts at the Harvard School of Public Health and at the Massachusetts Institute of Technology (MIT). Subsequently, he held a faculty position as an assistant professor of anaesthesiology (pharmacology) at Harvard Medical School, with appointments in the Anesthesia Services at the Massachusetts General Hospital and Shriners Burns Institute in Boston. He is author of 60 published articles over a variety of world-class journals.
